36C25626Q0812_RFQ.pdf

Combined Synopsis/Solicitation Notice

*= Required Field Combined Synopsis/Solicitation Notice

SUBJECT* RFQ - SDVOSB - Medtronic G3 Generator / Symplicity Spyral Catheters

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 77056-5643

SOLICITATION NUMBER* 36C25626Q0812

PUBLISH DATE/TIME/ZONE 05-21-2026 11:30am CENTRAL TIME, CHICAGO, USA QUESTION DATE/TIME/ZONE 05-28-2026 1:00pm CENTRAL TIME, CHICAGO, USA RESPONSE DATE/TIME/ZONE 06-02-2026 1:00pm CENTRAL TIME, CHICAGO, USA

ARCHIVE 2 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

SET-ASIDE SDVOSBC

PRODUCT SERVICE CODE* 6515

NAICS CODE* 339112

CONTRACTING OFFICE ADDRESS Department of Veterans Affairs

Network Contracting Office 16 Galleria Financial Center 5075 Westheimer Road, Suite 750 Houston TX 77056-5643

POINT OF CONTACT*

Contracting Officer Shasta Britt shasta.britt@va.gov

PLACE OF PERFORMANCE

ADDRESS Department of Veterans Affairs Michael E. DeBakey VA Medical Center

MEDVAMC

2002 Holcombe Blvd.

Houston Texas

POSTAL CODE 77030-4211

COUNTRY USA

ADDITIONAL INFORMATION

AGENCY’S URL https://www.va.gov URL DESCRIPTION Department of Veterans Affairs AGENCY CONTACT’S EMAIL ADDRESS shasta.britt@va.gov EMAIL DESCRIPTION 36C25626Q0812-RFQ Response-Vendor Name mailto:shasta.britt@va.gov https://www.va.gov/ mailto:shasta.britt@va.gov

DESCRIPTION

This is a Combined Synopsis/Solicitation (CSS) issued in accordance with FAR Part 12 and

FAR Part 13 procedures for the acquisition of commercial items. The Department of Veterans

Affairs, Network Contracting Office (NCO 16), is seeking quotes from verified Service-Disabled

Veteran-Owned Small Businesses (SDVOSBs). This announcement constitutes the only solicitation; quotes are being requested, and a written SF1449 solicitation will not be issued.

The solicitation is issued as an SDVOSB set-aside in accordance with VAAR, VAAM, and applicable SBA VetCert requirements.

Title: Medtronic G3 Generator / Symplicity Spyral Catheters.

The CSS documents and incorporated provisions and clauses are those in effect through FAC

2026-01 (eff. 03/13/2026), FAR Deviation APR 2026 (eff. 04/23/2026), VAAR DEVIATION MAR

2026 (eff. 03/17/2026), VAAM Alert 26-01 (eff. 10/01/2025), and Acquisition Policy Flash 26-26 eff. 03/17/2026). This CSS incorporates provisions and clauses by reference and full text. All provisions and clauses may be accessed electronically at www.acquisition.gov.

Contractors are required to be actively registered in the System for Award Management (SAM) and certified with the Small Business administrative (SBA) Small Business Search (SBS) as a

Service-Disable Veteran-Owned Small Business (SDVOSB). Vendor quote may be considered non-compliant and rejected if the Contracting Officer is unable to verify registration and

SDVOSB certification status.

The Government intends to award a single firm-fixed-price purchase order resulting from this

RFQ to the SDVOSB whose quote represents the best value to the Government considering price and technical acceptability. All quoted items must be new, OEM, and fully compliant with

Medtronic G3 Generator / Symplicity Spyral Catheters specifications; no refurbished, gray-market, or third-party substitutes will be accepted. The Government reserves the right to make no award.

See attached RFQ for full details… http://www.acquisition.gov/

36C25626Q0812

Table of Contents

SECTION B - CONTINUATION CONTRACT OPPORTUNITIES COMBINED SYNOPSIS

SOLICITATION

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK (SOW)

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

B.4 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.2 52.222-90 ADDRESSING DEI DISCRIMINATION BY FEDERAL CONTRACTORS

(APR 2026)

C.3 VAAR 852.219-76 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SUPPLIES AND PRODUCTS (JAN 2023)

(DEVIATION)

C.4 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 BRAND NAME JUSTIFICATION AND APPROVAL (JA)

SECTION E - SOLICITATION PROVISIONS

E.1 ADDENDUM TO FAR 52.212-1 INSTRUCTIONS TO OFFERORS —

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (TAILORED)

E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.3 52.216-1 TYPE OF CONTRACT (NOV 2025) (DEVIATION)

E.4 52.240-90 SECURITY PROHIBITIONS AND EXCLUSIONS REPRESENTATIONS

AND CERTIFICATIONS (NOV 2025) (DEVIATION)

E.5 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021) (TAILORED)

SECTION B - CONTINUATION CONTRACT OPPORTUNITIES

COMBINED SYNOPSIS SOLICITATION

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individual:

a. CONTRACTOR: Company Name:

ATTN/POC Name:

Address:

Phone:

Email:

UEI:

Contract# (if applicable):

b. GOVERNMENT: Contracting Officer 36C256

Department of Veterans Affairs Network Contracting Office 16 Galleria Financial Center 5075 Westheimer Road, Suite 750 Houston TX 77056-5643

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

a. 52.232-33 Payment by Electronic Funds Transfer - System for Award

Management through TUNGSTEN

3. INVOICES: Invoices shall be submitted in arrears:

a. Other: Upon receipt and acceptance by the Government

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests. http://www.fsc.va.gov/fsc/einvoice.asp

5. Offeror shall complete the following located in Sections B thru E of this solicitation to be deemed eligible:

a. Volume I:

a. Section B- CONTRACT ADMINISTRATION DATA, CONTRACTOR contact information.

b. Section C- 852.219-76 (SIGNED)

c. Submission of manufacturer’s authorized distributor letter, warranty, past performance, and specifications summarized in this CSS and SOW.

b. Volume II:

a. Section B- PRICE/COST SCHEDULE.

6. ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

(End of Contract Administration Data) http://www.fsc.va.gov/fsc/einvoice.asp

B.2 STATEMENT OF WORK (SOW)

GENERAL SPECIFICATIONS

1. Background: The Michael E. DeBakey VAMC (MEDVAMC) has a requirement for the

Medtronic Symplicity G3 generator and catheters for the cardiology section. The Medtronic Symplicity G3 system is a renal denervation technology designed to treat hypertension by delivering radiofrequency energy to the renal nerves, helping to reduce blood pressure in patients with uncontrolled hypertension.

2. Project Scope: The contractor shall provide equipment that meets or exceeds the following minimum salient characteristics necessary to support renal denervation procedures within Interventional Cardiology. All offered equipment must be fully compatible with each other as a unified renal denervation system.

2.1. RDN016 – Symplicity Spyral™ Catheter

2.1.1. The supplied renal denervation catheter must:

2.1.1.1. Be a percutaneous, flexible RF catheter designed for renal artery access.

2.1.1.2. Support multi electrode RF energy delivery with automated modulation.

2.1.1.3. Be designed for spiral deployment within the renal artery to achieve circumferential denervation.

2.1.1.4. Be sized and shaped for transfemoral access using standard interventional introducers.

2.1.1.5. Include radio opaque markers to assist with fluoroscopic positioning.

2.1.1.6. Provide real-time feedback (e.g., position, temperature, impedance) to the compatible generator system.

2.1.1.7. Be sterile, single use, and disposable.

2.1.1.8. Be electrically and mechanically compatible with the required renal denervation generator listed in this SOW.

2.1.1.9. Support automated energy control features to prevent vessel or tissue overheating.

2.2. RDNG3A – Symplicity G3™ Generator

2.2.1. The renal denervation generator must:

2.2.1.1. Deliver controlled radiofrequency (RF) energy specifically configured for renal sympathetic denervation.

2.2.1.2. Provide multi-channel energy delivery capability to support multi-electrode catheters.

2.2.1.3. Automatically adjust RF output using closed loop feedback from the connected catheter.

2.2.1.4. Display real time procedural metrics including:

2.2.1.4.1. Impedance

2.2.1.4.2. Temperature

2.2.1.4.3. Energy delivery duration

2.2.1.4.4. Electrode status

2.2.1.5. Include a touchscreen clinician interface for procedure setup and control.

2.2.1.6. Provide built-in system self-checks, calibration, and safety lockouts.

2.2.1.7. Be compatible with Symplicity Spyral type catheters or equivalent multi electrode renal denervation catheters.

2.2.1.8. Operate on standard U.S. hospital electrical power (120V).

2.2.1.9. Include capability for software or firmware updates when provided by the manufacturer.

2.2.1.10. Include a footswitch or hands-free activation option for RF energy delivery.

2.3. RDN019 – Symplicity G3™ Generator Cart

2.3.1. The generator cart must:

2.3.1.1. Be specifically designed to securely hold and transport the renal denervation generator.

2.3.1.2. Include locking casters for stability during operation.

2.3.1.3. Provide cable management to support safe and organized setup of generator to catheter connections.

2.3.1.4. Include integrated shelves or brackets to support accessories (e.g., footswitch, cables).

2.3.1.5. Be constructed from medical grade, cleanable materials.

2.3.1.6. Be sized for standard procedure room maneuverability and storage.

2.4. System Level Compatibility Requirements

2.4.1. All components provided must:

2.4.1.1. Function as a fully integrated renal denervation system.

2.4.1.2. Be mutually compatible without adapters, converters, or custom modifications.

2.4.1.3. Meet all requirements for sterility, biocompatibility, electrical safety, and EMC.

2.4.1.4. Comply with FDA clearance for renal denervation devices.

2.4.1.5. Include manufacturer documentation, instructions for use, and any required disposable accessories.

3. Supply Deliverables:

REF # Description QTY

RDN016 Symplicity Spyral™ Catheter 14

RDNG3A Symplicity G3™ Generator 1

RDN019 Symplicity G3™ Generator Cart 1

4. Warranty and Support: The warranty must cover all components of the requirement in accordance with standard manufacturer’s warranty. The vendor support will include assistance with device malfunctions.

5. Delivery Location: All items must arrive new, unused, and in original manufacturer packaging. Supply includes all necessary cables, connectors, manuals, and accessories required for operation.

Michael E. DeBakey VA Medical Center Cardiology 3C-341 2002 Holcombe Boulevard Houston, TX 77030

(End of SOW)

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

DESCRIPTION

OF SUPPLIES QTY UNIT UNIT PRICE AMOUNT

14.00 EA __________________ __________________

Symplicity Spyral Catheter

Contract Period: Base POP Begin: 06-15-2026 POP End: 09-14-2026 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

LOCAL STOCK NUMBER: RDN016

1.00 EA __________________ __________________

Symplicity G3 Generator

Contract Period: Base POP Begin: 06-15-2026 POP End: 09-14-2026 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical

LOCAL STOCK NUMBER: RDNG3A

1.00 EA __________________ __________________

Symplicity G3 Generator Cart

Contract Period: Base POP Begin: 06-15-2026 POP End: 09-14-2026 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical

LOCAL STOCK NUMBER: RDN019

GRAND TOTAL

B.4 DELIVERY SCHEDULE

* 90-day After Receipt of Order (ARO).

* It is important to recognize that the 90-day ARO serves as a guideline for VA procurement department, ensuring sufficient time for delivery, billing, and invoice processing for closeout procedures.

* It is imperative that the contractor ship as soon as possible.

* Price is a firm-fixed price (FFP) agreement and may not be changed, contractor shall not exceed the awarded amount on the issued contract order. The contractor shall communicate to

Program POC and CO on any orders that are anticipated to be delayed or exceed contractual obligation listed in Price/Cost Schedule

[End of Section B]

36C25626Q0802

SECTION C - CONTRACT CLAUSES

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

FAR

Number

Title Date

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS NOV 2023

52.203-19 PROHIBITION ON REQUIRING CERTAIN INTERNAL

CONFIDENTIALITY AGREEMENTS OR STATEMENTS

JAN 2017

52.204-9 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR

PERSONNEL

JAN 2011

52.204-13 SYSTEM FOR AWARD MANAGEMENT—MAINTENANCE

(DEVIATION)

NOV 2025

52.209-10 PROHIBITION ON CONTRACTING WITH INVERTED

DOMESTIC CORPORATIONS

NOV 2015

52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

NOV 2023

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEMENT STATUTES OR EXECUTIVE ORDERS—

COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES

OCT 2025

52.217-6 OPTION FOR INCREASED QUANTITY MAR 1989

52.217-7 OPTION FOR INCREASED QUANTITY—SEPARATELY

PRICED LINE ITEM

MAR 1989

52.219-6 NOTICE OF TOTAL SMALL BUSINESS SET-ASIDE

(DEVIATION)

NOV 2025

52.219-14 LIMITATIONS ON SUBCONTRACTING (DEVIATION) NOV 2025

52.219-33 NONMANUFACTURER RULE (DEVIATION) NOV 2025

52.222-19 CHILD LABOR—COOPERATION WITH AUTHORITIES

AND REMEDIES (DEVIATION)

MAR 2026

52.222-35 EQUAL OPPORTUNITY FOR VETERANS (DEVIATION) NOV 2025

52.222-36 EQUAL OPPORTUNITY FOR WORKERS WITH

DISABILITIES (DEVIATION)

NOV 2025

52.222-50 COMBATING TRAFFICKING IN PERSONS (DEVIATION) NOV 2025

52.225-8 DUTY-FREE ENTRY OCT 2025

52.226-8 ENCOURAGING CONTRACTOR POLICIES TO BAN TEXT

MESSAGING WHILE DRIVING

MAY 2024

52.232-33 PAYMENT BY ELECTRONIC FUNDS TRANSFER—

SYSTEM FOR AWARD MANAGEMENT

OCT 2018

52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL

BUSINESS SUBCONTRACTORS

MAR 2023

52.233-3 PROTEST AFTER AWARD AUG 1996

52.240-91 SECURITY PROHIBITIONS AND EXCLUSIONS

(DEVIATION)

NOV 2025

52.244-

6DEV

SUBCONTRACTS FOR COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES

OCT 2025

52.247-34 F.O.B. DESTINATION NOV 1991

52.249-8 DEFAULT (FIXED-PRICE SUPPLY AND SERVICE) APR 1984

852.203-70 COMMERCIAL ADVERTISING MAY 2018

852.211-70 EQUIPMENT OPERATION AND MAINTENANCE

MANUALS

NOV 2018

852.212-71 GRAY MARKET AND COUNTERFEIT ITEMS FEB 2023

852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED

SERVICE-DISABLED VETERAN-OWNED SMALL

BUSINESSES (DEVIATION)

JAN 2023

852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS NOV 2018

852.242-71 ADMINISTRATIVE CONTRACTING OFFICER OCT 2020

852.246-71 REJECTED GOODS OCT 2018

(End of Clause)

C.2 52.222-90 ADDRESSING DEI DISCRIMINATION BY FEDERAL

CONTRACTORS (APR 2026)

(a) Definitions. As used in this clause—

Program participation means membership or participation in, or access or admission to: training, mentoring, or leadership development programs; educational opportunities; clubs; associations;

or similar opportunities that are sponsored or established by the contractor or subcontractor.

Racially discriminatory diversity, equity, and inclusion (DEI) activities means disparate treatment based on race or ethnicity in the recruitment, employment (e.g., hiring, promotions), contracting

(e.g., vendor agreements), program participation, or allocation or deployment of an entity's resources.

(b) In connection with the performance of work under this contract, the Contractor agrees as follows:

(1) The Contractor will not engage in any racially discriminatory DEI activities;

(2) The Contractor will furnish all information and reports, including providing access to books, records, and accounts, as required by the Contracting Officer, for purposes of ascertaining compliance with this clause;

(3) In the event of the Contractor's or a subcontractor's noncompliance with this clause, this contract may be canceled, terminated, or suspended in whole or in part, and the

Contractor or subcontractor may be declared ineligible for further Government contracts;

(4) The Contractor will report any subcontractor's known or reasonably knowable conduct that may violate this clause to the Contracting Officer and take any appropriate remedial actions directed by the Contracting Officer; and

(5) The Contractor will inform the Contracting Officer if a subcontractor sues the

Contractor and the suit puts at issue, in any way, the validity of this clause.

(6) The Contractor recognizes that compliance with the requirements of this clause are material to the Government's payment decisions for purposes of 31 U.S.C. 3729(b)(4).

(c) The Contractor must include the substance of this clause, including this paragraph (c), in subcontracts at any tier, including those for commercial products and commercial services, except those where the place of delivery or performance is outside the United States.

(End of clause)

C.3 VAAR 852.219-76 VA NOTICE OF LIMITATIONS ON

SUBCONTRACTING—CERTIFICATE OF COMPLIANCE FOR SUPPLIES AND

PRODUCTS (JAN 2023) (DEVIATION)

(a) Pursuant to 38 U.S.C. 8127(l)(2), the offeror certifies that—

(1) If awarded a contract (see FAR 2.101 definition), it will comply with the limitations on subcontracting requirement as provided in the solicitation and the resultant contract, as follows:

(i) [ ] In the case of a contract for supplies or products (other than from a nonmanufacturer of such supplies), it will not pay more than 50% of the amount paid by the government to it to firms that are not certified SDVOSBs listed in the SBA certification database as set forth in 852.219–

73 or certified VOSBs listed in the SBA certification database as set forth in 852.219–74. Any work that a similarly situated certified SDVOSB/VOSB subcontractor further subcontracts will count towards the 50% subcontract amount that cannot be exceeded. Cost of materials are excluded and not considered to be subcontracted.

(ii) [ ] In the case of a contract for supplies from a nonmanufacturer, it will supply the product of a domestic small business manufacturer or processor, unless a waiver as described in 13

CFR 121.406(b)(5) is granted. The offeror understands that, as provided in 13 CFR

121.406(b)(7), such a waiver has no effect on requirements external to the Small Business Act, such as the Buy American Act or the Trade Agreements Act.

(2) Manufacturer or nonmanufacturer representation and certification.

(i) [ ] Manufacturer or producer. The offeror certifies that it is the manufacturer or producer of the end item being procured, and the end item is manufactured or produced in the United

States, in accordance with paragraph (a)(1)(i).

(ii) [ ] Nonmanufacturer. The offeror certifies that it qualifies as a nonmanufacturer in accordance with the requirements of 13 CFR 121.406(b) and paragraph (a)(1)(ii). The offeror further certifies it meets each element below as required in order to qualify as a nonmanufacturer.

[ ] The offeror certifies that it does not exceed 500 employees (or 150 employees for the

Information Technology Value Added Reseller exception to NAICS code 541519, which is found at 13 CFR 121.201, footnote 18).

[ ] The offeror certifies that it is primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied.

[ ] The offeror certifies that it will take ownership or possession of the item(s) with its personnel, equipment, or facilities in a manner consistent with industry practice.

(3) The offeror acknowledges that this certification concerns a matter within the jurisdiction of an Agency of the United States. The offeror further acknowledges that this certification is subject to Title 18, United States Code, Section 1001, and, as such, a false, fictitious, or fraudulent certification may render the offeror subject to criminal, civil, or administrative penalties, including prosecution.

(4) If VA determines that an SDVOSB/ VOSB awarded a contract pursuant to 38 U.S.C. 8127 did not act in good faith, such SDVOSB/VOSB shall be subject to any or all of the following:

(i) Referral to the VA Suspension and Debarment Committee;

(ii) A fine under section 16(g)(1) of the Small Business Act (15 U.S.C. 645(g)(1)); and

(iii) Prosecution for violating 18 U.S.C. 1001.

(b) The offeror represents and understands that by submission of its offer and award of a contract it may be required to provide copies of documents or records to VA that VA may review to determine whether the offeror complied with the limitations on subcontracting requirement specified in the contract or to determine whether the offeror qualifies as a manufacturer or nonmanufacturer in compliance with the limitations on subcontracting requirement. Contracting officers may, at their discretion, require the contractor to demonstrate its compliance with the limitations on subcontracting at any time during performance and upon completion of a contract if the information regarding such compliance is not already available to the contracting officer.

Evidence of compliance includes, but is not limited to, invoices, copies of subcontracts, or a list of the value of tasks performed.

(c) The offeror further agrees to cooperate fully and make available any documents or records as may be required to enable VA to determine compliance. The offeror understands that failure to provide documents as requested by VA may result in remedial action as the Government deems appropriate.

(d) Offeror completed certification/fill-in required. The formal certification must be completed, signed and returned with the offeror’s bid, quotation, or proposal. The Government will not consider offers for award from offerors that do not provide the certification, and all such responses will be deemed ineligible for evaluation and award.

Certification

I hereby certify that if awarded the contract, ________________________ will comply with the limitations on subcontracting specified in this clause and in the resultant contract. I further certify that I am authorized to execute this certification on behalf of ____________________________.

Printed Name of Signee: ______________________________

Printed Title of Signee: ________________________________

Signature: __________________________________________

Date: ______________________________________________

Company Name and Address: __________________________

(End of Clause)

C.4 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

Shipment of deliverable items, other than reports, shall be to:

Department of Veterans Affairs Michael E. DeBakey VA Medical Center Building 100, Cardiology 3C-341 2002 Holcombe BLVD Houston TX 77030-4298

(End of Clause)

(End of Addendum to 52.212-4)

[End of Section C]

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR

ATTACHMENTS

D.1 BRAND NAME JUSTIFICATION AND APPROVAL (J&A)

IAW RFO FAR 5.201 and 6.301, see attached J&A on next page…

[End of Section D]

RFO FAR 12.102 – Restricting Competition

BRAND NAME

Effective Date: 03/16/2026 Page 1 of 2 Acquisition ID#

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW RFO 12.102-1 For

Over Micro-Purchase Threshold but Not Exceeding the Simplified Acquisition Threshold

Acquisition Plan Action ID:

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO)

16, located at 5075 Westheimer Rd., Ste. 750, Houston, TX 77056. Program Office: Michael E. DeBakey VA Medical Center (MEDVAMC) located at 2002 Holcombe Blvd; Houston, Texas 77030. Purchase Request Number: .

2. Brief Description of Supplies/ Services required and the intended use and estimated amount: Michael E. DeBakey VA Medical Center (MEDVAMC) requires the procurement of Medtronic Symplicity Spyral™ Catheters and the Medtronic Symplicity G3™ Generator and Cart for use by the Cardiology Section to perform renal denervation procedures for the management of uncontrolled hypertension. This action is a new Firm Fixed Price (FFP) purchase order for commercially available medical devices under RFO FAR Part 12 – Commercial Products and Services. The procurement is a Brand Name, SDVOSB set aside supported by market research and RFI responses confirming that only Medtronic branded products meet the clinical requirement and that at least two SDVOSB distributors are authorized to supply the items. Brand Name Medtronic Items:

Item No. Description Qty RDN016 Symplicity Spyral™ Catheter 14 EA RDNG3A Symplicity G3™ Generator 1 EA RDN019 Symplicity G3™ Generator Cart 1 EA

The Medtronic Symplicity Renal Denervation (RDN) System is FDA approved and consists of componentry designed to work only within the Medtronic ecosystem. No other manufacturer produces clinically acceptable or compatible alternatives.

Total estimated value: .

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The acquisition requires Medtronic manufactured, proprietary components that cannot be substituted with equal products because:

a. The Symplicity Spyral™ Catheters (RDN016) are designed to operate exclusively with the Medtronic G3 Generator (RDNG3A).

b. The generator and catheter form a closed, proprietary, FDA approved system.

c. No interoperable or clinically validated “equal” or compatible catheters/generators exist.

d. Substitutions would invalidate the system’s regulatory basis and pose clinical risk.

e. Therefore, only the Medtronic brand can satisfy the Government’s minimum needs.

4. A Statutory/Regulatory Authority (Under the SAT):

a. Because the acquisition is below the Simplified Acquisition Threshold, FAR Part 6 J&A is not required. However, Brand Name Justification is required under:

RFO FAR 12.102 – Restricting Competition

BRAND NAME

Effective Date: 03/16/2026 Page 2 of 2 Acquisition ID#

i. RFO FAR 12.102 – Restricting Competition for Commercial Products (Brand Name)

ii. FAR 13.501(a) – Brand Name Justification for Simplified Acquisitions

b. The authority for setting aside for SDVOSB is met because two or more verified

SDVOSBs are available as authorized distributors.

i. 38 U.S.C. §8127 (Veterans First) and VAAR 819.70 procedures (Rule of

Two)

ii. VAAR 810.001-70 (Market Research)

5. Description of market research conducted and results or statement why it was not conducted:

f. The acquisition requires Medtronic manufactured, proprietary components that cannot be substituted with equal products because:

i. The Symplicity Spyral™ Catheters (RDN016) are designed to operate exclusively with the Medtronic G3 Generator (RDNG3A).

ii. The generator and catheter form a closed, proprietary, FDA approved system.

iii. No interoperable or clinically validated “equal” or compatible catheters/generators exist.

iv. Substitutions would invalidate the system’s regulatory basis and pose clinical risk.

g. Therefore, only the Medtronic brand can satisfy the Government’s minimum needs.

h. Published Market Research (RFI)

i. RFI 36C25626Q0652 posted 4/13/2026 – 4/24/2026.

ii. Multiple SDVOSB Medtronic authorized distributors responded.

iii. Market research verified via SBA VetCert (SBS database) confirmed two or more SDVOSBs with the appropriate NAICS and authorized access.

i. Results

i. No vendors offered any equal or alternative renal denervation systems.

ii. All respondents confirmed only Medtronic products meet clinical requirements.

iii. Thus, Rule of Two is met, permitting an SDVOSB set aside, while retaining brand name justification

j. Thus, Rule of Two is met, permitting an SDVOSB set aside, while retaining brand name justification

6. Contracting Officer's Certification: Purchase is approved in accordance with RFO 12.102.

I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Contracting Officer

NCO16 CAT HOU

SECTION E - SOLICITATION PROVISIONS

E.1 ADDENDUM TO FAR 52.212-1 INSTRUCTIONS TO OFFERORS —

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (TAILORED)

The following instructions apply to this solicitation and replace or supplement the standard provision language.

1. REQUIREMENT: The Michael E. DeBakey VA Medical Center (MEDVAMC), 2002

Holcombe Blvd, Houston, Texas 77030 is seeking Medtronic G3 Generator / Symplicity

Spyral Catheters. The government expects this announcement to result in a Firm-Fixed

Price Single-Award contract.

2. SET-ASIDE AUTHORITY: This RFQ is a TOTAL SET-ASIDE for certified Service-Disabled

Veteran-Owned Small Businesses (SDVOSBs) under VA’s Veterans First Contracting

Program (38 U.S.C. §§8127–8128; VAAR Subpart 819.70).

3. GENERAL INSTRUCTIONS

a. Offer Submission. Offerors shall submit quotes electronically via email to the

Contracting Officer (CO) by the date and time specified in the solicitation. Late offers will be handled in accordance with RFO FAR 52.212-1(c).

b. Offer Format. Offers shall be clear, concise, complete, and submitted in the formats described below. Failure to follow the instructions may result in the offer being deemed Unacceptable.

i. Two Volume Offer Structure. Offerors shall submit quotes in two separate volumes:

1. Volume I – Technical/Quality

2. Volume II – Price

ii. Each volume shall be submitted as a separate file. Pages shall be numbered and formatted in readable type (no smaller than 11 point).

4. VOLUME I – TECHNICAL / QUALITY (No Pricing Information Allowed): Volume I shall not exceed 15 pages. Technical offers containing price information may be deemed

Unacceptable.

a. Technical submissions shall demonstrate the offeror’s ability to fully comply with all requirements of the solicitation and the Statement of Work. At a minimum, Volume I must include the following:

i. OEM Medtronic Product Compliance.

1. Authorized Distributor/Reseller Letter.

ii. Delivery Schedule Compliance.

iii. Warranty Compliance.

iv. SDVOSB Status Verification.

1. Certified with the Small Business Administrative (SBA).

v. Limitations on Subcontracting Certification. VAAR 852.219‑76 signed.

5. VOLUME II – PRICE: Pricing shall be submitted in a separate file titled “Volume II – Price.”

The price volume shall include:

a. A completed pricing schedule for all CLINs.

b. All prices shall be fully burdened.

c. Offerors shall ensure mathematical accuracy. Inconsistencies may result in rejection or clarification requests.

d. No technical information shall be included in Volume II.

6. QUESTIONS: All questions shall be submitted in writing to the administrator publisher, Contract Specialist (CS) by the time specified and date documented on page one of this announcement. Answers will be provided via amendment. Offerors are responsible for monitoring publication to the SAM.gov.

7. INCURRING COSTS: Offerors are responsible for all costs incurred in preparing and submitting offers. The Government is not obligated to award a contract as a result of this solicitation.

8. SYSTEM FOR AWARD MANAGEMENT (SAM): Offerors must be registered and active in

SAM at the time of award.

9. SDVOSB VERIFICATION: Verifiable in the U.S. Small Business Administration (SBA)

Veteran Small Business Certification database at time of quotation submission and at time of award as a SDVOSB,

a. Any quoter submitting an offer as a joint venture must provide a certification from each SDVOSB joint partner, signed by an authorized official of each partner to the joint venture, stating that the parties to the joint venture

i. (1) have entered into a joint venture agreement that fully complies with paragraph (c) of 13 CFR § 128.402 and

ii. (2) will perform the contract in compliance with the joint venture agreement.

b. Failure to submit the certification with the quoter’s offer or the CO is unable to verify status on the SBA database will render the quoter ineligible for award.

c. SDVOSB shall be Prime.

10. NOTICE OF LPTA PROCEDURES: This procurement uses Lowest Price Technically

Acceptable procedures. Technical acceptability is determined solely by compliance with the

SOW requirements and CSS documentation described above. No additional credit will be given for exceeding requirements.

11. CO will conduct preliminary review of all response packets and failure to acknowledge any and all listed in this solicitation section may be cause for rejection of quote due to incomplete packet.

12. Failure to acknowledge, sign (SF30), and return “ALL” Amendments issued pursuant to this solicitation may be cause for rejection of quote due to incomplete packet.

13. If multiple email offers from the same offeror are received, the most recent and latest (dated) notice will be the one evaluated.

(End of Instructions)

Provisions that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following provisions are incorporated into 52.212-1 as an addendum to this solicitation:

E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY

REFERENCE (FEB 1998)

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

FAR

Number

Title Date

52.203-18 PROHIBITION ON CONTRACTING WITH ENTITIES THAT

REQUIRE CERTAIN INTERNAL CONFIDENTIALITY

AGREEMENTS OR STATEMENTS—REPRESENTATION

JAN 2017

52.204-7 SYSTEM FOR AWARD MANAGEMENT—REGISTRATION

(DEVIATION)

NOV 2025

52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

SEP 2023

52.229-11 TAX ON CERTAIN FOREIGN PROCUREMENTS—NOTICE

AND REPRESENTATION

JUN 2020

852.239-75 INFORMATION AND COMMUNICATION TECHNOLOGY

ACCESSIBILITY NOTICE

FEB 2023

(End of Provision)

E.3 52.216-1 TYPE OF CONTRACT (NOV 2025) (DEVIATION)

The Government contemplates award of a Firm-Fixed-Price, Requirements contract resulting from this solicitation.

(End of Provision)

E.4 52.240-90 SECURITY PROHIBITIONS AND EXCLUSIONS

REPRESENTATIONS AND CERTIFICATIONS (NOV 2025) (DEVIATION)

(a) Definitions. As used in this provision—

Backhaul, covered article, covered telecommunications equipment or services, critical technology, FASCSA order, Intelligence community, interconnection arrangements, national security system, roaming, sensitive compartmented information, sensitive compartmented information system, source, and substantial or essential component have the meanings provided in the clause 52.240-91, Security Prohibitions and Exclusions.

Business operations means engaging in commerce in any form, including by acquiring, developing, maintaining, owning, selling, possessing, leasing, or operating equipment, facilities, personnel, products, services, personal property, real property, or any other apparatus of business or commerce.

Marginalized populations of Sudan means—

(1) Adversely affected groups in regions authorized to receive assistance under section 8(c) of the Darfur Peace and Accountability Act (Pub. L. 109-344) (50 U.S.C. 1701 note); and

(2) Marginalized areas in Northern Sudan described in section 4(9) of such Act.

Restricted business operations means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment

Act of 2007) conducting the business can demonstrate—

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

(2) Are conducted under specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

(3) Consist of providing goods or services to marginalized populations of Sudan;

(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;

(5) Consist of providing goods or services that are used only to promote health or education;

or

(6) Have been voluntarily suspended.

Sensitive technology—

(1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically—

(i) To restrict the free flow of unbiased information in Iran; or

(ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and

(2) Does not include information or informational materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3) of the

International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3)).

(b) Procedures.

(1) Covered telecommunications and video surveillance. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) at https://www.sam.gov for entities excluded from receiving federal awards for “covered telecommunications equipment or services.”

(2) FASCSA Orders.

(i) The Offeror shall search in SAM for the phrase “FASCSA order” for any covered article, or any products or services produced or provided by a source, if there is an applicable FASCSA order described in paragraph (e) of FAR 52.240-91, Security Prohibitions and Exclusions.

(ii) The Offeror shall review the solicitation for any FASCSA orders that are not in SAM but are effective and apply to the solicitation and resultant contract (see FAR 40.204-1(c)(2)).

(iii) FASCSA orders issued after the date of solicitation do not apply unless added by an amendment to the solicitation.

(c) Covered telecommunications equipment or services representations. By submission of its offer, the Offeror represents that, after conducting a reasonable inquiry (that looks at any information in the Offeror’s possession but does not need to include an internal or third-party audit)—

(1) It will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation, except as waived by the solicitation, or as disclosed in paragraph (g); and

(2) It does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services, except as waived by the solicitation, or as disclosed in paragraph (g).

(d) FASCSA Representation. By submission of this offer, the offeror represents that it has conducted a reasonable inquiry, and that the offeror does not propose to provide or use in response to this solicitation any covered article, or any products or services produced or provided by a source, if the covered article or the source is prohibited by an applicable FASCSA order in effect on the date the solicitation was issued, except as waived by the solicitation, or as disclosed in paragraph (g). A reasonable inquiry will look at any information in the offeror’s possession but does not need to include an internal or third-party audit.

(e) Sudan certification. By submission of its offer, the offeror certifies, after conducting a reasonable inquiry (that looks at any information in the offeror’s possession but does not need https://www.sam.gov/ to include an internal or third-party audit), that the offeror does not conduct any restricted business operations in Sudan.

(f) Iran Representation and Certifications.

(1) Except as provided in paragraph (f)(2) of this provision or if a waiver has been granted in accordance with FAR 40.203-3, the offeror, after conducting a reasonable inquiry (that looks at any information in the offeror’s possession but does not need to include an internal or third-party audit), by submission of its offer—

(i) Represents, to the best of its knowledge and belief, that the offeror does not export any sensitive technology to the government of Iran or any entities or individuals owned or controlled by, or acting on behalf or at the direction of, the government of Iran;

(ii) Certifies that the offeror, or any person (as defined at section 15 of the Iran Sanctions Act of 1996, Pub. L. 104-172, 50 U.S.C. 1701 note) owned or controlled by the offeror, does not engage in any activities for which sanctions may be imposed under section 5 of the Act. These sanctioned activities are in the areas of development of the petroleum resources of Iran, production of refined petroleum products in Iran, sale and provision of refined petroleum products to Iran, and contributing to Iran’s ability to acquire or develop certain weapons or technologies; and

(iii) Certifies that the offeror, and any person owned or controlled by the offeror, does not knowingly engage in any transaction that exceeds $15,000 with Iran’s Revolutionary Guard

Corps or any of its officials, agents, or affiliates, the property and interests in property of which are blocked pursuant to the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.) (see OFAC’s Specially Designated Nationals and Blocked Persons List at https://www.treasury.gov/resource-center/sanctions/SDN-List/Pages/default.aspx)

(2) Exception for trade agreements. The representation and certification requirements of paragraph (f)(1) of this provision do not apply if—

(i) This solicitation includes a trade agreements notice or certification (e.g., 52.225-6, Trade

Agreements Certificate); and

(ii) The offeror has certified that all the offered products to be supplied are designated country end products or designated country construction material.

(iii) The offeror shall email questions concerning sensitive technology to the Department of

State at CISADA106@state.gov.

(g) Disclosure.

(1) If the Offeror is not able to represent compliance with the prohibitions in paragraphs (c) or

(d), then the Offeror shall disclose within 72 hours to the contracting office identified in paragraph (g)(2) the following information for each product or service not compliant:

(i) Contract number and order number, if applicable;

(ii) Identification of whether this disclosure relates to paragraph (c) on covered telecommunication equipment or services, or to paragraph (d) on FASCSA orders;

https://www.treasury.gov/resource-center/sanctions/SDN-List/Pages/default.aspx mailto:CISADA106@state.gov

(iii) A description of the products or services that the Contractor identifies or has reason to suspect is prohibited (include brand; model number, such as the original equipment manufacturer (OEM) number, manufacturer part number, or wholesaler number; and item description, as applicable);

(iv) The entity that produced the product or service (include entity name, unique entity identifier, Contractor and Government Entity (CAGE) code, facilities responsible for design, fabrication, assembly, packaging, and test of the product, and whether the entity was the OEM or a distributor (provide manufacturer codes and distributor codes used for the product));

(v) Description of the functionality of the product or service and how that functionality impacts the risk to the product or service;

(vi) An explanation of any factors relevant to determining if the product or service should be permitted by an applicable exception, exemption, or waiver (if the offeror would like the

Government to consider a waiver);

(vii) Whether alternative products or services are available that would be compliant with the prohibition;

(viii) If the product or service is related to item maintenance, include the following information on the item being maintained:

(A) Brand;

(B) Model number, OEM number, manufacturer part number, or wholesaler number; and

(C) Item description, as applicable.

(ix) Any readily available information about mitigation actions undertaken or recommended.

(2) If a disclosure is required to be submitted to a contracting office, the offeror shall submit the disclosure as follows:

(i) If a Department of Defense contracting office, the offeror shall submit the disclosure to the website at https://dibnet.dod.mil.

(ii) For all other contracting offices, the Offeror shall submit the disclosure to the Contracting

Officer.

(3) If the disclosure provided does not contain any of the information required by paragraph

(1), and the Offeror later discovers new information that is required by paragraph (1), then the

Offeror shall submit a subsequent disclosure within 72 hours of discovering the new information.

(h) Executive agency review of disclosures. The Contracting Officer will review disclosures provided in paragraph (g) to determine if any applicable waiver may be sought. The Contracting

Officer may choose not to pursue a waiver and may instead make an award to an Offeror that does not require a waiver.

(End of Provision)

(End of Addendum to 52.212-1) https://dibnet.dod.mil/

E.5 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (NOV 2021) (TAILORED)

a) Basis for Award: The Government intends to award a single firm-fixed-price contract resulting from this solicitation to the offeror responsible, whose offer conforms to the solicitation and is determined to be the Lowest Price Technically Acceptable (LPTA).

Technical factors are evaluated on an acceptable/unacceptable basis. Award will be made to the lowest-priced offeror whose technical quote is evaluated as Acceptable and whose past performance does not render the offeror ineligible for award.

b) Evaluation Factors: Offers shall be submitted in two volumes:

1) VOLUME I – TECHNICAL / QUALITY (Rated Acceptable or Unacceptable):

Technical acceptability will be evaluated against the requirements of the solicitation and Statement of Work (SOW).

i. To be rated Acceptable, the offeror must demonstrate, at a minimum, the following:

1. OEM Medtronic Product Compliance.

a. Authorized Distributor/Reseller Letter.

2. Delivery Schedule Compliance.

3. Warranty Compliance.

4. SDVOSB Status Verification.

5. Limitations on Subcontracting Certification.

ii. Offers that fail to demonstrate compliance with any required element above will be rated Unacceptable and will not be considered for award.

2) VOLUME II – PRICE

i. Price will be evaluated to determine reasonableness and to identify the lowest total evaluated price. Offerors shall provide complete pricing for all deliverable items. The Government will evaluate the total price for all items, lump sum.

ii. The Government reserves the right to verify price elements to ensure they reflect a clear understanding of the solicitation requirements.

iii. Offerors shall propose firm fixed price for the one-time purchase, as applicable. The firm-fixed price shall be fully burdened.

c) Evaluation Method:

1) Technical/Quality is evaluated Acceptable or Unacceptable.

2) Price will not be evaluated for technically unacceptable offerors.

3) The Government will not trade price for higher technical merit; award will be made strictly on LPTA.

d) Past Performance: The past performance evaluation will assess the relative risks associated with a quoter’s likelihood of success in fulfilling the solicitation’s requirements as indicated by the quoter’s record of past performance shall meet a minimum rating of Satisfactory.

1) The past performance evaluation may be based on the contracting officer’s knowledge of and previous experience with the supply or service being acquired;

from the Contractor Performance Assessment Reporting System (CPARS) at https://cpars.cpars.gov/cpars/app/home_input.action, Federal Awardee Performance Integrity Information System (FAPIIS) at https://sam.gov/content/fapiis, and/or Customer surveys or any other reasonable basis are acceptable.

https://cpars.cpars.gov/cpars/app/home_input.action https://sam.gov/content/fapiis

2) In the case of a quoter without a record of relevant past performance or for whom information on past performance is not available, the quoter cannot be evaluated favorably or unfavorably on past performance.

3) The Government is accepting alternate forms of past performance on past supplies/services similar or the same under this requirement.

e) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

f) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of Provision)

[End of Section E]