S02 Sources Sought RFI NX EQ Microwave Therapy Systems.pdf

Sources Sought Notice

*= Required Field Sources Sought Notice

SUBJECT* NX EQ Microwave Therapy Systems: Tissue Ablation

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 22408-2697

SOLICITATION NUMBER* 36C10G25Q0064

RESPONSE DATE/TIME/ZONE 03-12-2025 9:00AM EASTERN TIME, NEW YORK, USA

ARCHIVE 30 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

SET-ASIDE

PRODUCT SERVICE CODE* 6515

NAICS CODE* 334510

CONTRACTING OFFICE ADDRESS U.S. Department of Veterans Affairs

OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

POINT OF CONTACT*

Contract Specialist Trevor Mason Trevor.Mason@va.gov 202-867-4351

PLACE OF PERFORMANCE

ADDRESS Nationwide

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL https://www.va.gov/opal/sac/index.asp

URL DESCRIPTION VA | OALC | OPAL | SAC

AGENCY CONTACT’S EMAIL ADDRESS Trevor.Mason@va.gov EMAIL DESCRIPTION Trevor.Mason@va.gov

DESCRIPTION

1.0 DESCRIPTION

THIS IS A SOURCES SOUGHT NOTICE ONLY. This is not a solicitation for bids, proposals, proposal abstracts, or quotations. The Department of Veterans Affairs’ (VA) Strategic Acquisition Center (SAC) is issuing this Sources Sought Notice in accordance with the FAR 10.002(b)(2) as a means of conducting market research to identify qualified sources with the capability and the resources to meet the Veterans Health Administration’s (VHA) Non-Expendable Equipment National Program requirement for Microwave Tissue Ablation Systems.

The SAC in conjunction with VHA is seeking a qualified source to supply brand name or equal Ethicon NEUWAVE® Microwave Tissue Ablation Systems and associated equipment on an agency-wide basis. VA intends to award a single Requirements Contract with Firm-Fixed Price (FFP) orders IAW FAR 16.503, Requirements Contract to a supplier of this equipment. Vendors will be required to deliver Microwave Tissue Ablation System to VA medical centers and facilities throughout the United States.

The anticipated period of performance is for one 12-month base period with four 12-month option periods from the date of award. However, the Government's decision as to whether to continue with the contract, upon annual review, will be based upon successful performance during each previous year and continued need.

The associated North American Industrial Classification System (NAICS) code for this procurement is 334510 – Electromedical and Electrotherapeutic Apparatus Manufacturing and the associated size standard is 1,250 employees.

The FAR Provision found at 52.204-7(b)(1) requires that “All interested Offerors must be registered in SAM prior to submitting an offer or quotation.” You may access the SAM website at SAM.gov | Home. All offerors must be certified with the appropriate NAICS code on the SAM website. All SDVOSB/VOSB offerors must be verified in the SBA database at: https://veterans.certify.sba.gov/#search at the time of submission.

Submissions for this “sources sought” shall be submitted by email no later than April 9, 2025, at 9:00am EST to all the following:

Trevor.Mason@va.gov Sara.Vickroy@va.gov

This notice is for planning purposes only and does not constitute a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. This Sources Sought Notice is part of a continuous process for obtaining the latest information on the commercial status of the industry with respect to their current and near-term abilities. The information provided herein is subject to change and in no way binds the Government to solicit for, https://www.sba.gov/sites/sbagov/files/2023-06/Table%20of%20Size%20Standards_Effective%20March%2017%2C%202023%20%282%29.pdf https://sam.gov/content/home https://veterans.certify.sba.gov/#search mailto:Trevor.Mason@va.gov mailto:Sara.Vickroy@va.gov or award, a competitive contract. It is emphasized that this is a notice solely for planning and informational purposes. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. The Government may or may not issue a solicitation as a result of this notice. There is no solicitation available at this time.

2.0 SCOPE OF WORK

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Microwave Therapy Systems: Tissue Ablation product line as a candidate for a VA-wide (otherwise referred to as “national”) single Requirements contract award.

The Ethicon NEUWAVE® Microwave Tissue Ablation System or equal is designed for thermal ablation of soft tissue and/or regions of solid organs (e.g. liver). These systems typically consist of a microwave generator, a coaxial cable, a temperature sensor, and interstitial needle-like applicators as antennas; computed tomography, ultrasound, or magnetic resonance guidance is used to locate the applicator and sometimes to evaluate tissue ablation. The radiating antenna is placed on or near the tissue volume to be ablated using an applicator or catheter. The primary mechanism for tissue heating at microwave frequencies is vibration of the ions (e.g., ions of water molecules) in the tissues at the frequency of the electrical field. Interstitial tissue-ablation systems are mostly used for percutaneous coagulation necrosis of unresectable tumors at temperatures over 60 degrees C, but less than 100 degrees C.

The Contractor must demonstrate the ability to meet all requirements for the solicitation.

The objective is to provide Microwave Tissue Ablation Systems to be used by clinicians throughout the VA medical centers and facilities. The period of performance is for a base of 12-months with four 12-month option periods.

The following Contract Line Items are being considered:

Contract Line Items Brand Part

Number Description

0001 Ethicon NWC1US1N

NEUWAVE™ Microwave Ablation System (capital cart, power distribution module, single monitor, base system software, modem, back-up battery, power supply/power cord, 1 YR warranty)

0002 Ethicon ACUGUS

NEUWAVE™ ABLATE-IQ™ Software: Provides Ablation Location Tracking, Probe Placement Feedback, and Ablation Confirmation (Includes Base ABLATE-IQ software upgrade installation, 2nd monitor, dual monitor arm, mouse, 50 ft. network cable, 1 YR warranty on upgrade components)

0003 Ethicon AIQP

NEUWAVE™ ABLATE-IQ™ PREMIUM Software:

Includes Base Software plus Ablation Planning Capabilities, Create/Store User Profiles, Streamlined Workflow, and Procedure Reporting (Premium feature ABLATE-IQ software upgrade installation)

0004 Ethicon PR15 NEUWAVE™ PR Probe, 15 cm, 17 ga

0005 Ethicon PRS35 NEUWAVE™ LAP Surgical PR Probe, 35 cm, 11 ga to 13 ga, tapered (2.9M Cable)

0006 Ethicon LK15 NEUWAVE™ LK Probe, 15 cm, 17 ga 0007 Ethicon LK20 NEUWAVE™ LK Probe, 20 cm, 17 ga

0008 Ethicon LK20XT NEUWAVE™ LK XT Probe, 20 cm, 15 ga to 17 ga, tapered

0009 Ethicon CTBKT1 CT Bed Rail Mount, GE/Philips 0010 Ethicon CTBKT2 CT Bed Rail Mount, Siemens 0011 Ethicon CTBKT3 CT Bed Rail Mount, Toshiba 0012 Ethicon CTBKT4 CT Bed Rail Mount, Siemens Alt 0013 Ethicon FSWITCH1 NEUWAVE™ Footswitch Standard USB 0014 Ethicon FSWITCH2 NEUWAVE™ Footswitch Locking USB 0015 Ethicon RCPK NEUWAVE™ System PTC Clip, 5 pack 0016 Ethicon PD2MSURG NEUWAVE™ Surgical PDM Mount Kit

0017 Ethicon NSVPRM1 NEUWAVE™ System Premier Service Coverage Plan, 1 YR (Includes CLIN 0027)

0018 Ethicon NSVESL1 NEUWAVE™ System Essential Service Coverage Plan, 1 YR (Includes CLIN 0027)

0019 Ethicon NSVPRM2 NEUWAVE™ System Premier Service Coverage Plan, 2 YR (Includes CLIN 0027)

0020 Ethicon NSVESL2 NEUWAVE™ System Essential Service Coverage Plan, 2 YR (Includes CLIN 0027)

0021 Ethicon NSVPRM3 NEUWAVE™ System Premier Service Coverage Plan, 3 YR (Includes CLIN 0027)

0022 Ethicon NSVESL3 NEUWAVE™ System Essential Service Coverage Plan, 3 YR (Includes CLIN 0027)

0023 Ethicon NSVPRM4 NEUWAVE™ System Premier Service Coverage Plan, 4 YR (Includes CLIN 0027)

0024 Ethicon NSVESL4 NEUWAVE™ System Essential Service Coverage Plan, 4 YR (Includes CLIN 0027)

0025 Ethicon NSVPRM5 NEUWAVE™ System Premier Service Coverage Plan, 5 YR (Includes CLIN 0027)

0026 Ethicon NSVESL5 NEUWAVE™ System Essential Service Coverage Plan, 5 YR (Includes CLIN 0027)

0027 Ethicon NSVPM NEUWAVE™ Preventative Maintenance, 1 YR

The Department of Veterans Affairs (VA) is seeking vendors who can provide Ethicon NEUWAVE® Microwave Tissue Ablation System as listed above or equal commodities which meet all the following salient characteristics.

CLIN 0001 applies to SC’s 1-4 CLINs 0004-0008 applies to SC’s 5-6

SC # SALIENT CHARACTERISTICS METHOD OF

EVALUATION

SC 1

Must provide high quality acute care to efficiently ablate liver, kidney, lung, and other soft tissue tumors up to 5cm

Literature Review

SC 2 Must include a microwave power generator capable of delivering 140 Watts or greater Literature Review

SC 3 Must have a touchscreen user interface with continuous temperature and power feedback Literature Review

SC 4 Must include a dedicated mobile system cart Literature Review

SC 5

Must be capable of providing antennas/probes/applicators 15 gauge or smaller

Literature Review

SC 6

Must be capable of providing antennas/probes/applicators of various lengths including equal to or longer than 25cm

Literature Review

SC 7 FDA Approval Literature Review

SC 8

Manufacturer Warranties - should outline any length and coverage of warranties/guarantees associated with their products, as these can provide assurance of quality and reliability to the government

Literature Review

For each product (brand name and part number), the response must include descriptive literature demonstrating the product meets or exceeds the salient characteristics (SC) specified above.

The Government's intent is to include all ancillary items to ensure the equipment can function as designed by the OEM and as clinically required. Vendors are encouraged to provide any product solution or configuration so long as they meet the salient characteristics. Additionally, responses can include any additional product that may be beneficial. These items must be clearly identified by brand name and part number.

Responses to this Sources Sought Notice shall include the following:

1. Does vendor offer an annual service plan, Yes or No?

a. If Yes:

i. What does the plan cover?

ii. Does plan cover software updates only?

iii. Does the plan cover parts repair or replacement only?

iv. Does the plan cover both software and parts?

b. Vendor is requested to provide documentation that shows information on their service plan.

c. Is the service provided by the OEM or a subcontractor?

2. Full name and address of company

3. DUNS number/ CAGE Code/ SAM UIE

4. Business Size

5. Manufacturer or Distributor

a. If distributor provide full name, business size and address of manufacturer.

6. Country of Origin designation for all products

7. Ability to provide uninterrupted supply of products on a national scale

8. Technical Literature that clearly shows product(s) meet the identified salient characteristics and page numbers where each salient characteristic is met

9. Any additional product solution or configuration that would be beneficial to the clinical functionality of the product line identified.

Although not required, vendors responding to this Sources Sought may also submit a Capabilities Statement.

Contractors submitting capability statements in response to this RFI must specifically address the questions outlined above. Generic capability statements that do not directly pertain to this RFI will not be considered. Additionally, links requesting capability statements or further information will not be accessed. All responses must be submitted as an actual file attachment.