S02 - 36C25622Q1349 Amendment 0001.pdf

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Attached to
6515--Radio Frequency Ablation (RFA) Generator Federal contract opportunity
Solicitation number
36C25622Q1349
Issued by
Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 16

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36C25622Q1349_1.docx DOCX document
S02 - 36C25622Q1349 - Radio Frequency Ablation Generator.pdf PDF
P03 - Brand Name Justification - Redacted.pdf PDF
36C25622Q1349.docx DOCX document

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Text version

5. PROJECT NUMBER (if applicable)

CODE 7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER 3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO. 1. CONTRACT ID CODE

FACILITY CODE CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR

ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office. is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES

SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER 16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30 PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243

(Type or print) (Type or print)

(Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code)

(If other than Item 6)

(Specify type of modification and authority)

(such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

1 3

09-08-2022

36C256

Department of Veterans Affairs

Network Contracting Office 16

5075 Westheimer Road, Suite 750

Houston TX 77056-5643

36C256

Department of Veterans Affairs

Network Contracting Office 16

5075 Westheimer Road, Suite 750

Houston TX 77056-5643

To all Offerors/Bidders

36C25622Q1349

08-30-2022

X x x

Extend quote date 09-12-2022 at 10AM CST x 1(one)

The purpose of this amendment is to extend solicitation due date and revised the Price/Cost Schedule.

A. See updated B.2 Price/Cost Schedule.

B. Extend solicitation due date to September 12, 2022 at 10:00 AM CST.

C. This amendment will need to be signed and returned with quote submission to be eligible for award.

Stephanie Keo

Contracting Officer

VA-VHA-2020-49890DD7

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBE

R

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1.00 EA

Halofelx Energy Generator X1 Request (1) Radio Frequency Ablation (RFA) including installation, training by vendor representative, (1) service manual, and (1) operator manual.

PRINCIPAL NAICS CODE: 339112 – Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 – Medical and Surgical Instruments, equipment and Supplies POP Begin TBD POP End: TBD

0002 1.00 EA

CART-100 Halo Cart X1

PRINCIPAL NAICS CODE: 339112 – Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 – Medical and Surgical Instruments, equipment and Supplies

POP Begin TBD

POP End: TBD

0003 1.00 EA

Barrx Flex RFA Energy 3 Year Service Plan

PRINCIPAL NAICS CODE: 339112 – Surgical and Medical Instrument Manufacturing

PRODUCT/SERVICE CODE: 6515 – Medical and Surgical Instruments, Equipment and

Supplies

POP Begin TBD

POP End: TBD

GRAND TOTAL

BRAND NAME: SALIENT CHARACTERISTICS

The Medtronic Barrx RFA Radio Frequency Ablation (RFA) device needs to meet the following requirements:

• Precisely control the depth and uniformity of tissue ablation

• Seamless ability to change between circumferential and spot treatment areas during procedure

• Have multiple ablation catheter options, including balloon and focal catheters, for ablation of large tissue lesions or focus tissue for controlling patches of dysplasia

• Offer self adjusting balloon catheter, eliminating sizing, and reducing procedure time

• Automatically adjusts default power density settings to match catheter

• Must automatically sense catheter selection

• Include footswitch with hands free activation of ablation

• Must be able to ablate large lesions or provide ablation to focused areas.

• Provide active settings to operator of amount of energy being applied

• Allow either foot peddle or hand held operation of ablation activation.

• Cart with storage space for catheters and guide wires

• Rapid delivery of ablative energy for reduced procedure time:

Ready to deliver next dose in < 2 seconds

• Track and display total number of ablations

• Platform for future clinical and product innovation

(End of B.2 Price/Cost Schedule)

2022-09-08T11:22:31-0500
Stephanie R. Keo 406871

File details come from the government source that posted it. Updated .