36C10G25Q0112.docx

Combined Synopsis/Solicitation Notice

GENERAL INFORMATION

SET-ASIDE

OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

POINT OF CONTACT*

Contract Specialist Daleta Coles daleta.coles@va.gov Contracting Officer Hosea Berkley hosea.berkley@va.gov

PLACE OF PERFORMANCE

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

Combined Synopsis/Solicitation Notice

Solicitation Number:

36C10G25Q0112 Notice Type:

Combined Synopsis/Solicitation Synopsis: COMBINED SYNOPSIS/SOLICITATION This is a combined synopsis/solicitation for brand name or equal commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; offers are being requested, and a written solicitation will not be issued.

Solicitation number 36C10G25Q0112 is issued for this combined synopsis/solicitation; this solicitation is being issued as a Request for Quote (RFQ). This combined synopsis/solicitation incorporates provisions and clauses in effect through Federal Acquisition Circular (FAC) 2025-06, dated August 27, 2025. The statutory authority permitting other than full and open competition is 41 U.S.C. 3304(a)(1) as implemented by the Federal Acquisition Regulation (FAR) 6.302-1(c), “Only One Responsible Source and no Other Supplies or Services Will Satisfy Agency Requirements, Application for Brand-Name Descriptions.”

Requirement Description:

VA has a requirement to purchase NX EQ remOVE DC IMPULSE GENERATORS to deliver patient care at its VA Medical Centers Nationwide and in outlying territories. The remOVE DC Impulse Generator is a medical device used to fragment OTSC® (Over the Scope Clip) and FTRD® (Full Thickness Resection Device) clips, which are endoscopic instruments used in the digestive tract. It's part of a system designed to remove these clips, when necessary, for example, if they are mispositioned, causing complications, or if the procedure needs to be repeated. The REMOVE DC IMPULSE GENERATOR is a unique system that is designed to remove manufacturer's specific endoscopic clips. It is FDA certified for this functionality on Ovesco OTSC® and FTRD® clips only. There are no other systems available that are FDA certified to perform this function for OTSC® and FTRD® clip removal.

A single award Requirements contract will be awarded IAW FAR 52.211-6 Brand Name or Equal in accordance with all terms, conditions, provisions, specifications, and schedule of this solicitation herein. Offers shall contain the terms for cost/price and technical capabilities of the brand name or equal equipment. The Government reserves the right to award without discussions.

The associated North American Industrial Classification System (NAICS) code for this procurement is 334510 – Endoscopic equipment, electromedical (e.g., bronchoscopes, colonoscopes, cystoscopes), manufacturing, Product Service Code: 6515 – Medical and Surgical Instruments, Equipment, and Supplies. and the associated size standard is 750 employees. This procurement action is issued as a Sole Source, Full and Open competition after exclusion of one or more sources.

This acquisition is for a single award Requirements contract in accordance with FAR Part 16.5 for Ovesco ® brand name or equal NX EQ remOVE DC IMPULSE GENERATORS and related equipment and accessories as identified in ATTACHMENT A – PRICE COST SCHEDULE - NX EQ remOVE DC IMPULSE GENERATORS. All interested companies shall provide an offer for all Contract Line-Item Numbers (CLINs) listed in ATTACHMENT A – PRICE COST SCHEDULE – NX EQ remOVE DC IMPULSE GENERATORS and paragraph 2 below.

The ordering period is for one 12-month base year with four 12-month option years. Delivery is FOB destination.

Firm-Fixed Price Orders will be placed against this contract in writing and will provide the delivery locations, delivery dates and exact quantities.

The FAR provision at 52.212-1, Instructions to Offerors – Commercial Products and Commercial Services, applies to this acquisition including attached addenda (ATTACHMENT D) to the provision.

The FAR provision at 52.212-2, Evaluation -- Commercial Products and Commercial Services, and the specific evaluation criteria as attached addenda (ATTACHMENT D) also applies to this acquisition.

The Offeror is to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Products and Commercial Services, with its offer.

Clause at 52.212-4, Contract Terms and Conditions -- Commercial Products and Commercial Services, applies to this acquisition and a statement regarding any addenda to the clause. Addendum is attached (ATTACHMENT C).

Clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Products and Commercial Services, applies to this acquisition and a statement regarding which, if any, of the additional FAR clauses cited in the clause are applicable to the acquisition. Addendum is attached (ATTACHMENT C).

All interested offerors must be registered in the System for Award Management (SAM) prior to submitting an offer. You may access SAM at https://sam.gov/SAM/.

Questions regarding this combined synopsis/solicitation are due via email by 11:59 PM ET on November 21, 2025, to Contract Specialist, Daleta Coles at daleta.coles@va.gov and Contracting Officer, Hosea Berkley at Hosea.Berkley@va.gov. No calls will be accepted.

Offers are due via email by 11:59 PM ET on December 4, 2025, to Contract Specialist, Daleta Coles at daleta.coles@va.gov and Contracting Officer, Hosea Berkley at Hosea.Berkley@va.gov.

1. SCOPE OF WORK:

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the remOVE DC Impulse Generator product line as a candidate for a VA-wide (otherwise referred to as “national”) single Requirements contract award.

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program is seeking offerors that can provide remOVE DC Impulse Generator. The remOVE DC Impulse Generator is a medical device used to fragment OTSC® (Over the Scope Clip) and FTRD® (Full Thickness Resection Device) clips, which are endoscopic instruments used in the digestive tract. It's part of a system designed to remove these clips, when necessary, for example, if they are mispositioned, causing complications, or if the procedure needs to be repeated.

The remOVE DC Impulse Generator is a unique system that is designed to remove manufacturer's specific endoscopic clips. It is FDA certified for this functionality on Ovesco OTSC® and FTRD® clips only. There are no other systems available that are FDA certified to perform this function for OTSC® and FTRD® clip removal.

The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide remOVE DC Impulse Generator 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.

2. REQUIREMENT

This requirement will be IAW FAR clause 6.303, Brand Name which requires the quoter indicate that the product being offered is a remOVE DC Impulse Generator.

– remOVE DC Impulse electrical device for fragmentation of OTSC® and FTRD® clips in the digestive tract.

– Foot-activated switch with connector cable

– DC Cutter connection cord

– Power Cord

The Department of Veterans Affairs (VA) is seeking vendors who can provide the remOVE DC Impulse Generator as listed above which meet all the following salient characteristics: Vendors must quote product solutions that meet the salient characteristics. Products quoted in the technical volume must be captured on the Vendor’s pricing volume (Attachment A, Price Cost Schedule) of the solicitation. Vendors may quote any additional ancillary products which they deem to be essential to the functionality of the proposed solution; these items must be captured in the Vendor’s pricing volume with a quantity of zero.

*****“LOCATION IN TECHNICAL LITERATURE WHERE SC IS MET” MUST BE COMPLETED IN THE FOLLOWING TABLE (NO EXCEPTIONS):******

LITERATURE WHERE SC

IS MET

The following attachments are incorporated by reference. All criteria outlined in the attachments are applicable to this Combined Synopsis/Solicitation Notice.

See attached document: ATTACHMENT A – PRICE COST SCHEDULE - NX EQ remOVE DC Impulse Generator.

See attached document: ATTACHMENT B - CONTRACT ADMINISTRATION - NX EQ remOVE DC Impulse Generator.

See attached document: ATTACHMENT C - Contract Clauses NX EQ remOVE DC Impulse Generators.

See attached document: ATTACHMENT D - SOLICITATION PROVISIONS - NX EQ remOVE DC Impulse Generator.

See attached document: ATTACHMENT E - REPORTING TOOL - NX EQ remOVE DC Impulse Generator.

See attached document: ATTACHMENT A - PRICE COST SCHEDULE -NX EQ remOVE DC Impulse Generator.

See attached document: ATTACHMENT B - CONTRACT ADMINISTRATION - NX EQ remOVE DC Impulse Generator.

See attached document: ATTACHMENT C - Contract Clauses NX EQ remOVE DC Impulse Generators.

See attached document: ATTACHMENT D - SOLICITATION PROVISIONS - NX EQ remOVE DC Impulse Generator.

See attached document: ATTACHMENT E - REPORTING TOOL - NX EQ remOVE DC Impulse Generator.

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Combined Synopsis/Solicitation Notice