6515--NX EQ remOVE DC Impulse Generator (VA-26-00004179)

Closed Pre-Solicitation Posted

Solicitation number
36C10G25Q0101
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Place of performance
Nationwide, United States

Notice details come from SAM.gov. Updated .

About this opportunity

The Department of Veterans Affairs (VA) is seeking vendors through a Sources Sought Notice to provide the remOVE DC Impulse Generator, a specialized medical device used to fragment and remove endoscopic clips (OTSCA and FTRDA) in the digestive tract. The VA's Non-Expendable Equipment National Program intends to award a single national Requirements contract for this unique system, which is FDA certified specifically for Ovesco OTSC and FTRD clip removal and has no FDA-certified alternatives available. Vendors must demonstrate their ability to meet five salient characteristics including endoscopic clip cutting and removal capability, FDA 510K certification, secure fragment removal via grasping tools, a two-year warranty, and provision of a custom protective case. The evaluation will be conducted through literature review of technical documentation, and vendors must provide comprehensive company information including DUNS number, business size, manufacturer details, country of origin, and evidence of nationwide supply capabilities. Responses to this Sources Sought Notice are due by July 25, 2025, at 2:00 PM Eastern Time.

This procurement does not utilize any set-aside designation and is open to all eligible vendors, whether manufacturers or distributors of the Ovesco-manufactured equipment. The contract structure includes a base period of 12 months with four additional 12-month option periods, potentially spanning up to five years total. The solicitation encompasses six contract line items including the main impulse generator unit, protective case, two different cutter sets, a foreign body retrieval set, and an OTSG Xcavator tool. No specific award values or budget ranges are disclosed in this preliminary notice, and no current incumbents or contractors are identified. Vendors are encouraged to propose additional beneficial product configurations and must demonstrate their ability to provide uninterrupted supply on a national scale to support VA medical centers and facilities nationwide.

Notice text

Sources Sought Notice

Sources Sought Notice

Sources Sought Notice

*= Required Field

Sources Sought Notice

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.

Contract Line Items

Manufacture

Part Number

Description

0001

Ovesco

400.01

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

0002

Ovesco

810100

remOVE DC Impulse Protective Roller Case

0003

Ovesco

400.02.01s

remOVE DC Cutter Set 12

0004

Ovesco

400.02.02s

remOVE DC Cutter Set 14

0005

Ovesco

400.05

remOVE Foreign Body Retrieval Set

0006

Ovesco

200.15

OTSG Xcavator

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.

SC #

SALIENT CHARACTERISTICS

METHOD OF EVALUATION

Applicable CLIN

VENDOR S PROVIDE PAGE # WHERE EACH MTR IS MET IN YOUR TECHNICAL LITERATURE (SC Literature Map)

SC 1

Used for endoscopic OTSC® and FTRD® clip cutting and removal

Literature Review

0001, 0003 - 0006

SC 2

FDA 510K Certified

Literature Review

0001, 0003 - 0006

SC 3

Clip fragments are securely removed via grasping and cap tool

Literature Review

0001, 0005 and 0006

SC4

Two Year Warranty

Literature Review

0001

SC 5

Custom case for remOVE DC Impulse Generator

Literature Review

0002

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:

Full name and address of company

DUNS number/ CAGE Code/ SAM UIE

Business Size

Manufacturer or Distributor - If distributor provide full name, business size and address of manufacturer.

Country of Origin designation for all products.

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

Vendors are requested to provide documentation that shows information on their service plan.

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

If Yes:

What does the plan cover?

Does plan cover software updates only?

Does the plan cover parts repair or replacement only?

Does the plan cover both software and parts?

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

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.

Files

File Type Posted
36C10G25Q0101.docx DOCX document

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