6525--Werewolf Coblation System

Active

Contract Opportunity

This request for information (RFI/Sources Sought) is issued solely for information and planning purposes. This is NOT a solicitation.
THERE ARE 19 QUESTIONS AT THE BOTTOM OF THIS DOCUMENT. PLEASE ANSWER THEM COMPLETELY AND THOROUGHLY.
The submission of pricing, capabilities for planning purposes, and other market information is highly encouraged and allowed under this RFI in accordance with (IAW) Far 15.201(e).
DISCLAIMER
This RFI is issued solely for information and planning purposes and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. IAW FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.
SOURCES SOUGHT/RFI DESCRIPTION
This is NOT a solicitation announcement. This is a Sources Sought Notice / RFI only. The purpose of this Sources Sought Notice / RFI is to gain information about potential qualified sources and their size classification relative to NAICS 334510 (size standard of 1,250 Employees). Responses to this Sources Sought Notice / RFI will be used by the Government to make appropriate acquisition decisions. After review of the responses to this Sources Sought Notice / RFI, further RFIs and/or a solicitation or other announcements may be published.
The Department of Veterans Affairs (VA) is seeking sources capable of providing an arthroscopic surgical device and components.
Manufacturer: Smith & Nephew, Inc.
Item Description: Werewolf Ent
Quantity: 1
Item Number: 72290144

Manufacturer: Smith & Nephew, Inc.
Item Description: Werewolf Ent 8-Pin Adapter
Quantity: 1
Item Number: 72290136

Manufacturer: Smith & Nephew, Inc.
Item Description: ENT WW Power Cord/Manual #US Eng
Quantity: 1
Item Number: 72290088

Manufacturer: Smith & Nephew, Inc.
Item Description: Wired Foot Pedal
Quantity: 1
Item Number: 72290007

Equal to product Information:
Main component: Arthroscopic Surgical Device and components

Salient Characteristics

Must:
Must have a Power On/Off button.
Must provide automated outflow control to deliver ablation performance making the system safe for use on all joint soft tissue.
Must have Technology Modes including High, medium, and low.
Must have features:
Three ablation and coagulation modes for desired tissue effect: allowing user to control the mode from either the wand, foot pedal or touch screen interface.
Must have an integrated Pump: Designed to provide consistent saline delivery for efficient plasma formation.
Must have real-time temperature monitoring of the intra-articular fluid.
Must have features of safety mechanism that detect when a wand is in close proximity to metal, automatically suspending delivery to prevent potential harm or burn to the patient.

The list of salient characteristics is intended to be descriptive, not restrictive, of the supplies/services that are required.
If your company is interested and capable of providing the required supplies, please provide the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions:
(1) Submit your capabilities statement illustrating how your organization can/cannot meet the list of salient characteristics requirements. For instances where your company cannot meet the salient characteristics requirement(s), please explain. For instances where your company can meet the salient characteristics requirement(s), please show how your company meets/exceeds each requirement.
(2) Please review the list of salient characteristics requirements and provide any additional feedback or suggestions. If none, please reply as N/A.
(3) Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran-Owned Small Business (SDVOSB), Veteran-Owned Small Business (VOSB), HUBZone, Woman Owned Small Business (WOSB), Large Business, etc.
(4) Is your company considered small under the NAICS code identified in this RFI?
(5) Are you the manufacturer, authorized distributor, and/or can your company provide a solution to the required supplies/services described in the list of salient characteristics?
(6) If you are a large business, do you have any designated/authorized distributors? If so, please provide their company name, telephone, point of contact and size status (if available).
(7) If you re a small business and you are an authorized distributor/reseller for the items identified above, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified.
(8) Limitations on Subcontracting: How does your business ensure compliance with the limitations on subcontracting as outlined in 13 CFR § 125.6?
(9) Are the items you are identifying/providing considered Commercial of the Shelf (COTS) items as defined in FAR Part 2.101 under commercial items?
(10) Non-Manufacturer Rule: If applicable, can you confirm your business complies with the Non-Manufacturer rule? Specifically, does your company: Provide a product from a small business manufacturer or processor? Not exceed 500 employees? Primarily engage in the retail or wholesale trade and normally sell the type of item being supplied? Take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice?
(11) Please indicate whether your product conforms to the requirements of the Buy American Act?
(12) What is your lead time to deliver a single unit with all components? Is there scale in lead time with greater quantities? Please elaborate.
(13) What is estimated life span of your solution? What support/services does that entail?
(14) Does your proposed equipment have FDA clearance? Please specify what FDA clearance(s) have been obtained.
(15) Does your organization offer a leasing solution? Please elaborate.
(16) Does your company have a Federal Supply Schedule (FSS) GSA/NAC/SAC/BPA/NASA SEWP or any other Federal Government contract? If so, please provide the contract number(s).
(17) If you are an FSS GSA/NAC/SAC/BPA/NASA SEWP or any other Federal Government contract holder, are all the items/solutions you are providing information about available on your schedule/contract? Please state if all or some items are available on the contract.
(18) General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award.
(19) Please provide your SAM.gov Unique Entity ID/Cage Code number.
Responses to this notice shall be submitted via email to Nathan.munson@va.gov. Telephone responses will not be accepted. Responses must be received no later than Tuesday, August 19th, 2025 by 4:00 PM EST.
All responses to this Sources Sought/RFI will be used for planning purposes only. Responses to this Sources Sought Notice / RFI are not considered a request to be added to a prospective bidders list or to receive a copy of the solicitation. If further RFIs and/or a solicitation or other announcement is issued as a result of the information provided from this RFI, all interested parties must respond to the specific posting separately IAW the specifications of that announcement.

Attachments/Links