RFI_SSN Description - Piezo Surgery Syst. - Q0801.docx

36C26225Q0801

THIS REQUEST FOR INFORMATION (RFI) / SOURCES SOUGHT NOTICE IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES. THIS IS NOT A SOLICITATION.

SUBMISSION OF INFORMATION ABOUT PRICING, DELIVERY, THE MARKET, AND CAPABILITIES IS HIGHLY ENCOURAGED AND ALLOWED UNDER THIS RFI FOR PLANNING PURPOSES IN ACCORDANCE WITH (IAW) FAR 15.201(e).

DISCLAIMER

This notice is issued solely for information and planning purposes and does not constitute a solicitation. All information received in response to this notice 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 notice.

RFI/SOURCES SOUGHT DESCRIPTION

This is NOT a solicitation announcement. This is an RFI/Sources Sought Notice only. The purpose of this notice is to gain information about potential qualified sources and their size classification relative to NAICS 339112 (size standard of 1,000 Employees). Responses to this notice will be used by the Government to make appropriate acquisition decisions. After review of the responses to this notice, further RFIs/Sources Sought Notices and/or solicitation or other notices may be published.

The Department of Veterans Affairs (VA) is seeking sources capable of providing PIEZO SURGERY SYSTEM that at a minimum meets the brand name and/or can provide an equal product/solution for the VA San Diego Healthcare System using the draft Salient Characteristics listed below.

Equal to Product Information:

Main component: Piezo Surgery System Possible Capabilities: See the following Salient Physical and Functional Characteristics for this requirement:

1. Must be quick and effective cutting action

2. Must be able to improve intra-operative control and surgical sensitivity.

3. Must have maximum flexibility in designing osteotomic lines.

4. Micro-vibrations generated must be effective at cutting on mineralized tissue.

5. Device micro-vibrations must allow perfect control of the cutting action.

6. Cavitation effect must reduce the risk of bone necrosis

7. Cavitation must create a blood -free surgical field.

Brand-Name Product Information:

Manufacturer: Mectron Medical Type: Piezosurgery Flex Device System

5170002

Piezosurgery Flex Device

1 UN

3120127

Piezosurgery Medical Handpiece

2 EA

SCR-093-N

Medical Torque Wrench

2 EA

The above product information with the attached salient characteristics is intended to be descriptive, not restrictive, of the sought-after supplies to satisfy the Government's need.

If your company is interested and capable of providing the required supplies/services, please provide the information indicated below. Response to this notice should include your company name, address, point of contact, and size of business pursuant to the following questions:

(1) Submit your capabilities statement illustrating how your organization can/cannot meet the list of requirements listed above. For instances where your company cannot meet the requirement(s), please explain. For instances where your company can meet the requirement(s), please show how your company meets or exceeds each requirement.

(2) Please review the 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 an equal solution to the required supplies/services described in the SALIENT CHARACTERISTICS/SPECIFICATIONS?

(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 organization offer Trade-In/Rebate Credits? 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 DERONTE.REID@VA.GOV with subject line (Response to Notice: 36C26225Q0801). Responses must be received no later than Thursday, April 17, 2025 by 4:00 PM PST.

All responses to this notice will be used for planning purposes only. Responses to this RFI/ Sources Sought Notice are not considered a request to be added to a prospective bidders list or to receive a copy of the solicitation. If further RFIs/Sources Sought Notices and/or a solicitation or other notice is issued as a result of the information provided from this notice, all interested parties must respond to the specific posting separately IAW the specifications of that notice.

(End of Notice)