6515--644 - PROVU CAPITAL CONSOLE SET

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 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 RFI only. The purpose of this RFI is to gain information about potential small business manufacturers of the supplies below qualified sources and their size classification relative to NAICS 334510 (size standard of 1,250 Employees). Responses to this RFI will be used by the Government to make appropriate acquisition decisions. After review of the responses to this RFI, further RFIs and/or a solicitation or other announcements may be published. The Department of Veterans Affairs (VA) is seeking a laparoscopic radiofrequency ablation platform designed to treat uterine fibroids through targeted thermal destruction while preserving the uterus. The list of DRAFT characteristics is intended to be descriptive, not restrictive, of the supplies/services that are required. Model Number Description Quantity (ea) Country of Origin PCB-01 Console Set 1 PHB-03 Disposable Handpiece and Grounding Pad Set 1 Salient Characteristics: - Must have Real-Time Ultrasound Guidance for accurate localization of fibroids and procedural precision - Must have Controlled Radiofrequency Energy Delivery to ensure predictable and reproducible ablation zones, obtain temperature and impedance feedback, multi-point energy delivery within fibroids and efficient treatment of various fibroid sizes -Must have Safety Features such as automatic shutoff mechanisms, continuous monitoring of tissue response and single-use probes to maintain sterility and infection control -Must have workflow efficiency to be ability to treat multiple fibroids in a single session If your company is interested and capable of providing the required supplies and services, 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, 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 on…