6515--Renal Denervation System_VAGLA 36C26225Q1101

Page 5 of 5 Page 1 of 2 SOURCES SOUGHT SYNOPSIS ONLY This request for information (RFI) and sources sought is issued solely for information and planning purposes only and does not constitute a solicitation. 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. The submission of pricing, capabilities for planning purposes, and other market information is highly encouraged and allowed under this RFI in accordance with FAR 15.201(e). The purpose of this sources sought/RFI is to gain knowledge of potential qualified sources, their socioeconomic status, and their size classification relative to NAICS 339112 Surgical and Medical Instrument Manufacturing size standard of 1000 employees. Responses to this sources sought will be used by the Government to make appropriate acquisition decisions. This synopsis is neither a request for competitive proposal nor a solicitation of offers. This synopsis is to assist the VA in determining sources only and a solicitation is not currently available. If a solicitation is issued it shall be announced at a later date, and all interested parties must respond to that solicitation announcement separately from responses to this RFI and sources sought. The Department of Veterans Affairs Veterans Integrated Service Network (VISN) 22 is seeking potential sources capable of supplying (1) Symplicity Spyral Renal Denervation System, Sherpa and Launcher Guide Catheters or Equivalent. Also, Valleylab REM Polyhesive Electronodes or Equivalent. These instruments will be used for blood pressure procedures at the Greater Los Angeles. The proposed action is for a firm-fixed price, short-term contract. The Government contemplates issuing one (1) solicitation for these supplies to be provided to the following facilities: VA Greater Los Angeles Healthcare System 11301 Wilshire Blvd Los Angeles, CA 90073 Contractor shall provide the following information: Vendor: Address: Telephone Number: Business Size: Socioeconomic Category (i.e. SDVOSB, 8a, VOSB, etc.): UEI Number: FSS/ GSA Contract Holder Yes No FSS/ GSA Contract Number Effective Date / Expiration Date Responses to this sources sought are not request to be added to a prospective bidders list or to receive a copy of the solicitation. Information received as a result of this notice will normally be considered solely for the purpose of determining whether conduct a competitive procurement. This notice does not represent a commitment by the Government to pay for cost incurred in the preparation and submission of information or any other cost incurred as a response to this announcement. Inquiries will only be accepted in writing via email to Jonathan.Ford1@va.gov telephone responses shall not be accepted. Please respond by July 7, 2025 at 12:00pm PT. Note* The Non-Manufacturer Rule (NMR) in accordance with 13 CFR 121.406, September 4, 2019 applies to this acquisition. a) For small business set-asides other than construction or service contracts the prime contractor that s supplying products to the government is required to cover at least 50 percent of the cost of manufacturing those products. The non-manufacturer rule is an exception to that requirement. The rule allows a small business to supply products it did not manufacture as long as those products come from another small business. b) A manufacturer is defined as a business that, with its own facilities, performs primary activities in transforming inorganic or organic substances, including the assembly of parts and components, into the end product being acquired. In other words, a manufacturer makes or produces products. Businesses may qualify as a non-manufacturer if it meets the following criteria: Does not exceed 500 employees Is primarily engaged in the retail or wholesale trade and normally sells the type of products being supplied Will supply the end products of a small business manufacturer or processor made in the United States, or obtains a waiver of such requirement See Title 13 Part 121.406 of the Code of Federal Regulations (CFR) for detailed information about the non-manufacturer rule. The Following below is a description of the Salient Characteristics for the Supplies Needed For This Requirement: Symplicity Spyral Renal Denervation System, Sherpa and Launcher Guide Catheters, Valleylab REM Polyhesive Electronodes, or Equal Salient Characteristics: - Symplicity G3 Generator (RDNG3A) or Equivalent. - Cart For Symplicity G3 Generator (RDN019) or Equivalent - Symplicity Spyral Catheter (RDN016) or Equivalent - Sherpa NX Balanced 6Fr 55-cm Guide Catheter (SB6RDND1K) or Equivalent - Sherpa NX Balanced 6Fr 55-cm guide Catheter (SB6IMAK) or Equivalent - Launcher 6Fr 55-cm guide catheter (LA6IMAK) or Equivalent - Valleylab REM Polyhesive Adult Patient Return Electrode, 9' (2.7 m) or Equivalent (E7507) - Valleylab REM Polyhesive Adult Patient Return Electrode, 15' (4.6 m) or Equivalent (E7507DB) Generator Painted and nonpainted sheet metal Polycarbonate/acrylonitrile butadiene styrene blend (external covers) Thermoplastic elastomer (cord management strap) Glass (projected capacitance touchscreen) Electrical Data RF output power 6.5 W maximum per electrode (26 W total) 20% accuracy with impedance of 175 to 200 10% accuracy with impedance of 201 to 1200 Impedance measurement 175 to 250 , 20% 251 to 700 , 10% 701 to 1200 , 15% Fuse 2 Slow-Blow (T3.15A L, 250 V), 20 x 5 mm Temperature range Measurement 37 C to 65 C, 3 C Input power 100 to 240 V ~, 50/60 Hz universal power supply, 200 VA input power rating Disconnecting the AC power cord removes AC mains power from the unit AC power cables NEMA 5-15 3.0 m Rated accessory voltage 150 Vp Maximum output voltage 150 Vp Maximum current rating 700 mA averaged over 60 s Catheters Proximal shaft: polyether block amide laminated over stainless steel Intermediate tubing: polyether block amide with braided stainless steel Distal electrode array jacket: thermoplastic urethane Electrodes: 4 RF monopolar, gold, radiopaque Tip: thermoplastic Tip marker: platinum/iridium alloy Guidewire lumen: high-density polyethylene liner Spiral shaping element: nickel/titanium Guidewire loading tool: thermoplastic Handle-ABS, thermoplastic elastomer overmold Thermocouple-T-type Not present-Latex, Phthalate