6515--NX EQ Radiofrequency Therapy System: Tissue Ablation

Sources Sought Notice Sources Sought Notice Sources Sought Notice *= Required Field Sources Sought Notice 1.0 DESCRIPTION The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Radiofrequency Therapy System: Tissue Ablation product line as a candidate for a VA-wide (otherwise referred to as national ) single Requirements contract award. The Department of Veterans Affairs (DVA) Office of Procurement, Acquisition and Logistics (OPAL) Strategic Acquisition Center (SAC) on behalf of VHA is issuing this Sources Sought Notice in accordance with the FAR 10.002(b)(2)to determine the availability and technical capabilities of qualified sources. The SAC in conjunction with VHA is seeking a qualified source to provide Stryker MultiGen 2® brand name or equal Radiofrequency Therapy System: Tissue Ablation on an agency wide basis. VA intends to award a Requirements Contract with Firm-Fixed Price (FFP) orders IAW FAR 16.503, Requirements Contract to a supplier of this equipment. Vendors will be required to deliver Radiofrequency Therapy System: Tissue Ablation to VA medical centers and facilities throughout the United States. The anticipated period of performance is for one 12-month base period with four 12-month option periods from the date of award. However, the Government's decision as to whether or not to continue with the contract, upon annual review, will be based upon successful performance during each previous year and continued need. The associated North American Industrial Classification System (NAICS) code for this procurement is 334510 Electro Medical and Electrotherapeutic Apparatus Manufacturing and the associated size standard is 1,250 employees. The FAR Provision found at 52.204-7(b)(1) requires that All interested Offerors must be registered in SAM prior to submitting an offer or quotation. You may access the SAM website at https://www.sam.gov/portal/public/SAM/. All offerors must be certified with the appropriate NAICS code on the SAM website. All SDVOSB/VOSB offerors must be verified in the Vendor Information Pages (VIP) database at: https://www.vip.vetbiz.va.gov/ at the time of quote submission. This notice is for planning purposes only and does not constitute a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. This Sources Sought Notice is part of a continuous process for obtaining the latest information on the commercial status of the industry with respect to their current and near-term abilities. The information provided herein is subject to change and in no way binds the Government to solicit for, or award, a competitive contract. It is emphasized that this is a notice solely for planning and informational purposes. 2.0 SCOPE Radiofrequency Therapy System: Tissue Ablation deliver medium frequency electric current (in the range of 300 kHz to 3 MHz) for the destruction of tissue, lesioning of nerves, or for pain management. Radiofrequency generators should not be confused with high frequency (greater than 3 MHz) tumor ablation devices, or with general-purpose electrosurgical units used to cut and coagulate tissue. Radiofrequency generators produce a protein-denaturing alternating current that is used to selectively obliterate certain tissues without collateral damage to surrounding tissue. Nerve lesioning applications include treatment for trigeminal neuralgia (a form of chronic facial pain) and severe lower back and leg pain by obliterating pain-carrying nerve fibers. The following Contract Line Items are being considered: Contract Line Items # Part Number Description BS YR OY 1 OY 2 OY 3 OY 4 0001 8400-000-000 Multigen2 RF Generator 20 20 20 20 20 0002 8400-800-000 Multigen2 Splitter Cable 20 20 20 20 20 0003 0406-850-200 Monopolar Return Electrode Cable 20 20 20 20 20 0004 8400-825-010 VENOM100M Multigen2 Electrode 160 160 160 +1 (555) 000-0000 8400-825-015 VENOM15000M Multigen2 Electrode 80 80 80 80 80 The Department of Veterans Affairs (VA) is seeking vendors who can provide Stryker MultiGen 2® Radiofrequency Therapy System: Tissue Ablation as listed above or equal commodities which meet all of the following salient characteristics: SC # SALIENT CHARACTERISTICS METHOD OF EVALUATION APPLICABLE CLINS PAGE # WHERE SC IS FOUND IN TECHNICAL LITERATURE SC 1 FDA Cleared Literature Review 0001 - 0005 SC 2 Therapeutic Energy Delivered by Generator Output Power Over 50 - 100 Watt Literature Review 0001 - 0005 SC 3 Start Safety Features Literature Review 0001 - 0005 SC 4 Stimulator Radiofrequency Output Range 3 -10 Volts Literature Review 0001 - 0005 SC 5 Temperature Check Safety Features Literature Review 0001 - 0005 For each product (brand name and part number), the response must include descriptive literature demonstrating the product meets or exceeds the salient characteristics (SC) specified above. 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 Unique Entity ID 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 Technical Literature that clearly shows product(s) meet the identified salient characteristics (if submitting an or-equal item) 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 Notice may also submit a Capabilities Statement.