SOURCES SOUGHT
65 -- NX EQ Cryotherapy System: Tissue Ablation - Endoscopic
- Notice Date
- 4/7/2025 8:14:58 AM
- Notice Type
- Sources Sought
- NAICS
- 334510
— Electromedical and Electrotherapeutic Apparatus Manufacturing
- Contracting Office
- STRATEGIC ACQUISITION CENTER FREDERICKSBURG (36C10G) FREDERICKSBURG VA 22408 USA
- ZIP Code
- 22408
- Solicitation Number
- 36C10G25Q0075
- Response Due
- 4/21/2025 1:30:00 PM
- Archive Date
- 06/20/2025
- Point of Contact
- Levi Russin, Contract Specialist, Phone: 518-626-6757
- E-Mail Address
-
Levi.Russin@va.gov
(Levi.Russin@va.gov)
- Awardee
- null
- Description
- 1.0 DESCRIPTION The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Cryotherapy System: Tissue Ablation - Endoscopic product line as a candidate for the Department of Veterans Affairs VA-wide (otherwise referred to as national ) Non Expendable Equipment (NX) Requirements contract award. The Department of Veterans Affairs (VA) Office of Procurement, Acquisition and Logistics (OPAL) Strategic Acquisition Center (SAC) on behalf of VHA is issuing this Sources Sought 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 Varian® brand name or equal CryoCare Touch Tissue Ablation System 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 Cryotherapy System: Tissue Ablation - Endoscopic 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 Electromedical 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 proposal. You may access the SAM website at Home | SAM.gov. All offerors must be certified with the appropriate NAICS code on the SAM website. All SDVOSB/VOSB offerors must be verified in the Small Business Administration (SBA) database at Veteran Small Business Certification (VetCert) database at: Veteran Small Business Certification (sba.gov) at the time of proposal 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 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 Cryotherapy Tissue Ablation Systems are used for Cryoablation, a process that uses extreme cold (cryo) to destroy or damage tissue (ablation) whereby producing tissue necrosis at temperatures well below the freezing point of water (typically less than -20 degrees Celsius/-4 degrees Fahrenheit) using minimally invasive procedures. These systems typically consist of a central unit that provides the cryogen and includes electronic and mechanical components to perform and control the ablation; tubing to deliver the cryogen; and a probe (e.g., an applicator, needle, cannula, or catheter) to apply the cryogen directly or indirectly to the tissue. Ablation occurs when the cryogenic substance or cryogenic probe contacts the tissue. As the cells freeze, ice crystals form inside the cell and the subsequent cycle of freezing and thawing that follows actually destroys the tissue cells. Specifically, Cryotherapy System: Tissue Ablation - Endoscopic equipment are intended for use in open, minimally invasive or endoscopic surgical procedures in the areas of general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery, and thoracic surgery for prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. The following Contract Line Items are being considered: Contract Line Item# Brand Part Number Description Base Year Option Year I Option Year II Option Year III Option Year IV 0001 Varian, Inc. CRYO-38T CryoCare Touch Tissue Ablation System (CryoCare Touch Control Console, 15-inch LCD Touchscreen Monitor with folding Monitor Arm, Side Handles to facilitate mobility, Wheels with Wheel Locks, Power Supply, Argon Port (with Regulator and Supply Line), Helium Port (with Regulator and Supply Line), Cryoprobe Interface with eight (8) Cryoprobe Connections, TempProbe Interface with eight (8) TempProbe Connections, Alarm Audio Output on Back Panel, Remote Keypads, CryoCare Touch System Software, and initial 1 YR Warranty) 2 2 2 2 2 0002 Varian, Inc. CVA2400 Cryoprobe, Straight - Variable, 15 cm, 2.4 mm (8ft tubing) 100 100 100 100 100 0003 Varian, Inc. CVA2400RA Cryoprobe, V-Probe - Variable Right Angle, 15 cm, 2.4 mm (8ft tubing) 100 100 100 100 100 0004 Varian, Inc. CVA2400RA-12 Cryoprobe, V-Probe - Variable Right Angle, 15 cm, 2.4 mm (12ft tubing) 50 50 50 50 50 0005 Varian, Inc. PCS-17R Cryoprobe, Right Angled Slimline, Round Ice, 15 cm, 1.7 mm 100 100 100 100 100 0006 Varian, Inc. PCS-17RS Cryoprobe, Right Angled Short Slimline, Round Ice, 7 cm, 1.7 mm 50 50 50 50 50 0007 Varian, Inc. PCS-17 Cryoprobe, Right Angled Slimline, 15 cm, 1.7 mm 100 100 100 100 100 0008 Varian, Inc. RS-17L Cryoprobe, Right Angled Slimline, 20 cm, 1.7 mm 50 50 50 50 50 0009 Varian, Inc. PCS-24 Cryoprobe, Right Angled Slimline, 15 cm, 2.4 mm 50 50 50 50 50 0010 Varian, Inc. PCS-24L Cryoprobe, Right Angled Long Slimline, 23 cm, 2.4 mm 25 25 25 25 25 0011 Varian, Inc. R3.8 Cryoprobe, Right Angled, 13 cm, 3.8 mm 20 20 20 20 20 0012 Varian, Inc. R3.8L Cryoprobe, Right Angled Long, 28 cm, 3.8 mm 20 20 20 20 20 0013 Varian, Inc. PC-2.1E Cryoprobe, Isolis (Standard) Ellipsoidal, 15 cm, 2.1 mm 20 20 20 20 20 0014 Varian, Inc. PC-2.1EL Cryoprobe, Isolis (Long) Ellipsoidal 20 cm, 2.1 mm 20 20 20 20 20 0015 Varian, Inc. PC-2.1S Cryoprobe, Isolis (Standard) Spherical 15 cm, 2.1 mm 20 20 20 20 20 0016 Varian, Inc. PC-2.1SL Cryoprobe, Isolis (Long) Spherical 20 cm, 2.1 mm 20 20 20 20 20 0017 Varian, Inc. CRYO-48-F Cryoprobe, 29 cm, 8 mm 20 20 20 20 20 0018 Varian, Inc. CRYO-55-F TempProbe Short (for Direct Placement), 14.6 cm, 16 ga 250 250 250 250 250 0019 Varian, Inc. CRYO-204V Cryoablation Procedure Kit Variable (4 x CVA2400, 4 x Cryo-55F, 1 x Cryo-77) 25 25 25 25 25 0020 Varian, Inc. CRYO-207V Cryoablation Procedure Kit Variable (6 x CVA2400, 6 x Cryo-55F, 1 x Cryo-77) 25 25 25 25 25 0021 Varian, Inc. DP35-0551-111 Regulator, 1700 PSI with Filter 1 1 1 1 1 0022 Varian, Inc. DP35-0551-112 Regulator, 3100 PSI with Filter 1 1 1 1 1 0023 Varian, Inc. DP35-0551-905 Helium Regulator with Relief Valve 1 1 1 1 1 0024 Varian, Inc. DP35-0551-906 Helium Supply Hose 1 1 1 1 1 0025 Varian, Inc. DP35-0551-907 Argon Regulator with Relief Valve 1 1 1 1 1 0026 Varian, Inc. DP35-0551-908 Argon Regulator without Relief Valve 1 1 1 1 1 0027 Varian, Inc. DP35-0551-909 Argon Supply Hose 1 1 1 1 1 0028 Varian, Inc. CRYO-77 Uretheral Warming Catheter 50 50 50 50 50 0029 Varian, Inc. CRYO-EQ Cryoablation Equipment Rental (per case if required) 25 25 25 25 25 0030 Varian, Inc. CRYO-SVC Technical Support Services Fee (per case, if needed) 25 25 25 25 25 0031 Varian, Inc. CRYO-WARR (1) One Year Warranty and Service Maintenance for CryoCare Touch with Annual On-Site Preventative Maintenance Service. 10 10 10 10 10 The VA is seeking vendors who can provide Varian Medical Systems® CryoCare Touch Tissue Ablation System or equal as listed above which meet all the following salient characteristics: CLIN 0001 applies to SCs 1-5 CLINs 0002-0020 applies to SC 6 CLIN 0031 applies to SC 8 SC # SALIENT CHARACTERISTICS METHOD OF EVALUATION SC 1 Must provide high quality cryoablation treatment to efficiently ablate liver, prostate, kidney, and other soft tissue and tumors Literature Review SC 2 Must have a user-friendly / intuitive touchscreen user interface with integrated temperature, power, and timer to monitor, display, and control therapy duration Literature Review SC 3 Must provide audible and visual alarms and warnings Literature Review SC 4 Must include a dedicated mobile system or console cart, easy to roll with adequate space for components and tanks. Cart must have locking casters Literature Review SC 5 Must use a medical grade power cord and use standard electrical wall outlet - 110V-120V circuit, 120V 60Hz AC input Literature Review SC 6 Must provide probes / applicators / needles of various lengths including equal to or longer than 23 cm with a quick release and connect capability Literature Review SC 7 Must be FDA approved. Must demonstrate compliance with requirements of widely accepted product safety standards, as determined through independent testing by organizations such as the American National Standards Institute (ANSI), Underwriters Laboratories (UL), American Section of the International Association for Testing Materials, and International Electrotechnical Commission (IEC) Literature Review SC 8 Manufacturer Warranties - should outline any length and coverage of warranties/guarantees associated with their products, as these can provide assurance of quality and reliability to the government Literature Review Evaluation Sub-factors: Safety All safety features and functions of the offered equipment will be evaluated. Areas may include but are not limited to the following: Power and Temperature Sensors Probe/Applicator/Needle Power Settings for Ice Formation Control Design All design features and functions of the offered device will be evaluated. Areas may include but are not limited to the following: Centralized Control / Consolidated Touchscreen User Interface Availability of Various Probe/Applicator/Needle Sizes (length and gauged thickness) Supports the Simultaneous use of Multiple Probes/Applicators/Needles Cryo/Cooling System Availability of Distal Energy Control and Ice-Ball Formation Capable of Storing/Retrieving Case Logs Space Requirements / Footprint Performance Device will be evaluated for its ability to perform its intended function. Areas may include but are not limited to: System Cart Mobility and Functionality Ease of Use / Streamlined Workflow Ability to be Sanitized Using Hospital Approved Disinfectants/Cleaners Quality/Construction All aspects of construction and quality of material of the device will be evaluated. Areas may include but are not limited to the following: Life Span / Durability Training Service Program For each product (brand name and part number), the response must include descriptive literature demonstrating the product meets or exceeds the SCs specified above. The Government's intent is to include all ancillary items to ensure the equipment can function as designed by the Original Equipment Manufacturer and as clinically required. Vendors are encouraged to provide any product solution or configuration so long as they meet the SCs. 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 Identifier (UEI) number; 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 SCs (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 may also submit a Capabilities Statement.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/2f99d5ef2c6449feb5dc6d7b0165cb0d/view)
- Place of Performance
- Address: Enterprise-wide
- Record
- SN07400242-F 20250409/250407230055 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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