6515--NX EQ Cryotherapy System: Tissue Ablation - Endoscopic

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 Boston Scientific brand name or equal ICEfx Cryotherapy 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: CLIN Brand Part Number Item Description Base Year Option Year 1 Option Year 2 Option Year 3 Option Year 4 0001 BSCI, Inc FPRCH8000-02 ICEfx Cryoablation System (Includes: ICEfx Cryoablation Console, 10.1-inch Touchscreen Monitor, Power Cord, Console Cover, USB Flash Drive (4 GB), Wrench, Accessory Bag, Argon Gas Supply Line, Dual Cylinder Adapter, User Manual, Quick Reference Guide, and 1 year warranty) 1 1 1 1 1 0002 BSCI, Inc FPRCH8010 ICEfx Cart, With Wheels and Wheel Locks 1 1 1 2 2 0003 BSCI, Inc H7493968535330 IceRod 1.5 CX, Straight, 17.5 cm, 17 ga, Red 50 50 50 50 50 0004 BSCI, Inc FPRPR3533 IceRod 1.5 CX, Angled 90º, 17.5 cm, 17 ga, Red 25 25 25 25 25 0005 BSCI, Inc H7493968333170 IceSeed 1.5 CX, Straight, 10 cm, 17 ga, Black 50 50 50 50 50 0006 BSCI, Inc H7493967433170 IceSeed 1.5 CX, Angled 90º, 17.5 cm, 17 ga, Black 25 25 25 25 25 0007 BSCI, Inc H7493967233100 IceSeed 1.5 CX S, Angled 90º, 10 cm, 17 ga, Black 25 25 25 25 25 0008 BSCI, Inc H7493968435730 IceSphere 1.5 CX, Straight, 17.5 cm, 17 ga, Yellow 50 50 50 50 50 0009 BSCI, Inc FPRPR3573 IceSphere 1.5 CX, Angled 90º, 17.5 cm, 17 ga, Yellow 25 25 25 25 25 0010 BSCI, Inc FPRPR3561 IceSphere 1.5 S, Angled 90º, 17.5 cm, 17 ga, Yellow 25 25 25 25 25 0011 BSCI, Inc FPRPR3604 IceForce 2.1 CX, Straight, 17.5 cm, 14 ga, Gray 50 50 50 50 50 0012 BSCI, Inc FPRPR3602 IceForce 2.1 CX, Angled 90º, 17.5 cm, 14 ga, Gray 25 25 25 25 25 0013 BSCI, Inc FPRPR3618 IceForce 2.1 CX L, Angled 90º, 23 cm, 14 ga, Gray 25 25 25 25 25 0014 BSCI, Inc FPRPR3603 IcePearl 2.1 CX, Straight, 17.5 cm, 14 ga, White 50 50 50 50 50 0015 BSCI, Inc FPRPR3601 IcePearl 2.1 CX, Angled 90º, 17.5 cm, 14 ga, White 25 25 25 25 25 0016 BSCI, Inc FPRPR3617 IcePearl 2.1 CX L, Angled 90º, 23 cm, 14 ga, White 25 25 25 25 25 0017 BSCI, Inc FPRCH4004 Dual Tank Cylinder Gas Adapter, 5M PSI 1 1 1 1 1 0018 BSCI, Inc SRVM001GALLIFXFRPM Preventative Maintenance Services, Required Bi-Annual (2 Year Interval), Single Unit 1 1 1 1 1 0019 BSCI, Inc SRVM001GALLIFXEC01 EssentialCare Service Agreement, Single Unit, 1 Year- Point of Sale 1 0 0 0 0 0020 BSCI, Inc SRVM001GALLIFXEC02 EssentialCare Service Agreement, Single Unit, 2 Year- Point of Sale 0 1 0 0 0 0021 BSCI, Inc SRVM001GALLIFXEC03 EssentialCare Service Agreement, Single Unit, 3 Year- Point of Sale 0 0 1 0 0 0022 BSCI, Inc SRVM001GALLIFXEC04 EssentialCare Service Agreement, Single Unit, 4 Year- Point of Sale 0 0 0 1 1 0023 BSCI, Inc SRVM001GALLIFXEC05 EssentialCare Service Agreement, Single Unit, 1 Year- POST Warranty 1 0 0 0 0 0024 BSCI, Inc SRVM001GALLIFXEC06 EssentialCare Service Agreement, Single Unit, 2 Year- POST Warranty 0 1 0 0 0 0025 BSCI, Inc SRVM001GALLIFXEC07 EssentialCare Service Agreement, Single Unit, 3 Year- POST Warranty 0 0 1 0 0 0026 BSCI, Inc SRVM001GALLIFXEC08 EssentialCare Service Agreement, Single Unit, 4 Year- POST Warranty 0 0 0 1 1 Vendors who propose brands that meet all the salient characteristics (SCs) below should provide that information in the chart below in their response to this Sources Sought Notice. CLIN Brand Part Number Item Description Base Year Option Year 1 Option Year 2 Option Year 3 Option Year 4 0001 1 1 1 1 1 0002 1 1 1 2 2 0003 50 50 50 50 50 0004 25 25 25 25 25 0005 50 50 50 50 50 0006 25 25 25 25 25 0007 25 25 25 25 25 0008 50 50 50 50 50 0009 25 25 25 25 25 0010 25 25 25 25 25 0011 50 50 50 50 50 0012 25 25 25 25 25 0013 25 25 25 25 25 0014 50 50 50 50 50 0015 25 25 25 25 25 0016 25 25 25 25 25 0017 1 1 1 1 1 0018 1 1 1 1 1 0019 1 0 0 0 0 0020 0 1 0 0 0 0021 0 0 1 0 0 0022 0 0 0 1 1 0023 1 0 0 0 0 0024 0 1 0 0 0 0025 0 0 1 0 0 0026 0 0 0 1 1 The Department of Veterans Affairs (VA) is seeking vendors who can provide the Boston Scientific ICEfx Cryotherapy Tissue Ablation System or equal as listed above which meet all the following salient characteristics: CLIN 0001 applies to SCs 1-3 and 6 CLIN 0002 applies to SC 4 CLINs 0003-0016 applies to SC 5 SC # SALIENT CHARACTERISTICS METHOD OF EVALUATION SC 1 Must be FDA approved to provide cryoablation treatment to effectively ablate liver, prostate, kidney, and other soft tissue tumors Literature Review SC 2 Must have a touchscreen user interface with integrated temperature, power, and timer to monitor, display, and control treatment duration Literature Review SC 3 Must provide audible and visual alarms, alerts, and/or warnings Literature Review SC 4 Must include a dedicated mobile system/console cart with locking casters and adequate space for components and tanks Literature Review SC 5 Probes/Applicators/Needles must be offered in various lengths including equal to or longer than 23 cm with a quick release/connect capability Literature Review SC 6 Must provide a minimum one-year Manufacturer warranty Literature Review Evaluation Sub-factors: Safety Areas may include but are not limited to the following: Power and Temperature Sensors Probe/Applicator/Needle Power Settings for Ice Formation Control Design 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 Areas may include but are not limited to: System Cart Mobility and Functionality Streamlined Workflow Ability to be Sanitized Using Hospital Approved Disinfectants/Cleaners Quality/Construction Areas may include but are not limited to the following: Expected Life Span Training Service Agreement 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.