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

Active

Contract Opportunity

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.

Attachments/Links