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.