6515--CANCELLATION: 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 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.