6515--NX EQ Lithotripters - Endoscopy

1.0 DESCRIPTION

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Lithotripters - Endoscopy product line as a candidate for the Department of Veterans Affairs Enterprise-wide (otherwise referred to as national ) Non-Expendable (NX) Equipment (EQ) 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 Northgate Technologies, Inc. brand name or equal Autolith Touch®, Bipolar Electrohydraulic Lithotripter on an Enterprise-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 Electrohydraulic Lithotripsy System to VA medical centers and facilities throughout the United States, CONUS and OCONUS.

The anticipated period of performance is for one (1) 12-month base period with four (4) 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 339112 Surgical and Medical Instrument Manufacturing and the associated size standard is 1,000 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

Electrohydraulic lithotripsy (EHL) systems use an electrical current to create shock waves that directly fragment stones in the body. It is commonly used with a cholangioscope to fragment large bile or pancreatic duct stones that are difficult to remove by other means. After the stones are fragmented, they are now more easily extracted by the doctor.

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

Northgate Technologies, Inc.

M005466800

AUTOLITH® Touch EHL Generator

35

34

34

34

34

0002

Northgate Technologies, Inc.

M00546620

AUTOLITH® Touch EHL Probe - SpyGlass DS

210

204

204

204

204

0003

Northgate Technologies, Inc.

M00546760

AUTOLITH® Touch Foot Switch

35

34

34

34

34

0004

Northgate Technologies, Inc.

M00546750

AUTOLITH® Touch Extender Cable

35

34

34

34

34

The VA is seeking vendors who can provide the Northgate Technologies, Inc. Autolith Touch®, Bipolar Electrohydraulic Lithotripter or equal as listed above which meet all the following salient characteristics (SC):

SC 1 applies to CLINs 0001 - 0002

SC 2 applies to CLINs 0001 0004

SC 3 applies to CLIN 0002

SC 4 applies to CLINs 0001 0002

SC 5 applies to CLIN 0001

SC 6 applies to CLINs 0001 and 0003

SC #

SALIENT CHARACTERISTICS

METHOD OF EVALUATION

SC 1

Is indicated for biliary tract stone treatments

Literature Review

SC 2

FDA 510K Approved

Literature Review

SC 3

Probe is reinforced to prevent probe kinking, tip integrity or breaking for intracorporeal EHL use

Literature Review

SC 4

Generates shockwave, or pulse, to break up calculi (stones)

Literature Review

SC 5

Adjustable energy settings which allow the operator to modulate the power of the shockwaves

Literature Review

SC 6

Must have a foot switch for operation

Literature Review

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.