6515--NX EQ Cryotherapy Tissue Ablation Systems

Solicitation Number:

36C10G21Q0035

Notice Type:

Combined Synopsis/Solicitation

Synopsis:

COMBINED SYNOPSIS/SOLICITATION

This is a combined synopsis/solicitation for brand name or equal commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.

Solicitation number 36C10G21Q0035 is issued for this combined synopsis/solicitation; this solicitation is being issued as a Request for Quote (RFQ). This combined synopsis/solicitation incorporates provisions and clauses in effect through Federal Acquisition Circular (FAC) 2021-05, dated 10 March 2021.

Requirement Description:

VA has a requirement to purchase Cryotherapy Tissue Ablation Systems to deliver patient care at its VA Medical Centers around the country. Cryotherapy Tissue Ablation Systems are used for Cryoablation, a process that uses extreme cold (cryo) to destroy or damage tissue (ablation). Cryoablation is used in a variety of clinical applications using hollow needles (cryoprobes) through which cooled, thermally conductive, fluids are circulated through the system. Cryoprobes are inserted into or placed adjacent to tissue which is determined to be diseased in such a way that ablation will provide correction yielding benefit to the patient. When the probes are in place, the cryogenic freezing unit removes heat ("cools") from the tip of the probe and by extension from the surrounding tissues. Common applications of cryoablation is to ablate solid tumors found in the lung, liver, breast, kidney and prostate and for therapy intended to ablate particular tissues using catheterization procedures (e.g., cardiac). Specifically, Cardiac Cryoablation is a therapy that uses the removal of heat from tissue to treat cardiac arrhythmias. It restores normal electrical conduction by freezing the cardiac tissue or pathways that interfere with the normal distribution of the heart s electrical impulses. Cardiac Cryotherapy Tissue Ablation Systems are being procured to address this requirement and allow integration and compatibility with current Cryotherapy Tissue Ablation Systems in use.

A single award Requirements contract will be awarded for the purchase of brand name or equal equipment in accordance with all terms, conditions, provisions, specifications, and schedule of this solicitation herein. Quotes shall contain the terms for cost/price and technical capabilities of the band name or equal equipment. The Government reserves the right to award without discussions.

The associated North American Industrial Classification System (NAICS) code for this procurement is 339112 Surgical and Medical Instrument, Product Service Code: 6515 Medical and Surgical Instruments, Equipment, and Supplies and the associated size standard is 1,000 employees. This procurement action is issued as full and open competition.

This acquisition is for a single award Requirements contract in accordance with FAR Part 16.5 for Medtronic® brand name or equal Cryotherapy Tissue Ablation Systems and related equipment and accessories as identified in ATTACHMENT A NX EQ CRYOTHERAPY TISSUE ABLATION SYSTEMS PRICE COST SCHEDULE. All interested companies shall provide a quote for all Contract Line Item Numbers (CLINs) listed in ATTACHMENT A NX EQ CRYOTHERAPY TISSUE ABLATION SYSTEMS PRICE COST SCHEDULE.

The ordering period is for one year with four 12-month option years. Delivery is FOB destination. Firm-Fixed Price Orders will be placed against this contract in writing and will provide the delivery locations, delivery dates and exact quantities.

The FAR provision at 52.212-1, Instructions to Offerors Commercial, applies to this acquisition including attached addenda to the provision.

The FAR provision at 52.212-2, Evaluation -- Commercial Items, and the specific evaluation criteria as attached addenda also applies to this acquisition

The Offeror is to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with its offer.

Clause at 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition and a statement regarding any addenda to the clause. Addendum is attached.

Clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items, applies to this acquisition and a statement regarding which, if any, of the additional FAR clauses cited in the clause are applicable to the acquisition. Addendum is attached.

All interested Offerors must be registered in the System for Award Management (SAM) prior to submitting an offer or quotation. You may access SAM at https://sam.gov/SAM/.

Questions regarding this combined synopsis/solicitation are due via email by 11:59PM EST on

May 12, 2021 to Contract Specialist, Ninatile Bacote at Ninatile.Bacote@va.gov and Contracting Officer, Timothy Johnson at Timothy.Johnson13@va.gov. No calls will be accepted.

Quotes are due via email by 11:59PM EST on May 28, 2021 to Contract Specialist, Ninatile Bacote at Ninatile.Bacote@va.gov and Contracting Officer, Timothy Johnson at Timothy.Johnson13@va.gov.

Product Description

Salient Characteristics

Literature Review

1. SCOPE OF WORK:

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Cryotherapy Tissue Ablation Systems product line as a candidate for a VA-wide (otherwise referred to as national ) single Requirements contract award. Cryotherapy Tissue Ablation Systems are used for Cryoablation, a process that uses extreme cold (cryo) to destroy or damage tissue (ablation). Cryoablation is used in a variety of clinical applications using hollow needles (cryoprobes) through which cooled, thermally conductive, fluids are circulated through the system. Cryoprobes are inserted into or placed adjacent to tissue which is determined to be diseased in such a way that ablation will provide correction yielding benefit to the patient. When the probes are in place, the cryogenic freezing unit removes heat ("cools") from the tip of the probe and by extension from the surrounding tissues.

Common applications of cryoablation is to ablate solid tumors found in the lung, liver, breast, kidney and prostate and for therapy intended to ablate particular tissues using catheterization procedures (e.g., cardiac). Specifically, Cardiac Cryoablation is a therapy that uses the removal of heat from tissue to treat cardiac arrhythmias. It restores normal electrical conduction by freezing the cardiac tissue or pathways that interfere with the normal distribution of the heart s electrical impulses. Cardiac Cryotherapy Tissue Ablation Systems are being procured to address this requirement and allow integration and compatibility with current Cryotherapy Tissue Ablation Systems in use.

The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Cryotherapy Tissue Ablation Systems to be used by clinicians throughout the VA medical centers and facilities. The period of performance is for one 12-month base period with four 12-month option periods.

2. REQUIREMENT

This requirement will be IAW FAR clause 52.211-6, Brand Name or Equal which requires the quoter indicate that each product being offered as an equal product to the Medtronic CryoConsole Cardiac Cryoablation System. For each equal product, the offeror must include a description reflecting the salient characteristics (SC) and level of quality that will satisfy the salient physical, functional, or performance characteristics of the equal product(s) specified in the solicitation. The quoter must also clearly identify the item by brand name (if any) and make/model number. Finally, the quoter must include descriptive literature, such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the contracting officer, and clearly describe any modifications it plans to make to a product to make it conform to the solicitation requirements.

CONTRACT LINE ITEM#

BRAND

PART NUMBER

DESCRIPTION

0001

Medtronic

106A3

CryoConsole

0002

Medtronic

104FS

Foot Switch

0003

Medtronic

103N2

N2O Refrigerant Tank

0004

Medtronic

1038N

Power Cord CE

0005

Medtronic

1035C

Scavenging Hoses, 6.0 m - yellow

0006

Medtronic

1035CW

Scavenging Hoses, 6.0 m - white

0007

Medtronic

1035D

Scavenging Hoses, 7.5 m - yellow

0008

Medtronic

1035DW

Scavenging Hoses, 7.5 m - white

0009

Medtronic

1035E

Scavenging Hoses, 9.0 m - yellow

0010

Medtronic

1035EW

Scavenging Hoses, 9.0 m - white

0011

Medtronic

1035F

Scavenging Hoses, 12.0 m - yellow

0012

Medtronic

1035FW

Scavenging Hoses, 12.0 m - white

0013

Medtronic

1035G

Scavenging Hoses, 12.0 m WAGD (7.5mm) - purple

0014

Medtronic

1035H

Scavenging Hoses, 12.0 m WAGD (5.5mm) - purple

0015

Medtronic

1036W

Wrench

0016

Medtronic

2035W

EGG Cable

0017

Medtronic

2037A

Auto Connection Box

0018

Medtronic

65CS1

Cardioblate CryoFlex Control Panel

0019

Medtronic

671PCNA

Cardioblate CryoFlex Control Panel Power Cord

0020

Medtronic

67RAXNA

Cardioblate CryoFlex Regulator (with pressure sensor cable)

0021

Medtronic

67H08

Cardioblate CryoFlex Gas Hose

0022

Medtronic

67PS6

Cardioblate CryoFlex Pressure Sensor Cable (replacement only)

0023

Medtronic

65TC1

Cardioblate CryoFlex Tank Carrier

0024

Medtronic

60SF7

Cardioblate CryoFlex Single-Use Probe, 7 cm

0025

Medtronic

60SF2

Cardioblate CryoFlex Single-Use Probe, 10 cm

0026

Medtronic

60SF3

Cardioblate CryoFlex Single-Use Probe, 10 cm

0027

Medtronic

60CM1

Cardioblate CryoFlex Single-Use Clamp and Probe, 10 cm

0028

Medtronic

N/A

On-Site User Training

0029

Medtronic

N/A

On-Site Technical Training

0030

Medtronic

N/A

User Manual for CryoConsole System

0031

Medtronic

N/A

Service Manual for CryoConsole System

0032

Medtronic

N/A

Maintenance and Repair Program

0033

Medtronic

4FC12

Flexcath Steerable Sheath FLEXCATH ADVANCE 12F

0034

Medtronic

2ACH25

Achieve Advance Mapping Catheter Long MAPPING CATHETER ACHIEVE ST 25MM

0035

Medtronic

2ACHC

Achieve Advance Cable 2ACHC ACHIEVE ST 10-PIN

0036

Medtronic

2ACH15

Achieve Advance Mapping Catheter MAPPING CATHETER ACHIEVE ST 15MM

0037

Medtronic

2ACH20

Achieve Advance Mapping Catheter MAPPING CATHETER ACHIEVE ST 20MM

0038

Medtronic

990066

Achieve Electrical Cable CABLE 990066 ACHIEVE ELECTRICAL

0039

Medtronic

990063-015

Achieve Mapping Catheter CATHETER 990063-015 ACHIEVE 15MM

0040

Medtronic

990063-020

Achieve Mapping Catheter CATHETER 990063-020 ACHIEVE 20MM

0041

Medtronic

2AF234

Arctic Front Advance Catheter CATH 2AF234 ARCTIC FRONT ADV US 23MM

0042

Medtronic

2AF284

Arctic Front Advance Catheter CATH 2AF284 ARCTIC FRONT ADV US 28MM

0043

Medtronic

203CX

Coax Umb Cable (Individual) CABLE 203CX COAXIAL UMBILICAL

0044

Medtronic

203CXC

Coax Umb Cables (Box) CABLE 203CXC COAXIAL UMBILICAL BOX 12

0045

Medtronic

2035U

Electrical Umb Cable (Individual) CABLE 2035U ELECTRICAL UMBILICAL

0046

Medtronic

2035UC

Electrical Umb Cable (Box) CABLE 2035UC ELECTRICAL UMBILICAL BOX 12

0047

Medtronic

307F1

Freezor Cath CATHETER 307F1 FREEZOR1 SHT RED 7F

0048

Medtronic

307F3

Freezor Cath CATHETER 307F3 FREEZOR3 MED BLUE 7F

0049

Medtronic

307F5

Freezor Cath CATHETER 307F5 FREEZOR5 LONG ORANGE 7F

0050

Medtronic

227F1

Freezor XTRA Cath CATH 227F1 FREEZOR XTRA1 SURGICAL SH 7F

0051

Medtronic

227F3

Freezor XTRA Cath CATH 227F3 FREEZOR XTRA3 SURGICAL MED7F

0052

Medtronic

227F5

Freezor XTRA Cath CATH 227F5 FREEZOR XTRA5 SURGICAL LG 7F

0053

Medtronic

229F3

Freezor MAX Cath CATH 229F3 FREEZOR MAX3 SURGICAL MED 9F

0054

Medtronic

229F5

Freezor MAX Cath CATH 229F5 FREEZOR MAX5 SURGICAL LG 9F

0055

Medtronic

239F3

Freezor MAX Cath CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F

0056

Medtronic

239F5

Freezor MAX Cath CATHETER 239F5 FREEZOR MAX5 LG ORANGE9F

0057

Medtronic

20MRK

Manual Retraction Kit KIT 20MRK ARCTIC FRONT MANUALRETRACTION

0058

Medtronic

AFAPRO23

Arctic Front Advance Pro Catheter CATH AFAPRO23 AFA PRO 23

0059

Medtronic

AFAPRO28

Arctic Front Advance Pro Catheter CATH AFAPRO28 AFA PRO 28

The Department of Veterans Affairs (VA) is seeking vendors who can provide Medtronic® Cryoconsole Cardiac Cryoablation System brand name or equal, Cryotherapy Tissue Ablation System as listed above or equal commodities which meet all of the following salient characteristics. Offeror may propose any product solution or configuration so long as they meet the salient characteristics.

SC #

CLINs

SALIENT CHARACTERISTICS

METHOD

OF EVALUATION

PAGE # WHERE SC IS FOUND IN TECHNICAL LITERATURE

SC 1

0001

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 2

0001

Must provide cardiac cryoablation treatment

Literature Review

SC 3

0001, 0024, 0025, 0026, 0033, 0034, 0036, 0037, 0039, 0040, 0041, 0042, 0047, 0048, 0049, 0050, 0051, 0052, 0053, 0054, 0055, 0056, 0058, 0059

Probes and catheters must be lightweight, quick and easy to attach/detach and must effectively manage heat, cold and defrost

Literature Review

SC 4

0001, 0018, 0028, 0030, 0031

Must have a user-friendly and intuitive user interface

Literature Review

SC 5

0001

Must have a sturdy console cart, easy to roll with adequate space for components and tanks. Cart must have locking casters

Literature Review

SC 6

0001, 0004, 0019

Must use a medical grade power cord with a hospital grade plug. Must use standard electrical wall outlet - 110V-120V circuit, 120V 60Hz AC input

Literature Review

SC 7

0001, 0018

Must have an integrated temperature indicator and a timer for monitoring and controlling therapy duration

Literature Review

SC 8

0001, 0018

Must be able to be cleaned using hospital grade cleaning solutions. Surfaces must be nonabsorbent. Surface material must be able to tolerate a very high frequency of intense cleaning. Vendor must provide manufacturer-cleaning guidelines

Literature Review