6515--EnSite X EP System Catheter Navigation and Mapping System Brand-name Only

This is a COMBINED SYNOPSIS/SOLICITATION for commercial items prepared in accordance with the format in Subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. VA will conduct the procurement according to a combination of FAR Part 12, Acquisition of Commercial Items and Part 13, Simplified Acquisition Procedures as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

(ii) The solicitation number is 36C24521Q0823 and is issued as a Request for Quotation (RFQ).

(iii) The provisions and clauses incorporated into this solicitation document are those in effect through Federal Acquisition Circular 2021-06, fiscal year 2021. Provisions and clauses incorporated by reference have the same force and effect as if they were given in full text. The full text of the Federal Acquisition Regulations (FAR) and Veterans Affairs Acquisition Regulations supplement (VAAR) can be accessed on the Internet at http://www.arnet.gov/far (FAR) and http://vaww.appc1.va.gov/oamm/vaar (VAAR)

(iv) This requirement will be set-aside for Service-Disabled-Veteran-Owned Small Businesses. The North American Industry Classification System (NAICS) code is 339113, Surgical Appliance and Supplies Manufacturing and the size standard is 750 employees.

(v) EnSite X EP System. This requirement consists of five (5) line items:

PRODUCT DESCRIPTION

MANFACTURER

Qty

EnSite X EP System (ENSITE-SYSTEM-01)

ABBOTT MEDICAL

1

EnSite Contact Force Module (CFK3000)

ABBOTT MEDICAL

1

Ampere Generator Kit (H700494)

ABBOTT MEDICAL

1

Ampere Remote Control (H700490)

ABBOTT MEDICAL

1

Cool Pint Irrigation Pump (89003)

ABBOTT MEDICAL

1

(vi) This requirement is brand-name only. Justification and Approval attached.

Statement of Work:

Catheter Navigation and Mapping System SOW

Washington DC VAMC now has an additional electrophysiologist to allow expansion of our ablation and cardiac implantable electronic device programs. Washington DC VAMC will be providing cryoablation to treat atrial fibrillation. Further expansion of ablation for other arrhythmias necessitates the procurement of a three-dimensional catheter navigation and mapping system.

This equipment description and quantity required are specified in the table below:

Description

Part

Number

EnSite X EP System

Catheter navigation and mapping system capable of displaying the 3- dimensional (3-D) position of conventional and Sensor-Enabled electrophysiology catheters

Capable of displaying cardiac electrical activity as waveform traces and as dynamic 3D isopotential maps of the cardiac chamber.

Contoured surfaces of these 3-D maps are to be based on the anatomy of

the patient s own cardiac chamber

Provides diagnostic information to the physician to aid in the treatment of arrhythmias

ExSite X Amplifier

Accepts signals from catheters and electrodes attached to the patient

Converts signals to digital format and sends them to the workstation for processing and display

Display Workstation

workstation (computer), monitors, medical grade isolation transformer

keyboard and mouse for user inp

ENSITE- SYSTEM-01

EnSite Contact Force Module

EnSite Contact Force Module v.1.0

TactSys Quartz

Must allow contact force data to be viewed

CFK3000

Ampere Generator Kit

User controlled power or temperature modes

Monitor real-time temperature and impedance data

Presets available

Ability to manage procedural needs through user-configured interface

RF Output Power: 1 to 100 W adjustable in steps of 1 W

Impedance Range: Measures 50 O to 300 O in steps of 1 O

Target Temperature: 15° C to 80° C adjustable in steps of 1° C

RF Delivery Time: 1 to 999 seconds adjustable in steps of 1 second

Control Modes: Temperature; Power

Energy Delivery Modes: Independent; Sequential; Simultaneous

Operating Parameters: Values are digitally displayed on the Ampere

Generator front panel

Generator Dimensions: 266.7mm H x 360.68mm W x 363.22mm D (10.5 H x 14.2 W x14.3 D)

H700494

Generator Weight: 9.98 kg (22.0 lbs)

Supply Voltage: 100-240 VAC, 50/60 Hz

Safety Class: Class I; Type CF according to IEC 60601-1

Ampere Remote Control

15m fiber cord

H700490

Cool Point Irrigation Pump

Pump

Power cord

Pole clamp

1779 communications cable

Tubing set

Operator s Manual

1 year manufacturer s Warranty

89003

Delivery Timeframe: 30 days ARO (Negotiable)

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

(vii) All material shall be delivered to DC VA Medical Center, 50 Irving Street, NW, Washington, DC 20422.

(viii) 52.212-1 Instructions to Offerors - commercial Items, applies to this acquisition. There are no addenda to the provision.

(ix) 52.212-2, Evaluation - Commercial Items: FAR provision 52.212-2 does not apply to this solicitation. Award will be based on lowest price and meeting or exceeding Statement of Work requirements.

(x) 52.212-3 Offeror Representations and Certifications - Commercial Items- the Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required.

(xi) 52.212-4 Contract Terms and Conditions - Commercial Items: applies to this acquisition.

(xii) 52.212-5 Contracts Terms and Conditions Required To Implement Statutes or Executive Orders - Commercial Items; the following FAR clauses identified at paragraph (b) of FAR 52,204-10; 52.212.5 are considered checked and are applicable to this acquisition: 52.204-10, 52.209-6, 52.219-6, 52.219-8, 52.219-13, 52.219-28, 52.222-3, 52.222-19, 52.222-21; 52.222-26; 52.222-35, 52.222-36, 52.222-50, 52.223-18, 52.225-1, 52.225-3; 52.225-13, 52.232-34.

(xiii) 52.217-8 Option to Extend Services, 52.217-9 Option to Extend the Term, 52.52.232-18 Availability of Funds, 52.232-19 Availability of Funds for Next Fiscal Year. Any additional contract requirement(s) or terms and conditions determined by the Contracting Officer to be necessary for this acquisition and consistent with customary commercial practices will be addressed as necessary.

(xiv) Proposals/Quotes shall be submitted in writing to Chantey Bost at chantey.bost2@va.gov NLT 1600 on Tuesday, September 21, 2021 eastern standard time.

Quotes shall be submitted on company letterhead. Commercial format is encouraged.

All proposals/quotes shall include the following information:

Legal Business/Company Name (as it is indicated in www.sam.gov)

DUNS Number

Contract Number (if applicable)

Warranty Information (Can be a separate attachment)

Point of Contact Name

Telephone number

E-mail Address

(xvi) Point of contact for this solicitation is Chantey Bost, chantey.bost2@va.gov . Inquires must be in writing via email.