ATTACHMENT B - PRODUCT DESCRIPTION - NX EQ Microwave Therapy Systems Tissue Ablation.docx

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Attached to
NX EQ Microwave Therapy Systems: Tissue Ablation Federal contract opportunity
Solicitation number
36C10G25R0048
Issued by
Department of Veterans Affairs Headquarters

About this file

This is a Product Description document for a federal solicitation (36C10G25R0048) seeking Microwave Therapy Systems for tissue ablation under the Veterans Health Administration's Non-Expendable Equipment National Program. The VA requires Varian Medical Systems IntelliBlate Microwave Ablation Systems or equal products designed for thermal ablation of soft tissue and solid organ tumors, primarily for percutaneous coagulation necrosis of unresectable tumors. The systems must operate under FAR clause 52.211-6 "Brand Name or Equal" requirements and will be deployed across VA medical centers nationwide.

The solicitation includes 17 Contract Line Items (CLINs) covering complete system configurations, probes of various lengths, temperature sensors, rental options, technical support services, and warranty agreements ranging from one to five years. Key salient characteristics require FDA approval for ablating liver, kidney, lung and soft tissue tumors up to 5cm, a microwave generator delivering 140 watts or greater, touchscreen interface with continuous feedback, dedicated mobile cart, antennas/probes of 13 gauge or smaller in lengths equal to or longer than 25cm, and minimum one-year manufacturer warranty. The contract period includes a 12-month base with four 12-month option periods, and an existing Non-Manufacturer Rule Class Waiver applies to this product category.

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PRODUCT DESCRIPTION

For

NON-EXPENDABLE EQUIPMENT:

Varian Medical Systems IntelliBlate™ Microwave Ablation System or Equal

Prepared By:

Strategic Acquisition Center Department of Veterans Affairs 10300 Spotsylvania Avenue, Suite 400 Fredericksburg, VA 22408

1. SCOPE OF WORK

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Microwave Therapy Systems: Tissue Ablation product line as a candidate for a VA-wide (otherwise referred to as “national”) single Requirements contract award.

Microwave Therapy Systems: Tissue Ablation are designed for thermal ablation of soft tissue and/or regions of solid organs (e.g. liver). These systems typically consist of a microwave generator, a coaxial cable, a temperature sensor, and interstitial needle-like applicators as antennas; computed tomography, ultrasound, or magnetic resonance guidance is used to locate the applicator and sometimes to evaluate tissue ablation. The radiating antenna is placed on or near the tissue volume to be ablated using an applicator or catheter. The primary mechanism for tissue heating at microwave frequencies is vibration of the ions (e.g., ions of water molecules) in the tissues at the frequency of the electrical field. Interstitial tissue-ablation systems are mostly used for percutaneous coagulation necrosis of unresectable tumors at temperatures over 60 degrees C, but less than 100 degrees C.

The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Microwave Therapy Systems: Tissue Ablation to be used by clinicians throughout the VA medical centers and facilities. The period of performance is for a base of 12-months 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 offer to indicate that each product being offered as an “equal” product to the Varian Medical Systems IntelliBlate™ Microwave Ablation 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 offer must also clearly identify the item by brand name (if any) and make/model number. Finally, the offer 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 Items
Brand
Part Number
Description
0001
Varian Medical Systems
IB-MAG-STARTERKIT
IntelliBlate™ Microwave Ablation System Starter Kit (Comes with CLIN X003 or X004 and Ximitry Probes (one pack of 12 - any combination of CLINs X005, X008, and/or X010)
0002
Varian Medical Systems
IB-SYS-MAG-SVG-H
IntelliBlate™ Microwave Ablation System (includes myAblation Guide deployed on syngo.via View&Go with external computer, mobile cart, power supply/powercord, monitors, masts/stand, software, one year warranty)
0003
Varian Medical Systems
IB-SYS-MAG-SVG
IntelliBlate™ Microwave Ablation System (includes myAblation Guide deployed on syngo.via View&Go, mobile cart, power supply/powercord, monitors, masts/stand, software, one year warranty)
0004
Varian Medical Systems
IB-SYS-MAG-SYN
IntelliBlate™ Microwave Ablation System (includes myAblation Guide deployed on syngo.via workstation, mobile cart, power supply/powercord, monitors, masts/stand, software, one year warranty)
0005
Varian Medical Systems
IB-XPA-1315
IntelliBlate™ Ximitry Probe, 15 cm, 13 ga, Qty 1
0006
Varian Medical Systems
IB-XPA-1315-K3
IntelliBlate™ Ximitry Probe, 15 cm, 13 ga, Qty 3
0007
Varian Medical Systems
IB-XPA-1315-K12
IntelliBlate™ Ximitry Probe, 15 cm, 13 ga, Qty 12
0008
Varian Medical Systems
IB-XPA-1320
IntelliBlate™ Ximitry Probe, 20 cm, 13 ga, Qty 1
0009
Varian Medical Systems
IB-XPA-1320-K3
IntelliBlate™ Ximitry Probe, 20 cm, 13 ga, Qty 3
0010
Varian Medical Systems
IB-XPA-1327
IntelliBlate™ Ximitry Probe, 27 cm, 13 ga, Qty 1
0011
Varian Medical Systems
IB-XPA-1327-K3
IntelliBlate™ Ximitry Probe, 27 cm, 13 ga, Qty 3
0012
Varian Medical Systems
ABL-TP-1820
Temperature Sensor Probe, 20 cm, 18 ga, Qty 1
0013
Varian Medical Systems
IB-MWA-EQ
IntelliBlate™ System Daily Rental Fee
0014
Varian Medical Systems
IB-MWA-SVC
On-Site Technical Support Service Fee (per case, if needed) (NOTE: Used with CLIN X013)
0015
Varian Medical Systems
IB-COVERED-1YR
One Year Warranty and Service Maintenance Agreement (NOTE: Only for CLINs X001 - X004)
0016
Varian Medical Systems
IB-COVERED-3YR
Three Year Warranty and Service Maintenance Agreement (NOTE: Only for CLINs X001 - X004)
0017
Varian Medical Systems
IB-COVERED-5YR
Five Year Warranty and Service Maintenance Agreement (NOTE: Only for CLINs X001 - X004)

The Department of Veterans Affairs (VA) is seeking vendors who can provide Varian Medical Systems IntelliBlate™ Microwave Ablation Systems or equal as listed above which meet all the salient characteristics listed below. Vendors may quote any product solution or configuration so long as they meet the salient characteristics. Products quoted in the technical volume must be captured on the Vendor’s pricing volume (Attachment A, Price Cost Schedule) of the solicitation. Vendors may quote any additional ancillary products which they deem to be essential to the functionality of the proposed solution; these items must be captured in the Vendor’s pricing volume with a quantity of zero.

CLINs 0001-0004 applies to SC’s 1-4 CLINs 0005-0011 applies to SC’s 5-6 CLINs 0015-0017 applies to SC 7

**All offerors are required to fill out the Proposal Reference Page column. **

SC #
SALIENT CHARACTERISTICS
METHOD OF EVALUATION
PROPOSAL REFERENCE PAGE
SC 1
Must be FDA approved to effectively ablate liver, kidney, lung, and other soft tissue tumors up to 5cm
Literature Review
SC 2
Must include a microwave power generator capable of delivering 140 Watts or greater
Literature Review
SC 3
Must have a touchscreen user interface with continuous temperature and power feedback
Literature Review
SC 4
Must include a dedicated mobile system cart
Literature Review
SC 5
Antennas/Probes/Applicators must be 13 gauge or smaller
Literature Review
SC 6
Antennas/Probes/Applicators must be offered in various lengths including equal to or longer than 25cm
Literature Review
SC 7
Must provide a minimum one year Manufacturer Warranty
Literature Review

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