36C10G18Q0198-002.pdf

PRODUCT DECRIPTION

For

NON-EXPENDABLE EQUIPMENT:

Stereotactic Ear Nose Throat (ENT) Navigation System

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 Stereotactic ENT (Earn Nose Throat) Navigation System product line as a candidate for a VA-wide (otherwise referred to as “national”) single Requirements contract award. The Stereotactic ENT Navigation System is an image-guided computer-aided stereotactic surgical system designed to aid in the performance of minimally invasive otorhinolaryngology procedures by combining medical imaging, dedicated computer software, and surgical instrument tracking systems for guidance.

The systems provide surgeons with real-time, three-dimensional (3-D) positioning and orientation of surgical instruments (e.g., trephines, drills) relative to the patient's anatomy on a video display during surgery without the use of an endoscope.

Stereotactic ENT Navigation Systems are used in several procedures, including skull base procedures, nasal sinus surgery, and other intranasal and middle ear procedures.

The Contractor must demonstrate the ability to meet all requirements for the solicitation.

The objective is to provide ENT Navigation Systems to be used by clinicians throughout the VA medical centers and facilities. The period of performance is for one (1) 12 month base period with two (2) twelve (12) month option periods.

2. REQUIREMENT

This requirement will be IAW FAR clause 52.211-6, “Brand Name or Equal” which requires that the offeror indicate each product that is being offered as an “equal” product. For each equal product, the offeror must include a description reflecting the characteristics and level of quality that will satisfy the salient physical, functional, or performance characteristics of the equal product(s) specified in the solicitation. The offeror also must clearly identify the item by brand name (if any) and make/model number. Finally, the offeror 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.

CLIN Brand Part Number Item Description Base Year Opt 1 Opt 2

0001 Medtronic 9733700XOM Bundle Fusion Software/Instrument Set

10 EA 10 EA 10 EA

0002 Medtronic 9733560XOM Cart Fusion EM System 10 EA 10 EA 10 EA 0003 Medtronic 9733560XOM1 Fusion Software Support

Program Renewal

10 EA 10 EA 10 EA

0004 Medtronic 9733933XOM SFTWR Kit DICOM Software Q/R

10 EA 10 EA 10 EA

0005 Medtronic 9734400XOM Software STEALTHMERGE ENT

PG

10 EA 10 EA 10 EA

The Department of Veterans Affairs (VA) is seeking vendors who can provide Covidien/Medtronic brand of ENT Navigation System as listed above or equal commodities which meet all the following salient characteristics:

SC APPLICABLE CLINs SALIENT CHARACTERISTICS METHOD OF

EVALUATION

SC 1 0001 - 0005 Electromagnetic Tracking Literature Review SC 2 0001 - 0005 Ability to use stainless steel instruments. Literature Review SC 3 0001 - 0005 Instrument verification that requires brief or no calibration sequence.

Literature Review

SC 4 0001 - 0005 Ability to track three different instruments at once.

Literature Review