ATTACHMENT B_PRODUCT DESCRIPTION_NX EQ Ultrasonic Aspirator System Tissue Ablation.docx

PRODUCT DESCRIPTION

For

NON-EXPENDABLE EQUIPMENT:

Cusa Clarity Ultrasonic Aspirator System or equal Ultrasonic Aspirator System: Tissue Ablation

Prepared By:

Equipment Program Office Department of Veterans Affairs 5202 Presidents Court, Suite 103 Frederick, MD 21703

1. SCOPE OF WORK:

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

Ultrasonic Aspirators are surgical devices designed to fragment and remove soft tissue, bone, and tumors from various parts of the body. They are used during procedures in which surgical blades or blunt dissection instruments might damage surrounding healthy tissue or for cases in which a surgical laser would eradicate a lesion, leaving no specimen for pathological evaluation. Ultrasonic aspirators utilize mechanical vibration at ultrasonic frequencies for tissue removal while also providing suction and/or irrigation to the surgical site.

The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Ultrasonic Aspirator System: Tissue Ablation to be used by clinicians throughout the VA medical centers and VHA facilities throughout the Continental United States (CONUS) and Outside of the Continental United States (OCONUS). OCONUS includes locations such as Alaska, Hawaii, Puerto Rico, the Virgin Islands, Guam, the Philippines, American Samoa, and the Northern Mariana Islands. The period of performance is for a base of 12-months with four 12-month option periods.

2. REQUIREMENT

This requirement will be solicited and awarded as a “Brand Name or Equal” which requires the quoter indicate that each product being offered as an “equal” product to the Integra LifeSciences’ Cusa Clarity Ultrasonic Aspirator 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.

The Department of Veterans Affairs (VA) is seeking vendors who can provide Cusa Clarity Ultrasonic Aspirator System, Ultrasonic Aspirator System: Tissue Ablation or equal as listed above which meet all the salient characteristics listed below.

Vendors may offer any product solution or configuration so long as they meet the salient characteristics. Products offered in the technical volume must be captured on the Vendor’s pricing volume (Attachment A, Price Cost Schedule) of the solicitation.

Vendors may offer any additional ancillary products which they deem to be essential to the functionality of the offered solution; these items must be captured in the Vendor’s pricing volume with a quantity of zero. Vendors shall provide descriptive literature which will be used to thoroughly evaluate each proposal to determine the extent to which it meets the Salient Characteristics (SCs) listed in the Combined Synopsis/Solicitation Notice. Vendors are required to complete the highlighted area on the SCs Chart located below listing the location where compliance to the SCs can be found. The chart must be included with the vendor’s submission. Offers which do not include this complete chart will not be considered for award. Comment by Reass, Laura (OGC): Before posting, the brand name and equal references will be removed right? Comment by Andrews, Michael D. (OALC EPO AS3): Yes, brand name and equal references will be removed.

CLIN 0001 applies to the following SC’s: SC1, SC2, SC3, SC4, SC5, SC6 CLIN’s 0003-CLIN’s 0028 apply to the following SC: SC7

0003-0028

In addition to the noted Salient Characteristics that must be met, the following subfactors will also be assessed.

Design Design features and functions of the offered device will be evaluated. Areas include but are not limited to the following:

1. Variety and capabilities of handpieces and tips. List the frequencies and technical aspects of each handpiece and tips.

2. Accessories, i.e.; footswitch and others that control the system output and activation.

3. Scalability (ability to expand or accommodate future enhancements)

Ease of set-up/use Indicated clinical uses The Device will be evaluated for its ability to perform its intended function. Areas included but are not limited to:

1. Dual handpieces with distinct operating frequencies suitable for fine work and debulking.

2. Changed to Aspiration capabilities in relation to size and quantity of aspirated tissue.

3. Ease of cleaning/sterilization.

Safety The device will be assessed for patient safety features, including, but not limited to, the following areas:

1. Tissue Select Safety setting

2. alarms and warning indications

3. Contamination protection features

Quality/ Customer assistance /Training

1. Warranty terms and conditions

2. Availability and modes of training

3. Customer, Operator and Technical Support

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