The Naval Medical Logistics Command intends to negotiate on a sole source basis (IAW FAR 13.106-1(b)) with Boston Scientific Corporation, 500 Commander Shea Blvd., Quincy, MA 02171-1518, as the only responsible source that can provide an intracorporeal lithotripter system that is capable of simultaneous pneumatic and ultrasonic technology. Regulatory Requirements: The system and all of the components, shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The requirement is for an intracorporeal lithotripter system for NH Pensacola. This system shall be used to locate, view, fragment, and remove various urinary/kidney stones. The system shall be able to provide both ultrasonic and pneumatic lithotripsy simultaneously. The system shall have a single foot pedal. The system shall include a system to store all removed stones until the completion of the patient procedure. The system shall be able to operate in ultrasonic mode only if necessary. The system shall provide an ultrasonic oscillation frequency of range of 24-26 KHz. The system shall use a compressed air supply for pneumatic procedures ranging from 50-75PSI. The electrical requirements shall not exceed: 110VAC, 60Hz, 15Amps, and single phase. This acquisition is being conducted under simplified acquisition procedures FAR 13. There are no set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 339112 with a small business size standard of 500. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice will need to submit technical data, including cost, sufficient to determine capability in providing the same product. All capability statements received by the closing date of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Capability statements shall be submitted by email only as a MS Word or Adobe PDF attachment to Derek Bell at [email protected]. Statements are due not later than 9:00 AM. EST on 23 MAY 2011. No phone calls accepted.

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