SOURCES SOUGHT
66 -- Wire Fatigue Tester
- Notice Date
- 6/16/2011
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, Bldg 50 Room 422, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA1089124
- Archive Date
- 6/24/2011
- Point of Contact
- Nicholas E Sartain, Phone: 870-543-7370
- E-Mail Address
-
nick.sartain@fda.hhs.gov
(nick.sartain@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA) is conducting market research to support the Center for Devices and Radiological Health (CDRH) requirement for a wire fatigue tester. The FDA is seeking business sources, including total small businesses, service-disabled veteran-owned small businesses, HUBZone small businesses, and 8(a) certified companies. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort: The government is seeking capability statements from small business manufacturing companies that can provide a wire fatigue testers with temperature controlled water bath necessary components permitting immediate use. The instrument shall be equivalent to the salient characteristics described herein. • Capable of variable high speed rotation (35,000 RPM desired). • Rotation clockwise and counterclockwise. • Temperature controlled water bath capable of maintaining 37OC. • Capable of testing a wide range of wire diameters including 0.5mm. • Available optional attachments for different wire diameter sizes. • Ease of operation to include centering of small wires. • Wire break detection and cycle counter. • Available attachments for stents is desired. • Wire driven by chucks at both ends. • Distance between chucks is adjustable. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered instrument and components meet the technical requirements identified above. Many medical devices that CDRH researches and for which CDRH provides regulatory guidance contain specialty metal components that are subject to cyclical mechanical loading. Over time, this mechanical loading can lead to device failure through a process known as fatigue. To ensure the safety of implanted devices, such as coronary stents, endovascular grafts, septal occluders, inferior vena cava filters, and numerous dental and orthopedic implants, a complete understanding of the fatigue properties of their specialty metals components is critically important. One of the simplest and most cost effective ways to study fatigue in specialty metal components for medical devices is to perform wire fatigue testing in a rotating beam tester. High speed rotating beam wire fatigue testers would allow CDRH to conduct fatigue research which will assist in the prediction of device safety. The main focus of this research will be on emerging fatigue testing methodologies including Fatigue to Fracture (FtF). FtF is a test method which could provide more predictive information on device failure and shorter test times when compared to the current Test to Success methodology. High speed rotating beam wire fatigue testers will provide CDRH with the research capabilities in order to begin investigations on FtF methodology which will lead to improved long term durability and safety for a broad range of medical devices. These testers will be used as part of a research project for durability testing for specialty metal components in devices. The results of this project will help ensure the safety of a number of implanted medical devices with specialty metal components. High speed rotating beam wire fatigue testers are needed to complete the research proposed in this project. Firms believing they can meet the requirementss to the above specifications are encouraged to respond electronically with no less than the following information: • Business name, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address; • Sufficient descriptive literature that unequivocally demonstrates that offered products meet or exceed above specifications. • At a minimum provide the following: All descriptive material necessary for the government to determine whether the product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. Indicate whether the organization is the manufacturer of the items or authorized reseller. • Though this is not a request for quote, informational pricing must be submitted. The government is not responsible for locating or securing any information, not identified in the response. The associated North American Industry Classification System (NAICS) Code is- 334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. Interested Contractors must respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before June 23, 2011 by 09:00 hours (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OA/OAGS, Attn: Nick Sartain, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502 or email nick.sartain@fda.hhs.gov. Reference FDA1089124. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in FedBizOpps. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA1089124/listing.html)
- Place of Performance
- Address: 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN02474816-W 20110618/110616234800-c1c45714c9e21c15226eb19acc9f1441 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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