SOLICITATION NOTICE
66 -- Spine and Joint Stimulator upgrade
- Notice Date
- 8/28/2009
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334519
— Other Measuring and Controlling Device Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SOL-09-1062480
- Archive Date
- 9/17/2009
- Point of Contact
- Matthew J. Erbe, Phone: 3018277169, Jose Bumbray,
- E-Mail Address
-
matthew.erbe@fda.hhs.gov, jose.bumbray@fda.hhs.gov
(matthew.erbe@fda.hhs.gov, jose.bumbray@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- (i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii) The solicitation number is FDA-SOL-1062480. This solicitation is being issued as a BRAND NAME OR EQUAL to Request for Quotation (RFQ). (iii) This solicitation document and incorporated clauses are those in effect through Federal Acquisition Circular (FAC) 2005-36. (iv) The associated NAICS code is 334519 and the small business size standard is 500 employees. (v) MTS Bionix mechanical testing system upgrade. (vi) The Food and Drug Administration requests responses from qualified sources capable of supplying system upgrade in accordance with the salient characteristics listed below: Background - Upgrade of our current MTS Bionix mechanical testing system is needed to provide more realistic loading and motion of the spine and other joints. This will greatly increase the ability of DSFM researchers to investigate failure modes for currently marketed orthopaedic medical devices such bone cement in vertebroplasty surgery and dynamic spine stabilization systems. A spine mechanical testing system that can simulate spine kinematics (i.e. loading and motion) is needed to investigate joint mechanics studies of orthopaedic medical devices. More specifically, this system must be able to provide the following motions on full or partial cadaver spines: (1) flexion/extension motion up to +/- 45 degrees (2) lateral bending motion up to +/- 45 degrees (3) axial loading up to 2000 lb and axial motion of up to 4 inches and (4) torsional loading to a minimum of 550 in-lb and rotation of at least +/- 45 degrees. In addition, the spine testing system must have software and a real-time closed loop controller that directly controls the load and displacement channels previously specified. OSEL/DSFM reserves the right to reject the system if it can not provide the flexion/extension, lateral bending, axial, or torsion motions described above. In addition, OSEL/DSFM reserves the right to reject the system if the chosen system requires site requirements. The salient characteristics for a spine testing system are as follows: Spine testing system that can produce the following multi-axial motions/loads on a full or partial spine Flexion/extension motion up to +/- 45 degrees with operating speeds up to 3 degrees per second. Lateral bending motion up to +/- 45 degrees with operating speeds up to 3 degrees per second Axial loads up to 2000 lb and axial motion of up to 4 inches Torsional loads to a minimum of 550 in-lb and rotation of at least +/- 45 degrees. Fixtures or potting cups are needed to properly interface spine segment with the mechanical testing system and ensure proper load or motion transfer to spine. A controller is required that can provide real-time closed loop control with transducer conditioning and a function generator that can accurately drive up to at least 6 channels (flexion/extension, lateral bending, axial displacement, axial load, torsional rotation, and torque) A user-friendly software program that allows for precise control of spine motion, user defined test procedures, control for peaks and valleys in cyclic testing, and overload protection. A minimum of 1 year warranty on spine testing system is required. Installation and on-site training are required to ensure proper and safe use of system. Responsive technical support is required to ensure accurate analyses are performed. Special site requirements will not be available for housing the spine testing system as the location planned for this system will be in a laboratory subjected to normal temperature and humidity conditions. System must operate in standard laboratory conditions and must not require special heating or cooling. Trade-In allowance for Existing FlexTest SE Controller Evaluation: This acquisition is issued on a Lowest Price Technically Acceptable (LPTA) basis. Tradeoffs are not permitted and no additional credit will be given for exceeding the salient characteristic requirements of the solicitation. All ratings assigned are on a pass/fail basis. Exchanges may occur (see FAR 15.306(d)) CCR: Vendors must be registered in the Central Contractor Registration (CCR) prior to the award of the contract. You may register by going to www.ccr.gov. QUESTIONS DEADLINE: All questions are to be submitted via email to Matthew.Erbe@fda.hhs.gov, no later September 1, 2009, 2:00 pm EDT. QUOTATIONS DUE: All quotations are due to: Matthew.Erbe@fda.hhs.gov, no later than 4:30 pm, EDT on September 2, 2009. PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following agenda has been attached to the clause: None. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, FAR 52.232-33, FAR 52.246-9 and FAR 52.246-18. Clauses and provisions are incorporated by reference and apply to this acquisition. Responses to this notice shall be sent via email to Matthew.Erbe@fda.hhs.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-09-1062480/listing.html)
- Place of Performance
- Address: 10903 New Hampshire Avenue, Building 62, Room 2110, Silver Spring, MD 20993-0002, United States
- Zip Code: 20993-0002
- Zip Code: 20993-0002
- Record
- SN01932628-W 20090830/090829011216-a3b37a0a79bfad7d0e4640868fb26f85 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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