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Orthopaedic and Rehabilitation Devices Panel Meeting Brief Summary for June 2 & 3, 2004 |
The Orthopaedic and Rehabilitation Devices Panel (the Panel) met on Wednesday and Thursday, June 2 and 3, 2004 in Gaithersburg, MD.
(Topic 1) On June 2, 2004, the Panel made a recommendation to the Food and Drug Administration (FDA) on the approvability of the DePuy Spine, Inc. Charité Artifical Disc premarket approval application (PMA) P040006. The Charité Artificial Disc is intended for spinal arthroplasty in patients with single-level lumbar degenerative disc disease from L4-S1.
The sponsor and FDA summarized the safety and effectiveness data in the PMA. Two Panel members, a clinician and a statistician, then gave their perspectives on PMA data. After deliberations on the information in the submission, the Panel considered FDA’s questions.
The Panel then voted unanimously that FDA approve the PMA with conditions. The recommended conditions of approval are as follows:
(Topic 2) On June 3, 2004 in the morning, the Panel made a recommendation to FDA on the Orthopedic Surgical Manufacturers Association (OSMA) reclassification petition to reclassify the total mobile bearing knee (MBK) and unicompartmental MBK intended to replace the total knee or part of the knee joint, respectively, from class III into Class II.
OSMA members presented their MBK prostheses reclassification proposal, and an FDA reviewer presented the agency’s review regarding the proposed reclassification to the Panel. Two Panel members, a clinician, and a statistician then gave their perspectives on the information and data in the petition. After deliberations on the industry and FDA presentations and the information provided in the petition, the Panel considered FDA’s questions. The Panel then completed the reclassification questionnaire and summary data sheet.
The Panel then voted six to two to recommend that FDA reclassify the total MBKs into Class II. The Panel recommended five special controls to reasonably assure the safety and effectiveness of the device: 1) a special controls guidance document, 2) testing guidelines, 3) potential use of clinical data, 4) device specific training and labeling (to be negotiated with sponsors), and 5) patient identification cards (to include patient, surgeon, hospital, and implant information).
The Panel also voted five to three to recommend that FDA reclassify the unicompartmental MBK into Class II. The Panel recommended the same special controls as identified for the total MBK, with a stronger emphasis placed on the use of clinical data . In addition, the Panel also urged post market surveillance to track such adverse events as osteolysis, bearing dislocations, polyethylene failures, and revisions.
(Topic 3) On June 3, 2004 in the afternoon, the Panel made a recommendation to the (FDA) regarding OSMA’s guidance document submission entitled Clinical Trial Design for Hip Replacement Systems which was submitted to the Dockets Management Branch of FDA under 21 CFR 10.115(f)(3). The main focus of the submission was a proposed clinical study design for evaluating the safety and effectiveness of total hip joint replacement systems. The design includes a composite endpoint consisting of 3 objective performance criteria as a control for patient success with a benchmark for overall study success and a 4% delta for noninferiority. The panel was asked questions on the following topics which were discussed in detail during the meeting: the content of the proposed objective performance criteria and whether they are appropriate for the devices listed in the document, the proposed statistical plan, the duration of a study to provide assurance of safety and efficacy, suggestions about appropriate patient selection criteria, Outcome measures for surrogate endpoints, the need for post market studies and the hip systems that would be encompassed by such issues discussed. The panel’s responses to the six FDA questions on the guidance document constituted its recommendation on the draft guidance document.
Contact: Janet L. Scudiero, Executive Secretary, at 301-594-1184 ext. 176 or jls@cdrh.fda.gov.
Transcripts of this meeting may be purchased from
Neal R. Gross
Court Reporters and Transcribers
1323 Rhode Island Ave., N.W.
Washington, D.C.
202-234-4433 or 800-473-1433
Or
Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane, Rockville, MD 20857
301-443-1726.
Under normal circumstances, panel summary minutes are available 60-90 days
post meeting. Summaries are also available on the CDRH web site: http://www.fda.gov/cdrh/panel/index.html
Back to CDRH Advisory Committee Database
Updated June 7, 2004
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