(82 days)
TefGen is an implant material which is intended to be used as a temporary space making barrier over bone or other tissue.
TefGen non-reinforced (TefGen-FD) and TefGen reinforced (TefGen-RE) membranes are 100% PTFE non-absorbable guided tissue membranes.
The provided document is a 510(k) premarket notification summary for the "TefGen Guided Tissue Membrane." It asserts substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a study. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not explicitly available in this document.
Here's an attempt to extract relevant information and note what is missing:
1. A table of acceptance criteria and the reported device performance
This document does not present quantitative acceptance criteria or detailed performance data from a specific study designed to meet those criteria. The submission focuses on demonstrating substantial equivalence primarily through material composition and intended use, supported by existing literature on PTFE and general biocompatibility.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document does not describe a "test set" in the context of a performance study for the TefGen device itself. It references existing literature and general biocompatibility testing of PTFE.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no specific clinical study with a "test set" and expert ground truth establishment is described for the TefGen device's performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device for tissue regeneration, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated for the TefGen device itself in a dedicated study. The document relies on:
- Biocompatibility assays: USP Class VI, carcinogenicity studies, hemocompatibility studies (for PTFE as a material).
- Literature findings: Clinical reports and studies on high-density PTFE membranes for osseous defects and osteogenesis. These studies would have their own ground truths (e.g., histology, clinical outcomes, radiographic assessment), but those specifics are not detailed here for the TefGen device.
8. The sample size for the training set
Not applicable, as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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OCT 1 0 2007
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850
Mr. Bruce G. Ruefer President/CEO American Custom Medical, Company 2430 N. 7th Avenue, Suite 4 Bozeman, Montana 59715
Re: K964656
Trade Name: Tefgen Guided Tissue Membrane Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: 2 Product Code: NPK Dated: November 18, 1996 Received: November 20, 1996
Dear Mr. Ruefer:
This letter corrects our substantially equivalent letter of February 10, 1997.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sayite Y. Michintons
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Protesting and Promoting Public Health
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K964656 FEB 10 1997
TefGen™ 510(k) SUMMARY OF SAFETY AND EFFICACY
| Prepared by: | Bruce G. Ruefer, President |
|---|---|
| Date: | November 18, 1996 |
| Classification Name: | Augmentation Membrane, 76LYC |
| Common/Usual Names: | Barrier Membrane; Guided Tissue Membrane; or GTRMembrane. |
| Proprietary Name: | TefGen™ Guided Tissue Membrane |
| Establishment Reg. No. | 9006936 |
| Classification: | Class II |
| Performance Standards: | Not Applicable. |
| Substantial Equivalence: | The non-absorbable augmentation membrane is manufacturedby American Custom Medical and is equivalent in function to theaugmentation membranes manufactured and marketed by bothAmerican Custom Medical and W.L. Gore which are currently onthe market. |
| Product Description& Intended Use: | TefGen non-reinforced (TefGen-FD) and TefGen reinforced(TefGen-RE) membranes are 100% PTFE non-absorbableguided tissue membranes. TefGen is an implant material which isintended to be used as a temporary space making barrier overbone or other tissue. The material is easily conformable to avariety of shapes as required by specific cases. |
| Comparative TechnologicalCharacteristics: | TefGen is a biocompatible 100% PTFE membrane, is non-resorbable, is stiff enough to create a space, and is suppleenough to be formed over the margins of a defect; as are thepredicate devices. |
| Safety & Efficacy: | TefGen is composed of 100% polytetrafluoroethylene or PTFE.PTFE is the most inert polymer known at this time. PTFE's use asan implant material in the cardiovascular area is well substantiatedwith over 3,000,000 PTFE vascular grafts implanted to date. Manyother configurations of PTFE devices are marketed including softtissue and cardiovascular PTFE patches, PTFE suture, PTFE barriermembranes, and PTFE ear implant devices. |
| PTFE has been found to pass biocompatibility assays includingU.S.P. Class VI, carcinogenicity studies, hemocompatibility studies,and others. PTFE has been proven many times over to be non-reactive to body fluids and tissues making it a material of choice forbiomaterial applications. | |
| Literature: | ACM PTFE has been found to function as an acceptableaugmentation membrane as noted in the following articles:"The Use of High-Density Polytetrafluoroethylene Membrane toTreat Osseous Defects: Clinical Reports", B. Bartee, D.D.S., ImplantDentistry, 4, 1995, pgs. 21-26."Evaluation of a Full Density Polytetrafluoroethylene (PTFE) Film toPromote Osteogenesis in the Rat Model", J. Carr, et.al., OralImplantology, 21, 1995, pgs. 88-95."Influence of Three Membrane Types on Healing of Skull Lesions",B. Crump, et.al, presented at the 1995 IADR Annual Meeting,Singapore, June, 1995."The Influence of Three Membrane Types on Healing of BoneDefects", B. Crump, et.al., Oral Surgery, Oral Medicine, OralPathology and Oral Radiology, Oct. 1996, pgs. 365-374."High-density PTFE Membranes: Uses with Root-form Implants", J.Krauser, Dental Implantology Update, 7, pgs. 65-69, 1996.Clinical Research Associates Newsletter, 20:4, February 1996. |
| Conclusion: | The TefGen membrane configurations, non-reinforced (TefGen-FD)and reinforced (TefGen-RE), are substantially equivalent to thecurrently marketed TefGen-FD membrane and currently marketedGORE-TEX augmentation membrane. |
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TefGen™ 510(k) SUMMARY OF SAFETY AND EFFICACY (cont)
:
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.