(125 days)
TefGen-LS is an implant material which is intended to be used as a temporary space making barrier over bone or other tissue.
TefGen-LS membrane is a 100% PTFE non-absorbable guided tissue membrane. The material is easily trimmed to a variety of shapes as required by specific cases.
This document is a 510(k) summary for the TefGen-LS™ Guided Tissue Membrane, a non-absorbable augmentation membrane used as a temporary space-making barrier over bone or other tissue.
Here's an analysis of the acceptance criteria and the study information provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal acceptance criteria with specific numerical targets (e.g., a certain percentage of success, or a specific range for a physiological measurement). Instead, the determination of substantial equivalence is the primary criterion.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | TefGen-LS™ is stated to be substantially equivalent to the currently marketed TefGen-FD membrane and GORE-TEX augmentation membrane. This is based on: - Material: Composed of 100% PTFE, a known biocompatible material used extensively in medical implants. - Functionality: Non-resorbable, stiff enough to create space, and supple enough to be formed over defect margins, similar to predicate devices. - Biocompatibility: PTFE has passed USP Class VI, carcinogenicity, and hemocompatibility studies, demonstrating non-reactivity to body fluids and tissues. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily relies on literature review and biocompatibility testing to establish safety and efficacy for substantial equivalence. It does not describe a traditional "test set" in the context of a prospective, human clinical trial with a defined sample size for the TefGen-LS™ device itself.
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Test set for TefGen-LS™: Not explicitly described in terms of a specific number of human subjects or a defined dataset for performance evaluation. The evaluation is based on the established safety profile of PTFE and comparative technological characteristics.
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Data Provenance: The literature cited includes:
- "Implant Dentistry" (1995)
- "Oral Implantology" (1995)
- IADR Annual Meeting (Singapore, 1995)
- "Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology" (1996)
- "Dental Implantology Update" (1996)
- Clinical Research Associates Newsletter (1996)
These publications suggest a mix of clinical reports (e.g., Bartee), animal models (e.g., Carr, Crump), and general clinical updates. The specific countries of origin for the studies in the cited literature are not provided, but the journals are generally international or US-based. These appear to be retrospective data from existing literature rather than new prospective studies specifically for TefGen-LS™.
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)
This section is not applicable as the submission relies on published literature and general biocompatibility testing of the material (PTFE), rather than a specific test set requiring expert ground truth for a novel performance metric of the TefGen-LS™ device itself. The "ground truth" here is the established scientific understanding of PTFE's properties and its performance in predicate devices as documented in the provided literature.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
None is explicitly described. The evaluation is based on a review of existing scientific literature and technical comparisons.
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 device is a bone grafting material, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human reader performance with or without AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" used for establishing substantial equivalence primarily consists of:
- Literature-based evidence: Published clinical reports, animal studies, and general scientific understanding regarding the performance and safety of PTFE in similar medical applications, and specifically in augmentation membranes.
- Biocompatibility testing results: PTFE having passed USP Class VI, carcinogenicity, and hemocompatibility studies.
- Predicate device characteristics: Comparison to the established characteristics and performance of already marketed PTFE augmentation membranes (TefGen-FD and GORE-TEX).
8. The sample size for the training set
Not applicable. This is a physical medical device. It does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. As above, a training set is not relevant for this type of device submission.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its head and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850
OCT 1 0 2007
Mr. Bruce G. Ruefer President American Custom Medical, Company 2430 N. 7th Avenue, Suite 4 Bozeman, Montana 59715
Re: K965205 Trade Name: TefGen-LSTM Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: 2 Product Code: NPK Dated: March 12, 1997 Received: March 14, 1997
Dear Mr. Ruefer:
This letter corrects our substantially equivalent letter of April 30, 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,
Suyite Y. Michie Ouid.
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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APR 3.0 1997
TefGen-LS™ 510(k) SUMMARY OF SAFETY AND EFFICACY
| Prepared by: | Bruce G. Ruefer, President |
|---|---|
| Date: | December 20, 1996 |
| Classification Name: | Augmentation Membrane, 76LYC |
| Common/Usual Names: | Barrier Membrane; Guided Tissue Membrane; or GTRMembrane. |
| Proprietary Name: | TefGen-LS™ 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-LS membrane is a 100% PTFE non-absorbable guidedtissue membrane. TefGen-LS is an implant material which isintended to be used as a temporary space making barrier overbone or other tissue. The material is easily trimmed to a variety ofshapes as required by specific cases. |
| Comparative TechnologicalCharacteristics: | TefGen-LS 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-LS 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. |
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TefGen-LS™ 510(k) SUMMARY OF SAFETY AND EFFICACY (cont)
ACM PTFE has been found to function as an acceptable Literature: augmentation membrane as noted in the following articles: "The Use of High-Density Polytetrafluoroethylene Membrane to Treat Osseous Defects: Clinical Reports", 8. Bartee, D.D.S., Implant Dentistry, 4, 1995, pgs. 21-26. "Evaluation of a Full Density Polytetrafluoroethylene (PTFE) Film to Promote Osteogenesis in the Rat Model", J. Carr, et.al., Oral Implantology, 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 Bone Defects", B. Crump, et.al., Oral Surgery, Oral Medicine, Oral Pathology 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-LS membrane configuration is substantially equivalent to the currently marketed TefGen-FD membrane and currently marketed GORE-TEX augmentation membrane.
§ 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.