TEFGEN GUIDED TISSUE MEMBRANE

K964656 · American Custom Medical, Inc. · NPK · Feb 10, 1997 · Dental

Device Facts

• Record ID: K964656
• Device Name: TEFGEN GUIDED TISSUE MEMBRANE
• Applicant: American Custom Medical, Inc.
• Product Code: NPK · Dental
• Decision Date: Feb 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TefGen non-reinforced (TefGen-FD) and TefGen reinforced (TefGen-RE) membranes are 100% PTFE non-absorbable guided tissue membranes. TefGen is an implant material which is intended to be used as a temporary space making barrier over bone or other tissue.

Device Story

TefGen is a non-absorbable, 100% PTFE (polytetrafluoroethylene) membrane used as a temporary space-making barrier over bone or other tissue. It is available in non-reinforced (TefGen-FD) and reinforced (TefGen-RE) configurations. The device is conformable, allowing clinicians to shape it over the margins of a defect. It functions by creating a physical barrier to support tissue healing/osteogenesis. It is intended for use by dental or surgical professionals in clinical settings. The material is inert and non-reactive to body fluids and tissues, providing a stable environment for bone regeneration.

Clinical Evidence

No clinical trial data provided. Evidence consists of literature citations (Bartee 1995, Carr 1995, Crump 1995/1996, Krauser 1996) evaluating PTFE membrane performance in osseous defects and rat models, and established biocompatibility data (USP Class VI, carcinogenicity, hemocompatibility) for PTFE.

Technological Characteristics

Material: 100% Polytetrafluoroethylene (PTFE). Form factor: Non-reinforced (FD) and reinforced (RE) membranes. Principle: Mechanical barrier for space maintenance. Biocompatibility: USP Class VI compliant. Sterilization: Not specified.

Indications for Use

Indicated for use as a temporary space-making barrier over bone or other tissue to facilitate guided tissue regeneration.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• TefGen-FD membrane (American Custom Medical)
• GORE-TEX augmentation membrane (W.L. Gore)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
OCT 10 2007
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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Diette Y. Michieu OnD

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


Protecting 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 GTR Membrane. |
| 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 manufactured by American Custom Medical and is equivalent in function to the augmentation membranes manufactured and marketed by both American Custom Medical and W.L. Gore which are currently on the market. |
| Product Description & Intended Use: | TefGen non-reinforced (TefGen-FD) and TefGen reinforced (TefGen-RE) membranes are 100% PTFE non-absorbable guided tissue membranes. TefGen is an implant material which is intended to be used as a temporary space making barrier over bone or other tissue. The material is easily conformable to a variety of shapes as required by specific cases. |
| Comparative Technological Characteristics: | TefGen is a biocompatible 100% PTFE membrane, is non-resorbable, is stiff enough to create a space, and is supple enough to be formed over the margins of a defect; as are the predicate devices. |
| Safety & Efficacy: | TefGen is composed of 100% polytetrafluoroethylene or PTFE. PTFE is the most inert polymer known at this time. PTFE's use as an implant material in the cardiovascular area is well substantiated with over 3,000,000 PTFE vascular grafts implanted to date. Many other configurations of PTFE devices are marketed including soft tissue and cardiovascular PTFE patches, PTFE suture, PTFE barrier membranes, and PTFE ear implant devices.

PTFE has been found to pass biocompatibility assays including U.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 for biomaterial applications. |

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TefGen™ 510(k) SUMMARY OF SAFETY AND EFFICACY (cont)

Literature:

ACM PTFE has been found to function as an acceptable augmentation membrane as noted in the following articles:

"The Use of High-Density Polytetrafluoroethylene Membrane to Treat Osseous Defects: Clinical Reports", B. 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 membrane configurations, non-reinforced (TefGen-FD) and reinforced (TefGen-RE), are substantially equivalent to the currently marketed TefGen-FD membrane and currently marketed GORE-TEX augmentation membrane.

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