K Number

Device Name

IMTEC BIOBARRIER MEMBRANE

Manufacturer

IMTEC CORP.

Date Cleared

1997-08-26

(71 days)

Product Code

NPK

Regulation Number

872.3930

Intended Use

IMTEC Biobarner is a temporarily implantable material intended to be used as a space maintaining barrier over bone. It is intended for use in the oral cavity. The material is conformable to a variety of shapes as required for specific anatomical limitations.

Device Description

A long history exists for the safe and effective use of some nonresorbable biocompatible synthetic materials when implanted into the human body. The material most documented as safe and effective is a polymer known as polytetrafluoroethylene or PTFE. This material, first patented in 1941 and better known as "TEFLON" is composed of long chains of linked Carbon-Fluoride units. Over 100 (1) to 150 (2) publications by independent researchers in peer-reviewed scientific journals have established the material as a suitable material for reconstructive surgical procedures such as cardiovascular and hernial patches, vascular grafts, sutures and periodontal repairs. In periodontal procedures a technique known as "Guided Tissue Repair (GTR)" was introduced in 1982 by Nyman, et al (3). They first described the use of nonresorbable "Millipore Filter" in the procedure. The GTR principle is based on the isolation of incised oral epithelial and gingival connective tissue from treated root surfaces or from Alveolar bone in the case of osseointegrated dental implants. In the latter case the isolation allows osteoblasts and endothelial cell to repopulate the wound, consequently enhancing the closure of a bony defect around the implant. PTFE membranes have subsequently been used with success to exclude those cells without osteogenic potential (4-6).

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the material composition and its use as a physical barrier, with no mention of AI or ML capabilities.

Therapeutic

The device is described as a temporarily implantable material used to maintain space over bone in the oral cavity, primarily for Guided Tissue Repair. While it aids in the healing process by creating a barrier, its primary function is structural (space maintenance) rather than directly treating a disease or condition in a therapeutic sense (e.g., drug delivery, active physiological intervention).

Diagnostic

The device is described as a temporarily implantable material for space maintenance over bone in the oral cavity, used for reconstructive surgical procedures. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

The device description clearly states it is a "temporarily implantable material" made of PTFE, which is a physical substance, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is as a "temporarily implantable material intended to be used as a space maintaining barrier over bone" in the oral cavity. This describes a physical barrier used within the body during a surgical procedure.
Device Description: The description details the material (PTFE) and its use in a surgical technique (Guided Tissue Repair) to physically isolate tissues.
Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.

Therefore, the IMTEC Biobarner is a medical device used in vivo (within the body) for a surgical purpose, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

NPK

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

oral cavity

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

K972240

AUG 26 897

SAFETY AND EFFECTIVENESS: IMTEC/BIOBARRIER

Submitted by: M. K. Patterson, Jr., PhD Sr. Vice President, Regulatory Affairs

PERI-IMPLANT OSSEOUS REPAIRS:

In early studies using expanded PTFE membranes to cover implants, Becker, et al (7) placed implants in the mandible of dogs and created a defect by exposing threads of the implants. The implants were then covered with membrane. After 18 weeks the implants covered by the membranes showed marked bone growth when compared to controls Similar techniques have proven successful in humans ( 8 - 11).

The aforementioned studies were conducted using an expanded (porous ) form of PTFE. A recurring problem with porous PTFE has been that should primary closure of the tissue fail ,infection occurs, and the membrane must be prematurely removed. Bartee ( 12), suggested that "high density" PTFE (nonporous) membranes could be left exposed in the

oral cavity and promote the deposition of bone without compromising the bone grafting material. Subsequent studies (13 - 15) comparing various membrane types have confirmed his observation.

REFERENCES

Tinti, c. and Vincenzi, G.P, Expanded Polytetrafluoroethylene Titanium-Reinforced 1. Membranes for Regeneration of Mucogingival Recession Defects. J. Periodontol.
1994;

65:1088 -1094.

Promotional Literature, "The Regen Tech Review" Gore-Tex, W. L. Gore & Assoc., 2. Inc., Flagstaff, AZ.
Nyman, S., et al, New Attachment Following Surgical Treatment of Human 3. Periodontal Disease. J. Clin. Periodontal. 1982; 9: 290 -296
Gottlow, J. . et al, New attachment Formation as the Results of Controlled Tissue 4. Regeneration, J. Clin. Periodontal. 1984; 11: 494 -503.
Gottlow. J., et al. New Attachment Formation in the Human Periodontium by ട്. Guided Tissue Regeneration: Case Reports. J. Clin. Periodontol. 1986; 13: 604 -616.
1. Pontoriero, R., et al. Guided Tissue Regeneration in the Treatment of Furcation Defects in Man. J. Clin. Peridontol. 1987: 14: 618- 620.
Becker, W., et al. Bone formation at Dehisced Dental Implant Sites Treated with 7. Implant Augmentation Material: A pilot Study in Dogs. Int J. Peridont. Rest. Dent., 1990; 10:93 -101.
Becker, W. and Becker, B. E., Guided Tissue Regeneration for Implants Placed into 8. Extraction Sockets and for Implant Dehiscences: Surgical Techniques and Case Reports. Int. J. Peridont. Res. Dent., 1990; 10: 377 -391.
1. Nyman, S., et al. Bone Regeneration Adjacent to Titanium Dental Implants Using Guided Tissue Regeneration: A Report of Two Cases. Int. J. Oral Maxillofac. Implants. 1990; 5: 9 -14.

Mellonig, J. T. and Triplett, R. G. Guided Tissue Regeneration and Endosseous 10 Dental Implants. Int. J. Periodont. Res. Dent. 1993; 13: 109 -119.
1. Jovanovic, S. A., et al. The regenerative Potential of Plaque-induced Peri-implant Bone Defects Treated by Submerged Membrane Technique: An Experimental Study. Int. J. Maxillofac. Implants. 1993; 8: 13 -18.
Bartee, B. The Use of High-Density Polytetrafluoroethylene Membrane to Treat 12. Osseous Defects: Clinical Reports. Implant Dent. 1995; 4: 21 -26.
Carr, J. ,et al. Evauation of a Full Density polytetrafluoroethylene (PTFE) Film to 13. Promote Ostegenesis in the Rat Model. Oral Implantology. 1995; 21: 89 -95.
1. Crump, B., et al. The Influence of Three Membrane Types on Bone Defects. Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology. 1996; Oct: 365 -374
1. Krauser, Dental Implantology Update. 1996; 7: 65 -69.

)

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem depicts a human figure in profile, with outstretched arms, overlaid with a stylized bird in flight. The overall design is simple and conveys a sense of care and protection.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850

OCT 1 0 2007

M.K. Patterson Jr., Ph.D. Sr. Vice President Regulatory Affairs IMTEC Corporation 2401 North Commerce Admore, Oklahoma 73401

Re: K972240

Trade Name: Imtec Biobarrier Membrane Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: 2 Product Code: NPK Dated: June 10, 1997 Received: June 16, 1997

Dear Dr. Patterson:

This letter corrects our substantially equivalent letter of August 8, 2001.

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.

Page 2 -

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,

Sytte y. Michael Dmd.

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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Protecting and Promoting Public Health

510(k) Number (if known): Ka 12241

IMTEC BIOBARRIER MEMBRANE Device Name:

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susen Runner

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)