IMTEC BIOBARRIER MEMBRANE by IMTEC CORP.

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).

AI/ML Overview

The provided text is a 510(k) premarket notification for the IMTEC Biobarrier Membrane. It focuses on establishing substantial equivalence to existing devices based on the material's long history of safe and effective use, particularly expanded polytetrafluoroethylene (PTFE). The study described is a pre-clinical animal study, and the primary evidence for the device's efficacy relies on references to other scientific literature. The request asks for information relevant to AI/ML device evaluations, which rely on defined acceptance criteria, test sets, ground truth establishment, and often multi-reader multi-case studies or standalone performance evaluations.

Given the nature of the provided text, it's about a medical device (a membrane), not an AI/ML diagnostic or predictive device. Therefore, many of the requested categories for AI/ML device testing and evaluation are not applicable to this document.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it relies on demonstrating the material's historical efficacy and safety through existing literature and a pre-clinical animal study. The "performance" is qualitative, showing the material's ability to promote bone growth.

Acceptance Criteria (Implied)	Reported Device Performance
Safe and Biocompatible	"long history exists for the safe and effective use of some nonresorbable biocompatible synthetic materials" (specifically PTFE)
Effective for Guided Tissue Regeneration (GTR)	Demonstrated success of PTFE membranes in periodontal procedures (Nyman et al., Gottlow et al., Pontoriero et al.)
Promotes bone growth in peri-implant osseous repairs	In canine study (Becker et al.): "implants covered by the membranes showed marked bone growth when compared to controls." Success in humans also cited (Becker & Becker, Nyman et al., Mellonig & Triplett, Jovanovic et al.).
High-density PTFE can be exposed without compromising bone grafting	Bartee (12) suggested this, and subsequent studies (13-15) confirmed this observation.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size (Animal Study): In the Becker et al. (7) study referenced for peri-implant osseous repairs, implants were placed in the mandibles of "dogs". The specific number of dogs or implants is not provided in this extract.
Data Provenance: The referenced studies are from peer-reviewed scientific journals, suggesting international academic research. For the specific animal study mentioned, it was likely prospective research. However, the document draws heavily on a retrospective review of existing literature rather than a single prospective study specifically for the IMTEC Biobarrier Membrane.
The human studies referred to (8-11) are also from peer-reviewed literature, but no specific details on their sample sizes or countries of origin are given for this device's approval process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This concept is not applicable as the evaluation is not based on a diagnostic AI/ML device requiring expert ground truth for interpretation. The "ground truth" here is histological assessment of bone growth in the animal study and clinical outcomes reported in existing scientific literature. The "experts" are the authors and reviewers of the cited scientific papers.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/ML diagnostic or image-based evaluation requiring adjudication of expert interpretations.

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, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth relies on:

Pathology/Histology: For the animal study, the "marked bone growth" would have been assessed via histological analysis of tissue samples.
Clinical Outcomes Data: For the human studies referenced, the ground truth is derived from reported clinical success, such as new attachment formation and successful bone regeneration.
Scientific Consensus: The broader claim of safety and efficacy for PTFE is based on over 100-150 publications from independent researchers, reflecting a scientific consensus over time.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set. The "training" in a broad sense comes from the cumulative scientific knowledge and experience with PTFE.

9. How the ground truth for the training set was established

Not applicable, as there is no training set in the AI/ML context.

Summary

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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

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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.

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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.

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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.

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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,

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

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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)

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.