Collagen Dental Membrane is intended for use in oral surgical procedures as a resorbable material for placement in the area of dental implant, bone defect or ridge augmentation to aid in wound healing post surgery.

Device Description

The Collagen Dental Membrane is a resorbable, type I collagen matrix of defined geometry, in vivo stability, permeability and mechanical strength for use as a material to aid in wound healing in bone repair, ridge augmentation and dental implant procedures.

The device is provided in two sizes 20 mm x 30 mm x 40 mm. The device can be easily trimmed for a final fit during surgery to the appropriate size and shape required for the defect to be treated.

AI/ML Overview

A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Resorbable	Resorption time of 26 to 38 weeks in rat subcutaneous implantation model.
Biocompatible	Passed recommended FDA biocompatibility tests.
Cell occlusive	Designed to retard and/or prevent down growth of epithelium, and prevent contact of gingival connective tissue with implant and bony surface.
Clinically manageable	Designed for clinical manageability.
Suturable	Designed to be suturable.
Aid in wound healing	Demonstrated in animal and human studies (literature review).
Substantially equivalent to BioGide®	Concluded to be substantially equivalent.

Sample size used for the test set and the data provenance:
For the "Summary of In Vivo Resorption Studies," the study was conducted using a "rat subcutaneous implantation model." The specific number of rats or samples is not provided, nor is the country of origin. This was an animal study.
For the "Summary of Effectiveness Data" (Animal Data and Clinical Data), the information is derived from a "comprehensive literature search" and "results from human studies from the literature." No specific sample sizes for a single test set are provided, as this refers to aggregated literature. The provenance is from published animal and human studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The effectiveness data comes from a literature review of existing studies, not from a new test set with expert-established ground truth. Biocompatibility and in vivo resorption studies would typically involve laboratory analysis and histopathology, but no information on specific experts or their qualifications is provided in this summary.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. As noted above, the effectiveness data relies on a literature review, and the other studies (biocompatibility, in vivo resorption) are laboratory-based, not expert adjudication for a test set in the described manner.
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 collagen dental membrane, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is irrelevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical material (collagen dental membrane), not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For "Summary of In Vivo Resorption Studies": The ground truth for resorption time would likely be established through histological examination of explanted tissues, potentially involving pathology.
- For "Summary of Effectiveness Data" (Animal and Clinical): The ground truth is derived from the established scientific literature on Guided Bone Regeneration (GBR), which would typically involve histological evidence of bone formation, clinical outcomes (e.g., implant integration, bone fill), and expert interpretation from those studies.
The sample size for the training set:
Not applicable. This submission describes a physical medical device, not a machine learning model that requires a "training set."
How the ground truth for the training set was established:
Not applicable, as this device does not involve a machine learning model with a training set.

Summary

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AUG - 7 2001

K011695

510 (k) Summary of Safety And Effectiveness

Applicant name and address:	Collagen Matrix, Inc.509 Commerce StreetFranklin Lakes, NJ 07417
Contact person and telephone number:	Shu-Tung Li, Ph.D.President & CEOTel: (201) 405-1477
Date of summary:	May 24, 2001
Device generic name:	Collagen Dental Membrane
Device trade name:	None
Predicate device:	BioGide®,[510(k) #K960724]

Description of the device:

The device is provided in two sizes 20 mm x 30 mm x 40 mm. The device can be easily trimmed for a final fit during surgery to the appropriate size and shape required for the defect to be treated.

Intended Use of the Device

Technical Characteristics

Collagen Dental Membrane has been designed in accordance with the accepted principles of guided bone regeneration (GBR) as a wound healing material post surgery.

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Specifically, the device is designed to be resorbable, biocompatible, cell occlusive, clinically manageable, and suturable.

Summary of Biocompatibility Studies

The Collagen Dental Membrane is biocompatible based on the tests recommended by the FDA.

Summary of In Vivo Resorption Studies

In vivo resorption time for the Collagen Dental Membrane was evaluated in a rat subcutaneous implantation model. The results of the studies showed that Collagen Dental Membrane has an in vivo resorption time from 26 to 38 weeks.

Summary of Effectiveness Data

Animal Data

The concept of "Guided Bone Regeneration (GBR)" in bone repair, ridge augmentation and dental implant surgeries has been proven from animal model studies. That is, during the surgery, a barrier membrane is placed over the bone, ridge or dental implant to retard and/or prevent the down growth of epithelium, and to prevent the contact of gingival connective tissue with the implant and bony surface. Thereby, bone cells can grow into the defect site to fill the defect space or integrate with the dental implant for a firm anchor of the implant within the bone socket.

A comprehensive literature search showed that numerous materials have been studied as a barrier in the GBR studies in various animal models. The animal data provided evidence that the concept of GBR using membranes as a barrier to aid in wound healing has been verified using either resorbable or non-resorbable membranes is a valid approach.

b. Summary of Clinical Data

Results from human studies from the literature are consistent with animal studies. Similar to animal studies, the materials studied thus far, resorbable and nonresorbable,

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are both effective as a barrier to aid in wound healing in dental implant, ridge augmentation and bone repair procedures.

Conclusion

Thus, based on the biocompatibility testing conducted on the Collagen Dental Membrane and literature research on the various membranes, we conclude that the Collagen Dental Membrane is safe for implantation and is effective as a resorbable membrane to aid in wound healing post dental implant, bone repair and ridge augmentation surgeries. The Collagen Dental Membrane is substantially equivalent to BioGide®

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850

OCT 1 0 2007

Mr. Shu-Tung Li President Collagen Matrix, Incorporated 509 Commerce Street Franklin Lakes, New Jersey 07417

Re: K011695 Trade Name: Collagen Dental Membrane Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: 2 Product Code: NPL Dated: May 30, 2001 Received: May 31, 2001

Dear Mr. Li:

This letter corrects our substantially equivalent letter of August 7, 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,

Sujette y Michie On.D.

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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K011695

510(k) Number (if known):

Collagen Dental Membrane Device Name:

Indications for Use:

Collagen Dental Membrane is intended for use in oral surgical procedures as a resorbable Conagon Dontal Monttin the area of dental implant, bone defect or ridge augmentation to aid in wound healing post surgery.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ V (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Muald W. Sherman for MSR

(Division Sign-Off) Division of Dental, Infection Contr and General Hospital Devic 510(k) Number _

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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.