Collagen Dental Membrane IV is intended for use in oral surgical procedures as a resorbable membrane material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

Device Description

Collagen Dental Membrane IV is a white, nonfriable, conformable, resorbable, membrane matrix consisting of highly purified type I and III collagen derived from bovine dermis. It is flexible and conforms to the contours of the defect site. Collagen Dental Membrane IV is supplied sterile, non-pyrogenic, in various sizes, and for single use only.

AI/ML Overview

The provided text describes a 510(k) summary for the "Collagen Dental Membrane IV" device. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria based on performance studies. Therefore, much of the requested information regarding acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment is not present in the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Safety/Biocompatibility	Passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for biological evaluation of medical devices.	Device passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing.
Technical Characteristics	Similar to predicate devices in intended use, form, animal source, sizes, thickness, physical integrity, permeability, and conformability.	Collagen Dental Membrane IV and its predicates have similar technological characteristics in these aspects.

2. Sample size used for the test set and the data provenance:

Sample size for test set: Not specified. The document mentions "in vitro and in vivo tests," but does not detail the specific sample sizes used within these tests.
Data provenance: "in vitro and in vivo tests." No specific country of origin or whether the data was retrospective or prospective is mentioned.

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

Not applicable/Not specified. The document does not describe the use of experts to establish ground truth for performance metrics in a clinical study. The evaluation focused on safety and comparability to predicates.

4. Adjudication method for the test set:

Not applicable/Not specified. This is not a study 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 device is a resorbable membrane, not an AI-powered diagnostic tool, so an MRMC study is not relevant.

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

Not applicable. This is a medical device (collagen membrane), not an algorithm.

7. The type of ground truth used:

For safety/biocompatibility: The ground truth was established by adherence to recognized standards (FDA Blue Book Memorandum G95-1 and ISO 10993-1).
For technical characteristics comparison: The "ground truth" was a comparison to the established characteristics of the predicate devices. The document implies that the predicate devices' characteristics serve as the benchmark for "similarity."

8. The sample size for the training set:

Not applicable. This device is not an AI/machine learning model, so there is no training set in the conventional sense. The "training" or development would involve laboratory and animal studies, but not a "training set" of data for an algorithm.

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

Not applicable. As above, there is no "training set" for an algorithm. The development and verification process involved established laboratory and animal testing methods to ensure the materials met safety and performance criteria, which could be considered forms of "ground truth" for the material properties.

Summary

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SEP 1 8 2009

510(k) Summary of Safety and Effectiveness

Applicant Name and Address: Collagen Matrix, Inc. 509 Commerce Street Franklin Lakes, New Jersey 07417

Contact Person:

Peggy Hansen, RAC Vice President, Clinical, Regulatory, QA, and Marketing Tel: (201) 405-1477 Fax: (201) 405-1355

Date of Summary:

May 1, 2009

Device Common Name:

Device Trade Name:

Device Classification Name:

Barrier, animal source, intraoral 872.3930 NPL Class II

Resorbable Collagen Membrane

Collagen Dental Membrane IV

Predicate Device(s):

Collagen Dental Membrane - Conformable II K062881

Bio-Gide™ Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration K050446

Tutodent® Dental Membrane CopiOs™ Pericardium Membrane K073097

Description of the Device

Intended Use

implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

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Summary/Comparison of Technical Characteristics

Collagen Dental Membrane IV and its predicates have similar technological characteristics. In particular, the Collagen Dental Membrane IV and its predicate are similar with respect to intended use, form, animal source, sizes, thickness, physical integrity, permeability and conformability.

Safety

Collagen Dental Membrane IV has been evaluated in a number of in vitro and in vivo tests to assess its safety/biocompatibility. The device passed all applicable FDA Blue Book Memorandum G95-1and ISO 10993-1 testing for the biological evaluation of medical devices.

Conclusion

The results of the in vitro product characterization studies and in vivo animal studies show that Collagen Dental Membrane IV is safe and substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows a partial view of a document or logo. On the left, there's a stylized emblem with curved lines, possibly representing an eagle or a similar symbol. To the right of the emblem, the word "DEPART" is visible, suggesting that the full text might be "DEPARTMENT" followed by additional text below a horizontal line.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring. MD 20993-0002

SEP 1 8 2009

Ms. Peggy Hansen Vice President, Clinical, Regulatory Quality Assurance Collagen Matrix, Incorporated 509 Commerce Street Franklin Lakes, New Jersev 07417

Re: K090216

Trade/Device Name: Collagen Dental Membrane IV Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPL Dated: September 4, 2009 Received: September 9, 2009

Dear Ms. Hansen:

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 application (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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Page 2- Ms. Hansen

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K090216

Indications for Use

510(k) Number (if known): K090216

Device Name: Collagen Dental Membrane IV

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Mulvey for MSP

Division Sign-Off) nivision of Anesthesiology, General Hospital niection Control, Dental Devices

-10(k) Number: K090216

Page 1 of 1

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.