Collagen Dental Wound Dressings are absorbent, porous, collagen matrices engineered from highly purified type I collagen derived from porcine Achilles tendon. The Collagen Dental Wound Dressings are applied directly to the wound and protect the wound and delicate new tissue. Collagen Dental Wound Dressings are supplied sterile, non-pyrogenic, in various sizes, and for single use only.

AI/ML Overview

This appears to be a 510(k) summary for a medical device (Collagen Dental Wound Dressings), which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, some of the requested information (like MMRC studies, sample sizes for test/training sets with ground truth, expert qualifications) is not typically detailed in this type of submission.

Here's an attempt to extract and infer the information based on the provided text:

Acceptance Criteria and Device Performance Study

The primary study conducted to assess the Collagen Dental Wound Dressings was a comparison to predicate devices through in vitro and in vivo (biocompatibility) tests, along with referencing the clinical history of the predicate devices. The device's performance is demonstrated by its substantial equivalence to the legally marketed predicate devices, Collacare Dental (K110388) and Collagen Wound Dressing - Oral (K040403).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from equivalence claim)	Reported Device Performance
Technological Characteristics	Similar intended use, purified starting material (Type I collagen), form, sizes, physical integrity to predicate devices.	The Collagen Dental Wound Dressings and their predicates have similar technological characteristics, including intended use, purified starting material (Type I collagen), form, sizes, and physical integrity.
Biocompatibility	Meet applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 standards for biological evaluation of medical devices.	The products passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices.
Viral Safety	Demonstrate viral inactivation to ensure product safety.	Viral inactivation studies were performed to ensure the viral safety of the product. (Specific acceptance thresholds for viral inactivation are not provided in this summary but are implied to have been met).
Material Properties	Demonstrate acceptable material properties (e.g., absorption, porosity, physical integrity) through in vitro characterization.	In vitro characterization studies evaluated material properties, biological properties, chemical, and physical properties. (Specific results not detailed but implied to be acceptable for equivalence).
Safety	No unacceptable risks identified through in vitro, in vivo (biocompatibility), and viral inactivation studies.	The results of the in vitro product characterization studies, in vitro and in vivo biocompatibility studies, and viral inactivation studies show that Collagen Dental Wound Dressings are safe.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable in the context of a traditional clinical study with a "test set" of patients/samples designed to evaluate performance against specific endpoints in humans. The "tests" here refer to in vitro and in vivo (animal or lab) studies.
Data Provenance: The studies were non-clinical (in vitro and in vivo biocompatibility, viral inactivation). The clinical history of the predicate devices was referenced, implying retrospective use of existing clinical data from those older devices. The country of origin for the non-clinical studies is not specified but would likely be the manufacturing or testing facilities used by Collagen Matrix, Inc. in the US.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This is not applicable as there was no traditional clinical "test set" with human data requiring expert ground truth establishment for this 510(k) submission. The evaluation relied on non-clinical data and comparison to existing predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as there was no clinical test set requiring adjudication of findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical tests were performed on the product, however clinical history of the predicate device was referenced in the submission."

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

Not applicable. This device is a physical wound dressing, not a software algorithm, so the concept of an "algorithm only" performance study does not apply.

7. The Type of Ground Truth Used

For the non-clinical studies (in vitro and in vivo biocompatibility, viral inactivation), the "ground truth" was established by the scientific and regulatory standards (e.g., ISO 10993-1, FDA Blue Book Memorandum G95-1) and the successful completion of the tests according to established protocols.
For the equivalence claim, the "ground truth" was the established safety and effectiveness profile of the legally marketed predicate devices, as evidenced by their clinical history.

8. The Sample Size for the Training Set

Not applicable. There was no "training set" in the context of an AI/algorithm.

9. How the Ground Truth for the Training Set was Established

Not applicable. There was no "training set."

Summary

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K122115

1 2012

NOV

510(k) SUMMARY

1. Applicant Information

Applicant Name: Address:

Telephone: Fax: Contact Person:

Date Prepared:

Collagen Matrix, Inc. 15 Thornton Road Oakland, New Jersey 07436 (201) 405-1477 (201) 405-1355 Peggy Hansen, RAC VP, Clinical, Regulatory, QA, and Marketing October 4, 2012

2. Name of the Device

Device Common Name: Device Trade Name: Device Classification Name:

Collagen Wound Dressing Collagen Dental Wound Dressings Dressing, Wound, Collagen KGN Unclassified

Legally Marketed Devices to Which Substantial Equivalence is Claimed 3.

Predicate Device(s):

Collacare Dental, Collagen Dental Matrix K110388

Collagen Wound Dressing - Oral K040403

4. Description of the Device

Intended Use 5.

Collagen Dental Wound Dressings are intended for the management of oral wounds and sores, including:

Denture sores .
Oral ulcers (non-infected or viral) ●
Periodontal surgical wounds ●
Suture sites .

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. Burns
Extraction sites
Surgical wounds
Traumatic wounds

6. Summary/Comparison of Technical Characteristics

Collagen Dental Wound Dressings and their predicates have similar technological characteristics. In particular, the Collagen Dental Wound Dressings and the predicates are similar with respect to intended use, purified starting material (type I collagen), form, sizes, physical integrity. The substantial equivalence of Collagen Dental Wound Dressings and their predicates was demonstrated based on in vitro characterization studies, biocompatibility studies, and clinical history of the predicate devices.

In vitro characterization studies included evaluation of material properties, biological properties, chemical and physical properties.

Collagen Dental Wound Dressing representative products have been evaluated in a number of in vitro and in vivo tests to assess its safety/biocompatibility. The products passed all applicable FDA Blue Book Memorandum G95-1and ISO 10993-1 testing for the biological evaluation of medical devices. No clinical tests were performed on the product, however clinical history of the predicate device was referenced in the submission.

Viral inactivation studies were performed to ensure the viral safety of the product.

Conclusion of Non-clinical Studies

The results of the in vitro product characterization studies as well as in vitro and in vivo biocompatibility studies show that Collagen Dental Wound Dressings are safe and substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three wing-like strokes above a wavy line, representing water or movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

NOV

Collagen Matrix, Incorporated Ms. Peggy Hansen, RAC Vice President, Clinical, Regulatory, Quality Assurance, & Marketing 15 Thornton Road Oakland, New Jersey 07436

Re: K122115

Trade/Device Name: Collagen Dental Wound Dressings Regulation Number: Unclassified Regulation Name: Dressing, Wound, Collagen Regulatory Class: Unclassified Product Code: KGN Dated: October 4, 2012 Received: October 5, 2012

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

1 2012

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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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use

510(k) Number (if known):

Collagen Dental Wound Dressings Device Name:

Indications for Use:

Collagen Dental Wound Dressings are intended for the management of oral wounds and sores, including:

Denture sores �
Oral ulcers (non-infected or viral) .
Periodontal surgical wounds .
Suture sites .
Burns ●
Extraction sites .
Surgical wounds .
Traumatic wounds .

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)

Susan Runpe

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesi-Jogy, General Hos;الان
Division of Anesthesi-Jogy, General Devices Division of Anesthesishogy - Devicess
Infection Control, Dental Devices
Infection Control, Dental Devices

Page 1 of _1

510(k) Number:

Regulation Number and Section

N/A