Simultaneous use of GBR-membrane and implants
Augmentation around implants placed in immediate extraction sockets o
Augmentation around implants in delayed extraction sockets ●
Localized ridge augmentation for later implantation
Alveolar ridge reconstruction for prosthetic treatment ●
Filling of bone defects after root resection, cystectomy or removal of retained teeth
Guided bone regeneration in dehiscence defects and ●
Guided tissue regeneration procedures in periodontal defects. 0

Device Description

Collagen Dental Membrane - Conformable PP is a white, nonfriable, resorbable, single layered, conformable collagen membrane matrix manufactured from purified porcine peritoneum. Collagen Dental Membrane - Conformable PP is sterilized by gamma irradiation and is supplied sterile, non-pyrogenic and for single use only.

The collagen dental membrane has a thickness of approximately 0.1 to 0.8 mm and is available in the following sizes 12 x 25 mm. 15 x 20 mm, 25 x 25 mm, 20 x 30 mm, and 30 x 40 mm.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device called "Collagen Dental Membrane - Conformable PP". The purpose of this notification is to demonstrate substantial equivalence to legally marketed predicate devices, not typically to prove device performance against specific acceptance criteria in a clinical setting.

Therefore, the document does not contain information on acceptance criteria in the sense of predefined numerical thresholds for clinical performance metrics, nor does it describe a study specifically designed to establish such performance. Instead, it relies on demonstrating equivalence through non-clinical (bench and animal) testing and the existing clinical history of its predicate devices.

However, I can extract the information on the non-clinical tests performed. Please note that "acceptance criteria" here refers to the expected outcome of these non-clinical tests (e.g., non-cytotoxic, non-mutagenic), rather than clinical performance metrics.

Here is the information based on the document:

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

Test	Acceptance Criteria (Expected Outcome)	Reported Device Performance (Results)
Biocompatibility Testing
Cytotoxicity	Non-cytotoxic	Non-cytotoxic; No evidence of causing any cell lysis or toxicity.
Sensitization	No sensitization	No evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a sensitizer in the guinea pig test.
Intracutaneous Reactivity	No significant erythema or edema	Under the conditions of the study, there was no erythema or edema from the extract injected intracutaneously into rabbits. The test article extract met the requirements of the test since the difference between the mean score of the test extract and the corresponding control was passing.
Acute Systemic Toxicity	No mortality or systemic toxicity	No mortality or evidence of systemic toxicity.
Genotoxicity (Bacterial Reverse Mutation)	Non-mutagenic	Non-mutagenic to Salmonella typhimurium and to Escherichia coli strain WP2uvra.
Genotoxicity (Mouse Lymphoma Assay)	Non-mutagenic	None of the test article treatments induced substantial increases in the number of revertant colonies. Based on the criteria and conditions of the study protocol, the test article is considered non-mutagenic.
Pyrogenicity	Non-pyrogenic	Non-pyrogenic
Muscle Implantation	Non-irritant (or comparable to control)	The macroscopic reaction was not significant compared with the sponsor provided control article (bovine tendon collagen membrane) and not significant as compared to the negative control article (HDPE). Microscopically, the test article was classified as a nonirritant as compared to the sponsor provided control article and as a moderate irritant as compared to the negative control article.
Subchronic Toxicity	Minimum/no adverse tissue reaction	Minimum tissue reaction up to 24 weeks of implantation and no adverse tissue reaction to the host.
In vitro product characterization
Physical properties (Membrane thickness,	Similar to predicate devices	Evaluation performed to demonstrate substantial equivalence to predicate devices. (Specific numerical similarity not provided for each property, but implicitly met for SE.)
conformability, suture strength)
Physicochemical properties (Permeability,	Similar to predicate devices	Evaluation performed to demonstrate substantial equivalence to predicate devices. (Specific numerical similarity not provided for each property, but implicitly met for SE.)
hydrothermal transition temperature)
**In vivo animal studies (Stability, local	Similar to predicate devices	Conducted to evaluate in vivo stability and local tissue response to the subject device as compared to its predicate device (BioGide®). (Specific numerical or detailed findings of similarity are not provided in this summary, but the conclusion states that the animal study shows the device's safety and substantial equivalence).
tissue response)**
Viral Inactivation Studies	Virally safe	Performed to ensure the viral safety of the product. (Specific results not detailed, but the conclusion states safety was demonstrated.)

Regarding the other requested information:

Sample size used for the test set and the data provenance:
- Biocompatibility Testing: The "sample size" here refers to the number of animals or cells used in the specific tests.
  - Cytotoxicity: Not specified (in vitro cell culture).
  - Sensitization: Guinea Pig (number not specified).
  - Intracutaneous Reactivity: Rabbits (number not specified).
  - Acute Systemic Toxicity: Mice (number not specified).
  - Genotoxicity: Bacterial cultures (Salmonella typhimurium and Escherichia coli) and Mouse Lymphoma cells.
  - Pyrogenicity: Rabbits (number not specified).
  - Muscle Implantation: Rabbits (number not specified).
  - Subchronic Toxicity: Rat (number not specified).
- In vitro product characterization: Not applicable, as these are bench tests on device samples.
- In vivo animal studies: Rabbit intraoral model and rat subcutaneous model (number of animals not specified).
- Data Provenance: The studies are non-clinical (in vitro and animal studies) performed to support regulatory submission. The country of origin of the data is not specified but is implicitly from testing laboratories. These are prospective tests designed to evaluate the safety and characteristics of the new device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are non-clinical studies. "Ground truth" in this context would be the objective results of the validated test methods, not expert consensus on interpretations of medical images or patient outcomes.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data (e.g., imaging) by multiple readers. These are non-clinical, objective laboratory tests.
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 document pertains to a resorbable collagen dental membrane, not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical dental membrane, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests, the "ground truth" is established by the defined and validated methodologies of the respective ISO 10993 standards, USP standards, or specific test protocols (e.g., observation of cell lysis for cytotoxicity, measurement of immune response for sensitization, histological examination for implantation studies).
The sample size for the training set: Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable, for the same reason as above.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles facing to the right. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.

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

November 5,2014

Collagen Matrix, Inc. Peggy Hansen Vice President. Clinical, Regulatory, Quality Assurance and Marketing 15 Thornton Road Oakland, New Jersey 07436

Re: K141909

Trade/Device Name: Collagen Dental Membrane - Conformable PP Regulation Number: 21 CFR 872.3930 Regulation Name: Bone grafting material Regulatory Class: Class II Product Code: NPL Dated: October 6, 2014 Received: October 9, 2014

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.

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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Susan Runno DDS, mA

Erin I. Keith, M.S Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K141909 510(k) Number (if known):

Device Name: Collagen Dental Membrane - Conformable PP

Indications for Use:

Collagen Dental Membrane - Conformable PP is intended for use in oral surgical procedures as a resorbable membrane material for use in:

Simultaneous use of GBR-membrane and implants ●
Augmentation around implants placed in immediate extraction sockets o
Augmentation around implants in delayed extraction sockets ●
Localized ridge augmentation for later implantation
Alveolar ridge reconstruction for prosthetic treatment ●
Filling of bone defects after root resection, cystectomy or removal of retained teeth
Guided bone regeneration in dehiscence defects and ●
Guided tissue regeneration procedures in periodontal defects. 0

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)

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510(k) SUMMARY

1. Applicant Information

Applicant Name:	Collagen Matrix, Inc.
Address:	15 Thornton Road
	Oakland, New Jersey 07436
Telephone:	(201) 405-1477
Fax:	(201) 405-1355
Contact Person:	Peggy Hansen, RACVP, Clinical, Regulatory, QA, and Marketing
Date Prepared:	October 6, 2014

2. Name of the Device

Device Common Name:	Resorbable Collagen Membrane
Device Trade Name:	Collagen Dental Membrane – Conformable PP
Device Classification Name:	Barrier, animal source, intraoral872.3930NPLClass II

3. Legally Marketed Devices to Which Substantial Equivalence is Claimed

Predicate Device(s):

BIO-GIDE® K042197

Collagen Dental Membrane V K100156

4. Description of the Device

The collagen dental membrane has a thickness of approximately 0.1 to 0.8 mm and is available in the following sizes 12 x 25 mm. 15 x 20 mm, 25 x 25 mm, 20 x 30 mm, and 30 x 40 mm.

5. Intended Use

Collagen Dental Membrane - Conformable PP is intended for use in oral surgical procedures as a resorbable membrane material for use in:

· Simultaneous use of GBR-membrane and implants
· Augmentation around implants placed in immediate extraction sockets
· Augmentation around implants in delayed extraction sockets
· Localized ridge augmentation for later implantation

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· Alveolar ridge reconstruction for prosthetic treatment
· Filling of bone defects after root resection, cystectomy or removal of retained teeth
· Guided bone regeneration in dehiscence defects and
· Guided tissue regeneration procedures in periodontal defects.

6. Summary/Comparison of Technical Characteristics

Collagen Dental Membrane-Conformable PP and its predicate devices have similar technological characteristics. In particular, the Collagen Dental Membrane-Conformable PP and its predicates are similar with respect to intended use, material (porcine peritoneum), form, sizes, thickness, physical integrity, permeability and conformability.

Nonclinical Tests Submitted

The substantial equivalence of Collagen Dental Membrane-Conformable PP and its predicates was demonstrated based on in vitro characterization studies, biocompatibility studies, in vivo animal studies, and clinical history of the predicate devices.

In vitro product characterization testing was performed to demonstrate substantial equivalence of the subject device to its predicate devices. A series of bench tests were conducted which included an evaluation of physical properties such as membrane thickness, conformability, suture strength, and an evaluation of physicochemical properties such as product permeability and hydrothermal transition temperature.

A series of in vitro and in vivo biocompatibility testing was performed to assess safety of the Collagen Dental Membrane-Conformable PP as an implantable material. The device passed all applicable FDA Blue Book Memorandum G95-1and ISO 10993-1 testing for the biological evaluation of medical devices.

Test	Test Method/Model	Results
Cytotoxicity	Agarose Overlay, ISO10993-5	Non-cytotoxic; No evidence of causing any celllysis or toxicity.
Sensitization	Guinea PigMaximization, ISO10993-10	No evidence of causing delayed dermal contactsensitization in the guinea pig. The test articlewas not considered a sensitizer in the guinea pigtest.
IntracutaneousReactivity	Intracutaneous Study inRabbits, ISO 10993-10	Under the conditions of the study, there was noerythema or edema from the extract injectedintracutaneously into rabbits. The test articleextract met the requirements of the test since thedifference between the mean score of the testextract and the corresponding control waspassing.
Acute SystemicToxicity	Acute Systemic Toxicityin Mice, ISO 10993-11	No mortality or evidence of systemic toxicity.
Genotoxicity	Bacterial ReverseMutation Study, ISO10993-3	Non-mutagenic to Salmonella typhimurium andto Escherichia coli strain WP2uvra.

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Test	Test Method/Model	Results
Mouse LymphomaAssay, ISO 10993-3:2003		None of the test article treatments inducedsubstantial increases in the number of revertantcolonies. Based on the criteria and conditions ofthe study protocol, the test article is considerednon-mutagenic.
Pyrogenicity	Rabbit Pyrogen study-USP <151>	Non-pyrogenic
MuscleImplantation	Muscle ImplantationStudy in Rabbits, 2Weeks, ISO 10993-6	The macroscopic reaction was not significantcompared with the sponsor provided controlarticle (bovine tendon collagen membrane) andnot significant as compared to the negativecontrol article (HDPE). Microscopically, the testarticle was classified as a nonirritant ascompared to the sponsor provided control articleand as a moderate irritant as compared to thenegative control article.
SubchronicToxicity	Subcutaneousimplantation study in rat.	Minimum tissue reaction up to 24 weeks ofimplantation and no adverse tissue reaction tothe host.

In addition to the in vitro characterization tests, animal studies using a rabbit intraoral model, as well as a rat subcutaneous model were conducted to evaluate the in vivo stability and local tissue response to the subject device as compared to its predicate device (BioGide®).

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

Clinical Test Submitted

Given the similarities between Collagen Dental Membrane - Conformable PP and the predicate devices, it was determined that a clinical study would not be necessary to demonstrate substantial equivalence.

7. Conclusion of Non-clinical Studies

The results of the in vitro product characterization and biocompatibility testing, as well as the animal study show that Collagen Dental Membrane-Conformable PP is safe and substantially equivalent to the identified predicate devices.

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.