Collagen Dental Membrane - Conformable IIBP 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 - Conformable IIBP is a non-friable, resorbable membrane matrix consisting of purified intact collagen tissue derived from bovine pericardium. The membrane device is flexible and conforms to the contours of the defect site. Collagen Dental Membrane - Conformable IIBP is supplied pre-hydrated, sterile, non-pyrogenic, and for single use only.

The collagen dental membrane has a thickness of approximately 0.3 to 1.0 mm and is available in the following sizes 15 x 20 mm, 20 x 30 mm, and 30 x 40 mm.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for the device's efficacy or performance in its intended use (e.g., successful bone regeneration rate). Instead, the submission focuses on demonstrating substantial equivalence to predicate devices by comparing technical characteristics and showing safety (biocompatibility).

The closest we can get to acceptance criteria in the context of this document are the results of the nonclinical tests which demonstrate the device performs as expected for a medical implant and is safe.

Acceptance Criteria (Inferred)	Reported Device Performance (Collagen Dental Membrane - Conformable IIBP)
Material Properties:
- Intact purified collagen tissue (Material)	Intact purified collagen tissue
- Bovine pericardium (Collagen Source)	Bovine pericardium
- Membrane form	Membrane
- White to off-white color	White to off-white
- Non-friable (Physical Integrity)	Non-friable
- Available in sizes: 15x20mm, 20x30mm, 30x40mm	15x20mm, 20x30mm, 30x40mm
- Approx. 0.5 mm thickness (Note: document states approx. 0.3 to 1.0 mm earlier, but 0.5 mm in table)	Approx. 0.5 mm
- Conformable to defect site	Conformable to defect site
- Can be sutured (Suture Strength)	Can be sutured
- Semi-permeable; permeable to nutrients and macromolecules (Porosity)	Semi-permeable; permeable to nutrients and macromolecules
- Cross-linked (Yes)	Yes (Proprietary method)
- Gradual resorption, resorbed in approx. 16 weeks (Resorption Time/In Vivo Stability)	Gradual resorption, resorbed in approximately 16 weeks as demonstrated in animal testing
Safety/Biocompatibility:
- Biocompatible	Biocompatible
- Non-cytotoxic	Non-cytotoxic. No evidence of causing any cell lysis or toxicity.
- Non-sensitizing	No evidence of sensitization was observed. Not considered a sensitizer.
- Non-intracutaneous reactive	No erythema and no edema from the test extract injected intracutaneously into rabbits.
- Non-systemically toxic	No mortality or evidence of systemic toxicity.
- Non-pyrogenic	Non-pyrogenic.
- Non-mutagenic (Genotoxicity - Mouse Lymphoma)	None of the test article treatments induced substantial increases in the number of revertant colonies. Considered non-mutagenic.
- Non-mutagenic (Genotoxicity - Ames Assay)	Non-mutagenic to Salmonella typhimurium strains TA97a, TA98, TA100, and TA1535 and to Escherichia coli strain WP2-uvrA.
- Minimum tissue reaction up to 4 weeks (Implantation)	Minimum tissue reaction up to 4 weeks of implantation and no adverse tissue reaction to the host.
- Minimum tissue reaction up to 24 weeks (Subchronic/Chronic Toxicity)	Minimum tissue reaction up to 24 weeks of implantation and no adverse tissue reaction to the host.
- Virally safe	Viral inactivation studies performed to ensure viral safety. (Specific results not detailed, but implied successful.)
Device Presentation:
- Pre-hydrated	Pre-hydrated
- Sterile, SAL 10-6	Sterile, SAL 10-6
- Single use only	Single use only
- Double peel package (Packaging)	Double peel package

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

The document describes non-clinical tests (bench, in vitro, and animal studies) rather than a human clinical trial that would typically have a "test set" from a patient population.

Bench Tests (in vitro characterization): No specific sample sizes are provided for tests like membrane thickness, conformability, suture strength, permeability, or hydrothermal transition temperature.
Biocompatibility Studies (in vitro and in vivo):
- Cytotoxicity (ISO Agarose Overlay): Not specified.
- Sensitization (ISO Guinea Pig Maximization): Guinea pig. Number not specified.
- Intracutaneous Reactivity (Acute Intracutaneous in Rabbit): Rabbit. Number not specified.
- Acute Systemic Toxicity (ISO Systemic Toxicity in Mice): Mice. Number not specified.
- Pyrogenicity (USP Pyrogen Study – Material Mediated): Not specified (typically rabbit or LAL assay).
- Genotoxicity (In Vitro Mouse Lymphoma Assay): In vitro cell assay.
- Genotoxicity (Bacterial Mutagenicity Test - Ames Assay): In vitro bacterial assay.
- Implantation (Subcutaneous Implantation in Rats): Rats. Number not specified.
- Subchronic/Chronic Toxicity (Subcutaneous Implantation in Rats): Rats. Number not specified.
Animal Studies (in vivo stability and local tissue response):
- Rabbit intra-oral model: Rabbit. Number not specified.
- Rat subcutaneous model: Rat. Number not specified.
Viral Inactivation Studies: Not specified.

Data Provenance: The studies are non-clinical (laboratory and animal studies), so geographical provenance is not typically specified in the same way as human clinical data. The studies were performed to meet FDA Blue Book Memorandum G95-1 and ISO 10993-1 standards, indicating international (ISO) and U.S. (FDA) regulatory guidelines. All studies appear to be prospective as they were specifically conducted for this submission.

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

This type of information is not applicable to the non-clinical, non-human studies presented. Ground truth for the animal and in vitro tests would be established by the scientific methods and observations within the laboratory, not by expert consensus on interpretations of qualitative clinical data.

4. Adjudication Method for the Test Set

Not applicable as it's not a human clinical 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 is a medical device approval involving a physical implantable membrane, not an AI or imaging diagnostic device.

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

Not applicable, as it's not an AI or algorithm-based device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical studies described, the "ground truth" is based on:

Laboratory measurements and assays: For physical, chemical, and in vitro biological properties (e.g., cytotoxicity, genotoxicity, permeability, thickness).
Histopathological examination and observation: For results from animal implantation studies (e.g., tissue reaction, resorption characteristics).
Validated test methods: Adherence to standards like ISO 10993-1.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" in the context of this traditional medical device submission, as it's not an AI/machine learning model.

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

Not applicable.

Summary

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

November 24,2014

Collagen Matrix, Inc. Ms. Gloria Zuclich Senior Manager of Regulatory Affairs 15 Thornton Road Oakland, New Jersey 07436

Re: K142496

Trade/Device Name: Collagen Dental Membrane - Conformable IIBP Regulation Number: 21 CFR 872.3930 Regulation Name: Bone grafting material Regulatory Class: II Product Code: NPL Dated: September 04, 2014 Received: September 05, 2014

Dear Ms. Zuclich:

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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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

K142496 510(k) Number (if known):

Device Name: Collagen Dental Membrane - Conformable IIBP

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)

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510(k) Summary

1. Application Information Applicant Name: Collagen Matrix. Inc. Address: 15 Thornton Road Oakland, New Jersey 07436 Telephone: (201) 405-1477 Fax: (201) 405-1355 Contact Person: Gloria Zuclich Senior Manager of Regulatory Affairs Date of Summary: November 24, 2014 2. Name of the Device Device Trade Name: Collagen Dental Membrane - Conformable IIBP Device Common Name: Collagen Dental Membrane Device Classification Name: Barrier, animal source, intraoral 21 CFR 872.3930 Product Code NPL Device Class II 3. Legally Marketed Devices to Which Substantial Equivalence is Claimed Predicate Device(s): Collagen Dental Membrane IV K090216 Tutodent® Dental Membrane CopiOs™ Pericardium Membrane K073097 4. Description of the Device

The collagen dental membrane has a thickness of approximately 0.3 to 1.0 mm and is available in the following sizes 15 x 20 mm, 20 x 30 mm, and 30 x 40 mm.

5. Intended Use

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treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

6. Summary/Comparison of Technical Characteristics

Collagen Dental Membrane - Conformable IIBP and its predicates have similar technological characteristics. In particular, Collagen Dental Membrane - Conformable IIBP is substantially equivalent to Collagen Dental Membrane IV with regard to design and function. The bovine pericardium collagenous tissue material is also purified in the same manner as the bovine dermis collagenous tissue of Collagen Dental Membrane IV device. Collagen Dental Membrane - Conformable IIBP and Tutodent® Dental Membrane and CopiOs™ Pericardium Membrane are similar in design and function and utilize the same source of animal tissue, i.e. bovine pericardium.

Parameter	Collagen Dental Membrane-Conformable IIBP (Thissubmission)	Collagen Dental MembraneIV K090216	TutoDent® / CopiOs™K073097
Indications for Use	Intended for use in oralsurgical procedures as aresorbable membranematerial for use inaugmentation aroundimplants placed in immediateextraction sockets, delayedextraction sockets; localizedridge augmentation for laterimplantation; alveolar ridgereconstruction for prosthetictreatment; filling of bonedefects; guided boneregeneration in dehiscencedefects and guided tissueregeneration procedures inperiodontal defects.	Intended for use in oralsurgical procedures as aresorbable membranematerial for use inaugmentation aroundimplants placed in immediateextraction sockets, delayedextraction sockets; localizedridge augmentation for laterimplantation; alveolar ridgereconstruction for prosthetictreatment; filling of bonedefects; guided boneregeneration in dehiscencedefects and guided tissueregeneration procedures inperiodontal defects.	Intended for use in oralsurgical procedures as aresorbable material foraugmentation aroundimplants placed in immediateextraction sockets, delayedextraction sockets; localizedridge augmentation for laterimplantation; alveolar ridgereconstruction for prosthetictreatment; filling of bonedefects after root resection,cystectomy, removal ofretained teeth; guided boneregeneration in dehiscencedefects and guided tissueregeneration procedures inperiodontal defects.
Material	Intact purified collagen tissue	Intact purified collagen tissue	Intact purified collagen tissue
Collagen Source	Bovine pericardium	Bovine dermis	Bovine pericardium
Form	Membrane	Membrane	Membrane
Color	White to off-white	White to off-white	White to off-white
Physical Integrity	Non-friable	Non-friable	Non-friable
Sizes	15 x 20 mm20 x 30 mm30 x 40 mm	15 x 20 mm20 x 30 mm30 x 40 mm	15 x 20 mm20 x 30 mm30 x 40 mm
Thickness	Approx. 0.5 mm	Approx. 0.5 mm	Not tested
Conformability	Conformable to defect site	Conformable to defect site	Conformable to defect site
Suture Strength	Can be sutured	Can be sutured	Can be sutured
Porosity	Semi-permeable; permeableto nutrients andmacromolecules	Semi-permeable; permeableto nutrients andmacromolecules	Semi-permeable; permeableto nutrients andmacromolecules
Cross-linked	Yes	Yes	No
Method ofCrosslinking	Proprietary	Proprietary	Not applicable

A comparison between the subject and predicate devices is shown in the following table.

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Parameter	Collagen Dental Membrane-Conformable IIBP (Thissubmission)	Collagen Dental MembraneIV K090216	TutoDent® / CopiOs™K073097
ResorptionTime/In VivoStability	Gradual resorption, resorbedin approximately 16 weeksas demonstrated in animaltesting	Gradual resorption, 6-9months target	Gradual resorption, resorbedin approximately 8 to 16weeks as demonstrated inanimal testing
Biocompatibility	Biocompatible	Biocompatible	Biocompatible
How Supplied	Pre-hydrated	Dry, with hydration prior toimplantation	Dry, with hydration prior toimplantation
Sterility	Sterile, SAL 10-6	Sterile, SAL 10-6	Sterile, SAL 10-6
Pyrogenicity	Non-pyrogenic	Non-pyrogenic	Non-pyrogenic
Single Use/Reuse	Single use only	Single use only	Single use only
Packaging	Double peel package	Double peel package	Double peel package

Nonclinical Tests Submitted

The substantial equivalence of Collagen Dental Membrane - Conformable IIBP 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 IIBP 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	ISO Agarose OverlayMethod, ISO 10993-5	Non-cytotoxic. No evidence of causing any cell lysisor toxicity.
Sensitization	ISO Guinea PigMaximization SensitizationTest, ISO 10993-10	No evidence of sensitization was observed. Thetest article was not considered a sensitizer. The testarticle extract met the requirements of the test.
IntracutaneousReactivity	Acute IntracutaneousReactivity in Rabbit, ISO10993-10	No erythema and no edema from the test extractinjected intracutaneously into the rabbits. The testarticle extract met the requirements of the test.
Acute SystemicToxicity	ISO Systemic Toxicity inMice, ISO 10993-11	No mortality or evidence of systemic toxicity. Thetest article extract met the requirements of the test.
Pyrogenicity	USP Pyrogen Study –Material Mediated, ISO10993-11	Non-pyrogenic. The test article extract met therequirements of the test.
Genotoxicity	In Vitro Mouse LymphomaAssay, ISO 10993-3	None of the test article treatments inducedsubstantial increases in the number of revertantcolonies. Based on the criteria and conditions of thestudy protocol, the test article is considered non-mutagenic. The test article extract met therequirements of the test.

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Test	Test Method/ Model	Results
Genotoxicity	Bacterial MutagenicityTest - Ames Assay, ISO10993-3	Non-mutagenic to Salmonella typhimurium strainsTA97a, TA98, TA100, and TA1535 and toEscherichia coli strain WP2-uvrA. The test articleextract met the requirements of the test.
Implantation	SubcutaneousImplantation in Rats	Minimum tissue reaction up to 4 weeks ofimplantation and no adverse tissue reaction to thehost.
Subchronic/Chronic Toxicity	SubcutaneousImplantation in Rats	Minimum tissue reaction up to 24 weeks ofimplantation and no adverse tissue reaction to thehost.

In addition to the in vitro characterization tests, animal studies using a rabbit intra-oral model, as well as a rat subcutaneous model were conducted to evaluate the in vivo stability and local tissue response to the subject device.

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

Clinical Test Submitted

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

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 IIBP is as 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.