Collagen Dental Membrane - Conformable IIBP

K142496 · Collagen Matrix, Inc. · NPL · Nov 24, 2014 · Dental

Device Facts

• Record ID: K142496
• Device Name: Collagen Dental Membrane - Conformable IIBP
• Applicant: Collagen Matrix, Inc.
• Product Code: NPL · Dental
• Decision Date: Nov 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Collagen Dental Membrane - Conformable IIBP is a non-friable, resorbable barrier membrane derived from purified bovine pericardium. Supplied pre-hydrated and sterile for single-use in oral surgery. Device acts as a physical barrier to facilitate guided bone and tissue regeneration by preventing soft tissue ingrowth into bone defects while remaining permeable to nutrients. Used by dental surgeons in clinical settings; placed over bone graft sites or defects to support healing. Benefits include structural support for bone regeneration and conformability to complex defect contours. Device resorbs gradually over time, eliminating need for surgical removal.

Clinical Evidence

No clinical data submitted. Substantial equivalence established via bench testing, in vitro characterization, and in vivo animal studies (rabbit intra-oral and rat subcutaneous models). Biocompatibility testing performed per ISO 10993-1, including cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogenicity, and genotoxicity, all yielding passing results.

Technological Characteristics

Resorbable membrane composed of purified bovine pericardium collagen. Thickness 0.3-1.0 mm. Semi-permeable; cross-linked via proprietary method. Supplied pre-hydrated, sterile (SAL 10^-6), non-pyrogenic. Biocompatible per ISO 10993 standards. Non-friable, conformable, and suture-compatible.

Indications for Use

Indicated for patients requiring oral surgical procedures involving bone augmentation around implants (immediate/delayed extraction sockets), localized ridge augmentation, alveolar ridge reconstruction, bone defect filling, guided bone regeneration in dehiscence defects, and guided tissue regeneration in periodontal defects.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Collagen Dental Membrane IV (K090216)
• Tutodent® Dental Membrane (K073097)
• CopiOs™ Pericardium Membrane (K073097)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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:

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.

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: [phone] Fax: [phone] 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

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.

#### 5. Intended Use

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

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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<br>-Conformable IIBP (This<br>submission) | Collagen Dental Membrane<br>IV K090216 | TutoDent® / CopiOs™<br>K073097 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Intended for use in oral<br>surgical procedures as a<br>resorbable membrane<br>material for use in<br>augmentation around<br>implants placed in immediate<br>extraction sockets, delayed<br>extraction sockets; localized<br>ridge augmentation for later<br>implantation; alveolar ridge<br>reconstruction for prosthetic<br>treatment; filling of bone<br>defects; guided bone<br>regeneration in dehiscence<br>defects and guided tissue<br>regeneration procedures in<br>periodontal defects. | Intended for use in oral<br>surgical procedures as a<br>resorbable membrane<br>material for use in<br>augmentation around<br>implants placed in immediate<br>extraction sockets, delayed<br>extraction sockets; localized<br>ridge augmentation for later<br>implantation; alveolar ridge<br>reconstruction for prosthetic<br>treatment; filling of bone<br>defects; guided bone<br>regeneration in dehiscence<br>defects and guided tissue<br>regeneration procedures in<br>periodontal defects. | Intended for use in oral<br>surgical procedures as a<br>resorbable material for<br>augmentation around<br>implants placed in immediate<br>extraction sockets, delayed<br>extraction sockets; localized<br>ridge augmentation for later<br>implantation; alveolar ridge<br>reconstruction for prosthetic<br>treatment; filling of bone<br>defects after root resection,<br>cystectomy, removal of<br>retained teeth; guided bone<br>regeneration in dehiscence<br>defects and guided tissue<br>regeneration procedures in<br>periodontal 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 mm<br>20 x 30 mm<br>30 x 40 mm | 15 x 20 mm<br>20 x 30 mm<br>30 x 40 mm | 15 x 20 mm<br>20 x 30 mm<br>30 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; permeable<br>to nutrients and<br>macromolecules | Semi-permeable; permeable<br>to nutrients and<br>macromolecules | Semi-permeable; permeable<br>to nutrients and<br>macromolecules |
| Cross-linked | Yes | Yes | No |
| Method of<br>Crosslinking | 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<br>-Conformable IIBP (This<br>submission) | Collagen Dental Membrane<br>IV K090216 | TutoDent® / CopiOs™<br>K073097 |
|-----------------------------------------|---------------------------------------------------------------------------------------------------|----------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Resorption<br>Time/In Vivo<br>Stability | Gradual resorption, resorbed<br>in approximately 16 weeks<br>as demonstrated in animal<br>testing | Gradual resorption, 6-9<br>months target | Gradual resorption, resorbed<br>in approximately 8 to 16<br>weeks as demonstrated in<br>animal testing |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible |
| How Supplied | Pre-hydrated | Dry, with hydration prior to<br>implantation | Dry, with hydration prior to<br>implantation |
| 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 Overlay<br>Method, ISO 10993-5 | Non-cytotoxic. No evidence of causing any cell lysis<br>or toxicity. |
| Sensitization | ISO Guinea Pig<br>Maximization Sensitization<br>Test, ISO 10993-10 | No evidence of sensitization was observed. The<br>test article was not considered a sensitizer. The test<br>article extract met the requirements of the test. |
| Intracutaneous<br>Reactivity | Acute Intracutaneous<br>Reactivity in Rabbit, ISO<br>10993-10 | No erythema and no edema from the test extract<br>injected intracutaneously into the rabbits. The test<br>article extract met the requirements of the test. |
| Acute Systemic<br>Toxicity | ISO Systemic Toxicity in<br>Mice, ISO 10993-11 | No mortality or evidence of systemic toxicity. The<br>test article extract met the requirements of the test. |
| Pyrogenicity | USP Pyrogen Study –<br>Material Mediated, ISO<br>10993-11 | Non-pyrogenic. The test article extract met the<br>requirements of the test. |
| Genotoxicity | In Vitro Mouse Lymphoma<br>Assay, ISO 10993-3 | None of the test article treatments induced<br>substantial increases in the number of revertant<br>colonies. Based on the criteria and conditions of the<br>study protocol, the test article is considered non-<br>mutagenic. The test article extract met the<br>requirements of the test. |

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| Test | Test Method/ Model | Results |
|---------------------------------|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Genotoxicity | Bacterial Mutagenicity<br>Test - Ames Assay, ISO<br>10993-3 | Non-mutagenic to Salmonella typhimurium strains<br>TA97a, TA98, TA100, and TA1535 and to<br>Escherichia coli strain WP2-uvrA. The test article<br>extract met the requirements of the test. |
| Implantation | Subcutaneous<br>Implantation in Rats | Minimum tissue reaction up to 4 weeks of<br>implantation and no adverse tissue reaction to the<br>host. |
| Subchronic/<br>Chronic Toxicity | Subcutaneous<br>Implantation in Rats | Minimum tissue reaction up to 24 weeks of<br>implantation and no adverse tissue reaction to the<br>host. |

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.