COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN

K110600 · Collagen Matrix, Inc. · NPL · Jul 29, 2011 · Dental

Device Facts

• Record ID: K110600
• Device Name: COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN
• Applicant: Collagen Matrix, Inc.
• Product Code: NPL · Dental
• Decision Date: Jul 29, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Collagen Dental Membrane-Porcine Type I Collagen is intended for use in oral surgical procedures as a resorbable material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in wound healing.

Device Story

Device is a white, nonfriable, conformable, resorbable membrane matrix derived from purified porcine Achilles tendon type I collagen. Used in oral surgery by dental professionals to cover dental implant sites, bone defects, or ridge reconstructions. Acts as a barrier to aid wound healing. Supplied sterile, non-pyrogenic, for single use. Flexible nature allows it to conform to defect site contours. Resorbs over time, eliminating need for surgical removal.

Clinical Evidence

No clinical tests performed. Safety and effectiveness supported by in vitro characterization studies (material, biological, chemical, physical properties), biocompatibility testing (ISO 10993-1), and clinical history of predicate devices. Viral inactivation studies conducted to ensure safety.

Technological Characteristics

Material: Purified type I collagen from porcine Achilles tendon. Form: Resorbable, conformable, nonfriable membrane. Sterilization: Sterile. Biocompatibility: Compliant with ISO 10993-1 and FDA Blue Book Memorandum G95-1.

Indications for Use

Indicated for use in oral surgical procedures as a resorbable material for placement in the area of dental implant, bone defect, or ridge augmentation to aid in wound healing.

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-Conformable II (K062881)
• Ossix Plus (K053260)

Submission Summary (Full Text)

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K110600

### 510(k) SUMMARY

JUL 2 9 2011

### 1. Applicant Information

ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ

| Applicant Name: | Collagen Matrix, Inc. |
|-----------------|---------------------------------------------|
| Address: | 15 Thornton Road |
| | Oakland, New Jersey 07436 |
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Peggy Hansen, RAC |
| | VP, Clinical, Regulatory, QA, and Marketing |
| Date Prepared: | February 28, 2011 |

### 2. Name of the Device

Device Common Name: Resorbable Collagen Membrane Collagen Dental Membrane - Porcine Type | Collagen Device Trade Name: Device Classification Name: Barrier, animal source, intraoral 872.3930 NPL Class II

## 3. Legally Marketed Devices to Which Substantial Equivalence is Claimed

Predicate Device(s):

Collagen Dental Membrane-Conformable II K062881

Ossix Plus K053260

#### Description of the Device 4.

Collagen Dental Membrane-Porcine Type I Collagen is a white, nonfriable, conformable, resorbable, membrane matrix engineered from highly purified type I collagen derived from porcine Achilles tendon. It is flexible and conforms to the contours of the defect site. Collagen Dental Membrane-Porcine Type I Collagen is supplied sterile, non-pyrogenic, in various sizes, and for single use only.

#### 5. Intended Use

Collagen Dental Membrane-Porcine Type I Collagen is intended for use in oral surgical procedures as a resorbable material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in wound healing.

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#### Summary/Comparison of Technical Characteristics 6.

Collagen Dental Membrane-Porcine Type I Collagen and its predicates have similar technological characteristics. In particular, the Collagen Dental Membrane-Porcine Type I Collagen and its predicates are similar with respect to intended use, purified starting material (type I collagen), form, sizes, thickness, physical integrity, permeability and conformability. The substantial equivalence of Collagen Dental Membrane-Porcine Type I Collagen and its 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 Membrane-Porcine Type I Collagen 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. 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 Membrane-Porcine Type I Collagen is safe and substantially equivalent to the predicate devices.

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

Collagen Matrix, Incorporated Ms. Peggy Hansen Vice President, Clinical. Regulatory, OA, and Marketing 15 Thornton Road Oakland, New Jersey 07436

JUL 2 9 2011

Re: K110600

Trade/Device Name: Collagen Dental Membrane - Porcine Type I Collagen Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPL Dated: July 22, 2011 Received: July 25, 2011

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 clectronic 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 /ucm 115809.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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susan Runser
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): _ K \ 0 6 00

Collagen Dental Membrane – Porcine Type I Collagen Device Name: ________

Indications for Use:

Collagen Dental Membrane – Porcine Type I Collagen is intended for use in oral surgical procedures as a resorbable material for placement in the area of dental implant, bone defect, or ridge augmentation to aid in wound healing.

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 CBRH, Office of Device Evaluation (ODE)

Swart-Kaser

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K110600

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