COLLAGEN DURA MEMBRANE

K141608 · Collagen Matrix, Inc. · GXQ · Jan 16, 2015 · Neurology

Device Facts

• Record ID: K141608
• Device Name: COLLAGEN DURA MEMBRANE
• Applicant: Collagen Matrix, Inc.
• Product Code: GXQ · Neurology
• Decision Date: Jan 16, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5910
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Collagen Dura Membrane is intended for use as a dura substitute for the repair of dura mater.

Device Story

Collagen Dura Membrane is a sterile, non-pyrogenic, bovine-derived collagen matrix; used as a dura substitute for dural repair. Device is flexible, non-friable, and conformable to defect site contours; possesses mechanical strength allowing for suturing. Supplied in various sizes for single-use. Implanted by surgeons during neurosurgical procedures to replace or repair dura mater. Gradual resorption profile allows for tissue integration. Benefits include effective dural closure and biocompatibility, reducing risk of cerebrospinal fluid leakage.

Clinical Evidence

No clinical data provided. Evidence based on bench testing and animal studies. Bench testing included dimensions, suture pullout strength, tensile strength, conformability, hydrothermal transition temperature, and porosity. Biocompatibility testing followed ISO 10993 standards (cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, genotoxicity, pyrogenicity, implantation). Animal studies included rabbit dural defect repair, rat subcutaneous resorption, and canine craniectomy models, demonstrating performance equivalent to the predicate device.

Technological Characteristics

Material: Highly purified bovine dermis collagen. Form: Flexible, non-friable membrane. Mechanical: Suture-compatible. Sterilization: Sterile (SAL 10^-6). Standards: ISO 22442-1/2/3 (animal tissues), ISO 10993-3/5/6/10/11 (biocompatibility). Connectivity: N/A (implantable).

Indications for Use

Indicated for use as a dura substitute for the repair of dura mater in patients requiring dural repair.

Regulatory Classification

Identification

A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).

Predicate Devices

• Durepair® Dura Regeneration Matrix (K052211)

Submission Summary (Full Text)

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three overlapping human profiles facing to the right, with flowing lines extending from the bottom of the profiles.

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

January 16, 2015

Collagen Matrix, Inc. Peggy Hansen Senior VP, Marketing and Regulatory Affairs 15 Thornton Road Oakland, New Jersey 07436

Re: K141608 Trade/Device Name: Collagen Dura Membrane Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: Class II Product Code: GXQ Dated: December 15, 2014 Received: December 17, 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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

# Carlos L. Pena --S/^

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K141608

Device Name Collagen Dura Membrane

Indications for Use (Describe)

Collagen Dura Membrane is intended for use as a dura substitute for the repair of dura mater.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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### 510(k) SUMMARY

#### 1. Applicant Information

| Applicant Name: | Collagen Matrix, Inc. |
|-----------------|------------------------------------------------------------------|
| Address: | 15 Thornton Road<br>Oakland, New Jersey 07436 |
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Peggy Hansen, RAC<br>VP, Clinical, Regulatory, QA, and Marketing |
| Date Prepared: | January 15, 2015 |

#### 2. Name of the Device

Device Common Name: Device Trade Name: Device Classification Name: Dura Substitute Collagen Dura Membrane Dura Substitute 21 CFR 882.5910 Product Code GXQ Device Class II

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

Predicate Device(s):

Durepair® Dura Regeneration Matrix K052211

#### 4. Description of the Device

Collagen Dura Membrane is a white, nonfriable, conformable, membrane matrix consisting of highly purified collagen derived from bovine dermis. It is flexible and conforms to the contours of the defect site. The product's mechanical strength allows the membrane matrix to be sutured in place. Collagen Dura Membrane is supplied sterile, non-pyrogenic, in various sizes, and for single use only.

#### 5. Intended Use

Collagen Dura Membrane is intended for use as a dura substitute for the repair of dura mater.

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### 6. Summary/Comparison of Technical Characteristics

Collagen Dura Membrane has been determined to be substantially equivalent to the predicate devices having similar technological characteristics as follows:

| Parameter | Collagen Dura Membrane<br>(This submission) | Durepair® Dura Regeneration<br>Matrix |
|---------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Indications for Use | Intended for use as a dura<br>substitute for the repair of dura<br>mater. | Intended for use as a dura<br>substitute for the repair of dura<br>mater. |
| Collagen Source | Bovine dermis | Bovine dermis |
| Form | Membrane | Membrane |
| Color | White to off-white | White to off-white |
| Physical Integrity | Non-friable | Non-friable |
| Sizes | Variety of sizes | Variety of sizes |
| Suture Strength | Can be sutured | Can be sutured |
| Biocompatibility | Biocompatible | Biocompatible |
| In Vivo Stability | Gradual resorption | Gradual resorption |
| Sterility | Sterile, SAL 10-6 | Sterile, SAL 10-6 |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| Single Use/Reuse | Single use only | Single use only |
| Packaging | Double peel package | Double peel package |

### 7. Discussion of Non-clinical Testing

The substantial equivalence of Collagen Dura Membrane and its predicate was demonstrated based on in vitro characterization studies, biocompatibility studies, and an animal efficacy study.

Non-clinical testing was performed in accordance with FDA recognized consensus standards and FDA quidelines as follows:

FDA Guidance Document entitled, "Guidance document for Dura Substitute Device: Guidance for Industry", issued on November 9, 2000

ISO 22442-1 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices - Part 1 Analysis and Risk Management

ISO 22442-2 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices - Part 2 Controls on Sourcing, Collection, and Handling

ISO 22442-3 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices - Part 3 Validation of the Elimination and/or Inactivation of Viruses and Transmissible Agents

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ISO 10993-3:2009 Biological Evaluation of Medical Devices- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests for in vitro cytotoxicity

ISO 10993-6:2009 Biological Evaluation of Medical Devices- Part 6: Test for local effects after implantation

ISO 10993-10:2009 Biological Evaluation of Medical Devices- Part 10 Test for local effects after implantation

ISO 10993-11:2009 Biological Evaluation of Medical devices – Part 11 Tests for systemic toxicity

#### Non-clinical Testing Conducted

In vitro product characterization testing was performed to demonstrate substantial equivalence of the subject device to its predicate device. A series of bench tests were conducted to evaluate material properties, biological properties, chemical and physical properties. The comparative bench testing is summarized in the table below.

| Test | Test Method | Results |
|-------------------------------------------|--------------------------------------------------------------------|---------------------------------------------------------------------|
| Dimensions | Measurements | Dimensions similar to predicate device |
| Suture pullout<br>strength | Internal test method using<br>mechanical test apparatus | Suture strength similar to predicate device |
| Tensile<br>strength | Internal test method using<br>mechanical test apparatus | Tensile strength similar to predicate device |
| Conformability | Internal test method to<br>measure drape angle | Conformability similar to predicate device |
| Hydrothermal<br>transition<br>temperature | Internal test method using<br>differential scanning<br>calorimeter | Hydrothermal transition temperature similar<br>to predicate device. |
| Porosity /<br>Permeability | Internal test method | Permeability similar to predicate device |

A series of in vitro and in vivo biocompatibility testing was performed to assess safety of the Collagen Dura Membrane as an implantable material. The biocompatibility testing performed is summarized in the table below.

| Test | Test Method/ Model | Results |
|-------------------------------|------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Cytotoxicity | ISO Agarose Overlay Method -<br>Extract, ISO 10993-5 | Non-cytotoxic. |
| Sensitization | Murine Local Lymph Node<br>Assay, ISO 10993-10 | Not considered to be sensitizing. |
| Intracutaneou<br>s Reactivity | Acute Intracutaneous Reactivity<br>in Rabbit, ISO 10993-10 | No erythema and no edema from the<br>test extract injected intracutaneously<br>into the rabbits. |
| Acute | ISO Systemic Toxicity in Mice, | No mortality or evidence of significant |

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| Test | Test Method/ Model | Results |
|------------------------------------|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Systemic<br>Toxicity | ISO 10993-11 | systemic toxicity. |
| Genotoxicity | Bacterial Reverse Mutagenic<br>Study, ISO 10993-3 | Non-mutagenic to Salmonella<br>typhimurium tester strains TA98,<br>TA100, and TA1537, and to<br>Escherichia coli strain WP2uvrA. |
| Genotoxicity | Mouse Lymphoma Assay, ISO<br>10993-3 | None of the test article treatments<br>induced substantial increases in the<br>number of revertant colonies. Based<br>on the criteria and conditions of the<br>study protocol, the test article is<br>considered non-mutagenic. |
| Genotoxicity | In Vivo Mouse Micronucleus<br>Assay, ISO 10993-3 | None of the mice treated with the test<br>article preparations exhibited overt<br>signs of toxicity either immediately<br>post-treatment or during the induction<br>period. The levels of micronucleated<br>cells were within normal negative<br>ranges. Based on the criteria and<br>conditions of the study protocol, the<br>test article is considered non-<br>mutagenic. |
| Pyrogenicity | USP (151) Pyrogen Study -<br>Material Mediated | The test article was judged as<br>nonpyrogenic. |
| Implantation | Subcutaneous Implantation in<br>Rats, ISO 10993-6 | Minimum tissue reaction up to 4 weeks<br>of implantation and no adverse tissue<br>reaction to the host. |
| Subchronic<br>Systemic<br>Toxicity | Subcutaneous Implantation in<br>Rabbits, ISO 10993-11 | There was no evidence of systemic<br>toxicity or adverse findings attributed to<br>the test article at 13 week time point. |
| Chronic<br>Toxicity | Subcutaneous Implantation in<br>Rabbits, ISO 10993-11 | There was no evidence of systemic<br>toxicity or adverse findings attributed to<br>the test article at 26 week time point. |

An animal efficacy study and additional animal studies were conducted to evaluate the device as compared to its predicate device. No clinical tests were performed on the product; however clinical history of the predicate device was referenced in the submission. The animal studies performed are summarized in the table below.

| Test | Test Method/ Model | Results |
|----------------------------------|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Dura Repair<br>and<br>Resorption | Rabbit dural defect repair model<br>using the subject device and<br>predicate device as a control | Subject device performed as well as<br>the predicate device |
| Resorption | Rat subcutaneous model using<br>the subject device | Resorption profile verified design<br>criteria |
| Handling,<br>Implantability | Canine craniectomy model for<br>implanting the subject device<br>and predicate device | Subject device handles as well as the<br>predicate device using typical surgical<br>technique for implantation |

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

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#### 8. Conclusion of Non-clinical Studies

The predicate device was cleared based on the results of non-clinical data. Subject and predicate device performance data were compared to support the safety of the subject device and demonstrate that the Collagen Dura Membrane should perform as intended in the specified us conditions.