K Number
K141608
Device Name
COLLAGEN DURA MEMBRANE
Date Cleared
2015-01-16

(214 days)

Product Code
Regulation Number
882.5910
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Collagen Dura Membrane is intended for use as a dura substitute for the repair of dura mater.
Device Description
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.
More Information

Not Found

No
The device description and performance studies focus on the material properties and biological performance of a collagen membrane, with no mention of software, algorithms, or data processing that would indicate AI/ML.

No
The device is described as a "dura substitute for the repair of dura mater," which indicates it is a medical implant used for structural repair, not a device that provides therapeutic treatment.

No

Explanation: The device is described as a "dura substitute for the repair of dura mater", which is a therapeutic function, not a diagnostic one. It is a membrane matrix for surgical repair.

No

The device description clearly states it is a "membrane matrix consisting of highly purified collagen derived from bovine dermis," indicating it is a physical, implantable material, not software.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "as a dura substitute for the repair of dura mater." This describes a device that is implanted or used directly on the patient's tissue (dura mater) during a surgical procedure.
  • Device Description: The description details a physical membrane matrix made of collagen, designed to be sutured in place. This is a physical implantable material.
  • Lack of In Vitro Testing: While the performance studies include "in vitro characterization studies," these are tests on the device itself (dimensions, strength, etc.), not tests performed on patient samples (like blood, urine, or tissue) to diagnose a condition or monitor a patient's health.
  • Anatomical Site: The anatomical site is the "dura mater," which is a tissue within the body. IVDs typically interact with biological samples taken from the body.

An In Vitro Diagnostic device is specifically designed to be used outside the body (in vitro) to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.

N/A

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

GXQ

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Dura mater

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical testing was performed in accordance with FDA recognized consensus standards and FDA quidelines.
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.
A series of in vitro and in vivo biocompatibility testing was performed to assess safety of the Collagen Dura Membrane as an implantable material.
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.
Viral inactivation studies were performed to ensure the viral safety of the product.

Study Types and Key Results:

  • Dimensions: Measurements, Results: Dimensions similar to predicate device
  • Suture pullout strength: Internal test method using mechanical test apparatus, Results: Suture strength similar to predicate device
  • Tensile strength: Internal test method using mechanical test apparatus, Results: Tensile strength similar to predicate device
  • Conformability: Internal test method to measure drape angle, Results: Conformability similar to predicate device
  • Hydrothermal transition temperature: Internal test method using differential scanning calorimeter, Results: Hydrothermal transition temperature similar to predicate device.
  • Porosity / Permeability: Internal test method, Results: Permeability similar to predicate device
  • Cytotoxicity: ISO Agarose Overlay Method - Extract, ISO 10993-5, Results: Non-cytotoxic.
  • Sensitization: Murine Local Lymph Node Assay, ISO 10993-10, Results: Not considered to be sensitizing.
  • Intracutaneous Reactivity: Acute Intracutaneous Reactivity in Rabbit, ISO 10993-10, Results: No erythema and no edema from the test extract injected intracutaneously into the rabbits.
  • Acute Systemic Toxicity: ISO Systemic Toxicity in Mice, ISO 10993-11, Results: No mortality or evidence of significant systemic toxicity.
  • Genotoxicity: Bacterial Reverse Mutagenic Study, ISO 10993-3, Results: Non-mutagenic to Salmonella typhimurium tester strains TA98, TA100, and TA1537, and to Escherichia coli strain WP2uvrA.
  • Genotoxicity: Mouse Lymphoma Assay, ISO 10993-3, Results: 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.
  • Genotoxicity: In Vivo Mouse Micronucleus Assay, ISO 10993-3, Results: None of the mice treated with the test article preparations exhibited overt signs of toxicity either immediately post-treatment or during the induction period. The levels of micronucleated cells were within normal negative ranges. Based on the criteria and conditions of the study protocol, the test article is considered non-mutagenic.
  • Pyrogenicity: USP (151) Pyrogen Study - Material Mediated, Results: The test article was judged as nonpyrogenic.
  • Implantation: Subcutaneous Implantation in Rats, ISO 10993-6, Results: Minimum tissue reaction up to 4 weeks of implantation and no adverse tissue reaction to the host.
  • Subchronic Systemic Toxicity: Subcutaneous Implantation in Rabbits, ISO 10993-11, Results: There was no evidence of systemic toxicity or adverse findings attributed to the test article at 13 week time point.
  • Chronic Toxicity: Subcutaneous Implantation in Rabbits, ISO 10993-11, Results: There was no evidence of systemic toxicity or adverse findings attributed to the test article at 26 week time point.
  • Dura Repair and Resorption: Rabbit dural defect repair model using the subject device and predicate device as a control, Results: Subject device performed as well as the predicate device
  • Resorption: Rat subcutaneous model using the subject device, Results: Resorption profile verified design criteria
  • Handling, Implantability: Canine craniectomy model for implanting the subject device and predicate device, Results: Subject device handles as well as the predicate device using typical surgical technique for implantation

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K052211

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 882.5910 Dura substitute.

(a)
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).(b)
Classification. Class II (performance standards).

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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

1

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
Oakland, New Jersey 07436
Telephone:(201) 405-1477
Fax:(201) 405-1355
Contact Person:Peggy Hansen, RAC
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
(This submission) | Durepair® Dura Regeneration
Matrix |
|---------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Indications for Use | Intended for use as a dura
substitute for the repair of dura
mater. | Intended for use as a dura
substitute for the repair of dura
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.

TestTest MethodResults
DimensionsMeasurementsDimensions similar to predicate device
Suture pullout
strengthInternal test method using
mechanical test apparatusSuture strength similar to predicate device
Tensile
strengthInternal test method using
mechanical test apparatusTensile strength similar to predicate device
ConformabilityInternal test method to
measure drape angleConformability similar to predicate device
Hydrothermal
transition
temperatureInternal test method using
differential scanning
calorimeterHydrothermal transition temperature similar
to predicate device.
Porosity /
PermeabilityInternal test methodPermeability 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.

TestTest Method/ ModelResults
CytotoxicityISO Agarose Overlay Method -
Extract, ISO 10993-5Non-cytotoxic.
SensitizationMurine Local Lymph Node
Assay, ISO 10993-10Not considered to be sensitizing.
Intracutaneou
s ReactivityAcute Intracutaneous Reactivity
in Rabbit, ISO 10993-10No erythema and no edema from the
test extract injected intracutaneously
into the rabbits.
AcuteISO Systemic Toxicity in Mice,No mortality or evidence of significant

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TestTest Method/ ModelResults
Systemic
ToxicityISO 10993-11systemic toxicity.
GenotoxicityBacterial Reverse Mutagenic
Study, ISO 10993-3Non-mutagenic to Salmonella
typhimurium tester strains TA98,
TA100, and TA1537, and to
Escherichia coli strain WP2uvrA.
GenotoxicityMouse Lymphoma Assay, ISO
10993-3None 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.
GenotoxicityIn Vivo Mouse Micronucleus
Assay, ISO 10993-3None of the mice treated with the test
article preparations exhibited overt
signs of toxicity either immediately
post-treatment or during the induction
period. The levels of micronucleated
cells were within normal negative
ranges. Based on the criteria and
conditions of the study protocol, the
test article is considered non-
mutagenic.
PyrogenicityUSP (151) Pyrogen Study -
Material MediatedThe test article was judged as
nonpyrogenic.
ImplantationSubcutaneous Implantation in
Rats, ISO 10993-6Minimum tissue reaction up to 4 weeks
of implantation and no adverse tissue
reaction to the host.
Subchronic
Systemic
ToxicitySubcutaneous Implantation in
Rabbits, ISO 10993-11There was no evidence of systemic
toxicity or adverse findings attributed to
the test article at 13 week time point.
Chronic
ToxicitySubcutaneous Implantation in
Rabbits, ISO 10993-11There was no evidence of systemic
toxicity or adverse findings attributed to
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.

TestTest Method/ ModelResults
Dura Repair
and
ResorptionRabbit dural defect repair model
using the subject device and
predicate device as a controlSubject device performed as well as
the predicate device
ResorptionRat subcutaneous model using
the subject deviceResorption profile verified design
criteria
Handling,
ImplantabilityCanine craniectomy model for
implanting the subject device
and predicate deviceSubject device handles as well as the
predicate device using typical surgical
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.