(238 days)
Not Found
No
The device description and performance studies focus on the material properties and biological performance of a collagen matrix, with no mention of AI or ML technologies.
Yes
Explanation: The device is intended for use as a dura substitute for the repair of dura mater, which is a therapeutic intervention.
No
Explanation: The device is described as a "dura substitute for the repair of dura mater" and a "collagen matrix". This indicates its use as a therapeutic or restorative implant, not for diagnosing conditions. The performance studies also focus on material properties, biocompatibility, and efficacy in repair, not diagnostic capabilities.
No
The device description clearly states it is a physical matrix made from collagen, indicating it is a hardware device, not software.
Based on the provided information, 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 used in vivo (within the body) for surgical repair.
- Device Description: The description details a resorbable, biocompatible collagen matrix intended to be implanted. This is consistent with a surgical implant, not a diagnostic test performed in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to physically repair tissue within the body.
N/A
Intended Use / Indications for Use
Collagen Dural Regeneration Matrix is intended for use as a dura substitute for the repair of dura mater.
Product codes
GXQ
Device Description
Collagen Dural Regeneration Matrix is a white, non-friable, resorbable and biocompatible type I collagen matrix made from purified bovine Achilles tendon. Collagen Dural Regeneration Matrix is a porous, sponge-like collagen matrix with one smooth surface that conforms to the contours of the defect site. It 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
Non-clinical testing was performed, including in vitro product characterization studies (Dimensions, pH, Tensile strength, Conformability, Hydrothermal transition temperature, Liquid Permeability, Burst strength), and in vitro and in vivo biocompatibility testing (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Genotoxicity (Bacterial Reverse Mutagenic Study and Mouse Lymphoma Assay), Pyrogenicity, Muscle Implantation, Subchronic Toxicity, Chronic Toxicity). An animal efficacy study utilizing a rabbit dural defect repair model was conducted to evaluate the device as compared to its predicate device with regards to dura repair and resorption. A viral inactivation study was also performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 features a stylized depiction of a human figure, with three overlapping profiles facing to the right. The profiles are rendered in black and appear to be connected, forming a single, flowing shape. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 20, 2015
Collagen Matrix, Inc. Ms. Gloria Zuclich Senior Manager of Regulatory Affairs 15 Thornton Road Oakland, New Jersey 07436
Re: K150825
Trade/Device Name: Collagen Dural Regeneration Matrix Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: Class II Product Code: GXQ Dated: November 13, 2015 Received: November 16, 2015
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.
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 FD/△
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150825
Device Name Collagen Dural Regeneration Matrix
Indications for Use (Describe)
Collagen Dural Regeneration Matrix is intended for use as a dura substitute for the repair of dura mater.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ 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 USA | |
| Telephone: | (201) 405-1477 Ext. 317 |
| Fax: | (201) 405-1355 |
| Contact Person: | Gloria Zuclich |
| Senior Manager of Regulatory Affairs | |
| Date Prepared: | November 19, 2015 |
2. Name of the Device
| Device Trade Name: | Collagen Dural Regeneration Matrix |
|---|---|
| Device Common Name: | Collagen Dura Substitute |
| Device Classification Name: | Dura Substitute |
| Regulation Number 882.5910 | |
| Product Code GXQ | |
| Device Class II |
3. Leqally Marketed Devices to Which Substantial Equivalence is Claimed
DuraGen Plus® Dural Regeneration Matrix Predicate Device(s): K032693
4. Description of the Device
Collagen Dural Regeneration Matrix is a white, non-friable, resorbable and biocompatible type I collagen matrix made from purified bovine Achilles tendon. Collagen Dural Regeneration Matrix is a porous, sponge-like collagen matrix with one smooth surface that conforms to the contours of the defect site. It is supplied sterile, non-pyrogenic, in various sizes, and for single use only.
5. Intended Use
Collagen Dural Regeneration Matrix is intended for use as a dura substitute for the repair of dura mater.
6. Summary/Comparison of Technical Characteristics
Collagen Dural Regeneration Matrix has been determined to be substantially equivalent to the predicate device having similar technological characteristics as follows:
4
| Parameter | Collagen Dural Regeneration
Matrix (This submission) | DuraGen Plus® Dural Graft
Matrix |
|---------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|
| 510(k) | K150825 | K032693 |
| 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 Achilles tendon | Bovine Achilles tendon |
| Form | Porous Collagen Matrix | Porous Collagen Matrix |
| Color | White to off-white | White to off-white |
| Physical Integrity | Non-friable | Non-friable |
| Sizes | Variety of sizes | Variety of sizes |
| Conformability | Conformable | Conformable |
| 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 blister | Double blister |
7. Discussion of Non-clinical Testing
The substantial equivalence of Collagen Dural Regeneration Matrix 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 guidelines 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
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
5
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 |
| pH | Internal test method using | |
| pH meter | pH similar to predicate device | |
| Tensile | ||
| strength | Internal test method using | |
| mechanical test apparatus | Tensile strength similar to predicate device | |
| Conformability | Internal test method to | |
| measure drape angle | Conformability similar to predicate device | |
| Hydrothermal | ||
| transition | ||
| temperature | Internal test method using | |
| differential scanning | ||
| calorimeter | Hydrothermal transition temperature | |
| similar to predicate device. | ||
| Liquid | ||
| Permeability | Internal test method to | |
| measure permeability to | ||
| liquid | Minimally permeable; similar to predicate | |
| Burst strength | Internal test method to | |
| measure burst strength | Adequate for cerebrospinal fluid (CSF) | |
| pressure |
A series of in vitro and in vivo biocompatibility testing was performed to assess safety of the Collagen Dural Regeneration Matrix as an implantable material. The biocompatibility testing performed is summarized in the table below.
| Test | Test Method/ Model | Results |
|---|---|---|
| Cytotoxicity | Agarose Overlay, ISO 10993-5 | Non-cytotoxic |
| Sensitization | Guinea Pig Maximization, ISO | |
| 10993-10 | Under the conditions of this protocol, | |
| the test article did not elicit a | ||
| sensitization response. | ||
| Intracutaneous | ||
| Reactivity | Intracutaneous Reactivity in | |
| Rabbit, ISO 10993-10 | Polar Extract | |
| Under the conditions of the study, | ||
| there was no erythema and no edema | ||
| from the test extract injected | ||
| intracutaneously into the rabbits. | ||
| Test | Test Method/ Model | Results |
| Non-polar Extract | ||
| Under the conditions of the study, | ||
| there was no to very slight erythema or | ||
| edema from the extract injected | ||
| intracutaneously into rabbits. | ||
| Acute Systemic | ||
| Toxicity | Acute Systemic Toxicity in | |
| Mice, ISO 10993-11 | No mortality or evidence of systemic | |
| toxicity. | ||
| Genotoxicity | Bacterial Reverse Mutagenic | |
| Study, ISO 10993-3 | Non-mutagenic to Salmonella | |
| typhimurium (Test Strains: TA98, | ||
| TA1535, and TA1537) and to | ||
| Escherichia coli (Test Strain WP2uvrA) | ||
| Genotoxicity | Mouse Lymphoma Assay, ISO | |
| 10993-3 | The test article extracts did not cause | |
| a two-fold or greater increase in the | ||
| mean mutant frequency of the | ||
| L5178Y/TK+/- cell line either in the | ||
| presence or absence of metabolic | ||
| activation. The test article is | ||
| considered non-mutagenic. | ||
| Pyrogenicity | USP (151) Pyrogen Study – | |
| Material Mediated | The test article was judged as | |
| nonpyrogenic. | ||
| Muscle | ||
| Implantation | Muscle Implantation Study in | |
| Rabbits, 2 weeks, ISO 10993-6 | The macroscopic reaction was not | |
| significant as compared to the sponsor | ||
| provided control article or to the | ||
| negative control article. | ||
| Microscopically, the test article was | ||
| classified as a non-irritant as | ||
| compared to the sponsor provided | ||
| control article and as a slight irritant as | ||
| compared to the negative control | ||
| article. | ||
| Subchronic | ||
| Toxicity | Subcutaneous Implantation in | |
| Rabbits, ISO 10993-11 | Under the conditions of the 13-week | |
| study, there was no evidence of | ||
| systemic toxicity or adverse findings | ||
| attributed to the test article when | ||
| compared with the predicate control. | ||
| Chronic | ||
| Toxicity | Subcutaneous Implantation in | |
| Rabbits, ISO 10993-11 | Under the conditions of the 26-week | |
| subcutaneous implant toxicity study, | ||
| there was no evidence of systemic | ||
| toxicity or adverse findings attributed to | ||
| the test article. Based upon the | ||
| differences between the Test Article | ||
| Group Average Irritation Scores, the | ||
| test article was considered non-irritant | ||
| when compared to the predicate | ||
| control at 26 weeks. |
6
An animal efficacy study utilizing a rabbit dural defect repair model was conducted to evaluate the device as compared to its predicate device with regards to dura repair and resorption. No clinical tests were performed on the product; however clinical history of the predicate device was referenced in the submission.
7
A Viral inactivation study was performed to ensure the viral safety of the product.
8. Conclusion of Non-clinical Studies
The predicate device was cleared based on the results of non-clinical data. The subject device demonstrates equivalence to the predicate device.