(28 days)
Not Found
No
The device description and performance studies focus on the material properties and biological safety of the collagen matrix and HPMC, with no mention of AI or ML technologies.
No.
The device is an implantable matrix for dural repair, which is a structural and restorative function, not a therapeutic intervention in the sense of treating a disease or symptom.
No
The device is an implant for repair of dura mater, not a diagnostic tool. Its function is to replace or regenerate tissue, not to identify or monitor medical conditions.
No
The device description clearly states it is an "absorbable implant" comprised of physical materials (collagen matrix and HPMC), indicating it is a physical medical 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 is a surgical implant used directly on the patient's tissue.
- Device Description: The description details an "absorbable implant" comprised of collagen and HPMC, designed for surgical repair.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
DuraGen® Secure Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater.
Product codes (comma separated list FDA assigned to the subject device)
GXQ
Device Description
DuraGen® Secure Dural Regeneration Matrix is an absorbable implant for the repair of dura mater. This absorbable, sutureless onlay graft is comprised of a porous, highly purified collagen matrix and a thin layer of hydroxypropyl methyl cellulose (HPMC). HPMC is a non-cytotoxic, non-immunogenic, biocompatible plant-derived cellulose-based material. The addition of HPMC results in a dural graft which reduces the potential for the product to migrate, slide or displace during the surgical procedure, such as during irrigation of the surgical site or in a standing pool of fluid, without the use of sutures.
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)
A viral inactivation study was conducted to demonstrate that DuraGen® Secure Dural Regeneration Matrix demonstrates continued conformance to ISO 22442-3 Medical devices utilizing animal tissues and their derivatives -- Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents, FDA Recognition Number 15-47, through the combined enzymatic treatment and alkali treatment processes. These processes were performed in a validated scaled down process that is representative of all Integra LifeSciences Corporation's collagen products. The viral inactivation study resulted in a six log reduction of the viral titers. The results of the testing did not raise any new issues of safety or effectiveness compared to DuraGen® Secure Dural Regeneration Matrix.
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.
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).
0
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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted with three abstract human profiles facing to the right, suggesting a focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 6, 2017
Integra LifeSciences Corporation Yara Hamid Regulatory and Quality Associate 311 Enterprise Dr. Plainsboro, NJ 08536
Re: K163456
Trade/Device Name: DuraGen® Secure Dural Regeneration Matrix Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: Class II Product Code: GXQ Dated: December 8, 2016 Received: December 9, 2016
Dear Ms. Yara Hamid:
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 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.
1
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, Michael J. Hoffmann -S
Carlos L. Peña. PhD, MS for 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) K163456
Device Name
DuraGen® Secure Dural Regeneration Matrix
Indications for Use (Describe)
DuraGen® Secure Dural Regeneration Matrix is indicated 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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2. 510(k) SUMMARY
DuraGen® Secure Dural Regeneration Matrix
Submitter's name and address:
Integra LifeSciences Corporation
311 Enterprise Drive
Plainsboro, NJ 08536 USA
Telephone: 609-275-0500
Cell: 609-275-5363
Contact person and telephone number:
Yara Hamid
Regulatory and Quality Associate
Date the Summary was prepared: November 11, 2016
Name of the device:
| Proprietary Name: | DuraGen® Secure Dural Regeneration Matrix |
|---|---|
| Common Name: | Dura Substitute |
| Classification Name: | Dura substitute |
| Product Code: | GXQ |
| Regulation: | Class II, under 21 CFR 882.5910 |
Substantial Equivalence:
DuraGen® Secure Dural Regeneration Matrix is substantially equivalent in function and intended use to the predicate device detailed in Table 2-1.
4
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| K120600 | GXQ | DuraGen® Secure | |
| Dural Regeneration | |||
| Matrix | Integra LifeSciences | ||
| Corporation |
Table 2-1- Substantial Equivalence Table
Device Description:
DuraGen® Secure Dural Regeneration Matrix is an absorbable implant for the repair of dura mater. This absorbable, sutureless onlay graft is comprised of a porous, highly purified collagen matrix and a thin layer of hydroxypropyl methyl cellulose (HPMC). HPMC is a non-cytotoxic, non-immunogenic, biocompatible plant-derived cellulose-based material. The addition of HPMC results in a dural graft which reduces the potential for the product to migrate, slide or displace during the surgical procedure, such as during irrigation of the surgical site or in a standing pool of fluid, without the use of sutures.
Indication for Use:
DuraGen® Secure Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater.
Summary of Technological Characteristics:
DuraGen® Secure Dural Regeneration Matrix has the same design, material, and chemical composition, as the predicate device (K120600). The manufacturing and processing are exactly the same and have no changed.
Testing and Test Results:
A viral inactivation study was conducted to demonstrate that DuraGen® Secure Dural Regeneration Matrix demonstrates continued conformance to ISO 22442-3 Medical devices utilizing animal tissues and their derivatives -- Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents, FDA Recognition Number 15-47, through the combined enzymatic treatment and alkali treatment processes. These processes were performed in a validated scaled down process that is representative of all Integra LifeSciences Corporation's collagen products. The viral inactivation study resulted in a six log reduction of the viral titers. The results of the testing did not raise any new issues of safety or effectiveness compared to DuraGen® Secure Dural Regeneration Matrix.
5
Conclusion:
The DuraGen® Secure Dural Regeneration Matrix is substantially equivalent to the current marketed device, DuraGen® Secure Dural Regeneration Matrix. There have been no modifications to the design or manufacturing of the DuraGen® Secure Dural Regeneration Matrix that resulted in this filing, and the results of the viral inactivation study do not change the intended use or fundamental scientific technology of the device, and do not raise any new issues of safety or effectiveness.