(28 days)
Not Found
No
The summary describes a resorbable implant made of collagen and glycosaminoglycan for nerve repair. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance study focuses on viral inactivation, not algorithmic performance.
Yes
The device is described as a "resorbable implant" for repairing nerve discontinuities and creating a protective environment for nerve repair, indicating its role in treating a medical condition.
No
The device is a resorbable implant indicated for the repair of peripheral nerve discontinuities, not for diagnosing a condition.
No
The device description clearly states it is a resorbable implant composed of physical materials (bovine Type I collagen, glycosaminoglycan). It is a physical medical device, not software.
Based on the provided information, the NeuraGen® 3D Nerve Guide Matrix is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the repair of peripheral nerve discontinuities in the body. This is a therapeutic intervention, not a diagnostic test performed in vitro (outside the body).
- Device Description: The device is a resorbable implant designed to provide a protective environment and conduit for nerve repair. This is a physical device implanted in the body.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition.
- Anatomical Site: The device is used on the peripheral nerve, which is an anatomical structure within the body.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The NeuraGen® 3D Nerve Guide Matrix does not fit this description.
N/A
Intended Use / Indications for Use
The NeuraGen® 3D Nerve Guide Matrix is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
Product codes
JXI
Device Description
NeuraGen® 3D Nerve Guide Matrix is a resorbable implant for the repair of peripheral nerve discontinuities. NeuraGen® 3D Nerve Guide Matrix provides a protective environment for peripheral nerve repair after injury, and is designed to isolate and protect the nerve and to create a conduit for axonal growth across a nerve gap. NeuraGen® 3D is composed of bovine Type I collagen conduit and a porous inner matrix comprised of collagen and glycosaminoglycan (chondroitin-6-sulfate). When hydrated, NeuraGen® 3D Nerve Guide Matrix is an easy to handle, soft, pliable, non-friable, collagen conduit containing a porous three-dimensional matrix.
NeuraGen® 3D Nerve Guide Matrix is supplied sterile, non-pyrogenic, for single use in a variety of sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral nerve
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
A viral inactivation study was conducted to demonstrate that NeuraGen® 3D Nerve Guide Matrix demonstrates 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 NeuraGen® 3D Nerve Guide Matrix.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5275 Nerve cuff.
(a)
Identification. A nerve cuff is a tubular silicone rubber sheath used to encase a nerve for aid in repairing the nerve (e.g., to prevent ingrowth of scar tissue) and for capping the end of the nerve to prevent the formation of neuroma (tumors).(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. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 6, 2017
Integra LifeSciences Corporation Gabriella Green Regulatory Affairs Specialist 311 Enterprise Dr. Plainsboro, NJ 08536
Re: K163457
Trade/Device Name: NeuraGen® 3D Nerve Guide Matrix Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve Cuff Regulatory Class: Class II Product Code: JXI Dated: December 8, 2016 Received: December 9, 2016
Dear Ms. Green:
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) K163457
Device Name NeuraGen® 3D Nerve Guide Matrix
Indications for Use (Describe)
The NeuraGen® 3D Nerve Guide Matrix is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
| 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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3
2. 510(k) SUMMARY
NeuraGen® 3D Nerve Guide 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:
Gabriella Green Regulatory Affairs Associate
Date the Summary was prepared: December 8, 2016
Name of the device:
| Trade name: | NeuraGen® 3D Nerve Guide Matrix |
|---|---|
| Common Name: | Nerve Guide Matrix |
| Classification Name: | 21 CFR 882.5275: Nerve Cuff, Class II |
| Product Code: | JXI |
Substantial Equivalence:
NeuraGen® 3D Nerve Guide Matrix is substantially equivalent in function and intended use to the predicate device detailed in Table 2-1.
| 510(k)
Number | Product
Code | Trade Name | Manufacturer |
|------------------|-----------------|--------------------------|-------------------------------------|
| K130557 | JXI | NeuraGen® 3D Nerve Guide | Integra LifeSciences
Corporation |
Table 2-1: Substantial Equivalent
Device Description:
NeuraGen® 3D Nerve Guide Matrix is a resorbable implant for the repair of peripheral nerve discontinuities. NeuraGen® 3D Nerve Guide Matrix provides a protective environment for peripheral nerve repair after injury, and is designed to isolate and protect the nerve and to create a conduit for axonal growth across a nerve gap. NeuraGen® 3D is composed of bovine Type I collagen conduit and a porous inner matrix comprised of collagen and glycosaminoglycan (chondroitin-6-sulfate). When hydrated, NeuraGen® 3D Nerve Guide Matrix is an easy to handle, soft, pliable, non-friable, collagen conduit containing a porous three-dimensional matrix.
4
NeuraGen® 3D Nerve Guide Matrix is supplied sterile, non-pyrogenic, for single use in a variety of sizes.
Indication for Use:
The NeuraGen® 3D Nerve Guide Matrix is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
Summary of Technological Characteristics:
NeuraGen® 3D Nerve Guide Matrix has the same design, material, and chemical composition, as the predicate device (K130557). The manufacturing and processing are exactly the same.
Testing and Test Results:
A viral inactivation study was conducted to demonstrate that NeuraGen® 3D Nerve Guide Matrix demonstrates 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 NeuraGen® 3D Nerve Guide Matrix.
Conclusion:
The NeuraGen® 3D Nerve Guide Matrix is substantially equivalent to the current marketed device, NeuraGen® 3D Nerve Guide Matrix. There have been no modifications to the design or manufacturing of the NeuraGen® 3D Nerve Guide Matrix that resulted in this filing. 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.