(30 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical and biological properties of a collagen implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for the management of peripheral nerve injuries, which constitutes a therapeutic purpose.
No
The device is described as an absorbable collagen implant designed to protect injured peripheral nerves, not to diagnose conditions.
No
The device description clearly states it is an "absorbable collagen implant" and describes its physical properties and how it is handled and placed, 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 for the "management of peripheral nerve injuries" and provides a "nonconstricting encasement for injured peripheral nerves". This describes a device used in vivo (within the body) for a therapeutic purpose.
- Device Description: The description details an "absorbable collagen implant" that is placed around the nerve. This is a physical implant, not a reagent or instrument used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is mechanical protection and support for nerve healing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
NeuraWrap™ Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
Product codes (comma separated list FDA assigned to the subject device)
JXI
Device Description
NeuraWrap™ nerve protector is an absorbable collagen implant that provides a nonconstricting encasement for injured peripheral nerves for protection of the neural environment. NeuraWrap is designed to be an interface between the nerve and the surrounding tissue. When hydrated, NeuraWrap is an easy to handle, soft, pliable, nonfriable, porous collagen conduit. The wall of the conduit has a longitudinal slit that allows NeuraWrap to be spread open for easy placement over the injured nerve. The resilience of the collagen conduit allows NeuraWrap to recover and maintain closure once the device is placed around the nerve. NeuraWrap is provided sterile, non-pyrogenic, for single use only, in double peel packages 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 nerves
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)
Biocompatibility studies have demonstrated NeuraWrap Nerve Protector to be noncytotoxic, non-pyrogenic, non-irritating, non-sensitizing, non-toxic, non- genotoxic and non-hemolytic. Mechanical and physical testing demonstrate that NeuraWrap Nerve Protectors are able to hold a suture, resist repeated compression from surrounding tissues, have a porous outer surface and tube wall, and allow the passage of molecules of specific size through the tube wall.
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.
Not Found
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
§ 882.5275 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
JUL 1 6 2004
L04/620
Confidential
NeuraWrap™ Nerve Protector
510(K) SUMMARY
Submitter's name and address:
Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA
Contact person and telephone number:
Diana Bordon Manager, Regulatory Affairs Telephone: (609) 275-0500 (609) 275-9445 Fax:
Date Summary was prepared:
June 14, 2004
Name of the device:
| Proprietary Name: | NeuraWrapTM |
|---|---|
| Common Name: | Nerve Protector |
| Classification Name: | Nerve Cuff (per 21 CFR section 882.5275) |
Substantial Equivalence:
NeuraWrap™ Nerve Protector is substantially equivalent in function and intended use to the following products which have been cleared to market under Premarket Notifications 510(k): NeuraGen® Nerve Guide and Fastube™ Nerve Cuff.
Device Description:
NeuraWrap™ nerve protector is an absorbable collagen implant that provides a nonconstricting encasement for injured peripheral nerves for protection of the neural environment. NeuraWrap is designed to be an interface between the nerve and the surrounding tissue. When hydrated, NeuraWrap is an easy to handle, soft, pliable, nonfriable, porous collagen conduit. The wall of the conduit has a longitudinal slit that allows NeuraWrap to be spread open for easy placement over the injured nerve. The resilience of the collagen conduit allows NeuraWrap to recover and maintain closure once the device is placed around the nerve. NeuraWrap is provided sterile, non-pyrogenic, for single use only, in double peel packages in a variety of sizes.
Intended Use:
NeuraWrap™ Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
Testing and Test Results:
Biocompatibility studies have demonstrated NeuraWrap Nerve Protector to be noncytotoxic, non-pyrogenic, non-irritating, non-sensitizing, non-toxic, non- genotoxic and non-hemolytic. Mechanical and physical testing demonstrate that NeuraWrap Nerve Protectors are able to hold a suture, resist repeated compression from surrounding tissues, have a porous outer surface and tube wall, and allow the passage of molecules of specific size through the tube wall.
Conclusion
NeuraWrap™ Nerve Protector is safe and effective under the proposed conditions of use, and substantially equivalent to its predicate devices. Safety and efficacy are supported through physician experience with the equivalent NeuraGen product, testing of descriptive characteristics, biocompatibility, mechanical and physical property testing.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three streams emanating from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 6 2004
Ms. Diana Bordon Manager, Regulatory Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K041620
Trade/Device Name: NeuraWrap™ Nerve Protector Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve cuff Regulatory Class: II Product Code: JXI Dated: June 15, 2004 Received: June 16, 2004
Dear Ms. Bordon:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
2
Page 2 - Ms. Diana Bordon
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
b. Mark A. Milkenm
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K04/620
510(k) Number:
Device Name: NeuraWrap™ Nerve Protector
Indications for Use
NeuraWrap™ Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milherson
(Division Sign-Division of General, Restorative, and Neurological Devices
510(k) Number K041626