NEURA WRAP NERVE PROTECTOR

K041620 · Integra Lifesciences Corp. · JXI · Jul 16, 2004 · Neurology

Device Facts

• Record ID: K041620
• Device Name: NEURA WRAP NERVE PROTECTOR
• Applicant: Integra Lifesciences Corp.
• Product Code: JXI · Neurology
• Decision Date: Jul 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5275
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

NeuraWrap is an absorbable collagen implant designed as a nonconstricting, porous conduit for injured peripheral nerves. It acts as an interface between the nerve and surrounding tissue. The device features a longitudinal slit allowing it to be spread open for placement around the nerve; its inherent resilience enables it to recover and maintain closure once positioned. Provided sterile and for single use, it is intended for use by clinicians to protect the neural environment. By providing a physical barrier, it supports the management of nerve injuries where tissue loss is minimal.

Clinical Evidence

No clinical data provided. Evidence consists of biocompatibility studies (non-cytotoxic, non-pyrogenic, non-irritating, non-sensitizing, non-toxic, non-genotoxic, non-hemolytic) and bench testing of mechanical/physical properties, including suture retention, compression resistance, and permeability.

Technological Characteristics

Absorbable collagen conduit; porous wall structure; longitudinal slit for placement; resilient material properties. Sterile, single-use, non-pyrogenic. No electronic components or software.

Indications for Use

Indicated for management of peripheral nerve injuries without substantial loss of nerve tissue.

Regulatory Classification

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).

Predicate Devices

• NeuraGen® Nerve Guide
• Fastube™ Nerve Cuff

Submission Summary (Full Text)

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# 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: [phone] [phone] 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.

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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.

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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 [phone]. 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 [phone] or [phone] 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

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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