COLLAGEN NERVE WRAP

K060952 · Collagen Matrix, Inc. · JXI · Jul 14, 2006 · Neurology

Device Facts

• Record ID: K060952
• Device Name: COLLAGEN NERVE WRAP
• Applicant: Collagen Matrix, Inc.
• Product Code: JXI · Neurology
• Decision Date: Jul 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Collagen Nerve Wrap is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue and where gap closure can be achieved by flexion of the extremity.

Device Story

Collagen Nerve Wrap is a resorbable, porous collagen matrix conduit used as a non-constricting encasement 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. Provided sterile for single use, it is applied by a surgeon during clinical procedures to protect the neural environment. By providing a protective barrier, it supports the management of nerve injuries.

Clinical Evidence

Evidence includes animal studies, in vitro product characterization, and in vitro/in vivo biocompatibility testing. No human clinical trial data reported.

Technological Characteristics

Resorbable collagen matrix; porous conduit form factor with longitudinal slit for placement; biocompatible material; sterile, non-pyrogenic; single-use.

Indications for Use

Indicated for management of peripheral nerve injuries without substantial nerve tissue loss where gap closure is achievable via extremity flexion.

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

• Collagen Nerve Cuff (K012814)
• NeuraWrap™ Nerve Protector (K041620)
• FASTUBE™ Nerve Regeneration Device (K850785)

Submission Summary (Full Text)

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K060952 (1/2)

## 510(k) Summary of Safety and Effectiveness

# JUL 1 4 2006

| Applicant Name and Address: | Collagen Matrix, Inc.<br>509 Commerce Street<br>Franklin Lakes, New Jersey 07417 |
|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Peggy Hansen, RAC<br>Director, Clinical, Regulatory, and Quality Assurance<br>Tel: [phone]<br>Fax: [phone] |
| Date of Summary: | April 5, 2006 |
| Device Common Name: | Nerve Protector |
| Device Trade Name: | Collagen Nerve Wrap |
| Device Classification Name:<br>Regulation Number:<br>Device Class:<br>Product Code: | Cuff, Nerve<br>882.5275<br>Class II<br>JXI |
| Predicate Device(s): | Collagen Nerve Cuff, K012814<br>Collagen Matrix, Inc., Franklin Lakes, NJ |
| | NeuraWrap™ Nerve Protector, K041620<br>Integra LifeSciences Corporation, Plainsboro, NJ |
| | FASTUBETM Nerve Regeneration Device, K850785<br>Research Medical, Inc., Salt Lake City, UT |

### Description of the Device

Collagen Nerve Wrap is a resorbable collagen matrix that provides a non-constricting encasement for injured peripheral nerves for protection of the neural environment. Collagen Nerve Wrap is designed to be an interface between the newe and the surrounding tissue. When hydrated, Collagen Nerve Wrap is an easy to handle, soft, pliable, nonfriable, porous collagen conduit. The wall of the conduit has a longitudinal slit that allows Collagen Nerve Wrap to be spread open for easy placement over the injured nerve. The resilience of the Collagen Nerve Wrap allows the product to recover and maintain closure once the device is placed around the nerve. Collagen Nerve Wrap is provided sterile, non-pyrogenic, for single use only, in a variety of sizes, and in double peel packages.

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060952(k/2)

### Intended Use

Collagen Nerve Wrap is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue and where gap olosure can be achieved by flexion of the extremity.

### Summary/Comparison of Technical Characteristics

Collagen Nerve Wrap and its predicates have the same technological characteristics. In particular, Collagen Nerve Wrap and their predicates are the same with respect to intended use, design, materials, material characterization, form, and sizes.

#### Safety

Collagen Nerve Wrap has been evaluated by a number of tests to assess its safety/biocompatibility. The device passed all selected FDA Blue Book Memorandum G95-1and ISO 10993-1 testing for the biological evaluation of medical fevices.

#### Effectiveness

The characteristics of the Collagen Nerve Wrap meet the design requirements for an effective nerve protector.

#### Conclusion

The results of an animal study, in vitro product characterization studies, in vitro and in vivo biocompatibility studies, show that Collagen Nerve Wrap is safe and substantially equivalent to its predicates.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 4 2006

Collagen Matrix, Inc. % Ms. Peggy Hansen, RAC Director, Clinical, Regulatory, and Quality Assurance 509 Commerce Street Franklin Lakes, New Jersey 07417

Re: K060952

Trade/Device Name: Collagen Nerve Wrap Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve cuff Regulatory Class: II Product Code: JXI Dated: June 16, 2006 Received: June 19, 2006

Dear Ms. Hansen:

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 complics 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

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Page 2 - Ms. Peggy Hansen, RAC

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. 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/cdrl/industry/support/index.html.

Sincerely yours,

Aurbene Buckup
Mark N. Malleman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K060952

# Indications for Use

ko60952 510(k) Number (if known): __

Device Name: __Collagen Nerve Wrap

Indications for Use:

发电子游戏 - 2017-08-19 11:

Collagen Nerve Wrap is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue and where gap closure can be achieved by flexion of the extremity.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arbare Brechus SN MXM
Division Sign Off

Division of General, Restorative and Neurological Devices

510(k) Number K060952

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