NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03

K032115 · Polyganics B.V., · JXI · Oct 10, 2003 · Neurology

Device Facts

• Record ID: K032115
• Device Name: NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03
• Applicant: Polyganics B.V.,
• Product Code: JXI · Neurology
• Decision Date: Oct 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Neurolac® nerve guide is indicated for the reconstruction of a peripheral nerve discontinuity up to 20 mm in patients who have sustained a complete division of a nerve.

Device Story

Neurolac® is a flexible, transparent, resorbable poly(DL-lactide-co-ε-caprolactone) tube. It functions as a protective conduit for peripheral nerve regeneration, guiding axonal growth across nerve gaps. Used by surgeons in clinical settings to bridge nerve discontinuities. The device provides a physical environment that supports natural healing processes. It is supplied sterile in various sizes.

Clinical Evidence

No clinical data. Safety and effectiveness demonstrated via bench testing (in vitro suture retention, in vitro degradation) and in vivo animal model testing for nerve function recovery.

Technological Characteristics

Resorbable poly(DL-lactide-co-ε-caprolactone) tube. Flexible, transparent form factor. Sterile, single-use. No electronic components or software.

Indications for Use

Indicated for patients with complete peripheral nerve division requiring reconstruction of nerve gaps up to 20 mm.

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

• Neurotube™ (K983007)
• NeuroGen™ Nerve Guide (K011168)

Submission Summary (Full Text)

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Neurolac® Nerve Guide
Polyganics BV

Traditional 510(k) Premarket Notification

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| | K032115<br>510(k)<br>Summary of Safety and Effectiveness |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Polyganics BV<br>L.J. Zielstraweg 1<br>9713 GX, Groningen<br>The Netherlands<br>www.polyganics.com |
| Contact<br>Person: | Jan Bart Hak, Ph.D.<br>Manager Clinical and Regulatory Affairs<br>Tel : [phone]<br>Fax : [phone]<br>Mobile : [phone]<br>E-mail : [e-mail] |
| Date<br>Prepared: | May 20, 2003 |
| General<br>Provisions: | Trade Name: Neurolac® Nerve guide<br>Common Name: Nerve guide<br>Classification Name: Nerve Cuff, 21 CFR 882.5275<br>Device Classification: Class II |
| Predicate<br>Devices: | <ul><li>Neurotube™ Neuroregen L.L.C. K983007</li><li>NeuroGen™ Integra Life Sciences Corp. K011168</li></ul> |
| Performance<br>Standards | For the Nerve Cuff performance, the FDA, under section 514 of the Food,<br>Drug and Cosmetic Act, has not established standards. |
| Indications<br>for Use | The Neurolac® nerve guide is indicated for the reconstruction of a peripheral<br>nerve discontinuity up to 20 mm in patients who have sustained a complete<br>division of a nerve. |

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Neurolac® Nerve Guide Polyganics BV

Traditional 510(k) Premarket Notification

| Device<br>Description | Neurolac® is designed to be a flexible and transparent resorbable poly(DL-<br>lactide-co-ε-caprolactone) tube to provide a protective environment for<br>peripheral nerve regeneration after injury and to create a conduit to guide<br>axonal growth across a nerve gap.<br>Neurolac® nerve guides are provided sterile in Tyvek pouch packages and<br>retainer in a variety of sizes. |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance<br>Data: | The safety and effectiveness of the Neurolac nerve guides have been<br>demonstrated via data collected from design verification tests and analyses.<br>The design verification testing consisted of the following:<br>- In vitro suture retention testing<br>- In vitro degradation testing<br>- In vivo nerve function recovery |
| Summary of<br>Substantial<br>Equivalence | The design, fundamental technology and intended use (safety and efficacy)<br>featured with the Neurolac® Nerve Guide are substantially equivalent to<br>those featured with the competitor devices Neurotube™ (ref. 510(k) 983007;<br>Neuroregen L.L.C.) and the NeuroGen™ Nerve Guide (ref. 510(k) 011168;<br>Integra Life Sciences Corporation).<br><br>Biocompatibility, mechanical and physical property testing, in vitro<br>degradation testing, and performance testing in an animal model provide<br>reasonable scientific evidence that Neurolac® nerve guide is substantially |

equivalent to the predicate devices. Evaluation of the Polyganics Neurolac® Nerve guide based on biocompatibility testing, animal tests, results from literature and the comparison of the Neurolac® nerve guide with its predicate devices, shows that the Neurolac® nerve guide is safe for implantation.

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Public Health Service

OCT 1 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jan Bart Hak, Ph.D. Manager, Clinical and Regulatory Affairs Polyganics BV L.J. Zielstraweg 1 9713 GX, Groningen The Netherlands

Re: K032115

Trade/Device Name: Neurolac® Nerve Guide Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve cuff Regulatory Class: II Product Code: JXI Dated: July 3, 2003 Received: July 17, 2003

Dear Dr. Hak:

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 - Jan Bart Hak, Ph.D.

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.

Miriam C. Pivort

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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Neurolac® Nerve Guide Polyganics BV

Traditional 510(k) Premarket Notification

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## Indications for Use Form

510(k) Number:

032115

Device Name: Neurolac® Nerve Guide

Indications for Use:

The Neurolac nerve guide is indicated for the reconstruction of a peripheral nerve discontinuity up to 20 mm in patients who have sustained a complete division of a nerve.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)

OR

510(k) Number

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K032115

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