NEUROLAC NERVE GUIDE

K050573 · Polyganics B.V., · JXI · May 4, 2005 · Neurology

Device Facts

• Record ID: K050573
• Device Name: NEUROLAC NERVE GUIDE
• Applicant: Polyganics B.V.,
• Product Code: JXI · Neurology
• Decision Date: May 4, 2005
• 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-s-caprolactone) tube; functions as a protective conduit for peripheral nerve regeneration; guides axonal growth across nerve gaps up to 20 mm; intended for nerves with internal diameter ≤ 9.5 mm. Device provided sterile in various sizes (4-10 mm). Used by surgeons in clinical settings to bridge nerve gaps; provides physical barrier to prevent fibrous tissue ingrowth while allowing nutrient exchange. Benefits include support for nerve healing and functional recovery.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing including in vitro suture retention testing, in vitro degradation testing, and in vivo nerve function recovery studies.

Technological Characteristics

Resorbable poly(DL-lactide-co-s-caprolactone) tube. Dimensions: 4-10 mm diameter. Sterile, single-use. Mechanical properties verified via suture retention and degradation testing. No electronic or software components.

Indications for Use

Indicated for reconstruction of peripheral nerve discontinuity up to 20 mm in patients with complete nerve division.

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

• Salumedica™ nerve cuff (K002098)
• Neurogen™ nerve guide (K011168)
• Neurolac® nerve guide (K032115)

Submission Summary (Full Text)

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K050573

## - 4 2005 MAY

Neurolac® (4-10 mm) nerve guide

Traditional 510(k) Premarket Notification

#

| Submitter | Polyganics BV<br>L.J. Zielstraweg 1<br>9713 GX, Groningen<br>The Netherlands<br>www.polyganics.com |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact<br>Person | Jan Nieuwenhuis<br>Managing Director<br>Tel : [phone]<br>Fax : [phone]<br>Mobile : [phone]<br>E-mail : [e-mail] |
| Date<br>Prepared | March 2, 2005 |
| 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 | Salumedica™ nerve cuff, Salumedica, K002098<br>Neurogen™ nerve guide, Integra life science, K011168<br>Neurolac® nerve guide, Polyganics BV, K032115 |
| 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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K050-575

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Traditional 510(k) Premarket Notification Neurolac® (4-10 mm) nerve guide Neurolac® (4-10 mm) is designed to be a flexible and transparent resorbable Device poly(DL-lactide-co-s-caprolactone) tube to provide a protective environment Description for peripheral nerve regeneration, for nerves with an internal diameter ≤ 9.5 mm, after injury and to create a conduit to guide axonal growth across a nerve gap. Neurolac® (4-10mm) nerve guides are provided sterile in Tyvek pouch packages and retainer in a variety of sizes (4, 5, 6, 7, 8, 10 mm). The safety and effectiveness of the Neurolac nerve guides have been dem-Performance onstrated via data collected from design verification tests and analyses. The Data design verification testing consisted of the following: In vitro suture retention testing -In vitro degradation testing -In vivo nerve function recovery of The design, fundamental technology and intended use (safety and efficacy) Summary featured with the Neurolac® Nerve Guide are substantially equivalent to Substantial Equivalence those featured with the competitor devices Neurogen™ nerve guide (ref. 510(k) 011168; Integra Life Science) and the Salumedica™ nerve cuff (ref. 510(k) 002098; Salumedica). Biocompatibility, mechanical and chemical and physical property testing, in vitro degradation testing and performance testing, clinical testing and testing in an animal model provide scientific evidence that Neurolac (1-3 mm) nerve quide (510(k) 032115) is safe for implantation. Evaluation of the Polyganics Neurolac (4-10 mm) nerve guide based on results from literature and the

> comparison of the Neurolac (4-10 mm) nerve guide with its predicate devices, shows that the material of which the Neurolac (4-10mm) nerve guide is

made, is safe for implantation.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The text is in all caps and is written in a sans-serif font. The logo is black and white.

MAY - 4 2005

1

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050573

Trade/Device Name: Neurolac® nerve guide Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve cuff Regulatory Class: II Product Code: JXI Dated: March2, 2005 Received: March 7, 2005

Dear Dr. Hak:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrobare) to tegans atment date of the Medical Device Amendments, or to commerce pror to May 20, 1978, in excordance with the provisions of the Federal Food, Drug, de vices that have been recise and require approval of a premarket approval application (PMA). and Cosmetion Ace (110) that the device, subject to the general controls provisions of the Act. The r ou may, dictore, mainer of the Act include requirements for annual registration, listing of general controls profitering 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), If your device is clussified (bes as c) ontrols. Existing major regulations affecting your device it may of subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA ean be fourd in the over in concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oc davised that I Dr o wean that your device complies with other requirements of the Act inal I DA has made a acterimiations administered by other Federal agencies. You must of any I cutures and regularients and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807), adomig (21 CFR Part 820); and if applicable, the electronic form in the quant) systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - J.B. Hak, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maneting your maneting of your device to a legally prematics notification. "The PDF inturlight 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 If you desire specific advice for your as [phone] . Also, please note the regulation entitled, Contact the Office of Compullios as (21 the Part 807.97). You may obtain Misolanding by release to premainters within as a many the Act from the Division of Small other gelleral information on your response Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Signature

Ja Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KOSOS73

Neurolac® (4-10 mm) nerve guide K050573

Traditional 510(k) Premarket Notification

## Indications for Use Form

510(k) Number:

K050573

Neurolac® nerve guide Device Name:

Indications for Use:

The Neurolac nerve guide is indicated for the reconstruction of a peripheral nerve
s and and the collection in the last a boys oustsined a complete division of a The Neurolac herve guide is indicated for the roomstrained a complete division of a nerve.

Prescription Use_ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE OF
LEE – CONTINE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE OF – NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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4/8/2005

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