NEUROLAC(R) NERVE GUIDE

K112267 · Polyganics B.V., · JXI · Oct 20, 2011 · Neurology

Device Facts

• Record ID: K112267
• Device Name: NEUROLAC(R) NERVE GUIDE
• Applicant: Polyganics B.V.,
• Product Code: JXI · Neurology
• Decision Date: Oct 20, 2011
• Decision: SESE
• Submission Type: Special
• 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; functions as a nerve conduit to guide axonal growth across nerve gaps; provides protective environment for peripheral nerve regeneration. Device is provided sterile in various sizes. Modification involves line extension with 37% reduction in wall thickness to improve suturability. Used by surgeons in clinical settings for peripheral nerve repair. Output is a physical scaffold; clinical benefit is restoration of nerve continuity and support for regeneration.

Clinical Evidence

Bench testing only. In vitro study compared thinner-walled Neurolac to cleared predicate. Metrics included dimensional stability (inner/outer diameter, wall thickness), water uptake (swelling), weight loss, NMR analysis of degradation products, DSC (glass transition temperature), intrinsic viscosity, mechanical/flexural/compression properties, and suturability. Results demonstrated performance equivalence to the predicate.

Technological Characteristics

Material: poly(DL-lactide-co-ε-caprolactone). Form factor: resorbable tube. Dimensions: 1.5-3mm ID, 3cm length. Sterilization: EtO. Shelf-life: 42 months. Packaging: polycarbonate tray, Tyvek pouch. Mechanical properties stable for 10-11 weeks.

Indications for Use

Indicated for patients with complete peripheral nerve division requiring reconstruction of nerve discontinuities 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

• Neurolac Polyganics BV (K032115)

Submission Summary (Full Text)

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OCT 2 0 2011

| | K112267 | | | | |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| | page 1/3 | | | | |
| | Special 510(k) Summary of Safety and Effectiveness<br>Line extension to Neurolac nerve guide | | | | |
| Submitter: | Polyganics BV<br>Rozenburglaan 15A<br>9727 DL Groningen<br>The Netherlands<br>www.polyganics.com | | | | |
| Contact Person: | Betty IJmker.<br>Manager Regulatory Affairs<br>Tel : [phone]<br>Fax : [phone]<br>E-mail : [e-mail] | | | | |
| Date Prepared: | 20 September 2011 | | | | |
| General<br>Provisions: | Trade Name: Neurolac® Nerve guide | | | | |
| | Common Name: Nerve guide | | | | |
| | Classification Name: Nerve Cuff, 21 CFR 882.5275 | | | | |
| | Device Classification: Class II | | | | |
| Predicate Device: | • Neurolac Polyganics BV K032115 | | | | |
| Performance<br>Standards | For the Nerve Cuff performance, the FDA, under section 514 of the Food, Drug and<br>Cosmetic Act, has not established standards. | | | | |
| Indications for<br>Use | The Neurolac® nerve guide is indicated for the reconstruction of a peripheral nerve<br>discontinuity up to 20 mm in patients who have sustained a complete division of a<br>nerve. | | | | |
| | | | | | |

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Device Neurolac® is designed to be a flexible and transparent resorbable poly(DL-lactide-Description co-e-caprolactone) tube to provide a protective environment for peripheral nerve reqeneration after injury and to create a conduit to quide axonal growth across a nerve gap.

ン

Neurolac® nerve guides are provided sterile in Tyvek pouch packages and retainer in a variety of sizes.

The modification in this submission concerns a line extension to the predicate devices with a thinner wall thickness.

In vitro testing for this line extension demonstrated that the technological Performance Data: characteristics and performance criteria of the additional thinner-walled Neurolac nerve guides are comparable to the current cleared Neurolac nerve guides and that they can perform in a manner equivalent to Neurolac devices currently on the market for the same intended use. The results of the in vitro testing are summarized below:

| Properties | | Cleared Neurolac nerve<br>guides | Neurolac with 37%<br>wall thickness reduction |
|---------------------------|-------------------------------|------------------------------------------------------|---------------------------------------------------------|
| Dimensional<br>changes | Inner<br>diameter | Lumen maintained till<br>week 10-11 | Lumen maintained till<br>week 10-11 |
| | Outer<br>diameter | Gradual increase | Gradual increase |
| | Wall<br>thickness | Gradual increase in<br>outward direction | Gradual increase in<br>outward direction |
| Weight<br>changes | Swelling<br>(water<br>uptake) | Stable in initial weeks and<br>then gradual increase | Stable in initial weeks<br>and then gradual<br>increase |
| | Weight loss | After week 10-11 | After week 10-11 |
| Analysis | NMR | Degradation prodcuts<br>after week 12 | Degradation products<br>after week 12 |
| | DSC | Gradual decrease in Tg | Gradual decrease in Tg |
| | Intrinsic<br>Viscosity | Slow and gradual<br>decrease | Slow and gradual<br>decrease |
| Mechanical<br>properties | | Stable for initial 10-11<br>weeks | Stable for initial 10-11<br>weeks |
| Flexural<br>properties | | Stable for initial 10-11<br>weeks | Stable for initial 10-11<br>weeks |
| Compression<br>properties | | Stable for initial 10-11<br>weeks | Stable for initial 10-11<br>weeks |
| Suturability<br>testing | | Difficult suturing | Easy suturing |

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Summary of Substantial Equivalence The design, materials, fundamental technology and intended use (safety and efficacy) featured with the Neurolac® Nerve Guide are substantially equivalent to those featured with the following cleared device: Neurolac nerve guides (K032115; Polyganics BV). The basis for equivalence is demonstrated by the comparisons in the following table:

| | Neurolac nerve guide<br>thinner-walls (this<br>submission) | Neurolac nerve guide<br>(K032115) |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Reconstruction of a<br>peripheral nerve<br>discontinuity up to 20 mm in<br>patients who have<br>sustained a complete<br>division of a nerve. | Reconstruction of a<br>peripheral nerve discontinuity<br>up to 20 mm in patients who<br>have sustained a complete<br>division of a nerve. |
| Material | poly(DL-lactide-co-ε-<br>caprolactone) | poly(DL-lactide-co-ε-<br>caprolactone) |
| Design | Tube | Tube |
| Sizes | 1.5 - 3mm ID<br>3cm length | 1.5 - 3mm ID<br>3cm length |
| Sterilization | EtO | EtO |
| Shelf-life | 42 months | 42 months |
| Packaging | Single use, polycar-bonate<br>tray, single tyvek pouch,<br>cardboard box. | Single use, polycar-bonate<br>tray, single tyvek pouch,<br>cardboard box. |

Differences between the devices do not raise any significant issues of safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an abstract eagle design with three curved lines representing the eagle's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 2 0 2011

Polyganics BV c/o Betty IJmker Manager Regulatory Affairs Rozenburglaan 15A 9727 DL Groningen The Netherlands

Re: K112267

Trade/Device Name: Neurolac Nerve Guide Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve Cuff Regulatory Class: II Product Code: JXI Dated: September 20, 2011 Received: September 23, 2011

Dear Ms. Ijmker:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Ms. Betty IJmker

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Luke Riving

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

## 510(k) K112267 Number

Neurolac® nerve guide Device Name

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Indications 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 for Use division of a nerve.

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use x (Per 21 CFR 801. 109)

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Over-The-Counter Use_

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OR

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K112267