NEURAGEN 3D

K130557 · Integra LifeSciences Corporation · JXI · Apr 24, 2014 · Neurology

Device Facts

• Record ID: K130557
• Device Name: NEURAGEN 3D
• Applicant: Integra LifeSciences Corporation
• Product Code: JXI · Neurology
• Decision Date: Apr 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5275
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

NeuraGen® 3D is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

Device Story

NeuraGen® 3D Nerve Guide Matrix is a resorbable implant for peripheral nerve repair. Device consists of bovine Type I collagen conduit containing a porous 3D inner matrix of collagen and glycosaminoglycan (chondroitin-6-sulfate). Implanted by surgeons to isolate nerve injury, protect the site, and provide a conduit for axonal growth across nerve gaps. Supplied sterile for single use in various diameters and lengths. Acts as a physical scaffold to facilitate natural nerve regeneration. Benefits include protection of the nerve repair site and support for axonal bridging.

Clinical Evidence

Bench testing included conduit inner diameter, angle of occlusion, enzyme digestion, permeability, and chemical residual content. Biocompatibility testing performed per ISO 10993 (cytotoxicity, sensitization, irritation, systemic toxicity, mutagenicity, pyrogenicity). Animal study conducted in a critical-sized nerve defect model in a rat to evaluate efficacy. All bench and biocompatibility tests passed or met requirements.

Technological Characteristics

Resorbable implant; bovine Type I collagen conduit; porous inner matrix of collagen and glycosaminoglycan (chondroitin-6-sulfate). Dimensions: 1.5-7 mm inner diameters, lengths up to 6.35 cm. Sterilized via ethylene oxide. Biocompatibility per ISO 10993.

Indications for Use

Indicated for repair of peripheral nerve discontinuities in patients 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

• NeuraGen® Nerve Guide (K011168)
• Surgisis® Nerve Cuff (K031069)
• SaluMedica™ Nerve Cuff (K002098)
• Avagen Wound Dressing (K022127)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the word "INTEGRA." in large, bold, sans-serif font. Below the word "INTEGRA." is the phrase "LIMIT UNCERTAINTY" in a smaller, sans-serif font. To the right of the word "INTEGRA." are four black squares of varying sizes, stacked vertically. The squares appear to be a part of the logo.

#### 510(K) SUMMARY

#### NeuraGen® 3D Nerve Guide Matrix

Submitter's name and address:

Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA

#### Contact person and telephone number:

Stephen Beier Senior Specialist, Regulatory Affairs Telephone: [phone] Facsimile: 609.275.9445

#### Date Summary was prepared:

March 14, 2014

#### Name of the device:

Proprietary Name: NeuraGen® 3D Common Name: Nerve guide matrix Classification name: Nerve Cuff (21 CFR 882.5275) Product Code: JXI

#### Substantial Equivalence:

NeuraGen® 3D is substantially equivalent in function and intended use to the predicate devices detailed in the following table.

| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---------------|--------------|---------------------------|-------------------------------------|
| K011168 | JXI | NeuraGen® Nerve<br>Guide | Integra LifeSciences<br>Corporation |
| K031069 | JXI | Surgisis® Nerve Cuff | Cook Biotech<br>Incorporated |
| K002098 | JXI | SaluMedica™ Nerve<br>Cuff | SaluMedica™ L.L.C. |
| K022127 | KGN | Avagen Wound<br>Dressing | Integra LifeSciences<br>Corporation |

#### Device Description:

NeuraGen® 3D Nerve Guide Matrix is a resorbable implant for the repair of peripheral nerve discontinuities. NeuraGen® 3D Nerve Guide Matrix provides a protective environment for peripheral nerve repair after injury, and is designed to isolate and protect the nerve and to create a conduit for axonal growth across a nerve gap. NeuraGen® 3D is composed of bovine Type I collagen conduit and a porous inner matrix comprised of collagen and glycosaminoglycan (chondroitin-6-sulfate). When hydrated, NeuraGen® 3D Nerve Guide Matrix is an easy to handle, soft, pliable, non-friable, collagen conduit containing a porous three-dimensional matrix. NeuraGen® 3D Nerve Guide Matrix is supplied sterile, non-pyrogenic, for single use in a variety of sizes.

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Image /page/1/Picture/1 description: The image shows the word "INTEGRA" in all capital letters. Below the word "INTEGRA" is the phrase "LIMIT UNCERTAINTY" in smaller capital letters. To the right of the word "INTEGRA" is a graphic of four squares of varying sizes stacked on top of each other.

#### Intended Use/Indications for Use:

The NeuraGen® 3D is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

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lntegra LifeSciences Corporation
Traditional 510(k) Premarket Notificat
NeuraGen® 3D Nerve Guide Matrix

Image /page/2/Picture/1 description: The image shows the word "INTEGRA" in a vertical orientation. To the right of the word, there is the phrase "LIMIT UNCERTAINTY" in a smaller font size. The text is in black and white, and the image appears to be a close-up of a document or label.

Substantial Equivalence Comparison:
The NeuraGen® 3D is similar in design and materials to the predicate devices:

| Product | Indications for Use | Physical Structure | Resorbable | Range of Lengths. | Range of Diameters | of Material | Biocomp- atibility | Sterility |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|------------|------------------------------------|------------------------------------------------------------|----------------------------------------------------------------------|--------------------|----------------------|
| NeuraGen® 3D<br>(proposed<br>device) | NeuraGen® 3D is indicated for<br>the repair of peripheral nerve<br>discontinuities where gap<br>closure can be achieved by<br>flexion of the extremity. | Collagen conduit<br>with a collagen-<br>glycosaminoglycan<br>inner matrix. | Yes. | Up to<br>6.35cm | 1.5, 2, 3, 4, 5,<br>6, 7 mm inner<br>tube diameters | Type I collagen and<br>glycosaminoglycan<br>(chondroitin-6-sulfate). | Yes. | Provided<br>sterile. |
| NeuraGen®<br>Nerve Guide | NeuraGen® Nerve Guide is<br>indicated for the repair of<br>peripheral nerve<br>discontinuities where gap<br>closure can be achieved by<br>flexion of the extremity. | Collagen conduit. | Yes. | Up to 4cm | 2, 3, 4, 5, 6, 7<br>mm inner tube<br>diameters | Type I collagen. | Yes. | Provided<br>sterile. |
| Avagen<br>Wound<br>Dressing | Avagen Wound Dressing is<br>indicated for the management<br>of wounds. | Collagen-<br>glycosaminoglycan<br>bilayer sheet. | Yes. | N/A;<br>provided<br>in sheet form. | N/A; provided<br>in sheet form. | Type I collagen and<br>glycosaminoglycan<br>(chondroitin-6-sulfate). | Yes. | Provided<br>sterile. |
| Surgisis®<br>Nerve Cuff | The Surgisis® Nerve Cuff is<br>indicated for the repair of<br>peripheral nerve<br>discontinuities where gap<br>closure can be achieved by<br>flexion of the extremity | Porcine derived<br>conduit (with or<br>without slit) | Yes. | Up to 5cm | 1.5, 2, 3, 4, 5,<br>6, and 7 mm<br>inner tube<br>diameters | Porcine small intestinal<br>submucosa (SIS). | Yes. | Provided<br>sterile. |

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lntegra LifeSciences Corporation
Traditional 510(k) Premarket Notification
NeuraGen® 3D Nerve Guide Matrix

Image /page/3/Picture/1 description: The image shows the word "INTEGRA" in a vertical orientation. To the right of the word, the phrase "LIMIT UNCERTAINTY" is written in a smaller font size, also vertically. The text is black and the background is white.

| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Sterilif | Provided<br>sterile. |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Biocomp-- atibility | Ves. |
| .<br><br>Materia | 5, and 10 Polyvinyl alcohol (PVA |
| of<br>Diameters<br>Range | mm inner tube<br>diameters<br>ನ |
| Range of<br>Lengths | 6.35 cm |
| Resorb-<br>able | Yes. |
| | Alcohol<br>Hydrogel |
| | Polyvinyl<br>conduit.<br>(PVA) |
| " See =" Physical Structure" ("Structure") " Physical Structure | ntended for use in repair of<br>with Saulbria™ Biomaterial is<br>The SaluMedica™ Nerve Cuff<br>liscontinuities and where gap<br>nerve |
| | closure can be achieved<br>exion of the extremit<br>periphera |
| Product ----------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | SaluMedica™<br>Nerve Cuff |

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Image /page/4/Picture/1 description: The image shows the word "INTEGRA." in all caps, with a period after the word. Below the word is the phrase "LIMIT UNCERTAINTY" in smaller, all-caps letters. To the right of the word "INTEGRA." are three squares stacked on top of each other. The top square is filled with a pattern of smaller squares, while the other two squares are solid black.

#### Testing and Test Results:

The NeuraGen® 3D was determined to be substantially equivalent to the listed predicate devices after rigorous testing. Specifically, bench tests performed included confirmation of inner diameter, angle of occlusion, enzyme digestion, permeability, and chemical residual content. Furthermore, biocompatibility per ISO 10993 was performed to demonstrate that the device was both safe for implantation and to further establish equivalence among predicate devices. An animal study was conducted to study the efficacy of the product in a clinically relevant, critical sized nerve defect model in a rat.

| Test | Results | Conclusions |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-------------------------------|
| Conduit Inner Diameter | Each tested conduit exhibited inner diameter within specified tolerance | Pass |
| Inner Matrix Pore<br>Diameter | Average pore diameter of the inner matrix is within specified tolerance | Pass |
| Enzyme Digestion | Average enzyme digestion ≤99 AU/g | Pass |
| Residual Formaldehyde | Free formaldehyde residue ≤215 ug/device | Pass |
| Cytotoxicity - Agar<br>Diffusion | No evidence of causing cell lysis or toxicity<br>(Grade 0) | Non-cytotoxic |
| Sensitization Test | No evidence of causing delayed dermal<br>contact sensitization | Non-sensitizer |
| Irritation Test | Test article mean score consistent with<br>corresponding control mean score | Non-irritant |
| Acute Systemic Toxicity | No mortality and no evidence of systemic<br>toxicity | Non-toxic |
| Sub-Acute Systemic<br>Toxicity | No evidence of systemic toxicity and non-irritant | Non-toxic |
| Chronic Systemic<br>Toxicity | No evidence of systemic toxicity and non-irritant | Non-toxic |
| Bacterial Reverse<br>Mutation Test | Article extracts non-mutagenic to tested<br>strains | Non-mutagenic |
| Chromosomal<br>Aberration Assay | Extract equivocal | Equivocal results |
| Mouse Micronucleus<br>Assay | Article in assay non-mutagenic | Non-mutagenic |
| Endotoxin-mediated<br>pyrogenicity | Test article contained less than 0.06 EU/mL | Non-pyrogenic |
| Material-mediated<br>pyrogenicity | Animal temperatures within USP limits | Non-pyrogenic |
| Ethylene Oxide<br>Sterilization Residuals | Meets requirements of ISO 10993-7, passes<br>each of four timepoints (24 hours, 30 days,<br>total daily intake) | Residual levels<br>acceptable |

Through the examination of the device performance properties and results of the testing and characterization activities, it was demonstrated that the proposed device was substantially equivalent to the predicate devices identified.

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Image /page/5/Picture/1 description: The image shows the word "INTEGRA" in large, bold, sans-serif font. Below the word "INTEGRA" is the phrase "LIMIT UNCERTAINTY" in a smaller, sans-serif font. To the right of the word "INTEGRA" are three black squares of varying sizes, stacked vertically. The squares appear to be part of a logo or design element associated with the brand.

#### Conclusion:

The NeuraGen® 3D is substantially equivalent to the commercially marketed device, NeuraGen® Nerve Guide (K011168). Additional predicate devices to which this device demonstrates substantial equivalence include the Cook Biotech Surgisis® Nerve Cuff (K031069) the SaluMedica™ Nerve Cuff (K002098), and Avagen Wound Dressing (K022127).

The design expressed in this 510(k) Premarket Notification does not change the indications for use, intended use, or fundamental scientific technology of the predicate devices, nor does it raise any new issues of safety or effectiveness.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three wavy lines below it.

Public Health Service

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

#### April 24, 2014

Integra LifeSciences Corporation Mr. Stephen Beier Senior Specialist, Regulatory Affairs 311 Enterprise Drive Plainsboro, NJ 08536

Re: K130557

Trade/Device Name: NeuraGen 3D Nerve Guide Matrix Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve Cuff Regulatory Class: Class II Product Code: JXI Dated: March 26, 2014 Received: March 27, 2014

Dear Mr. Beier:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportalProblem/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Felipe Aquel -S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) K130557

#### Device Name

NeuraGen 3D Nerve Guide Matrix

#### Indications for Use (Describe)

NeuraGen® 3D is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

. .

### Please do not write below this line - continue on a separate page if needed.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

. ·

# Date: 2014.04.25 13:16:29 -04'00'

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