Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a resorbable implant made of collagen and glycosaminoglycan for nerve repair. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The performance studies are bench tests and an animal study, not related to AI/ML model validation.

Therapeutic

Yes
The device is indicated for the repair of peripheral nerve discontinuities and provides a protective environment for nerve repair, acting as a conduit for axonal growth, which directly treats an injury and improves function.

Diagnostic

No
The device, NeuraGen® 3D, is a resorbable implant for repairing peripheral nerve discontinuities, providing a protective environment and conduit for nerve growth. It is not designed to diagnose conditions or diseases.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a resorbable implant composed of bovine Type I collagen conduit and a porous inner matrix, indicating it is a physical medical device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the repair of peripheral nerve discontinuities in the human body. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
Device Description: The device is a resorbable implant designed to provide a protective environment and create a conduit for axonal growth. This describes a physical device implanted into the body to aid in healing.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) outside of the body to provide information about a physiological state, health, or disease.

IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for conditions. This device is a surgical implant used for repair within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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.

Product codes

JXI

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral nerve

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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.

Studies and Results:

Conduit Inner Diameter: Each tested conduit exhibited inner diameter within specified tolerance. (Pass)
Inner Matrix Pore 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 Diffusion: No evidence of causing cell lysis or toxicity (Grade 0). (Non-cytotoxic)
Sensitization Test: No evidence of causing delayed dermal contact sensitization. (Non-sensitizer)
Irritation Test: Test article mean score consistent with corresponding control mean score. (Non-irritant)
Acute Systemic Toxicity: No mortality and no evidence of systemic toxicity. (Non-toxic)
Sub-Acute Systemic Toxicity: No evidence of systemic toxicity and non-irritant. (Non-toxic)
Chronic Systemic Toxicity: No evidence of systemic toxicity and non-irritant. (Non-toxic)
Bacterial Reverse Mutation Test: Article extracts non-mutagenic to tested strains. (Non-mutagenic)
Chromosomal Aberration Assay: Extract equivocal. (Equivocal results)
Mouse Micronucleus Assay: Article in assay non-mutagenic. (Non-mutagenic)
Endotoxin-mediated pyrogenicity: Test article contained less than 0.06 EU/mL. (Non-pyrogenic)
Material-mediated pyrogenicity: Animal temperatures within USP limits. (Non-pyrogenic)
Ethylene Oxide Sterilization Residuals: Meets requirements of ISO 10993-7, passes each of four timepoints (24 hours, 30 days, total daily intake). (Residual levels acceptable)

Key Metrics

Not Found

Predicate Device(s)

K011168, K031069, K002098, K022127

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 882.5275 Nerve cuff.

(a)
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).(b)
Classification. Class II (performance standards).

Summary

0

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: 609.936.5436 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
Guide	Integra LifeSciences
Corporation
K031069	JXI	Surgisis® Nerve Cuff	Cook Biotech
Incorporated
K002098	JXI	SaluMedica™ Nerve
Cuff	SaluMedica™ L.L.C.
K022127	KGN	Avagen Wound
Dressing	Integra LifeSciences
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.

1

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.

2

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

3

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.

| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Sterilif | Provided
sterile. |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Biocomp-- atibility | Ves. |
| .

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

4

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
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
Diffusion	No evidence of causing cell lysis or toxicity
(Grade 0)	Non-cytotoxic
Sensitization Test	No evidence of causing delayed dermal
contact sensitization	Non-sensitizer
Irritation Test	Test article mean score consistent with
corresponding control mean score	Non-irritant
Acute Systemic Toxicity	No mortality and no evidence of systemic
toxicity	Non-toxic
Sub-Acute Systemic
Toxicity	No evidence of systemic toxicity and non-irritant	Non-toxic
Chronic Systemic
Toxicity	No evidence of systemic toxicity and non-irritant	Non-toxic
Bacterial Reverse
Mutation Test	Article extracts non-mutagenic to tested
strains	Non-mutagenic
Chromosomal
Aberration Assay	Extract equivocal	Equivocal results
Mouse Micronucleus
Assay	Article in assay non-mutagenic	Non-mutagenic
Endotoxin-mediated
pyrogenicity	Test article contained less than 0.06 EU/mL	Non-pyrogenic
Material-mediated
pyrogenicity	Animal temperatures within USP limits	Non-pyrogenic
Ethylene Oxide
Sterilization Residuals	Meets requirements of ISO 10993-7, passes
each of four timepoints (24 hours, 30 days,
total daily intake)	Residual levels
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.

5

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.

6

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

7

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

8

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'

PSC Publishing Services (30) } +1) -6740 EP

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