AxoGuard Nerve Connector

K162741 · Cook Biotech Incorporated · JXI · Oct 31, 2016 · Neurology

Device Facts

• Record ID: K162741
• Device Name: AxoGuard Nerve Connector
• Applicant: Cook Biotech Incorporated
• Product Code: JXI · Neurology
• Decision Date: Oct 31, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5275
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Nerve Cuff is intended for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity. The device is supplied sterile and is intended for one-time use.

Device Story

Bioabsorbable, extracellular collagen matrix (porcine small intestinal submucosa) nerve cuff; implanted around injured peripheral nerve; provides scaffold for patient cell infiltration and remodeling into native tissue; protects damaged/severed nerve during healing; supplied sterile in clamshell container; used by surgeons in clinical settings; device dimensions (1.5-10 mm diameter, 1-5 cm length) allow for varied nerve repair applications.

Clinical Evidence

Bench testing only. Includes user handling validation by surgeons, ultimate tensile strength (ISO 7198/5081), suture retention strength (ISO 7198), and compression/rebound testing. Biocompatibility established via predicate data (ISO 10993-1, -3, -5, -6, -10, -11). Sterilization validated per EN ISO 11135.

Technological Characteristics

Material: Porcine small intestinal submucosa (collagen types III, IV, VI). Form factor: Hollow tube. Dimensions: 1.5-10 mm diameter, 1-5 cm length. Thickness: 100-1000 μm. Sterilization: Ethylene Oxide (EN ISO 11135). Biocompatibility: ISO 10993 compliant.

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

• Surgisis Nerve Cuff (K031069)

Reference Devices

• Nerve Cuff (K132660)

Submission Summary (Full Text)

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

October 31, 2016

Cook Biotech Incorporated Katrina Molland, PhD Regulatory Affairs Specialist 1425 Innovation Place West Lafayette, Indiana 47906

Re: K162741

Trade/Device Name: AxoGuard Nerve Connector Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve Cuff Regulatory Class: Class II Product Code: JXI Dated: September 29, 2016 Received: September 30, 2016

Dear Dr. Molland:

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 devicerelated 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.

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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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 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,

# Michael J. Hoffmann -A

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

Enclosure

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# Indications for Use

510(k) Number (if known) K162741

Device Name AxoGuard Nerve Connector

Indications for Use (Describe)

The Nerve Cuff is intended for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity. The device is supplied sterile and is intended for one-time use.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) SUMMARY

Submitted by: Perry Guinn, Vice President, Quality Assurance and Regulatory Affairs Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906 [phone] 29 September, 2016

## Name of Device:

| Trade/Proprietary Names: | Nerve Cuff |
|--------------------------|----------------------------|
| | AxoGuard Nerve Connector |
| Common/Usual Names: | Cuff, Nerve |
| Product Code: | JXI |
| Device Class: | 21 CFR §882.5275, Class II |
| Classification Panel: | Neurology |

#### Predicate Device:

The predicate device is Surgisis Nerve Cuff (K031069), cleared May 15, 2003 and manufactured by Cook Biotech Incorporated.

#### Reference Device:

The reference device is the Nerve Cuff (K132660), cleared July 23, 2014 and manufactured by Cook Biotech Incorporated.

#### Intended Use:

The Nerve Cuff is intended for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

The device is supplied sterile and is intended for one-time use.

This intended use is identical to that of the predicate device cleared under K031069.

#### Device Description:

The Nerve Cuff is composed of a bioabsorbable, extracellular collagen matrix (Small Intestinal Submucosa, SIS). The SIS material that comprises the Nerve Cuff is identical to that of its predicate (Surgisis Nerve Cuff, K031069), and reference device (Nerve Cuff, K132660). Both the predicate and reference devices are also manufactured by Cook Biotech Incorporated. The Nerve Cuff is implanted around an injured nerve to provide a scaffold which becomes infiltrated by the patient's cells and is remodeled into native tissue. In addition, the Nerve Cuff protects the damaged or severed nerve while the nerve heals. The device is packaged in a dried state and supplied sterile in a clamshell container inside a sealed pouch.

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#### Comparison to Predicate Device:

The Nerve Cuff is substantially equivalent with respect to intended use, materials and technological characteristics to its predicate, Surgisis Nerve Cuff. This Special 510(k) describes a size change to supply the Nerve Cuff in shorter lengths and one narrower diameter. The subject device is identical to the predicate with regard to intended use, indications for use, target population, anatomical site, use setting, performance, materials, compatibility with the environment and other devices, chemical safety, design, standards met, biocompatibility, and sterility. The subject device differs from the predicate device solely in regard to its dimensions as detailed in the Substantial Equivalence Table (Table 5-5).

The introduction of new device sizes does not affect substantial equivalence to the predicate device.

## Comparison to Reference Device:

The size range of the reference device is identical to the expanded size range that forms the basis for this submission. The subject and reference (K132660) devices have a common predicate, the Surgisis Nerve Cuff (K031069). They are identical in material composition, and differ in design only with respect to a slit in the reference device. Their intended uses are nearly the slit allows the reference device to be used where there is no gap in the injured nerve.

# Summary of Non-Clinical Tests:

The functional performance verification and product characterization testing that was conducted on the subject device is provided in Table 5-1:

| Test | Test Method Summary | Results |
|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| User handling validation | Surgeon handling of representative final<br>product<br><br>Acceptance criteria: product possesses<br>acceptable characteristics for handling,<br>trimming and suturing | The handling characteristics of<br>the subject device are<br>substantially equivalent to the<br>predicate device based on<br>acceptability to the end user. All<br>samples met acceptance criteria. |
| Pre-clinical study<br>discussion /evaluation of<br>product line by key<br>opinion leaders | Discussion of product line and surgeon<br>handling of representative final product<br><br>Acceptance criteria: No concerns<br>regarding pre-clinical data and<br>acceptable device handling<br>characteristics | No concerns regarding pre-<br>clinical data and the handling<br>characteristics of the subject<br>device are substantially<br>equivalent to the predicate device<br>based on acceptability to the end<br>user. All samples met acceptance<br>criteria. |

# Table 5-1. Functional Performance Information

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Product characterization using known standards and/or clinically relevant acceptance criteria was performed on the predicate device. A summary of this testing is provided in Table 5-2. The predicate test data was leveraged to support the substantial equivalence of the subject device material and manufacturing process is identical for the subject and predicate device.

| Test | Test Method Summary | Results |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Ultimate tensile strength | Testing according to<br>ISO 7198:1990 and<br>ISO 5081 | The ultimate tensile strength of<br>the material composing the<br>subject device is greater than the<br>predicate device. |
| Suture retention strength | Testing according to<br>ISO 7198:1998 | The suture retention strength of<br>the material composing the<br>subject device is sufficient to<br>perform the intended use. All<br>samples met acceptance criteria. |
| Compression and rebound | Devices were tested for maximum force<br>required to collapse the tube and ability<br>to rebound to original diameter | All samples met acceptance<br>criteria with performance<br>comparable to that of the<br>predicate device. |

# Table 5-2. Bench Testing Information

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# Biocompatibility Testing:

Biocompatibility of the predicate device has been established in accordance with ISO 10993-1:2009 -Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process to demonstrate that the device is safe for permanent contact (>30 days) implantation as detailed in Table 5-3. The predicate test data was leveraged to support the substantial equivalence of the subject device as the device material and manufacturing process is identical for the subject and predicate device.

| Test | Test Method Summary | Results |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Cytotoxicity | ISO 10993-5: Direct contact<br>cytotoxicity following ISO elution | Pass<br>Non-cytotoxic |
| Sensitization | ISO 10993-10: Maximization test in<br>guinea pigs (sodium chloride and<br>sesame oil extraction vehicles) | Pass<br>No evidence of sensitization |
| Intracutaneous reactivity | ISO 10993-10: Intracutaneous<br>reactivity test in rabbits (sodium<br>chloride and sesame oil extraction<br>vehicles) | Pass<br>No evidence of intracutaneous<br>reactivity |
| Acute systemic toxicity | ISO 10993-11: Acute systemic toxicity<br>test in mice (sodium chloride and<br>cottonseed oil extraction vehicles) | Pass<br>No mortality or evidence of acute<br>systemic toxicity |
| Subchronic and chronic<br>toxicity | ISO 10993-11: Direct subcutaneous<br>implant in rats for 4 weeks(subchronic)<br>and 18 weeks (chronic) | Pass<br>Non-irritating to subcutaneous<br>tissue<br>No evidence of subchronic or<br>chronic toxicity |
| Genotoxicity | ISO 10993-3: Bacterial reverse<br>mutation study | Pass<br>Device extracts are non-mutagenic |
| Implantation | ISO 10993-6: Muscle implantation in<br>rabbits for 4, 12, and 24 weeks | Pass<br>Irritation not greater than control<br>materials at 24 weeks |

#### Table 5-3. Biocompatibility Information

## Sterilization:

The method employed to ensure sterility of the predicate device is provided in Table 5-4. The predicate test data was leveraged to support the substantial equivalence of the subject device material and manufacturing process is identical for the subject and predicate device.

| Table 5-4. Sterilization Information | |
|--------------------------------------|--|
|--------------------------------------|--|

| Test | Test Method Summary | Results |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Sterilization validation | Validation method in conformance with<br>EN ISO 11135-2007<br>The validation of sterilization was<br>performed using the over-kill method<br>per guidelines outlined in sections 9.3.2<br>and 9.3.3 of the EN ISO 11135<br>standard. | Pass<br>Devices have a sterility assurance<br>level (SAL) of 10-6 |

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# Substantial Equivalence:

Table 5-5 below provides a comparison of the subject device, its predicate and the reference device.

| Device | Nerve Cuff<br>(Subject Device) | Surgisis Nerve Cuff<br>(Predicate Device) | Nerve Cuff<br>(Reference Device) |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Cook Biotech Inc. | Cook Biotech Inc | Cook Biotech Inc |
| 510(k) number | unassigned | K031069 | K132660 |
| Product Code | JXI | JXI | JXI |
| Material | Porcine small intestinal<br>submucosa; primarily<br>collagen types, III, IV,<br>and VI | Porcine small intestinal<br>submucosa; primarily<br>collagen types, III, IV,<br>and VI | Porcine small intestinal<br>submucosa; primarily<br>collagen types, III, IV,<br>and VI |
| Shape | Hollow tube | Hollow tube | Hollow tube with a slit |
| Supplied sterile? | Yes | Yes | Yes |
| Sterilization method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Intended for single<br>use? | Yes | Yes | Yes |
| Packaging<br>configuration | Clamshell tray in Tyvek<br>pouch with an outer box | Clamshell tray in a<br>double Tyvek pouch | Clamshell tray in Tyvek<br>pouch with an outer box |
| Shelf Life | 18 months | 18 months | 18 months |
| Intended Use | Intended for the repair of<br>peripheral nerve<br>discontinuities where gap<br>closure can be achieved<br>by flexion of the<br>extremity. | Intended for the repair of<br>peripheral nerve<br>discontinuities where gap<br>closure can be achieved<br>by flexion of the<br>extremity | Intended for the repair of<br>peripheral nerve injuries<br>in which there is no gap<br>or where a gap closure is<br>achieved by flexion of<br>the extremity. |
| Dimensions | 1.5-10 mm diameter x 1-<br>5 cm length | Diameter (mm)<br>Length (cm)<br>2<br>5<br>7 | 1.5-10 mm diameter x 1-<br>5 cm length |
| Thickness | 100-1000 μm | 100-1000 μm | 100-1000 μm |

Table 5-5. Substantial Equivalence Information

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## Conclusion:

The Nerve cuff is substantially equivalent to its predicate device in terms of indications for use, methods of operation, and fundamental technological characteristics. Successful risk analysis and completion of verification and validation activities provides evidence to support the conclusion that the size modification does not introduce new risks and that the subject device performs comparably to the predicate device that is currently marketed for the same intended use.