Nerve Tape

K210665 · Biocircuit Technologies, Incorporated · JXI · Jul 15, 2022 · Neurology

Device Facts

• Record ID: K210665
• Device Name: Nerve Tape
• Applicant: Biocircuit Technologies, Incorporated
• Product Code: JXI · Neurology
• Decision Date: Jul 15, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Nerve Tape is indicated for the repair of peripheral nerve discontinuities where can be achieved by flexion of the extremity.

Device Story

Nerve Tape is a bioabsorbable nerve cuff used for peripheral nerve repair. It consists of a porcine small intestinal submucosa (SIS) collagen matrix integrated with nickel-titanium (NiTiNOL) microhooks. The device is supplied sterile in a dried state and rehydrated before use. During surgery, the rectangular wrap is applied around the nerve ends; the microhooks provide mechanical fixation and apposition, replacing the need for traditional sutures. The SIS scaffold supports nerve remodeling and protection during healing. It is intended for use by surgeons in clinical settings for nerve injuries where gap closure is possible through extremity flexion. The device benefits patients by providing a sutureless fixation method for nerve coaptation, potentially simplifying the surgical procedure while maintaining repair strength equivalent to standard suturing.

Clinical Evidence

No human clinical studies were performed. Safety and efficacy were established via non-clinical bench testing and an animal study. Bench testing included monotonic tensile strength (compared to suture), dimension compliance, corrosion resistance (ASTM F2129), and transformation temperature (ASTM F2004). Biocompatibility was assessed per ISO 10993-1. An animal study using a rabbit tibial nerve transection model compared Nerve Tape to AxoGuard® Nerve Connector and nylon suture at 4 and 16 weeks, evaluating macroscopic tissue response, muscle weight/girth, and histology. Results demonstrated the device is as safe and effective as the predicates.

Technological Characteristics

Bioabsorbable porcine small intestinal submucosa (SIS) matrix (collagen types I, III, IV, VI); NiTiNOL microhooks for fixation. Dimensions: 2-7mm diameter, 1.4-2.2cm length, 100-750 μm thickness. Sterilization: Ethylene Oxide (ISO 11135:2014). NiTiNOL components tested per ASTM F2129 (corrosion) and ASTM F2004 (transformation temperature).

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

• Cook Biotech Inc. AxoGuard® Nerve Connector (K162741)
• Cook Biotech Inc. Nerve Cuff (AxoGuard® Nerve Protector) (K132660)

Submission Summary (Full Text)

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July 15, 2022

BioCircuit Technologies, Inc. % Jack Griffis Scientific and Regulatory Advisor 1819 Peachtree Road NE, Suite 205 Atlanta, Georgia 30309

Re: K210665

Trade/Device Name: Nerve Tape Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve Cuff Regulatory Class: Class II Product Code: JXI Dated: April 6, 2022 Received: April 7, 2022

Dear Jack Griffis:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K210665

Device Name Nerve Tape

Indications for Use (Describe)

Nerve Tape is indicated for the repair of peripheral nerve discontinuities where can be achieved by flexion of the extremity.

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

### 510(k) Number: K210665

July 15th, 2022 Date Submitted:

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

- A. Submitter: BioCircuit Technologies, Inc. 1819 Peachtree Rd NE, Suite 205 Atlanta, Georgia 30309 470-698-2117
- B. Company Contact: Jack Griffis Scientific Advisor [phone] (direct) [e-mail]
- C. Device Information: Trade Name: Nerve Tape Common Name: Nerve Cuff
- D. Classification: Nerve Cuff 21 CFR §882.5275 (Product Code: JXI) Class II
- E. Primary Predicate Device: Cook Biotech Inc. AxoGuard® Nerve Connector (K162741)

### F. Additional Predicate Device: Cook Biotech Inc. Nerve Cuff (Marketed as AxoGuard® Nerve Protector) (K132660)

### G. Physical Description:

The Nerve Tape device is composed of a bioabsorbable, extracellular collagen matrix derived from small intestinal submucosa (SIS). Microhooks made of a nickel-titanium alloy (NiTiNOL) are integrated into the nerve contacting side of the SIS for mechanical fixation and apposition of nerve ends. The device is packaged in a dried state and supplied sterile, and is rehydrated prior to use.

- H. Indications for Use: Nerve Tape™ is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
- l. Comparison to Predicate Device:

The subject Nerve Tape device is substantially equivalent in intended use to the predicate Cook Biotech Inc. AxoGuard® Nerve Connector and Cook Biotech Inc. Nerve Cuff devices in surgical repair of peripheral nerves. The subject and predicate devices are surgically fabricated with similar or identical bioresorbable porcine SIS material (certified to ISO 22442) which serves as scaffold that protects protection and supports remodeling while the injured nerve heals. The Nerve Tape differs from the predicates in the method of nerve cuff fixation. The Nerve Tape contains embedded microhooks,

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whereas the predicate devices require suturing to maintain coaptation strength. A comparison of subject and predicate devices is provided in Table 1.

| Parameter | Nerve Tape<br>(Proposed) | AxoGuard® Nerve Connector<br>(Predicate, K162741) | Nerve Cuff<br>(Predicate, K132660) |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | BioCircuit Technologies, Inc. | Cook Biotech Inc. | Cook Biotech Inc. |
| 510(k) Number | K210665 | K162741 | K132660 |
| Product Code | JXI | JXI | JXI |
| Classification<br>Number | 21 CFR 882.5275 | 21 CFR 882.5275 | 21 CFR 882.5275 |
| Common name | Cuff, Nerve | Cuff, Nerve | Cuff, Nerve |
| Intended use | Intended for peripheral nerve injuries<br>where a gap closure is achieved by<br>flexion of the extremity. | Intended for peripheral nerve<br>injuries where a gap closure is<br>achieved by flexion of the<br>extremity. | Intended for peripheral nerve<br>injuries where there is no gap or<br>where a gap closure is achieved<br>by flexion of the extremity. |
| Materials of<br>Fabrication | Porcine small intestinal submucosa;<br>primarily collagen types I, III, IV, & VI<br>(manufactured by Cook Biotech Inc.),<br>NITINOL | Porcine small intestinal<br>submucosa; primarily collagen<br>types I, III, IV, & VI<br>(manufactured by Cook Biotech<br>Inc.) | Porcine small intestinal<br>submucosa; primarily collagen<br>types I, III, IV, & VI<br>(manufactured by Cook Biotech<br>Inc.) |
| Shape | Rectangular wrap (rolls into a hollow<br>tube) | Hollow tube | Hollow tube with a slit |
| Supplied Sterile? | Yes | Yes | Yes |
| Sterilization<br>method | Ethylene Oxide (cycle by Cook Biotech<br>Inc.) | Ethylene Oxide (cycle by Cook<br>Biotech Inc.) | Ethylene Oxide (cycle by Cook<br>Biotech Inc.) |
| Intended for<br>single use? | Yes | Yes | Yes |
| Packaging<br>Configuration | Clamshell tray in Tyvek-poly pouch<br>with an outer box (packaged by Cook<br>Biotech Inc.) | Clamshell tray in Tyvek pouch<br>with an outer box<br>(packaged by Cook Biotech Inc.) | Clamshell tray in Tyvek pouch<br>with an outer box<br>(packaged by Cook Biotech Inc.) |
| Shelf Life | 18 months | 18 months | 18 months |
| Intended use | Intended for peripheral nerve injuries<br>where a gap closure is achieved by<br>flexion of the extremity. | Intended for peripheral nerve<br>injuries where a gap closure is<br>achieved by flexion of the<br>extremity. | Intended for peripheral nerve<br>injuries where there is no gap or<br>where a gap closure is achieved<br>by flexion of the extremity. |
| Dimensions<br>(Wrapped) | 2-7mm diameter x 1.4-2.2cm length | 1.5-10mm diameter x 1-5 cm<br>length | 1.5-10mm diameter x 1-5 cm<br>length |
| Thickness<br>(Wrapped) | 100-750 μm | 100-1000 μm | 100-1000 μm |
| Method of<br>fixation | NITINOL microhooks | Suture | Suture |

## Table 1. Table of Substantial Equivalence

The technological characteristics of the subject Nerve Tape device are substantially equivalent to the predicate devices as demonstrated through bench, biocompatibility and animal testing.

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### J. Summary of Non-Clinical Tests:

Product characterization using known standards and/or relevant acceptance criteria were performed on the Nerve Tape device. A summary of this testing is provided in Table 2.

| Test | Test Method Summary | Results |
|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| User handling validation/<br>Ease of Use | Surgeon performance and handling of Nerve Tape, nylon<br>suture and AxoGuard® Nerve Connector were assessed for<br>ease of use in application to the transected rabbit tibial<br>nerves | The ease of use characteristics of<br>the Nerve Tape device are<br>substantially equivalent to the<br>predicate device. All samples met<br>acceptance criteria. |
| Monotonic tensile<br>strength | Repair strength as assessed via device retention strength<br>on repaired cadaveric nerve in comparison to standard<br>suture repair according to the literature | The tensile strength of the Nerve<br>Tape device is substantially<br>equivalent to standard suture for<br>nerve repair. All samples met<br>acceptance criteria. |
| Dimension Compliance | Compliance with dimensional criteria for all components<br>and assemblies | Pass |
| Corrosion Resistance (for<br>NiTiNOL components) | ASTM F2129: Cyclic potentiodynamic polarization<br>measurements for corrosion susceptibility | Pass |
| Transformation<br>temperature (DSC, for<br>NiTiNOL components) | Per the US FDA Guidance Document, "Technical<br>Considerations for Non-Clinical Assessment of Medical<br>Devices Containing Nitinol", and ASTM F2004,<br>Transformation Temperature of Nickel-Titanium Alloys by<br>Thermal Analysis | Pass |
| Magnetic resonance<br>imaging safety and<br>compatibility | Per the US FDA Guidance Document, "Testing and Labeling<br>Medical Devices for Safety in the Magnetic Resonance (MR)<br>Environment" | Pass |

Table 2. Non-Clinical Bench Testing Information

### K. Biocompatibility Testing:

Biocompatibility of the Nerve Tape device has been established in accordance with ISO 10993-1:2018 – 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. The biocompatibility endpoints that were assessed include cytotoxicity, sensitization, acute systemic toxicity, subchronic/chronic systemic toxicity, pyrogenicity, implantation and genotoxicity.

### L. Sterilization:

Ethylene oxide sterilization validation and ethylene oxide residuals testing of the Nerve Tape device are provided in Table 4.

| Test | Test Method Summary | Results |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Sterilization validation | Validation method in conformance with ISO 11135:2014, Sterilization of<br>healthcare products with ethylene oxide, and AAMI TIR28:2016, Product adoption<br>and process equivalence for ethylene oxide sterilization. | Pass |
| EO Residuals | ISO 10993-7:2008, Ethylene oxide sterilization residuals | Pass |

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

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#### M. Animal Studies:

Testing using a rabbit tibial nerve transection model were evaluated for usability and tissue responses were assessed following implantation and treatment with either the Nerve Tape device, the AxoGuard® Nerve Connector or nylon suture, and evaluated at the 4-week or 16-week evaluation time points. Outcome measures included macroscopic assessment of the nerve implant sites, muscle weight and girth, and histological assessment of the implant sites and surrounding tissues. The studies demonstrated that the Nerve Tape device is as safe and effective as the AxoGuard® Nerve Connector and nylon suture in repairing peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

### N. Clinical Studies:

No human studies were necessary to prove the safety and efficacy of the device.

### Conclusion:

The Nerve Tape device has the same intended use as the predicate devices. Nonclinical testing demonstrated that the Nerve Tape is substantially equivalent to the predicate device(s).