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.

AI/ML Overview

The provided text outlines the acceptance criteria and the studies conducted to demonstrate the substantial equivalence of the Nerve Tape device to predicate devices, rather than a study proving the device meets general acceptance criteria in a comparative effectiveness study with human readers.

However, based on the information provided for the Neve Tape device, here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission, the "acceptance criteria" are generally based on demonstrating "substantial equivalence" to a legally marketed predicate device. The performance is assessed against these predicate devices and established standards.

Test / Characteristic	Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate/Standard)	Reported Device Performance
User handling validation / Ease of Use	Ease of use characteristics substantially equivalent to the predicate device.	The ease of use characteristics of the Nerve Tape device are substantially equivalent to the predicate device (AxoGuard® Nerve Connector). All samples met acceptance criteria.
Monotonic tensile strength	Tensile strength substantially equivalent to standard suture for nerve repair.	The tensile strength of the Nerve Tape device is substantially equivalent to standard suture for nerve repair. All samples met acceptance criteria.
Dimension Compliance	Compliance with dimensional criteria for all components and assemblies.	Pass
Corrosion Resistance (NiTiNOL components)	Meeting ASTM F2129 standards for corrosion susceptibility.	Pass
Transformation temperature (NiTiNOL components)	Meeting US FDA Guidance Document "Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol" and ASTM F2004.	Pass
Magnetic resonance imaging safety and compatibility	Meeting US FDA Guidance Document "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment".	Pass
Biocompatibility	Established in accordance with ISO 10993-1:2018 for permanent contact (>30 days) implantation across various endpoints.	Biocompatibility endpoints (cytotoxicity, sensitization, acute systemic toxicity, subchronic/chronic systemic toxicity, pyrogenicity, implantation, genotoxicity) were assessed and established with no adverse findings.
Sterilization validation	Conformance with ISO 11135:2014 and AAMI TIR28:2016.	Pass
EO Residuals	Conformance with ISO 10993-7:2008.	Pass
Animal Study (Safety and Effectiveness)	As safe and effective as the predicate device (AxoGuard® Nerve Connector) and nylon suture in repairing peripheral nerve discontinuities.	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.

2. Sample sized used for the test set and the data provenance

User Handling Validation/Ease of Use: "All samples met acceptance criteria." The specific sample size for the rabbit tibial nerve cases is not explicitly stated, but it involved multiple surgeons performing applications.
Monotonic Tensile Strength: "All samples met acceptance criteria." The specific sample size of cadaveric nerve repairs is not explicitly stated.
Animal Studies: The study used a rabbit tibial nerve transection model. Specific sample sizes for the number of rabbits or nerve repairs are not given, but evaluations were performed at 4-week or 16-week time points. This is prospective animal data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

User handling validation/Ease of Use: "Surgeon performance and handling... were assessed for ease of use". The number of surgeons and their specific qualifications are not detailed beyond being "surgeons." They were implicitly the "experts" assessing ease of use.
Animal Studies: "Outcome measures included macroscopic assessment of the nerve implant sites, muscle weight and girth, and histological assessment of the implant sites and surrounding tissues." These assessments would have been performed by qualified individuals (e.g., veterinary pathologists, histologists), but the specific number and qualifications are not mentioned.

4. Adjudication method for the test set

The document does not describe a formal adjudication method for ground truth in the context of human expert review. The "acceptance criteria" are based on performance metrics against established standards or predicate devices, and internal assessments (e.g., "All samples met acceptance criteria").

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No such MRMC study was performed or described. This submission relates to a physical medical device (Nerve Tape), not an AI-assisted diagnostic or interpretative tool. Therefore, the concept of "human readers improve with AI assistance" is not applicable here.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This refers to a physical medical device, not an algorithm. Therefore, "standalone algorithm-only performance" is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's performance was established through:

Quantitative measurements against standards: For mechanical properties (tensile strength), material properties (corrosion resistance, transformation temperature), and dimensional compliance.
Compliance with validated protocols: For biocompatibility and sterilization.
Direct observation and assessment: By surgeons for ease of use.
Histological assessment and macroscopic evaluation: For the animal study, which serves as a form of "pathology" and direct physiological outcome data.

8. The sample size for the training set

This document describes a premarket notification for a physical medical device. The concepts of "training set" and "test set" are typically used in the context of machine learning (AI) models. While the manufacturer likely conducted internal development and testing during the design phase, the document does not present data in terms of a formal "training set" like one would for an AI algorithm.

9. How the ground truth for the training set was established

As above, the concept of a formal "training set" and its "ground truth" as it applies to AI/ML devices is not relevant to this submission for a physical medical device. The "ground truth" for the various non-clinical and animal studies described were established through standardized test methods, material specifications, and biological evaluations.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 (404) 583-6889 (direct) jackgriffisiii@gmail.com
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:

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(Proposed)	AxoGuard® Nerve Connector(Predicate, K162741)	Nerve Cuff(Predicate, K132660)
Manufacturer	BioCircuit Technologies, Inc.	Cook Biotech Inc.	Cook Biotech Inc.
510(k) Number	K210665	K162741	K132660
Product Code	JXI	JXI	JXI
ClassificationNumber	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 injurieswhere a gap closure is achieved byflexion of the extremity.	Intended for peripheral nerveinjuries where a gap closure isachieved by flexion of theextremity.	Intended for peripheral nerveinjuries where there is no gap orwhere a gap closure is achievedby flexion of the extremity.
Materials ofFabrication	Porcine small intestinal submucosa;primarily collagen types I, III, IV, & VI(manufactured by Cook Biotech Inc.),NITINOL	Porcine small intestinalsubmucosa; primarily collagentypes I, III, IV, & VI(manufactured by Cook BiotechInc.)	Porcine small intestinalsubmucosa; primarily collagentypes I, III, IV, & VI(manufactured by Cook BiotechInc.)
Shape	Rectangular wrap (rolls into a hollowtube)	Hollow tube	Hollow tube with a slit
Supplied Sterile?	Yes	Yes	Yes
Sterilizationmethod	Ethylene Oxide (cycle by Cook BiotechInc.)	Ethylene Oxide (cycle by CookBiotech Inc.)	Ethylene Oxide (cycle by CookBiotech Inc.)
Intended forsingle use?	Yes	Yes	Yes
PackagingConfiguration	Clamshell tray in Tyvek-poly pouchwith an outer box (packaged by CookBiotech Inc.)	Clamshell tray in Tyvek pouchwith an outer box(packaged by Cook Biotech Inc.)	Clamshell tray in Tyvek pouchwith an outer box(packaged by Cook Biotech Inc.)
Shelf Life	18 months	18 months	18 months
Intended use	Intended for peripheral nerve injurieswhere a gap closure is achieved byflexion of the extremity.	Intended for peripheral nerveinjuries where a gap closure isachieved by flexion of theextremity.	Intended for peripheral nerveinjuries where there is no gap orwhere a gap closure is achievedby flexion of the extremity.
Dimensions(Wrapped)	2-7mm diameter x 1.4-2.2cm length	1.5-10mm diameter x 1-5 cmlength	1.5-10mm diameter x 1-5 cmlength
Thickness(Wrapped)	100-750 μm	100-1000 μm	100-1000 μm
Method offixation	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/Ease of Use	Surgeon performance and handling of Nerve Tape, nylonsuture and AxoGuard® Nerve Connector were assessed forease of use in application to the transected rabbit tibialnerves	The ease of use characteristics ofthe Nerve Tape device aresubstantially equivalent to thepredicate device. All samples metacceptance criteria.
Monotonic tensilestrength	Repair strength as assessed via device retention strengthon repaired cadaveric nerve in comparison to standardsuture repair according to the literature	The tensile strength of the NerveTape device is substantiallyequivalent to standard suture fornerve repair. All samples metacceptance criteria.
Dimension Compliance	Compliance with dimensional criteria for all componentsand assemblies	Pass
Corrosion Resistance (forNiTiNOL components)	ASTM F2129: Cyclic potentiodynamic polarizationmeasurements for corrosion susceptibility	Pass
Transformationtemperature (DSC, forNiTiNOL components)	Per the US FDA Guidance Document, "TechnicalConsiderations for Non-Clinical Assessment of MedicalDevices Containing Nitinol", and ASTM F2004,Transformation Temperature of Nickel-Titanium Alloys byThermal Analysis	Pass
Magnetic resonanceimaging safety andcompatibility	Per the US FDA Guidance Document, "Testing and LabelingMedical Devices for Safety in the Magnetic Resonance (MR)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 ofhealthcare products with ethylene oxide, and AAMI TIR28:2016, Product adoptionand 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).

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).