(497 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical function of the Nerve Tape, with no mention of AI or ML.
Yes.
The device is indicated for the repair of peripheral nerve discontinuities, which addresses a pathological condition and promotes restoration of function, classifying it as a therapeutic device.
No
The device description and intended use indicate it is for the repair of nerve discontinuities, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is composed of a bioabsorbable matrix and nickel-titanium alloy microhooks, indicating it is a physical medical device, not software-only.
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. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implant (bioabsorbable matrix with microhooks) used for mechanical fixation.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The device described is a surgical implant used for nerve repair, which falls under the category of medical devices used for treatment or restoration of function within the body.
N/A
Intended Use / Indications for Use
Nerve Tape is indicated for the repair of peripheral nerve discontinuities where can be achieved by flexion of the extremity.
Product codes (comma separated list FDA assigned to the subject device)
JXI
Device 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Tests:
Product characterization using known standards and/or relevant acceptance criteria were performed on the Nerve Tape device.
- User handling validation/Ease of Use: Surgeon performance and handling of Nerve Tape, nylon suture and AxoGuard® Nerve Connector were assessed for ease of use in application to the transected rabbit tibial nerves.
- Results: The ease of use characteristics of the Nerve Tape device are substantially equivalent to the predicate device. All samples met acceptance criteria.
- Monotonic tensile strength: Repair strength as assessed via device retention strength on repaired cadaveric nerve in comparison to standard suture repair according to the literature.
- Results: 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.
- Results: Pass.
- Corrosion Resistance (for NiTiNOL components): ASTM F2129: Cyclic potentiodynamic polarization measurements for corrosion susceptibility.
- Results: Pass.
- Transformation temperature (DSC, for NiTiNOL components): Per the US FDA Guidance Document, "Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol", and ASTM F2004, Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis.
- Results: Pass.
- Magnetic resonance imaging safety and compatibility: Per the US FDA Guidance Document, "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment".
- Results: Pass.
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.
Sterilization:
Ethylene oxide sterilization validation and ethylene oxide residuals testing of the Nerve Tape device are provided in Table 4.
- Sterilization validation: Validation method in conformance with ISO 11135:2014, Sterilization of healthcare products with ethylene oxide, and AAMI TIR28:2016, Product adoption and process equivalence for ethylene oxide sterilization.
- Results: Pass.
- EO Residuals: ISO 10993-7:2008, Ethylene oxide sterilization residuals.
- Results: Pass.
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.
Clinical Studies:
No human studies were necessary to prove the safety and efficacy of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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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3
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:
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,
4
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 |
| Classification
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
where a gap closure is achieved by
flexion of the extremity. | Intended for peripheral nerve
injuries where a gap closure is
achieved by flexion of the
extremity. | Intended for peripheral nerve
injuries where there is no gap or
where a gap closure is achieved
by flexion of the extremity. |
| Materials of
Fabrication | Porcine small intestinal submucosa;
primarily collagen types I, III, IV, & VI
(manufactured by Cook Biotech Inc.),
NITINOL | Porcine small intestinal
submucosa; primarily collagen
types I, III, IV, & VI
(manufactured by Cook Biotech
Inc.) | Porcine small intestinal
submucosa; primarily collagen
types I, III, IV, & VI
(manufactured by Cook Biotech
Inc.) |
| Shape | Rectangular wrap (rolls into a hollow
tube) | Hollow tube | Hollow tube with a slit |
| Supplied Sterile? | Yes | Yes | Yes |
| Sterilization
method | Ethylene Oxide (cycle by Cook Biotech
Inc.) | Ethylene Oxide (cycle by Cook
Biotech Inc.) | Ethylene Oxide (cycle by Cook
Biotech Inc.) |
| Intended for
single use? | Yes | Yes | Yes |
| Packaging
Configuration | Clamshell tray in Tyvek-poly pouch
with an outer box (packaged by Cook
Biotech Inc.) | Clamshell tray in Tyvek pouch
with an outer box
(packaged by Cook Biotech Inc.) | Clamshell tray in Tyvek pouch
with an outer box
(packaged by Cook Biotech Inc.) |
| Shelf Life | 18 months | 18 months | 18 months |
| Intended use | Intended for peripheral nerve injuries
where a gap closure is achieved by
flexion of the extremity. | Intended for peripheral nerve
injuries where a gap closure is
achieved by flexion of the
extremity. | Intended for peripheral nerve
injuries where there is no gap or
where a gap closure is achieved
by flexion of the extremity. |
| Dimensions
(Wrapped) | 2-7mm diameter x 1.4-2.2cm length | 1.5-10mm diameter x 1-5 cm
length | 1.5-10mm diameter x 1-5 cm
length |
| Thickness
(Wrapped) | 100-750 μm | 100-1000 μm | 100-1000 μm |
| Method of
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.
5
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, nylon | |
| suture and AxoGuard® Nerve Connector were assessed for | ||
| ease of use in application to the transected rabbit tibial | ||
| nerves | The ease of use characteristics of | |
| the Nerve Tape device are | ||
| substantially equivalent to the | ||
| predicate device. All samples met | ||
| acceptance criteria. | ||
| Monotonic tensile | ||
| strength | Repair strength as assessed via device retention strength | |
| on repaired cadaveric nerve in comparison to standard | ||
| suture repair according to the literature | 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 (for | ||
| NiTiNOL components) | ASTM F2129: Cyclic potentiodynamic polarization | |
| measurements for corrosion susceptibility | Pass | |
| Transformation | ||
| temperature (DSC, for | ||
| NiTiNOL components) | Per the US FDA Guidance Document, "Technical | |
| Considerations for Non-Clinical Assessment of Medical | ||
| Devices Containing Nitinol", and ASTM F2004, | ||
| Transformation Temperature of Nickel-Titanium Alloys by | ||
| Thermal Analysis | Pass | |
| Magnetic resonance | ||
| imaging safety and | ||
| compatibility | Per the US FDA Guidance Document, "Testing and Labeling | |
| Medical 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 of | |
| healthcare products with ethylene oxide, and AAMI TIR28:2016, Product adoption | ||
| and process equivalence for ethylene oxide sterilization. | Pass | |
| EO Residuals | ISO 10993-7:2008, Ethylene oxide sterilization residuals | Pass |
| Table 4. Sterilization Information | |
|---|---|
| ------------------------------------ | -- |
6
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).