(102 days)
NerveTape is indicated for the repair of peripheral nerve discontinuities where can be achieved by flexion of the extremity.
The proposed BioCircuit Technologies, Inc. NerveTape device is composed of a bioabsorbable, extracellular collagen matrix (small intestinal submucosa, SIS) with integrated microhooks made of a nickel-titanium alloy, commonly referred to as NiTiNOL (identical to the predicate), for mechanical fixation and apposition of nerve ends. The NerveTape is implanted around an injured nerve to provide a scaffold which becomes infiltrated and remodeled by the patient's cells. The device protects the damaged or severed nerve while the nerve heals.
The device is packaged and supplied sterile in a clamshell container inside a sealed pouch. The device is identical to the predicate, except for the SIS substrate manufacturer and the addition of a smaller size. The dimensions of the finished device range from 11mm x 12mm x 22mm. The device is intended for the repair of nerves of diameters ranging from 1.5mm to 7mm.
Here is an analysis of the provided text regarding the NerveTape device, focusing on acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Verification: Ease of Use (Simulated Use in Cadaver) | Product possesses acceptable characteristics for handling, trimming, and implantation. | The handling characteristics of the subject device are substantially equivalent or superior to the predicate device based on acceptability to the end-user. All samples met acceptance criteria. |
| Performance Verification: 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 ultimate tensile strength of the proposed device nerve repairs is substantially equivalent or superior to the predicate device. All samples met acceptance criteria. |
| Specification Compliance | Compliance with go/no-go dimensional and visual inspection criteria for all components and assemblies. | All samples met acceptance criteria. |
| Biocompatibility: Cytotoxicity (ANSI/AAMI/ISO 10993-5) | Test article extract's cytotoxic potential assessed by change in morphology of cell line. | The proposed device met the requirements of the test. (and for SIS material: met the requirements of the test, and cell viability/cytotoxic potential determined by XTT dye method met requirements) |
| Biocompatibility: Irritation (ANSI/AAMI/ISO 10993-23) | Potential for the proposed device/SIS material to produce irritation from intradermal injections. | The proposed device met the requirements of the test. (and for SIS material: met the requirements of the test and is a non-irritant) |
| Biocompatibility: Skin Sensitization (ANSI/AAMI/ISO 10993-10) | Potential for the proposed device/SIS material to invoke a dermal skin sensitization reaction in guinea pigs. | The proposed device met the requirements of the test. (and for SIS material: met the requirements of the test and is not considered to be a contact skin sensitizer) |
| Biocompatibility: Systemic Toxicity (Acute) (ANSI/AAMI/ISO 10993-11) | Potential for the proposed device/SIS material to produce acute systemic toxicity from a single dose administered by IV and IP injection. | The proposed device met the requirements of the test. (and for SIS material: met the requirements of the test) |
| Biocompatibility: Sterilization Residuals (ANSI/AAMI/ISO 10993-7) | Reported values of sterilant gas residue compared against the ISO standard for acceptable limits for permanent implants. | The proposed device met the requirements of the test. |
| Biocompatibility: Bacterial Endotoxins Test (BET) (ANSI/AAMI ST72, USP , etc.) | Acceptable detected endotoxins must not exceed the maximum allowable limit for permanent implants. | The proposed device met the requirements of the test. |
| Biocompatibility: Systemic Toxicity (Subacute/Subchronic) (for SIS material only) (ANSI/AAMI/ISO 10993-11) | Potential for the SIS material to produce systemic toxicity from repeated exposure via dual route in rats over at least 14 days. | There is no potential toxicity of the SIS material from repeated exposure based on toxicological endpoints evaluated. |
| Biocompatibility: Pyrogenic Response (for SIS material only) (ANSI/AAMI/ISO 10993-11) | Potential for the SIS material to produce a pyrogenic response due to intravenous exposure (no increases in temperature of 0.5℃ or more). | The SIS material met the requirements of the test. |
| Biocompatibility: Genotoxicity (In Vitro Micronucleus Test) (for SIS material only) (ANSI/AAMI/ISO 10993-3) | Potential for extract of SIS material to induce micronuclei or hypodiploidy in cultured CHO cells. | The SIS material extract did not induce micronuclei or hypodiploidy and met the requirements of the test. |
| Biocompatibility: Genotoxicity (Bacterial Mutagenicity Test - Ames Assay) (for SIS material only) (ANSI/AAMI/ISO 10993-3) | Potential for extract of SIS material to induce gene mutations in bacteria. | The SIS material extract did not elicit evidence of bacterial mutagenicity and met the requirements of the test. |
| Biocompatibility: Local Effects After Implantation (Acute Intramuscular, 4 weeks) (for SIS material only) (ANSI/AAMI/ISO 10993-6) | Histological evaluation to determine if SIS material is well tolerated compared to control. | The SIS material was well tolerated in comparison to the control article and met the requirements of the test. |
| Biocompatibility: Local Effects After Implantation (Chronic Intramuscular, 16 weeks) (for SIS material only) (ANSI/AAMI/ISO 10993-6) | Histological evaluation to determine if SIS material is well tolerated compared to control. | The SIS material was well tolerated in comparison to the control article and met the requirements of the test. |
| Histological Comparison (SIS material only) | Absence of nuclei and cytoplasmic material, integrity of collagen network, and level of α-gal antigen in decellularized tissue compared to native tissue. | The decellularization process removed microscopic evidence of intact cells and nuclei, and preserved the collagen network. |
| Sterilization Validation | Conformance with ISO 11135:2014 and AAMI TIR28:2016 for Ethylene Oxide sterilization. | Pass |
| Animal Study (Tibial Nerve Implantation) | Proposed device meets all acceptance criteria and is substantially equivalent or superior to the predicate device. | The proposed device met all acceptance criteria and was substantially equivalent or superior to the predicate device. |
2. Sample Size Used for the Test Set and the Data Provenance
- Performance Verification (Ease of Use, Monotonic Tensile Strength): The text states "All samples met acceptance criteria," implying a sample size was used for these tests, but the exact number of samples is not specified.
- Biocompatibility Testing:
- Device Biocompatibility (largest size, sterile product): "all testing performed on sterile product of largest size" – implies at least one sample of the largest size was used for each test. Specific sample numbers (e.g., number of mice, rabbits, cell samples) are mentioned within the individual test summaries (e.g., "rabbits" for irritation, "guinea pigs" for sensitization, "mice" for systemic toxicity) but not a precise cumulative number.
- Decellularized Porcine Small Intestine Submucosa (SIS) Biocompatibility (raw material): "all testing performed on non-sterile, decellularized porcine small intestine raw material - SIS" – similar to device testing, specific animal counts are mentioned for relevant tests.
- Animal Studies: "a statistically valid number of rabbits" underwent implantation. The exact number of rabbits is not specified beyond being "statistically valid."
- Data Provenance: The studies are non-clinical (laboratory/animal studies). The biological components (porcine SIS) originate from pigs. The testing appears to be conducted in a controlled lab setting, not specified by country, but implies in-house or contracted lab testing for regulatory submission. All studies are prospective tests conducted on the device/material.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
There is no information provided regarding experts establishing "ground truth" in the traditional sense for these non-clinical, performance, and biocompatibility tests. The "ground truth" for these tests is based on established scientific standards (e.g., ISO, AAMI, USP protocols) and objective measurements or observations (e.g., cell morphology, tensile strength, histological evaluation, chemical quantification). For the "Ease of Use" test, "acceptability to the end-user" implies evaluation by surgeons, but the number and qualifications of these surgeons are not specified.
4. Adjudication Method for the Test Set
Not applicable for these types of non-clinical tests. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or image interpretation studies where expert consensus is needed to resolve discrepancies in subjective assessments. Here, the results are based on objective measurements against predefined criteria/standards.
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
Not applicable. This device is a physical medical device (nerve cuff), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The Type of Ground Truth Used
The ground truth for most tests is based on:
- Established scientific standards and normative values: e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization, literature for standard suture repair strength.
- Objective measurements and observations: e.g., cell morphology, concentration of residuals, temperature changes, histological findings, tensile strength measurements, dimensional/visual inspection.
- Comparison to a predicate device: For performance tests, the proposed device's performance is compared directly against the predicate device to demonstrate substantial equivalence or superiority.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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).