(192 days)
The EARP Nerve Cuff Electrode is used to perform localized stimulation of neural tissue and to locate, identify, and monitor spinal nerve roots during surgery.
The EARP Nerve Cuff Electrode conducts electrical signal as a component of intraoperative neuromonitoring. The EARP Nerve Cuff Electrode is used with commercially available neuromonitoring systems and does not stimulate or record signal itself. The standard connectors at the proximal end of the EARP Nerve Cuff Electrode interface with the neuromonitoring equipment and the distal cuff contacts the target tissue. The EARP Nerve Cuff Electrode is provided sterile packaged and is for single use only.
The provided text describes the 510(k) summary for the EARP Nerve Cuff Electrode, a surgical nerve stimulator/locator. It does not pertain to an AI/ML medical device, but rather a physical medical device. Therefore, many of the requested elements for describing the acceptance criteria and study proving an AI/ML device's performance are not present in this document.
However, I can extract the information related to the acceptance criteria and the study that proves the physical device meets these criteria, based on the provided FDA 510(k) summary.
Here's an attempt to answer as much as possible given the limitations of the provided text, recognizing that it's for a traditional medical device, not an AI/ML one:
Acceptance Criteria and Device Performance for the EARP Nerve Cuff Electrode
Since this is a physical medical device submission, the "acceptance criteria" are based on non-clinical performance and biocompatibility testing, demonstrating the device's safety and effectiveness in its intended use, and its substantial equivalence to predicate devices. The "study" refers to the non-clinical testing performed.
1. A table of acceptance criteria and the reported device performance
The document lists "Summary of Non-Clinical Testing" which serves as the "study" proving the device meets the acceptance criteria. The acceptance criteria are implied by the "Conclusion" column (e.g., "no evidence of causing cell lysis or toxicity" for cytotoxicity), and the "Pass/Fail" column indicates whether the device met these criteria.
| Acceptance Criteria (Implied) | Reported Device Performance (Conclusion) | Pass/Fail |
|---|---|---|
| Biocompatibility Testing: | ||
| Cytotoxicity (ISO 10993-5): No evidence of cell lysis or toxicity | The test article extract showed no evidence of causing cell lysis or toxicity. The test article extract met the requirements of the test since the grade was less than a grade 2 (mild reactivity). | Pass |
| Sensitization (ISO 10993-10): No delayed dermal contact sensitization | The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a sensitizer in the guinea pig maximization test. | Pass |
| Irritation (ISO 10993-23): Acceptable difference in mean scores | The test article met the requirements of the test since the difference between each test article extract overall mean score and corresponding control extract overall mean score was 0.0 and 0.1 for the SC and SO test article extracts, respectively. | Pass |
| Acute Systemic Toxicity (ISO 10993-11): No mortality or systemic toxicity | There was no mortality or evidence of systemic toxicity from the extracts injected into mice. Each test article extract met the requirements of the study. | Pass |
| Material-Mediated Pyrogenicity (USP<151>, ISO 10993-11): Acceptable rise in rabbit temperatures | The total rise of rabbit temperatures during the 3 hour observation period was within acceptable USP requirements. The test article met the requirements for the absence of pyrogens. | Pass |
| Other Non-Clinical Testing: | ||
| Dimensional characteristics, materials, function, intended use | Evaluated to ensure it performed as intended and supported substantial equivalence to predicate devices. (Specific performance values not detailed, but implied as 'Pass' overall.) | Pass |
| Tensile and flexural testing (mechanical integrity, continuity, isolation, visual appearance) | Evaluated to ensure it performed as intended and supported substantial equivalence to predicate devices. (Specific performance values not detailed, but implied as 'Pass' overall.) | Pass |
| Electrical safety testing (high potential and electrical leakage per ISO 14708-1) | Evaluated to ensure it performed as intended and supported substantial equivalence to predicate devices. (Specific performance values not detailed, but implied as 'Pass' overall.) | Pass |
| Electrode lead wire performance per 21 CFR 898.12 (IEC 60601-1) | Evaluated to ensure it performed as intended and supported substantial equivalence to predicate devices. (Specific performance values not detailed, but implied as 'Pass' overall.) | Pass |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact sample sizes (e.g., number of units, animals, or test replicates) for each test. It mentions "mice" and "guinea pig" for specific biocompatibility tests, implying the use of animal models according to the ISO standards.
- Data Provenance: The provenance is through laboratory testing conducted on the device components or extracts. The document does not specify the country of origin where the tests were performed, nor whether the data involved retrospective or prospective collection of patient data, as this is laboratory testing of a physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not applicable to the type of device described. "Ground truth" established by experts is typically relevant for interpretative devices like AI/ML products where human experts provide labels or diagnoses for comparison. For a physical medical device like an electrode, the "ground truth" is established by adherence to recognized performance standards (e.g., ISO, IEC, USP) and validated laboratory test methodologies. The "experts" would be the qualified personnel performing and interpreting these specific laboratory tests.
4. Adjudication method for the test set
This concept is not applicable as there is no "adjudication" of human interpretations for this type of device. The results are based on objective measurements from standardized laboratory tests.
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
This concept is not applicable as this is not an AI/ML device, and no human reader study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable as this is not an AI/ML device and does not involve an algorithm. The device's "standalone" performance is assessed through its physical characteristics and electrical/biocompatibility safety in laboratory settings.
7. The type of ground truth used
The "ground truth" for this physical device is established by:
- Established Performance Standards: Adherence to ISO, IEC, and USP standards for biocompatibility, electrical safety, and mechanical integrity.
- Objective Measurements: Laboratory measurements of physical, chemical, and electrical properties compared against pre-defined specifications derived from these standards or engineering requirements.
8. The sample size for the training set
This concept is not applicable as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This concept is not applicable as this is not an AI/ML device that requires a training set.
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Nvision Biomedical Technologies, Inc. % Jeffrey Brittan Vice President of Product Realization Watershed Idea Foundry 1815 Aston Ave.. Suite 106 Carlsbad, California 92008
Re: K230853
Trade/Device Name: EARP Nerve Cuff Electrode Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: September 6, 2023 Received: September 7, 2023
Dear Jeffrey Brittan:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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.
Patrick Antkowiak -S
for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional
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Enclosure
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Indications for Use
510(k) Number (if known)
Device Name EARP Nerve Cuff Electrode
Indications for Use (Describe)
The EARP Nerve Cuff Electrode is used to perform localized stimulation of neural tissue and to locate, identify, and monitor spinal nerve roots during surgery.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
DATE PREPARED October 4, 2023
MANUFACTURER
Nvision Biomedical Technologies, Inc. 4590 Lockhill Selma San Antonio, TX 78249, USA Telephone: (210) 545-3713 Fax: (866) 764-1139 Official Contact: Diana Langham, Director of Regulatory and Corporate Compliance
REPRESENTATIVE/CONSULTANT
Jeffrey Brittan Vice President of Product Realization Watershed Idea Foundry Telephone: (714) 287-6780 Email: jeffbrittan(a)watershedideas.com
PROPRIETARY NAME OF SUBJECT DEVICE
EARP Nerve Cuff Electrode
COMMON NAME Nerve Stimulator
DEVICE CLASSIFICATION
Surgical nerve stimulator/locator (Classification Regulations: 21 CFR 874.1820, Product Codes: ETN, Class: II)
PREMARKET REVIEW Ear, Nose, & Throat
INDICATIONS FOR USE
The EARP Nerve Cuff Electrode is used to perform localized stimulation of neural tissue and to locate, identify, and monitor spinal nerve roots during surgery.
DEVICE DESCRIPTION
The EARP Nerve Cuff Electrode conducts electrical signal as a component of intraoperative neuromonitoring. The EARP Nerve Cuff Electrode is used with commercially available neuromonitoring systems and does not stimulate or record signal itself. The standard connectors at the proximal end of the EARP Nerve Cuff Electrode interface with the neuromonitoring equipment and the distal cuff contacts the target tissue. The EARP Nerve Cuff Electrode is provided sterile packaged and is for single use only.
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K230853 Page 2 of 3
PREDICATE DEVICE IDENTIFICATION
The subject EARP Nerve Cuff Electrode is substantially equivalent to the following predicates:
| 510(k) Number | Manufacturer & Predicate Device Name | Predicate |
|---|---|---|
| K103128 | Cadwell Lab Disposable Stimulator Probes | Primary |
| K944061 | Ad-Tech Medical Cueva Cranial Nerve Electrode | Additional |
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for nerve stimulators or electrodes. The EARP Nerve Cuff Electrode was evaluated to ensure that it performed as intended and supported substantial equivalence to the predicate devices. Testing and analysis included:
- Analysis of dimensional characteristics, materials, function, and intended use .
- Tensile and flexural testing (to verify mechanical integrity, continuity, isolation, and . visual appearance)
- Electrical safety testing (high potential and electrical leakage per ISO 14708-1)
- Electrode lead wire performance per 21 CFR 898.12 (IEC 60601-1)
- Biocompatibility testing including cytotoxicity, sensitization, irritation/intracutaneous . reactivity, acute systemic toxicity, and material-mediated pyrogenicity:
| Endpoint | Test Description | Conclusion | Pass/Fail |
|---|---|---|---|
| Cytotoxicity(ISO 10993-5) | Elution Method(1X MEM extraction vehicle) | The test article extract showed no evidence ofcausing cell lysis or toxicity. The test articleextract met the requirements of the test since thegrade was less than a grade 2 (mild reactivity). | Pass |
| Sensitization(ISO 10993-10) | Maximization Sensitization Study(Polar and non-polar extractionvehicles) | The test article extracts showed no evidence ofcausing delayed dermal contact sensitization inthe guinea pig. The test article was notconsidered a sensitizer in the guinea pigmaximization test. | Pass |
| Irritation(ISO 10993-23) | Intracutaneous Study(Polar and non-polar extractionvehicles) | The test article met the requirements of the testsince the difference between each test articleextract overall mean score and correspondingcontrol extract overall mean score was 0.0 and0.1 for the SC and SO test article extracts,respectively. | Pass |
| Acute SystemicToxicity(ISO 10993-11) | Systemic Toxicity Study(Polar and non-polar extractionvehicles) | There was no mortality or evidence of systemictoxicity from the extracts injected into mice.Each test article extract met the requirements ofthe study. | Pass |
| Material-MediatedPyrogenicity(USP<151>,ISO 10993-11) | Pyrogen Study - Material Mediated(Sterile non-pyrogenic salineextraction vehicle) | The total rise of rabbit temperatures during the 3hour observation period was within acceptableUSP requirements. The test article met therequirements for the absence of pyrogens. | Pass |
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Subject Device | Predicate Devices | ||
|---|---|---|---|
| EARP Nerve Cuff Electrode | Cadwell Lab | Ad-Tech Medical | |
| Disposable Stimulator Probes | Cueva Cranial Nerve Electrode | ||
| Indicationsfor Use | The EARP Nerve Cuff Electrode isused to perform localized stimulationof neural tissue and to locate,identify, and monitor spinal nerveroots during surgery. | Cadwell Disposable Stimulator Probeis used to perform localizedstimulation of neural tissue and tolocate, identify and monitor cranialmotor nerves, peripheral nerves andspinal nerve roots during surgery. | The Cueva Cranial Nerve Electrode isintended for use to monitor cranialnerves during skull base typesurgeries. |
| Principle ofOperation | Conducts signal betweenneuromonitoring equipment andnerve (interfaces w/ commerciallyavailable neuromonitoring systems) | Conducts signal betweenneuromonitoring equipment andnerve (interfaces w/ commerciallyavailable neuromonitoring systems) | Conducts signal betweenneuromonitoring equipment andnerve (interfaces w/ commerciallyavailable neuromonitoring systems) |
| Product Codes/Reg# | ETN (21 CFR 874.1820)Stimulator, Nerve | ETN (21 CFR 874.1820)Stimulator, Nerve | GZL (21 CFR 882.1330)Electrode, Depth |
| Duration of Use | Intraoperative(Single use) | Intraoperative(Single use) | Intraoperative(Single use) |
| Implanted | No(Removed after use) | No(Removed after use) | No(Removed after use) |
| TissueEngagement | Direct nerve contact(C-shaped cuff) | Direct nerve contact(Forked tip) | Direct nerve contact(C-shaped cuff) |
| Tip ContactExposure | 2mm(Strip) | 2mm(Balls) | ~2mm(Strip) |
| Electrode ExposedSurface Area | $15.4 - 42.6mm^2$ | $~25.1 - 33.2mm^2$ | $~10.4 - 14.5mm^2$ |
| Bipolar orMonopolar? | Bipolar | Bipolar and monopolar versions | Monopolar |
| Electrode ContactMaterial | Conductive metal(Platinum) | Conductive metal(Stainless Steel) | Conductive metal(Platinum) |
| ElectrodeInsulation | Polymer(Polyimide) | Polymer(PTFE) | Polymer |
| Cuff Material | Polymer(Silicone) | N/A | Polymer(Silicone) |
| LeadLength | 1.8m | 2.0m | 1.8m |
| Lead WireMaterial | Conductive metal(Stainless steel) | Conductive metal(Tin plated copper) | Conductive metal |
| Lead WireInsulation | Polymer(FEP) | Polymer(PVC) | Polymer |
| Connector Style | 1.5mm safety socket | 1.5mm safety socket | 1.5mm safety socket |
| Applicator ToolLength | 260mm | 190 to 330mm (handle & shaft) | 250mm |
| Provided Sterile? | Yes | Yes | Yes |
CONCLUSION
Based on testing and analysis of device characteristics, it can be concluded that the subject device does not raise new issues of safety compared to the predicate devices. The equivalent indications for use, technological characteristics, and performance characteristics for the EARP Nerve Cuff Electrode are assessed to be substantially equivalent to the predicate devices.
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.