(192 days)
Not Found
No
The summary describes a passive electrode component used with existing neuromonitoring systems and explicitly states it does not stimulate or record signals itself. There is no mention of AI/ML in the device description, intended use, or performance studies.
No
The device is used to perform localized stimulation of neural tissue and to locate, identify, and monitor spinal nerve roots during surgery, which falls under diagnostic and monitoring purposes rather than therapeutic treatment. It is a component of intraoperative neuromonitoring and does not stimulate or record signal itself.
No
Explanation: The device is described as an electrode for stimulating and monitoring neural tissue as part of intraoperative neuromonitoring, but it explicitly states the device "does not stimulate or record signal itself." It functions as a component of other neuromonitoring systems. Therefore, it does not independently perform diagnostic functions.
No
The device description clearly states it is a physical electrode (EARP Nerve Cuff Electrode) that conducts electrical signals and interfaces with neuromonitoring equipment. It is provided sterile and for single use, indicating a physical component. The performance studies also focus on physical and electrical characteristics, not software validation.
Based on the provided information, the EARP Nerve Cuff Electrode is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of the EARP Nerve Cuff Electrode is to directly stimulate and monitor neural tissue and spinal nerve roots during surgery. It interacts directly with the patient's body, not with a sample taken from the body.
- The device description confirms direct interaction with tissue. It states the "distal cuff contacts the target tissue."
- The performance studies focus on device integrity and biocompatibility. This is typical for devices that interact directly with the body, not for IVDs which would focus on analytical performance with biological samples.
Therefore, the EARP Nerve Cuff Electrode is a medical device used for intraoperative neuromonitoring, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
ETN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Neural tissue, spinal nerve roots, cranial motor nerves, peripheral nerves.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intraoperative / Surgical setting
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)
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.
Key results from biocompatibility testing:
- Cytotoxicity (ISO 10993-5): 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): 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): 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): 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, ISO 10993-11): 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.
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
§ 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.
0
Image /page/0/Picture/0 description: The image shows the date October 6, 2023. The text is written in a clear, sans-serif font. The date is likely part of a document or calendar entry. The text is horizontally aligned and centered.
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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"
1
(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
2
Enclosure
3
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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4
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.
5
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 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) | Maximization Sensitization Study | ||
| (Polar and non-polar extraction | |||
| vehicles) | 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) | Intracutaneous Study | ||
| (Polar and non-polar extraction | |||
| vehicles) | 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) | Systemic Toxicity Study | ||
| (Polar and non-polar extraction | |||
| vehicles) | 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, | |||
| ISO 10993-11) | Pyrogen Study - Material Mediated | ||
| (Sterile non-pyrogenic saline | |||
| extraction vehicle) | 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 |
6
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 | ||
| 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. | Cadwell Disposable Stimulator Probe | ||
| is used to perform localized | |||
| stimulation of neural tissue and to | |||
| locate, identify and monitor cranial | |||
| motor nerves, peripheral nerves and | |||
| spinal nerve roots during surgery. | The Cueva Cranial Nerve Electrode is | ||
| intended for use to monitor cranial | |||
| nerves during skull base type | |||
| surgeries. | |||
| Principle of | |||
| Operation | Conducts signal between | ||
| neuromonitoring equipment and | |||
| nerve (interfaces w/ commercially | |||
| available neuromonitoring systems) | Conducts signal between | ||
| neuromonitoring equipment and | |||
| nerve (interfaces w/ commercially | |||
| available neuromonitoring systems) | Conducts signal between | ||
| neuromonitoring equipment and | |||
| nerve (interfaces w/ commercially | |||
| available 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) | |||
| Tissue | |||
| Engagement | Direct nerve contact | ||
| (C-shaped cuff) | Direct nerve contact | ||
| (Forked tip) | Direct nerve contact | ||
| (C-shaped cuff) | |||
| Tip Contact | |||
| Exposure | 2mm | ||
| (Strip) | 2mm | ||
| (Balls) | ~2mm | ||
| (Strip) | |||
| Electrode Exposed | |||
| Surface Area | $15.4 - 42.6mm^2$ | $~25.1 - 33.2mm^2$ | $~10.4 - 14.5mm^2$ |
| Bipolar or | |||
| Monopolar? | Bipolar | Bipolar and monopolar versions | Monopolar |
| Electrode Contact | |||
| Material | Conductive metal | ||
| (Platinum) | Conductive metal | ||
| (Stainless Steel) | Conductive metal | ||
| (Platinum) | |||
| Electrode | |||
| Insulation | Polymer | ||
| (Polyimide) | Polymer | ||
| (PTFE) | Polymer | ||
| Cuff Material | Polymer | ||
| (Silicone) | N/A | Polymer | |
| (Silicone) | |||
| Lead | |||
| Length | 1.8m | 2.0m | 1.8m |
| Lead Wire | |||
| Material | Conductive metal | ||
| (Stainless steel) | Conductive metal | ||
| (Tin plated copper) | Conductive metal | ||
| Lead Wire | |||
| Insulation | Polymer | ||
| (FEP) | Polymer | ||
| (PVC) | Polymer | ||
| Connector Style | 1.5mm safety socket | 1.5mm safety socket | 1.5mm safety socket |
| Applicator Tool | |||
| Length | 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.