PAIRED HYDROGEL ELECTRODE

K110138 · Neurovision Medical Products, Inc. · ETN · Apr 8, 2011 · Ear, Nose, Throat

Device Facts

• Record ID: K110138
• Device Name: PAIRED HYDROGEL ELECTRODE
• Applicant: Neurovision Medical Products, Inc.
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Apr 8, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Indications for Use

The Paired Hydrogel Electrode is used for evoked electrophysiological monitoring in soft tissue surgeries were motor nerves are at risk.

Device Story

The Paired Hydrogel Electrode is a surface electrode designed for EMG monitoring during surgery. It consists of two 'Comfort Gel A' discs conjoined at a single DIN plug, effectively shorting the electrodes to provide a single pole of electrophysiological monitoring. This configuration allows for coverage of surface areas too wide for a single electrode. The device is used in clinical surgical settings, operated by healthcare professionals, and connects to standard EMG monitoring units. By facilitating the detection of motor nerve activity, the electrode assists surgeons in identifying and avoiding nerves at risk during soft tissue procedures, potentially reducing the risk of nerve damage.

Clinical Evidence

Bench testing only. Performance testing demonstrated equivalence in electrode adhesion, impedance, and electrophysiological properties compared to the predicate singlet electrode. Biocompatibility testing was conducted per ISO 10993 (Irritation) and the Agarose Overlay Method (Cytotoxicity). Shelf-life testing was performed according to ANSI/AAMI EC12:2000, demonstrating a 3-year shelf life.

Technological Characteristics

Surface electrode consisting of two 'Comfort Gel A' discs conjoined at a single DIN plug. Non-sterile. 3-year shelf life. Compatible with standard EMG units. Biocompatible materials tested for sensitization, cytotoxicity, and irritation.

Indications for Use

Indicated for patients undergoing soft tissue surgeries where motor nerves are at risk, requiring evoked electrophysiological monitoring.

Regulatory Classification

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.

Predicate Devices

• Neonatal ECG Electrode (K092744)
• 3M Pediatric 'Red Dot' hydrogel electrode
• RLN Systems Nerve Locator/Monitor; Model A (K902080)
• Neurovision (SE: Surface Electrode) Nerve Locator/Monitor (K954601)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Neurovision Medical. The word "neurovision" is in large, bold, black letters. Below the word is a black line with a heartbeat symbol in the middle, followed by the word "MEDICAL" in smaller, black letters.

Special 510k - Paired Hydrogel Electrode APR - 8 2011

K110138

### 5. 510K Summarv

In accordance with Title 21 of the Code of Federal Regulations, Part 807 and in particular 21 CFR 8807.92, the following summary of information is provided:

#### Applicant Information

Christine Vergely Regulatory Affairs Manager Neurovision Medical Products, Inc. 2225 Sperry Ave., Suite 1000 Ventura, CA 93003 PH 805-866-6999 Fax: [phone] [e-mail]

#### Date of Summary:

#### Device Identification:

Trade or Proprietary Name: Paired Hydrogel Electrode (final name TBD) Common or Usual Name: Hydrogel Surface Electrode Classification Name: Surgical nerve stimulator/locator Device Class: Class II Classification: 8874.1820 ETN Product Code:

#### Predicate Devices

- The Paired Hydrogel Electrodes are substantially equivalent to the following predicate devices currently distributed commercially in the U.S .:
- . M203KEN; Neonatal ECG Electrode (K092744), referred to in this document as the Singlet Hydrogel (K092744)
- 3M Pediatric "Red Dot" hydrogel electrode accessory RLN Systems Nerve Locator/Monitor; . Model A (K902080), superseded by,
- . Neurovision (SE: Surface Electrode) Nerve Locator/Monitor (K954601)

#### Device Description

The Paired Hydrogel Electrodes are a modification of the M203KEN electrode currently distributed as the Singlet and Triplet Hydrogel Electrodes by Neurovision Medical Products. The Paired Hydrogel Electrode is created by attaching two Singlet M203KEN electrodes by their lead wires to the same DIN plug (shorting the electrodes). The Paired version is designed to provide a single pole of electrophysiological monitoring across a surface too wide to be covered by a single electrode.

#### Indication for Use

The Paired Hydroget Electrode is used for evoked electrophysiological monitoring in soft tissue surgeries were motor nerves are at risk.

#### Technological Characteristics of Device in Relation to Predicate Devices

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Image /page/1/Picture/0 description: The image shows the logo for Neurovision Medical. The word "neurovision" is in large, bold, black letters. Below the word "neurovision" are two horizontal lines with a heartbeat symbol in between them, followed by the word "MEDICAL" in smaller, black letters.

# Special 510k – Paired Hydrogel Electrode

| 510(k) number | Subject Device<br>K042744 | K954601 | K092744 | K902080 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Brand Name | PAIRED HYDROGEL<br>ELECTRODE | NERVE<br>LOCATOR/MONITOR<br>SYSTEM,<br>MODIFICATION | NEONATAL ECG<br>ELECTRODES | RED DOT 2269<br>INFANT<br>MONITORING<br>ELECTRODE |
| Description | Surface Electrode for<br>EMG Monitoring | Neurovision SE (surface<br>electrode) Nerve/Locator<br>Monitor | Neonatal ECG Electrode,<br>M203KEN | Neonatal ECG<br>Monitoring Electrode |
| Indications for<br>Use | The Paired Hydrogel<br>Electrode is used for<br>evoked<br>electrophysiological<br>monitoring in soft<br>tissue surgeries were<br>motor nerves are at<br>risk. | The Neurovision SE is an<br>electronic device consisting<br>of a surgical nerve<br>stimulator and an evoked<br>EMG monitor with<br>integrated detecting or<br>warning capability. This<br>device is intended for use in<br>surgical procedures where<br>motor nerves are at risk to<br>assist the surgeon in<br>locating these nerves. | Neonatal ECG Electrodes are<br>intended for use in pediatric or<br>neonatal electrocardiographic<br>procedures where resting<br>ECG<br>monitoring is deemed<br>necessary and is ordered by a<br>physician.<br>Such procedures include, in<br>particular, patient ECG<br>surveillance and ECG<br>diagnosis recording. The<br>Neonatal ECG Electrodes are<br>applied to the surface of the<br>body, single use only, and<br>disposable.<br>Neonatal ECU electrodes<br>should be changed every 24<br>hours. | Neonatal ECG<br>Monitoring |
| Product Code | ETN | ETN | DRX | DRX |
| Materials and<br>Design | 2 Comfort Gel A discs<br>conjoined at DIN plug | Uses FDA approved surface<br>electrodes | 1 Comfort Gel A disc<br>terminated at DIN plug. | FDA approved pediatric<br>ECG/EMG/EKG<br>hydrogel electrode |
| Bio-<br>compatibility | Tested free of<br>Sensitization,<br>Cytotoxicity and<br>Irriation | Per approved electrodes | Tested free of Sensitization,<br>Cytotoxicity and Irriation | FDA approved |
| Compatible<br>devices | EMG units | EMG units | EMG units | ECG, EKG, EMG units |
| Shelf-Life | 3 years | N/A | 3 years | N/A |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Attachment to<br>Stimulator | DIN connector | DIN connector | DIN connector | Snap lead wire |

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Image /page/2/Picture/0 description: The image shows the logo for Neurovision Medical. The word "neurovision" is in large, bold, black letters. Below the word "neurovision" are two horizontal lines with a small waveform between them, followed by the word "MEDICAL" in smaller, bold, black letters.

# Special 510k - Paired Hydrogel Electrode

#### Performance Testing

Performance testing of the electrode adhesion, impedance, and electrophysiological properties demonstrated equivalence between the paired hydrogel electrode and the predicate singlet.

Animal testing demonstrated the Biocompatibility of the materials and was conducted according to ISO 10993: Biological Evaluation of Medical Devices, Part 10: Tests for Irritation. Cytoxicity testing was according to the Agarose Overlay Method.

Shelf life testing was according to ANSI/AAMI EC12:2000 : Disposable ECG Electrodes and demonstrated a 3 vear shelf life.

(End of 510(k) Summary)

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged along the perimeter of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Neurovision Medical Products, Inc. c/o Ms. Christine Vergély Regulatory Affairs Manager 2225 Sperry Ave., Suite 1000 Ventura, CA 93003

Re: K110138

Trade/Device Name: Paired Hydrogel Electrode Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: March 14, 2011 Received: March 16, 2011

APR - 8 2011

Dear Ms. Vergély:

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. 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.

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Page 2 - Ms. Christine Vergély

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Ruhlin mf

Malvina B. Eydelman, M Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the logo for Neurovision Medical. The word "neurovision" is in large, bold, black letters. Below the word "neurovision" are two horizontal lines with a small EKG waveform between them, followed by the word "MEDICAL" in smaller, bold, black letters.

Special 510k - Paired Hydrogel Electrode

# Indications for Use

# 4. Indications for Use:

Device Name: Paired Hydrogel Electrode

The Paired Hydrogel Electrode is used for evoked electrophysiological monitoring in soft tissue surgeries were motor nerves are at risk.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Model Hyman

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) (Division of Ophthalmic, Neurological and Ear,

Nose and Throat Devices

510(k) Number K110138