Disposable Snap Electrode

K172703 · Embla Systems · GXY · Nov 13, 2017 · Neurology

Device Facts

• Record ID: K172703
• Device Name: Disposable Snap Electrode
• Applicant: Embla Systems
• Product Code: GXY · Neurology
• Decision Date: Nov 13, 2017
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Intended Use

The Disposable Snap Electrodes are intended to be used with compatible 1.5mm touchproof button snap cables for transferring surface biopotential signals to use during sleep studies, EEG, EMG, and recording evoked potential signals from a cutaneous location. For use on Adults.

Device Story

Disposable Snap Electrode; cutaneous surface electrode; 4mm snap contact; connects to 1.5mm touchproof button snap cables. Transfers biopotential signals from patient skin to external monitoring equipment. Used in hospitals, clinics, and home settings; applied by medical professionals. Facilitates sleep studies, EEG, EMG, and evoked potential recording. Benefits patient by enabling non-invasive physiological signal acquisition for diagnostic monitoring.

Clinical Evidence

Bench testing only. Evaluations confirmed compliance with performance requirements: AC impedance, DC offset, combined offset instability, bias current, adhesion (minimum 10 hours), and lead wire compatibility. Biocompatibility testing (cytotoxicity, sensitization, primary irritation) performed per ANSI/AAMI/ISO 10993-1:2009/(R)2013.

Technological Characteristics

Cutaneous electrode; 1.9-inch diameter; Ag/AgCl contact material; solid hydrogel conductive media; adhesive backing. Supplied non-sterile. Compatible with 1.5mm touchproof button snap cables. Shelf life 18 months. Biocompatibility per ANSI/AAMI/ISO 10993-1.

Indications for Use

Indicated for adult patients requiring surface biopotential signal transfer for sleep studies, EEG, EMG, and evoked potential recording from cutaneous locations.

Regulatory Classification

Identification

A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

Predicate Devices

• Disposable Pre-gelled Surface Electrode (K142159)
• Multipurpose Neuroplus Electrode (K021537)

Submission Summary (Full Text)

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November 13, 2017

Embla Systems Sanjay Mehta Senior Manager, Quality Assurance & Regulatory Affairs 1 Hines Road. Suite 202 Kanata, ON, CA, K2K 3C7

Re: K172703

Trade/Device Name: Disposable Snap Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: August 31, 2017 Received: September 7, 2017

Dear Sanjay Mehta:

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.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Michael J. Hoffmann -S

for Carlos L. Peña. PhD. MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K172703

Device Name Disposable Snap Electrode

Indications for Use (Describe)

The Disposable Snap Electrodes are intended to be used with compatible 1.5mm touchproof button snap cables for transferring surface biopotential signals to use during sleep studies, EEG, EMC, and recording evoked potential signals from a cutaneous location. For use on Adults.

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-----------------------------------------------------------------------------------------|
| <span style="font-family: Arial;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/1 description: The image contains the logo for Natus Neurology. The word "natus" is written in a teal sans-serif font, with a registered trademark symbol next to it. Below "natus" is the word "neurology" in a smaller, black, italicized sans-serif font.

## 510(k) Summary

This summary is provided to support the 510(k) pre-market notification for the Disposable Snap Electrode.

| Company Name: | Embla Systems<br>1 Hines Road, Suite 202<br>Kanata, ON, CA, K2K 3C7 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Mr. Sanjay Mehta<br>Senior Manager, Quality Assurance & Regulatory Affairs<br>Phone: [phone]<br>Email: [e-mail] |
| Date Summary Prepared: | November 3, 2017 |
| Trade Name: | Disposable Snap Electrode |
| Common Name: | Cutaneous Electrode |
| Classification Name: | 21 CFR 882.1320 Cutaneous Electrode<br>Product Code: GXY |
| Predicate Devices: | K142159 Disposable Pre-gelled Surface Electrode<br>Rochester Electro-Medical, Inc.<br>K021537 Multipurpose Neuroplus Electrode<br>Vermont Medical, Inc. |

## Product Description

The Disposable Snap Electrode is a cutaneous applied electrode supporting interface of biopotential signals to user equipment. The Snap Electrode has a 4 mm snap contact that can connect with commercially available snap electrode lead wires.

## Intended Use of the Device

The Disposable Snap Electrodes are intended to be used with compatible 1.5mm touchproof button snap cables for transferring surface biopotential signals to use during sleep studies, EEG, EMG, and recording evoked potential signals from a cutaneous location. For use on Adults.

#### Summary of Technological Characteristics

The following table provides a side-by-side comparison of the Disposable Snap Electrode to the predicate devices applied to support this pre-market notification.

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| Table 1: Substantial Equivalence Technical Characteristics | | | |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Disposable Snap Electrodes<br>Under Review | Vermont Med., Inc.<br>Multipurpose Neuroplus<br>Electrode,<br>(Predicate K021537) | Rochester Electro-Medical,<br>Inc.<br>Disposable Pre-gelled Surface<br>Electrode<br>(Predicate K142159) |
| Intended<br>Use | A cutaneous electrode applied<br>directly to a patient's skin either to<br>record physiological signals. | A cutaneous electrode applied<br>directly to a patient's skin either to<br>record physiological signals. | A cutaneous electrode applied<br>directly to a patient's skin either to<br>record physiological signals and/or<br>to apply electrical stimulation. |
| Indications<br>for Use | The Disposable Snap Electrodes<br>are intended to be used with<br>compatible 1.5mm touch proof<br>button snap cables for transferring<br>surface biopotential signals to use<br>during sleep studies, EEG, EMG,<br>and recording evoked potential<br>signals from a cutaneous location.<br>For use on Adults. | The Vermed A10005 electrode is<br>designed to measure muscle<br>activity from the surface of the<br>skin. The A10005 can be used for<br>Sleep Studies, surface EMG, NCS<br>and EP. The A10005 electrode is<br>provided in a NON-STERILE<br>format only, and should be used on<br>the surface of the skin. | The Disposable Pre-gelled Surface<br>Electrodes are intended for<br>recording/stimulation and<br>monitoring of Electromyography<br>(EMG), Electroencephalograph<br>(EEG) and Evoked Potential (EP)<br>signals. |
| Environment<br>of Use | Hospitals, clinics and home. | Hospitals, clinics and home. | Hospitals, clinics and home. |
| Single<br>patient use,<br>disposable | Yes | Yes | Yes |
| Duration of<br>use | Duration of a sleep study,<br>anticipated to be up to 10 hours | Duration of clinical uses,<br>anticipated to be ≤ 24 hours. | Duration of clinical uses,<br>anticipated to be ≤ 24 hours. |
| Patient<br>applied<br>location | Cutaneous | Cutaneous | Cutaneous |
| Overall<br>diameter | 1.9 inches | 0.875 to 1.375 inches | Unknown |
| Pre-gelled<br>electrode<br>conductive<br>media | Yes | Yes | Yes |
| Electrode<br>contact<br>material | Silver, Silver Chloride (Ag/AgCl) | Ag/AgCl | Ag/AgCl |
| Patient<br>contact<br>material | Adhesive<br>Electrode conductive media | Adhesive<br>Electrode conductive media | Adhesive<br>Electrode conductive media |
| Sterility | Supplied non-sterile | Supplied non-sterile | Supplied non-sterile |
| Pre-attached<br>lead wires | No | No | Yes |
| Snap lead<br>wire<br>compatible | Yes | Yes | Not applicable, pre-wired lead wire |
| Table 1: Substantial Equivalence Technical Characteristics | | | |
| Feature | Disposable Snap Electrodes<br>Under Review | Vermont Med., Inc.<br>Multipurpose Neuroplus<br>Electrode,<br>(Predicate K021537) | Rochester Electro-Medical, Inc.<br>Disposable Pre-gelled Surface<br>Electrode<br>(Predicate K142159) |
| Shelf Life | 18 months | 18 months | Unknown |
| Connection<br>to user's<br>equipment | Yes | Yes | Yes |

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Image /page/5/Picture/0 description: The image contains the logo for "natus neurology". The word "natus" is in a large, teal, sans-serif font. Below it, the word "neurology" is in a smaller, black, italicized, sans-serif font. The logo is simple and modern.

As indicated in Table 1, the Disposable Snap Electrode under review is substantially equivalent to the predicate devices. The electrode under review has a larger overall diameter than the predicate device. Cutaneous electrodes are selected and applied by medical professionals. The medical professional applies the electrode to a cutaneous location that can accommodate this diameter.

#### Performance Tests to Demonstrate Substantial Equivalencv

To establish the technical equivalency of the Disposable Snap Electrode, evaluations were conducted to confirm compliance with performance requirements, including:

| Test | Summary of Requirement | Result |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------|
| Performance<br>requirements | Essential performance for: AC Impedance, DC offset, Combined<br>offset instability, Combined offset instability test and Bias current | Pass |
| Adhesion | Retains adhesion to cutaneous location for minimum of 10 hours. | Pass |
| Dimensions | 1.9 inches +/- 10% | Pass |
| Lead wire compatibility | Compatible with snap electrode lead wires. | Pass |

## Standards Applied

In compliance with ANSI/AAMI/ISO 10993-1: 2009/(R)2013, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, the biocompatibility evaluations of the skin contacting Solid Hydrogel and adhesive materials of the Disposable Snap Electrode were performed by the suppliers. The following biocompatibility evaluation reports for the Solid Hydrogel were provided by the supplier:

- · Cytotoxicity,
- · Sensitization, and
- · Irritation by Primary Skin Irritation Test.

The skin contact tape adhesive supplier provided a summary of the biocompatibility test results for the adhesive. The adhesive supplier indicates the following biocompatibility tests were performed:

- · Cytotoxicity,
- · Sensitization, and
- · Primary Irritation.

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Image /page/6/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in a teal, sans-serif font, with the "n" slightly larger than the other letters. Below "natus" is the word "neurology" in a smaller, black, italicized, sans-serif font. The logo is simple and modern, and the colors are eye-catching.

# Conclusion

The Disposable Snap Electrode meets performance requirements. The intended use and technology of the Disposable Snap Electrode are the same as the predicate devices. The Disposable Snap Electrode is substantially equivalent to the predicate devices.