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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Disposable Snap Electrode." This notification focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving a new device's efficacy through extensive clinical studies involving AI. Therefore, much of the requested information regarding AI-specific studies, MRMC studies, ground truth establishment for training data, and expert adjudication cannot be directly extracted from this document.

However, I can extract the acceptance criteria and performance data for the device itself (the electrode), as well as details about the testing methodology for its substantial equivalence.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Summary of Requirement)	Reported Device Performance
Performance requirements	Essential performance for: AC Impedance, DC offset, Combined 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

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the performance tests (e.g., how many electrodes were tested for adhesion, impedance, etc.). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for these performance tests. This level of detail is typically not included in a 510(k) summary, which focuses on regulatory substantial equivalence.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the device is a simple cutaneous electrode, not an AI-driven diagnostic or image-based device requiring expert interpretation of complex data for ground truth establishment. The performance tests are largely engineering and material science evaluations.

4. Adjudication Method for the Test Set

Not applicable for the type of device and tests described. Adjudication methods like 2+1 or 3+1 are used for evaluating human or AI interpretations of medical images or complex diagnostic scenarios, not for evaluating physical device performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. This type of study is specifically designed to assess the impact of an AI system on human reader performance for tasks such as diagnosis or lesion detection. This document describes a physical medical device (an electrode), not an AI algorithm.

6. Standalone (Algorithm Only) Performance

Not applicable. The device is a physical electrode, not a standalone algorithm.

7. Type of Ground Truth Used

For the performance tests, the "ground truth" is defined by the engineering specifications and functional requirements of a cutaneous electrode. For example:

For "Performance requirements": The ground truth is compliance with established electrical performance standards for electrodes (e.g., AC impedance, DC offset).
For "Adhesion": The ground truth is the physical ability to retain adhesion for a specified duration (10 hours).
For "Dimensions": The ground truth is the measured dimensions falling within the specified tolerance.
For "Lead wire compatibility": The ground truth is successful physical and electrical connection with standard snap electrode lead wires.

8. Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI model that requires a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable. As stated above, this is an electrode, not an AI model requiring a training set and corresponding ground truth.

Summary of what the document does prove:

The document serves as a 510(k) notification, aiming to prove that the "Disposable Snap Electrode" is substantially equivalent to legally marketed predicate devices. This is achieved by:

Comparing technological characteristics (Table 1) to two predicate devices (K021537 and K142159). Key comparisons include intended use, indications for use, environment of use, single patient use/disposability, duration of use, patient applied location, diameter, pre-gelled status, electrode contact material, patient contact material, sterility, pre-attached lead wires, snap lead wire compatibility, and shelf life.
Demonstrating compliance with performance requirements relevant to an electrode, as outlined in the "Performance Tests" table. These are standard engineering/functional tests for electrodes.
Confirming biocompatibility based on supplier-provided test results for cytotoxicity, sensitization, and irritation of the materials.
Concluding that "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."

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

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

Company Name:	Embla Systems1 Hines Road, Suite 202Kanata, ON, CA, K2K 3C7
Company Contact:	Mr. Sanjay MehtaSenior Manager, Quality Assurance & Regulatory AffairsPhone: (905) 287-5055Email: Sanjay.Mehta@natus.com
Date Summary Prepared:	November 3, 2017
Trade Name:	Disposable Snap Electrode
Common Name:	Cutaneous Electrode
Classification Name:	21 CFR 882.1320 Cutaneous ElectrodeProduct Code: GXY
Predicate Devices:	K142159 Disposable Pre-gelled Surface ElectrodeRochester Electro-Medical, Inc.K021537 Multipurpose Neuroplus ElectrodeVermont Medical, Inc.

Product Description

Intended Use of the Device

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 ElectrodesUnder Review	Vermont Med., Inc.Multipurpose NeuroplusElectrode,(Predicate K021537)	Rochester Electro-Medical,Inc.Disposable Pre-gelled SurfaceElectrode(Predicate K142159)
IntendedUse	A cutaneous electrode applieddirectly to a patient's skin either torecord physiological signals.	A cutaneous electrode applieddirectly to a patient's skin either torecord physiological signals.	A cutaneous electrode applieddirectly to a patient's skin either torecord physiological signals and/orto apply electrical stimulation.
Indicationsfor Use	The Disposable Snap Electrodesare intended to be used withcompatible 1.5mm touch proofbutton snap cables for transferringsurface biopotential signals to useduring sleep studies, EEG, EMG,and recording evoked potentialsignals from a cutaneous location.For use on Adults.	The Vermed A10005 electrode isdesigned to measure muscleactivity from the surface of theskin. The A10005 can be used forSleep Studies, surface EMG, NCSand EP. The A10005 electrode isprovided in a NON-STERILEformat only, and should be used onthe surface of the skin.	The Disposable Pre-gelled SurfaceElectrodes are intended forrecording/stimulation andmonitoring of Electromyography(EMG), Electroencephalograph(EEG) and Evoked Potential (EP)signals.
Environmentof Use	Hospitals, clinics and home.	Hospitals, clinics and home.	Hospitals, clinics and home.
Singlepatient use,disposable	Yes	Yes	Yes
Duration ofuse	Duration of a sleep study,anticipated to be up to 10 hours	Duration of clinical uses,anticipated to be ≤ 24 hours.	Duration of clinical uses,anticipated to be ≤ 24 hours.
Patientappliedlocation	Cutaneous	Cutaneous	Cutaneous
Overalldiameter	1.9 inches	0.875 to 1.375 inches	Unknown
Pre-gelledelectrodeconductivemedia	Yes	Yes	Yes
Electrodecontactmaterial	Silver, Silver Chloride (Ag/AgCl)	Ag/AgCl	Ag/AgCl
Patientcontactmaterial	AdhesiveElectrode conductive media	AdhesiveElectrode conductive media	AdhesiveElectrode conductive media
Sterility	Supplied non-sterile	Supplied non-sterile	Supplied non-sterile
Pre-attachedlead wires	No	No	Yes
Snap leadwirecompatible	Yes	Yes	Not applicable, pre-wired lead wire
Table 1: Substantial Equivalence Technical Characteristics
Feature	Disposable Snap ElectrodesUnder Review	Vermont Med., Inc.Multipurpose NeuroplusElectrode,(Predicate K021537)	Rochester Electro-Medical, Inc.Disposable Pre-gelled SurfaceElectrode(Predicate K142159)
Shelf Life	18 months	18 months	Unknown
Connectionto user'sequipment	Yes	Yes	Yes

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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
Performancerequirements	Essential performance for: AC Impedance, DC offset, Combinedoffset 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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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.

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
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.(b)
Classification. Class II (performance standards).