(67 days)
Not Found
No
The summary describes a passive electrode for signal transfer and does not mention any AI/ML components or functions.
No.
The device is intended for transferring biopotential signals for diagnostic purposes (sleep studies, EEG, EMG), not for treating a condition or disease.
No
The device is described as an electrode for transferring biopotential signals. While these signals can be used for diagnostic purposes (e.g., sleep studies, EEG, EMG), the electrode itself is a measurement tool that collects the signals, not a device that processes or interprets them to make a diagnosis.
No
The device description clearly states it is a "Disposable Snap Electrode," which is a physical hardware component applied to the skin. The performance studies also focus on physical characteristics like impedance, adhesion, and dimensions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to transfer surface biopotential signals for use during sleep studies, EEG, EMG, and recording evoked potential signals. These are all measurements of electrical activity within the body, not tests performed in vitro (outside the body) on biological samples like blood, urine, or tissue.
- Device Description: The device is a cutaneous applied electrode that interfaces with the skin to pick up these electrical signals. This is a direct interaction with the body, not a test on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, this device falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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, EMC, and recording evoked potential signals from a cutaneous location. For use on Adults.
Product codes (comma separated list FDA assigned to the subject device)
GXY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cutaneous
Indicated Patient Age Range
Adults
Intended User / Care Setting
Hospitals, clinics and home.
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)
To establish the technical equivalency of the Disposable Snap Electrode, evaluations were conducted to confirm compliance with performance requirements, including:
- 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
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
§ 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).
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
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);
1
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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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
1 Hines Road, Suite 202
Kanata, ON, CA, K2K 3C7 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Mr. Sanjay Mehta
Senior Manager, Quality Assurance & Regulatory Affairs
Phone: (905) 287-5055
Email: 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 Electrode
Product Code: GXY |
| Predicate Devices: | K142159 Disposable Pre-gelled Surface Electrode
Rochester Electro-Medical, Inc.
K021537 Multipurpose Neuroplus Electrode
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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Image /page/4/Picture/0 description: The image contains the logo for "natus. neurology". The word "natus" is in a teal sans-serif font, with a small registered trademark symbol next to it. Below "natus" is the word "neurology" in a smaller, italicized, sans-serif font, also in teal.
| Table 1: Substantial Equivalence Technical Characteristics | |||
|---|---|---|---|
| Feature | Disposable Snap Electrodes | ||
| Under Review | Vermont Med., Inc. | ||
| Multipurpose Neuroplus | |||
| Electrode, | |||
| (Predicate K021537) | Rochester Electro-Medical, | ||
| Inc. | |||
| Disposable Pre-gelled Surface | |||
| Electrode | |||
| (Predicate K142159) | |||
| Intended | |||
| Use | A cutaneous electrode applied | ||
| directly to a patient's skin either to | |||
| record physiological signals. | A cutaneous electrode applied | ||
| directly to a patient's skin either to | |||
| record physiological signals. | A cutaneous electrode applied | ||
| directly to a patient's skin either to | |||
| record physiological signals and/or | |||
| to apply electrical stimulation. | |||
| Indications | |||
| for Use | The Disposable Snap Electrodes | ||
| are intended to be used with | |||
| compatible 1.5mm touch proof | |||
| 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. | The Vermed A10005 electrode is | ||
| designed to measure muscle | |||
| activity from the surface of the | |||
| skin. The A10005 can be used for | |||
| Sleep Studies, surface EMG, NCS | |||
| and EP. The A10005 electrode is | |||
| provided in a NON-STERILE | |||
| format only, and should be used on | |||
| the surface of the skin. | The Disposable Pre-gelled Surface | ||
| Electrodes are intended for | |||
| recording/stimulation and | |||
| monitoring of Electromyography | |||
| (EMG), Electroencephalograph | |||
| (EEG) and Evoked Potential (EP) | |||
| signals. | |||
| Environment | |||
| of Use | Hospitals, clinics and home. | Hospitals, clinics and home. | Hospitals, clinics and home. |
| Single | |||
| patient use, | |||
| disposable | Yes | Yes | Yes |
| Duration of | |||
| use | 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. | |||
| Patient | |||
| applied | |||
| location | Cutaneous | Cutaneous | Cutaneous |
| Overall | |||
| diameter | 1.9 inches | 0.875 to 1.375 inches | Unknown |
| Pre-gelled | |||
| electrode | |||
| conductive | |||
| media | Yes | Yes | Yes |
| Electrode | |||
| contact | |||
| material | Silver, Silver Chloride (Ag/AgCl) | Ag/AgCl | Ag/AgCl |
| Patient | |||
| contact | |||
| material | Adhesive | ||
| Electrode conductive media | Adhesive | ||
| Electrode conductive media | Adhesive | ||
| Electrode conductive media | |||
| Sterility | Supplied non-sterile | Supplied non-sterile | Supplied non-sterile |
| Pre-attached | |||
| lead wires | No | No | Yes |
| Snap lead | |||
| wire | |||
| compatible | Yes | Yes | Not applicable, pre-wired lead wire |
| Table 1: Substantial Equivalence Technical Characteristics | |||
| Feature | Disposable Snap Electrodes | ||
| Under Review | Vermont Med., Inc. | ||
| Multipurpose Neuroplus | |||
| Electrode, | |||
| (Predicate K021537) | Rochester Electro-Medical, Inc. | ||
| Disposable Pre-gelled Surface | |||
| Electrode | |||
| (Predicate K142159) | |||
| Shelf Life | 18 months | 18 months | Unknown |
| Connection | |||
| to user's | |||
| 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 | ||
| 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 |
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.