(53 days)
Not Found
No
The document describes a disposable EEG electrode and its physical characteristics, intended use as a substitute for existing electrodes, and comparison to a predicate device. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is an EEG electrode, which is a diagnostic device used to measure electrical activity in the brain, not a therapeutic device used for treatment.
No.
The device is described as an EEG electrode, which is a component used to acquire electrical signals from the brain. While these signals can be used for diagnostic purposes, the electrode itself is a measurement tool and does not perform the diagnostic interpretation or analysis. Its intended use is as a direct substitute for existing reusable EEG electrodes, which are signal acquisition devices.
No
The device description explicitly states the HydroSpots are physical, disposable electrodes made of silver/silver chloride, pre-gelled, and designed to be adhered to the head and mate with a wire. This indicates a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as "direct substitutes for existing reusable EEG electrodes." EEG electrodes are used to measure electrical activity of the brain, which is a physiological process occurring within the body.
- Device Description: The description focuses on the physical characteristics and function of the electrodes for signal transmission from the body's surface.
- No Mention of In Vitro Testing: There is no mention of the device being used to test samples (like blood, urine, tissue) outside of the body.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used for direct physiological measurement on the body.
N/A
Intended Use / Indications for Use
The HydroSpots are intended as direct substitutes for existing reusable EEG electrodes.
Product codes
Not Found
Device Description
The HydroSpots are single-use, pre-gelled, disposable, silver/silver chloride EEG electrodes. They are designed to satisfy the customers who prefer the traditional electrode placement system that involves measuring the head, marking the electrode locations, and adhering electrodes to the head.
The HydroSpots have a similar form factor to the industry standard leadwire attached electrodes. The product design mimics the traditional electrode placement system while maintaining the other benefits provided by the heapiece electrodes that are listed below.
a. Ease of patient clean up. Both electrodes use a conductive adhesive gel to transmit the signal from the body's surface to the silver/silver chloride substrate. The hydrogel minimizes patient clean up as the hydrogel removes cleanly from the hair.
b. Ease of electrode clean up. The traditional electrodes have to be washed between patients while the HydroSpots and HydroDot electrodes are disposable.
The design features a pre-galled cup electrode with an optional adhesive ring that may be exposed and used to secure the electrode to the skin. The electrode is designed to mate with a wire such that the wire is reusable and the electrode which makes direct patient contact is disposable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
Physiometrix, Inc. 510(k), Premarket Notification HydroSpot System, Model 1500 & 1501
HYDROSPOTS SUMMARY OF SAFETY AND EFFECTIVENESS
| Date: | February 20, 1996 |
|---|---|
| Company: | Physiometrix, Inc. |
| Five Billerica Park | |
| 101 Billerica Avenue | |
| N. Billerica, MA 01862 | |
| Contact: | Dawn E. Frazer |
| Director, Regulatory Affairs & Quality Assurance | |
| (508) 670-2422 | |
| (800) 474-9746 | |
| Subject Device: | Model 1501, HydroSpot EEG Electrodes |
| Model 1500, HydroSpot EEG Leadwires | |
| Predicate Device: | K930080, HydroDot NeuroMonitoring System |
| Classification: | Class II, CFR 21 Part 882.1320, Cutaneous Electrodes |
| Description: | The HydroSpots are single-use, pre-gelled, disposable, silver/silver chloride EEG electrodes. They are designed to satisfy the customers who prefer the traditional electrode placement system that involves measuring the head, marking the electrode locations, and adhering electrodes to the head. |
The HydroSpots have a similar form factor to the industry standard leadwire attached electrodes. The product design mimics the traditional electrode placement system while maintaining the other benefits provided by the heapiece electrodes that are listed below.
a. Ease of patient clean up. Both electrodes use a conductive adhesive gel to transmit the signal from the body's surface to the silver/silver chloride substrate. The hydrogel minimizes patient clean up as the hydrogel removes cleanly from the hair.
b. Ease of electrode clean up. The traditional electrodes have to be washed between patients while the HydroSpots and HydroDot electrodes are disposable. |
| Intended Use: | The HydroSpots are intended as direct substitutes for existing reusable EEG electrodes. |
| Design/Materials: | The HydroSpots are fabricated from a combination of materials that are widely used in the sensing electrode industry, silver/silver chloride, conductive hydrogel, and skin contact adhesive. |
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1
The design features a pre-galled cup electrode with an optional adhesive ring that may be exposed and used to secure the electrode to the skin. The electrode is designed to mate with a wire such that the wire is reusable and the electrode which makes direct patient contact is disposable.