(78 days)
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No
The summary describes a skin preparation solution and does not mention any AI or ML components or functionalities.
No
The device is described as a skin preparation material to reduce skin impedance and increase signal quality for EEG electrodes, which assists in diagnostic procedures, not therapeutic ones.
No
Explanation: The device is described as "skin preparation materials" used to "reduce skin impedance and increase signal quality recorded with EEG electrodes." It aids in the acquisition of signals for diagnosis but does not itself diagnose a condition.
No
The device description clearly states it is a "skin preparation solution" and "materials," indicating a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prepare the skin surface for EEG electrodes to improve signal quality. This is a topical application for a physiological measurement, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a skin preparation solution applied externally.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a disease or condition.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
HydroPrep and NuPrep are skin preparation materials that are designed for use by EEG Technicians. Both substances are applied to the skin surface with a cotton swab in order to reduce skin impedance and increase signal quality recorded with EEG electrodes. HydroPrep is not intended for use with stimulating electrodes.
Product codes
882.1275 Electroonductive media
Device Description
HydroPrep is a skin preparation solution similar to NuPrep. It is different in that is has more water and more salt that the current formulation. It used the same preservatives and gritty media.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
skin surface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
EEG Technicians
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
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Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1275 Electroconductive media.
(a)
Identification. Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.(b)
Classification. Class II (performance standards).
0
Physiometrix, Inc.
510(k), Premarket Notification Model 1700, HydroPrep
MAY 14 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
| Date: | February 24, 1997 |
|---|---|
| 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 1700, HydroPrep |
| Predicate Device: | K885306, NuPrep (Weaver & Co.) |
| Classification: | 882.1275 Electroonductive media |
| Description: | HydroPrep is a skin preparation solution similar to NuPrep. It is different in that is |
| has more water and more salt that the current formulation. It used the same | |
| preservatives and gritty media. | |
| Intended Use: | HydroPrep and NuPrep are skin preparation materials that are designed for use |
| by EEG Technicians. Both substances are applied to the skin surface with a | |
| cotton swab in order to reduce skin impedance and increase signal quality | |
| recorded with EEG electrodes. HydroPrep is not intended for use with stimulating | |
| electrodes. |