(147 days)
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No
The description focuses on the physical characteristics and electrical performance of a disposable EEG sensor, with no mention of AI or ML for signal processing or interpretation.
No
The device is used to record electro-physiological signals, which is for diagnostic purposes, not for treating a condition.
No
The device is described as an EEG sensor used to record electro-physiological signals. It captures data but does not interpret or diagnose; it provides the input for diagnostic interpretation by a healthcare professional or another device.
No
The device description explicitly states it is a "pre-gelled array of three (3) Zipprep electrodes" and describes its physical application to the patient's skin. 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 to "enable recording of electro-physiological (such as EBG) signals" by being "applied directly to the patient's skin." This describes a device that measures physiological signals from the patient's body.
- Device Description: The description reinforces this by stating it's an "array of three (3) Zipprep electrodes that is applied to the patient's skin to record electro-physiological (such as EEG) signals."
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) in vitro (outside the body). IVDs are specifically designed for testing these types of samples to provide information about a patient's health.
This device is clearly designed for in vivo (within the living body) measurement of electrical activity.
N/A
Intended Use / Indications for Use
The Aspect EEG Sensor is applied directly to the patient's skin to enable recording of electro-physiological (such as EBG) signals.
Product codes
electrode, cutaneous electrode
Device Description
The Aspect Medical Systems, Inc. Zipprep™ Disposable EEG Sensor (hereafter referred to as the Aspect EEG Sensor, is a rectangular shaped, pre-gelled array of three (3) Zipprep electrodes that is applied to the patient's skin to record electro-physiological (such as EEG) signals. It is a low impedance, single patient use, disposable electrode sensor that is designed for application to the frontal/temporal area. The main body of the Aspect EEG Sensor, which houses two (2) electrodes, is placed on the forehead. The satellite, which houses one (1) electrode, is placed over the temple area. The Zipprep electrode area of the Sensor is composed of a basepad with a pressure sensitive adhesive that contacts the skin. A pocket in the basepad houses the flexible tines disk, which adheres to a ring shaped piece of film. A polyurethane sponge is placed over the tines. The aqueous gel (hydrogel) is also placed in this area. The Zipprep electrode is "self-prepping", in that no brisk skin or alcohol rub is necessary to prepare the skin to lower the impedance prior to applying the electrode. The flexible tines in the Zipprep electrodes part the outermost layer of skin while the gel flows around the tines and forms a conductive bridge with the skin. Two (2) Zipprep electrodes are mounted in a rectangular shaped basepad composed of polyethylene (PE) foam. The third Zipprep electrode (the satellite electrode) is mounted in a smaller, rectangular shaped basepad also composed of PE foam. On one side of the foam (the skin side) there is a pressure sensitive adhesive, which allows it to adhere to the skin with no additional taping necessary. On the other side of the PE foam there is a Mylar substrate. The electrode sections are connected by a thin strip of Mylar. Flexible circuit technology is utilized by printed silver/silver chloride ink on the Mylar substrate. A polyester insulator is used to restrict electrical contact to the element area. The Aspect EEG Sensor has a flexible tab on one end, with a polypropylene housing designed to provide rigidity to the flexible tab.
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
frontal/temporal area, forehead, temple area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Biocompatibility testing was conducted in accordance with the International Standard ISO-10993, Biological Evaluation of Medical Devices Part I: Evaluation and Testing. Results are summarized as follows: Primary Skin Irritation - Pass; not a primary skin irritant. Cytotoxicity - Pass; results indicate the device passes relative to its intended use. Delayed Contact Sensitization study - Results due May 31, 1996.
- Electrical testing was conducted in accordance with the American National Standard for Disposable ECG Electrodes, developed by AAMI and approved in December, 1991 by ANSI. The Sensor passed all testing in accordance with the Standard.
- A clinical evaluation was conducted at Ohio State University. Impedance, signal quality, usability and skin irritation were evaluated. Results indicate the Aspect EEG Sensor performs in the manner in which it is intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
510(k) SUMMARY Aspect Medical Systems, Inc. Zipprep EEG Sensor
Company Name
Aspect Medical Systems, Inc. 2 Vision Drive Natick, MA 01760-2059
Telephone: (508) 653-0603
Device Name/Classification
| Proprietary Name: | Aspect Medical Systems Zipprep EEG Sensor |
|---|---|
| Common Name: | Electrode, Cutaneous Electrode |
Cutaneous Electrodes have been classified by the Neurological Devices Panel as Class II devices. Refer to 21 CFR 882.1320.
Description
The Aspect Medical Systems, Inc. Zipprep™ Disposable EEG Sensor (hereafter referred to as the Aspect EEG Sensor, is a rectangular shaped, pre-gelled array of three (3) Zipprep electrodes that is applied to the patient's skin to record electro-physiological (such as EEG) signals.
It is a low impedance, single patient use, disposable electrode sensor that is designed for application to the frontal/temporal area. The main body of the Aspect EEG Sensor, which houses two (2) electrodes, is placed on the forehead. The satellite, which houses one (1) electrode, is placed over the temple area.
Electrode Area of Sensor
The Zipprep electrode area of the Sensor is composed of a basepad with a pressure sensitive adhesive that contacts the skin. A pocket in the basepad houses the flexible tines disk, which adheres to a ring shaped piece of film. A polyurethane sponge is placed over the tines. The aqueous gel (hydrogel) is also placed in this area.
The Zipprep electrode is "self-prepping", in that no brisk skin or alcohol rub is necessary to prepare the skin to lower the impedance prior to applying the electrode. The flexible tines in the Zipprep electrodes part the outermost layer of skin while the gel flows around the tines and forms a conductive bridge with the skin.
1
Sensor
Two (2) Zipprep electrodes are mounted in a rectangular shaped basepad composed of polyethylene (PE) foam. The third Zipprep electrode (the satellite electrode) is mounted in a smaller, rectangular shaped basepad also composed of PE foam. On one side of the foam (the skin side) there is a pressure sensitive adhesive, which allows it to adhere to the skin with no additional taping necessary. On the other side of the PE foam there is a Mylar substrate. The electrode sections are connected by a thin strip of Mylar. Flexible circuit technology is utilized by printed silver/silver chloride ink on the Mylar substrate. A polyester insulator is used to restrict electrical contact to the element area.
The Aspect EEG Sensor has a flexible tab on one end, with a polypropylene housing designed to provide rigidity to the flexible tab.
Indications for Use
The Aspect EEG Sensor is applied directly to the patient's skin to enable recording of electro-physiological (such as EBG) signals.
Statement of Substantial Equivalence
The Aspect EEG Sensor is substantially equivalent to the following devices:
Similarities
- The Aspect EEG Sensor is similar to the 510(k) Aspect Zipprep Electrode in the 1) following ways:
- The indications for use are identical. O
- The technology is identical O
- Both use silver-silver chloride as the conducting material. In addition, the O following materials are the same:
Identical polyethylene basepad material Identical nylon flexible tines Identical liquid gel - hydrogel Identical silver-silver chloride conducting material
The Aspect EEG Sensor is similar to the NDM ECG Backpad in the following ways:
2
- Fixed array of electrodes O
- 0 Pre-gelled
- Flexible circuit technology 0
Differences
-
- The Aspect EEG Sensor is different from the 510(k) Aspect Zipprep Electrode in the following minor ways:
- O The Aspect EEG Sensor has a polyurethane sponge over tines, whereas the Zipprep Electrode does not.
- The Aspect EEG Sensor has flexible Mylar circuitry with Ag/Ag Cl O conductors and a flexible tab for connection. The Zipprep Electrode has standard snap construction.
- O The Aspect EEG Sensor has no foam ring.
- 0 The Aspect EEG Sensor has a film ring located beneath the tines
- The Aspect EEG Sensor adhesive is slightly more adherent than the 0 adhesive used on the Zipprep Electrode.
-
- The Aspect EEG Sensor is different from the NDM ECG Backpad in the following minor ways:
- The Aspect EEG Sensor has 3 electrodes. The NDM Backpad has 4. 0
- The Aspect Sensor is used for EEG recordings and is placed on the O forehead, whereas the NDM Backpad is used for ECG recordings and is placed on the back.
- The Aspect EEG Sensor is approximately 8.5" x 1.5". The NDM Backpad O is approximately 9" x 7".
- The Aspect EEG Sensor has Silver-silver chloride printed circuitry. The O NDM Backpad has Copper printed circuitry.
Testing
- Biocompatibility testing was conducted in accordance with the International Standard ISO-10993, Biological Evaluation of Medical Devices Part I: Evaluation and Testing. Results are summarized as follows:
3
Primary Skin Irritation - Pass; not a primary skin irritant Cytotoxicity - Pass; results indicate the device passes relative to its intended use Delayed Contact Sensitization study - Results due May 31, 1996
Electrical testing was conducted in accordance with the American National 2) Standard for Disposable ECG Electrodes, developed by AAMI and approved in December, 1991 by ANSI. The Sensor passed all testing in accordance with the Standard.
A clinical evaluation was conducted at Ohio State University. Impedance, signal 3) quality, usability and skin irritation were evaluated. Results indicate the Aspect EEG Sensor performs in the manner in which it is intended.
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