(15 days)
Not Found
No
The summary describes a sensor for recording electrophysiological signals and mentions an electronic smart card for configuration and identification. There is no mention of AI, ML, or any processing of the recorded signals using such technologies. The focus is on the sensor itself and its application.
No.
The device is used to record electrophysiologic signals (EEG) for monitoring, not to treat a disease or condition.
Yes
The device is described as enabling recordings of electrophysiological signals (like EEG) in pediatric patients, which are then used for diagnostic purposes. It captures data from the patient's body to help assess a medical condition.
No
The device description explicitly states it is a "4 electrode array" and includes an "electronic smart card memory device," indicating it is a hardware component, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The BIS Pediatric Sensor is described as being applied directly to the patient's skin to record electrophysiological signals (like EEG). This is a non-invasive, in vivo measurement, not a test performed on a sample taken from the body.
- Intended Use: The intended use is to enable recordings of electrophysiological signals in pediatric patients, which is a physiological measurement, not a diagnostic test on a biological sample.
Therefore, the 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 BIS Pediatric Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals in pediatric patients.
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
The Sensor is a single patient use, disposable, pre-gelled 4 electrode array that is applied directly to the pediatric patient's forehead to record electro-physiological signals. It has an electronic smart card memory device in the tab area that contains configuration and identification information.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's forehead, patient's skin
Indicated Patient Age Range
pediatric patients
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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).
0
K 041670
'JUL - 6 2004
Appendix D
510(k) Summary
Date: May 28, 2004
| Aspect Medical Systems, Inc., 141 Needham St., Newton, MA 02464
| Contact Person: Renee Gould (617) 559-7788 | |
|---|---|
| Proprietary Name: | BIS Pediatric Sensor |
| Common Name: | Electrode, Cutaneous Electrode |
| Classification: | Class II device. Refer to 21 CFR 882.1320 |
| Predicate Devices: | K001980, Aspect Pediatric EEG BIS Sensor cleared September 27, 2000 |
| and K002734, Aspect Enhanced XP BIS Sensor cleared September 14, 2000. | |
| Device Description: | The Sensor is a single patient use, disposable, pre-gelled 4 electrode array that is applied directly to the pediatric patient's forehead to record electro-physiological signals. It has an electronic smart card memory device in the tab area that contains configuration and identification information. |
| Indications for Use: | The BIS Pediatric Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals in pediatric patients. |
| Similarities: | |
| same indications for use as the Pediatric Sensor, same intended use as both predicate devices same operating principle as both predicate devices: The flexible tines disk, surrounded by the hydrogel, is used to part the outermost layer of skin. While the flexible tines part the skin, hydrogel flows around the tines, forming a conductive bridge with the skin. incorporate the same basic design as Enhanced Sensor and same montage, incorporate the same materials as both predicate devices, have the same shelf life as both predicate devices, and is packaged using the same materials and processes as both predicate devices. | |
| Differences: | smaller size (overall length shorter) and different basepad shape from the Enhanced Sensor to accommodate smaller heads. The "1-2-4-3 basepad "circles" as stated in the Instructions are a different shape. Refer to the Photographs in Section 3. The electrodes have not changed. The shape was changed for better fit. |
- addition of the 4th electrode and shape change for better fit to the Pediatric Sensor. .
1
In summary, the BIS Pediatric Sensor described in this submission is substantially equivalent to the predicate devices. Aspect Medical Systems believes these modifications do not raise new questions of safety or effectiveness. The intended use is the same as both predicate devices. The indications for use remain the same as the Pediatric Sensor. The fundamental scientific technology remains the same as the Pediatric Sensor and Enhanced Sensor predicate devices.
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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. The eagle is stylized and composed of three thick, curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 6 2004
Aspect Medical Systems, Inc. c/o Mr. Ned E. Devine, Jr. Entela, Inc. 3033 Madison Avenue, SE Grand Rapids, Michigan 49548
Re: K041670
Trade/Device Name: BIS Pediatric Sensor Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated: June 18, 2004 Received: June 21, 2004
Dear Mr. Devine:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Ned E. Devine, Jr.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
C. Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Appendix B
Indications for Use Statement
210(k) Number (if known)
Device Name
BIS Pediatric Sensor
Indications For Use
The BIS Pediatric Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals in pediatric patients.
Muriam C. Provost
Division of General, Restorative, and Neurological Devices
510(k) Number K041670
X Prescription Use (Per 21 CFR 801 Subpart D)
AND/OR
Over-The Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
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