The BIS Pediatric Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals in pediatric patients.

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.

AI/ML Overview

This 510(k) premarket notification for the BIS Pediatric Sensor by Aspect Medical Systems, Inc. does not contain a study to prove that the device meets specific acceptance criteria based on performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (K001980 and K002734).

Here's an analysis of the provided text in relation to your request:

A table of acceptance criteria and the reported device performance:
The document does not specify quantitative acceptance criteria or report performance data for the BIS Pediatric Sensor. The submission asserts that the device is "substantially equivalent" to predicate devices, implying similar performance.
Sample size used for the test set and the data provenance:
No test set, performance study, or associated sample size is mentioned in the document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
There is no mention of experts or ground truth establishment for a test set, as no performance study is detailed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no test set or performance study is described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This device is a physical sensor, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with AI assistance is not relevant or mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The device is a sensor for recording biological signals, not an algorithm. The assessment is for its physical design and functionality related to signal acquisition, not algorithmic performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
No ground truth is discussed, as no performance study requiring such data is presented. The "ground truth" for this type of device typically revolves around its ability to accurately and reliably capture the intended physiological signal (EEG), which would be assessed through standard engineering and clinical validation tests, but these are not detailed in this summary.
The sample size for the training set:
Not applicable. This device is a hardware sensor, not a machine learning model, so there is no "training set."
How the ground truth for the training set was established:
Not applicable, as there is no training set for a machine learning model.

Summary of the document based on your questions:

The 510(k) summary focuses on demonstrating that the BIS Pediatric Sensor is "substantially equivalent" to two predicate devices (K001980 and K002734). The key points for this determination are:

Intended Use/Indications for Use: Same as predicate devices (recording electrophysiological signals in pediatric patients).
Fundamental Scientific Technology: Same operating principle (flexible tines disk, hydrogel) and basic design as predicate devices.
Materials and Shelf Life: Same as predicate devices.
Differences: Smaller size and different basepad shape compared to the Enhanced Sensor to better accommodate smaller heads, and the addition of a 4th electrode and corresponding shape change for the Pediatric Sensor. These modifications are explicitly stated to "not raise new questions of safety or effectiveness."

No specific performance studies with acceptance criteria or reported performance metrics are included in this 510(k) summary. The FDA's clearance (JUL - 6 2004) is based on the finding of substantial equivalence.

Summary

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K 041670

'JUL - 6 2004

Appendix D

510(k) Summary

Date: May 28, 2004

Aspect Medical Systems, Inc., 141 Needham St., Newton, MA 02464Contact 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, 2000and 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. .

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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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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

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Appendix B

Indications for Use Statement

210(k) Number (if known)

K041670

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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Regulation Number and Section

§ 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).