Indication for use for GE Entropy Sensor (REF M1123614): This GE Entropy Sensor is intended to be used for adults with GE Entropy measurement devices to enable recording of physiological signals (such as EEG). To connect this sensor to the measurement device, use the GE Entropy Cable. Indication for use for GE Entropy Cable (REF M1050784): Use the sensor cable only with GE Entropy measurement devices together with GE Entropy Sensor or Entropy Sensor.

Device Description

The GE Entropy Sensor is a sensor assembly with three (3) pre-gelled EEG electrodes. The GE Entropy Sensor is applied to the skin of the patient to record electrophysiological (such as EEG and FEMG) signals. It is a low impedance, single patient use, non-sterile disposable electrode sensor that is designed for application to the frontal/temporal area. The GE Entropy Sensor is designed to provide ease of use and electrode placement accuracy. It is used in conjunction with the M-ENTROPY and E-ENTROPY module. The Entropy sensor collects EEG and facial EMG signals from these areas, and the differential signal from the temple to the center of the forehead is used to calculate the Entropy variables. To obtain the lowest possible skin impedance, a preparation pad is used to lightly abrade the skin to remove the insulating outer layer. One preparation pad is included with each sensor. The GE Entropy Sensor is individually packaged inside a moisture tight foil pouch. One preparation pad is included inside the same foil pouch. A selling box for the GE Entropy Sensor contains 25 sensor pouches and an instruction insert. The GE Entropy Cable is a reusable cable that connects the GE Entropy Sensor (REF M1123614) or Entropy Sensor (REF 8002858) to the M-ENTROPY or E-ENTROPY module both mechanically and electrically. The GE Entropy Sensor is connected directly to the sensor-end of the GE Entropy Cable and the device-end of the cable is connected directly to the M-ENTROPY or E-ENTROPY module. The GE Entropy Cable is individually packaged in a plastic bag together with an instruction insert.

AI/ML Overview

This document describes the GE Entropy Sensor and Cable, which are accessories for EEG measurement devices. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel algorithm or performance study in the traditional sense.

Therefore, many of the requested categories (like AI performance, ground truth establishment for training, expert adjudication, MRMC studies) are not applicable to this type of submission. The "acceptance criteria" here refer to compliance with recognized standards and a demonstration of equivalent specifications and safety to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Standard/Requirement	Reported Device Performance / Compliance
Electrical Safety	FDA 21 CFR Part 898, § 898.12 (Performance standard for electrode lead wires and cables)	Assessed against and met.
	EN 60601-1:2005 (General requirements for safety)	Assessed against and met.
	IEC 601-2-26:1994 (Particular requirements for electroencephalographs)	Assessed against and met.
	ANSI/AAMI EC12-2000	Assessed against and met.
	ANSI/AAMI ES1:1993	Assessed against and met.
	UL 2601-1	Assessed against and met.
	CAN/CSA C22.2N0601.1	Assessed against and met.
	IEC 664-1 (Insulation coordination)	Assessed against and met.
	ANSI/AAMI EC53-1995 (ECG cables and leadwires)	Assessed against and met.
Biocompatibility	ISO 10993-1, -5, -10 (Biological evaluation of medical devices)	Assessed against and met.
Risk Management	ISO 14971:2000 (Application of risk management to medical devices)	Assessed against and met.
Labeling/Documentation	FDA /ODE Guidance for Content of Premarket Submission for Software Contained in Medical Devices, May 11, 2005	Assessed against and met.
	ISO 15223:2000 (Symbols for medical device labeling)	Assessed against and met.
	EN 980+A1+A2 (Graphical symbols for medical devices)	Assessed against and met.
Functional Equivalence	3 wet gel electrodes, conductivity, adhesion on the patient's forehead, plug interface, air clearances (for ESU/defibrillation safety)	Demonstrated similarity to predicate device.

2. Sample Size Used for the Test Set and Data Provenance

This submission is for medical device accessories (electrodes and cables), not an algorithm or diagnostic tool that uses patient data in a "test set" for performance evaluation in the typical sense. The testing performed involved technical validation and verification against engineering standards. Therefore, concepts like patient data provenance do not directly apply. The testing was conducted internally by GE Healthcare.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The ground truth for this type of submission is defined by compliance with established engineering and safety standards, not by expert interpretation of patient data.

4. Adjudication Method for the Test Set

Not applicable. There was no "test set" of patient data requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is not an AI or diagnostic imaging device that would typically undergo an MRMC study.

6. Standalone (Algorithm Only) Performance Study

No. This device is an accessory (sensor and cable) for existing medical equipment and does not contain a standalone algorithm.

7. Type of Ground Truth Used

The "ground truth" here is compliance with international and national recognized standards for electrical safety, biocompatibility, and functional specifications for medical devices of this type. This is demonstrated through various engineering tests and certifications.

8. Sample Size for the Training Set

Not applicable. This submission is for hardware medical device accessories and does not involve a "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This submission does not involve a training set.

Summary

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K062580

Premarket Notification 510(k) Summary As required by section 807.92 GE Entropy Sensor (REF M1123614) and GE Entropy Cable (REF M1050784)

GENERAL COMPANY INFORMATION as required by 807.92(a)(1)

COMPANY NAME/ADDRESS/PHONE/FAX:

GE Healthcare 86 Pilgrim Road Needham, MA 02492 USA Tel: 781-449-8685 Fax: 781-433-1344

NAME OF CONTACT:

Mr. Joel Kent

DEC 2 1 2007

DATE: December 19, 2007

DEVICE NAME as required by 807.92(a)(2)

TRADE NAME:

GE Entropy Sensor (REF MI 123614) GE Entropy Cable (REF M1050784)

COMMON NAME:

Entropy sensor Entropy cable

CLASSIFICATION NAME:

The following Class II classifications appear applicable:

FDA Product Code	Classification Name	21 CFR Section
GXY	Electrode, cutaneous	882.1320

NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as required by 807.92(a)(3)

The disposable GE Entropy Sensor (REF M1123614) is substantially equivalent in safety and effectiveness to the predicate Datex-Ohmeda Entropy Sensor cleared with the M-Entropy/E-Entropy modules and accessories submissions (K023459 and K050835). The reusable GE Entropy Cable (REF M1050784) is substantially equivalent in safety and effectiveness to the predicate Datex-Ohmeda ENT-3 Entropy Sensor Cable cleared with the M-Entropy/E-Entropy modules and accessories submissions (K023459 and K050835).

Page I of 3

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DEVICE DESCRIPTION as required by 807.92(a)(4)

The GE Entropy Cable is a reusable cable that connects the GE Entropy Sensor (REF M1123614) or Entropy Sensor (REF 8002858) to the M-ENTROPY or E-ENTROPY module both mechanically and electrically. The GE Entropy Sensor is connected directly to the sensor-end of the GE Entropy Cable and the device-end of the cable is connected directly to the M-ENTROPY or E-ENTROPY module. The GE Entropy Cable is individually packaged in a plastic bag together with an instruction insert.

INTENDED USE as required by 807.92(a)(5)

Indication for use for GE Entropy Sensor (REF MI 123614)

This GE Entropy Sensor is intended to be used for adults with GE Entropy measurement devices to enable recording of physiological signals (such as EEG). To connect this sensor to the measurement device, use the GE Entropy Cable

Indication for use for GE Entropy Cable (REF M1050784):

Use the sensor cable only with GE Entropy measurement devices together with GE Entropy Sensor or Entropy Sensor

SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6)

3 wet gel electrodes, conductivity, adhesion on the patient's forehead, plug interface, and air clearances that ensures safe use during electrosurgery and defibrillation.

The proposed disposable GE Entropy Sensor has the following differences compared to the predicate device:

Pre-attached leadwires, materials, dimensions, labeling, artwork and different wording of the instruction for use insert

The reusable GE Entropy Cable (REF M1050784) is substantially equivalent in safety and effectiveness to the predicate Datex-Ohmeda ENT-3 Entropy Sensor Cable cleared with the M-Entropy/E-Entropy modules and accessories submissions (K023459 and K050835). The GE Entropy Cable has the following similarities to the predicate device:

Materials, cable and cable surface, connector interfaces, dimensions

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The proposed reusable GE Entropy Cable has the following differences compared to the predicate device:

Labeling, artwork and different wording of the instruction for use insert

In summary, GE Entropy Sensor and GE Entropy Cable, described in this submission are substantially equivalent in safety and effectiveness to the predicate Datex-Ohmeda Entropy Sensor and ENT-3 Entropy Sensor Cable (K023459 and K050835).

SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)

The GE Entropy Sensor (REF MI 123614) and GE Entropy Cable (REF M1050784) have been assessed against the standards below. The devices have been thoroughly tested through validation and verification of specifications.

. FDA 21 CFR Part 898, § 898.12 (Performance standard for electrode lead wires and cables)
. EN 60601-1:2005 (Part 1: General requirements for safety)
. IEC 601-2-26:1994 Particular requirements for electroencephalographs
. ANSI/AAMI EC12-2000
. ANSI/AAMI ES1:1993
UL 2601-1
CAN/CSA C22.2N0601.1
IEC 664-1 Insulation coordination for equipment within low-voltage systems .
. ANSI/AAMI EC53-1995 ECG cables and leadwires
FDA /ODE Guidance for Content of Premarket Submission for Software Contained in Medical ● Devices, May 11, 2005
ISO 15223:2000 Medical Devices Symbols to be used with medical device labeling and . information to be supplied
. EN 980+A 1+A2 Graphical symbols for use in the labeling of medical devices
ISO 10993-1, -5, -10Biological evaluation of medical devices ●
ISO 14971:2000 Medical devices -- Application of risk management to medical devices .

CONCLUSION:

The summary above shows that there are no new questions of safety and effectiveness for the GE Entropy Sensor (REF M1123614) and GE Entropy Cable (REF M1050784) as compared to the predicate device.

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

GE Healthcare c/o Mr. Joel C. Kent Manager, Quality and Regulatory Affairs 86 Pilgrim Road Needham, MA 02492

Re: K062580 Trade/Device Name: GE Entropy Sensor (REF M1123614) Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: II Product Code: GXY Dated (Date on orig SE ltr): November 16, 2007 Received (Date on orig SE ltr): November 20, 2007

Dear Mr. Kent:

This letter corrects our substantially equivalent letter of December 21, 2007.

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roview 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 for use stated in the encreations of 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 (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, mainter no a . . Act include requirements for annual registration, listing of devices, oontons provisions or actice, labeling, and prohibitions against misbranding and adulteration.

APR - 9 2012

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be may be sabyer de additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): __K062580

Device Name: GE Entropy Sensor (REF M1123614) and GE Entropy Cable (REF M1050784)

Indications for Use:

Indication for use for GE Entropy Sensor (REF M1123614)

Indication for use for GE Entropy Cable (REF M1050784):

Use the sensor cable only with GE Entropy measurement devices together with GE Entropy Sensor or Entropy Sensor

Over-The-Counter Use Prescription Use _ X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Page of

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Division of General, Restorative. and Neurological Devices

510(k) Number L062586

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).