GE ENTROPY SENSOR

K082540 · GE Healthcare · GXY · Nov 28, 2008 · Neurology

Device Facts

• Record ID: K082540
• Device Name: GE ENTROPY SENSOR
• Applicant: GE Healthcare
• Product Code: GXY · Neurology
• Decision Date: Nov 28, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

This GE Entropy Sensor is intended to be used for adults and pediatric patients older than 2 years 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.

Device Story

GE Entropy Sensor is a disposable, non-sterile, low-impedance sensor assembly featuring three pre-gelled EEG electrodes; designed for application to patient's frontal/temporal area. Includes a preparation pad for skin abrasion to reduce impedance. Device connects to GE Entropy Cable, which interfaces with M-ENTROPY or E-ENTROPY modules. Sensor collects EEG and facial EMG signals; differential signal from temple to forehead center is used by the host module to calculate Entropy variables. Used in clinical settings by healthcare providers to monitor physiological signals. Output is processed by the host module to assist in clinical decision-making regarding patient state. Benefits include ease of use and electrode placement accuracy.

Clinical Evidence

Bench testing only. Validation and verification of specifications performed against standards including IEC 60601-1, IEC 601-2-26, ANSI/AAMI EC12, ANSI/AAMI EC53, and ISO 10993 (biocompatibility). No clinical data presented.

Technological Characteristics

Disposable, single-patient use, non-sterile sensor with 3 pre-gelled EEG electrodes. Includes skin preparation pad. Connectivity: Wired connection to GE Entropy Cable. Standards: FDA 21 CFR 898.12, EN 60601-1, IEC 601-2-26, ANSI/AAMI EC12, ANSI/AAMI EC53, ISO 10993, ISO 14971.

Indications for Use

Indicated for adults and pediatric patients older than 2 years for recording physiological signals (EEG/EMG) when used with GE Entropy measurement devices.

Regulatory Classification

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.

Predicate Devices

• GE Entropy Sensor (REF M1123614) (K062580)

Submission Summary (Full Text)

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K082540

## Premarket Notification 510(k) Summary As required by section 807.92 GE Entropy Sensor (REF M1038681)

NOV 2 8 2008

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

## COMPANY NAME/ADDRESS/PHONF/FAX:

GF. Healthcarc 86 Pilgrim Road Needham, MA 02492 USA Tel: [phone] Fax: [phone]

### NAME OF CONTACT:

Mr. Joel Kent

DATE:

July 30, 2008

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

TRADE NAME:

GE Entropy Sensor (REF M1038681)

COMMON NAME:

--

Entropy sensor

CLASSIFICATION NAME:

The following Class II classifications appear applicable:

FDA Product Code ___ Classification Name 21 CFR Section

GXY Liectrode, 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 M1038681) is substantially equivalent in safety and effectiveness to the predicate GE Entropy Sensor (RFF MI 123614) cleared Dec. 21, 2007 (K062580).

Approved 2008-8-6 15:58 EET DST M1149634 002

Antti Ylöstalo PROJ-REPORT, GE Entropy Sensor Premarket Notification Summary (Pediatric Claim)

Reproduced from the clactronic master in MATRIX

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

The GF. Entropy Sensor (M1038681) is a sensor ussembly 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 FEMO) signals. It is a low impedance, single patient use, non-sterile disposable clectrode 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 arcas, and the differential signal from the temple to the center of the forehead is used to calculate the Entropy variables. To obtain the Jowest 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 Sensor is connected directly to the sensor-end of the GL Entropy Cable and the device-end of the cable is connected directly to the M-L'NTROPY or E-ENTROPY module.

## INTENDED USF. as required by 807.92(a)(5)

## Indication for use for GL Entropy Sensor (REF M1038681)

This GE Entropy Sensor is intended to be used for adults and pcdiatric patients older than 2 years 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.

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

The disposable GE Entropy Sensor (REF M1038681) is substantially equivalent in safety and effectiveness to the predicate GE Entropy Sensor (REF Ml 123614) cleared Dec. 21, 2007 (K062580). The GE Entropy Sensor (REF M1038681) is physically cquivalent to the predicate GE Entropy Sensor (REF M1123614).

There are only two changes between the proposed GE Entropy Sensor (M1038681) and the predicate GE Entropy Sensor (REF MI 123614).

The proposed disposable GE Entropy Sensor (REF M1038681) has changed laheling to incorporate pediatric use in patients older than 2 years. Only the labeling, artwork and different wording of the instruction for use insert have changed.

The proposed disposable GE Entropy Sensor (RBF M1038681) wires has been rerouted inside the connector and shrink wrap/flag sticker has been removed to enable a change in the electrode order from 2-1-3 to 1-2-3. This improves the usability of the product. This change does not affect to form, fit or function nor safety and effectiveness of the product.

The basis for the new claim is the fact that the GL Entropy measurement device with which this sensor can be used has now been cleared by FDA for use in pediatric patients older than 2 years · (K061907) cleared March 27, 2008.

### SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCI.USIONS as required by 807.92(b)(1)(3)

M1149634

Reproduced from the electronic master in MATRIX

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The GE Entropy Sensor (KEF M1038681) have been assessed against the standards below. The devices have been thoroughly tested through validation and verification of specifications. There are no differences in standards compared to the predicate device (REF MI123614).

- . 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 C22.2NO601.1
- 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+AI+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 disposable GE Entropy Sensor (REF M1038681) and it is substantially equivalent in safety and effectiveness to the predicate GE Entropy Sensor (KEF MI 123614) cleared Dec. 21, 2007 (K062580).

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure in profile. The logo is black and white.

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: K082540

Trade/Device Name: Entropy Sensor (REF M1038681) Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: II Product Code: GXY Dated (Date on orig SE ltr): August 12, 2008 Received (Date on orig SE ltr): September 2, 2008

Dear Mr. Kent:

This letter corrects our substantially equivalent letter of November 28, 2008.

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 (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, oood 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 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.

APR - 9 2012

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Page 2 - Mr. Joel C. Kent

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/CDRH0ffices/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

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): _

Device Name: GE Entropy Sensor (REF M1038681)

Indications for Use:

Indication for use for GE Entropy Sensor (REF M1038681)

This GL Entropy Sensor is intended to be used for adults and pediatric patients older than 2 years 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.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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

(Division Sign-Of Division of General, Restorative, and Neurological Devices

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