ENTROPY EASYFIT SENSOR

K103129 · GE Healthcare · GWQ · Jul 19, 2011 · Neurology

Device Facts

• Record ID: K103129
• Device Name: ENTROPY EASYFIT SENSOR
• Applicant: GE Healthcare
• Product Code: GWQ · Neurology
• Decision Date: Jul 19, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Entropy EasyFit Sensor is intended to be used for adults and pediatric patients older that 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

Entropy EasyFit Sensor is a cutaneous sheet electrode designed for use with GE Entropy measurement devices. It functions as an interface to capture physiological signals, specifically EEG, from the patient's skin. The sensor connects to the measurement device via the GE Entropy Cable. It is intended for use in clinical environments by healthcare professionals. The device facilitates the monitoring of patient physiological states, aiding clinicians in data acquisition for patient assessment.

Clinical Evidence

Clinical validation was performed in a hospital environment to assess usability and signal quality. Results demonstrated that the Entropy EasyFit Sensor is substantially equivalent to the predicate devices in terms of safety and effectiveness.

Technological Characteristics

Cutaneous sheet electrode; designed for EEG signal acquisition; connects via GE Entropy Cable to GE Entropy measurement devices. Complies with voluntary safety and EMC standards. Development included risk analysis, design reviews, and verification/validation testing.

Indications for Use

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

Regulatory Classification

Identification

An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

Predicate Devices

• GE Entropy Sensor (K082540)
• Entropy Sensor (K061907)

Submission Summary (Full Text)

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JUL 1 9 2011

K103129

=

ノ GE Healthcare 510(k) Premarket Notification Submission

## 510(k) Summary

| 510(k) Summary | |
|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
| Date: | Oct 19th, 2010 |
| Submitter: | GE Healthcare Finland Oy<br>Kuortaneenkatu 2<br>Helsinki FIN-00510<br>FINLAND |
| Primary Contact Person: | Tommi Jokiniemi<br>RA Leader<br>GE Healthcare Finland Oy<br>Tel [phone]<br>Fax [phone] |
| Secondary Contact Person: | Mari Salmenkaita<br>RA Leader<br>GE Healthcare Finland Oy<br>Tel [phone]<br>Fax [phone] |
| Device: | Entropy EasyFit Sensor |
| Common/Usual Name: | Entropy Sensor, Electrode, Cutaneous |
| Classification Names: | 882.1400, 882.1320 |
| Product Code: | GWQ, GXY |
| Predicate Device(s): | K082540 GE Entropy Sensor<br>K061907 Entropy Sensor |
| Device Description: | Cutaneous sheet electrode to be used with GE Entropy measurement devices. |
| Intended Use: | Entropy EasyFit Sensor is intended to be used for adults and pediatric patients older that 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. |

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# GE Healthcare 510(k) Premarket Notification Submission

The Entropy EasyFit Sensor employs the same fundamental Technology: scientific technology as its predicate devices.

Determination of Summary of Non-Clinical Tests: Substantial Equivalence:

- The Entropy EasyFit Sensor and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:
- Risk Analysis .
- . Requirements Reviews
- . Design Reviews
- . Testing on unit level (Module verification)
- . Integration testing (System verification)
- Performance testing (Verification) .
- Safety testing (Verification) .
- . Simulated use testing (Validation)

### Summary of Clinical Tests:

To support EMC, safety and bench testing in demonstrating the proposed devices are equivalent to the cleared predicate devices regarding safety and effectiveness a clinical validation test was performed on the proposed devices in hospital environment.

The results of the validation conclude that both the usability and signal quality of the Entropy EasyFit Sensor are substantially equivalent to the compared predicate device(s).

- GE Healthcare considers the Entropy EasyFit Sensor to be as Conclusion: safe, as effective, and performance is substantially equivalent to the predicate device(s).

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

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

Mr. Joel Kent Regulatory Affairs Manager GE Healthcare 86 Pilgrim Road Needham, Massachusetts 02492

JUL 1 9 2011

Re: K103129 ·

Trade/Device Name: Entropy EasyFit Sensor Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWQ, GXY Dated: July 5, 2011 Received: July 6, 2011

Dear Mr. Kent:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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Page 2 - Mr. 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/CentersOf

fices/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/Saf ety/Reporta Problem/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 yours.

Anthony
Anthony D. Watson, B.S., M.S., M.B.A.

#### Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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GE Healthcare 510(k) Premarket Notification Submission

510(k) Number (if known): K103129

Device Name: Entropy EasyFit Sensor

Indications for Use:

Entropy EasyFit 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 (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schultheis

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(K) Number: K103129