(270 days)
Not Found
No
The summary describes a cutaneous sheet electrode for recording physiological signals (EEG) and mentions clinical validation for usability and signal quality, but there is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as a sensor used to record physiological signals, specifically EEG, for measurement purposes in conjunction with GE Entropy measurement devices. It does not exert any direct therapeutic action or provide treatment.
No
The device is described as a sensor that records physiological signals (such as EEG) in conjunction with GE Entropy measurement devices. While it collects data that might be used for diagnosis, the sensor itself is not described as performing analysis or interpretation to reach a diagnosis. Its function is to enable the recording of signals, which are then likely interpreted by the connected measurement device or a clinician.
No
The device is described as a "Cutaneous sheet electrode," which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to enable the recording of physiological signals (EEG) using a GE Entropy measurement device. This is a physiological monitoring function, not a diagnostic test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: It's described as a "Cutaneous sheet electrode." This is a device that makes contact with the skin to pick up electrical signals, which is consistent with physiological monitoring.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting specific substances, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function falls outside of that definition.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
GWQ, GXY
Device Description
Cutaneous sheet electrode to be used with GE Entropy measurement devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults and pediatric patients older that 2 years
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)
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).
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.
K082540 GE Entropy Sensor, K061907 Entropy Sensor
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
§ 882.1400 Electroencephalograph.
(a)
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.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters and the border are in black, creating a high-contrast design. The logo is simple and recognizable, representing the well-known multinational corporation.
JUL 1 9 2011
=
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 |
| Kuortaneenkatu 2 | |
| Helsinki FIN-00510 | |
| FINLAND | |
| Primary Contact Person: | Tommi Jokiniemi |
| RA Leader | |
| GE Healthcare Finland Oy | |
| Tel +358-10-394 6561 | |
| Fax +358-9-272 6532 | |
| Secondary Contact Person: | Mari Salmenkaita |
| RA Leader | |
| GE Healthcare Finland Oy | |
| Tel +358-10-394 2122 | |
| Fax +358-9-272 6532 | |
| 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 |
| 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 (800) 638-2041 or (301) 796-7100 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