(270 days)
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.
Cutaneous sheet electrode to be used with GE Entropy measurement devices.
The GE Entropy EasyFit Sensor is a cutaneous sheet electrode intended for use with GE Entropy measurement devices to record physiological signals (such as EEG) in adults and pediatric patients older than 2 years.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state quantitative acceptance criteria or a direct comparison table. However, the summary of clinical tests indicates that the device's performance was evaluated against predicate devices.
| Acceptance Criterion (Inferred from Report) | Reported Device Performance |
|---|---|
| Usability substantial equivalence to predicate device(s) | Concluded to be substantially equivalent to predicate device(s). |
| Signal quality substantial equivalence to predicate device(s) | Concluded to be substantially equivalent to predicate device(s). |
| Safety substantial equivalence to predicate device(s) | Concluded to be as safe as predicate device(s). |
| Effectiveness substantial equivalence to predicate device(s) | Concluded to be as effective as predicate device(s). |
2. Sample Size for the Test Set and Data Provenance:
The document mentions a "clinical validation test" performed "in hospital environment" but does not specify the sample size or the country of origin of the data. The study appears to be prospective, as it was a validation test performed on the proposed devices.
3. Number of Experts and Qualifications:
The document does not specify the number of experts used or their qualifications for establishing ground truth, as the focus was on demonstrated equivalence through a clinical validation study rather than expert consensus on specific diagnoses.
4. Adjudication Method:
The document does not mention any adjudication method for the test set.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
The document does not mention a MRMC comparative effectiveness study. The study described is a clinical validation test against predicate devices, focusing on usability and signal quality for substantial equivalence, not on human reader improvement with AI assistance.
6. Standalone Performance:
The submission highlights "integration testing (System verification)" and "Performance testing (Verification)," which implies testing of the device's standalone functionality. The clinical validation focused on the performance of the sensor itself (signal quality, usability) in a clinical setting when used with GE Entropy measurement devices, effectively evaluating its standalone contribution within the intended system.
7. Type of Ground Truth Used:
The ground truth used for the clinical validation test seems to be derived from the performance and characteristics of the legally marketed predicate devices (K082540 GE Entropy Sensor and K061907 Entropy Sensor). The goal was to demonstrate "substantial equivalence" to these established devices in terms of usability and signal quality.
8. Sample Size for the Training Set:
The document does not specify any training set size. This is expected, as the Entropy EasyFit Sensor is a hardware device (electrode) and not an AI/ML algorithm that requires a training set.
9. How Ground Truth for Training Set was Established:
Not applicable, as there is no mention of a training set for an AI/ML algorithm. The device is a sensor, and its evaluation focuses on its physical and electrical characteristics and performance in a clinical setting compared to its predicates.
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JUL 1 9 2011
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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 OyKuortaneenkatu 2Helsinki FIN-00510FINLAND |
| Primary Contact Person: | Tommi JokiniemiRA LeaderGE Healthcare Finland OyTel +358-10-394 6561Fax +358-9-272 6532 |
| Secondary Contact Person: | Mari SalmenkaitaRA LeaderGE Healthcare Finland OyTel +358-10-394 2122Fax +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 SensorK061907 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
§ 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).