(87 days)
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.
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.
The provided document is a 510(k) Premarket Notification summary for the GE Entropy Sensor (REF M1038681). This document does not contain a detailed study proving the device meets specific acceptance criteria in the way a clinical trial or performance study report typically would.
Instead, this 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (GE Entropy Sensor REF M1123614, cleared Dec. 21, 2007 (K062580)). The primary changes described for the new device are:
- Labeling modification to incorporate pediatric use in patients older than 2 years. This claim is based on the predicate device's associated GE Entropy measurement device (K061907) being cleared for pediatric use.
- Internal wire rerouting and removal of a shrink wrap/flag sticker to change electrode order from 2-1-3 to 1-2-3, solely for improved usability, with no impact on form, fit, function, safety, or effectiveness.
Therefore, the document does not present a study with specific acceptance criteria, sample sizes, expert ground truth, or MRMC studies that would typically be associated with proving a device's performance against new clinical metrics. The "acceptance criteria" are instead compliance with recognized standards and a demonstration that the minor changes made to the sensor do not introduce new questions of safety or effectiveness compared to the predicate.
Here's the information based on the provided text, categorized to match your request, while highlighting the absence of typical performance study details:
Acceptance Criteria and Device Performance (as inferred from the 510(k) document)
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Safety and Effectiveness: No new questions of safety and effectiveness compared to the predicate device. | The GE Entropy Sensor (REF M1038681) is "substantially equivalent in safety and effectiveness" to the predicate GE Entropy Sensor (REF M1123614). The changes (labeling for pediatric use, internal wire rerouting for usability) do not affect form, fit, function, safety, or effectiveness. The basis for pediatric use is the FDA clearance of the associated measurement device (K061907) for pediatric patients older than 2 years. |
| Compliance with Recognized Standards: Adherence to relevant national and international medical device standards. | The device has been assessed against and found to comply with the following standards (no differences in standards compared to the predicate): |
- 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, -10 (Biological evaluation of medical devices)
- ISO 14971:2000 (Medical devices -- Application of risk management to medical devices) |
| Functionality: Ability to record physiological signals (EEG, FEMG) via 3 pre-gelled electrodes. | The device is a "sensor assembly with three (3) pre-gelled EEG electrodes" designed to "record electrophysiological (such as EEG and FEMG) signals." The changes made (electrode order) do not affect this core function and "improves usability." |
| Biocompatibility: Safe for skin contact. | Assessed against ISO 10993-1, -5, -10 "Biological evaluation of medical devices." |
Since this is a 510(k) for substantial equivalence based on minor non-clinical changes and leveraging prior clearances of associated devices, the following requested information is not applicable or not provided in this type of submission:
- Sample size used for the test set and the data provenance: Not applicable; no specific clinical test set for performance evaluation is described. The assessment is based on design changes and standard compliance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no ground truth establishment for a test set is described.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable; this device is an EEG sensor, not an AI diagnostic algorithm, and no MRMC study is mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable; this is a sensor, not an algorithm.
- The type of ground truth used: Not applicable; no new ground truth was established for performance evaluation of the sensor itself, beyond compliance with standards and the predicate device's existing performance.
- The sample size for the training set: Not applicable; this is a physical sensor, not a machine learning model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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).