(131 days)
The Gereonics Ultra-Piezo Respiratory Effort Sensor is intended for use in sleep disorders studies to measure respiratory effort for monitoring or recording on a physiological recording system. The Ultra-Piezo Respiratory Effort Sensor is NOT intended for use as an Apnea Alarm.
The Gereonics Ultra-Piezo Respiratory Effort Sensor is intended for use in Sleep Disorders Testing for the measurement of respiratory effort and frequency. It is designed for use with a bioamplifier attached to a physiological recording system. The Respiratory Effort Strap Sensor utilizes a processed polyvinylidene fluoride plastic film sensor as the detector for breathing motion. The small breathing deflection of the human body, typically measured on the stomach (abdomen) or chest (thorax), creates a small voltage in the piezoelectric plastic film sensor. There is no external voltage supply -- the sensor stressed by inhalation and exhalation directly converts motion to voltage. A passive low pass electronic filter is connected directly to the sensor and filters out frequencies above 15 Hertz to minimize noise and allow breathing frequencies to be monitored. The output from the passive filter, typically +/- 200 to 300 microvolts at 0.1 Hz, is connected to a bioamplifier in the physiological recording system where the signal is amplified for monitoring or recording. The sensor is secured to the body using a one inch wide strap system of Velcro hook and elastic loop material.
The provided text describes a medical device, the Gereonics Ultra-Piezo Respiratory Effort Sensor, and its equivalence to legally marketed predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically found for performance-based medical devices.
Instead, the submission focuses on demonstrating substantial equivalence to existing devices on the market (Pro-Tech, Inc.'s Crystal Trace Respiratory Effort Sensor and an EPMS, Inc. product). This means that the device is deemed safe and effective because it is very similar to devices that have already been cleared by the FDA.
Therefore, many of the requested items (e.g., sample sizes, ground truth establishment, MRMC studies, standalone performance) are not applicable to this type of 510(k) submission, as it relies on a comparison rather than a de novo performance study against defined acceptance criteria.
Here's a breakdown of the information that is available and what is not:
Acceptance Criteria and Device Performance Study (Not Applicable for this Submission Type)
The document explicitly states the device is cleared based on demonstrating substantial equivalence to predicate devices, not on a performance study against specific acceptance criteria. This section would typically contain information from a prospective clinical trial or detailed engineering verification/validation tests. Such information is not present in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
Not directly applicable. The submission does not define specific "acceptance criteria" in terms of performance metrics (like sensitivity, specificity, accuracy) that the device had to meet through a dedicated study. Instead, the "acceptance" was based on demonstrating similar design, composition, and function to previously cleared devices.
The table provided in the text compares features for substantial equivalence:
| Features | Gereonics | Pro-Tech |
|---|---|---|
| Velcro hook and loop elastic straps | Yes | Yes |
| Various strap sizes for adult and pediatric use | Yes | Yes |
| Plastic film piezo sensor | Yes | Yes |
| Built-in passive electronic filter | (at sensor) | (molded in cable) |
| Termination of about 8 foot cable with | ||
| DIN 45-802 Safety Connectors | Yes | Yes |
| Connects to physiological recording system | Yes | Yes |
| Comparable voltage output | Yes | Yes |
| Completely passive system | ||
| No batteries or power supply | Yes | Yes |
| Velcro, Inc. strap width | 1 inch | 1.5 inches |
| Materials in contact with body | Velcro loop | Velcro loop |
| & elastic |
Reported Device Performance: The document states the device provides a "Comparable voltage output" to the predicate device (Pro-Tech). This is the closest statement to performance, but it's a comparative statement rather than a specific performance metric against a defined threshold. The typical output is described as "+/- 200 to 300 microvolts at 0.1 Hz."
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No test set or clinical study data is described or referenced for the Gereonics device in this document, as the submission relies on substantial equivalence. Data provenance for performance testing is therefore not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. No test set requiring expert ground truth establishment is described.
4. Adjudication Method for the Test Set
Not applicable. No test set is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. No MRMC study is mentioned. The clearance is based on substantial equivalence to existing devices, not a study of human readers' improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a passive sensor, not an AI algorithm. No standalone performance study (in the context of an AI algorithm) was conducted or is relevant. The device output is intended to be amplified and monitored/recorded by a physiological recording system.
7. The Type of Ground Truth Used
Not applicable. Pertaining to the Gereonics device itself, no ground truth data (expert consensus, pathology, outcomes) was used for a performance study. The ground truth for its "performance" is implicitly the established performance of the legally marketed predicate devices it is compared to for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, no training set exists for this device.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).