(160 days)
The MATRx plus is indicated for use by a lay person in a home and hospital use under the direction of a Health Care Professional (HCP).
MATRx plus records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse, respiratory effort and body position during sleep.
MATRx plus uses these recordings to produce a report for the HCP that may aid in the diagnosis and assessment of sleep disordered breathing for adult patients.
The MATRx plus device may also be used with an automated mandibular positioner that uses feedback control to record changes in the patient's respiratory status related to repositioning of the mandible during an overnight study.
MATRx plus uses these recordings to produce a report for the HCP that can be used to prospectively identify patients with mild to moderate obstructive sleep apnea who may be suitable for oral appliance therapy and to recommend a target mandibular position.
The use of the device does not replace the need for follow-up testing to determine the initial and ongoing effectiveness of the therapy as recommended by clinical practice guidelines.
MATRx plus is a ventilatory effort recorder and closed loop auto-titration device for oral appliances. MATRx plus is a 5-channel battery-powered respiratory pressure sensor and oximetry system. MATRx plus provides recordings of respiratory pressure, snoring, respiratory effort, pulse rate, oxygen saturation, and body position during sleep.
The device is worn on the patient's abdomen attached to a reusable effort belt and all relevant respiratory information during sleep is collected via nasal cannula, pulse oximetry module, and respiratory effort sensor. The disposable plastic nasal cannula is connected to the MATRx plus recorder and fixed at the patient's nose. The cannula is dual lumen and functions to individually sample the pressure from each naris. The oximetry sensor is fixed at the patient's finger and connects directly to the device. The Recorder receives input from the sensors and wirelessly transmits the data to a bedside Tablet during the study. The Tablet is set up through a connection to the web portal by the healthcare professional (HCP) prior to deploying the device to the patient for home use. The Tablet runs the MATRx plus application and records and stores the data. The MATRx plus application on the Tablet is also used to guide the user through the set up and conduct of the study through a stepwise user interface. At the end of a recording, the Tablet advises the patient if sufficient data for analysis were recorded during the night.
During an auto-titration study, the patient wears temporary Titration Trays connected to a mandibular positioner. During the study, the device moves the mandible in response to respiratory events in order to determine if the patient is a suitable candidate for oral appliance therapy.
After recording, the MATRx plus must be returned to the HCP. The data are automatically uploaded to the secure Portal where they can be accessed and downloaded to the Data Viewer. The Data Viewer can generate a report with the recorded and analyzed data (respiratory pressure, respiratory effort, pulse rate, oxygen saturation) to aid in diagnosis (when used as a ventilatory effort recorder) or to assist the HCP in the clinical management of oral appliance therapy for patients with obstructive sleep apnea.
The device is intended to be used on adult patients, upon referral from their healthcare provider.
The device is not to be used as an apnea monitor or in a life supporting or life sustaining situation and must not be used in the vicinity of an MRI device.
The MATRx plus device underwent non-clinical and clinical testing to demonstrate its substantial equivalence to its predicate device (K191925).
Here's an breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Single Arm Study (Prediction of Outcome for Mild/Moderate Sleep Apnea Patients) | |
| Sensitivity (LCL) > 0.60 (against established clinical endpoints for responder/non-responder prediction) | Sensitivity = 97.1% (LCL = 84.7%) |
| Target Accuracy (LCL) > 0.60 | Target Accuracy = 90.9% (LCL = 75.7%) |
| Cross-over Study (Non-inferiority in Predictive Accuracy compared to Predicate Device) | |
| Predictive accuracy non-inferiority margin: 0.125 (compared to predicate device) | Predictive accuracy demonstrated to be non-inferior to the predicate device with a negligible mean target accuracy difference of 0.17 mm. ("meaning the difference was less than 0.125, but not explicitly stated what percentage it was exactly") |
| Mean target accuracy difference |
§ 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).