(278 days)
The Watch-PAT200U (WP200U) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200U is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging (Rapid Eye Movement (REM) Sleep, Deep Sleep and Wake), snoring level and body position. The WP200U generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI"), PAT sleep staging identification (PSTAGES) and optional snoring level and body position discrete states from an external integrated snoring and body position (SBP) sensor. The WP200U's PSTAGES and SBP provide supplemental information to its PRDI/PAHI. The WP200U's PSTAGES and SBP are not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted.
The WP200U is indicated for use in patients 12 years of age or greater.
The Watch-PAT200U System (WP200U) is a non-invasive home care device for use with patients suspected to have sleep related, breathing disorders. The WP200U is a diagnostic aid for the detection of sleep related breathing disorders [Respiratory disturbance index (RDI), apnea hypopnea index (AHI)] and sleep staging (Rapid Eye Movement (REM), Light Sleep, Deep Sleep and Wake) based on Peripheral Arterial tonometry (PAT), a non-invasive technology. According to the physician discretion, the WP200U may be connected to an external integrated snoring and body position (SBP) sensor.
The WP200U device consists of the following: (1) a unified PAT and pulse oximeter probe which is used to detect the PAT signal and to measure blood oxygen saturation; (2) an embedded actigraph, which is used to determine periods of sleep based on the motion of the wrist; (3) external integrated snoring and body position sensor — SBP (Optional); (4) electronics, which include a controller that records the signals provided by the PAT finger probe, oximeter, actigraph and SBP; (5) the device software; and (6) a power supply.
The provided text describes the Watch-PAT200U (WP200U) device and outlines its substantial equivalence to a predicate device, primarily focusing on the expansion of its intended use to include an adolescent population (12 to 17 years old). The document highlights performance data and clinical studies used to support this expanded indication.
Here's an attempt to extract the requested information, understanding that certain details like specific acceptance criteria numerical values for RDI/AHI or the number of experts for polysomnography scoring are not explicitly stated in this document.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Adolescent Population) |
|---|---|---|
| PAHI Correlation (vs. PSG AHI) | High correlation required for diagnostic aid. | R = 0.92, p |
§ 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).