(87 days)
The Invacare Twilight Full Face Mask is intended to be used with positive airway pressure (PAP) devices, such as CPAP and Bi-Level, which provide 4-20 cmH2O for the treatment of adult obstructive sleep apnea. There is a port on the mask to allow for pressure measurement. The mask is to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single or multiple patient re-use.
The Twilight full Face Mask consists of a mask that fits over the nose and mouth of a patient and a headgear to hold the mask in place. The mask has a removable molded silicone cushion that seals around the patient's nose and mouth. The cushion mounts to a rigid clear plastic frame. The frame has built in exhalation ports, a full swivel for locating the pressure device hose, a tubing swivel to allow for twisting of the hose, and a built in anti-asphyxia valve to allow the inner volume of the mask to be open to the outer atmosphere when there is no pressure being supplied by the flow generator device. Mounted to the frame is an adjustable forehead support for resting against the patient's forehead. The headgear has quick release clips and loop adjustment on the straps.
The provided document describes a 510(k) Pre-market Notification for the Invacare Twilight Full Face Mask, which aims to demonstrate substantial equivalence to legally marketed predicate devices rather than necessarily proving the device meets specific acceptance criteria in a quantitative performance study. The document focuses on comparing the proposed device's specifications and intended use to those of existing devices.
Therefore, the requested information elements related to detailed study methodologies (sample size, ground truth, expert adjudication, MRMC studies, training sets) are largely not applicable in the context of this 510(k) submission, as it relies on a comparison of device characteristics and adherence to general performance standards rather than a clinical efficacy trial.
However, I can extract the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The "Acceptance Criteria" here are implicitly defined by the specifications of the predicate devices. The "Reported Device Performance" is the Invacare Twilight Full Face Mask's own specifications. Substantial equivalence is demonstrated by showing that these specifications are comparable.
| Specification | Invacare Twilight Full Face Mask (Reported Performance) | ResMed Mirage Full Face Mask Series 2 (Predicate) | Respironics Spectrum 2 Reusable Full Face Mask (Predicate) | Acceptance Criteria (Implied by Predicates) |
|---|---|---|---|---|
| Intended Use | With PAP devices (CPAP/Bi-Level, 4-20 cmH2O) for adult (>30kg) obstructive sleep apnea. Single/multiple patient re-use. | Multi-patient use for adult (>30kg) CPAP/bi-level therapy. | Adults with Respironics CPAP/bi-level devices. Covers nose/mouth. Built-in exhalation. Single/multiple patient re-use. | Comparable intended use for adult obstructive sleep apnea with PAP devices in the 4-20 cmH2O range, suitable for single or multiple patient re-use. |
| Patient Use | Adults >30Kg | Adults >30Kg | Adults | For adult patients, generally >30kg. |
| Single/Multiple Patient Use | Multiple-patient | Multiple-patient | Multiple-patient | Multiple-patient re-use. |
| Input Device Range | 4-20 cmH2O | 4-20 cmH2O | 3-40 cmH2O | Within a clinically acceptable range for PAP therapy, generally including 4-20 cmH2O. |
| Mask Frame Material | Polycarbonate | Polycarbonate | Polycarbonate | Biocompatible and durable material, such as polycarbonate. |
| Nasal Cushion Material | Silicone | Silicone | Silicone | Biocompatible and comfortable material, such as silicone. |
| Anti-asphyxia Valve | Yes - silicone | Yes - silicone | Yes - silicone | Presence of an anti-asphyxia valve, typically silicone. |
| Hose Connection Input | For Ø22mm hose | For Ø22mm hose | For Ø22mm hose | Standard Ø22mm hose connection. |
| Exhalation Ports | 5 | 6 | 44 | Sufficient exhalation ports to prevent re-breathing (specific number may vary but must be effective). |
| Swivel Connections | 360° Rotation | 360° Rotation | 360° Rotation | 360° rotation for hose flexibility. |
| Ports | 1 port (for pressure measurement) | 2 ports | 1 port (for pressure measurement) | At least one port for pressure measurement. |
| Exhaust Flow | 23 LPM @ 4 cmH2O | |||
| 53 LPM @ 20 cmH2O | 22 LPM @ 4 cmH2O | |||
| 54 LPM @ 20 cmH2O | Below 5 cmH2O, unknown | |||
| ~ 43 LPM @ 20 cmH2O | Comparable exhaust flow rates to ensure proper CO2 washout, particularly at common therapy pressures. | |||
| Pressure Drop at patient connection |
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).