(75 days)
The ComfortLite Nasal Mask is intended to provide an interface for application of CPAP or bi-level therapy for the treatment of Obstructive Sleep Apnea. The mask is for use in the home or hospital/institutional environment on adults.
The ComfortLite Nasal Mask is a nasal interface for application of non-invasive CPAP or bi-level therapy. The mask consists of a nasal interface with a built-in exhalation device, interface adjustment mechanisms, and 6" of standard 22 mm tubing connected to a crown swivel (elbow) for connection to the CPAP or Bi-level device. The mask is supported by a baseball-cap type headgear to allow a seal with the patient's nostrils via the nasal interface.
The mask is available with three types of nasal interface: simple cushion, direct seal cushion, and nasal pillow. The nasal interface may be adjusted vertically by an extension tube twist mechanism and horizontally by an angle selector. In addition, a thin, bendable support stabilizer arm is located on the outer body of the direct seal cushion and nasal pillow to allow for more fine adjustment of these nasal interfaces. The mask has a built-in exhalation device, thus no separate exhalation device is needed.
The mask directs standard 6 ft. 22 mm tubing, provided with a CPAP or Bi-level device, over the user's head.
The provided text describes a 510(k) premarket notification for the ComfortLite Nasal Mask, where the manufacturer states that "Design verification tests were performed on the ComfortLite Nasal Mask as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria." However, the document does not provide specific details about the acceptance criteria or the actual results of these tests. It only makes a general statement that the device met them.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about the study that proves the device meets specific acceptance criteria based on the provided text.
The document focuses on demonstrating substantial equivalence to predicate devices and describing the device itself. It does not contain the detailed reporting of design verification test results or the underlying study methodology that would typically include the information requested.
§ 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).