(90 days)
The TAP PAP Nasal Pillow Mask is intended to be used by individuals who have been diagnosed by a Physician as requiring CPAP or Bi-Level ventilator treatment. The TAP PAP Nasal Pillow Mask is intended for single patient adult (>66lb/30kg) use in the home, hospital or other clinical setting.
The TAP PAP Nasal Pillow Mask consists of a boil & bite type dental appliance. A small bracket that extends beyond the lips to attach the mask frame (Mask - Upper Mouth Piece Adjustment Joint). Two soft silicone nasal pillows are located on the mask frame to seal against the nostrils. The nasal pillows come in three sizes and can be individually rotated to align with the user's nares. A corrugated flexible tube extends upwards from the mask frame to a 22 mm connector which connects to a breathing tube of a CPAP or bi-level device. The mask frame has exhalation vents (bias holes) that allow exhaled gases to be continually flushed.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: TAP PAP Nasal Pillow Mask
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Pressure Drop | No pass/fail criteria, reportable values only. (Implied: must be low enough for CPAP machines to supply required flow, and patient exhalation through mouth should have no resistance). | 50 lpm: 0.2 cm H₂O |
| 100 lpm: 0.6 cm H₂O | ||
| Bias (vent) Flow / Exhaust Flow | No pass/fail criteria, reportable values only. Should be comparable to the predicate. (Implied: Higher leak rate indicates greater CO2 washout and is not clinically significant). | 6 cm H₂O: 23 lpm |
| 10 cm H₂O: 30 lpm | ||
| 20 cm H₂O: 42 lpm | ||
| Dead Space | No pass/fail criteria, reportable values only. Should be comparable to the predicate. (Implied: Higher reported value is acceptable if CO2 washout demonstrates effectiveness). | 95 ml |
| CO2 Washout (per ISO 17510-2) | Changes in CO2 at various pressures to be |
§ 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).