(255 days)
WIZARD 310/320 series CPAP Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. These masks are intended for single-patient reuse in the home and multi-patient, multi-use in the hospital environment. These masks are to be used on patients greater than 30 kg for whom positive airway pressure (CPAP or bi-level system) has been prescribed.
The WiZARD 310 Nasal Mask and WiZARD 320 Full Face Mask provide an interface such that airflow from a positive pressure source is directed to the patient's nostril and mouth. The masks are held in place with adjustable headgear that straps the mask to the face. Series of vent are feature on the cushion that serves as an exhalation vent to purge the exhaled carbon dioxide from the mask. Air coming out from these holes is very diffuse and quiet. WiZARD 310/320 series CPAP mask are connected to the CPAP or bi-level system via standard 22 mm breathing tubing. A quickly-release mechanism also includes which allow the mask can be removed quickly.
The WiZARD 310 Nasal Mask and WiZARD 320 Full Face Mask are appropriate when used under the conditions and purposes intended as indicated in the labeling provided with the product. The WiZARD 310 Nasal Mask and WiZARD 320 Full Face Mask are the prescription device supplied non-sterile.
The provided text describes a CPAP mask and its FDA 510(k) clearance, which focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel acceptance criteria or a study proving a device's performance against specific clinical acceptance criteria.
Therefore, I cannot create a table of acceptance criteria and reported device performance because the provided document does not contain this information in the context of a new study proving performance. The document primarily highlights:
- Comparison to a predicate device: The core of the submission is to show the WiZARD 310/320 series CPAP Mask is substantially equivalent to the WiZARD 210/220 Series CPAP Mask (K103174) and reference devices AirFit F20 (K170924) and AirFit N20 (K171212).
- Safety and Performance Testing: Non-clinical testing was performed to demonstrate equivalent performance to the predicate device, focusing on biocompatibility and reliability.
Here's a breakdown of the information that can be extracted based on the provided text, and what information is not available within this document:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not explicitly provided as a set of clinical performance acceptance criteria with corresponding study results. The document focuses on demonstrating substantial equivalence through comparison to a predicate device and non-clinical testing.
- Instead, the document lists "performance characteristics" that are deemed similar to the predicate device. These are not acceptance criteria in the sense of demonstrating a certain level of efficacy or diagnostic accuracy. They are design and functional specifications.
Summary of "Similar Performance Characteristics" to Predicate Device:
| Item | Predicate Device (WiZARD 210/220 Series CPAP Mask, K103174) | Subject Device (WiZARD 310/320 Series CPAP Mask) | Remarks |
|---|---|---|---|
| Principles of Operation | Interface for airflow from positive pressure source | Same | Substantially equivalent |
| Patient Use Type | Adult >30 Kg | Same | Substantially equivalent |
| Indication | Obstructive sleep apnea | Same | Substantially equivalent |
| Environment | Home, Hospital | Same | Substantially equivalent |
| Reuse | Single patient multi-use for home; Multi-patient multi-use for hospital | Same | Substantially equivalent |
| Patient Support System | CPAP or bi-level system | Same | Substantially equivalent |
| Shelf Life | 5 years | Same | Substantially equivalent |
| Use of Life | 6 months | Same | Substantially equivalent |
| Mask Size | L/M/S | Same | Substantially equivalent |
| Sterility | Clean, non-sterile | Same | Substantially equivalent |
| Validated Cleaning | Warm water | Same | Substantially equivalent |
| Validated Disinfection | Thermal water/High level chemical disinfectant | Same | Substantially equivalent |
| Therapy Pressure Range | 4~20 cmH2O | WiZARD 310: 4 | Difference noted, but deemed not to raise new questions of safety/effectiveness. |
| Hose Connection | 22 mm hose | Same | Substantially equivalent |
| CPAP Tubing Connection Point | Port compliance to ISO 5356-1 | Same | Substantially equivalent |
| Swivel Connection | 360 degree rotation | Same | Substantially equivalent |
| Secure and Less-leak Interface | Single layer cushion | Same | Substantially equivalent |
| Operation Range | +5°C to +35°C, 15% to 95% R.H | Same | Substantially equivalent |
| Storage and Transport | -15°C to +60°C, 10% to 90% R.H | Same | Substantially equivalent |
| Noise (dB) |
§ 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).