(367 days)
WiZARD 230 Nasal Pillow Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. This mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital environment. This mask only can be used on patients greater than 30 kg for whom positive airway pressure (CPAP or bi-level system) has been prescribed.
The WiZARD 230 Nasal Pillow Mask provides an interface such that airflow from a positive pressure source is directed to the patient's nostril. The mask is held in place with adjustable headgear that straps the mask to the face.
WiZARD 230 Nasal Pillow Mask is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.
WiZARD 230 Nasal Pillow Mask is a prescription device supplied nonsterile.
The provided document describes the acceptance criteria and the study that proves the WiZARD 230 Nasal Pillow Mask meets these criteria. This is a 510(k) premarket notification for a medical device seeking substantial equivalence to a predicate device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Requirement | Reported Device Performance |
|---|---|---|
| Biocompatibility | All materials used in the construction of the mask shall be compliant with ISO 10993-1 | PASS (All material which may contact the patient or the clinician must be biocompatible) |
| Performance | Overall performance shall be compliant to ISO17510-2 | PASS (Test items described in ISO 17510-2) |
| Safety | Overall performance shall be compliant to ISO17510-2 | PASS (Test items including cleaning/disinfection and CO2 rebreathing (normal and single fault condition)) |
| Shelf Life | Should be compliant to product specification | PASS (5 years shelf life) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). The testing appears to be conducted in a laboratory or controlled environment to meet international standards (ISO 10993-1, ISO 17510-2) rather than using patient-specific data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for a test set. The evaluation seems to be based on compliance with established international standards for medical devices and their materials.
4. Adjudication Method
The document does not describe an adjudication method. The "testing" referred to is compliance testing against ISO standards for performance, safety, and biocompatibility, which typically involves objective measurements and pass/fail criteria rather than expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed. This is a device for delivering CPAP therapy, and the evaluation is primarily focused on its physical and functional compliance with safety and performance standards, not on interpretation of medical images or diagnostic accuracy.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This question is not applicable. The WiZARD 230 Nasal Pillow Mask is a physical medical device, not an algorithm or AI system. Its performance is evaluated based on its physical characteristics, material safety, and functional capabilities in delivering airflow, as per ISO standards.
7. Type of Ground Truth Used
The "ground truth" for the acceptance criteria is based on international standards for medical devices:
- ISO 10993-1: For biocompatibility of materials.
- ISO 17510-2: For the performance and safety of respiratory protective devices.
8. Sample Size for the Training Set
This question is not applicable. As the device is a physical product and not an AI or machine learning model, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as above.
§ 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).