(111 days)
The Hsiner Pediatric CPAP Silicone Nasal Mask is intended to be use with patients (> 30 kg) who have been prescribed CPAP/VPAP therapy in a home, hospital or institutional environments. This device is intended to be use under the specific direction of a physician.
The Hsiner Nasal Pillow Mask is intended to be use patients (> 30 kg) who have been prescribed CPAP/VPAP therapy in a home, hospital or institutional environments. This device is intended to be use under the specific direction of a physician.
Hsiner's Pediatric CPAP Silicone Nasal Mask and Hsiner's Nasal Pillow Mask are both product line extensions to their existing line of CPAP interface devices for the application of CPAP/VPAP therapy.
The provided 510(k) summary (K120920) describes the acceptance criteria and the study that proves the device meets them.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ISO 17510-2:2007) | Reported Device Performance |
|---|---|
| Resistance to flow | Well below the requirement |
| CO₂ rebreathing | Well below the requirement |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of clinical data. The performance evaluation was conducted according to technical standards (ISO 17510-2). The document indicates "No clinical test was performed for this device." Therefore, there is no sample size for a clinical test set, nor data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable as no clinical study or ground truth established by experts was performed for the performance evaluation. The evaluation was based on engineering measurements against a technical standard.
4. Adjudication Method for the Test Set
Not applicable as no clinical study or expert adjudication was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The device is a physical medical device (CPAP masks), not an AI-assisted diagnostic or imaging device, so this type of study is not relevant.
6. Standalone (Algorithm Only) Performance
Not applicable. The device is a physical medical device, not an algorithm. The performance evaluation was conducted on the physical properties of the masks.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation was established by the technical requirements and thresholds defined in ISO 17510-2: "Sleep apnea breathing therapy-Part 2: Masks and application accessories." This is a set of engineering standards, not expert consensus, pathology, or outcomes data in the traditional sense of a clinical study.
8. Sample Size for the Training Set
Not applicable. The device is a physical medical device; there is no "training set" like there would be for a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as point 8.
§ 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).