(30 days)
The nasal mask is intended for prescription use to be used during nasal CPAP or Bi-level Positive Pressure therapy for adult patients (>30 kg).
The SOYALA GEL vented is a molded plastic mask, including an exhalation system, for the delivery of CPAP or Bi-level Positive Pressure therapy. It consists of a gel mask cushion, gel forehead cushion, mask frame, coarse adjustment component, fine adjustment component, forehead support, headgear clip, ports for pressure measurement, port cap, rotating sleeve, elbow, and retaining ring. The mask provides a swivel and securely attached elbow connection for simple and secure handling of the tubing between the mask and the therapy device.
The provided text describes a 510(k) premarket notification for a medical device called "SOYALA GEL vented," a nasal mask for CPAP or Bi-level Positive Pressure therapy. The submission claims substantial equivalence to a predicate device (SOYALA, K060405).
However, the document does not contain information about:
- Acceptance criteria for performance testing.
- Results of a study proving the device meets acceptance criteria.
- Sample sizes for test sets, data provenance, ground truth establishment, expert qualifications, or adjudication methods for any studies.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Training set information.
The document primarily focuses on:
- Device identification: Name, classification, product code.
- Submitter information.
- Device description: Components and intended function.
- Predicate device: Claim of substantial equivalence to SOYALA (K060405).
- FDA correspondence: A letter from the FDA stating that the device is substantially equivalent to a legally marketed predicate device and can be marketed.
- Indications for Use: "The nasal mask is intended for prescription use to be used during nasal CPAP or Bi-level Positive Pressure therapy for adult patients (>30 kg)."
Therefore, based solely on the provided text, I cannot complete the requested tables and information regarding acceptance criteria and performance studies, as this data is not present. The FDA clearance is based on substantial equivalence to a predicate device, which often relies on demonstrating similar design, materials, and intended use, rather than presenting a detailed de novo clinical outcomes study with specific performance acceptance criteria outlined in the 510(k) summary itself.
§ 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).