(217 days)
For Inhalation and Humidification by way of Sterile Water in a closed system during Inhalation Therapy.
This product is Sterile Water with Saline for Inhalation Therapy. It is packaged in a closed system and it is disposable after one use. The water is sterile and endotoxin free according to the USP. The product is used for Inhalation and Humidification during Inhalation Therapy.
The provided text describes a 510(k) summary for the RESPIFLO/S device, which is a "Sterile Water with Saline for Inhalation Therapy." However, the document does not contain information relevant to the acceptance criteria or study design for an AI/algorithm-based medical device as requested in the prompt.
The document discusses:
- The product name and classification.
- A legally marketed device to which substantial equivalence is claimed (Hudson RCI AQUAPAK/S).
- A description and intended use of the RESPIFLO/S device (Sterile Water with Saline for Inhalation Therapy).
- A summary of technological characteristics, stating it's "the exact same in nature and design as a currently marketed" product.
- A summary of test data, mentioning sterile water with saline according to USP, endotoxin-free, 3-year and 5-year stability testing, and a closed/disposable system. It refers to "Confidential Testing, Methods and Results" in Section 11, which is not provided.
Therefore, I cannot provide the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, as the document pertains to a physical medical product (sterile water with saline) and not an AI or algorithm-based device.
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).