(51 days)
The Trek S nebulizer compressor is a portable, DC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The Trek S is intended for adult and pediatric patients.
The Trek S nebulizer compressor is a portable, DC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The Trek™ S is intended for adult and pediatric patients. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments.
The provided document, K060357, describes a 510(k) submission for the PARI Trek™ S nebulizer compressor. This device is a nebulizer compressor, which is a mechanical device, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies (such as ground truth, expert adjudication, MRMC studies, training set, etc.) are not applicable in this context.
The submission focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and non-clinical performance summaries.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured Performance) | Reported Device Performance (PARI Trek™ S) |
|---|---|
| Total Output Rate (TOR) | Comparable to predicate devices |
| Mass Median Diameter (MMD) | Comparable to predicate devices |
| Volume % |
§ 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).