(71 days)
A hand-held nebulizer to aerosolize commonly prescribed liquid drugs (except pentamadine) for inhalation by patients in the Home, Hospital and Nursing Home settings - anywhere aerosolized drug delivery is utilized.
The Inspired Medical Products Sidestream Nebulizer is identical to the Medic-Aid Sidestream Nebulizer cleared under K924123.
Made of three components - top, baffle, base.
Materials in contact with patient - polypropylene.
Provided clean, non-sterile.
The provided text is a 510(k) premarket notification for a medical device called the "Sidestream Drug Nebulizer." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and performance studies in the way an AI/ML device might.
Therefore, the document does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML device. Specifically:
- It does not mention a test set, training set, ground truth, expert consensus, MRMC studies, or standalone performance results.
- It does not involve detailed performance metrics like sensitivity, specificity, or accuracy that would be associated with AI/ML diagnostic tools.
Instead, the document's purpose is to demonstrate that the new "Sidestream Drug Nebulizer" is substantially equivalent to existing predicate devices (Medic-Aid Sidestream Nebulizers K924123 and K914152B) based on comparable intended use, environment of use, patient population, design, materials, and performance standards. The key finding is stated as: "There are no differences in performance, safety, or efficacy between the intended device and the predicates."
If this were an AI/ML device, the acceptance criteria and study information would be crucial. However, for this traditional medical device submission, the "study" is a comparison to predicates, and the "acceptance criteria" are satisfied by demonstrating this substantial equivalence.
§ 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).