(112 days)
The AeroChamber MAX™ Valved Holding Chamber is intended to be used by patients who are under the care of treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.
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The provided document is a 510(k) premarket notification letter from the FDA to Trudell Medical International regarding the AeroChamber Max Valved Holding Chamber. This type of document declares substantial equivalence to a legally marketed predicate device, rather than detailing specific acceptance criteria and study results in the manner requested for an AI/ML device.
Therefore, the specific information requested about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for an AI/ML device is not available in this document.
The document primarily focuses on:
- Device: AeroChamber Max Valved Holding Chamber
- Classification: Class II
- Regulation Number: 21 CFR 868.5630 (Nebulizer)
- FDA Determination: Substantially equivalent to predicate devices.
- Intended Use: Administer aerosolized medication from Metered Dose Inhalers for patients under licensed health care provider care, in home, hospitals, and clinics.
This document does not contain the detailed performance metrics and study design typically found in a clinical trial report or a submission for AI/ML-based diagnostic/screening devices.
§ 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).