(201 days)
The SILFAB model Super 2 Max N28 Compressor / Nebulizer is an ACpowered air compressor that provides compressed air for home health care use. This device is used in conjunction with a jet (pneumatic) nebulizer to convert certain inhalable drugs into an aerosol for inhalation by a patient. The device can be used with adult or pediatric patients suffering from respiratory disorders such as asthma, allergies, etc
The SILFAB model Super 2 Max N28 Compressor / Nebulizer is an ACpowered air compressor that provides compressed air for home health care use. This device is used in conjunction with a jet (pneumatic) nebulizer to convert certain inhalable drugs into an aerosol for inhalation by a patient.
I am sorry, but the provided text is a 510(k) clearance letter for a medical device (a compressor/nebulizer). It confirms that the device is substantially equivalent to a legally marketed predicate device.
This type of document does not contain information about:
- Acceptance criteria or reported device performance in a clinical study. 510(k)s often rely on demonstrating equivalence to existing devices, and detailed clinical study results with specific performance metrics are not typically included in the summary of a clearance letter.
- Sample sizes, data provenance, ground truth establishment, or expert qualifications for performance studies.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Training set details.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.
§ 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).