(91 days)
Androflo™ is intended for use as an adjunct to patient assessment in continuous monitoring of respiratory rate (breathing frequency).
Androflo™ is indicated for clinical use in adult patients under the supervision of qualified health care professionals trained in the use of the equipment.
Androflo™ is not intended for home use or for use as an apnea monitor.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "ANDROFLOW-RESPIRATORY RATE MONITOR." It confirms that the device has been found substantially equivalent to a predicate device. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot fulfill your request for this information based on the provided text. To answer your questions, I would need a different document, such as a summary of safety and effectiveness (SSE) or a clinical study report that was part of the 510(k) submission.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).