(203 days)
The Neumovent GraphNet is intended to provide continuous ventilation to patients requiring respiratory support. The device is intended for patients from neonatelinfant to adult and for a wide variety of clinical conditions. The device is intended to be used in hospital and hospitaltype facilities and during hospital and hospital-type transport provided that electrical power and compressed gas are supplied.
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I am sorry, but the provided text from the FDA letter primarily concerns the substantial equivalence determination for the "Ventilator Model Neumovent GraphNet" (K101401). It does not contain information about acceptance criteria for a study, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth, or how ground truth was established for training sets.
The letter explicitly states that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...to legally marketed predicate devices." This means the review focused on comparing the new device to existing, legally marketed devices, rather than a detailed study proving performance against specific acceptance criteria.
To answer your request, I would need a document that describes a specific study conducted for the device, including the methodology, acceptance criteria, and results.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).