(436 days)
The V8800 Critical Care Ventilator is an electronically controlled, powered machine intended to provide continuous ventilation to patients with respiratory failure or respiratory insufficiency, requiring respiratory support.
The V8800 Critical Care Ventilator may be used by trained professional health care providers under the supervision of a physician.
The V8800 Critical Care Ventilator is intended for patients ranging from pediatric to adult, and for use in a wide variety of clinical conditions. Specifically, the V8800 Critical Care Ventilator is applicable for adult and pediatric patients weighing at least 3.5 kg (7.7 Ibs.), who require the following types of ventilator support: Positive Pressure Ventilation, delivered invasively (by ET or Tracheotomy tube) or non-invasively (by mask) via Assist/Control, SIMV, CPAP and other modes of ventilation.
The V8800 Critical Care Ventilator is not intended for use with neonatal pediatric patients weighing less than 3.5 kg (7.7 lbs.) whose approximate age range is from birth to 1 month of age.
The V8800 Crtical Care Ventilator is intended for use in hospital-type facilities. It may be used during intra-hospital transport provided that electrical power and compressed gas are supplied.
The V8800 Critical Care Ventilator is an electronically controlled, powered machine intended to provide continuous ventilation to patients with respiratory failure or respiratory insufficiency, requiring respiratory support.
I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter for a medical device (Oricare V8800 Critical Care Ventilator) and an "Indications for Use Statement."
While it confirms the device's regulatory clearance and intended use, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment details as requested in your prompt.
Therefore, I cannot extract the information needed to fill out your table and elaborate on the study details.
§ 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).