(236 days)
The BiPAP® Synchrony™ HC is a non-invasive, pressure support ventilator used to
- i) Augment the breathing of patients suffering from acute or chronic respiratory insufficiency
- ii) Maintain airway patency and provide ventilatory support to patients who experience obstructive sleep apnea.
It is not intended to provide the total ventilatory requirements of the patient.
The BiPAP® Synchrony™ HC is intended for use with nasal masks and full-face masks as recommended by Respironics.
The BiPAP Synchrony is intended to provide non-invasive ventilation in adult patients (>30kg) for the treatment of respiratory insufficiency (a condition in which the patient can continue without ventilation for some period, such as overnight) or obstructive sleep apnea. The Synchrony ventilator is intended for use with nasal masks and fullface masks as recommended by Respironics.
The BiPAP® Synchrony™ HC is a noninvasive pressure support ventilator and is classified under product code MNS (continuous ventilator, non-life supporting).
The BiPAP Synchrony HC provides therapy in the Continuous Positive Airway Pressure (CPAP) Spontaneous/Timed (S/T), Pressure Assist, and Timed modes.
The provided text describes a medical device, the BiPAP® Synchrony™ HC, and its substantial equivalence to a predicate device. It details the device's functions, intended use, and various tests performed to demonstrate its safety and effectiveness. However, the document does not contain the specific information required to answer your questions about acceptance criteria and a study that proves the device meets those criteria.
Here's why and what's missing:
- No Acceptance Criteria Table: The document states that "Testing was performed to demonstrate that the performance of the BiPAP® Synchrony™ HC in its intended environment is as safe and effective as that of the legally marketed predicate device." It also mentions compliance with "standards referenced in the 'Draft FDA Reviewer Guidance for Ventilators,' July 1995 as well as with the 'Draft Reviewer Guidance for Premarket Notifications, 'November 1993." However, it does not provide a table outlining specific acceptance criteria (e.g., minimum accuracy percentages, maximum deviation values) for its performance and then reporting the device's measured performance against those criteria.
- No Study Details: While the document confirms that "performance-related testing in addition to electrical safety, electromagnetic compatibility, mechanical and environmental testing" was conducted, it does not provide any details about a specific study (e.g., clinical trial, validation study) that would assess the device's performance against predefined acceptance criteria. Therefore, information regarding sample sizes, data provenance, expert qualifications, ground truth establishment, or comparative effectiveness studies is absent.
In summary, based on the provided text, I cannot answer your request as the necessary study details and acceptance criteria are not present. The document focuses on regulatory approval (510(k) submission) by demonstrating substantial equivalence, which is a different scope than detailing specific performance studies with acceptance criteria.
§ 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).