(90 days)
No
The description focuses on microprocessor control and automatic pressure adjustments based on sensor data, which is typical for advanced respiratory devices but does not explicitly mention or describe the use of AI or ML algorithms for learning or adaptation beyond pre-programmed logic. The "Not Found" entries for mentions of AI/ML and training/test sets further support this conclusion.
Yes
The device description explicitly states its intended use is to "provide non-invasive ventilatory support to treat adult patients with OSA and Respiratory Insufficiency." This function directly addresses a medical condition, qualifying it as therapeutic.
No
The provided text describes the BiPAP AutoSV as a device for providing ventilatory support and pressure therapy to treat conditions like OSA and respiratory insufficiency. It does not mention any function for diagnosing patients.
No
The device description clearly outlines hardware components such as a microprocessor controlled blower, flow sensor, redundant pressure sensors, and a user interface display, indicating it is a physical device with integrated software, not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide non-invasive ventilatory support to treat patients with specific respiratory conditions. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a system that delivers positive pressure to the patient's airway. It measures flow and pressure to regulate this delivery. This is consistent with a respiratory support device, not a device that analyzes biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly designed to provide therapy by assisting with breathing, which falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BiPAP AutoSV is intended to provide non-invasive ventilatory support to treat adult patients with OSA and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing.
Product codes (comma separated list FDA assigned to the subject device)
MNS
Device Description
The Respironics BiPAP AutoSV is a microprocessor controlled blower based Bi-level positive pressure system that delivers two positive pressure levels (IPAP/EPAP). The dual pressure levels provide a more natural means of delivering pressure support therapy to the patient resulting in improved patient comfort. A flow sensor and redundant pressure sensors in the patient airway feed data on measured flow and pressure into a microprocessor controller, which in turn regulates the blower assembly. A user interface displays clinical data and enables the operator to set and adjust certain clinical parameters.
The BiPAP AutoSV pressure control that contains various which are used to configure positive pressure therapies. With these controls, the device delivers minimum pressure support determined by the EPAP and IPAP Min controls. The device may automatically provide additional pressure support with inspiratory pressures between IPAP Min and IPAP Max to normalize patient ventilation during sleep disordered breathing events. Note: When EPAP
§ 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).
0
Abbreviated 510(k) Tab 5 - 510(k) summary
Date of Submission 22 November 2006
Official Contact Zita A. Yurko Manager, Regulatory Affairs Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668 Zita.yurko@respironics.com
724-387-4120 t 724-882-4120 с 724-387-4216 f
Classification Reference 21 CFR 868.5895
Product Code
Common/Usual Name Ventilator, continuous, non-life supporting
Proprietary Name Respironics BiPAP AutoSV Ventilatory Support System
MNS – Non-Continuous ventilator
Predicate Device(s) Respironics BiPAP Synchrony HC (K992530) Respironics BiPAP Synchrony S/T (K012323) Respironics BiPAP Harmony (K031656) Resmed VPAP III ST-A / Kidsta system (K060105)
Reason for submission new device
Substantial Equivalence
The BiPAP AutoSV has the following similarities to the previously cleared predicate device:
- 0 Same intended use.
- Same operating principle. D
- Same technology. 0
1
Tab 5 – 510(k) summary
O Same manufacturing process.
The BiPAP Synchrony was cleared in K992530/K012323/K020777. The VPAP Adapt was cleared in K051364. Respironics has performed a risk analysis to identify the consideration of using the existing BiPAP Synchrony electromechanical platform with the AutoSV algorithm to treat adult patients with OSA and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing. To determine equivalence between the Respironics BiPAP AutoSV and the Resmed VPAP Adapt, comprehensive bench testing was performed. This testing including collecting waveform performance data, triggering data, alarms data, and overall event diction and control data for comparison to the VPAP Adapt. Bench testing has confirmed that the BiPAP AutoSV performs equivalently to the device predicate VPAP Adapt (K051364). All tests were verified to meet the required acceptance criteria.
Intended Use
The BIPAP AutoSV is intended to provide non-invasive ventilatory support to treat adult patients with OSA and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing.
Device Description
The Respironics BiPAP AutoSV is a microprocessor controlled blower based Bi-level positive pressure system that delivers two positive pressure levels (IPAP/EPAP). The dual pressure levels provide a more natural means of delivering pressure support therapy to the patient resulting in improved patient comfort. A flow sensor and redundant pressure sensors in the patient airway feed data on measured flow and pressure into a microprocessor controller, which in turn regulates the blower assembly. A user interface displays clinical data and enables the operator to set and adjust certain clinical parameters.
The BiPAP AutoSV pressure control that contains various which are used to configure positive pressure therapies. With these controls, the device delivers minimum pressure support determined by the EPAP and IPAP Min controls. The device may automatically provide additional pressure support with inspiratory pressures between IPAP Min and IPAP Max to normalize patient ventilation during sleep disordered breathing events. Note: When EPAP