(92 days)
No
The description mentions a "microprocessor controlled blower based Bi-level positive pressure system" and "microprocessor controller" that regulates the blower based on flow and pressure data. The AVAPS feature is described as a "pressure control that contains various controls". There is no mention of AI, ML, or any learning algorithms. The performance studies focus on equivalence to existing therapy and bench testing, not on the performance of a learning model.
Yes
The device is intended to provide non-invasive ventilatory support to treat adult patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency, which is a therapeutic purpose.
No
The device is described as providing ventilatory support and pressure delivery, not as a tool for identifying or characterizing diseases or conditions. Its purpose is therapeutic, not diagnostic.
No
The device description clearly outlines hardware components such as a microprocessor controlled blower, flow sensor, redundant pressure sensors, and a user interface, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The BiPAP Synchrony with AVAPS is a ventilatory support system. It delivers positive pressure to a patient's airway to assist with breathing. It does not perform any tests on biological samples.
- Intended Use: The intended use is to provide non-invasive ventilatory support for treating respiratory conditions. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a system that controls airflow and pressure based on measurements from sensors in the patient airway. This is consistent with a respiratory support device, not an IVD.
Therefore, the BiPAP Synchrony with AVAPS falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BiPAP Synchrony with Average Volume Assured Pressure Support (AVAPS) is intended to provide non-invasive ventilatory support to treat adult patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. The Synchrony may be used in the hospital or home.
The Synchrony is intended for use with nasal masks and full-face masks as recommended by Respironics.
Product codes
MNS
Device Description
The Respironics BiPAP Synchrony with AVAPS 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 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 AVAPS feature is professionally selected and rides on top of the existing modality provided by the BiPAP Synchrony. The BiPAP Synchrony with AVAPS pressure control that contains various controls which are used to configure positive pressure therapies.
The BiPAP Synchrony with AVAPS is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed), others are user adjustable.
The BiPAP Synchrony with AVAPS Ventilatory Support System is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 22mm tubing, a method of venting exhaled gases and a patient device (mask).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
For use in the home or hospital/institutional environment
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Respironics performed clinical study to assure therapy provided with AVAPS was equivalent to or better than existing therapy provided without AVAPS. Results from this study determined that AVAPS is as effective as that of therapy without AVAPS. Further, a risk analysis to identify the consideration of using the existing BiPAP Synchrony electromechanical platform with the Average Volume Assured Pressure Support Ventilation therapy feature to treat adult patients with OSA and Respiratory Insufficiency. To determine equivalence between the Respironics BiPAP Synchrony with AVAPS and the Respironics BiPAP Synchrony, 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. Bench testing has confirmed that the BiPAP Synchrony with AVAPS performs equivalently to the device predicate BiPAP Synchrony (K992530/K012323/K020777). All tests were verified to meet the required acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Traditional 510(k) Tab 5 – 510(k) summary