(150 days)
The Synchrony is intended to provide non-invasive ventilation in adult patients (>30 kg) 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 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.
The Respironics BiPAP Synchrony Ventilatory Support System is a microprocessor controlled blower based Bi-level positive pressure system that delivers two different 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. Respironics is modifying the existing device with the addition of 3 alarms, expanding the EPAP setting to 30 cmH2O and adding a remote control accessory for use in a clinical setting. The BiPAP Synchrony 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 interface device.
This 510(k) submission (K012323) is for a modification to the Respironics BiPAP Synchrony Ventilatory Support System, specifically adding 3 alarms, expanding the EPAP setting to 30 cmH2O, and adding a remote control accessory. It is a modification to an existing device, not a new device requiring extensive clinical studies with human readers or AI.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "Design verification tests were performed on the Respironics BiPAP Synchrony Ventilatory Support System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria."
However, the specific acceptance criteria and the detailed performance results (e.g., alarm thresholds, EPAP accuracy, remote control reliability) are NOT explicitly provided in the public summary. The 510(k) summary typically contains a high-level overview. Detailed test reports would be part of the full 510(k) submission, which is not publicly released in its entirety.
Table Placeholder (based on general understanding of device modifications):
| Acceptance Criteria Category | Specific Criteria (Inferred/Generic) | Reported Device Performance |
|---|---|---|
| New Alarms | Alarms activate correctly for specified conditions (e.g., low pressure, high pressure, disconnect). | "Verified to meet the required acceptance criteria." (Specifics not provided) |
| Alarm audibility and visibility meet relevant standards. | "Verified to meet the required acceptance criteria." (Specifics not provided) | |
| Expanded EPAP Setting | EPAP delivery accuracy across the expanded range (up to 30 cmH2O). | "Verified to meet the required acceptance criteria." (Specifics not provided) |
| EPAP stability under varying conditions. | "Verified to meet the required acceptance criteria." (Specifics not provided) | |
| Remote Control | Remote control functionality (e.g., start/stop, pressure adjustments) works reliably. | "Verified to meet the required acceptance criteria." (Specifics not provided) |
| Remote control range and interference resistance. | "Verified to meet the required acceptance criteria." (Specifics not provided) | |
| Overall Safety | No new safety hazards introduced by modifications. | "Modifications have no impact on the safety and effectiveness of the device." |
| Overall Effectiveness | Device continues to provide non-invasive ventilation as intended. | "Modifications have no impact on the safety and effectiveness of the device." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size for the test set or the data provenance. Design verification tests generally involve testing multiple units of the modified device. Given this is a device modification (not a clinical study of diagnostic accuracy), the "test set" would refer to the units of the device being tested, not patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable to this 510(k) submission as it describes a modification to a medical device's hardware/software features, not a diagnostic or prognostic algorithm that requires expert consensus on ground truth from clinical data. The "ground truth" for this type of submission is defined by engineering specifications and regulatory standards.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving interpretation of medical data, where there might be disagreement among experts. For device design verification, a pass/fail criterion based on pre-defined specifications is typical.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks. This submission is about a device modification, not a diagnostic AI tool.
6. If a Standalone (Algorithm Only) Performance Study Was Done:
No, a standalone (algorithm only) performance study was not done. This concept is for AI algorithms separate from a human operator. The modifications here are integrated features of the BiPAP Synchrony device.
7. The Type of Ground Truth Used:
The ground truth used for these design verification tests would be engineering specifications and performance requirements for the alarms, EPAP delivery, and remote control functionality, as well as adherence to relevant regulatory standards (e.g., for safety, EMC). It is not clinical ground truth like pathology, expert consensus on images, or outcomes data, as this is not a diagnostic or treatment outcome study.
8. The Sample Size for the Training Set:
This information is not applicable. "Training set" refers to data used to train machine learning models. This 510(k) describes a traditional medical device modification, not an AI/ML-driven device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as #8.
§ 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).