(90 days)
The Respironics BiPAP Synchrony 2 is intended to provide non-invasive ventilation for pediatric patients 7 years or older (> 40 lbs) and adult patients (> 66 Ibs) with respiratory insufficiency or obstructive sleep apnea, in the hospital or home.
The Respironics BiPAP Synchrony 2 Ventilatory Support System 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 Synchrony 2 also has a CPAP mode in which a fixed pressure is delivered and four bilevel operating modes which determine how the changes between IPAP and EPAP pressures are made, Spontaneous, Spontaneous/Timed, Timed and Pressure Control.
The BiPAP Synchrony 2 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 2 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 the Mirage Kidsta mask (K060105).
Acceptance Criteria and Performance Study for BiPAP Synchrony 2
The provided document describes the predicate device comparison and bench testing performed for the BiPAP Synchrony 2 Ventilatory Support System, particularly for its expanded indication for pediatric patients. Since this is an abbreviated 510(k) submission, the full details of the specific acceptance criteria tables and complete study reports are not always provided in this summary. However, based on the text, we can infer the type of criteria and the nature of the study.
Note: The document explicitly states that the device is a "Non-Continuous ventilator" and "non-life supporting." This context is important as the rigor of testing and acceptance criteria can differ significantly from life-supporting devices.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the submission focuses on demonstrating equivalence to predicate devices and expanding a pediatric indication primarily through bench testing, the acceptance criteria are generally established against the performance of the predicate devices or relevant industry standards for ventilator performance.
| Acceptance Criteria Category | Description of Acceptance Criteria (Inferred from text) | Reported Device Performance (Inferred from text) |
|---|---|---|
| Equivalence to Predicate Devices | Performance of BiPAP Synchrony 2 should be equivalent to or better than the predicate devices (BiPAP Synchrony HC, S/T, Harmony, and Resmed VPAP III ST-A / Kidsta system) for the intended use, operating principle, and technology. | Confirmed: "The BiPAP Synchrony 2/ Kidsta system has the following similarities to the previously cleared predicate device: Same intended use. Same operating principle. Same technology." "Bench testing has confirmed that the BiPAP Synchrony 2 performs equivalently to the device predicate VPAP III ST-A (K060105)." |
| Pediatric Use (Safety & Efficacy) | Demonstrated safety and efficacy for pediatric patients (7 years and older > 40 lbs) without introducing new risks compared to adult use. | Confirmed: "Respironics has performed a risk analysis to identify the additional considerations of using the BiPAP Synchrony 2 / Kidsta system on pediatric patients (> 7 years and > 40 lbs). Additional testing... was performed to ensure the safety and efficacy..." "We conclude that the existing and cleared adult indications for use can be safety and effectively applied to pediatric patients (> 7 years and > 40 lbs)." |
| Pressure Performance | Delivery of specified and consistent pressure levels (IPAP/EPAP), and CPAP modes within acceptable limits. | Confirmed: "This testing included, pressure performance... All tests were verified to meet the required acceptance criteria." |
| Waveform Performance | Accurate and stable delivery of pressure waveforms. | Confirmed: "This testing included... waveform performance... All tests were verified to meet the required acceptance criteria." |
| Triggering & Cycling | Correct and responsive triggering (initiation of breath) and cycling (termination of breath) mechanisms. | Confirmed: "This testing included... triggering, cycling... All tests were verified to meet the required acceptance criteria." |
| Alarm Functionality | Proper function of both pre-set and user-adjustable alarms. | Confirmed: "This testing included... alarm functionality testing. All tests were verified to meet the required acceptance criteria." |
| Kidsta Mask Compatibility | Demonstrated compatibility and performance when used with the Mirage Kidsta mask. | Confirmed: "Additionally bench testing was performed to demonstrate compatibility of the Kidsta mask (K060105) with the BiPAP Synchrony." |
2. Sample Size for the Test Set and Data Provenance
The study described primarily involves bench testing.
- Sample Size: The document does not specify the exact number of units or test cycles used in the bench testing. It refers to "additional testing" and "bench testing" which implies a sufficient number of tests were conducted to cover the various performance parameters.
- Data Provenance: The testing was conducted by Respironics, Inc., presumably at their facilities. The data is thus prospective, generated specifically for this submission. The country of origin of the data is the United States.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. This was not a clinical study involving human patients or ground truth established by medical experts in the context typically seen for diagnostic AI/ML devices. The "ground truth" for this device's performance was established through engineering specifications, regulatory standards, and comparison to predicate device performance, which would have been validated by Respironics' internal engineering and quality assurance teams.
4. Adjudication Method for the Test Set
N/A. As this was primarily bench testing against engineering specifications and predicate device performance, there was no adjudication method in the traditional sense involving multiple human readers/experts. Performance verification was likely based on measured values falling within predefined tolerance bands relative to specifications or predicate device performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not performed. This type of study is typically conducted for diagnostic devices where human readers interpret results, and the AI system aims to assist or improve their performance. The BiPAP Synchrony 2 is a therapeutic device (ventilator) and the submission focuses on its mechanical performance and safety.
6. Standalone (Algorithm only without human-in-the-loop performance) Study
N/A. This device is not an algorithm-only device. It is a physical medical device (ventilator) with integrated software/firmware for controlling its mechanical functions. The performance described is inherently that of the device operating as intended, without a direct "human-in-the-loop" evaluative component in the same way an AI diagnostic tool would be assessed.
7. Type of Ground Truth Used
The ground truth used for this submission's testing was:
- Engineering Specifications: Performance parameters (pressure, waveform, triggering, cycling, alarms) were likely measured against predefined internal engineering specifications and relevant industry standards for non-invasive ventilators.
- Predicate Device Performance: Performance data from the legally marketed predicate devices (Respironics BiPAP Synchrony HC, S/T, Harmony, and Resmed VPAP III ST-A / Kidsta system) served as a benchmark for demonstrating equivalence.
- Risk Analysis Outcomes: The pediatric indication added considerations from a risk analysis, which would have informed specific test requirements to ensure safety and efficacy in that population based on clinical understanding.
8. Sample Size for the Training Set
N/A. This device is not an AI/ML device in the sense that it requires a "training set" for an algorithm. It is a microprocessor-controlled mechanical device. Its control algorithms are developed through engineering design, not machine learning from a data set.
9. How the Ground Truth for the Training Set Was Established
N/A. See point 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).