(164 days)
The Respironics CoughAssist T70 assists patients in clearing retained bronchopulmonary secretions by gradually applying a positive pressure to the airway, then rapidly shifting to a negative pressure. This rapid shift in pressure, via a facemask, mouthpicce or an endotracheal or tracheostomy tube, produces a high expiratory flow rate from the lungs, simulating a cough.
The Philips Respironics CoughAssist T70 is intended for use on adult or pediatric patients unable to cough or clear secretions effectively. It may be used either with a facemask or mouthpiece, or with an adapter to a patient's endotracheal or tracheostomy tube. The device is intended to be used in the hospital, institutional environment or in the home.
The Philips Respironics CoughAssist T70 is a portable electric device which utilizes a blower and a valve to apply alternating positive and then a negative pressure to a patient's airway in order to assist the patient in clearing retained bronchopulmonary secretions by simulating a cough. It includes a means to adjust the pressure and suction levels applied, a pressure gauge to measure the pressures, and a means (optional) to reduce the positive pressure (inhale) flow. The air is delivered to and from the patient via a breathing circuit incorporating a flexible tube, a bacterial filter and either a facemask, a mouthpiece or an adapter to a tracheostomy or endotracheal tube.
The Philips Respironics CoughAssist T70 device is a noncontinuous ventilator designed to assist patients in clearing bronchopulmonary secretions by simulating a cough. The device applies alternating positive and negative pressure to the airway. This summary describes its acceptance criteria and the studies performed to demonstrate its performance and substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Philips Respironics CoughAssist T70 are primarily based on meeting product specifications through non-clinical testing and demonstrating substantial equivalence to its predicate devices, Emerson CoughAssist, Model CA-3000 (K002598) and Dima Italia Negavent DA-3 Plus Pegaso (K072292). The device performance was verified through various engineering tests. While specific quantitative acceptance criteria (e.g., precise pressure tolerances, flow rates, or triggering times) are not explicitly numerical values in the provided text, the document details functional and safety requirements that the device's performance was verified against.
| Feature/Characteristic | Acceptance Criteria (Implied from testing/description) | Reported Device Performance |
|---|---|---|
| User Interface | To meet product requirements for the CoughAssist T70 UI, ensuring all display functions, user controls, and informational messages perform as intended, and proper data and therapy information are displayed. | Verified to meet product requirements through bench testing, code reviews, and software unit testing. All display functions, user controls, and informational messages performed as intended, displaying proper data and expected therapy information. |
| Delivered Pressure | To deliver accurate pressure for the intended duration of insufflation, exsufflation, and pause phases, and demonstrate pressure and flow stability across all patient test cases, including extreme flow rates and sensor malfunctions. Inhale (0 to 70 cmH2O) and Exhale (0 to -70 cmH2O) pressures should be maintained. | Verification testing confirmed accurate pressure delivery for the intended duration of all therapy phases. Demonstrated pressure and flow stability across all patient test cases, including extreme flow rates and sensor malfunctions (inaccuracies and/or complete dropout). |
| CoughTrak | To meet product specifications with each defined patient case simulation, ensuring availability, operation, and triggering performance across the range of patient cases. The device should trigger the insufflation phase when patient effort (pressure decrease below threshold) is detected. | Verified to meet product specifications with each defined patient case simulation. Availability, operation, and triggering performance were verified across the range of patient cases. |
| Data Management | To meet product specifications for SD card data integrity, including proper storage of therapy data, and compatibility with DirectView and Encore. | Verified to meet product specifications for SD card data integrity through software verification, code reviews, and testing. |
| Oximetry Accessory | To verify the behavior of pulse oximetry data and proper display of data received from the oximetry accessory (current SpO2 and heart rate). | Tested to verify the behavior of pulse oximetry data and the proper display of data received by the oximetry accessory. |
| Wired Remote Control | To verify the availability and operation of the remote-control device (foot pedal) to initiate manual therapy. | Verification testing conducted to verify the availability and operation of the CoughAssist T70 wired remote control device. |
| External Suctioning Accessory Interface | To demonstrate that the device provides power to an external suctioning accessory as specified. | Verified to demonstrate that the device provides power to a suctioning accessory as specified. |
| Power Management | To properly interface with a detachable battery, display battery information, charge the battery, indicate low battery charge, maintain compatibility with an external DC power supply, display power supply information, and indicate low external battery. | Verified to properly interface with the detachable battery, properly display battery information, properly charge the battery, and indicate a low battery charge. Verified compatibility with an external DC power supply, proper display of power supply information, and indication of low external battery. |
| Software Algorithms | To function safely and effectively under worst-case scenarios, including stability throughout the operating flow range, steady-state stability with open and occluded patient circuits, disturbance rejection at rapid flow transitions, and avoiding instability during extreme flow rates. | Black-box and white-box performance testing, including open and closed loop conditions and worst-case scenario inputs (extreme flow rates, sensor malfunctions, inaccurate or complete sensor dropout), demonstrated that the software algorithms functioned safely and effectively. |
| General Safety & Effectiveness | To meet all applicable ISO, ASTM, and IEC standards and regulatory guidance and perform equivalently to predicate devices. | Successfully passed all test protocols for relevant ISO, ASTM, and IEC standards (ISO 14971, ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60068, IEC 62304) and FDA guidance documents. Confirmed to perform equivalently to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text indicates that the testing was non-clinical bench testing.
- Sample size: The document does not specify a quantitative sample size for the test set in terms of human subjects or distinct physical devices tested. Instead, it refers to testing across "all patient test cases identified in the Product Requirements Document" and "defined patient case simulations" for features like CoughTrak. It also mentions "worst-case scenario inputs." This indicates a comprehensive set of simulated conditions rather than a traditional human subject sample size.
- Data Provenance: The data provenance is entirely retrospective and non-clinical. The testing involved "side by side bench testing methodologies," "open and closed loop conditions," and "software unit testing and code reviews." No human or animal data were used in this specific submission. The data is generated from laboratory and engineering verification activities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This was a non-clinical bench study. The "ground truth" for the test set was defined by the product requirements and technical specifications of the device and its predicate, verified by engineering and software testing. There were no human experts establishing ground truth for patient outcomes or diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable. As a non-clinical bench study, there was no adjudication method involving multiple human reviewers or experts. The "ground truth" was based on engineering specifications and direct measurement/observation of device behavior against those specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done. This submission focuses on the engineering and software modifications and their performance relative to predefined specifications and predicate devices, not on human reader performance with or without AI assistance. The device is a secretion clearance device, not an interpretative AI system.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes, a form of standalone performance was conducted, as the entire evaluation was non-clinical bench testing without human-in-the-loop performance. The "black-box performance testing" and "white-box testing" of the software algorithms specifically assessed the device's (and its algorithms') ability to function according to specifications in various simulated patient scenarios and extreme conditions. This directly evaluates the device's intrinsic functional performance.
7. Type of Ground Truth Used
The ground truth used for the non-clinical testing was based on:
- Engineering Specifications/Product Requirements: The device's performance was compared against predetermined design input specifications and product requirements defined in the Product Requirements Document. These specifications dictated expected pressure delivery, flow stability, trigger performance, data integrity, and compliance with various standards.
- Predicate Device Performance: Equivalence to predicate devices (Emerson CoughAssist CA-3000 and Dima Italia Negavent DA-3 Plus Pegaso) was a key ground truth criterion, implying that the new device should perform at least as well as the established, legally marketed devices.
- Regulatory Standards: Compliance with relevant ISO, ASTM, and IEC standards (e.g., IEC 60601-1 for safety) formed another layer of ground truth, where successful adherence to these standards demonstrated acceptable performance.
8. Sample Size for the Training Set
Not applicable. The provided document concerns a 510(k) submission for device modifications based on non-clinical bench testing. It describes the verification of engineering design and software algorithms, which involve empirical tuning of PID gains during development, but does not refer to a "training set" in the context of machine learning or AI models with external data. The device's control algorithms were "empirically tuned to achieve the necessary response and stability," implying an iterative development and testing process, but not a distinct training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no explicit "training set" in the context of machine learning. The "ground truth" during development, influencing the empirical tuning of control algorithms, would have been derived from desired physical performance characteristics (e.g., pressure response, stability, flow rates) under various simulated conditions, established through engineering principles, system modeling, and iterative bench testing.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).