(87 days)
The RespIn11 is intended to provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy' (1991). According to AARC guidelines, specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the RespIn11 is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation.
RespIn11 is a medical device developed for an effective therapy of airway obstruction conditions. The device is made up of a jacket connected to a vibration/pulsation generator where the pulsations are obtained by the pressure differences of a multistage blower. These pulsations are transmitted to the subject's chest through an air pressure piston system specially designed and inserted into the front and rear cavities of the vest provided. The compression then release cycle on the chest wall generates a differential air speed in the bronchial airway in the lungs. This produces a shearing effect which pulls the mucus off the bronchial airway walls and to then be moved through mucociliary action into the larger upper airways to then be eliminated naturally through coughing or if necessary by external suction. This respiratory therapy is called HFCWO (High Frequency Chest Wall Oscillation).
RespInnovation SAS's RespIn11 device, a powered percussor for High-Frequency Chest Wall Oscillation (HFCWO) therapy, was deemed substantially equivalent to a predicate device, The Vest (K024309), based on its performance testing and comparison of characteristics. The information provided outlines the acceptance criteria and the study that demonstrated the device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for RespIn11 were established by demonstrating substantial equivalence to the predicate device, The Vest (K024309). The performance of RespIn11 was compared directly to The Vest in various specifications.
| Feature / Acceptance Criteria | RespInnovation RespIn11 Performance | Predicate Device (The Vest, K024309) Performance | Comparison Outcome |
|---|---|---|---|
| Indications for Use | Intended to provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment, following AARC guidelines for retained secretions, secretion clearance difficulty, or atelectasis caused by mucus plugging. Also indicated for collecting mucus for diagnostic evaluation. | Same intended use, following AARC guidelines for retained secretions, secretion clearance difficulty, or atelectasis caused by mucus plugging. Also indicated for collecting mucus for diagnostic evaluation. | Equivalent |
| Prescriptive Nature | Yes | Yes | Identical |
| Technology | Pneumatic percussor, electronic control | Pneumatic percussor, electronic control | Identical |
| Environment of Use | Hospital, sub-intensive, clinical offices, home | Hospital, sub-intensive, clinical offices, home | Identical |
| Power | 100-240 VAC, 50-60 Hz, 4.7 A MAX | 100 V AC to 230 V AC, 50 Hz to 60 Hz, 3.4 A @ 100 VAC, 2.0 A @ 230 VAC | Equivalent |
| Standards Compliance | IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-1-2 | Identical |
| Alarms | None | None | Identical |
| Control Unit Interface | Alphanumeric | Alphanumeric | Identical |
| Performance (Frequency) | Frequencies between 5 - 20 Hz | Frequencies between 5 - 20 Hz | Equivalent |
| Performance (Pressure) | Pressure applied in 0-10 steps (max pressure = 50 mbar) | Pressure applied in 0-10 steps (max pressure = 50 mbar) | Identical |
| Performance (Therapy Times) | Session therapy from 5 to 30 minutes depending upon Dr.'s recommendations per patient | From 0 to 60 minutes (common prescription specifies treatment between 10 and 30 minutes) | Equivalent |
| Patient Interface (Jacket Sizes) | 2 jacket sizes: S/M, L/XXL | 4 "vest" styles | Equivalent |
| Operating Temperature | 10°C to 34°C (50°F to 95 °F) | 50°F to 93°F (10°C to 34°C) ambient temperature | Equivalent |
| Patient Population | Intended for patients whose clinician has determined this treatment is appropriate. | Similar to the predicate, for patients whose clinician has determined this treatment is appropriate. | Similar |
| User Interface | Alphanumeric control unit | Alphanumeric control unit | Identical |
| Safety and EMC | Compliance with IEC 60601-1 (Safety) and IEC 60601-1-2 (Electromagnetic Compatibility) | Compliance with IEC 60601-1 (Safety) and IEC 60601-1-2 (Electromagnetic Compatibility) | Identical |
2. Sample Size and Data Provenance for Test Set
The device's performance was evaluated through various engineering and regulatory compliance tests. The document does not specify a separate "test set" sample size in terms of patient data or clinical trials, as the primary method of proving substantial equivalence was through a comparison of technical specifications and performance characteristics against a legally marketed predicate device.
The study presented here is a premarket notification (510(k)) summary, which typically relies on comparisons to predicate devices and engineering bench testing rather than extensive clinical studies with human subjects. Thus, there is no specified sample size for a test set based on patient data, nor information on data provenance (country of origin, retrospective/prospective).
The performance testing mentioned ("Frequency Testing," "Pressure Testing," "Pneumatic Testing," "Fault condition testing," "IEC 60601-1 Safety," "IEC 60601-1-2 Electromagnetic Compatibility") would have been conducted on the device itself, likely in a laboratory setting.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This type of submission (510(k) for a powered percussor) does not typically involve human expert adjudication for image analysis or diagnostic tasks to establish ground truth in the way AI/CADe devices do. The "ground truth" here is based on engineering specifications, regulatory standards compliance, and the established performance of the predicate device.
4. Adjudication Method for Test Set
Not applicable. As there was no test set involving human interpretation where ground truth needed to be established through expert consensus, no adjudication method was used or described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not conducted or described in this 510(k) summary. This type of study focuses on the impact of AI on human reader performance, which is not relevant for a powered percussor device that primarily performs a physical therapy.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
Yes, in a sense, a "standalone performance" was assessed. The engineering and compliance tests (Frequency, Pressure, Pneumatic, Fault, Safety, EMC testing) evaluate the device's inherent functional capabilities and adherence to standards independently. The device itself (RespIn11) is the "algorithm" in this context, performing its intended function without requiring human interpretation or decision-making as part of its core therapeutic mechanism. The summary states: "The results of the testing demonstrate that the RespIn11 performs equivalent to the predicate."
7. Type of Ground Truth Used
The "ground truth" for demonstrating substantial equivalence was based on:
- Predicate Device Specifications: The established performance parameters and technical specifications of the legally marketed predicate device, The Vest (K024309).
- Engineering Standards: Compliance with recognized international standards such as IEC 60601-1 (Safety) and IEC 60601-1-2 (Electromagnetic Compatibility).
- Functional Testing: The results of direct performance tests (frequency, pressure, pneumatic, fault conditions) demonstrating the device's physical output met established operating ranges and safety requirements.
8. Sample Size for the Training Set
Not applicable. As this device is a physical therapy device and not an AI/machine learning algorithm that requires training data, there is no "training set" in the context of machine learning.
9. How Ground Truth for Training Set Was Established
Not applicable, for the same reasons as point 8.
§ 868.5665 Powered percussor.
(a)
Identification. A powered percussor is a device that is intended to transmit vibration through a patient's chest wall to aid in freeing mucus deposits in the lung in order to improve bronchial drainage and that may be powered by electricity or compressed gas.(b)
Classification. Class II (performance standards).