(59 days)
The intended use of the Modified Vest™ Airway Clearance System is the same as the predicate device, which is 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 Vest™ Airway Clearance System 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.
The Advanced Respiratory Vest™ Airway Clearance System is a high-frequency chest wall oscillator designed to be used in a wide variety of settings for enhancing the mobilization of bronchial secretions. The primary components of The Vest™ Airway Clearance System include an air-pulse generator and an inflatable vest. Oscillating positive pressure air pulses are applied to the vest by the air-pulse generator. The resulting pressure pulses cause the vest to inflate and deflate against the chest of the user creating high-frequency chest wall oscillation and mobilization of bronchial secretions.
Here's a breakdown of the acceptance criteria and the study details for the Modified Vest™ Airway Clearance System based on the provided K024309 submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functional equivalence to predicate device (K012928 and K993629) in promoting airway clearance and bronchial drainage. | "Functional and performance comparisons were made and it is concluded that the device that is the subject of this 510(k) is substantially equivalent to the predicate device." |
| Ability to generate air pulses and provide high-frequency chest wall oscillation. | "All devices have reciprocating bellows that generate the air pulses." The description of the device states it "is a high-frequency chest wall oscillator... Oscillating positive pressure air pulses are applied to the vest by the air-pulse generator." |
| User control over air pulse frequency and pressure. | "Operator controls remain consistent with predicate devices. The user can adjust air pulse frequency and pressure." The change in mechanism from analog potentiometers to digital momentary switches demonstrates this function is retained. |
| Compatibility with existing Vest System vests. | "The same vests will be used on the new device as were available for the predicate devices." |
| Maintenance of intended use for enhancing mobilization of bronchial secretions and collecting mucus for diagnostic evaluation. | "The new model is intended to promote airway clearance or improve bronchial drainage by enhancing the mobilization of bronchial secretions when external manipulation of the thorax is the physician's choice of treatment." The "Indications for Use Statement" explicitly states, "The intended use of the Modified Vest™ Airway Clearance System is the same as the predicate device..." and re-affirms both uses. |
2. Sample Size Used for the Test Set and Data Provenance
This submission does not specify a test set sample size or data provenance in terms of country of origin or retrospective/prospective nature. The "Performance Testing" section describes a comparison to a predicate device rather than a clinical study with a distinct test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The submission does not detail a clinical study with a test set requiring expert-established ground truth. The evaluation is based on functional and performance comparison to a predicate device.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a test set or an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly performed or referenced in this document. The submission focuses on substantial equivalence based on technical and functional comparisons to predicate devices, not on a clinical trial with human readers and AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No standalone performance study of an algorithm without human-in-the-loop performance was conducted or described, as this device is a physical medical device (Powered Percussor) and not an AI/software-as-a-medical-device. The "performance testing" described is for the device itself against a predicate device.
7. Type of Ground Truth Used
The "ground truth" in this context is the established functionality and performance of the predicate devices (The Vest™ Vest System, K012928, and K993629). The new device's performance is gauged against the known characteristics and approved indications for use of these existing, legally marketed devices.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical device (Powered Percussor), not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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).