(86 days)
The intended use of the ABI Vest Airway Clearance System is to promote airway clearance or improve bronchial drainage by enhancing mobilization of bronchial secretions where external manipulation of the thorax is the physician's choice of treatment. The indications typically follow the Clinical Practice Guideline published by the American Association for Respiratory Care (AARC) 1991. In addition, the device is also indicated for the purpose of collecting mucus for diagnostic evaluation.
The intended use of the ABIVest™ 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 ABIVest™ 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 ABI 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 ABI 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 patient creating high-frequency chest wall oscillation and mobilization of bronchial secretions. The frequency of the air pulse is operator controlled and adjustable from 5 to 25 Hz.
This document is a 510(k) premarket notification for the ABI Vest Airway Clearance System. It explicitly states that no performance testing was required for this submission. The purpose of this 510(k) was solely to expand the indicated use of an already cleared device to include collecting mucus for diagnostic evaluation, making it substantially equivalent to its predicate device (ThAIRapy® Vest System K965192) in all other aspects.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth, and MRMC studies cannot be extracted from this document, as no such studies were conducted or presented for this specific submission.
The document indicates:
- Comparison of Technological Characteristics: "The ABI Vest System is identical to the previously cleared ABI Vest™ Airway Clearance System (a.k.a. ThAIRapy® Vest System) (K965192)... The only reason for this submission is to include in the device's indication for use that the device can be used for the mobilization of bronchial secretions to promote bronchial drainage for purposes of collecting mucus for diagnostic evaluation."
- Performance Testing: "None required."
§ 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).