(156 days)
The Vest APX System is intended to provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. 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 APX System is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for the purposes of collecting mucus for diagnostic evaluation.
The Vest APX System may be used for the pediatric population (6 months and older) to geriatric population.
The Vest APX System is a high-frequency chest wall oscillation device designed to be used in a wide variety of settings for enhancing the mobilization of bronchial secretions. The primary components of The Vest APX System consist of a control unit, hoses, and an inflatable garment. Oscillating positive pressure air pulses are applied to the garment by the control unit. The Blower provides the baseline pressure to the system. The user will input the different intensity from 1 -10 on the Graphical User Interface (GUI) and the blower will produce different static pressure based on speed. The air pulse generator (APG) provides the air pulsations (oscillations) based on the frequency input (ranging from 5 to 20 Hertz) provided by user via the GUI. The APG is driven by the Brushless Direct Current (BLDC) motor.
The resulting pressure pulses cause the garment to inflate and deflate against the chest of the patient, creating high-frequency chest wall oscillation and mobilization of bronchial secretions. This form of airway clearance therapy is referred to as high-frequency chest wall oscillation (HFCWO).
The provided text describes a 510(k) premarket notification for a medical device called "The Vest APX System." This document aims to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, "The Vest Airway Clearance Systems." The basis for this determination is a comparison of technological characteristics and performance data.
However, the document does not contain specific acceptance criteria, reported device performance metrics in a quantitative table format, details about a usability study beyond mentioning it, or information about sample size for test sets or training sets, ground truth establishment, or multi-reader multi-case studies as requested in the prompt. The "performance data" section only lists compliance with certain electromagnetic compatibility and safety standards, and biocompatibility.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, sample size for test sets or training sets, data provenance, number of experts, adjudication methods, details of MRMC studies, standalone performance, or ground truth establishment based on the provided text.
The information primarily focuses on demonstrating substantial equivalence through similar intended use, indications for use, and technological characteristics, particularly through non-clinical testing.
Here's a summary of what is available regarding testing:
Nonclinical Tests Performed:
- Comparative pressure testing for the subject and predicate garments: This test would likely compare the pressure outputs or profiles generated by both the new device (The Vest APX System) and the predicate device (The Vest Airway Clearance Systems) when used with their respective garments. The goal would be to demonstrate similar functional performance in terms of pressure application for airway clearance.
- Usability testing per IEC 62366-1:2015 + A1:2020: This indicates that a usability study was conducted following international standards for medical device usability. The purpose is to evaluate if the device can be used safely and effectively by its intended users.
- Additional comparative pressure testing for the 16"-19" Child XS Garment with the subject and predicate devices: This specific comparative pressure test focuses on a particular garment size (Child XS) to ensure equivalent performance for this pediatric population.
Performance Data / Compliance:
The Vest APX System meets the following standards:
- IEC 60601-1-2 Edition 4.1 2020-09 (Electromagnetic Disturbances)
- ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] (General requirements for basic safety and essential performance)
- IEC 60601-1-11 Edition 2.1 2020-07 (Requirements for medical electrical equipment in home healthcare environment)
- ISO 10993-1:2018 (Biological evaluation of medical devices - Biocompatibility)
What is NOT provided in the text:
- A specific table of acceptance criteria (e.g., minimum pressure output, maximum deviation, specific usability scores).
- Quantitative reported device performance to compare against acceptance criteria.
- Sample sizes for any of the tests (e.g., how many garments were tested for pressure, how many users in the usability study).
- Data provenance for any test data.
- Details on ground truth for any test (e.g., what was the "gold standard" for pressure measurements).
- Any information regarding experts involved in establishing ground truth or adjudication.
- Details about a multi-reader multi-case study (this device is a physical therapy device, not an AI diagnostic tool, so such a study would not be applicable).
- Standalone performance (again, not an AI diagnostic tool).
- Information on training sets, as this is not a machine learning or AI 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).