(245 days)
The Vest® Airway Clearance Systems is intended to provide airway clearance therapy when external manipulation of the thorax is the physician's choice or treatment. Indications for this form of therapy are described by the American Association of Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy. 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 the purposes of collecting mucus for diagnostic evaluation.
The Vest® Airway Clearance System consists of an inflatable garment attached to an Air Pulse Generator that rapidly inflates and deflates the inflatable garment. This causes the chest wall to be gently compressed and released, which creates airflow within the lungs. This process moves the mucus toward the large airways where it can be cleared by coughing or suctioning. This type of Airway Clearance Therapy is referred to as High Frequency Chest Wall Oscillation (HFCWO).
The system consists of an Air Pulse Generator, connecting hose, and multiple styles and sizes of garments. The garments are single patient, multi-use.
The provided text is a 510(k) Summary for the Hill-Rom "The Vest® Airway Clearance Systems (Model 105)". This document states that the new device is substantially equivalent to a previously cleared predicate device (K024309) and therefore does not include a study demonstrating the new device meets specific acceptance criteria based on clinical outcomes or performance metrics like accuracy, sensitivity, or specificity. Instead, the focus is on comparative non-clinical bench testing to prove equivalence.
Therefore, much of the requested information, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets, is not applicable in the context of this 510(k) submission as it relies on substantial equivalence to a predicate device rather than novel performance demonstration.
However, I can extract the information provided regarding the testing performed to support substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence claim based on non-clinical testing rather than clinical performance metrics, the "acceptance criteria" here refer to the successful completion and comparison of non-clinical tests to demonstrate that modifications do not raise new safety or effectiveness concerns compared to the predicate device.
| Acceptance Criteria (Success of Test) | Reported Device Performance (Outcome) |
|---|---|
| - Comparative Pressure mapping | Demonstrated equivalent performance between the proposed Air Pulse Generator and garments and the predicate Vest® Airway Clearance System (K024309). |
| - Environmental and Mechanical testing | Demonstrated that the modifications (software update, additional garment styles, locking connecting hose) do not raise new safety or risks compared to the predicate. |
| - Electrical Safety (Various Standards) | Compliance with ANSI/AAMI ES60601-1:2005/(R)2012, C1:2009/(R)2012, A2:2010/(R)2012, IEC 60601-1:2005+CORR,1 (2006) + CORR. 2 (2007), EN 60601-1:2006 +CORR: 2010, CAN/CSA-C22.2 No. 6060101 (2008), EN 60601-102: 2007. |
| - Electromagnetic Compatibility (EMC) | Compliance with 47 CFR FCC Part 15B:2012 (CLASS B), ETSI EN 300 328 V1.7.1:2006, ETSI EN 301 489-1 V1.9.2:2011, ETSI EN 301 489-17 V2.2.1:2012. |
| - Biocompatibility Review | Biocompatibility testing was not needed as materials are identical to the predicate and do not have direct or indirect contact with patient skin or tissue. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is described as "comparative non-clinical bench testing." The tests performed are listed in the table above and in the "Non-clinical Testing Summary" section of the 510(k) summary (page 6 of the document). These tests were conducted to demonstrate that the updated device, with its minor modifications, performs equivalently to the predicate device and does not introduce new safety or effectiveness risks.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable to this 510(k) submission. The document describes non-clinical bench testing, which typically does not involve human sample sizes or data provenance in the same way clinical studies do. The testing involved comparing the proposed device components (Air Pulse Generator, connecting hose, garments) with the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The ground truth for this type of non-clinical bench testing is based on engineering specifications and compliance with established standards, not expert clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the testing is non-clinical bench testing against engineering standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The device is an airway clearance system, not an AI-powered diagnostic device, and therefore MRMC studies are not relevant to its clearance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical medical device, not an algorithm, so standalone performance in this context is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission are the established engineering specifications and international standards (e.g., IEC 60601-1, FCC Part 15B, etc.) that the device must meet, and the performance characteristics of the predicate device (K024309), which the new device aims to be substantially equivalent to.
8. The sample size for the training set
This information is not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this type of device submission.
§ 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).