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K Number
K033276
Device Name
VPAP III ST-A
Manufacturer
RESMED LTD.
Date Cleared
2004-06-07

(241 days)

Product Code
MNS
Regulation Number
868.5895
Type
Traditional
Panel
AN
Reference & Predicate Devices
K974417
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The VPAP III ST-A system is Intended to provide non-invasive ventilation for patients with respiratory insufficiency or obstructive sleep apnea (OSA), in the hospital or home.

Device Description

The VPAP III ST-A provides a mode of non-invasive positive pressure ventilation (NPPV) called Pressure Support with PEEP, which delivers two treatment pressures (bi-level ventilation). A higher pressure is applied when the patient inhales - IPAP or inspiratory positive airway pressure, and a lower pressure is applied when the patient exhales - EPAP or expiratory positive airway pressure, sometimes referred to as PEEP or positive end-expiratory pressure. The difference between the two treatment pressures represents the amount of pressure support provided to the patient.

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets them.

The text is a 510(k) premarket notification letter and summary for a medical device (Resmed VPAP III-STA). While it discusses the device's technical characteristics, its intended use, and states that performance data was collected, it does not provide the acceptance criteria or the specific detailed results of the study.

Here's what I can tell you based on the provided text, and what's missing:

What is present:

  • Device Name: Resmed VPAP III-STA
  • Predicate Device: VPAP II ST-A (K974417)
  • Intended Use: "The VPAP III ST-A system is intended to provide non-invasive ventilation for patients with respiratory insufficiency or obstructive sleep apnea (OSA), in the hospital or home."
  • Performance Data Mention: "The VPAP III ST-A was tested in accordance with the recommendations of the FDA Draft Reviewer Guidance for Ventilators (July 1995)." and "The VPAP III ST-A ventilator complies with the following standards: IEC 60601-1-2; IEC 60068-2-27/ -6/ -34; IEC 10993-1; ASTM F 1100-90."
  • Conclusion: The device is "substantially equivalent" to its predicate.

What is missing (and therefore I cannot provide answers to your specific questions):

  1. Table of acceptance criteria and reported device performance: The text mentions testing was done and standards were complied with, but it does not specify what the acceptance criteria were (e.g., specific pressure accuracy ranges, flow rate tolerances) or what the measured performance results were.
  2. Sample size used for the test set and data provenance: No information on the number of subjects, cases, or the origin (country, retrospective/prospective) of any clinical test data is provided.
  3. Number of experts used to establish ground truth and qualifications: There is no mention of experts, ground truth, or adjudication methods for any clinical study because the document focuses on substantial equivalence based on technological characteristics and compliance with standards, not necessarily a clinical outcomes study with human readers.
  4. Adjudication method: Not applicable as there is no mention of expert review or ground truth establishment in this context.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is not mentioned. The filing is for a ventilator, not an AI or imaging diagnostic tool that typically uses MRMC studies.
  6. Standalone (algorithm only) performance: Not applicable as this is a physical medical device (ventilator), not a diagnostic algorithm.
  7. Type of ground truth used: Not specified, as detailed study results are absent.
  8. Sample size for the training set: Not applicable as this is a physical medical device, not an AI model that typically uses a training set for machine learning.
  9. How ground truth for the training set was established: Not applicable.

To obtain the information you're asking for, you would generally need to review the full submission to the FDA, which would include detailed test reports, or clinical study reports if they were conducted. The provided text is a high-level summary and approval letter, not the detailed technical and clinical evidence itself.

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).