(199 days)
The Fisher & Paykel Healthcare single patient use masks are intended for use as an accessory to ventilators to enable noninvasive positive pressure ventilation (NPPV) therapy (CPAP or bi-level) to be delivered to spontaneously breathing adult patients (>30 kg) with respiratory insufficiency or respiratory failure who have been prescribed NPPV. The masks are to be fitted and therapy maintained by trained medical practitioners in a hospital/institutional environment with patient monitoring in place.
The Nivairo™ RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve (herein referred to as RT045) is a non-vented hospital full face mask with anti-asphyxiation valve for use with single limb circuits. The RT045 is a single use device intended to deliver noninvasive positive pressure ventilation (NPPV) to a patient as part of a passively vented noninvasive ventilation system.
The RT045 is an oronasal full face mask intended to be used in a hospital/institutional environment by trained medical staff with patient monitoring systems in place. It connects to a single limb breathing circuit via a 22mm female swivel adaptor to receive pressurized breathing gases from an external flow source or ventilator (CPAP or Bi-Level).
The RT045 mask is a prescription only device, provided in a non-sterile state.
I am sorry, but the provided text is a 510(k) premarket notification for a medical device (Nivairo™ RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve). This document primarily focuses on establishing substantial equivalence to a predicate device based on technological characteristics and non-clinical performance data.
The document states: "Clinical performance testing was not required to demonstrate substantial equivalence for the RT045."
Therefore, I cannot provide information on:
- Acceptance criteria and device performance based on a study of the device's effectiveness in clinical use. The document does not describe such a study.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How the ground truth for the training set was established.
The document does mention that non-clinical performance data was conducted to demonstrate substantial equivalence. It refers to:
- Performance testing of the RT045 compared to the RT040 (predicate device).
- Evaluations against standards:
- ISO 5356-1:2004 Anaesthetic and respiratory equipment- Conical connectors: Part 1: Cones and sockets.
- ISO 10993-1:2009 Biological Evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
- Clauses 5.3 and 5.5 of ISO 17510-2:2007 Sleep Apnoea Breathing Therapy- Part 2: Masks and Application Accessories.
However, the specific "acceptance criteria" and "reported device performance" in relation to these non-clinical tests are not detailed in the provided text in a way that would allow for a table similar to what you requested for clinical studies. The document only states that "These data demonstrates substantial equivalence of the RT045 to the RT040. The results of the comparative bench testing do not raise any new questions regarding safety or effectiveness for the RT045."
§ 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).