(168 days)
The demand valve is used for the application of 100 vol% oxygen during manual ventilation with the resuscitator bag, as well as during direct non-invasive inhalation with the resuscitator mask in spontaneously breathing patients.
The valve, non - rebreathing QualityFlow O2 demand valve is a medical device to deliver medical oxygen or a medical air - oxygen mixture to a patient on demand. Unlike continuous oxygen systems, the demand valve only supplies medical gas when the patient inhales, reducing oxygen consumption and ensuring the patient receives gas only when needed. The QualityFlow O2 Demand Valve from DEHAS consists of a membrane that is activated by negative pressure during inspiration and a valve mechanism that controls gas flow. During inspiration, the valve opens due to the movement of the membrane, while during expiration it is closed by a return spring. The function of the demand valve is based on providing gas only when a negative pressure is applied to the membrane, e.g. by the patient inhaling with a connected mask or suction of the resuscitator when connected (expansion after previous compression of the resuscitator). The valve therefore ensures that gas only flows when it is needed.
The provided document is a 510(k) Premarket Notification for a medical device called "QualityFlow O2 Demand Valve". This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, and thus does not require clinical studies in many cases.
Based on the provided text, the device in question (QualityFlow O2 Demand Valve) is a mechanical device, not an AI/software-driven one. Therefore, the questions related to AI/MRMC studies, training/test sets, ground truth establishment by experts, and adjudication methods are not applicable to this submission. The "acceptance criteria" discussed in this document refer to the device's ability to meet various engineering, safety, and performance standards, rather than diagnostic accuracy metrics common for AI/ML devices.
Here's an analysis based on the information relevant to this type of medical device submission:
1. Table of Acceptance Criteria (Relevant Standards) and Reported Device Performance:
The document summarizes non-clinical tests performed according to international standards to demonstrate substantial equivalence and that the device performs as intended.
| Acceptance Criteria (Standard Used) | Description of Test | Reported Device Performance |
|---|---|---|
| ISO 5356-1 Third edition 2004-05-15: Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets | Specifies the dimension and dimensional requirements for cones and bushings intended for the connection of anesthesia and ventilator equipment (e.g., in ventilation systems, anesthetic gas transport systems and vaporizers). | Result: pass |
| IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION: Medical devices - Part 1: Application of usability engineering to medical devices | Used to verify and validate the usability of the QualityFlow O2 demand valve. | Result: pass |
| ISO 14971 Third Edition 2019-12: Medical devices - Application of risk management to medical devices | Process for identification and assessment of hazards and associated risks, control of these risks, and monitoring effectiveness of risk control measures. | Result: pass |
| ISO 15001:2010: Anesthetic and respiratory equipment - Compatibility with oxygen | Used to ensure the oxygen compatibility of the used materials. | Result: pass |
| ISO 10993-1 Fifth edition 2018-08: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | Used for biological evaluation of medical devices and testing within a risk management process. | Result: pass |
| ISO 18562-1 First edition 2017-03: Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process | Evaluated biocompatibility of breathing gas pathways, specifically for indirect patient contact via medical oxygen (gas pathway contact, limited exposure |
§ 868.5870 Nonrebreathing valve.
(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).