(245 days)
The air-oxygen mixer Quality Mix is used to administer a continuous, precise mix of medical air and medical oxygen through its outlet ports - to infants, children and adults. The exact fractional inspiratory oxygen concentration (FiO2) corresponds to the selected FiO2 setting on the control knob (dial).
It is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician in professional healthcare settings.
This product is not intended for use as a life supporting device.
Warning: By using flows above 70 LPM, the risk of high flow such as ar trapping, barotrauma, and gastric insufflation (leading to possible aspiration) can occur.
The air-oxygen blender Quality Mix is a compact air/oxygen mixing device, which provides a precise mixing of medical grade air and oxygen gases. The blender is a pneumatic powered device with flowmeters which can be connected to outlet ports to regulate the gas flow.
The Quality Mix series medical air / oxygen blender includes following models: Quality Mix High Flow; Quality Mix High Flow XL and Quality Mix Low Flow; Quality Mix Low Flow XL.
The Quality Mix series air / oxygen blender is designed, tested and manufactured in accordance with the standard ISO 11195:2018 Gas mixers for medical use - Stand - alone qas mixers.
The Acceptance Criteria and the study proving the device meets them are detailed below, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The device is the Quality Mix Blender, Oxymixer. The acceptance criteria are largely derived from compliance with the ISO 11195:2018 standard for gas mixers for medical use and are demonstrated through performance specified in comparison to the predicate device (Precision Blender K053232).
| Acceptance Criteria (from ISO 11195:2018 and performance specifications) | Reported Device Performance (Quality Mix Blender) | Result |
|---|---|---|
| Essential Performance Requirements (Clause 4 of ISO 11195:2018) | Fulfils Clause 4 essential performance requirements | Pass |
| Clause 9: Reverse gas flow | Performs as intended | Pass |
| Clause 11: Alarm systems | Performs as intended | Pass |
| Clause 12: Accuracy of indicated oxygen concentration | ± 3% | Pass |
| Clause 13: Gas supply failure | Performs as intended | Pass |
| Primary Outlet Flow Range | High Flow: 15 – 120 LPM (at 50 psi) | Pass |
| Low Flow: 3 – 30 LPM (at 50 psi) | Pass | |
| Auxiliary Outlet Flow Range (Bleed Closed) | High Flow: 15 – 120 LPM (at 50 psi) | Pass |
| Low Flow: 3 – 30 LPM (at 50 psi) | Pass | |
| Auxiliary Outlet Flow Range (Bleed Open) | High Flow: 0 – 105 LPM (at 50 psi, with ±3% accuracy for low flows) | Pass |
| Low Flow: 0 – 27 LPM (at 50 psi, with ±3% accuracy for low flows) | Pass | |
| Bleed Flow | High Flow: ≤ 13 LPM at 50 psi | Pass |
| Low Flow: ≤ 3 LPM at 50 psi | Pass | |
| Maximum Combined Flow (all outlets) | High Flow: ≥ 120 LPM | Pass |
| Low Flow: ≥ 30 LPM | Pass | |
| Bypass Flow (loss of air or oxygen supply) | High Flow: > 85 LPM | Pass |
| Low Flow: > 15 LPM | Pass | |
| Bypass Alarm Activation (pressure difference) | Activates when pressure difference ≥ 13.05 psi (0.9 bar) | Pass |
| Alarm Reset | Resets when pressure difference ≤ 4.35 psi (0.3 bar) | Pass |
| Alarm Sound Level | ≥ to 80 dB at 1 ft (0.3 m) | Pass |
| Oxygen Concentration Adjustment Range | 21 – 100 % | Pass |
| Gas Supply Pressure | 46.41 – 94.27 psi (3.2 – 6.5 bar) | Pass |
| Air and oxygen pressure differential | Should be within max 0.7 bar | Pass |
| Mixed Gas Stability | ± 1% Oxygen | Pass |
| Operating Temperature Range | 41°F to 122°F (5°C to 50°C) | Pass |
| Pressure Drop | High Flow: ≤ 0.21 bar at 30 LPM and 60% FiO2 (inlet 3.2-6.5 bar) | Pass |
| Low Flow: ≤ 0.14 bar at 10 LPM and 60% FiO2 (inlet 3.2-6.5 bar) | Pass | |
| Biocompatibility (ISO 18562-1, -2, -3) | Pass for particulate matter and VOC emissions | Pass |
| Risk Management (ISO 14971) | Applied for hazard identification, risk control, and monitoring | Pass |
| Usability (IEC 62366-1) | Verified and validated | Pass |
| Environmental Testing (Strength, Vibration, Shock) | Passed EN 1789, EN 60068-2-6, EN 60068-2-27, EN 60068-2-64 | Pass |
| Flow-metering devices (DIN EN ISO 15002) | Flowmeter accuracy, leak test, environmental, and mechanical condition met | Pass |
| Oxygen Compatibility (ISO 15001) | Ensured oxygen compatibility of used materials | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The provided text describes non-clinical performance and safety testing. There is no mention of a "test set" in the context of patient data or clinical samples for the device itself. The testing was performed on the device units in a laboratory setting. No specific sample size (i.e., number of devices tested) is explicitly stated for each test, but it is implied that testing was conducted on representative units of the Quality Mix Blender series. The provenance of this data is from the manufacturer's internal testing as well as cooperation with an authorized, certified competence center for medical oxygen blenders for usability testing (likely in Germany, as the manufacturer is based in Germany). This is a retrospective analysis of device performance against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the study described is non-clinical performance testing of a medical device against engineering standards, not a diagnostic or AI-assisted clinical study requiring expert ground truth in the traditional sense. The "ground truth" for these tests are the objective measurements and specifications outlined in the referenced international standards (e.g., ISO 11195:2018, IEC 62366-1, ISO 14971).
4. Adjudication Method for the Test Set
Not applicable. This was non-clinical device performance and safety testing against established engineering and performance standards, not a clinical study involving human interpretation or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, an MRMC comparative effectiveness study was not done. This submission is for a breathing gas mixer, which is a hardware device (Quality Mix Blender), not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. As stated above, this is a hardware device, not an algorithm or AI-powered system.
7. The Type of Ground Truth Used
The ground truth used for these evaluations is based on International Standards and established engineering specifications. These include:
- ISO 11195:2018 (Gas mixers for medical use - Stand-alone gas mixers)
- ISO 14971:2007 (Medical devices - Application of risk management to medical devices)
- IEC 62366-1:2015 (Medical devices - Application of usability engineering to medical devices)
- EN 1789:2007+A2:2014 (Medical vehicles and their equipment - Road ambulances)
- EN 60068-2-6:2008 (Environmental testing - Part 2-6: Tests - Test Fc: Vibration (sinusoidal))
- EN 60068-2-27:2009 (Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock)
- EN 60068-2-64:2008 (Environmental testing – Part 2-64: Tests – Test Fh: Vibration, broadband random and guidance)
- DIN EN ISO 15002:2020-05 (Flow-metering devices for connection to terminal units of medical gas pipeline systems)
- ISO 15001:2010 (Anesthetic and respiratory equipment - Compatibility with oxygen)
- ISO 18562-1, -2, -3 (Biocompatibility evaluation of breathing gas pathways in healthcare applications)
These standards define the performance metrics, test methods, and acceptable ranges for the device's functionality, safety, and compatibility.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is a hardware medical device, not a machine learning or AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 868.5330 Breathing gas mixer.
(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).