(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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services - USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 23, 2023
DEHAS Medical Systems GmbH % Tom Hirte Senior Director, Regulatory Affairs Draeger Medical Systems GmBH 3135 Ouarry Road Telford, Pennsylvania 18969
Re: K221494
Trade/Device Name: Quality Mix Blender, Oxymixer Regulation Number: 21 CFR 868.5330 Regulation Name: Breathing Gas Mixer Regulatory Class: Class II Product Code: BZR Dated: December 19, 2022 Received: December 22, 2022
Dear Tom Hirte:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
James J. Lee -S
James J. Lee, Ph.D. Division Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221494
Device Name Quality Mix Blender, Oxymixer
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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8 510(K) SUMMARY
In accordance with 21 CFR 807.92 the following summary of information is provided:
Date: January 12, 2023
Type: Traditional 510(k)
510(K) Number: K221494/S001
8.1. Submitter
DEHAS Medical Systems GmbH
Wesloer Straße 107-109
23568 Luebeck, Germany
Primary contact person
Jens Mittendorf
Managing Director / Head of Engineering & Development
Phone: +49-451-80904-200
+49-451-80904-111 Fax:
E-Mail: J.Mittendorf@dehas.de
Statement
Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule" .... 510(k) Summaries and 510(k) Statements...." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.
8.2. Device
Device trade name: Quality Mix blender, Oxymixer
Common name: Breathing gas mixer
Classification name: Anesthesia Inhalation, Breathing Gas Mixer (21 CFR 868.5330)
Regulatory Class: II
Product Code : BZR
Models:
Quality Mix Low Flow, range 3-30 liters per minute
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Quality Mix Low Flow XL, range 3-30 liters per minute
Quality Mix High Flow, range 15-120 liters per minute
Quality Mix High Flow XL, range 15-120 liters per minute
8.3. Predicated device equivalence
DEHAS Medical Systems GmbH is claiming substantial equivalence to the Precision Blender (K053232) from Precision Medical Inc.
8.4. Indications for use
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 air trapping, barotrauma, and gastric insufflation (leading to possible aspiration) can occur.
8.5. Patient Group
The Quality Mix blender may be used on equipment where patient population is infant, pediatric and adult patients.
8.6. Environments of use
Professional healthcare settings, where the delivery and monitoring of air/ oxygen mixtures is required.
8.7. Device description
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.
8.8. Technology
The Quality Mix blender is designed to use two gas sources of medical air and oxygen (46,41- 94,27 psi). The two gas sources enter through the diameter - indexed air and oxygen inlet connectors located on the bottom of the Quality Mix blender. Once through the filters, each gas passes through a duckbill check valve which prevents possible reverse gas flow from either the oxygen or the air supply systems. The two gases then pass
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through a two-stage balance regulator module. The purpose of this regulator module is to equalize the operating pressures of the air and oxygen gas sources.
Once these pressures have been balanced, the gases are proportioned according to the oxygen concentration selected on the oxygen concentration selection dial. The oxygen concentration dial allows the clinician to select a desired oxygen concentration from 21% to 100% O2.
When the pressure difference between the two inlet gases exceeds the prescribed value, or if there is a gas supply failure of one of the gas sources because of disconnection, the bypass poppet will move to one site and create a path for the high-pressure gas to flow into the alarm. This triggers the audible alarm. From this point, the mixed gas flows to the outlet port. The bleed valve on the auxiliary outlet port needs to be activated to ensure the oxygen concentration accuracy of ±3% when the intended output flow in low flow applications is below the specified range of ≤15 lpm for the High Flow blender and ≤3 lpm for the Low Flow blender.
8.9. Determination of substantial equivalence
The subject device has the same indication for use, the same patient group, and the same environment of use as the predicate device Precision Blender (K053232).
The subject device also has the same technological characteristics for example design components, the same function and uses the same energy source as the predicate device. Both devices accept room air and 100% oxygen gas and adjust the molar fraction of oxygen gas in the room air by mechanical means, and blended gas is supplied to the patient. They have identical specifications for the delivery of blended gas and they use the same technoloqy for the audible alarm if the pressure differential between the two inlet gases exceeds the prescribed value or if one gas source is disconnected. Both devices are pneumatically powered only and they produce an audible alarm. The subject device and the predicate device are not intended to be used sterile, nor do either device contain electrical components. The subject device and the predicate device are provided in versions of High Flow and Low Flow blenders.
Please see the table below for more details.
| Item /Manufacturer | Quality MixBlender | Quality MixBlender | PRECISIONBLENDER | PRECISIONBLENDER |
|---|---|---|---|---|
| DEHAS MedicalSystems GmbHWesloer Str.107-10923568 Luebeck,Germany | DEHAS MedicalSystems GmbHWesloer Str.107-10923568 Luebeck,Germany | PrecisionMedical, Inc.®300 Held Drive,Northampton,PA 18067, USA | PrecisionMedical, Inc.®300 Held Drive,Northampton,PA 18067, USA | |
| Model | Quality MixHigh Flow; XL | Quality Mix LowFlow; XL | PM5200 HighFlow | PM5300 LowFlow |
| Item /Manufacturer | Quality MixBlenderDEHAS MedicalSystems GmbHWesloer Str.107-10923568 Luebeck,Germany | Quality MixBlenderDEHAS MedicalSystems GmbHWesloer Str.107-10923568 Luebeck,Germany | PRECISIONBLENDERPrecisionMedical, Inc.®300 Held Drive,Northampton,PA 18067, USA | PRECISIONBLENDERPrecisionMedical, Inc.®300 Held Drive,Northampton,PA 18067, USA |
| 510 (K)Number | K221494/S001 | K221494/S001 | (K053232) | (K053232) |
| Product Code | BZR | BZR | BZR | BZR |
| RegulationNumber | 21 CFR868.5330 | 21 CFR868.5330 | 21 CFR868.5330 | 21 CFR868.5330 |
| Patient Group | Infant, pediatric,and adultpatients | Infant, pediatric,and adultpatients | Infant, pediatricand adultpatients | Infant, pediatric,and adultpatients |
| Primary OutletFlow Range | 15 – 120 LPMWith both supply pressures at 50 psi(3,4 bar) with BLEED closed | 3-30 LPMWith both supply pressures at 50 psi(3,4 bar) with BLEED closed | 15 – 120 LPMWith both supply pressures at 50 psi(3,4 bar) with BLEED closed | 3-30 LPMWith both supply pressures at 50 psi(3,4 bar) with BLEED closed |
| AuxiliaryOutlet FlowRange | 15 – 120 LPMWith both supply pressures at 50 psi(3,4 bar) with BLEED closed0 – 105 LPMWith both supply pressures at 50 psi(3,4 bar) with BLEED open | 3-30 LPMWith both supply pressures at 50 psi(3,4 bar) with BLEED closed0 – 27 LPMWith both supply pressures at 50 psi(3,4 bar) with BLEED open | 15 – 120 LPMWith both supply pressures at 50 psi(3,4 bar) with BLEED closed2-100 LPMWith both supply pressures at 50 psi(3,4 bar) with BLEED open | 3-30 LPMWith both supply pressures at 50 psi(3,4 bar) with BLEED closed0-30 LPMWith both supply pressures at 50 psi(3,4 bar) with BLEED open |
| Bleed Flow | ≤ 13 LPM at 50psi (3,4 bar) | ≤ 3 LPM at 50 psi(3,4 bar) | 13 LPM or lessat 50 psi (3,4bar) | 3 LPM or less at50 psi (3,4 bar) |
| MaximumCombinedFlow (alloutlets) | ≥ 120 LPM | ≥ 30 LPM | ≥ 120 LPM | ≥ 30 LPM |
| Bypass Flow(loss of air oroxygensupply) | > 85 LPM | > 15 LPM | > 85 LPM | > 45 LPM |
| Bypass AlarmActivation(range ofactivation if | At inlet Pressure46,41 psi (3,2bar) | At inlet Pressure46,41 psi (3,2bar) | 50 psi (3,45 bar)13,25 - 25 psi(0,9 - 1.7 bar) | 50 psi (3,45 bar)18 - 22 psi(1.2 - 1.5 bar) |
| Item /Manufacturer | Quality MixBlender | Quality MixBlender | PRECISIONBLENDER | PRECISIONBLENDER |
| DEHAS MedicalSystems GmbH | DEHAS MedicalSystems GmbH | PrecisionMedical, Inc.® | PrecisionMedical, Inc.® | |
| Wesloer Str.107-109 | Wesloer Str.107-109 | 300 Held Drive,Northampton, | 300 Held Drive,Northampton, | |
| 23568 Luebeck,Germany | 23568 Luebeck,Germany | PA 18067, USA | PA 18067, USA | |
| there is apressuredifferencebetween bothgas sourcesor loss of gassupply) | When pressuredifference of oneinlet gas isdetected of ≥13,05 psi (≥ 0,9bar). | When pressuredifference of oneinlet gas isdetected of ≥13,05 psi (≥ 0,9bar). | ||
| At inlet Pressure60,92 psi (4,2bar) | At inlet Pressure60,92 psi (4,2bar) | 60 psi (4.14 bar) | 60 psi (3,.5 bar) | |
| When pressuredifference of oneinlet gas isdetected of ≥13,05 psi (≥ 0,9bar). | When pressuredifference of oneinlet gas isdetected of ≥13,05 psi (≥ 0,9bar). | 16 – 24 psi(1.1 - 1.65 bar) | 16 – 24 psi(1.1 - 1.65 bar) | |
| At inlet Pressure94,27 psi (6,5bar) | At inlet Pressure94,27 psi (6,5bar) | |||
| When pressuredifference of oneinlet gas isdetected of ≥13,05 psi (≥ 0,9bar). | When pressuredifference of oneinlet gas isdetected of ≥13,05 psi (≥ 0,9bar). | |||
| Alarm Reset | When the pressure differencebetween the two inlet gases isrestored to ≤ 4,35 psi (0,3 bar) toeach other, the alarm will be reset. | When pressure differential is 6 psi(0.4 bar) or less | ||
| Alarm SoundLevel | ≥ to 80 dB at a distance of 1 ft. (0,3 m) | ≥ to 80 dB at 1 ft. (0,3 m) | ||
| OxygenConcentrationAdjustmentRange | 21 – 100 % | 21 – 100 % | ||
| Gas Supplypressure | 46,41 – 94,27 psi (3,2 – 6,5 bar) | 30 - 75 psi (2.1 – 5.2 bar) | ||
| Item /Manufacturer | Quality MixBlender | Quality MixBlender | PRECISIONBLENDER | PRECISIONBLENDER |
| DEHAS MedicalSystems GmbH | DEHAS MedicalSystems GmbH | PrecisionMedical, Inc.® | PrecisionMedical, Inc.® | |
| Wesloer Str.107-109 | Wesloer Str.107-109 | 300 Held Drive,Northampton, | 300 Held Drive,Northampton, | |
| 23568 Luebeck,Germany | 23568 Luebeck,Germany | PA 18067, USA | PA 18067, USA | |
| Air and oxygen pressure differentialshould be within max 0.7 bar | Air and oxygen within 10 psi (0.69bar) of each other | |||
| Mixed GasStability | ± 1% Oxygen | ± 1% Oxygen | ||
| ConnectionTypes | DISS Type - air & oxygen inlets &outlets and / or NIST Type - air&oxygen inlets | DISS Type - air & oxygen inlets&outlets and / or NIST Type - air &oxygen inlets | ||
| Dimensions | 12.2" High x 16,5" Wide x 13" Deep[cm] | 10.4" High x 5.7" Wide x 12.5" Deep[cm] | ||
| Weight | 1.6 kg | 2.29 lbs. (1.04 kg) | ||
| ShippingWeight | 4.0 kg | 2.95 lbs. (1.34 kg) | ||
| OperatingTemperatureRange | 41° F to 122°F (5°C to 50°C) | 59° F to 104°F (15°C to 40°C) | ||
| % OxygenControl | 21-100% | 21-100% | 21 - 100% | 21-100% |
| Accuracy(FiO2) | ± 3% | ± 3% | ± 3% | ± 3% |
| Normaloperatingpressure | air/ oxygen | air/ oxygen | air and oxygen | air and oxygen |
| 46,41 - 94,27psi | 46,41 - 94,27 psi | 30 - 70 psi | 30 - 70 psi | |
| Pressure Drop | High Flow:≤ 0.21 bar atinlet pressuresfrom 3,2 to 6,5bar, with a flowrate of 30 LPMat 60% FiO2 | Low Flow:≤ 0.14 bar at inletpressures from3,2 to 6,5 bar,with a flow rate of10 LPM at 60%FiO2 | High Flow:≤ 3 psi (0.21 bar)at 30-90 psi (2.1- 6.2 bar) and at30 LPM flow rateat 60% FiO2 | Low Flow:≤ 2 psi (0.14 bar)at 30-90 psi (2.1- 6.2 bar) and at10 LPM flow rateat 60% FiO2 |
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Table 1: Table of comparison
The following quality assurance measures were applied to the development of the device:
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- Risk analysis .
- Requirements evaluation reports .
- Raw materials verification .
- . Final acceptance testing requirements
- Performance testing verification .
8.10. Summary of non - clinical tests
For comparison, we performed a number of non-clinical tests according to the equivalent standards to demonstrate that the subject device performs as intended and is substantial equivalent to the predicate device Precision Blender (K053232).
We used the following international standards for testing to demonstrate substantial equivalence:
| Used Standard | Standard used for | Result:Pass /fail |
|---|---|---|
| ISO 11195:2018(second edition) Gasmixers for medical use -Standalone gas mixers | ISO 11195:2018-01 Gasmixers for medical use -Stand-alone gas mixers(second edition)General Performance TestReport related to StandaloneBlenders. This testing includedapplicable elements of thestandard for blendersaccording clause 4 essentialperformance requirements:Clause 9:Reverse gas flowClause 11:Alarm systemsClause 12:Accuracy of indicated oxygenconcentrationClause 13:Gas supply failure | The Quality Mix BlenderHigh Flow and Low Flowperforms as intendedwithin the specifiedfunctions andperformance and fulfilsthe essential performancerequirements clause 4according to the standardISO 11195:2018-01 forGas mixers for medicaluse - Stand - alone gasmixers.Result: pass |
| ISO 14971 Secondedition 2007-03-01Medical devices - | This international standard hasbeen used as a process forour medical devices for the | Result: pass |
| Application of riskmanagement to medicaldevicesFR Recognition ListNumber: 043FR Recognition Number:5-40 | identification and assessmentof hazards and associatedrisks, the control of these risksand the monitoring of theeffectiveness of risk controlmeasures. | |
| IEC 62366 – 1 Edition1.0 2015-02 Medicaldevices Part 1:Application of usabilityengineering to medicaldevices (includingCORRIGENDUM 12016) | This standard has been usedto verify and validate theusability of the Quality Mixblender series. | Usability report QualityMix blender seriesperformed in cooperationwith an authorized,certified competencecenter for medical oxygenblenders.Result: pass |
| FR Recognition ListNumber: 046FR Recognition Number:5-114 | ||
| German version EN1789:2007+A2:2014Medical vehicles andtheir equipment - Roadambulances | We performed Laboratory Testwith Report environmentaltesting regarding strength,vibration, shock of the device. | Vibration (sinusoidal) TestShock Test |
| German version EN60068-2-6:2008Environmental testing -Part 2-6: Tests - TestFc: Vibration (sinusoidal) | Vibration, broadbandrandom TestResult: pass | |
| German version EN60068-2-27:2009Environmental testing -Part 2-27: Tests - TestEa and guidance: Shock | ||
| German version EN60068-2-64:2008 | ||
| Environmental testing –Part 2-64: Tests – TestFh: Vibration, broadbandrandom and guidance | ||
| DIN EN ISO15002:2020-05 Flow-metering devices forconnection to terminalunits of medical gaspipeline systems | General performance testreport for flow-meteringdevices for connection toblenders of Quality Mix Series(Compensated Thorpe tubeflowmeter. | This testing includedFlowmeter accuracy,Leak test, environmentaland mechanical condition.Result: pass |
| ISO 15001:2010Anesthetic andrespiratory equipment -Compatibility withoxygen | The standard has been usedto ensure the oxygencompatibility of the usedmaterials. | Aspects of compatibilitythat are addressedinclude cleanliness,resistance to ignition andthe toxicity of products ofcombustion and/ordecomposition.Result: pass |
| ISO 18562-1Biocompatibilityevaluation of breathinggas pathways inhealthcare applications -Part 1: Evaluation andtesting within a riskmanagement processISO 18562-2Biocompatibilityevaluation of breathinggas pathways inhealthcare applications -Part 2: Tests foremissions of particulatematterISO 18562-3Biocompatibilityevaluation of breathinggas pathways inhealthcare applications -Part 3: Tests foremissions of volatileorganic compounds | Biocompatibility evaluation ofbreathing gas pathways inhealthcare applications. | We did performBiocompatibility testing:Gas emission VOCtesting with a riskassessment of anyidentified chemical.Contact classification ofblender:Indirect patient contactprovided via the mixtureof gases brought togetherby the blender andsupplied to the patient(gas pathway contact), formedical devices with gaspathway contact to thepatient, compliance toISO 18562-1 is requiredDuration:The duration of use isclassified as permanent(more than 30 days)within the scope of thestandard ISO 18562-1 |
| Testing:The followingbiocompatibility testswere carried out: | ||
| Tests for particulatematter emissionsaccording to ISO 18562-2 | ||
| Tests for volatile organiccompound (VOC)emissions according toISO 18562-3 | ||
| Result: pass |
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Table 2: Summary of non - clinical tests
Conclusion:
In all cases the subject device passed or meets the acceptance criteria of general requirements for performance and basic safety. We can find the subject device substantially equivalent to the predicate device Precision Blender (K053232).
There are no differences which raise any different questions of safety and effectiveness.
8.11. Animal testing
No animal testing was performed.
8.12. Clinical tests
The subject of this premarket submission, Quality Mix blender series, do not require clinical studies to support substantial equivalence.
8.13. Discussion of Differences
There are a few differences between the subject device and the predicate device Precision Blender (K053232). The differences between the predicate and the subject device are addressed when we compare the subject device to the reference devices
They are:
Environments MRI
The environments of use of the Quality Mix series are same as the predicate device Precision Blender (K053232). But the Subjected Device is not for use in MRI Environments, due to the use of ferrous materials / metallic components. Therefore the Device as stated in the safety information's and labeling is marked as MR unsafe. The predicate Device Precision Blender (K053232) can be used in MRI environments of only 3 Tesla MR Systems. Both devices are not intended to be used sterile.
Physical characteristics:
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510 (K) SUMMARY
Regarding the dimensions and weight, the physical characteristics are similar. All devices have been physically designed and evaluated to be used in clinical settings for their intended use.
Auxiliary outlet flow range (with both supply pressures at 50 psi (3,4 bar) with Bleed Flow open):
The specification of the auxiliary outlet flow range of the air-oxygen blender QualityMix series (High Flow, Low Flow) is similar to the predicate blender devices. The Low Flow and the High Flow blender require a minimum flow rate depending on the model if the auxiliary outlet is in use at low flow applications. This bleed flow is necessary to ensure the concentration accuracy ±3 % when using the blender on this outlet port for low flows, typically below ≤3 lpm (Low Flow blender) and below ≤15 lpm (High Flow blender). Therefore the bleed flow in low flow applications must be activated on this outlet port. Because of this necessary bleed flow, the flow rate in this application on the auxiliary outlet port ensures with an accuracy of ±3 % 0-27 lpm for Quality Mix Low Flow and 0 -105 lpm for Quality Mix High Flow blenders.
The predicate device ensures under same conditions an auxiliary outlet flow range of 0-30 lpm (Low Flow) and 2-100 lpm (High Flow) with an accuracy of ± 3%.
Bypass flow (loss of air or oxygen supply):
Regarding specification of the bypass flow of the Air Oxygen blender Quality Mix Series (High Flow, Low Flow) the performance is similar to the predicate blender devices.
The Quality Mix blender series has an alarm / bypass function, which quarantees a flow of > 85 LPM for the High Flow blenders and > 15 LPM for the Low Flow blenders in emergency situations, if one of the gas supply sources has a malfunction or loss.
The predicate device insures under same conditions a bypass flow of > 85 LPM for the High Flow blender and >45 LPM for the Low Flow blender.
Technical function of bypass flow of the subject device and the predicate device is the same. The bypass flow function ensures that the flow of the remaining gas is maintained. if other one of the two gas supply sources is malfunctioning and the remaining gas supply is at the indicated supply pressure value of normal operating condition.
At both devices, the gas bypass function operates in unison with the alarm. Once the pressure alarm is activated, the bypass function is actuated and the qas with the higher pressure flows directly to the outlet port, bypassing the mixing function of the blender. The oxygen concentration flowing out of the blender will be that of gas with the higher pressure.
Therefore, both devices meet the requirements of the ISO 11195 standard in the case of gas supply failure conditions.
Bypass alarm activation:
The difference is, that the alarm function of the subject device is more sensitive than the predicate device to inform the user of pressure differentials between medical air and medical oxygen. This safety mechanism was taken into account during the development and risk analysis and tested during the usability assessment. In this case, the alarm of the subject device arises at any inlet pressure range of tested normal operating conditions in
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510 (K) SUMMARY
Page 39
a case of a difference in pressure (O2 and Air) of≥13,05psi (0,9 bar) of the used gases and cease again before the difference in pressure drops below the value of ≤4,35 psi (≤0,3 bar).
The alarm of the predicate device Precision Blender (K053232) arises under tested normal operating conditions at a pressure difference between both gases between ≥16 - 24 psi (1.1 - 1.65 bar).Furthermore, the alarm function of the predicate device is infected and reacts by any different inlet pressure range.
Gas supply pressure / normal operating pressure of the blender:
Regarding normal operating pressure, the subject device was tested and specified within 46.41 - 94.27 psi (3.2 - 6.5 bar) inlet pressure of both gases. The predicate device Precision Blender (K053232) within 30 – 75 psi (2.1 – 5.2 bar). This difference does not raise any questions of safety and effectiveness. Both blenders have been tested by verification and meet the requirements of ISO 11195: 2018 that the gas blenders must cover and work in the entire nominal range of medical gas pipeline systems for compressed medical gases and vacuum according to ISO 7396-1 in hospital environments.
Operating temperature:
The operating temperature of the subject device is similar to the predicate device.
The operating temperature of the subject device is +5C° - +50C°.
The operating temperature of the predicate Precision Blender (K053232) device is 15C° – 40C°.
Pressure drop:
In comparison and according to the technical data and performance test, the subject device has similar performance of pressure drop in the range of ≤ 3 psi with a flow rate of 30 I/ min at 60% FiO2 (High Flow) and ≤ 2 psi with a flow rate of 10 I/ min at 60% FiO2 (Low Flow) at a set inlet pressure of 46,41 - 94,27 psi (3,2 - 6,5 bar).
The predicate device has a performance of pressure drop in the range of ≤ 3 psi with a flow rate of 30 l/ min at 60% FiO2 (High Flow) and ≤ 2 psi with a flow rate of 10 l/ min at 60% FiO2 (Low Flow) at a set inlet pressure of 2.1 - 6.2 bar (normal operating conditions).
The Quality Mix blenders has nearly the same performance specifications as the predicate device. The only difference is the specified range of the optimal and used inlet pressure under normal operating conditions.
8.14. Substantial equivalence conclusion
The subject device has the same intended use as the predicate device, and the technological differences do not raise different questions of safety and effectiveness.
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§ 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).