Who is the manufacturer of Quality Mix Blender, Oxymixer?

Dehas Medical Systems GmbH filed the 510(k) submission for Quality Mix Blender, Oxymixer (K221494).

What is the FDA product code for Quality Mix Blender, Oxymixer?

BZR. It is classified under 21 CFR 868.5330 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for Quality Mix Blender, Oxymixer?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Quality Mix Blender, Oxymixer?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Quality Mix Blender, Oxymixer

K221494 · Dehas Medical Systems GmbH · BZR · Jan 23, 2023 · Anesthesiology

Device Facts

Record ID	K221494
Device Name	Quality Mix Blender, Oxymixer
Applicant	Dehas Medical Systems GmbH
Product Code	BZR · Anesthesiology
Decision Date	Jan 23, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5330
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended 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.

Device Story

Pneumatic air-oxygen blender; inputs medical air and oxygen (46.41-94.27 psi) via diameter-indexed connectors. Internal two-stage balance regulator module equalizes gas pressures; oxygen concentration dial (21-100%) proportions gases. Mixed gas delivered to outlet ports. Used in professional healthcare settings by qualified personnel. Includes audible alarm triggered by pressure differential (≥13.05 psi) or supply failure; bypass poppet allows high-pressure gas to flow directly to outlet during failure. Bleed valve ensures concentration accuracy in low-flow applications. Provides clinicians with precise FiO2 delivery; supports respiratory therapy. MR unsafe due to metallic components.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including performance testing per ISO 11195:2018 (reverse gas flow, alarm systems, concentration accuracy, gas supply failure), usability engineering (IEC 62366-1), environmental testing (vibration/shock), and biocompatibility (ISO 18562-1/2/3).

Technological Characteristics

Pneumatic, non-electric, standalone gas mixer. Materials compliant with ISO 15001 (oxygen compatibility). Dimensions: 12.2" x 16.5" x 13". Operating pressure: 46.41-94.27 psi. Connectivity: DISS/NIST inlet/outlet ports. No software/firmware.

Indications for Use

Indicated for infants, children, and adults requiring continuous, precise air-oxygen mixtures in professional healthcare settings. Not for life support.

Regulatory Classification

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.

Predicate Devices

Precision Blender (K053232)

Related Devices

K142291 — GMX Series Medical Air/Oxygen Blender · Gentec (Shanghai) Corporation · May 19, 2015
K053232 — PRECISION BLENDER · Precision Medical, Inc. · Jan 10, 2006
K023745 — SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G · Sechrist Industries, Inc. · Jan 17, 2003
K031707 — SK MED M201 PLUS MIXER · Sk Med · Aug 1, 2003
K113232 — MAXMIXING BLOCK · Maxtec, Inc. · Mar 1, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 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 {4}------------------------------------------------ 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 {5}------------------------------------------------ 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 Mix Blender | Quality Mix Blender | PRECISION BLENDER | PRECISION BLENDER | |--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | DEHAS Medical Systems GmbH Wesloer Str. 107-109 23568 Luebeck, Germany | DEHAS Medical Systems GmbH Wesloer Str. 107-109 23568 Luebeck, Germany | Precision Medical, Inc.® 300 Held Drive, Northampton, PA 18067, USA | Precision Medical, Inc.® 300 Held Drive, Northampton, PA 18067, USA | | Model | Quality Mix High Flow; XL | Quality Mix Low Flow; XL | PM5200 High Flow | PM5300 Low Flow | | Item / Manufacturer | Quality Mix Blender DEHAS Medical Systems GmbH Wesloer Str. 107-109 23568 Luebeck, Germany | Quality Mix Blender DEHAS Medical Systems GmbH Wesloer Str. 107-109 23568 Luebeck, Germany | PRECISION BLENDER Precision Medical, Inc.® 300 Held Drive, Northampton, PA 18067, USA | PRECISION BLENDER Precision Medical, Inc.® 300 Held Drive, Northampton, PA 18067, USA | | 510 (K) Number | K221494/S001 | K221494/S001 | (K053232) | (K053232) | | Product Code | BZR | BZR | BZR | BZR | | Regulation Number | 21 CFR 868.5330 | 21 CFR 868.5330 | 21 CFR 868.5330 | 21 CFR 868.5330 | | Patient Group | Infant, pediatric, and adult patients | Infant, pediatric, and adult patients | Infant, pediatric and adult patients | Infant, pediatric, and adult patients | | Primary Outlet Flow Range | 15 – 120 LPM With both supply pressures at 50 psi (3,4 bar) with BLEED closed | 3-30 LPM With both supply pressures at 50 psi (3,4 bar) with BLEED closed | 15 – 120 LPM With both supply pressures at 50 psi (3,4 bar) with BLEED closed | 3-30 LPM With both supply pressures at 50 psi (3,4 bar) with BLEED closed | | Auxiliary Outlet Flow Range | 15 – 120 LPM With both supply pressures at 50 psi (3,4 bar) with BLEED closed 0 – 105 LPM With both supply pressures at 50 psi (3,4 bar) with BLEED open | 3-30 LPM With both supply pressures at 50 psi (3,4 bar) with BLEED closed 0 – 27 LPM With both supply pressures at 50 psi (3,4 bar) with BLEED open | 15 – 120 LPM With both supply pressures at 50 psi (3,4 bar) with BLEED closed 2-100 LPM With both supply pressures at 50 psi (3,4 bar) with BLEED open | 3-30 LPM With both supply pressures at 50 psi (3,4 bar) with BLEED closed 0-30 LPM With both supply pressures at 50 psi (3,4 bar) with BLEED open | | Bleed Flow | ≤ 13 LPM at 50 psi (3,4 bar) | ≤ 3 LPM at 50 psi (3,4 bar) | 13 LPM or less at 50 psi (3,4 bar) | 3 LPM or less at 50 psi (3,4 bar) | | Maximum Combined Flow (all outlets) | ≥ 120 LPM | ≥ 30 LPM | ≥ 120 LPM | ≥ 30 LPM | | Bypass Flow (loss of air or oxygen supply) | > 85 LPM | > 15 LPM | > 85 LPM | > 45 LPM | | Bypass Alarm Activation (range of activation if | At inlet Pressure 46,41 psi (3,2 bar) | At inlet Pressure 46,41 psi (3,2 bar) | 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 Mix Blender | Quality Mix Blender | PRECISION BLENDER | PRECISION BLENDER | | | DEHAS Medical Systems GmbH | DEHAS Medical Systems GmbH | Precision Medical, Inc.® | Precision Medical, 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 a pressure difference between both gas sources or loss of gas supply) | When pressure difference of one inlet gas is detected of ≥ 13,05 psi (≥ 0,9 bar). | When pressure difference of one inlet gas is detected of ≥ 13,05 psi (≥ 0,9 bar). | | | | | At inlet Pressure 60,92 psi (4,2 bar) | At inlet Pressure 60,92 psi (4,2 bar) | 60 psi (4.14 bar) | 60 psi (3,.5 bar) | | | When pressure difference of one inlet gas is detected of ≥ 13,05 psi (≥ 0,9 bar). | When pressure difference of one inlet gas is detected of ≥ 13,05 psi (≥ 0,9 bar). | 16 – 24 psi (1.1 - 1.65 bar) | 16 – 24 psi (1.1 - 1.65 bar) | | | At inlet Pressure 94,27 psi (6,5 bar) | At inlet Pressure 94,27 psi (6,5 bar) | | | | | When pressure difference of one inlet gas is detected of ≥ 13,05 psi (≥ 0,9 bar). | When pressure difference of one inlet gas is detected of ≥ 13,05 psi (≥ 0,9 bar). | | | | Alarm Reset | When the pressure difference between the two inlet gases is restored to ≤ 4,35 psi (0,3 bar) to each other, the alarm will be reset. | | When pressure differential is 6 psi (0.4 bar) or less | | | Alarm Sound Level | ≥ to 80 dB at a distance of 1 ft. (0,3 m) | | ≥ to 80 dB at 1 ft. (0,3 m) | | | Oxygen Concentration Adjustment Range | 21 – 100 % | | 21 – 100 % | | | Gas Supply pressure | 46,41 – 94,27 psi (3,2 – 6,5 bar) | | 30 - 75 psi (2.1 – 5.2 bar) | | | Item / Manufacturer | Quality Mix Blender | Quality Mix Blender | PRECISION BLENDER | PRECISION BLENDER | | | DEHAS Medical Systems GmbH | DEHAS Medical Systems GmbH | Precision Medical, Inc.® | Precision Medical, 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 differential should be within max 0.7 bar | | Air and oxygen within 10 psi (0.69 bar) of each other | | | Mixed Gas Stability | ± 1% Oxygen | | ± 1% Oxygen | | | Connection Types | 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) | | | Shipping Weight | 4.0 kg | | 2.95 lbs. (1.34 kg) | | | Operating Temperature Range | 41° F to 122°F (5°C to 50°C) | | 59° F to 104°F (15°C to 40°C) | | | % Oxygen Control | 21-100% | 21-100% | 21 - 100% | 21-100% | | Accuracy (FiO2) | ± 3% | ± 3% | ± 3% | ± 3% | | Normal operating pressure | air/ oxygen | air/ oxygen | air and oxygen | air and oxygen | | | 46,41 - 94,27 psi | 46,41 - 94,27 psi | 30 - 70 psi | 30 - 70 psi | | Pressure Drop | High Flow: ≤ 0.21 bar at inlet pressures from 3,2 to 6,5 bar, with a flow rate of 30 LPM at 60% FiO2 | Low Flow: ≤ 0.14 bar at inlet pressures from 3,2 to 6,5 bar, with a flow rate of 10 LPM at 60% FiO2 | High Flow: ≤ 3 psi (0.21 bar) at 30-90 psi (2.1 - 6.2 bar) and at 30 LPM flow rate at 60% FiO2 | Low Flow: ≤ 2 psi (0.14 bar) at 30-90 psi (2.1 - 6.2 bar) and at 10 LPM flow rate at 60% FiO2 | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ Table 1: Table of comparison The following quality assurance measures were applied to the development of the device: {9}------------------------------------------------ - 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) Gas mixers for medical use - Standalone gas mixers | ISO 11195:2018-01 Gas mixers for medical use - Stand-alone gas mixers (second edition) General Performance Test Report related to Standalone Blenders. This testing included applicable elements of the standard for blenders according clause 4 essential performance requirements: Clause 9: Reverse gas flow Clause 11: Alarm systems Clause 12: Accuracy of indicated oxygen concentration Clause 13: Gas supply failure | The Quality Mix Blender High Flow and Low Flow performs as intended within the specified functions and performance and fulfils the essential performance requirements clause 4 according to the standard ISO 11195:2018-01 for Gas mixers for medical use - Stand - alone gas mixers. Result: pass | | ISO 14971 Second edition 2007-03-01 Medical devices - | This international standard has been used as a process for our medical devices for the | Result: pass | | Application of risk management to medical devices FR Recognition List Number: 043 FR Recognition Number: 5-40 | identification and assessment of hazards and associated risks, the control of these risks and the monitoring of the effectiveness of risk control measures. | | | IEC 62366 – 1 Edition 1.0 2015-02 Medical devices Part 1: Application of usability engineering to medical devices (including CORRIGENDUM 1 2016) | This standard has been used to verify and validate the usability of the Quality Mix blender series. | Usability report Quality Mix blender series performed in cooperation with an authorized, certified competence center for medical oxygen blenders. Result: pass | | FR Recognition List Number: 046 FR Recognition Number: 5-114 | | | | German version EN 1789:2007+A2:2014 Medical vehicles and their equipment - Road ambulances | We performed Laboratory Test with Report environmental testing regarding strength, vibration, shock of the device. | Vibration (sinusoidal) Test Shock Test | | German version EN 60068-2-6:2008 Environmental testing - Part 2-6: Tests - Test Fc: Vibration (sinusoidal) | | Vibration, broadband random Test Result: pass | | German version EN 60068-2-27:2009 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock | | | | German version 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 | General performance test report for flow-metering devices for connection to blenders of Quality Mix Series (Compensated Thorpe tube flowmeter. | This testing included Flowmeter accuracy, Leak test, environmental and mechanical condition. Result: pass | | ISO 15001:2010 Anesthetic and respiratory equipment - Compatibility with oxygen | The standard has been used to ensure the oxygen compatibility of the used materials. | Aspects of compatibility that are addressed include cleanliness, resistance to ignition and the toxicity of products of combustion and/or decomposition. Result: pass | | ISO 18562-1 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process ISO 18562-2 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter ISO 18562-3 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds | Biocompatibility evaluation of breathing gas pathways in healthcare applications. | We did perform Biocompatibility testing: Gas emission VOC testing with a risk assessment of any identified chemical. Contact classification of blender: Indirect patient contact provided via the mixture of gases brought together by the blender and supplied to the patient (gas pathway contact), for medical devices with gas pathway contact to the patient, compliance to ISO 18562-1 is required Duration: The duration of use is classified as permanent (more than 30 days) within the scope of the standard ISO 18562-1 | | | | Testing: The following biocompatibility tests were carried out: | | | | Tests for particulate matter emissions according to ISO 18562-2 | | | | Tests for volatile organic compound (VOC) emissions according to ISO 18562-3 | | | | Result: pass | {10}------------------------------------------------ {11}------------------------------------------------ {12}------------------------------------------------ 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: {13}------------------------------------------------ #### 510 (K) SUMMARY Regarding the dimensions…