The Midas Flowmeter is intended for use as a continuous flow conscious sedation system to deliver a mixture of nitrous oxide and oxygen gases to a patient. When used with the electronic automatic vacuum switch (eAVS), the Midas Flowmeter is used to control the scavenging of waste analgesic gas.

Device Description

The Midas Flowmeter is used within a healthcare environment during a nitrous oxide (N20)/oxygen (O2) conscious sedation system. The device is a digitally controlled, software driven, continuous flow device that precisely meters nitrous oxide and oxygen medical gases and delivers gas mixtures to a conscious, spontaneously breathing patient. The Midas Flowmeter uses electronic mechanisms to control the flowrate and mixture percentage of gases delivered to a patient. The optional eAVS is an accessory to the Midas Flowmeter. It is used within the nitrous oxide/oxygen conscious sedation system to allow removal of waste analgesic gases through a connected vacuum source. The eAVS connects the exhalation line of the patient's breathing circuit to vacuum tubing from the vacuum source and controls the vacuum flowrate (i.e., scavenging flowrate). The eAVS is specifically designed to work with the Midas Flowmeter and all functionality control of the eAVS has been integrated into the user interface of the Midas Flowmeter.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence of a new medical device to existing predicate devices. It primarily discusses comparisons of technical characteristics and compliance with recognized standards.

Crucially, this document does NOT contain explicit acceptance criteria tables or a detailed study report that proves the device meets specific performance metrics in a clinical or simulated environment with ground truth from experts, as would be expected for an AI/ML powered device.

The document states:

"The characteristics of the Midas Flowmeter and optional eAVS do not require clinical investigation due to safety and efficacy being supported by non-clinical testing performed."
"The verification and validation testing of the Midas Flowmeter and optional eAVS was found to be acceptable and supports the claims of substantial equivalence."

This indicates that the device's performance was evaluated through bench testing and compliance with recognized consensus standards, rather than a clinical study involving human readers or expert-established ground truth for a test set.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or the type of ground truth used, because such a study (as described in the prompt) was not performed or detailed in this 510(k) submission.

The document focuses on:

Comparison of Technical Characteristics: Showing the Midas Flowmeter and eAVS are similar in function, intended use, and technology to predicate devices (FlowStar Touch Digital Mixer Flowmeter and Nitronox Scavenger Plus).
Compliance with Standards: Listing various IEC, ISO, AAMI, and ASTM standards that the device was tested against to demonstrate safety and performance (e.g., IEC 60601-1 for basic safety, ISO 11195 for gas mixers).
Non-clinical Performance Data (Bench Testing): A bulleted list of "performance bench testing" categories like "Gas Flow Rate Adjustment," "Touchscreen Display," "Accuracies and Faults," and "Life Testing." However, it does not provide the specific acceptance criteria for these tests nor the detailed results in a quantitative manner as requested. It simply states that "The results of the testing demonstrated that the Midas Flowmeter and optional eAVS met all of the acceptance criteria for functional, operational, and performance characteristics..."

In summary, none of the specific elements required to answer your prompt (e.g., table of acceptance criteria with reported performance, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, training set details) are present in this 510(k) document because the device is a hardware system (a gas mixer) and was cleared based on non-clinical bench testing and adherence to recognized standards, not clinical performance studies with AI/ML components involving human expert review or data-driven ground truth.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services 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.

September 19, 2024

Parker Hannifin Corporation Deanna Perry Regulatory Compliance Specialist 245 Township Line Road Hatfield, Pennsylvania 19440

Re: K241465

Trade/Device Name: Midas Flowmeter; eAVS Regulation Number: 21 CFR 868.5330 Regulation Name: Breathing Gas Mixer Regulatory Class: Class II Product Code: BZR, CBN Dated: August 16, 2024 Received: August 16, 2024

Dear Deanna Perry:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

{1}------------------------------------------------

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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.

{2}------------------------------------------------

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,

Bradley Q. Quinn -S

Bradley Quinn Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K241465

Device Name Midas Flowmeter; eAVS

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ 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."

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Parker Porter. The logo consists of the word "Parker" in a bold, sans-serif font, with a horizontal line extending from the left side of the "P". To the right of "Parker" is a vertical yellow line, followed by the word "Porter" in a similar font. The logo is simple and modern, with a clear emphasis on the company name.

510K SUMMARY

1. Date of Submission

May 23, 2024

2. Sponsor

Parker Hannifin Corporation Precision Fluidics Division 245 Township Line Road Hatfield, PA 19440

Contact Person: Deanna Perry Phone: 215-660-8104 Email: deanna.perry@parker.com

Subject Device 3.

Trade Name	Porter Midas™ Flowmeter	eAVS
Common or Usual Name	Breathing gas mixer	Scavenging apparatus
Classification Name	Mixer, breathing gases,anesthesia inhalation	Gas scavenging apparatus
Product Classification	Class II	Class II
Regulatory Class	21 CFR 868.5330	21 CFR 868.5430
Product Code	BZR	CBN
Model Numbers	60206120	EAVS-5000

4. Primary Predicate Device

FlowStar Touch Digital Mixer Flowmeter, K222794

This predicate device has not been subject to a design-related recall.

5. Reference Device

Nitronox Scavenger Plus, K223452

This reference device has not been subject to a design-related recall.

6. Device Description

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Parker Porter. The word "Parker" is in white font on a black background, with a horizontal line extending from the "P" in Parker. A yellow vertical line separates "Parker" from "Porter", which is in black font on a white background.

The Midas Flowmeter uses electronic mechanisms to control the flowrate and mixture percentage of gases delivered to a patient.

The optional eAVS is an accessory to the Midas Flowmeter. It is used within the nitrous oxide/oxygen conscious sedation system to allow removal of waste analgesic gases through a connected vacuum source. The eAVS connects the exhalation line of the patient's breathing circuit to vacuum tubing from the vacuum source and controls the vacuum flowrate (i.e., scavenging flowrate). The eAVS is specifically designed to work with the Midas Flowmeter and all functionality control of the eAVS has been integrated into the user interface of the Midas Flowmeter.

The Midas Flowmeter may be configured into in two different configurations. First, a remote configuration (model number: 6120), allowing the touchscreen display module to be mounted on a cabinet while the control module is located within the cabinet. Second, a portable configuration (model number: 6020), allowing the touchscreen display module to be connected to the control module and mounted onto a cart to other mounting options for portability.

7. Intended Use / Indications for Use

8. Technological Characteristics

The Midas Flowmeter uses electronic mechanisms to control the flowrate and mixture percentage of gases delivered to a patient. The device contains a manifold block assembly that includes valves to control gas flowrate to allow for variable flowrate. The device includes flow sensors that measure the gas flowrate. The device also incorporates a microcontroller unit to regulate flowrate, a Bluetooth module for wireless communication with a paired iPadOS device (iPad only), and a touchscreen interface for user inputs.

The Midas Flowmeter provides several onboard diagnostic and alert capabilities that can tell the user if the Midas Flowmeter has encountered a problem. Onboard diagnostics include:

Valve leak checks at powerup, ●
Communication checks, .
. Inability to achieve desired mixed gas flowrate,
. Inability to achieve desired oxygen flowrate.

The eAVS controls the rate at which disposal of the gases exhaled by the patient is conducted. The flowmeter senses when eAVS is attached with a communication cable and

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Parker Porter. The logo consists of the words "Parker Porter" in a sans-serif font. The word "Parker" is in black and the word "Porter" is in white. There is a yellow vertical line separating the two words. To the left of the word "Parker" is a black box with a white design.

switches its power on. The eAVS consists of a valve used to control scavenging flowrate, a flow sensor used to measure the rate of scavenging flow, and a scavenger controller board to communicate to the Midas Flowmeter. The eAVS maintains its valve opening and flow measurements independently of the flowmeter. The flowmeter controller periodically requests the scavenger flow rate for display to the user interface. The vacuum flow can be increased or decreased by the user, with commands being routed from the user interface to the eAVS by the flowmeter.

9. Comparison of the Technological Characteristics with the Predicate Device

Product Features	Subject DeviceParker HannifinCorporation'sPorter Midas™ Flowmeterand optional eAVS	Predicate DeviceBaldus Sedations GmbH & Co.KGFlowStar Touch Digital MixerFlowmeterK222794	Comments
Intended Use	The Midas Flowmeter andoptional eAVS is intended foruse as a continuous flowconscious sedation system todeliver a mixture of nitrousoxide and oxygen gases to apatient. When used with theeAVS, the Midas Flowmeter isused to control the scavenging ofwaste analgesic gas.	The FlowStar Touch Digital MixerFlowmeter is intended foradministering an adjustablemixture of Nitrous Oxide analgesicgas and Oxygen to a conscious,spontaneously breathing patient.	Same.The FlowStar TouchMixer is only intended tomix nitrous oxide andoxygen. While the MidasFlowmeter is intended tomix nitrous oxide andoxygen and removewaste analgesic gaswhile the eAVS isattached.
PrescriptionUse or Overthe Counter	Prescription Use	Prescription Use	Same.Both devices areprescription use.
Principle ofOperation	Software driven, continuousflow system.	Software driven, continuous flowsystem.	Same.Both devices aresoftware driven devicesthat mix nitrous oxideand oxygen continuouslyto delivery to a patientthrough a breathingcircuit during aprocedure.
Where Used	To be used by healthcareprofessionals in a healthcaresetting.	To be used by healthcareprofessionals in a healthcaresetting.	Same.Both devices areintended for use by ahealthcare professionalin a healthcare setting.
PatientContact	The Midas Flowmeter isdesigned for indirect patientcontact.	The FlowStar Touch Digital MixerFlowmeter is designed for indirectpatient contact.	Same.
ProductFeatures	Subject DeviceParker HannifinCorporation'sPorter Midas™ Flowmeterand optional eAVS	Predicate DeviceBaldus Sedations GmbH & Co.KGFlowStar Touch Digital MixerFlowmeterK222794	Comments
Gas delivery	Gas mixture delivery iscontinuous.Oxygen Flush: Minimum 20LPMOxygen Flow: 1.0-18.0 LPMOxygen %: 30%-100%Oxygen Resuscitator Flow: 225-390 L/minNitrous Oxide Flow: 0-12.6LPMNitrous Oxide %: 0-70%Mixed Gas Flow: 1.1 – 18.0LPM	Gas mixture delivery iscontinuous.Oxygen Flush: 40-55 L/minOxygen Flow:1.0-18 L/minOxygen %: 30%-100%Oxygen Resuscitator Flow: 100-250 L/minNitrous Oxide Flow: 0-12.6 L/minNitrous Oxide %: 0-70%Mixed Gas Flow: 3-18 L/min	Both devices are notdesign for indirectpatient contact.Similar.Performancecharacteristics havesimilar ranges thatsupport appropriate gasmixing and delivery tosupport continuous flowconscious sedation.
Gas inputfittings	DISS connector (Diameter IndexSafety System)O2 Inlet: DISS 1240N2O Inlet: DISS 1040AO2 Outlet: DISS 1240 demandvalve (male thread)	DISS connector (Diameter IndexSafety System)	Same.Both devices use DISSFittings.
Displays	The display module consists ofthe following components: anoff-the-shelf touchscreen LCD,an off-the-shelf Single BoardComputer (SBC), a paintedcover glass, a capacitive switchoverlay, and a Display InterfaceBoard. The touchscreen LCD,SBC, painted cover glass andcapacitive switch overlay areprovided as a finished assemblycalled the touchscreen displayassembly.Image: Porter Midas Display	Touch Panel Display	Similar.Both have useradjustment controls,power button, O2 flush,and similar touchscreens.Differences are limitedto user interface layout.
	Image: Baldus Display
Power Source	Power Supply Specification:80-264 VAC47-63HzDevice Usage Specification:100-240 VAC50-60 Hz	110-230 V50-60 Hz	Similar.The Midas Flowmeterpower supply is rated foroutside normal limits(nominal), to allow forinternational use.
ProductFeatures	Subject DeviceParker HannifinCorporation'sPorter Midas™ Flowmeterand optional eAVS	Predicate DeviceBaldus Sedations GmbH & Co.KGFlowStar Touch Digital MixerFlowmeterK222794	Comments
MonitoringandAlarms	The Midas Flowmeter usesonboard diagnostics to conductself-checks at start-up andduring operation. When an issueis detected, a notification willappear in the NotificationDisplay and is accompanied by acontinuous, audible alert. Anaudible notification may besilenced but the visualnotification remains on screenuntil corrected.O2 Alerts: Unable to provide therequested flow of O2; Oxygenvalve failed too fully close.N2O Alerts: Unable to providethe requested flow of N2O;Nitrous Oxide valve failed toofully close.Flush Flow Low: O2 Flush flowrate is below 19.5 LPM.Other Alerts: sensor faults,communication failures,software errors, scavengerfailures, leak detection,	The FlowStar Touch Digital MixerFlowmeter for Analgesia devicehas an alarm system whichgenerates an alarm in the case ofan insufficient O2 supply. Thedevice will shut off the sedationwhen the O2 supply reaches acritical level.Check O2: If no oxygen is beingsupplied, the unit emits visual andacoustic information signalsCheck N2O: If no nitrous oxide isbeing supplied, the unit emitsvisual and acoustic informationsignals. This also happens if thepressure is too low or there is ameasurement section failureO2 Minimum Flow 3 l/min:Visual and acoustic signals: TheO2 minimum flow is 3 1/min. Themixture administered can nevercontain less than 1 liter of O2.Max. Flow Reached: Once themaximum total flow (18 l/min) isreached, this is signaled visually inthe top right and a signal tonesound.Flush Flow Low: This messageappears if the flow rate is less thanthe minimum value of 18 l/minwhen the O2 Flush button ispressed. The alarms are equivalentto those of the predicate.	Similar.The FlowStar TouchMixer Flowmeter has analarm system, whereMidas Flowmeter hasnotifications and alerts toinform the end user ofactions to be reviewed.The Midas Flowmetersincludes more detailedalerts for various aspects(i.e., software andscavenger features).

Table 1: Device and Primary Predicate Product Overview

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for Parker Porter. The logo is divided into two sections. The left section is a black rectangle with the word "Parker" in white letters. To the left of the word "Parker" is a white horizontal line that extends to the left edge of the black rectangle. The right section of the logo is white with the word "Porter" in black letters. A thin yellow vertical line separates the two sections.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for Parker Porter. The logo consists of the word "Parker" in a bold, sans-serif font, with a horizontal line extending from the left side of the "P" in "Parker". To the right of "Parker" is a vertical yellow line, followed by the word "Porter" in a similar font but slightly smaller in size. The word "Parker" and the horizontal line are white against a black background, while the word "Porter" is black against a white background.

Table 2: Accessory and Reference Product Overview

ProductFeatures	Subject DeviceParker HannifinCorporation'seAVS	Reference DeviceParker Hannifin Corporation'sNitronox® Scavenger PlusK223452	Comments
Intended Use	When used with the eAVS, theMidas Flowmeter is used tocontrol the scavenging ofwaste analgesic gas.	The Scavenger Plus is intended tocontrol the vacuum flowrate forscavenging of waste analgesic gas.	Same.Both devices areintended to removewaste analgesic gas.

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for Parker Porter. The logo consists of the word "Parker" in a bold, sans-serif font, with a stylized "P" that includes a horizontal line extending to the left. To the right of "Parker" is a vertical yellow line, followed by the word "Porter" in a similar font but not as bold. The background behind "Parker" is black, while "Porter" is on a white background.

	Subject Device	Reference Device	Comments
ProductFeatures	Parker HannifinCorporation'seAVS	Parker Hannifin Corporation'sNitronox® Scavenger PlusK223452
TargetPopulation	Adults and pediatrics	Adults and pediatrics	Same.Both devices have thesame target population.
PrescriptionUse or Overthe Counter	The eAVS is for prescriptionuse only.	The Scavenger Plus is forprescription use only.	Same.
Where used	To be used by healthcareprofessionals in a healthcaresetting.	To be used by healthcareprofessionals in a healthcare setting.	Same.Both devices areintended for use by ahealthcare professionalin a healthcare setting.
Control ofFlow/Pressure	The eAVS consists of a valveused to control scavengingflowrate, an air flow sensorused to measure the rate ofscavenging flow, and a controlboard to communicate to theMidas Flowmeter.	The Scavenger Plus receives wastegas from the exhalation line of thebreathing circuit, where it travels tothe reservoir bag before beingremoved by the vacuum source. Theadjustable orifice and valves controlthe rate at which the gas is removed.	Different.The eAVS relies on thesoftware mechanisms tocommunicate thecontrol of vacuumflowrate. While,Scavenger Plus is afully pneumaticallydevice.
ConnectionPort - Inlet	19mm port to connect to theexhalation line of a breathingcircuit	19mm port to connect to theexhalation line of a breathing circuit	Same.Both devices have thesame size inletconnection port.
ConnectionPort - Outlet	3/8-inch (9.25 mm) hose barb	3/8-inch (9.25 mm) hose barb	Same.Both devices have thesame size outletconnection port.

10. Non-clinical Performance Data

The test strategy for the Midas Flowmeter and optional eAVS included performance bench testing of the device characteristics, safety features, and control mechanism. The results of the testing demonstrated that the Midas Flowmeter and optional eAVS met all of the acceptance criteria for functional, operational, and performance characteristics and therefore there are no different questions of safety or efficacy related to the subject device. A list of performance bench tests conducted on the Midas Flowmeter and eAVS is provided below.

Gas Flow Rate Adjustment ●
Touchscreen Display
Working with Barriers ●
Software Updates and Corruption ●
Scavenger
Bag Tee ●

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the logo for Parker Porter. The logo consists of the word "Parker" in white font on a black background, followed by a yellow vertical line. To the right of the yellow line is the word "Porter" in black font on a white background. The logo is simple and modern.

Button Functionality
. Accuracies and Faults
Tolerance ●
. Life Testing
Language .
Bluetooth ●
The Midas Flowmeter and optional eAVS were test to different Recognized Consensus Standards. The results of the testing demonstrated that the Midas Flowmeter and optional eAVS met all of the acceptance criteria for functional, operational, and performance characteristics and therefore there are safe and effective and are substantially equivalent to the predicate devices. Testing confirmed compliance with the applicable portions of the following standards:
IEC 60601-1:2005 +AMD1:2012+AMD2:2020, Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014, AMD1:2020, Medical electrical equipment Part 1-2: ● General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbance- Requirements and tests
ISO 18562:2017. Biocompatibility evaluation of breathing gas pathways in ● healthcare applications (Parts 1, 2, & 3)
ISO 15001:2010, Anesthetic and Respiratory Equipment Compatibility with ● Oxygen
IEC 62366-1:2015/AMD1:2020, Medical devices -- Application of usability ● engineering to medical devices
ANSI HE 75:2009 (R)2018, Human Factors Engineering
AAMI TIR12. Designing. Testing, And Labeling Medical Devices Intended for ● Processing by Health Care Facilities
AAMI ST98, A Compendium of Processes, Materials, Test Methods, And ● Acceptance Criteria for Cleaning Reusable Medical Devices testing at Nelson Labs
ASTM D4169-22, Standard Practice for Performance Testing of Shipping Containers and Systems
IEC 60601-1-11:2020, Medical Electrical Equipment Part 1-11: General ● Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in The Home Healthcare Environment
ISO 11195:2018, Gas mixers for medical use Stand-alone gas mixers .

11. Clinical Data

The characteristics of the Midas Flowmeter and optional eAVS do not require clinical investigation due to safety and efficacy being supported by non-clinical testing performed. The verification and validation testing of the Midas Flowmeter and optional eAVS was found to be acceptable and supports the claims of substantial equivalence.

12. Substantial Equivalence Discussion

Both the Midas Flowmeter subject device and FlowStar Touch Digital Mixer Flowmeter (K222794) predicate device have the same intended use, use environment, operating principle,

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the logo for Parker Porter. The logo consists of the word "Parker" in white letters on a black background, followed by a yellow vertical line, and then the word "Porter" in black letters on a white background. To the left of the word "Parker" is a white symbol that looks like a stylized "P".

and fundamental technology with similar technological characteristics. Both devices are intended for administering a mixture of nitrous oxide and oxygen to a conscious, spontaneously breathing patient. The differences between the two devices are limited to the monitoring system, external interface connector, and device configurations. The features and performance characteristics are determined to be substantially equivalent through comparison of the Midas Flowmeter with the primary predicate device.

Both the optional eAVS subject device and Nitronox Scavenger Plus (K223452) reference device have the same intended use, use environment, operating principle, and fundamental technology with similar technological characteristics. Both devices are intended to be used to remove waste gas in a healthcare facility environment with a vacuum source. Both devices have features for maintaining the scavenging pressure to ensure proper removal of waste gas. The differences between the two devices are limited to software and design characteristics. The incorporation of the eAVS features to extent the indications for use of the Midas Flowmeter to include gas scavenging control is determined to be substantially equivalent through comparison of the eAVS with the reference device.

13. Conclusions

It has been shown in this 510(k) submission that the differences between the Midas Flowmeter and optional eAVS and the primary predicate and secondary predicate devices do not raise any different questions regarding safety and efficacy. The Midas Flowmeter and optional eAVS are determined to be substantially equivalent to the predicate and reference devices.

Regulation Number and Section

§ 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).