Midas Flowmeter; eAVS

K241465 · Parker Hannifin Corporation · BZR · Sep 19, 2024 · Anesthesiology

Device Facts

• Record ID: K241465
• Device Name: Midas Flowmeter; eAVS
• Applicant: Parker Hannifin Corporation
• Product Code: BZR · Anesthesiology
• Decision Date: Sep 19, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5330
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 Story

Midas Flowmeter is a digitally controlled, software-driven, continuous flow system for nitrous oxide/oxygen conscious sedation; delivers gas mixtures to conscious, spontaneously breathing patients. Optional eAVS accessory manages waste analgesic gas scavenging. System inputs include user settings via touchscreen and gas flow data from internal sensors; microcontroller regulates gas manifold valves to achieve desired flow/mixture. eAVS uses a valve and flow sensor to manage vacuum flow, with control integrated into the Midas user interface. Used by healthcare professionals in clinical settings. Device provides onboard diagnostics/alerts for valve leaks, flow failures, and sensor faults. Benefits include precise gas delivery and automated scavenging control, reducing waste gas exposure. Configurations include remote (cabinet-mounted display) and portable (cart-mounted).

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including gas flow accuracy, safety features, software validation, and compliance with recognized consensus standards (IEC 60601-1, IEC 60601-1-2, ISO 18562, ISO 15001, IEC 62366-1, ISO 11195).

Technological Characteristics

Electronic gas mixer with manifold block assembly, flow sensors, and microcontroller. Features Bluetooth for iPadOS connectivity and touchscreen interface. Power: 80-264 VAC, 47-63Hz. Connectivity: Wireless (Bluetooth) and wired (eAVS communication cable). Standards: IEC 60601-1, IEC 60601-1-2, ISO 18562, ISO 15001, IEC 62366-1, ANSI HE 75, AAMI TIR12, AAMI ST98, ASTM D4169, IEC 60601-1-11, ISO 11195.

Indications for Use

Indicated for conscious, spontaneously breathing adult and pediatric patients requiring nitrous oxide and oxygen sedation in a healthcare setting.

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

• FlowStar Touch Digital Mixer Flowmeter (K222794)

Reference Devices

• Nitronox Scavenger Plus (K223452)

Submission Summary (Full Text)

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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).

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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.

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known) K241465

Device Name Midas Flowmeter; eAVS

#### Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 10pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 10pt;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: [phone] Email: [e-mail]

#### Subject Device 3.

| Trade Name | Porter Midas™ Flowmeter | eAVS |
|------------------------|--------------------------------------------------|--------------------------|
| Common or Usual Name | Breathing gas mixer | Scavenging apparatus |
| Classification Name | Mixer, breathing gases,<br>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 | 6020<br>6120 | 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

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.

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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

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.

#### 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

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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 Device<br>Parker Hannifin<br>Corporation's<br>Porter Midas™ Flowmeter<br>and optional eAVS | Predicate Device<br>Baldus Sedations GmbH & Co.<br>KG<br>FlowStar Touch Digital Mixer<br>Flowmeter<br>K222794 | Comments |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Midas Flowmeter and<br>optional eAVS is intended for<br>use as a continuous flow<br>conscious sedation system to<br>deliver a mixture of nitrous<br>oxide and oxygen gases to a<br>patient. When used with the<br>eAVS, the Midas Flowmeter is<br>used to control the scavenging of<br>waste analgesic gas. | The FlowStar Touch Digital Mixer<br>Flowmeter is intended for<br>administering an adjustable<br>mixture of Nitrous Oxide analgesic<br>gas and Oxygen to a conscious,<br>spontaneously breathing patient. | Same.<br>The FlowStar Touch<br>Mixer is only intended to<br>mix nitrous oxide and<br>oxygen. While the Midas<br>Flowmeter is intended to<br>mix nitrous oxide and<br>oxygen and remove<br>waste analgesic gas<br>while the eAVS is<br>attached. |
| Prescription<br>Use or Over<br>the Counter | Prescription Use | Prescription Use | Same.<br>Both devices are<br>prescription use. |
| Principle of<br>Operation | Software driven, continuous<br>flow system. | Software driven, continuous flow<br>system. | Same.<br>Both devices are<br>software driven devices<br>that mix nitrous oxide<br>and oxygen continuously<br>to delivery to a patient<br>through a breathing<br>circuit during a<br>procedure. |
| Where Used | To be used by healthcare<br>professionals in a healthcare<br>setting. | To be used by healthcare<br>professionals in a healthcare<br>setting. | Same.<br>Both devices are<br>intended for use by a<br>healthcare professional<br>in a healthcare setting. |
| Patient<br>Contact | The Midas Flowmeter is<br>designed for indirect patient<br>contact. | The FlowStar Touch Digital Mixer<br>Flowmeter is designed for indirect<br>patient contact. | Same. |
| Product<br>Features | Subject Device<br>Parker Hannifin<br>Corporation's<br>Porter Midas™ Flowmeter<br>and optional eAVS | Predicate Device<br>Baldus Sedations GmbH & Co.<br>KG<br>FlowStar Touch Digital Mixer<br>Flowmeter<br>K222794 | Comments |
| Gas delivery | Gas mixture delivery is<br>continuous.<br>Oxygen Flush: Minimum 20<br>LPM<br>Oxygen Flow: 1.0-18.0 LPM<br>Oxygen %: 30%-100%<br>Oxygen Resuscitator Flow: 225-390 L/min<br>Nitrous Oxide Flow: 0-12.6<br>LPM<br>Nitrous Oxide %: 0-70%<br>Mixed Gas Flow: 1.1 – 18.0<br>LPM | Gas mixture delivery is<br>continuous.<br>Oxygen Flush: 40-55 L/min<br>Oxygen Flow:1.0-18 L/min<br>Oxygen %: 30%-100%<br>Oxygen Resuscitator Flow: 100-<br>250 L/min<br>Nitrous Oxide Flow: 0-12.6 L/min<br>Nitrous Oxide %: 0-70%<br>Mixed Gas Flow: 3-18 L/min | Both devices are not<br>design for indirect<br>patient contact.<br>Similar.<br>Performance<br>characteristics have<br>similar ranges that<br>support appropriate gas<br>mixing and delivery to<br>support continuous flow<br>conscious sedation. |
| Gas input<br>fittings | DISS connector (Diameter Index<br>Safety System)<br>O2 Inlet: DISS 1240<br>N2O Inlet: DISS 1040A<br>O2 Outlet: DISS 1240 demand<br>valve (male thread) | DISS connector (Diameter Index<br>Safety System) | Same.<br>Both devices use DISS<br>Fittings. |
| Displays | The display module consists of<br>the following components: an<br>off-the-shelf touchscreen LCD,<br>an off-the-shelf Single Board<br>Computer (SBC), a painted<br>cover glass, a capacitive switch<br>overlay, and a Display Interface<br>Board. The touchscreen LCD,<br>SBC, painted cover glass and<br>capacitive switch overlay are<br>provided as a finished assembly<br>called the touchscreen display<br>assembly.<br>Image: Porter Midas Display | Touch Panel Display | Similar.<br>Both have user<br>adjustment controls,<br>power button, O2 flush,<br>and similar touchscreens.<br>Differences are limited<br>to user interface layout. |
| | Image: Baldus Display | | |
| Power Source | Power Supply Specification:<br>80-264 VAC<br>47-63Hz<br>Device Usage Specification:<br>100-240 VAC<br>50-60 Hz | 110-230 V<br>50-60 Hz | Similar.<br>The Midas Flowmeter<br>power supply is rated for<br>outside normal limits<br>(nominal), to allow for<br>international use. |
| Product<br>Features | Subject Device<br>Parker Hannifin<br>Corporation's<br>Porter Midas™ Flowmeter<br>and optional eAVS | Predicate Device<br>Baldus Sedations GmbH & Co.<br>KG<br>FlowStar Touch Digital Mixer<br>Flowmeter<br>K222794 | Comments |
| Monitoring<br>and<br>Alarms | The Midas Flowmeter uses<br>onboard diagnostics to conduct<br>self-checks at start-up and<br>during operation. When an issue<br>is detected, a notification will<br>appear in the Notification<br>Display and is accompanied by a<br>continuous, audible alert. An<br>audible notification may be<br>silenced but the visual<br>notification remains on screen<br>until corrected.<br>O2 Alerts: Unable to provide the<br>requested flow of O2; Oxygen<br>valve failed too fully close.<br>N2O Alerts: Unable to provide<br>the requested flow of N2O;<br>Nitrous Oxide valve failed too<br>fully close.<br>Flush Flow Low: O2 Flush flow<br>rate is below 19.5 LPM.<br>Other Alerts: sensor faults,<br>communication failures,<br>software errors, scavenger<br>failures, leak detection, | The FlowStar Touch Digital Mixer<br>Flowmeter for Analgesia device<br>has an alarm system which<br>generates an alarm in the case of<br>an insufficient O2 supply. The<br>device will shut off the sedation<br>when the O2 supply reaches a<br>critical level.<br>Check O2: If no oxygen is being<br>supplied, the unit emits visual and<br>acoustic information signals<br>Check N2O: If no nitrous oxide is<br>being supplied, the unit emits<br>visual and acoustic information<br>signals. This also happens if the<br>pressure is too low or there is a<br>measurement section failure<br>O2 Minimum Flow 3 l/min:<br>Visual and acoustic signals: The<br>O2 minimum flow is 3 1/min. The<br>mixture administered can never<br>contain less than 1 liter of O2.<br>Max. Flow Reached: Once the<br>maximum total flow (18 l/min) is<br>reached, this is signaled visually in<br>the top right and a signal tone<br>sound.<br>Flush Flow Low: This message<br>appears if the flow rate is less than<br>the minimum value of 18 l/min<br>when the O2 Flush button is<br>pressed. The alarms are equivalent<br>to those of the predicate. | Similar.<br>The FlowStar Touch<br>Mixer Flowmeter has an<br>alarm system, where<br>Midas Flowmeter has<br>notifications and alerts to<br>inform the end user of<br>actions to be reviewed.<br>The Midas Flowmeters<br>includes more detailed<br>alerts for various aspects<br>(i.e., software and<br>scavenger features). |

# Table 1: Device and Primary Predicate Product Overview

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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.

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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

| Product<br>Features | Subject Device<br>Parker Hannifin<br>Corporation's<br>eAVS | Reference Device<br>Parker Hannifin Corporation's<br>Nitronox® Scavenger Plus<br>K223452 | Comments |
|---------------------|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Intended Use | When used with the eAVS, the<br>Midas Flowmeter is used to<br>control the scavenging of<br>waste analgesic gas. | The Scavenger Plus is intended to<br>control the vacuum flowrate for<br>scavenging of waste analgesic gas. | Same.<br><br>Both devices are<br>intended to remove<br>waste analgesic gas. |

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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 |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product<br>Features | Parker Hannifin<br>Corporation's<br>eAVS | Parker Hannifin Corporation's<br>Nitronox® Scavenger Plus<br>K223452 | |
| Target<br>Population | Adults and pediatrics | Adults and pediatrics | Same.<br>Both devices have the<br>same target population. |
| Prescription<br>Use or Over<br>the Counter | The eAVS is for prescription<br>use only. | The Scavenger Plus is for<br>prescription use only. | Same. |
| Where used | To be used by healthcare<br>professionals in a healthcare<br>setting. | To be used by healthcare<br>professionals in a healthcare setting. | Same.<br>Both devices are<br>intended for use by a<br>healthcare professional<br>in a healthcare setting. |
| Control of<br>Flow/Pressure | The eAVS consists of a valve<br>used to control scavenging<br>flowrate, an air flow sensor<br>used to measure the rate of<br>scavenging flow, and a control<br>board to communicate to the<br>Midas Flowmeter. | The Scavenger Plus receives waste<br>gas from the exhalation line of the<br>breathing circuit, where it travels to<br>the reservoir bag before being<br>removed by the vacuum source. The<br>adjustable orifice and valves control<br>the rate at which the gas is removed. | Different.<br>The eAVS relies on the<br>software mechanisms to<br>communicate the<br>control of vacuum<br>flowrate. While,<br>Scavenger Plus is a<br>fully pneumatically<br>device. |
| Connection<br>Port - Inlet | 19mm port to connect to the<br>exhalation line of a breathing<br>circuit | 19mm port to connect to the<br>exhalation line of a breathing circuit | Same.<br>Both devices have the<br>same size inlet<br>connection port. |
| Connection<br>Port - Outlet | 3/8-inch (9.25 mm) hose barb | 3/8-inch (9.25 mm) hose barb | Same.<br>Both devices have the<br>same size outlet<br>connection 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 ●

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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,

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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.