(119 days)
No
The description focuses on precise digital control of gas flow and mixture, with no mention of learning, adaptation, or complex pattern recognition characteristic of AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is intended to deliver a mixture of nitrous oxide and oxygen gases to a patient for conscious sedation, which is a therapeutic intervention.
No
The device is used to deliver a mixture of nitrous oxide and oxygen gases to a patient for conscious sedation and to control the scavenging of waste analgesic gas. It does not diagnose any condition.
No
The device description explicitly states it is a "digitally controlled, software driven, continuous flow device" that uses "electronic mechanisms to control the flowrate and mixture percentage of gases delivered to a patient." This indicates the device includes hardware components for gas delivery and control, in addition to software.
Based on the provided information, the Midas Flowmeter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to deliver a mixture of nitrous oxide and oxygen gases to a patient for conscious sedation. This is a therapeutic and anesthetic application, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description focuses on controlling and delivering gases to a patient's respiratory system. It does not mention analyzing biological samples (blood, urine, tissue, etc.) which is the core function of an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical components or processes associated with IVDs, such as reagents, assays, sample preparation, or analysis of biological markers.
Therefore, the Midas Flowmeter is a medical device used for patient treatment and management, not for in vitro diagnostic testing.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
BZR, CBN
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults and pediatrics
Intended User / Care Setting
To be used by healthcare professionals in a healthcare setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- 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 .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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)
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) | |
|---|---|
| ☑ 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 | 6020 | |
| 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.
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
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
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 Device
Parker Hannifin
Corporation's
Porter Midas™ Flowmeter
and optional eAVS | Predicate Device
Baldus Sedations GmbH & Co.
KG
FlowStar Touch Digital Mixer
Flowmeter
K222794 | Comments |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Midas Flowmeter and
optional eAVS 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
eAVS, the Midas Flowmeter is
used to control the scavenging of
waste analgesic gas. | The FlowStar Touch Digital Mixer
Flowmeter is intended for
administering an adjustable
mixture of Nitrous Oxide analgesic
gas and Oxygen to a conscious,
spontaneously breathing patient. | Same.
The FlowStar Touch
Mixer is only intended to
mix nitrous oxide and
oxygen. While the Midas
Flowmeter is intended to
mix nitrous oxide and
oxygen and remove
waste analgesic gas
while the eAVS is
attached. |
| Prescription
Use or Over
the Counter | Prescription Use | Prescription Use | Same.
Both devices are
prescription use. |
| Principle of
Operation | Software driven, continuous
flow system. | Software driven, continuous flow
system. | Same.
Both devices are
software driven devices
that mix nitrous oxide
and oxygen continuously
to delivery to a patient
through a breathing
circuit during a
procedure. |
| Where Used | To be used by healthcare
professionals in a healthcare
setting. | To be used by healthcare
professionals in a healthcare
setting. | Same.
Both devices are
intended for use by a
healthcare professional
in a healthcare setting. |
| Patient
Contact | The Midas Flowmeter is
designed for indirect patient
contact. | The FlowStar Touch Digital Mixer
Flowmeter is designed for indirect
patient contact. | Same. |
| Product
Features | Subject Device
Parker Hannifin
Corporation's
Porter Midas™ Flowmeter
and optional eAVS | Predicate Device
Baldus Sedations GmbH & Co.
KG
FlowStar Touch Digital Mixer
Flowmeter
K222794 | Comments |
| Gas delivery | Gas mixture delivery is
continuous.
Oxygen Flush: Minimum 20
LPM
Oxygen Flow: 1.0-18.0 LPM
Oxygen %: 30%-100%
Oxygen Resuscitator Flow: 225-390 L/min
Nitrous Oxide Flow: 0-12.6
LPM
Nitrous Oxide %: 0-70%
Mixed Gas Flow: 1.1 – 18.0
LPM | Gas mixture delivery is
continuous.
Oxygen Flush: 40-55 L/min
Oxygen Flow:1.0-18 L/min
Oxygen %: 30%-100%
Oxygen Resuscitator Flow: 100-
250 L/min
Nitrous Oxide Flow: 0-12.6 L/min
Nitrous Oxide %: 0-70%
Mixed Gas Flow: 3-18 L/min | Both devices are not
design for indirect
patient contact.
Similar.
Performance
characteristics have
similar ranges that
support appropriate gas
mixing and delivery to
support continuous flow
conscious sedation. |
| Gas input
fittings | DISS connector (Diameter Index
Safety System)
O2 Inlet: DISS 1240
N2O Inlet: DISS 1040A
O2 Outlet: DISS 1240 demand
valve (male thread) | DISS connector (Diameter Index
Safety System) | Same.
Both devices use DISS
Fittings. |
| Displays | The display module consists of
the following components: an
off-the-shelf touchscreen LCD,
an off-the-shelf Single Board
Computer (SBC), a painted
cover glass, a capacitive switch
overlay, and a Display Interface
Board. The touchscreen LCD,
SBC, painted cover glass and
capacitive switch overlay are
provided as a finished assembly
called the touchscreen display
assembly.
Image: Porter Midas Display | Touch Panel Display | Similar.
Both have user
adjustment controls,
power button, O2 flush,
and similar touchscreens.
Differences are limited
to user interface layout. |
| | Image: Baldus Display | | |
| Power Source | Power Supply Specification:
80-264 VAC
47-63Hz
Device Usage Specification:
100-240 VAC
50-60 Hz | 110-230 V
50-60 Hz | Similar.
The Midas Flowmeter
power supply is rated for
outside normal limits
(nominal), to allow for
international use. |
| Product
Features | Subject Device
Parker Hannifin
Corporation's
Porter Midas™ Flowmeter
and optional eAVS | Predicate Device
Baldus Sedations GmbH & Co.
KG
FlowStar Touch Digital Mixer
Flowmeter
K222794 | Comments |
| Monitoring
and
Alarms | The Midas Flowmeter uses
onboard diagnostics to conduct
self-checks at start-up and
during operation. When an issue
is detected, a notification will
appear in the Notification
Display and is accompanied by a
continuous, audible alert. An
audible notification may be
silenced but the visual
notification remains on screen
until corrected.
O2 Alerts: Unable to provide the
requested flow of O2; Oxygen
valve failed too fully close.
N2O Alerts: Unable to provide
the requested flow of N2O;
Nitrous Oxide valve failed too
fully close.
Flush Flow Low: O2 Flush flow
rate is below 19.5 LPM.
Other Alerts: sensor faults,
communication failures,
software errors, scavenger
failures, leak detection, | The FlowStar Touch Digital Mixer
Flowmeter for Analgesia device
has an alarm system which
generates an alarm in the case of
an insufficient O2 supply. The
device will shut off the sedation
when the O2 supply reaches a
critical level.
Check O2: If no oxygen is being
supplied, the unit emits visual and
acoustic information signals
Check N2O: If no nitrous oxide is
being supplied, the unit emits
visual and acoustic information
signals. This also happens if the
pressure is too low or there is a
measurement section failure
O2 Minimum Flow 3 l/min:
Visual and acoustic signals: The
O2 minimum flow is 3 1/min. The
mixture administered can never
contain less than 1 liter of O2.
Max. Flow Reached: Once the
maximum total flow (18 l/min) is
reached, this is signaled visually in
the top right and a signal tone
sound.
Flush Flow Low: This message
appears if the flow rate is less than
the minimum value of 18 l/min
when the O2 Flush button is
pressed. The alarms are equivalent
to those of the predicate. | Similar.
The FlowStar Touch
Mixer Flowmeter has an
alarm system, where
Midas Flowmeter has
notifications and alerts to
inform the end user of
actions to be reviewed.
The Midas Flowmeters
includes more detailed
alerts for various aspects
(i.e., software and
scavenger 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
| Product
Features | Subject Device
Parker Hannifin
Corporation's
eAVS | Reference Device
Parker Hannifin Corporation's
Nitronox® Scavenger Plus
K223452 | Comments |
|---------------------|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Intended Use | When used with the eAVS, the
Midas Flowmeter is used to
control the scavenging of
waste analgesic gas. | The Scavenger Plus is intended to
control the vacuum flowrate for
scavenging of waste analgesic gas. | Same.
Both devices are
intended to remove
waste 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 | |
|---|---|---|---|
| Product | |||
| Features | Parker Hannifin | ||
| Corporation's | |||
| eAVS | Parker Hannifin Corporation's | ||
| Nitronox® Scavenger Plus | |||
| K223452 | |||
| Target | |||
| Population | Adults and pediatrics | Adults and pediatrics | Same. |
| Both devices have the | |||
| same target population. | |||
| Prescription | |||
| Use or Over | |||
| the Counter | The eAVS is for prescription | ||
| use only. | The Scavenger Plus is for | ||
| prescription use only. | Same. | ||
| Where used | To be used by healthcare | ||
| professionals in a healthcare | |||
| setting. | To be used by healthcare | ||
| professionals in a healthcare setting. | Same. | ||
| Both devices are | |||
| intended for use by a | |||
| healthcare professional | |||
| in a healthcare setting. | |||
| Control of | |||
| Flow/Pressure | The eAVS consists of a valve | ||
| used to control scavenging | |||
| flowrate, an air flow sensor | |||
| used to measure the rate of | |||
| scavenging flow, and a control | |||
| board to communicate to the | |||
| Midas Flowmeter. | The Scavenger Plus receives waste | ||
| gas from the exhalation line of the | |||
| breathing circuit, where it travels to | |||
| the reservoir bag before being | |||
| removed by the vacuum source. The | |||
| adjustable orifice and valves control | |||
| the rate at which the gas is removed. | Different. | ||
| The eAVS relies on the | |||
| software mechanisms to | |||
| communicate the | |||
| control of vacuum | |||
| flowrate. While, | |||
| Scavenger Plus is a | |||
| fully pneumatically | |||
| device. | |||
| Connection | |||
| Port - Inlet | 19mm port to connect to the | ||
| exhalation line of a breathing | |||
| circuit | 19mm port to connect to the | ||
| exhalation line of a breathing circuit | Same. | ||
| Both devices have the | |||
| same size inlet | |||
| connection port. | |||
| Connection | |||
| Port - Outlet | 3/8-inch (9.25 mm) hose barb | 3/8-inch (9.25 mm) hose barb | Same. |
| Both devices have the | |||
| same size outlet | |||
| 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 ●
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.