Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System

K191027 · Maquet Critical Care AB · BSZ · Mar 18, 2020 · Anesthesiology

Device Facts

• Record ID: K191027
• Device Name: Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
• Applicant: Maquet Critical Care AB
• Product Code: BSZ · Anesthesiology
• Decision Date: Mar 18, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The system is intended for use in administering Anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe. The system is intended for use by healthcare professionals, trained in the administration of Anesthesia. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment. When not in operation, the system is designed for in-hospital transport.

Device Story

Flow-i, Flow-c, and Flow-e are software-controlled, semi-closed anesthesia systems. They mix and deliver inhalation anesthetics (Sevoflurane, Desflurane, Isoflurane, nitrous oxide) and provide mechanical ventilation. Operated by trained healthcare professionals in hospital settings. The system includes a core for gas administration and a user interface for monitoring and settings. New features include an automated lung recruitment maneuver (RM) with breath-by-breath parameter display (EIP, PEEP, Cdyn), a 'MAC Brain' indicator trending agent level delays, and an automated pause function for circuit disconnection. The device uses an AION Platinum patient gas analyzer. Output is displayed on the UI to assist clinicians in adjusting anesthesia delivery and ventilation parameters. Benefits include precise anesthetic delivery, respiratory support, and improved monitoring of lung recruitment and brain agent levels.

Clinical Evidence

No clinical data. Evidence consists of bench testing, software verification (code review, static analysis, system testing), waveform testing, comparative testing for MAC Brain and recruitment maneuvers, biocompatibility testing, and human factors validation.

Technological Characteristics

Software-controlled semi-closed anesthesia workstation. Components: AION Platinum gas analyzer, volume reflector, inspiratory/pneumatic block. Connectivity: Standalone/networked. Standards: ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-1-8, ISO 80601-2-13, ISO 80601-2-55, CGA V-5. Software: Embedded, version 4.7. Sterilization: Not specified (device is a workstation).

Indications for Use

Indicated for neonatal to adult patients requiring inhalation anesthesia and mechanical ventilation (controlled or supported). Contraindicated for use in MRI environments.

Regulatory Classification

Identification

A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).

Predicate Devices

• Maquet FLOW-i Anesthesia System (K160665)

Reference Devices

• GE Aisys CS2 (K170872)

Submission Summary (Full Text)

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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.

Maquet Critical Care AB % Mark Smith Sr. Regulatory Affairs Specialist Getinge 45 Barbour Pond Drive Wayne, New Jersey 07470

Re: K191027

Trade/Device Name: Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: Class II Product Code: BSZ Dated: February 17, 2020 Received: February 18, 2020

# Dear Mark Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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. 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,

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

Enclosure

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# Indications for Use

510(k) Number (if known) K191027

Device Name Flow-i Anesthesia System Flow-c Anesthesia System Flow-e Anesthesia System

#### Indications for Use (Describe)

The indication for Flow-c/Flow-e Anesthesia System is administering inhalation Anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment, by healthcare professionals trained in inhalation Anesthesia administration.

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

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K191027

Image /page/3/Picture/1 description: The image shows the text "Page 1 of 8" at the top. Below that is the word "GETINGE" in large, bold, blue letters. To the right of the word is a blue abstract symbol that looks like three curved arrows pointing inward.

# 510(k) SUMMARY

as required by section 21 CFR 807.92

| Device owner | Maquet Critical Care AB |
|--------------------------------------|-------------------------------------|
| | Röntgenvägen 2 |
| | SE-171 54 Solna, Sweden |
| | Tel: [phone] |
| Contact Persons for this submission: | Ms. Kribu Valdre |
| | Regulatory Affairs Manager |
| | Phone: direct: (011) 46 10 335 7300 |
| | Email: [e-mail] |
| Application Correspondent: | Mr. Mark N. Smith |
| | Manager, Regulatory Affairs |
| | Getinge |
| | 45 Barbour Pond Drive |
| | Wayne, NJ 07470 |
| | Email: [e-mail] |
| | Phone: [phone] |
| | |

Date prepared: March 18, 2020

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Image /page/4/Picture/2 description: The image shows the logo for GETINGE. The logo consists of the word "GETINGE" in a bold, sans-serif font, followed by a stylized symbol. The symbol is composed of four curved shapes arranged in a circular pattern, resembling a stylized flower or asterisk. The logo is simple and modern, with a clean and professional appearance.

| Trade Name: | Model: |
|---------------------------------|-------------------------|
| Flow-i Anesthesia System | Flow-i C20 |
| | Flow-i C30 |
| | Flow-i C40 |
| Flow-c Anesthesia System | Flow-c |
| Flow-e Anesthesia System | Flow-e |
| Device Classification | |
| Common Name | Gas-Machine, Anesthesia |
| Classification Number | BSZ |
| Class | II |
| Regulation Number | 21 CFR 868.5160 |
| Predicate Device Identification | |
| Maquet FLOW-i Anesthesia System | K160665 |
| Reference Device Identification | |
| GE Aisys CS2 | K170872 |

### Indications for Use

The indication for the Flow-i/Flow-c/Flow-e Anesthesia system is administering inhalation Anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment, by healthcare professionals trained in inhalation Anesthesia administration.

#### Intended use of the Device

The system is intended for use in administering Anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.

The system is intended for use by healthcare professionals, trained in the administration of Anesthesia.

The system is intended for use on neonatal to adult patient populations.

The system is intended for use in hospital environments, except MRI environment. When not in operation, the system is designed for in-hospital transport.

### Device Description

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Image /page/5/Picture/2 description: The image shows the logo for GETINGE. The text "GETINGE" is in a bold, sans-serif font and is colored in a dark blue. To the right of the text is a stylized symbol that appears to be made up of four curved arrows pointing inward towards a central point, also in varying shades of blue.

Flow-i, Flow-c and Flow-e Anesthesia systems within the Flow Anesthesia family 4.7 are high-performance Anesthesia systems designed to meet the many ventilatory challenges within Anesthesia, as well as to provide inhalation Anesthesia. It is intended to serve a wide range of patients from neonatal to adult.

Flow Anesthesia family is a software-controlled semi-closed system for inhalation Anesthesia (Sevoflurane, Desflurane, Isoflurane and/or nitrous oxide).

The Flow-i/-c/-e 4.7 consists of a core, where gases are mixed and administered, and a User Interface where the settings are made and ventilation and anesthesia are monitored.

The Flow-i/-c/-e 4.7 is based on the cleared predicate device FLOW-i 4.2 (K160665) with some improvements.

# COMPARISON TO PREDICATE

# Comparison of Intended Use

The Intended Use for the modified Flow-i, Flow-c and Flow-e Anesthesia systems within the Flow Anesthesia family version 4.7 is identical to the predicate device, FLOW-i Anesthesia System version 4.2 (K160665).

### Comparison of Technology Characteristics

The following changes have been made to Flow-i/-c/e 4.7 compared to the cleared predicate device FLOW-i 4.2 (K160665) without significant change with regards to safety and/or effectiveness:

- A new function that supports lung recruitment of patients
The subject devices Flow-i, Flow-e and Flow-e Anesthesia systems within the Flow Anesthesia family version 4.7 introduces a function that facilitates the lung recruitment maneuver (RM) by displaying a breath-by-breath presentation of relevant breathing parameters, i.e. End Inspiratory Pressure (EIP), Positive End Expiratory Pressure (PEEP) and Dynamic Compliance (Cdyn). It is available as Automatic RM and as RM trends (manual recruitment).

The added function RM is substantially equivalent to the recruitment maneuver in the reference device (K170872) and does not affect the overall performance or technology of the device.

- Modifications of the Patient Gas Analyzer (PGA)

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Image /page/6/Picture/2 description: The image shows the logo for GETINGE. The text "GETINGE" is in a bold, sans-serif font and a dark blue color. To the right of the text is a stylized symbol, also in dark blue, that resembles a four-pointed star or a stylized flower with curved petals.

The subject devices' PGA component has been updated from the AION™ to the AION™ Platinum version. The AIONTM PGA had the patient O2 sensor as a stand-alone component within the AION™ PGA, whereas the updated AION™ Platinum includes the O2 sensor and the gas analyser within the same component housing.

The exchange of the Patient Gas Analyzer AION™ to the AION™ Platinum does not affect the overall performance or technology of the device, as it does not affect the anesthesia delivery, the monitoring of ventilation or the alarm handling.

#### A new user interface indicator, MAC Brain ●

The display of the MAC value has been updated to include a bar indicator on the user interface. This bar indicator now includes MAC Brain and is shown side by side with the MAC value. The purpose of MAC Brain is to display the delay of the variation of agent level in the brain compared to the observed exhaled agent level. The MAC Brain value is based on the MAC value and is trended.

The addition of MAC Brain does not affect the overall performance or technology of the device, as it does not affect the anesthesia delivery, the monitoring of ventilation or the alarm handling.

#### Addition of a Pause function ●

A new pause function is introduced in the subject devices for the possibility to temporarily disconnect the breathing circuits in clinical situations (e.g. for removing condensed water or repositioning the patient). The pause function can be used both in both automatic and manual ventilation.

The Pause function is present in the cleared predicate device FLOW-i 4.2 through a manual action. In the subject device the Pause function is now supported by automatic timings.

- Option to set lower fresh gas flow ●
The lower level for the fresh gas flow into the breathing system will be possible to adjust from 0.1 1/min, as compared to 0.3 1/min in the predicate device FLOWi 4.2.

Oxygen supply is maintained through the rebreathing system via the volume reflector in the same way as in the cleared predicate device FLOW-i 4.2. This change does not affect the overall performance or technology of the device.

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Image /page/7/Picture/2 description: The image shows the logo for GETINGE. The word "GETINGE" is written in a bold, sans-serif font in dark blue. To the right of the word is a stylized symbol that looks like four curved arrows pointing towards the center, also in shades of blue.

- Hardware changes to the subject devices to improve supply and production .
- o A new battery.
- o Modified inspiratory channel and pneumatic block.
- o Removal of the secondary, electronically controlled, locking of the vaporizer latch.
- o Introduction of a new Power Supply Unit (PSU) with the same specifications as used in the predicate device FLOW-i 4.2.

These hardware changes do not affect the overall performance or technology, as they do not change the anesthesia delivery, the monitoring of ventilation or the alarm handling.

- Minor changes to equipment labels. .
- o Adding equipment enclosure IP21 rating.

The change of IP classification improves the rating of the electrical protection for the cabinet, but does not affect the anesthesia delivery, the monitoring of ventilation or the alarm handling in the sense that it affects the substantial equivalence.

- Minor Software updates. ●
- o Adaption of the software to the changes stated above, i.e. patient gas analyzer modifications, battery handling and modifications of the inspiratory channel and pneumatic block.
- o Adaption in the software to support SW options for Flow-c and Flow-e. These SW options are included in the standard settings for Flow-i.
- O Updated range for Air, O2, N2O supply pressure
- 0 Updated accuracy of CO2 gas measurement range 0-1%.
- o Quick settings in the user interface for O2 concentration, Fresh gas flow (FGF) and agent concentration.
- o System Check Out (SCO) improvements.

These minor software changes do not affect the overall performance or technology, as they do not change the anesthesia delivery, the monitoring of ventilation or the alarm handling.

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- Addition of two new device models Flow-c Anesthesia System and Flow-e ● Anesthesia System.
The addition of two new models does not affect the overall performance or technology, as they do not change the anesthesia delivery, the monitoring of ventilation or the alarm handling.

- Material changes in:
- o The filter in the patient gas pathway
- o Volume reflector
- o Vaporizers
- o Inspiratory and pneumatic block
- o The water trap membrane (used in the Patient Gas Analyzer)

These material changes do not affect the overall performance or technology, nor were they found to raise different questions about safety and effectiveness compared to the cleared predicate device.

### Similarities and differences

The subject devices are similar in all aspects, except from what is stated above, to the cleared predicate device. The modifications above do not individually, or as a sum. impact device safety and effectiveness or change the technology or performance compared to the cleared predicate device (K160665).

### Non-clinical Testing and Performance

Maquet Critical Care has conducted risk analysis and performed necessary verification and validation activities to demonstrate that the design output of the modified devices meets the design input requirements:

#### Software

- Code review
- Static code analysis ●
- System testing ●

#### Performance

- . System testing

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- Regression ●
- Free User testing
- Waveform testing
- Comparative testing for MAC Brain ●
- Comparative testing for Recruitment Maneuver ●

# Biocompatibility

- . Volatile Organic Compounds
- Particulate Testing ●

Human Factors Validation Testing

The following product standards are included in the verification:

- ANSI/AAMI ES 60601-1:2005 + A1:2012. Medical electrical equipment . Part 1: General requirements for basic safety and essential performance, Recognition Number 19-4
- IEC 60601-1-2:2014, Medical electrical equipment Part 1-2: General ● requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and Test, Recognition Number 19-8
- IEC 60601-1-8:2006 + A1:2012, Medical electrical equipment Part 1-8: . General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems, Recognition Number 5-76
- ISO 80601-2-13:2011, Medical electrical equipment -- Part 2-13: Particular ● requirements for basic safety and essential performance of an anaesthetic workstation, Recognition Number 1-104
- . ISO 80601-2-55:2011, Medical electrical equipment -- Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors, Recognition Number 1-96

The connector to high-pressure gas is verified according to CGA V-5:2008, Recognition Number 1-81.

# Conclusion for Substantial Equivalence

The Flow-i/-c/-e Anesthesia Systems version 4.7 have identical intended use and indications for use as the predicate FLOW-i version 4.2 (K160665). Maquet has conducted risk analysis and performed necessary verification and validation activities to demonstrate that the design outputs of the modified device meet the design input requirements. The proposed changes do not affect the safety and effectiveness compared

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to the predicate device FLOW-i Anesthesia System. Maquet Critical Care AB has concluded that the Flow-i, Flow-c and Flow-e Anesthesia systems within the Flow Anesthesia family version 4.7 (K191027) is substantially equivalent to the cleared predicate device, FLOW-i Anesthesia System version 4.2 (K160665).