MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30

K102182 · Maquet Critical Care AB · BSZ · May 9, 2011 · Anesthesiology

Device Facts

• Record ID: K102182
• Device Name: MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30
• Applicant: Maquet Critical Care AB
• Product Code: BSZ · Anesthesiology
• Decision Date: May 9, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The indication for FLOW-i 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.

Device Story

FLOW-i is a software-controlled circle anesthesia system for delivering inhalation agents (Sevoflurane, Desflurane, Isoflurane, nitrous oxide). It utilizes ICU-ventilator technology, a 1.2L volume reflector (replacing bag-in-bottle), and electronically controlled injector vaporizers. Inputs include patient gas concentrations, flow, and pressure; system monitors these via a graphical user interface. The device provides manual, volume control, pressure control, and pressure support ventilation. Used in hospital settings by trained healthcare professionals. The system enables precise gas delivery and dynamic fresh gas flow, allowing rapid response to setting changes. It provides continuous monitoring and alarm management. Benefits include high-performance ventilation, improved expiratory measurement accuracy, and ergonomic usability via a touchscreen interface. In power loss, manual ventilation with oxygen is supported.

Clinical Evidence

Bench testing only. Performance evaluated through technical data, measurement ranges/accuracy, electrical/mechanical safety, electromagnetic compatibility, software validation, usability, tightness, alarm verification, packaging, and biocompatibility. No clinical data presented.

Technological Characteristics

Circle anesthesia system; volume reflector (1.2L); electronically controlled injector vaporizers; touchscreen interface. Ventilator modes: manual, volume control, pressure control, pressure support. Connectivity: graphical user interface for parameter setting and monitoring. Power: mains with battery backup. Software-controlled gas modules (O2, air, N2O).

Indications for Use

Indicated for neonatal to adult patients requiring inhalation anesthesia and ventilatory support (controlled or assisted). 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, KION Anesthesia Workstation (K024213)
• GE Datex-Ohmeda, Aisys Anesthesia System (K090233)
• Maquet, SERVO-i Ventilator System (K073179)

Submission Summary (Full Text)

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# GETINGE GROUP

## 510 (K) Summary [as required by 21 CFR 807.92(c) ]

MAY - 9 2011

Date May 6, 2011

#### Submitter's Name & Address

Maquet Critical Care AB Röntgenvägen 2 SE-171 54 Solna, Sweden Phone: [phone] Fax: [phone]

Contact persons for this submission:

Mr. Karl-Yngve Keck Phone: [phone] Email: [e-mail]

U.S. contact:

Ms. Whitney Törning Director, Regulatory Affairs Maquet Inc. 45 Barbour Pond Drive Wayne, NJ 07470 Phone: [phone] Fax: [phone] Email: [e-mail]

| Trade name: | Model: | Model number |
|--------------------------|----------------------------------------|--------------------|
| FLOW-i Anesthesia System | MAQUET FLOW-i C20<br>MAQUET FLOW-i C30 | 6677200<br>6677300 |

#### Device Classification

| Common Name | Classification<br>Number | Class | Regulation Number |
|-------------------------|--------------------------|-------|-------------------|
| Gas-Machine, Anesthesia | 73 BSZ | II | 21 CFR 868.5160 |

#### Predicate Device Identification

| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|----------------------------------------------------------------|----------|
| Maquet, KION Anesthesia Workstation | K024213 |
| GE Datex-Ohmeda, Aisys Anesthesia System | K090233 |
| Maquet, SERVO-i Ventilator System | K073179 |

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#### Device Description

FLOW-i is a high-performance anesthesia system 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-i is a software-controlled circle system for inhalation anesthesia (Sevoflurane, Desflurane, Isoflurane and/or nitrous oxide).

The most important features that enhance FLOW-i performance compared with a traditional anesthesia system are:

- o a ventilator whose functionality is based on ICU-ventilator technology,
- the volume reflector technology, o
- the electronically controlled injector vaporizers and o
- o the ergonomic design.

#### Ventilator

The available ventilation modes in FLOW-i are manual ventilation, Volume Control, Pressure Control and Pressure Support.

The ventilator comprises electronically controlled so-called gas modules to supply the gas mixture (oxygen and air/nitrous oxide) at a dynamic flow requested for high-performance automatic ventilation, or at a constant fresh gas flow during manual ventilation. The gas modules facilitate precise control of gas flow and pressure during automatic ventilation. There are three gas modules (oxygen, air, nitrous oxide) to deliver fresh gas, and one reflector gas module (oxygen) to drive the rebreathing gas.

Pressure, flow and gas concentrations to and from the patient are monitored and displayed on a graphical user interface on a control panel. Via the graphical user interface the user can set all parameters for the ventilation modes just as in an ICU-ventilator, as well as all gas concentrations, alarm limits etc.

FLOW-i is also equipped to enable the patient to be manually ventilated with oxygen in case the system loses its electrical power (mains and battery backup).

#### Volume reflector

The volume reflector replaces the "bag-in-bottle" used in many traditional circle systems. It has a fixed volume of 1.2 liters and no moving parts and is open at both ends. The exhaled gas mixture from the patient is introduced at one end of the volume reflector. During automatic ventilation, the stored gas mixture in the volume reflector is returned to the patient by applying a flow of oxygen from the reflector gas module to the volume reflector's other end. Owing to the design, there is minimal mixing between the exhaled gas and the oxygen in the volume reflector. The amount of exhaled gas returning to the patient via the CO2 absorber is determined by the ratio between the minute volume and the set fresh gas flow.

The volume reflector enables high ventilation performance. Another advantage is that the system can deliver the requested breathing gas even in case of leakage, e.g. at the tracheal tube. The volume reflector cannot be emptied like a "bag-in-bottle".

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## MAQUET GETINGE GROUP

#### Vaporizers

The FLOW-i anesthesia delivery system uses a vaporizer with an electronically controlled injector. The gas mixture from the gas modules passes through the vaporizer chamber, where the agent is injected, before the fresh gas is delivered to the breathing circuit. The fresh gas flow varies during the inspiration phase in automatic ventilation. This means that the amount of added anesthetic agent also varies during the breath cycle in order to maintain the intended anesthetic agent concentration in the fresh gas. Changes made in set agent concentrations will be instamaneous. The available setting ranges for the anesthetic agents are: Sevoflurane 0-8%, Desflurane 0-18% and Isoflurane 0-5%.

#### Ergonomic design

FLOW-i has many ergonomic features, e.g. it is available as a height-adjustable workstation. The control panel can be tilted or rotated and is mounted on a movable support arm, while the touch screen on the control panel enables easy access to FLOW-i functions.

#### Indications for Use

The indication for FLOW-i 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.

#### Non-clinical Testing and Performance

Performance testing has resulted in data that demonstrates that FLOW-i Anaesthesia System performs within its specifications and within the acceptable limits of the applied performance standards. The following performance characteristics of FLOW-i Anaesthesia System were thoroughly tested: technical data, measurement ranges and measurement accuracy, construction, features, interfaces, handling, critical situations and interventions.

To evaluate the safety and effectiveness of the FLOW-i Anaesthesia System the following areas have been tested:

- Electrical and mechanical Safety .
- Electromagnetic Compatibility .
- Software Validation .
- Usability .
- Tightness .
- Verification of Alarms .
- . Packaging
- Verification of Operating Data and Accuracy of Measurements .
- Performance .

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- Biocompatibility .
- Vaporizer filling system �

### Comparison of Technological Characteristics to Predicate Devices

#### Comparison of Intended Use

The intended use for the subject device and the predicate devices KION K024213 and Aisys K090233 is in all essentials the same. The devices are all intended for delivery of inhalation anesthesia for the patient ranges from neonatal to adult and shall be used by healthcare professionals trained in the administration of anesthesia in hospital environments. None of the devices is intended to be used during transport or in a MRI environment.

#### Comparison of Technology Used

Summary of technological characteristics of the subject device and the predicate devices: In most respects the subject device uses the same (or very similar) technology as the predicate device KION K024213, but with modern components.

The modifications are essentially as follows:

- 1. The mechanical vaporizers from KION K024213 are replaced with electronic vaporizers.
- 2. The bag-in-bottle is replaced with a volume reflector.
- 3. The flow transducer technology is re-used from the predicate device SERVO-i K073179
- 4. The touchscreen technology is re-used from the predicate device SERVO-i K073179.

The reasons for the modifications are:

- 1. The mechanical vaporizers are replaced with electronic vaporizers to facilitate a more dynamic fresh gas flow, thereby enabling better ventilation performance and faster response to changes of fresh gas settings, i.e. flow and concentrations.
- 2. The bag-in-bottle is replaced with a volume reflector in order to improve ventilation ~… performance.
- 3. The new flow transducer is introduced to improve expiratory measurement accuracy.
- 4. The touchscreen is introduced to improve the usability aspects.

#### Conclusion

Maquet believes that the FLOW-i is substantially equivalent to the two predicate anesthesia machines (KION K024213 and AISYS K090233) regarding intended use of the devices, the indications for use and the fundamental technology of the devices. Maquet has conducted the necessary verification and validation activities to demonstrate that the design outputs of the subject device meet the design input requirements. Maquet has concluded that FLOW-i is substantially equivalent to the two predicate devices.

Formatted: Bullets and Numbering

Formatted: Bullets and Numbering

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Maquet Critical Care AB C/O Ms. Whitney Törning Director, Regulatory Affairs Maquet, Incorporated 45 Barbour Pond Drive Wayne, New Jersey 07470

MAY - 9 2011

Re: K102182 Trade/Device Name: MAQUET Flow-I Anesthesia System Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: May 6, 2011 Received: May 9, 2011

Dear Ms. Törning:

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 mendments, or to devices that have been reclassified in accordance with the provisions of Antinuitie, or to do rood and Cosmetic Act (Act) that do not require approval of a premarket the Federal I vou, Drag, and Qosmonay, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, requirence for unitual vagainst 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.

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## Page 2 3 Ms. Törning

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that PDA 3 Issualloo of a booseans and evice complies with other requirements mean that FDA nas made a deceminations administered by other Federal agencies. of the Act of ally I cucral statues and reguirements, including, but not limited to: registration You'llust comply with an the rist 8 1 c FR Part 801); medical device reporting and listing (21 CFR 1 art 607); laceming (21 CFR 803); good manufacturing (reporting of medical ucvice-related as relob evens) (QS) regulation (21 CFR Part 820);
(2016) requirements as set forth in the quality systems (QS) regulation (21 CFR 1612 practice requirements as set rorm in the quality of control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for incp.//www.rua.gov.rt.ooud Radiological Health's (CDRH's) Office of Compliance. Also, the center 101 Devices and rused, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Tou may other baller generational and Consumer Assistance at its toll-free Division of Dinastian [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susan Turner

Anthony Watson, B.S., M.S., M.B.A.

Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices

Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number: K102182

... : ..

MAQUET Flow-l Anesthesia System

Indications for Use:

The indication for FLOW-i 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.

Over-The-Counter Use Prescription Use x AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page _1_ of _1__

(Posted November 13, 2003)

Susan Levine

(Division Sign-Of
Division of Anesthesiology, General Hospital
Infection Control and Dental Devices
510(k) Numban,
KARA