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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the MAQUET FLOW-i Anesthesia System. It outlines the device's description, intended use, and a comparison to predicate devices, but it does not contain information about specific acceptance criteria, study details, or performance metrics in a quantifiable sense typically found in clinical studies or performance validation reports.

Therefore, many of the requested fields cannot be filled from the given text.

Here's an attempt to answer based on the provided text, highlighting what is not available:

1. A table of acceptance criteria and the reported device performance

The document mentions "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." However, it does not provide specific acceptance criteria values or detailed reported performance data.

Acceptance Criteria	Reported Device Performance
Specific Values Not Provided in Text	Specific Values Not Provided in Text
(e.g., Accuracy of gas flow within X%)	(e.g., Gas flow accuracy observed Y%)
(e.g., Concentration stability within Z%)	(e.g., Concentration stability observed W%)
Performs within its specifications	Performs within its specifications
Performs within acceptable limits of applied performance standards	Performs within acceptable limits of applied performance standards

2. Sample size used for the test set and the data provenance

The document doesn't explicitly mention "test set" in the context of human studies for performance. The non-clinical testing refers to:

Sample Size: Not specified.
Data Provenance: Not applicable as these are non-clinical technical tests, not patient data studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This information would typically be relevant for studies involving human interpretation or clinical evaluations, which are not detailed in this non-clinical testing summary.

4. Adjudication method for the test set

Not applicable. As there's no mention of a human-involved test set requiring ground truth establishment, no adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The FLOW-i Anesthesia System is described as a medical device for administering anesthesia, not an AI-assisted diagnostic or interpretive tool that would involve human "readers" or an MRMC study in this context.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The document describes "Non-clinical Testing and Performance" which includes verification of operating data and accuracy of measurements, software validation, electrical and mechanical safety, etc. These are standalone evaluations of the device's components and system without explicit human intervention during the performance measurement itself, fitting a broad interpretation of "standalone performance." However, it's not an "algorithm only" performance in the sense of AI.

7. The type of ground truth used

For the non-clinical testing mentioned:

Ground Truth: Engineering specifications, regulatory standards, physical measurements, and expected operational parameters. For instance, for "Verification of Operating Data and Accuracy of Measurements," the ground truth would be the known input values and expected output values based on established physics and engineering principles.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would typically have a "training set" in the conventional sense. The device's functionality is based on established engineering principles and software logic, not on learning from a dataset.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The text starts with a capital 'K', followed by '162182'. The handwriting is somewhat stylized, with some characters connected and others distinct. The overall impression is that of a quick note or label.

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: (011) 46 8 730 73 00 Fax: (011) 46 8 730 78 38

Contact persons for this submission:

Mr. Karl-Yngve Keck Phone: (011) 46 8 730 72 65 Email: karl-yngve.keck@maquet.com

U.S. contact:

Ms. Whitney Törning Director, Regulatory Affairs Maquet Inc. 45 Barbour Pond Drive Wayne, NJ 07470 Phone: 973-709-7994 Fax: 973-709-7994 Email: whitney.torning@maquet.com

Trade name:	Model:	Model number
FLOW-i Anesthesia System	MAQUET FLOW-i C20MAQUET FLOW-i C30	66772006677300

Device Classification

Common Name	ClassificationNumber	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 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

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.
1. The bag-in-bottle is replaced with a volume reflector.
1. The flow transducer technology is re-used from the predicate device SERVO-i K073179
1. 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.
1. The bag-in-bottle is replaced with a volume reflector in order to improve ventilation ~… performance.
1. The new flow transducer is introduced to improve expiratory measurement accuracy.
1. 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

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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 (301) 796-7100 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:

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

Regulation Number and Section

§ 868.5160 Gas machine for anesthesia or analgesia.

(a)
Gas machine for anesthesia —(1)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.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. 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).(2)
Classification. Class II (performance standards).