The indication for FLOW-i Anaesthesia System is administering inhalation Anaesthesia 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 Anaesthesia administration.

Device Description

FLOW-i (K102182 SE5/9/2011) is a high-performance Anaesthesia system designed to meet the many ventilatory challenges within Anaesthesia, as well as to provide inhalation Anaesthesia. It is intended to serve a wide range of patients from neonatal to adult.

FLOW-i is a software-controlled semi-closed system for inhalation Anaesthesia (Sevoflurane, Desflurane, Isoflurane and/or nitrous oxide).

The most important performance features of the FLOW-i Anaesthesia system are:

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

The proposed modification (K112114) includes two additional ventilation modes and a backup function:

o PRVC, Pressure Regulated Volume Control
O SIMV (VC and PC), Synchronized Intermittent Mandatory Ventilation
o Pressure Support with Backup

In addition to the new ventilation modes the proposed modification includes a number of minor changes.

PRVC is a controlled mode of ventilation which combines the advantages of volume controlled and pressure controlled ventilation. FLOW-i assures that the preset tidal volume is delivered at the lowest possible pressure in order to protect the lungs. The flow during inspiration is decelerating and patient can trigger extra breaths.

SIMV is designed to improve synchronization of breaths which can decrease patient's tendency to fight against the Anaesthesia ventilator.

Backup functionality has been added to Pressure Support to add safety for the patient and improve the work flow for the users by minimizing apnea alarms.

AI/ML Overview

The provided text describes modifications to the MAQUET FLOW-i Anaesthesia System (K112114) and claims substantial equivalence to a previously cleared version of the FLOW-i (K102182) and the GE Datex-Ohmeda, Aisys Anaesthesia System (K090233). Rather than outlining specific acceptance criteria and a detailed study proving performance against them, the document focuses on demonstrating that the updated device performs within its specifications and applied performance standards through various non-clinical tests.

Here's a breakdown of the requested information based on the provided text, highlighting what is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it lists areas where performance testing was conducted to ensure the device performs "within its specifications and within the limits of the applied performance standards."

Acceptance Criteria (Implied)	Reported Device Performance
Technical data specifications	Performs within specifications
Measurement ranges	Performs within specified ranges
Measurement accuracy	Accuracy verified
Delivery accuracy	Accuracy verified
Construction	Verified
Features	Verified
Interfaces	Verified
Handling	Verified
Critical situations	Verified
Interventions	Verified
Electrical safety	Covered in evaluation
Mechanical safety	Covered in evaluation
Electromagnetic Compatibility	Covered in evaluation
Software Validation	Covered in evaluation
Usability	Covered in evaluation
Tightness	Covered in evaluation
Verification of Alarms	Covered in evaluation
Packaging	Covered in evaluation
Verification of Operating Data	Covered in evaluation
Biocompatibility	Covered in evaluation
Vaporizer filling system	Covered in evaluation
New Ventilation Modes (PRVC, SIMV)	Functionality equivalent to predicate device (Aisys)
Backup Functionality (Pressure Support)	Assessed for safety and workflow improvement

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in terms of a patient cohort or a dataset with a defined sample size for clinical evaluation. The testing described is non-clinical, focusing on device performance characteristics. Therefore, information on data provenance (country of origin, retrospective/prospective) is not applicable or provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the study described is a non-clinical device performance and verification study, not a clinical study involving expert assessment of medical data.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study is mentioned. The study is a non-clinical verification and validation of device performance against specifications and standards, not a comparison of human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is an anaesthesia system, which is inherently a human-in-the-loop system controlled by healthcare professionals. The concept of "standalone algorithm performance" as typically applied to AI/ML software is not relevant here. The performance testing focuses on the system's ability to deliver ventilation and anaesthesia as specified.

7. The Type of Ground Truth Used

For the non-clinical performance and verification testing, the "ground truth" would be established by the engineering and design specifications for the device, and compliance with recognized standards (e.g., electrical safety, EMC). It relies on objective measurements against these predefined acceptable ranges and behaviors. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this type of non-clinical evaluation.

8. The Sample Size for the Training Set

No training set is mentioned as this device is not an AI/ML algorithm that undergoes a "training" phase. The system is software-controlled, but the "validation" described is for the software's functionality and performance against design requirements, not statistical learning from a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set is mentioned.

Summary

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MAQUET

GETINGE GROUP

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

JAN 1 3 2012

Date July 22, 2011 K 112114

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

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

Applicant Correspondent:

Ms. Whitney Törning Director, Regulatory Affairs Maquet Inc. 45 Barbour Pond Drive Wayne, NJ 07470 Phone: 973-709-7994 Fax: 973-973-807-9210 Email: whitney.torning@maquet.com

Trade name:	Model:	Model number:
FLOW-i Anaesthesia System	MAQUET FLOW-i C20MAQUET FLOW-i C30MAQUET FLOW-i C40	667720066773006677400

Device Classification

Common Name	ClassificationNumber	Class	Regulation Number
Gas-Machine, Anaesthesia	73 BSZ	II	21 CFR 868.5160

Predicate Device Identification

Legally marketed devices to which equivalence is being claimed	510(k) #
Maquet FLOW-i Anesthestia System	K102182
GE Datex-Ohmeda, Aisys Anaesthesia System	K090233

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Device Description

FLOW-i is a software-controlled semi-closed system for inhalation Anaesthesia (Sevoflurane, Desflurane, Isoflurane and/or nitrous oxide).

The most important performance features of the FLOW-i Anaesthesia system are:

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

The proposed modification (K112114) includes two additional ventilation modes and a backup function:

o PRVC, Pressure Regulated Volume Control
O SIMV (VC and PC), Synchronized Intermittent Mandatory Ventilation
o Pressure Support with Backup

In addition to the new ventilation modes the proposed modification includes a number of minor changes.

SIMV is designed to improve synchronization of breaths which can decrease patient's tendency to fight against the Anaesthesia ventilator.

Backup functionality has been added to Pressure Support to add safety for the patient and improve the work flow for the users by minimizing apnea alarms.

Indications for Use

The indication for FLOW-i Anaesthesia System is administering inhalation Anaesthesia 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 MRJ environment, by healthcare professionals trained in inhalation Anaesthesia administration.

Non-clinical Testing and Performance

Performance testing has demonstrated that the FLOW-i Anaesthesia System performs within its specifications and within the 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, delivery accuracy, construction, features, interfaces, handling, critical situations and interventions.

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

Electrical and mechanical Safety .
Electromagnetic Compatibility .
Software Validation .
Usability .
Tightness .
Verification of Alarms .
Packaging ●
Verification of Operating Data and Accuracy of Measurements .
Performance .
t Biocompatibility
Vaporizer filling system .

Comparison of Technological Characteristics to Predicate Devices

The indications for use and fundamental technology for the modified FLOW-i Anaesthesia System is identical to the cleared FLOW-i Anaesthesia System K102182.

Comparison of Intended Use

The Intended Use for the modified FLOW-i Anaesthesia System (K112114) and the predicate devices FLOW-i Anaesthesia System and Aisys (K090233) are in all essentials the same.

Comparison of Technology Used

The modified device has the same technological characteristics as the cleared FLOW-i Anaesthesia System (K102182). The functionality of the new ventilation modes is equivalent to the predicate anaesthesia machine Aisys (K090233).

Conclusion

MAOUET believes that the modified FLOW-i Anaesthesia System (K112114) is substantially equivalent to the cleared FLOW-i Anaesthesia System (K102182) and Aisys (K090233) regarding intended use of the devices, the indications for use and the fundamental technology of the devices. Based on the risk analysis, MAQUET has conducted the necessary design 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 predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle, represented by three curved lines that suggest the bird's head, body, and tail.

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 Torning Director, Regulatory Affairs Maquet Incorporated 45 Barbour Pond Drive Wayne, New Jersey 07470

JAN 1 3 2012

Re: K112114

Trade/Device Name: 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: January 3, 2012 Received: January 4, 2012

Dear Ms. Torning:

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. 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.

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Page 2 - Ms. Torning

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation 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 the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Rh for

Anthony D. 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: K112114

Device Name: FLOW-i 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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Y. Schulten

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k 11 2 114

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).