FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40

K160665 · Maquet Critical Care AB · BSZ · Mar 29, 2017 · Anesthesiology

Device Facts

• Record ID: K160665
• Device Name: FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40
• Applicant: Maquet Critical Care AB
• Product Code: BSZ · Anesthesiology
• Decision Date: Mar 29, 2017
• Decision: SESE
• Submission Type: Abbreviated
• 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 Anesthesia System is a software-controlled, semi-closed inhalation anesthesia delivery system (Sevoflurane, Desflurane, Isoflurane, N2O). It integrates ICU-ventilator technology with volume reflector technology and electronically controlled injector vaporizers. Operated by trained healthcare professionals in hospital settings, it supports patients from neonates to adults. The system provides mechanical ventilation (Volume/Pressure Control, PRVC, SIMV, Pressure Support) and monitors airway pressure, gas concentrations, and tidal/minute volumes. New features in version 4.2 include a function suggesting ventilation start values based on patient category, gender, weight, and length (PBW), and airway resistance measurement following hold maneuvers. Output is displayed for clinician review to guide anesthesia and ventilation management, potentially improving patient safety through optimized ventilation settings and enhanced monitoring.

Clinical Evidence

No clinical data. The device modifications were validated through non-clinical bench testing, including requirement verification, regression testing, free user testing, and code review/static analysis to ensure compliance with updated standards (IEC 60601-1:2005, ISO 80601-2-13:2011, ISO 80601-2-55:2011).

Technological Characteristics

Semi-closed anesthesia system; software-controlled. Features: ICU-ventilator technology, volume reflector, electronically controlled injector vaporizers. Standards: AAMI/ANSI ES 60601-1:2005, IEC 60601-1-2:2007, ISO 80601-2-13:2011, ISO 80601-2-55:2011. Connectivity: FLOW-i Communication Interface (FCI). Power: US/IEC outlets. Sterilization: Not specified (system components).

Indications for Use

Indicated for inhalation anesthesia administration and ventilation support (controlled or assisted) in neonatal to adult patients. 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 version 3.0 (K133958)

Submission Summary (Full Text)

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

March 29, 2017

Maquet Critical Care AB c/o Mark Dinger Senior Regulatory Affairs Specialist Maquet Medical Systems USA 45 Barbour Pond Drive Wayne, New Jersey 07470

Re: K160665

Trade/Device Name: Flow-i Anesthesia System C20, Flow-i Anesthesia System C30, Flow-i Anesthesia System C40 Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: Class II Product Code: BSZ Dated: February 28, 2017 Received: March 1, 2017

Dear Mark Dinger:

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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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, 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 (if known) K160665

#### Device Name

FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40

Indications for Use (Describe)

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 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) | |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| <span style="font-size:12px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:12px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) SUMMARY as required by section 21 CFR 807.92

## Submitter Name & Address

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

| Contact Persons for this submission: | Carina Lundberg<br>Regulatory Affairs Manager<br>Phone: direct: (011) 46 10 335 7300<br>Email: [e-mail] |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Application Correspondent: | Mark Dinger<br>Sr. Regulatory Affairs Specialist<br>Maquet Medical Systems USA<br>45 Barbour Pond Drive<br>Wayne, NJ 07470<br>Email: [e-mail]<br>Phone: [phone]<br>Fax: [phone] |

Date prepared: March 2, 2016

## Trade Name :

FLOW-i Anesthesia System C20 FLOW-i Anesthesia System C30 FLOW-i Anesthesia System C40

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## Device Classification

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

## Predicate Device Identification

| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|----------------------------------------------------------------|----------|
| Maquet FLOW-i Anesthesia System version 3.0 | K133958 |

## 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.

## 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

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

The most important performance features of the FLOW-i Anesthesia System are:

- 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. O

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This 510(k) submission for the FLOW-i Anesthesia System is based on the following modifications:

- Updates of the product for compliance with 3td edition of the 60601 standard package .
- IEC 60601-1:2005 O
- ISO 80601-2-13:2011 o
- ISO 80601-2-55:2011 O
- Implementation of a new function that provides recommended ventilation values (PBW)
- Possibility to set a lower alarm limit for the Airway pressure alarm: High
- Display of Airway resistance measurement following an Inspiratory and/or Expiratory Hold

## Non-clinical Testing and Performance

The following characteristics of FLOW-i Anesthesia System were tested: technical data, measurement ranges and measurement accuracy, delivery accuracy, construction, features, interfaces, handling, critical situations and interventions.

The design verification activities for the modified FLOW-i Anesthesia System version 4.2 consist of:

- Requirement verification of affected requirements
- Regression testing
- Free User Testing ●
- Code review and static code analysis
- Verification of applicable product standards
- AAMI/ANSI ES 60601-1:2005 and A1:2012, Recognition Number 19-4 O
- IEC 60601-1-2:2007, Recognition Number 19-1 о
- AAMI/ANSI/IEC 60601-1-8:2006. Recognition Number 5-92 O
- ISO 80601-2-13:2011, Recognition Number 1-104 O
- ISO 80601-2-55:2011, Recognition Number 1-96 O
- ISO 5356-1:2004, Recognition Number 1-62 O
- ISO 5360:2012, Recognition Number 1-91 O
- CGA V-5:2008, Recognition Number 1-81 o

Design validation has been performed in order to ensure the product meets its intended use and user needs.

Design verification and validation has demonstrated that the FLOW-i Anesthesia System performs within its specifications and within the limits of the applied performance standards.

## Clinical Investigation

The functionality added in the proposed FLOW-i Anesthesia System version 4.2 does not add any new functions that need to be validated by clinical investigation.

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## CHANGES AND SUBSTANTIAL EQUIVALENCE DISCUSSION

## Comparison of Intended Use

The Intended Use for the modified FLOW-i Anesthesia System version 4.2 is identical to the predicate device. FLOW-i Anesthesia System version 3.0 (K133958).

## Comparison of Technology Used

There are minor changes in the technological characteristics for the modified FLOW-i Anesthesia System version 4.2 compared to the predicate device FLOW-i Anesthesia System version 3.0 (K133958). See below.

## Similarities and differences

The main improvements introduced in the modified FLOW-i Anesthesia System version 4.2 from the predicate device FLOW-i Anesthesia System version 3.0 (K133958) are:

## Updates of the product for compliance with 3td edition of the 60601 standard package

The second edition Anesthesia standard, IEC 60601-2-13:2003, gave the manufacturer the option to choose between BTPS (Body Temperature and Pressure ambient, Saturated humidity) and ambient. The third edition Anesthesia standard, ISO 80601-2-13:2011, mandates BTPS.

The predicate version of FLOW-i presented volumes as AP21 (Ambient Pressure at 21%, dry).

The subject FLOW-i Anesthesia System version 4.2 presents volumes as appearing at the Ypiece by the patient interface as BTPS - volumes presented are compensated for normal body temperature (37°C), ambient pressure and relative humidity (100%).

### A new function that provides recommended ventilation values (PBW)

A new function that provides reasonable good ventilation setting start values which are confirmed by the user. Based on entered patient category, gender, weight, and length start-up values for the Respiratory Rate (RR), the Tidal Volume (TV) or the Minute Volume (MV) are suggested.

In mechanical ventilation this function can be used to help reduce the risk that differences in body weight will affect the estimated ventilation needs for different patients. Once the user has started ventilating the patient, the user will fine tune the settings.

### Possibility to lower the alarm limit for the Airway pressure alarm: High

The lower alarm limit for the Airway pressure alarm: High will be possible to set to 10 cmH2O, previously 16 cmH2O.

## Display of Airway resistance measurement

Following an Inspiratory and/or Expiratory Hold, FLOW-i will in addition provide measurement of the airway resistance.

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## Other minor modifications to the FLOW-i Anesthesia System 4.2 consist of:

Software upgrades:

- Vaporizer improvements
- System Check Out (SCO) improvements
- Improvement of O2 measurement
- . Improvements to the FLOW-i Communication Interface (FCI)

None of the modifications above implemented in the modified FLOW-i Anesthesia System version 4.2 raise any new type of questions of safety and effectiveness.

### Labeling changes:

Updates of labelling for compliance with 3th edition of the 60601 standards package

None of the labeling changes implemented in the modified FLOW-i Anesthesia System version 4.2 changes the technology or performance of the FLOW-i Anesthesia System.

## Hardware/Accessories changes:

- US power outlets have been added as an option for the power outlets. In the previous . FLOW-i version only IEC power outlets existed. The only change is the power outlets. No other change has been made to the isolation transformer.
- . The CO2 absorber switch will be changed to a two position switch.
- The two hand grip to open the patient cassette lid has been replaced with a one hand . grip. The window on the top of the lid will be enlarged for visibility of the inspiratory and expiratory valves.

None of the hardware/accessories changes above implemented in the modified FLOW-i Anesthesia System version 4.2 change the technology or performance of the FLOW-i Anesthesia System.

## Conclusion for Substantial Equivalence:

Maquet believes that these modifications do not affect the intended use of the device, the indications for use nor raise any new type of questions of safety and effectiveness. Maquet has conducted the risk analysis and performed the 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 of the FLOW-i Anesthesia System. Maquet has concluded that the modified FLOW-i Anesthesia System is substantially equivalent to the predicate device, FLOW-i Anesthesia System (K133958).

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# SUBSTANTIAL EQUIVALENCE TABLE

| | Predicate Device | SUBJECT DEVICE |
|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Device | FLOW-i Anesthesia System version 3.0 | FLOW-i Anesthesia System version 4.2 |
| Manufacturer | Maquet Critical Care AB | Maquet Critical Care AB |
| Device<br>Classification Name | Gas-Machine, Anesthesia | Gas-Machine, Anesthesia |
| 510(k) Number | K133958 | K160665 |
| Indications for Use<br>according to the<br>510(k) Summary | The indication for FLOW-i Anesthesia System is<br>administering inhalation Anesthesia while controlling the<br>entire ventilation of patients with no ability to breathe, as<br>well as in supporting patients with a limited ability to<br>breathe. The system is intended for use on neonatal to adult<br>patient populations. The system is intended for use in<br>hospital environments, except MRI environment, by<br>healthcare professionals trained in inhalation Anesthesia<br>administration. | Same |
| Patient range | Neonatal to adult patient populations | Same |
| Settings (adjustable<br>parameters): | | |
| Ventilation Modes | • Manual Ventilation<br>• Volume Control<br>• Pressure Control<br>• Pressure Support + backup<br>• Pressure Regulated Volume Control (PRVC)<br>• SIMV | Same |
| SIMV rate (b/min) | 1 – 60 | Same |
| Backup rate (b/min) | 2 – 60 | Same |
| Fresh gas oxygen conc | 21 – 100 % when Oxygen/Air is selected<br><br>28 – 100 % when Oxygen/Nitrous Oxide is selected.<br><br>Accuracy:<br>21 – 59%: ±3 % v/v<br>60-100%: ±5 % v/v | Same |
| Isoflurane conc | 0 – 5 %. | Same |
| | Accuracy: ±15% of set value or ±5% of maximum possible<br>setting (whichever is greater) | |
| Sevoflurane conc | 0 – 8 %. | Same |
| | Accuracy: ±15% of set value or ±5% of maximum possible<br>setting (whichever is greater) | |
| Desflurane conc | 0-10%: for set Fresh Gas Flow less than 20 l/min and<br>maximal Fresh Gas Flow less than 75 l/min<br><br>0-18%: for set Fresh Gas Flow less than 10 l/min and<br>maximal Fresh Gas Flow less than 40 l/min | Same |
| | Accuracy: ±15% of set value or ±5% of maximum possible<br>setting (whichever is greater) | |
| Fresh gas flow | 0.3 – 20 l/min | Same |
| | Accuracy:<br>± 15 % of set value or ±5% of maximum possible<br>setting (whichever is greater) | |
| Tidal volume | ± 10 % or ± 50 ml/min (whichever is greater)<br>100 – 2000 ml in the adult patient category.<br>20 – 350 ml in the infant patient category. | Same |
| | Accuracy: ±15% or 10 ml, whichever is greater | |
| Minute volume | 0.5 – 60 l/min in the adult patient category.<br>0.3 – 20 l/min in the infant patient category. | Same |
| | Accuracy: ±10% or 10 ml, whichever is greater | |
| PEEP (positive end<br>expiratory pressure) | 0 – 50 cmH2O | Same |
| | Accuracy: ±2 cmH2O or ±10 % (whichever is greater | |
| Pressure level above PEEP | 0 to 120 cmH2O – PEEP in the adult patient category.<br>0 to 80 cmH2O – PEEP in the infant patient category. | Same |
| | Predicate Device | SUBJECT DEVICE |
| Device | FLOW-i Anesthesia System version 3.0 | FLOW-i Anesthesia System version 4.2 |
| Manufacturer | Maquet Critical Care AB | Maquet Critical Care AB |
| Breathing frequency | 4 – 100 breaths per minute. | Same |
| Inspiration and Expiration ratio; I:E | Accuracy:<br>±5 % or ± 1 bpm (whichever is greater)<br>1:10 – 4:1 in automatic modes | Same |
| Monitoring<br>Measurement range<br>and accuracy: | | |
| Pressure | -30 cmH2O – 140 cmH2O | Same |
| Oxygen conc | Accuracy:<br>±5% or ±2 cm H2O (whichever is greater)<br>0 to 100% | Same |
| Tidal volume | Accuracy:<br>±1 vol% @ (0-25%)<br>±2 vol% @ (25 – 80%)<br>±3 vol% @ (80-100%)<br>Exp. Tidal volume:<br>Measurement range: 5-2000 ml | Same |
| Carbon dioxide conc | Accuracy:<br>± 4ml (5-20 ml)<br>±10% or 10 ml, whichever is greater (20-2000ml)<br>0 to 10% | Same |
| Isoflurane conc | Accuracy:<br>± 0.1 vol% @ (0-1%)<br>± 0.2 vol% @ (1-5%)<br>± 0.3 vol% @ (5-7%)<br>± 0.5 vol% @ (7-10%)<br>0 to 5% | Same |
| Sevoflurane conc | Accuracy:<br>±0.15 vol% @ (0-1%)<br>±0.2 vol% @ (1-5%)<br>0 to 8% | Same |
| Desflurane conc | Accuracy:<br>±0.15 vol% @ (0-1%)<br>± 0.2 vol% @ (1-5%)<br>± 0.4 vol% @ (5-8%)<br>0 to 18% | Same |
| Alarms:<br>Airway pressure: High | Accuracy:<br>±0.15 vol% @ (0-1%)<br>± 0.2 vol% @ (1-5%)<br>± 0.4 vol% @ (5-10%)<br>± 0.6 vol% @ (10-15%)<br>± 1.0 vol% @ (15-18%)<br>16 to 120 cmH2O | 10 to 120 cmH2O |
| Software and<br>hardware changes | | |
| US outlets | Not available | Available |
| Recommended ventilation<br>values (PBW) | Not available | New software functionality |
| Airway resistance<br>measurement following an<br>Inspiratory and/or<br>Expiratory Hold | Not available | New measurement |

Specifications from FLOW-i User´s Manual, section 13 Technical Specifications, and: software and hardware changes

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