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.

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

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

AI/ML Overview

This document describes the marketing application for changes to the Maquet FLOW-i Anesthesia System, specifically versions C20, C30, and C40. The primary purpose of the document is to demonstrate "substantial equivalence" to a previously cleared predicate device (FLOW-i Anesthesia System version 3.0, K133958), allowing the manufacturer to market the updated device without a new premarket approval application (PMA).

Based on the provided text, there is no information about a study that proves the device meets specific acceptance criteria in the way a clinical AI/ML device would be evaluated for accuracy or performance on a test set of data.

This document is a 510(k) summary, which focuses on device modifications and demonstration of substantial equivalence through non-clinical testing and comparison to a predicate device, rather than a clinical performance study with predefined acceptance criteria for diagnostic/therapeutic efficacy.

Therefore, it is not possible to fill out the requested table and details regarding acceptance criteria, test set sample size, expert ground truth establishment, MRMC studies, or standalone performance, as these concepts are not applicable to the information provided in this 510(k) submission.

The acceptance criteria here pertain to meeting regulatory standards, ensuring safety, and demonstrating that the modifications do not introduce new questions of safety and effectiveness, meaning its performance is equivalent to the predicate device.

However, I can extract the following relevant information regarding the changes and how the manufacturer demonstrated the device's continued performance and safety:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present acceptance criteria as quantitative performance metrics for a diagnostic or therapeutic function. Instead, it details that the modifications introduce new functionalities and updates for regulatory compliance, and that the device "performs within its specifications and within the limits of the applied performance standards."

The "acceptance criteria" can be inferred as successful completion of the listed non-clinical tests and demonstration that the modified device remains substantially equivalent to the predicate. The "performance" is the successful outcome of these tests and the comparison to the predicate.

Feature/Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (as demonstrated)
Compliance with 3rd edition 60601 standard package (IEC 60601-1, ISO 80601-2-13, ISO 80601-2-55)	Meets the requirements of the updated standards.	Design verification and validation demonstrated compliance. Changes like BTPS volume reporting implemented.
New function: Recommended ventilation values (PBW)	Provides reasonable good ventilation setting start values.	Software functionality implemented to suggest RR, TV, MV based on patient data.
Lower alarm limit for Airway pressure alarm: High	Allows setting a lower limit for enhanced flexibility/safety.	Alarm limit can be set to 10 cmH2O (previously 16 cmH2O).
Display of Airway resistance measurement	Measures and displays airway resistance after hold.	New measurement provided following Inspiratory and/or Expiratory Hold.
Software upgrades (Vaporizer, SCO, O2 measurement, FCI)	Improved functionality as intended.	Implemented and tested; concluded not to raise new safety/effectiveness questions.
Hardware/Accessories changes (US power outlets, CO2 absorber switch, patient cassette lid)	Maintains safety and performance while providing convenience/usability.	Implemented and tested; concluded not to change technology or performance.
Overall Safety and Effectiveness	No adverse effect on safety or effectiveness compared to predicate.	Risk analysis performed, necessary verification and validation activities completed; concluded substantial equivalence.

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

Sample Size: Not applicable in the context of a "test set" for a diagnostic/therapeutic AI/ML algorithm. This submission focuses on engineering validation and verification.
Data Provenance: Not applicable. The tests performed are laboratory/bench testing and engineering evaluations against design requirements and safety standards. There is no patient data involved in the "test set."

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

Not applicable. Ground truth in this context refers to engineering specifications and regulatory compliance, not expert clinical labels on patient data. Performance was verified against technical specifications and standard requirements.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set:

Not applicable. This is not a clinical study involving human readers or interpretation of results that require adjudication.

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:

No MRMC comparative effectiveness study was done. This 510(k) is for modifications to a medical device (anesthesia system), not a diagnostic AI/ML algorithm that assists human readers.

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

Not applicable. The device is a physical anesthesia system with integrated software, not a standalone algorithm. Its "performance" is its ability to deliver and monitor anesthesia according to specifications and safety standards.

7. The Type of Ground Truth Used:

Ground Truth Type: Engineering specifications, industry standards (e.g., IEC 60601, ISO 80601), and the performance characteristics of the predicate device.
Examples: Accuracy range for gas concentrations (e.g., Sevoflurane conc: Accuracy: ±0.15 vol% @ (0-1%)), pressure ranges, alarm thresholds, volume measurement accuracy.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML algorithm trained on a dataset. The software changes are programming implementations, not machine learning model training.

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

Not applicable. There is no concept of a "training set" in the context of this device's modifications. The software and hardware changes are based on design requirements, safety standards, and user needs, which were then verified and validated through non-clinical testing.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus-like design with three human profiles facing right, representing health and human services.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Image /page/1/Picture/8 description: The image contains a signature and the name "Tina Kiang". There is also a "-s" below the name. The signature is a series of loops and lines, and the name is written in a simple, sans-serif font.

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)

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ 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: (011) 46 10 335 7300

Contact Persons for this submission:	Carina LundbergRegulatory Affairs ManagerPhone: direct: (011) 46 10 335 7300Email: carina.lundberg@getinge.com
Application Correspondent:	Mark DingerSr. Regulatory Affairs SpecialistMaquet Medical Systems USA45 Barbour Pond DriveWayne, NJ 07470Email: mark.dinger@getinge.comPhone: 973-709-7691Fax: 973-909-9954

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	ClassificationNumber	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 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
DeviceClassification Name	Gas-Machine, Anesthesia	Gas-Machine, Anesthesia
510(k) Number	K133958	K160665
Indications for Useaccording to the510(k) Summary	The indication for FLOW-i Anesthesia System isadministering inhalation Anesthesia while controlling theentire ventilation of patients with no ability to breathe, aswell as in supporting patients with a limited ability tobreathe. The system is intended for use on neonatal to adultpatient populations. The system is intended for use inhospital environments, except MRI environment, byhealthcare professionals trained in inhalation Anesthesiaadministration.	Same
Patient range	Neonatal to adult patient populations	Same
Settings (adjustableparameters):
Ventilation Modes	• Manual Ventilation• Volume Control• Pressure Control• Pressure Support + backup• Pressure Regulated Volume Control (PRVC)• 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 selected28 – 100 % when Oxygen/Nitrous Oxide is selected.Accuracy:21 – 59%: ±3 % v/v60-100%: ±5 % v/v	Same
Isoflurane conc	0 – 5 %.	Same
	Accuracy: ±15% of set value or ±5% of maximum possiblesetting (whichever is greater)
Sevoflurane conc	0 – 8 %.	Same
	Accuracy: ±15% of set value or ±5% of maximum possiblesetting (whichever is greater)
Desflurane conc	0-10%: for set Fresh Gas Flow less than 20 l/min andmaximal Fresh Gas Flow less than 75 l/min0-18%: for set Fresh Gas Flow less than 10 l/min andmaximal Fresh Gas Flow less than 40 l/min	Same
	Accuracy: ±15% of set value or ±5% of maximum possiblesetting (whichever is greater)
Fresh gas flow	0.3 – 20 l/min	Same
	Accuracy:± 15 % of set value or ±5% of maximum possiblesetting (whichever is greater)
Tidal volume	± 10 % or ± 50 ml/min (whichever is greater)100 – 2000 ml in the adult patient category.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.0.3 – 20 l/min in the infant patient category.	Same
	Accuracy: ±10% or 10 ml, whichever is greater
PEEP (positive endexpiratory 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.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:±5 % or ± 1 bpm (whichever is greater)1:10 – 4:1 in automatic modes	Same
MonitoringMeasurement rangeand accuracy:
Pressure	-30 cmH2O – 140 cmH2O	Same
Oxygen conc	Accuracy:±5% or ±2 cm H2O (whichever is greater)0 to 100%	Same
Tidal volume	Accuracy:±1 vol% @ (0-25%)±2 vol% @ (25 – 80%)±3 vol% @ (80-100%)Exp. Tidal volume:Measurement range: 5-2000 ml	Same
Carbon dioxide conc	Accuracy:± 4ml (5-20 ml)±10% or 10 ml, whichever is greater (20-2000ml)0 to 10%	Same
Isoflurane conc	Accuracy:± 0.1 vol% @ (0-1%)± 0.2 vol% @ (1-5%)± 0.3 vol% @ (5-7%)± 0.5 vol% @ (7-10%)0 to 5%	Same
Sevoflurane conc	Accuracy:±0.15 vol% @ (0-1%)±0.2 vol% @ (1-5%)0 to 8%	Same
Desflurane conc	Accuracy:±0.15 vol% @ (0-1%)± 0.2 vol% @ (1-5%)± 0.4 vol% @ (5-8%)0 to 18%	Same
Alarms:Airway pressure: High	Accuracy:±0.15 vol% @ (0-1%)± 0.2 vol% @ (1-5%)± 0.4 vol% @ (5-10%)± 0.6 vol% @ (10-15%)± 1.0 vol% @ (15-18%)16 to 120 cmH2O	10 to 120 cmH2O
Software andhardware changes
US outlets	Not available	Available
Recommended ventilationvalues (PBW)	Not available	New software functionality
Airway resistancemeasurement following anInspiratory and/orExpiratory 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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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).