The Trilogy Evo Universal ventilator provides continuous or intermittent pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended for pediativ through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional/hospital settings and non-emergency transport settings for example wheelchair. It may be used for both invasive ventilation.

Device Description

The Trilogy Evo Universal ventilator is a microprocessor controlled blower based pressure support, pressure control or volume controlled ventilator intended for the care of individuals who require mechanical ventilation. The ventilator is intended to provide continuous or intermittent ventilatory support. The ventilator is suitable for use in institutional/hospital settings and non-emergency transport settings for example wheelchair. It is applicable for adults and pediatric patients weighing at least 2.5 kg who require the following types of ventilatory support:

Control Modes

A/C-PC: Assist control .
. A/C-VC: Assist control

Spontaneous modes

CPAP: Continuous positive airway pressure .
PSV: Pressure support ventilation .

Mixed modes

S/T: Spontaneous/timed ventilation .
. SIMV-PC: Synchronized intermittent mandatory ventilation (pressure control)
SIMV-VC: Synchronized intermittent mandatory ventilation (volume control)

In addition to the therapy modes, the Trilogy Evo Universal provides the following major functions:

Therapy Features including Backup Ventilation, Inspiratory Time Min/Max and Sigh ●
Power Management of various power sources (AC, internal and detachable Li-lon batteries and ● external Pb-Acid battery)
Physiological alarms
. Graphical User Interface using a touch screen display, status LEDs and dedicated keys for user input
. Bluetooth and USB Communications
Compatibility with various patient interfaces and multiple circuit types
Connectivity with hospital monitors ●
. Capability to connect, display and alarm SpO2, FiO2 and ETCO2 monitors
. Ventilation with supplemental low flow oxygen or oxygen blender

The associated accessories include:

Bacteria Filter ●
Circuits, including Passive, Active and Dual Limb
FiO2 Sensor ●
. Active Exhalation Valves
. Leak Device
. Heat and Moisture Exchangers (HME's)
Oximeter and Sensors
Capnography Sensors and cable ●
Flow Sensors
Detachable Battery and Battery Cables ●
Roll Stand
Mounting Bracket .

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Trilogy Evo Universal Ventilator, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Predicate)	Reported Device Performance (Trilogy Evo Universal)
Intended Use	Continuous or intermittent ventilatory support for individuals requiring mechanical ventilation, with or without air/oxygen blending. Intended for pediatric through adult patients weighing at least 5kg (11lbs). Oximetry Interface kit measures functional oxygen saturation and pulse rate. Used in home, hospitals, institutions, and portable applications (wheelchairs, gurneys). Invasive and noninvasive ventilation. Not a transport ventilator.	Continuous or intermittent positive pressure ventilation for individuals requiring mechanical ventilation. Intended for pediatric through adult patients weighing at least 2.5 kg. Measures, displays, records, and alarms SpO2, FiO2, CO2, and Pulse Rate data when integrated with appropriate accessories. Suitable for institutional/hospital settings and non-emergency transport settings (e.g., wheelchair). Used for both invasive and non-invasive ventilation.
Patient Population	Pediatrics and Adults	Pediatrics and Adults
Principle Of Operation	Microprocessor controlled, Electronically powered, Software driven	Microprocessor controlled, Electronically powered, Software driven
Performance	Met ISO 80601-2-12 requirements on essential performance of ventilators.	Met ISO 80601-2-12 requirements on essential performance of ventilators.
Waveform Comparison	Comparable waveform results	Comparable waveform results
Design	LCD screen, hard keys, and LED indicators.	Graphic user interface with LCD with touch screen.
Delivery method to patient	Continuous or intermittent positive pressure ventilation	Continuous or intermittent positive pressure ventilation
Energy Used for device	AC and DC (Battery) Power	AC and DC (Battery) Power
Therapy Types	Invasive and Non-Invasive Mechanical ventilation	Invasive and Non-Invasive Mechanical ventilation
Software	Not explicitly stated as a separate criterion, but implied under "Principle of Operation" and the software's "major" level of concern.	Software verification and validation testing performed based on product requirements, meeting FDA guidance for "major" level of concern software. All product requirements met with passing test results.
Biocompatibility	Not explicitly stated, but implied as a general safety requirement	Biocompatibility evaluation conducted in accordance with FDA Guidance and ISO 10993-1. Testing (cytotoxicity, sensitization, irritation, genotoxicity, implantation, extractables, condensate) found materials biocompatible. Gas pathway materials evaluated via Gas emission VOC, Inorganic gases (CO, CO2, Ozone) and PM2.5 testing.
General & Electrical Safety, EMC	Not explicitly stated, but implied to meet relevant standards.	Complies with AAMI/ANSI/ES 60601-1:2005/A1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2013, IEC 60601-1-8:2012, ISO 80601-2-12:2011, ISO 80601-2-55:2011, ISO 80601-2-61: 2011, ISO 5356-1:2015, ISO 5367:2014.
Human Factors	Not explicitly stated, but implied as a general safety requirement.	Human Factors/Usability Engineering process followed IEC 62366-1 and FDA guidance. Human factors validation study indicates appropriate user operation and acceptable residual risk.

Study That Proves the Device Meets Acceptance Criteria:

The document states that the "Trilogy Evo Universal device is as safe and as effective as the predicate device, Trilogy Series Ventilator with Oximetry (K111610) and is deemed substantially equivalent to the predicate device, Trilogy Series Ventilator with Oximetry (K111610)." This substantial equivalence is primarily established through non-clinical tests and a comparison of technological characteristics with the predicate device.

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

The document does not specify a numerical sample size for the test set used in the non-clinical tests.
Data Provenance: The document does not explicitly state the country of origin of the data or whether the data was retrospective or prospective. The tests were performed on the device itself as part of the verification and validation process.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth in the non-clinical tests. The tests rely on compliance with established standards and internal validation processes rather than expert interpretation of data like in a diagnostic study.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method for the test set in the context of expert consensus, as the testing involves engineering and performance validation against predefined standards and requirements rather than subjective expert evaluation of study data.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical tests were not required to demonstrate the safety and effectiveness of the Trilogy Evo Universal ventilator. Product functionality has been adequately assessed by non-clinical tests." Therefore, there is no mention of human readers improving with or without AI assistance, as AI assistance in the diagnostic sense is not the primary function of this ventilator.

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

This question is not directly applicable in the traditional sense of a diagnostic AI algorithm. The device itself is a standalone medical device that performs ventilation. The "software verification and validation testing" assessed the algorithm (software) without human intervention during the automated tests. The "Human Factors" study assessed the human-in-the-loop performance from the perspective of safe and effective user interaction with the device, rather than an AI diagnostic aid.

7. The type of ground truth used:

The ground truth for the non-clinical tests was primarily established by engineering specifications, regulatory standards (e.g., ISO, IEC), and predefined product requirements. For example:
- Performance: Compliance with ISO 80601-2-12 and "All product requirements have been met with passing test results."
- Software: Compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Biocompatibility: Compliance with ISO 10993-1.
- Safety/EMC: Compliance with AAMI/ANSI/ES 60601-1 and various IEC/ISO standards.
- Human Factors: Compliance with IEC 62366-1 and FDA guidance, with validation showing appropriate user operation and acceptable residual risk.

8. The sample size for the training set:

The document does not specify a sample size for a training set. This is because the device is a ventilator, not a machine learning model that requires a "training set" in the common sense of AI/ML software for diagnosis or prediction. The software development process likely involved various internal testing and refinement, but not a distinct "training set" like one would find in, for example, an image recognition algorithm.

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

As a "training set" as commonly understood in AI/ML is not applicable here, the question of how its ground truth was established is not relevant to this document. The "ground truth" for the device's functionality was based on the performance standards and design specifications it was built to meet.

Summary

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July 18, 2019

Respironics Inc. Ms. Colleen Witt Senior Regulatory Affairs Manager 1740 Golden Mile Highway Monroeville, Pennsylvania 15146

Re: K181166

Trade/Device Name: Trilogy Evo Universal Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous ventilator Regulatory Class: Class II Product Code: CBK Dated: July 5, 2019 Received: July 9, 2019

Dear Ms. Witt:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

James J. Lee, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181170

Device Name Trilogy Evo Universal Ventilator

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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Submitter
Official Contact	Colleen WittSenior Manager, Regulatory Affairscolleen.witt@philips.comRespironics Inc.1740 Golden Mile HighwayMonroeville, PA 15146
	Phone: 412-613-1670Fax: 724-387-7490
Date of Preparation	May 1, 2018
Device
Proprietary Name:	Trilogy Evo Universal (K181170)
Common/Usual Name:	Ventilator, Continuous, Facility Use
Device Classification:	21 CFR 868.5895 - Class II
Classification Name/Product Code:	CBK, Ventilator, Continuous, Facility UseDQA, OximeterCCK, Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Primary Predicate Device:	Trilogy Series of Ventilators with Oximetry (K111610)
Predicate Devices:	Breas Medical, Vivo 60 (K160481)Puritan Bennett 840 (K151252)
Reference Device:	Philips NM3 Monitor, Model 7900 (K091459)

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Device Description

Control Modes

A/C-PC: Assist control .
. A/C-VC: Assist control

Spontaneous modes

CPAP: Continuous positive airway pressure .
PSV: Pressure support ventilation .

Mixed modes

S/T: Spontaneous/timed ventilation .
. SIMV-PC: Synchronized intermittent mandatory ventilation (pressure control)
SIMV-VC: Synchronized intermittent mandatory ventilation (volume control)

In addition to the therapy modes, the Trilogy Evo Universal provides the following major functions:

Therapy Features including Backup Ventilation, Inspiratory Time Min/Max and Sigh ●
Power Management of various power sources (AC, internal and detachable Li-lon batteries and ● external Pb-Acid battery)
Physiological alarms
. Graphical User Interface using a touch screen display, status LEDs and dedicated keys for user input
. Bluetooth and USB Communications
Compatibility with various patient interfaces and multiple circuit types
Connectivity with hospital monitors ●
. Capability to connect, display and alarm SpO2, FiO2 and ETCO2 monitors
. Ventilation with supplemental low flow oxygen or oxygen blender

The associated accessories include:

Bacteria Filter ●
Circuits, including Passive, Active and Dual Limb
FiO2 Sensor ●
. Active Exhalation Valves
. Leak Device
. Heat and Moisture Exchangers (HME's)
Oximeter and Sensors
Capnography Sensors and cable ●
Flow Sensors
Detachable Battery and Battery Cables ●
Roll Stand
Mounting Bracket .

Indications for Use

The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories. The ventilator

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is suitable for use in institutional/hospital settings and non-emergency transport settings for example wheelchair. It may be used for both invasive and non-invasive ventilation.

The Intended Use of the Trilogy Evo Universal is the same as compared to the primary predicate, Trilogy Series of Ventilator with Oximetry, K11610, to provide invasive and noninvasive positive pressure ventilation. The Indications for Use for the Trilogy Evo Universal is not identical to the predicate device, Trilogy Series of Ventilator with Oximetry, K111610; however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate.

Comparison of Technological Characteristics with the Predicate Device

The Trilogy Evo Universal ventilator is similar to the Primary Predicate Device, Trilogy Series of Ventilator with Oximetry that was cleared under K111610. The Trilogy Evo ventilator has the same intended use and similar indications for use, operating principles, technologies and manufacturing processes as the predicate device. See table below for a comparison of the Trilogy Evo Universal ventilator to the primary predicate device, Trilogy Series of Ventilator with Oximetry.

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Comparison of Technological Characteristics with the Predicate Device

Characteristic	Subject Device:Trilogy Evo UniversalManufacturer: Respironics	Predicate Device:Trilogy Series Ventilator withOximetry (K111610)Manufacturer:Respironics	Comments
Intended Use	The Trilogy Evo Universal ventilatorprovides continuous or intermittentpositive pressure ventilation for the careof individuals who require mechanicalventilation. Trilogy Evo Universal isintended for pediatric through adultpatients weighing at least 2.5 kg. Theventilator can measure, display, record,and alarm SpO2, FiO2, CO2, and PulseRate data when integrated with theappropriate accessories. The ventilatoris suitable for use in institutional/hospitalsettings and non-emergency transportsettings for example wheelchair. It maybe used for both invasive and non-invasive ventilation.	The Trilogy Series of Ventilators (with orwithout the oximetry interface kit) areintended to provide continuous orintermittent ventilatory support for thecare of individuals who requiremechanical ventilation with or withoutair/oxygen blending. Trilogy is intendedfor pediatric through adult patientsweighing at least 5kg (11lbs). TheOximetry Interface kit is intended tomeasure functional oxygen saturation ofarterial hemoglobin (%SPO2) and pulserate. The device is intended to be usedin the home, hospitals and institutions,and portable applications such aswheelchairs and gurneys. It may beused for both invasive and noninvasiveventilation. It is not intended to be usedas a transport ventilator.	Substantially equivalent to K111610.Patient weight expanded from 5.0 kgto 2.5 kg. Comparison testing withpredicate ventilator demonstratessubstantial equivalence.
PatientPopulation	Pediatrics and Adults	Pediatrics and Adults	Substantially equivalent
Principle OfOperation	Microprocessor controlledElectronically poweredSoftware driven	Microprocessor controlledElectronically poweredSoftware driven	Substantially equivalent.
Performance	Met ISO 80601-2-12 requirements onessential performance of ventilators	Met ISO 80601-2-12 requirements onessential performance of ventilators	Substantially equivalent
WaveformComparison	Comparable waveform results	Comparable waveform results	Substantially equivalent
Characteristic	Subject Device:Trilogy Evo UniversalManufacturer: Respironics	Predicate Device:Trilogy Series Ventilator withOximetry (K111610)Manufacturer:Respironics	Comments
Design	Consists of a graphic user interface withLCD with touch screen	Consists of an LCD screen, hard keysand LED indicators	Substantially equivalent.
Delivery methodto patient	Continuous or intermittent positivepressure ventilation	Continuous or intermittent positivepressure ventilation	Substantially equivalent.
Energy Used fordevice	AC and DC (Battery) Power	AC and DC (Battery) Power	Substantially equivalent.
Principle ofOperation	Microprocessor controlled	Microprocessor controlled	Substantially equivalent.
Therapy Types	Invasive and Non-Invasive Mechanicalventilation	Invasive and Non-Invasive Mechanicalventilation	Substantially equivalent.

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Section 6: 510(k) Summary

The additional predicate devices, Vivo 60 (K160481) and Puritan Bennett 840 Series Ventilator System (K151252) were selected as predicate devices to support the following:

PB 840 supports Trilogy Evo Universal's expanded patient weight of greater than 2.5 kg and expanded settings for several mode ● parameters.
Vivo 60 supports Trilogy Evo Universal's CO2 monitoring, the dual limb circuit as well as expanded settings for several . mode parameters

The reference device, NM3_7900 (K091459) was selected as a reference device to support Trilogy Evo Universal's dynamic lung parameters.

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Performance Data

Non-Clinical Tests

Software verification and validation testing

Software verification and validation testing was performed on the Trilogy Evo Universal ventilator based on the product reguirements. Testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." This software was considered to have a "major" level of concern, since a failure in the software could result in death or serious injury to the patient.

Verification Testing included the following:

System Performance .
Closed Loop Control Testing
Environmental Testing ●
. Cleaning and Disinfection
Sterilization, where applicable .
Durability testing ●
Power Management .
. Alarm performance testing
. User Interface testing
Therapy mode performance testing
. Connectivity testing
Comparison Performance Waveform and Triggering / Cycling testing ●
DO-160 Testing ●
RFID following AIM Standard ●

All product requirements have been met with passing test results.

Biocompatibility Testing

The biocompatibility evaluation for the Trilogy Evo Universal device was conducted in accordance with FDA Guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process", and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process, as recognized by FDA. Biocompatibility testing (i.e. cytotoxicity, sensitization, irritation, genotoxicity and implantation) including extractable and evaluation/risk assessment as well as condensate testing has been performed.

The materials which are in the gas pathway have been evaluated via Gas emission VOC, Inorganic gases (CO, CO2, and Ozone) and PM2.5 testing with a risk based assessment.

The materials were found to be biocompatible for the intended population and type of patient contact.

General Safety, Electrical Safety and Electromagnetic Compatibility (EMC)

General Safety, Electrical safety and EMC testing were conducted on the Trilogy Evo Universal device. The system complies with the following standards:

AAMI/ANSI/ES 60601-1:2005/A1:2012 ●
IEC 60601-1-2:2014
IEC 60601-1-6:2013 ●
. IEC 60601-1-8:2012
ISO 80601-2-12:2011 ●

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. ISO 80601-2-55:2011
ISO 80601-2-61: 2011
ISO 5356-1:2015 ●
ISO 5367:2014 ●

Human Factors

The Trilogy Evo Universal ventilator has been found to be appropriate for the intended users, uses, and use environments. The Human Factors/Usability Engineering process followed on this project aligns with IEC 62366-1, Medical Devices - Part 1: Application of Usability Engineering to Medical Devices, and the latest applicable FDA guidance, Applying Human Factors and Usability Engineering to Medical Devices (February, 2016). Results of following this process, in particular the results of the human factors validation study, indicate that intended users can operate the Trilogy Evo Universal ventilator appropriately and that residual risk associated with use of the device is acceptable.

Guidance Documents

The following guidance documents were used in the design of the Trilogy Evo Universal ventilator:

Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
. Compliance on Off-The-Shelf Software Use in Medical Devices
General Principles of Software Validation ●
Applying Human Factors and Usability Engineering to Medical Devices .
Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
. Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
Cybersecurity for Networked Medical Devices Containing Off- the-Shelf (OTS) Software ●
. Management of Cybersecurity in Medical Devices
Radio Frequency Wireless Technology in Medical Devices ●
Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically Powered ● Medical Devices
. Pulse Oximeters - Premarket Notification Submissions [510(k)s]

The testing of Trilogy Evo Universal verified that all product requirements have been met with passing test results. The verification and validation testing demonstrated of the overall substantial equivalence of the Trilogy Evo Universal device.

Clinical Tests

Clinical tests were not required to demonstrate the safety and effectiveness of the Trilogy Evo Universal ventilator. Product functionality has been adequately assessed by non-clinical tests.

Conclusion

The Trilogy Evo Universal device is as safe and as effective as the predicate device, Trilogy Series Ventilator with Oximetry (K111610) and is deemed substantially equivalent to the predicate device, Trilogy Series Ventilator with Oximetry (K111610).

Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).