Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a microprocessor-controlled ventilator with various modes and features, but there is no mention of AI or ML technology being used for decision-making, control, or analysis.

Therapeutic

Yes.
The device is a ventilator, which provides mechanical ventilation to individuals requiring respiratory support. This directly addresses medical conditions and aims to restore or maintain physiological function, classifying it as a therapeutic device.

Diagnostic

Yes

Explanation: The "Intended Use" section states, "The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories." The ability to measure and display physiological data indicates a diagnostic capability.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "microprocessor controlled blower based pressure control or volume controlled ventilator," indicating it is a hardware device with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Trilogy Evo ventilator is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states that the device provides mechanical ventilation for individuals requiring breathing support. This is a life-support function directly applied to the patient's respiratory system.
Device Description: The description details the ventilator's functions related to delivering air and monitoring physiological parameters like SpO2, FiO2, CO2, and Pulse Rate. These are measurements taken from the patient, not tests performed on biological samples outside the body.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.

IVD devices are specifically designed to perform tests on biological samples to provide information about a person's health status. The Trilogy Evo ventilator's function is to assist with breathing, which is a direct therapeutic intervention, not a diagnostic test on a sample.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo 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 is suitable for use in institutional, home, and non-emergency transport settings for example wheelchair or personal vehicle. It may be used for both invasive and non-invasive ventilation.

Product codes

CBK, NOU

Device Description

The Trilogy Evo ventilator is a microprocessor controlled blower based 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, home, and non-emergency transport settings for example wheelchair or personal vehicle. 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)
AVAPS-AE modes
AVAPS-AE with PC Breath enabled, with auto backup ●
. AVAPS-AE with PC Breath enabled, without auto backup
AVAPS-AE with PC Breath disabled, with auto backup
. AVAPS-AE with PC Breath disabled, without auto backup
The AVAPS-AE mode is intended for noninvasive use in adult and pediatric patients weighing over 10kg with Respiratory Insufficiency or Respiratory Failure.
In addition to the therapy modes, the Trilogy Evo provides the following major functions:
Therapy Features including Backup Ventilation, Inspiratory Time Min/Max and Sigh .
Power Manaqement 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
. Remote alarm and nurse call capability
. 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:
Filters ●
Circuits, including Passive, Active and Dual Limb, and Mouth Piece Ventilation .
FiO2 Sensor ●
. Active Exhalation Valves
Leak Device
Oximeter and Sensors ●
. Capnography Sensors and cable
. Flow Sensors
Detachable Battery and Battery Cables ●

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

pediatric through adult patients weighing at least 2.5 kg.

Intended User / Care Setting

institutional, home, and non-emergency transport settings for example wheelchair or personal vehicle.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Tests:
Software verification and validation testing was performed on the Trilogy Evo ventilator based on the product requirements. 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 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 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
IEC 60601-1-11:2015
ISO 80601-2-12:2011
ISO 80601-2-55:2011
ISO 80601-2-61: 2011
ISO 80601-2-72: 2015
ISO 5356-1:2015
ISO 5367:2014

Human Factors:
The Trilogy Evo 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 ventilator appropriately and that residual risk associated with use of the device is acceptable.

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

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K111610, K160481, K151252, K162877, K121623

Reference Device(s)

K091459

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous ventilator Regulatory Class: Class II Product Code: CBK, NOU 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

1

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 (OS) 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 mediation-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 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181166

Device Name Trilogy Evo Ventilator

Indications for Use (Describe)

The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo 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 is suitable for use in institutional, home, and non-emergency transport settings for example wheelchair or personal vehicle. It may be used for both invasive and non-invasive ventilation.

Type of Use (Select one or both, as applicable)
X 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 Witt
Senior Manager, Regulatory Affairs
colleen.witt@philips.com
Respironics Inc.
1740 Golden Mile Highway
Monroeville, PA 15146

Phone: 412-613-1670
Fax: 724-387-7490 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Preparation | May 1, 2018 |
| Device | |
| Proprietary Name: | Trilogy Evo (K181166) |
| Common/Usual Name: | Ventilator, Continuous, Facility Use |
| Device Classification: | 21 CFR 868.5895 - Class II |
| Classification Name/
Product Code: | CBK, Ventilator, Continuous, Facility Use
NOU, Continuous, Ventilator, Home Use
DQA, Oximeter
CCK, 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)
VOCSN Unified Respiratory System (URS) (K162877)
BiPAP A40 Ventilatory Support System (K121623) |
| Reference Device: | Philips NM3 Monitor, Model 7900 (K091459) |

4

Device Description

The Trilogy Evo ventilator is a microprocessor controlled blower based 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, home, and non-emergency transport settings for example wheelchair or personal vehicle. 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)

AVAPS-AE modes

AVAPS-AE with PC Breath enabled, with auto backup ●
. AVAPS-AE with PC Breath enabled, without auto backup
AVAPS-AE with PC Breath disabled, with auto backup
. AVAPS-AE with PC Breath disabled, without auto backup

The AVAPS-AE mode is intended for noninvasive use in adult and pediatric patients weighing over 10kg with Respiratory Insufficiency or Respiratory Failure.

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

Therapy Features including Backup Ventilation, Inspiratory Time Min/Max and Sigh .
Power Manaqement 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
. Remote alarm and nurse call capability
. 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:

Filters ●
Circuits, including Passive, Active and Dual Limb, and Mouth Piece Ventilation .
FiO2 Sensor ●
. Active Exhalation Valves
Leak Device
Oximeter and Sensors ●
. Capnography Sensors and cable
. Flow Sensors
Detachable Battery and Battery Cables ●

5

. Nurse Call cables
Roll Stand ●
Mounting Bracket ●

Indications for Use

The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo 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 is suitable for use in institutional, home, and non-emergency transport settings for example wheelchair or personal vehicle. It may be used for both invasive and non-invasive ventilation.

The Intended Use of the Trilogy Evo is the same as compared to the primary predicate, Trilogy Series of Ventilator with Oximetry, K111610, to provide invasive positive pressure ventilation. The Indications for Use for the Trilogy Evo 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 ventilator is similar to the Primary Predicate Device, Trilogy Series of Ventilator with Oximetry. 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 ventilator to the primary predicate device, Trilogy Series of Ventilator with Oximetry, K111610.

6

Comparison of Technological Characteristics with the Predicate Device

| Characteristic | Subject Device:
Trilogy Evo
Manufacturer: Respironics | Predicate Device:
Trilogy Series Ventilator with
Oximetry (K111610)Manufacturer:
Respironics | Comments |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Trilogy Evo ventilator provides
continuous or intermittent positive
pressure ventilation for the care of
individuals who require mechanical
ventilation. Trilogy Evo is intended for
pediatric through adult patients weighing
at least 2.5 kg. The ventilator can
measure, display, record, and alarm
SpO2, FiO2, CO2, Respiratory Rate,
and Pulse Rate data when integrated
with the appropriate accessories. The
ventilator is suitable for use in
institutional, home, and non-emergency
transport settings for example
wheelchair or personal vehicle. It may
be used for both invasive and non-
invasive ventilation. | The Trilogy Series of Ventilators (with or
without the oximetry interface kit) are
intended to provide continuous or
intermittent ventilatory support for the
care of individuals who require
mechanical ventilation with or without
air/oxygen blending. Trilogy is intended
for pediatric through adult patients
weighing at least 5kg (11lbs). The
Oximetry Interface kit is intended to
measure functional oxygen saturation of
arterial hemoglobin (%SPO2) and pulse
rate. The device is intended to be used
in the home, hospitals and institutions,
and portable applications such as
wheelchairs and gurneys. It may be
used for both invasive and noninvasive
ventilation. It is not intended to be used
as a transport ventilator. | Substantially equivalent to K111610.
Patient weight expanded from 5.0 kg
to 2.5 kg. Comparison testing with
predicate ventilator demonstrates
substantial equivalence.
AVAPS-AE Mode is substantially
equivalent to the predicate device,
BiPAP A40 (K121623). The mode is
limited to that intended patient
population. |
| Patient
population | Pediatrics and Adults | Pediatrics and Adults | Substantially equivalent |
| Principle Of
Operation | Microprocessor controlled
Electronically powered
Software driven | Microprocessor controlled
Electronically powered
Software driven | Substantially equivalent. |
| Performance | Met ISO 80601-2-12 and 80601-2-72
requirements on essential performance
of ventilators | Met ISO 80601-2-12 and 80601-2-72
requirements on essential performance
of ventilators | Substantially equivalent |
| Waveform
Comparison | Comparable waveform results | Comparable waveform results | Substantially equivalent |
| Characteristic | Subject Device:
Trilogy Evo
Manufacturer: Respironics | Predicate Device:
Trilogy Series Ventilator with
Oximetry (K111610)Manufacturer:
Respironics | Comments |
| Design | Consists of a graphic user interface with
LCD with touch screen | Consists of an LCD screen, hard keys
and LED indicators | Substantially equivalent. |
| Delivery method
to patient | Continuous or intermittent positive
pressure ventilation | Continuous or intermittent positive
pressure ventilation | Substantially equivalent |
| Energy Used for
device | AC and DC (Battery) Power | AC and DC (Battery) Power | Substantially equivalent |
| Principle of
Operation | Microprocessor controlled | Microprocessor controlled | Substantially equivalent |
| Therapy Types | Invasive and Non-Invasive Mechanical
ventilation | Invasive and Non-Invasive Mechanical
ventilation | Substantially equivalent |

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Section 6: 510(k) Summary

The additional predicate devices, Vivo 60 (K160481), Puritan Bennett 840 Series Ventilator System (K151252) and VOCSN Unified Respiratory System (K162877) were selected as predicate devices to support the following:

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

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

8

Performance Data

Non-Clinical Tests

Software verification and validation testing

Software verification and validation testing was performed on the Trilogy Evo ventilator based on the product requirements. 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 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 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 ●
IEC 60601-1-11:2015 ●
ISO 80601-2-12:2011

9

. ISO 80601-2-55:2011
ISO 80601-2-61: 2011
ISO 80601-2-72: 2015 ●
ISO 5356-1:2015 ●
. ISO 5367:2014

Human Factors

The Trilogy Evo 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 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 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 for Devices Intended for Home Use ●
. 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 verified that all product requirements have been met with passing test results. The verification and validation testing demonstrated the overall substantial equivalence of the Trilogy Evo device.

Clinical Tests

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

Conclusion

The Trilogy Evo 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).