Who is the manufacturer of Trilogy Evo Universal?

Respironics, Inc. filed the 510(k) submission for Trilogy Evo Universal (K181170).

What is the FDA product code for Trilogy Evo Universal?

CBK. It is classified under 21 CFR 868.5895 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for Trilogy Evo Universal?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Trilogy Evo Universal?

Trilogy Series of Ventilators with Oximetry (K111610); Breas Medical, Vivo 60 (K160481); Puritan Bennett 840 (K151252).

Who can help prepare an FDA 510(k) submission like Trilogy Evo Universal?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Trilogy Evo Universal

K181170 · Respironics, Inc. · CBK · Jul 18, 2019 · Anesthesiology

Device Facts

Record ID	K181170
Device Name	Trilogy Evo Universal
Applicant	Respironics, Inc.
Product Code	CBK · Anesthesiology
Decision Date	Jul 18, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5895
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended 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 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.

Device Story

Microprocessor-controlled, blower-based ventilator providing pressure/volume-controlled ventilation; supports invasive/non-invasive modes (A/C-PC, A/C-VC, CPAP, PSV, S/T, SIMV-PC, SIMV-VC). Inputs include patient airway pressure/flow, plus integrated SpO2, FiO2, and CO2 monitoring via external sensors. Device processes inputs to manage ventilation delivery, trigger/cycle breaths, and generate physiological alarms. Operated by clinicians in hospitals or non-emergency transport; features touchscreen GUI, status LEDs, and dedicated keys. Output displayed on screen for real-time monitoring and clinical decision-making regarding respiratory support. Benefits include precise ventilatory assistance and integrated monitoring for patients requiring mechanical support.

Clinical Evidence

No clinical data. Safety and effectiveness demonstrated via non-clinical bench testing, including software verification/validation, biocompatibility, electrical safety (AAMI/ANSI/ES 60601-1), EMC (IEC 60601-1-2), and human factors validation per IEC 62366-1.

Technological Characteristics

Microprocessor-controlled, blower-based ventilator. Energy: AC/DC (internal/detachable Li-Ion, external Pb-Acid). Connectivity: Bluetooth, USB, hospital monitor integration. Software: Major level of concern. Standards: ISO 80601-2-12 (ventilators), ISO 80601-2-55 (respiratory gas monitors), ISO 80601-2-61 (pulse oximeters), ISO 5356-1, ISO 5367, IEC 60601-1-8 (alarms).

Indications for Use

Indicated for pediatric through adult patients weighing at least 2.5 kg requiring continuous or intermittent mechanical ventilation (invasive or non-invasive) in institutional/hospital or non-emergency transport settings.

Regulatory Classification

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.

Predicate Devices

Trilogy Series of Ventilators with Oximetry (K111610)
Breas Medical, Vivo 60 (K160481)
Puritan Bennett 840 (K151252)

Reference Devices

Philips NM3 Monitor, Model 7900 (K091459)

Related Devices

K220107 — Mindray SV600 Ventilator, Mindray SV800 Ventilator · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jun 16, 2023
K083526 — TRILOGY 100 VENTILATOR · Respironics Inc., Sleep & Home Respiratory Group · Mar 13, 2009
K131252 — PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM · Covidien · Feb 24, 2014
K062710 — GE DATEX-OHMEDA ENGSTROM CARESTATION · Datex-Ohmeda, Inc. · Dec 8, 2006
K970460 — NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840) · Puritan Bennett Corp. · Apr 30, 1998

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "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 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K181170 Device Name Trilogy Evo Universal Ventilator #### Indications for Use (Describe) 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. | Type of Use (Select one or both, as applicable) | |-----------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ______________________________________________________________________________________________________________________________________________________________________________ | 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 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 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) | | Reference Device: | Philips NM3 Monitor, Model 7900 (K091459) | {4}------------------------------------------------ ## 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 . ## 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 {5}------------------------------------------------ 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. {6}------------------------------------------------ ## Comparison of Technological Characteristics with the Predicate Device | Characteristic | Subject Device: Trilogy Evo Universal Manufacturer: Respironics | Predicate Device: Trilogy Series Ventilator with Oximetry (K111610)Manufacturer: Respironics | Comments | |-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended 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 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 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. | | 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 requirements on essential performance of ventilators | Met ISO 80601-2-12 requirements on essential performance of ventilators | Substantially equivalent | | Waveform Comparison | Comparable waveform results | Comparable waveform results | Substantially equivalent | | Characteristic | Subject Device: Trilogy Evo Universal 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. | {7}------------------------------------------------ ## 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. {8}------------------------------------------------ ## 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 ● {9}------------------------------------------------ - . 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).