(442 days)
No
The summary describes a standard microprocessor-controlled ventilator with various modes and features, but there is no mention of AI or ML in the intended use, device description, or any other section.
Yes
The device is a ventilator, which provides mechanical ventilation to patients requiring respiratory support, directly treating a physiological function.
No
Explanation: The device is primarily a ventilator that provides mechanical ventilation. While it can measure, display, record, and alarm some physiological data (SpO2, FiO2, CO2, and Pulse Rate), these are monitoring functions to support the ventilation therapy, not for diagnosing a medical condition. Its intended use and description focus on providing ventilatory support.
No
The device description clearly outlines hardware components such as a microprocessor, blower, touch screen display, LEDs, dedicated keys, and various physical accessories (filters, circuits, sensors, batteries, etc.). It is a physical ventilator with integrated software control.
Based on the provided information, the Trilogy Evo Universal ventilator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Trilogy Evo Universal Function: The Trilogy Evo Universal ventilator is a life support device that provides mechanical ventilation to patients. While it can measure and display physiological data like SpO2, FiO2, CO2, and Pulse Rate, these measurements are taken in vivo (within the living body) and are used to monitor the patient's respiratory status and guide ventilation therapy. They are not analyzing specimens taken from the body.
The device's intended use, device description, and the types of measurements it takes all point to it being a respiratory support device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
CBK, DQA, CCK
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 .
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
Suitable for use in institutional/hospital settings and non-emergency transport settings for example wheelchair.
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: Performed based on product requirements. This software was considered to have a "major" level of concern. Verification Testing included 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, and RFID following AIM Standard. All product requirements were met with passing test results.
- Biocompatibility Testing: Evaluated in accordance with FDA Guidance, "Use of International Standard ISO 10993-1," and ISO 10993-1. Testing included cytotoxicity, sensitization, irritation, genotoxicity and implantation, extractable and evaluation/risk assessment, and condensate testing. Gas emission VOC, Inorganic gases (CO, CO2, and Ozone) and PM2.5 testing were conducted for materials in the gas pathway. Materials found biocompatible.
- General Safety, Electrical Safety and Electromagnetic Compatibility (EMC) Testing: Conducted on the Trilogy Evo Universal device, complying with 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, ISO 80601-2-55:2011, ISO 80601-2-61: 2011, ISO 5356-1:2015, ISO 5367:2014.
- Human Factors: Human Factors/Usability Engineering process aligned with IEC 62366-1 and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices." Results indicate intended users can operate the device appropriately and residual risk is acceptable.
Clinical Tests: Clinical tests were not required to demonstrate the safety and effectiveness.
Key results: 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. 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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).