(88 days)
Not Found
No
The description mentions a "microprocessor controlled blower based" system and lists various ventilation modes, but there is no mention of AI, ML, or any learning or adaptive capabilities.
Yes
The device is a ventilator, providing continuous or intermittent ventilatory support to individuals requiring mechanical ventilation, which directly impacts patient health and involves therapeutic interventions like CPAP, Pressure Control Ventilation, and Volume Controlled Ventilation.
No
The device is described as a "ventilatory support system" that provides "continuous or intermittent ventilatory support" and delivers "therapy." Its function is to provide breathing assistance, not to diagnose a medical condition. While it displays clinical data, this is for monitoring and adjusting therapy, not for making a diagnosis.
No
The device description clearly states it is a "microprocessor controlled blower based pressure support, pressure control or volume controlled ventilator," indicating it is a hardware device with integrated software for control and user interface.
Based on the provided information, the Respironics Trilogy 200 system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the Trilogy 200 clearly states its purpose is to provide ventilatory support to individuals requiring mechanical ventilation. It interacts directly with the patient's respiratory system, not with in vitro specimens.
- The intended use and device description focus on delivering air and controlling breathing parameters. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
The Trilogy 200 is a ventilator, a life-support device used to assist or replace breathing.
N/A
Intended Use / Indications for Use
The Respironics Trilogy200 system provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy200 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation.
Product codes
CBK
Device Description
The Respironics Trilogy 200 Ventilatory Support System 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 suitable for use in the institutional/hospital, home and transport settings and is applicable for adults and pediatric patients weighing at least 5 kg (11 lbs) who require the following types of ventilatory support.
- CPAP Continuous Positive Airway Pressure
- S Spontaneous Ventilation
- S/T Spontaneous and Timed Ventilation
- T Timed Ventilation
- PC Pressure Control Ventilation
- PC-SIMV Pressure Controlled Synchronized Intermittent Mandatory Ventilation
- AC – Assist Control Ventilation
- CV - Control Ventilation
- SIMV - Synchronized Intermittent Mandatory Ventilation
A user interface displays clinical data and enables the operator to set and adjust certain clinical parameters. The Trilogy 200 Ventilator is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed), others are user adjustable. The Trilogy 200 Ventilator can deliver therapy to patients > 5kg (11 Ibs), invasively (via ET tube) or noninvasively (via masks that are cleared for use with this patient population including small child, pediatric and adult sizes).
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 5 kg (11 lbs.)
Intended User / Care Setting
Used in home, institution/hospital, and portable applications such as wheelchairs and gurneys
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)
To demonstrate performance and functionality of the Trilogy was unaffected as a result of these changes, extensive waveform performance, triggering and alarm functionality testing was performed. All tests were verified to meet the required acceptance criteria. Results of this testing concluded that the verification testing raises no new issues of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
TAB 3
.........
الم
JAN 2 9 2010
510(K) SUMMARY OF SAFETY & EFFECTIVENESS
| Original Date of Submission | 30 October 2009 |
|---|---|
| Device Trade Name | Trilogy 200 |
| Common/Usual Name | Ventilator, continuous, life supporting |
| Establishment Registration # | 2518422 |
| Address of Mfr. Facility | Respironics, Inc. |
| 1001 Murry Ridge Lane | |
| Murrysville, PA 15668 | |
| (724) 387-4120 FAX (724)-387-7490 CELL (724) 882-4120 | |
| Classification | Class II device |
| Classification Panel | Anesthesiology Devices |
| Classification Reference | 21 CFR 868.5895 |
| Product Code | CBK - Continuous Ventilator, Facility Use |
| Predicate Device(s) | Respironics Trilogy 100 (K083526) |
| Labeling | Draft Labeling can be found in Tab 5. |
| Indications for Use | The Respironics Trilogy200 system provides continuous or intermittent |
| ventilatory support for the care of individuals who require mechanical | |
| ventilation. Trilogy200 is intended for pediatric through adult patients | |
| weighing at least 5 kg (11 lbs.). | |
| The device is intended to be used in home, institution/hospital, and | |
| portable applications such as wheelchairs and gurneys, and may be | |
| used for both invasive and non-invasive ventilation. | |
| Reason for Submission | Modified device |
1
Substantial Equivalence
The Trilogy 200 system has the following similarities to the previously cleared predicate device:
- O Same intended use.
- D Same operating principle.
- O Same technology.
- O Same manufacturing process.
There is no change to the intended use, operating principle, technology or manufacturing process for the Trilogy 200. There are minor mechanical changes to the Trilogy 200 to accommodate the universal porting block modification discussed in this submission. All other modifications did not change the electromechanical platform of the Trilogy 100, cleared in K083526.
To demonstrate performance and functionality of the Trilogy was unaffected as a result of these changes, extensive waveform performance, triggering and alarm functionality testing was performed. All tests were verified to meet the required acceptance criteria. Results of this testing concluded that the verification testing raises no new issues of safety or effectiveness.
Respironics has followed the FDA's Guidance for Industry and FDA Staff document "pre-market assessment of pediatric medical devices" and applied the principle of FDA's Least Burdensome Approach to demonstrate the Substantial Equivalence of the Trilogy 200 system. As a result we conclude that the existing indications for use can be safely and effectively applied to this device.
Device Description
The Respironics Trilogy 200 Ventilatory Support System 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 suitable for use in the institutional/hospital, home and transport settings and is applicable for adults and pediatric patients weighing at least 5 kg (11 lbs) who require the following types of ventilatory support.
- CPAP Continuous Positive Airway Pressure
- S Spontaneous Ventilation
- S/T Spontaneous and Timed Ventilation
- T Timed Ventilation
- PC Pressure Control Ventilation
- PC-SIMV Pressure Controlled Synchronized Intermittent Mandatory Ventilation
2
AC – Assist Control Ventilation
CV - Control Ventilation
SIMV - Synchronized Intermittent Mandatory Ventilation
A user interface displays clinical data and enables the operator to set and adjust certain clinical parameters.
The Trilogy 200 Ventilator is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed), others are user adjustable.
The Trilogy 200 Ventilator can deliver therapy to patients > 5kg (11 Ibs), invasively (via ET tube) or noninvasively (via masks that are cleared for use with this patient population including small child, pediatric and adult sizes).
(End of Tab.)
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The bird is composed of three curved lines that create a sense of movement and flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Respironics, Incorporated Ms. Zita A: Yurko Director, Regulatory Affairs Sleep & Home Respiratory Group 1740 Golden Mile Highway Monroeville, Pennsylvania 15146
JAN 29 2010
Re: K093416
Trade/Device Name: Trilogy 200 Regulation Number: 21CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: October 30, 2009 Received: November 2, 2009
Dear Ms. Yurko:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2- Ms. Yurko
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/Medica]Devices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page _ 1_ of__1
Indications for Use
510(k) Number (if known): K093416
Device Name:
The Respironics Trilogy 200 system provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy200 is intended for pediatric through adult patients weighing at least 5 kg (11 Ibs.).
The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation.
Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
hubtt
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K093416