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 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.

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).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Respironics Trilogy 200, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain a specific table of acceptance criteria with corresponding performance metrics. However, it states:

Acceptance Criteria	Reported Device Performance
Performance and functionality of the Trilogy was unaffected as result of changes.	"extensive waveform performance, triggering and alarm functionality testing was performed. All tests were verified to meet the required acceptance criteria."

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

The document does not explicitly state the sample size used for the test set or the data provenance. It generally refers to "extensive waveform performance, triggering and alarm functionality testing."

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

The document does not mention the use of experts to establish ground truth for a test set. This appears to be a technical and functional performance verification, rather than a clinical study requiring expert interpretation.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. Given it's a technical performance verification, this would likely not be applicable in the same way it would be for a clinical trial.

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

No, an MRMC comparative effectiveness study was not done. The submission is for a modified device (Trilogy 200) demonstrating substantial equivalence to a predicate device (Trilogy 100) through performance and functionality testing, not a clinical trial evaluating human reader performance.

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

This question is not directly applicable to the device described. The Trilogy 200 is a ventilator, a mechanical device providing ventilatory support. It doesn't rely on an "algorithm only" or AI in the sense of image analysis or diagnostic support. The "testing" referred to is about the ventilator's mechanical and electronic performance.

7. The Type of Ground Truth Used

The ground truth for this device's performance verification would be defined by the pre-established engineering and performance specifications for a ventilator. For example, specific waveform characteristics, triggering thresholds, and alarm activation points would be the "ground truth" against which the device's performance was measured. It's not clinical "ground truth" in the sense of pathology or outcomes data.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here. This is a medical device (ventilator) undergoing performance verification, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

As above, the concept of a "training set" and establishing ground truth for it is not applicable to this type of device submission.

Summary

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TAB 3

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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 LaneMurrysville, 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 intermittentventilatory support for the care of individuals who require mechanicalventilation. Trilogy200 is intended for pediatric through adult patientsweighing at least 5 kg (11 lbs.).
	The device is intended to be used in home, institution/hospital, andportable applications such as wheelchairs and gurneys, and may beused for both invasive and non-invasive ventilation.
Reason for Submission	Modified device

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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

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

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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.

(End of Tab.)

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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.

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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

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Page _ 1_ of__1

Indications for Use

510(k) Number (if known): K093416

Device Name:

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)

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(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K093416

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).