TRILOGY 200 VENTILATOR

K093416 · Respironics, Inc. · CBK · Jan 29, 2010 · Anesthesiology

Device Facts

• Record ID: K093416
• Device Name: TRILOGY 200 VENTILATOR
• Applicant: Respironics, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Jan 29, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Trilogy 200 is a microprocessor-controlled, blower-based ventilator providing pressure support, pressure control, or volume-controlled ventilation. It supports CPAP, S, S/T, T, PC, PC-SIMV, AC, CV, and SIMV modes. The device delivers therapy invasively (via ET tube) or non-invasively (via masks) to patients weighing ≥ 5 kg. Used in hospitals, homes, and transport settings (wheelchairs/gurneys). Operators include clinicians or caregivers. The device features a user interface for setting clinical parameters and displaying data, plus fixed and adjustable alarms to alert users to treatment changes. It functions as a modified version of the Trilogy 100, incorporating a universal porting block. The system assists patients requiring mechanical ventilation, potentially improving respiratory outcomes through precise pressure/volume delivery.

Clinical Evidence

Bench testing only. Performance and functionality were verified through extensive waveform performance, triggering, and alarm functionality testing. All tests met established acceptance criteria, demonstrating that modifications did not negatively impact the device's performance compared to the predicate.

Technological Characteristics

Microprocessor-controlled, blower-based ventilator. Supports pressure support, pressure control, and volume-controlled ventilation. Features a universal porting block. Operates via AC/DC power. Designed for invasive and non-invasive delivery. Includes user interface and alarm system.

Indications for Use

Indicated for pediatric through adult patients weighing at least 5 kg (11 lbs) requiring continuous or intermittent mechanical ventilatory support. Suitable for invasive or non-invasive use in home, hospital, or portable 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

• Respironics Trilogy 100 (K083526)

Submission Summary (Full Text)

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## TAB 3

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# 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.<br>1001 Murry Ridge Lane<br>Murrysville, PA 15668<br>[phone] FAX [phone] CELL [phone] |
| 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<br>ventilatory support for the care of individuals who require mechanical<br>ventilation. Trilogy200 is intended for pediatric through adult patients<br>weighing at least 5 kg (11 lbs.). |
| | The device is intended to be used in home, institution/hospital, and<br>portable applications such as wheelchairs and gurneys, and may be<br>used 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

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

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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.

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.)

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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 [phone] or [phone] 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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#### 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)

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

510(k) Number: k093416