TRILOGY 100 VENTILATOR

K083526 · Respironics Inc., Sleep & Home Respiratory Group · CBK · Mar 13, 2009 · Anesthesiology

Device Facts

• Record ID: K083526
• Device Name: TRILOGY 100 VENTILATOR
• Applicant: Respironics Inc., Sleep & Home Respiratory Group
• Product Code: CBK · Anesthesiology
• Decision Date: Mar 13, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Respironics Trilogy100 system provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy100 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. It is not intended to be used as a transport ventilator.

Device Story

Microprocessor-controlled, blower-based ventilator; provides pressure support, pressure control, or volume-controlled ventilation. Inputs include user-defined clinical parameters via interface; device monitors patient-ventilator interaction. Outputs include delivered air/oxygen mixture via invasive (ET tube) or non-invasive (mask) interfaces; real-time pressure display; clinical data storage. Used in home, hospital, and portable settings (wheelchairs/gurneys) by clinicians or patients/caregivers. Alarms alert users to treatment changes. Supports multiple modes: CPAP, S, S/T, T, PC, PC-SIMV, AC, CV, SIMV. Benefits patients by providing necessary respiratory support for those unable to breathe adequately on their own.

Clinical Evidence

Bench testing only. Performance testing conducted per ASTM F1100-90, F1246-91, ISO 10651-2, and ISO 10651-6. EMC testing per IEC 60601-1-2. Electrical, mechanical, and environmental testing performed per FDA Draft Reviewers Guidance (1993). Software validation performed per FDA Guidance (2005). Results confirm design and system requirements met.

Technological Characteristics

Microprocessor-controlled blower-based system. Supports CPAP, S, S/T, T, PC, PC-SIMV, AC, CV, SIMV modes. Features Bi-Flex and AVAPS therapy. Connectivity includes serial interface and remote data access. Powered by electrical source. Designed for invasive/non-invasive use. Complies with ASTM F1100-90, F1246-91, ISO 10651-2/6, and IEC 60601-1-2 standards.

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, institutional, or portable settings. Not for use as a transport ventilator.

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 BiPAP Synchrony with AVAPS (K070328)
• Respironics PLV Continuum P2000 (K022750)
• Pulmonetic LTV-1000 (K984056/K051767)
• Newport Medical HT-50 (K9912133)

Reference Devices

• Respironics BiPAP PLV Continuum (K034032)

Submission Summary (Full Text)

{0}------------------------------------------------

30 November 2008

Official Contact

Date of Submission

Zita A. Yurko Director, Regulatory Affairs Respironics, Inc. 1740 Golden Mile Highway Monroeville, PA 15146 [e-mail]

724-387-4120 t 724-882-4120 c 724-387-7490 f

21 CFR 868.5895

Classification Reference

Product Code

NOU - Continuous Ventilator, Home Use

CBK - Continuous Ventilator, Facility Use

Common/Usual Name Ventilator, continuous, non-life supporting

New Device

Proprietary Name Respironics Trilogy 100 Ventilator Ventilatory Support System

Respironics BiPAP Synchrony with AVAPS (K070328)

Respironics PLV Continuum P2000 (K022750)

Pulmonetic LTV-1000 (K984056/K051767)

Newport Medical HT-50 (K9912133)

Reason for submission

Predicate Device(s)

000017

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# Substantia! Equivalence

The Trilogy 100 Ventilator has the following similarities to the selected cleared predicate devices:

- D Same intended use.
- Same operating principle.
- Same technology. 0
- Same manufacturing process. ם

The modes of ventilation on Trilogy 100 are similar to those on other currently marketed continuous ventilator. Trilogy 100 has similar performance characteristics to the predicate devices, as listed below, as such; the Trilogy 100 ventilator does not raise any new questions of safety or effectiveness,

The following features are either unchanged or similar to the Respironics BiPAP Synchrony with AVAPS (K070328):

- Environment of Use o
- o Physical Characteristics of the Design
- Physical Characteristics of the Manufacturing Process 0
- Physical Characteristics of the Energy Delivered 0
- Physical Characteristics of the Materials o
- Physical Characteristics of the Anatomical Sites O
- Physical Characteristics of the Energy Source ಂ
- Rise Time O
- Ramp 0
- Triggering o
- Pressure Regulation method o
- Alarm/Power Control Indicators o
- Patient Alarms (for Pressure Support modalities) 0
- System Error Alarms (for Pressure Support Modalities) o

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- Tab 5 510(k) summary
- Required Alarms: FDA Reviewers Guidance for Ventilators and ASTM F1100-90 (for MNS class ಿ ventilators)
- Device Settings (Tidal Volume) 0
- Inspiratory Time Setting Method 0
- Rise Time Setting Method ం
- Degree of protection against electric shock 0
- Degree of protection patient applied part o
- Pressure Support Modes of Operation (CPAP, S, S/T, T, PC) o
- Therapy features (Bi-Flex and AVAPS) o

The following features are either unchanged or similar to the Respironics BiPAP PLV Continuum (K034032):

- Patient Population 0
- Environment of Use o
- Product Code 0
- Physical Characteristics of the Design o
- Physical Characteristics of the Manufacturing Process ర
- Physical Characteristics of the Energy Delivered O
- Physical Characteristics of the Materials 0
- o Physical Characteristics of the Anatomical Sites
- Physical Characteristics of the Modem o
- Physical Characteristics of the Energy Source O
- Rise Time 0
- Ramp O
- Triggering 0
- O Pressure Regulation method

{3}------------------------------------------------

- Alarm/Power Control Indicators ರ
- Patient Alarms for CBK devices ಂ
- System Error Alarms for CBK devices o
- Required Alarms: FDA Reviewers Guidance for Ventilators and ASTM F1100-90 (for CBK class 0 ventilators)

- L

- Data Storage o
- Rise Time Setting Method o
- Serial Interface O
- Degree of protection against electric shock 0
- Degree of protection patient applied part o
- Modes of Operation (Positive Pressure Ventilation, Assist Control, Volume Controlled, Pressure o Controlled and Pressure Support)

The following features are either unchanged or similar to the Pulmonetic LTV-1000 (K984056/K051767):

- Patient Population o
- Environment of Use 0
- Product Code o
- Physical Characteristics of the Design o
- Physical Characteristics of the Manufacturing Process 0
- Physical Characteristics of the Energy Delivered o
- Physical Characteristics of the Materials o
- Physical Characteristics of the Anatomical Sites o
- Physical Characteristics of the Modem 0
- Rise Time o
- Ramp 0

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- Tab 5 510(k) summary
- Triggering O
- Pressure Regulation method 0
- Alarm/Power Control Indicators ਼
- Patient Alarms o
- System Error Alarms ు
- Required Alarms: FDA Reviewers Guidance for Ventilators and ASTM F1100-90 (for CBK class 0 ventilators)
- Humidifier o
- Humidifier Interface O
- Remote Data Access ಂ
- Data Storage 0
- User Interface 0
- Real-Time Pressure Display 0
- Device Settings display (Pressure) O
- Device Settings display (Rate) o
- Device Settings (Tidal Volume) 0
- Inspiratory Time Setting Method 0
- Rise Time Setting Method O
- Serial Interface 0
- Degree of protection against electric shock o
- Degree of protection patient applied part o
- Modes of Operation (Positive Pressure Ventilation, Assist/Control, SIMV, CPAP) o

The following features are either unchanged or similar to the Newport Medical HT-50 (K992133):

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### Abbreviated 510(k)

- Patient Population O
- Environment of Use o
- Product Code 0
- Physical Characteristics of the Design O
- Physical Characteristics of the Manufacturing Process o
- Physical Characteristics of the Energy Delivered o
- Physical Characteristics of the Materials o
- Physical Characteristics of the Anatomical Sites 0
- Physical Characteristics of the Modem o
- 0 Physical Characteristics of the Energy Source
- CPAP Pressure Range O
- 0 IPAP Pressure Range
- EPAP Pressure Range o
- Inspiratory Time Range 0
- Rise Time ం
- Ramp ಂ
- Triggering 0
- Pressure Regulation method O
- Alarm/Power Control Indicators o
- Patient Alarms o
- System Error Alarms o
- Required Alarms: FDA Reviewers Guidance for Ventilators and ASTM F1100-90 (for CBK class o ventilators)
- Remote Data Access 0
- Data Storage 0

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- Real-Time Pressure Display o
- Device Settings display (Pressure) o
- Device Settings display (Rate) 0
- Device Settings (Tidal Volume) O
- Inspiratory Time Setting Method O
- Rise Time Setting Method 0
- Serial Interface 0
- Oxygen Safety Valve ಂ
- Degree of protection against electric shock o
- o Degree of protection patient applied part
- Modes of Operation (Positive Pressure ventilation and assist/control, SIMV and CPAP) o

Bench testing has confirmed that the Trilogy 100 Ventilator performs equivalently to the cited device predicates. Performance testing was conducted per the applicable sections of ASTM F1100-90, F1246-91, ISO 10651-2 and ISO 10651-6. EMC testing was performed per IEC 60601-1-2. Electrical, mechanical and environmental testing was performed in accordance with the FDA Draft Reviewers Guidance for Pre-market Notification Submission (1993). Software validation testing was performed per FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices (2005). The results of all testing demonstrate that all design and system requirements for the Trilogy 100 have been met.

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 100 Ventilator to its predicate devices. We conclude that the existing and cleared predicate device indications for use can be safety and effectively applied to the Trilogy 100 ventilator.

## Intended Use

The Respironics Trilogy100 system provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.).

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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. It is not intended to be used as a transport ventilator.

# Device Description

The Respironics Trilogy 100 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, 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 100 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 100 Ventilator can deliver invasive (via ET tube) or non-invasively (via a mask)

(End of Tab.)

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Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 2009

Ms. Zita A. Yurko Respironics, Incorporated Sleep and Home Respiratory Group 1740 Golden Mile Highway Monroeville, Pennsylvania 15146

Re: K083526

> Trade/Device Name: Trilogy 100 Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: February 27, 2009 Received: March 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours

\$\xi\$

Ginette Y. Michaud, M.D. Acting 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):

Trilogy 100 Ventilator Device Name: __

The Respironics Trilogy100 system provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy100 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. It is not intended to be used as a transport ventilator.

Prescription Use Over-The-Counter Use X 1 Teschiption Ose ____________________________________________________________________________________________________________________________________________________________ (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:

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