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 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)

AI/ML Overview

The provided text is a 510(k) premarket notification for the Respironics Trilogy 100 Ventilator. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials to establish new acceptance criteria and prove performance against those criteria. Therefore, the document does not contain the detailed information typically found in a study designed to establish and meet novel acceptance criteria for a new device.

However, based on the information provided, I can infer the "acceptance criteria" as demonstrating substantial equivalence to predicate devices, and the "study" proving this as the compilation of technical characteristics and bench testing results comparing the Trilogy 100 to its predicates.

Here's a breakdown of the available information, addressing as many of your points as possible:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance (as described in the submission)
Same intended use as predicate devices	"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." (Matches predicate's intended use).
Same operating principle as predicate devices	"Same operating principle."
Same technology as predicate devices	"Same technology."
Same manufacturing process as predicate devices	"Same manufacturing process."
Similar modes of ventilation as predicate devices	"The modes of ventilation on Trilogy 100 are similar to those on other currently marketed continuous ventilator." Specific modes listed include CPAP, S, S/T, T, PC, PC-SIMV, AC, CV, SIMV.
Similar performance characteristics to predicate devices (e.g., Rise Time, Ramp, Triggering, Pressure Regulation, Alarms)	"Trilogy 100 has similar performance characteristics to the predicate devices, as listed below..." The document details numerous features that are "either unchanged or similar" to the specific predicate devices (Respironics BiPAP Synchrony with AVAPS, Respironics BiPAP PLV Continuum, Pulmonetic LTV-1000, Newport Medical HT-50). These include: - Environment of Use - Physical Characteristics of Design, Manufacturing, Energy Delivery, Materials, Anatomical Sites, Energy Source - Rise Time, Ramp, Triggering, Pressure Regulation method - Alarm/Power Control Indicators, Patient Alarms, System Error Alarms - Device Settings (Tidal Volume, Pressure, Rate), Inspiratory Time Setting, Rise Time Setting - Protection against electric shock and patient applied part - Therapy features (Bi-Flex and AVAPS, where applicable to specific predicates) - Data Storage, Serial Interface, User Interface, Real-Time Pressure Display, Humidifier, Oxygen Safety Valve, Modem
Compliance with specific standards (ASTM F1100-90, F1246-91, ISO 10651-2, ISO 10651-6, IEC 60601-1-2) and FDA guidance documents.	"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."

Detailed Study Information (as much as can be inferred from the document):

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a "sample size" in the context of patient data. The "test set" here refers to the extensive bench testing and engineering verification and validation activities. The document implies a comprehensive set of tests covering various performance parameters and safety aspects according to industry standards.
- Data Provenance: The nature of the testing (bench testing, EMC testing, electrical, mechanical, environmental testing, software validation) suggests the data was generated in a controlled laboratory environment. No country of origin for specific data is mentioned beyond Respironics, Inc. being in Monroeville, PA, USA. The testing is prospective in the sense that it was performed specifically for this submission to verify the device's design and performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the sense of medical experts establishing "ground truth" for patient data. The "ground truth" for this type of submission is defined by the technical specifications and performance requirements derived from predicate devices and applicable standards. The "experts" involved would be the engineers, quality assurance personnel, and regulatory affairs specialists at Respironics responsible for designing, testing, and documenting the device's compliance. Their qualifications are not detailed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is not a study involving human interpretation of medical data. Performance was measured against predefined technical specifications and standards, likely through automated or manual measurements by testing engineers.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done. This device is a ventilator, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not an AI algorithm. The device itself (the ventilator) underwent standalone performance testing. The detailed bench testing and compliance with standards are the standalone performance evaluation of the device's functions.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this 510(k) submission, the "ground truth" is primarily based on:
  - Standard Specifications: Requirements outlined in ASTM F1100-90, F1246-91, ISO 10651-2, ISO 10651-6, IEC 60601-1-2.
  - Predicate Device Performance: Documented performance characteristics and safety profiles of the legally marketed predicate devices.
  - FDA Guidance Documents: Benchmarking against relevant FDA guidance for ventilators and software.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI algorithm where a "training set" (implying data used to teach an algorithm) is relevant. The "design phase" and prior knowledge from predicate devices inform the design of the Trilogy 100.
How the ground truth for the training set was established:
- Not applicable for the reason stated above.

Summary

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

30 November 2008

Official Contact

Date of Submission

Zita A. Yurko Director, Regulatory Affairs Respironics, Inc. 1740 Golden Mile Highway Monroeville, PA 15146 Zita.yurko@respironics.com

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

{1}------------------------------------------------

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

{2}------------------------------------------------

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

{4}------------------------------------------------

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):

{5}------------------------------------------------

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

{6}------------------------------------------------

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

{7}------------------------------------------------

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
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.)

{8}------------------------------------------------

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.

{9}------------------------------------------------

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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

{10}------------------------------------------------

Indications for Use

510(k) Number (if known):

Trilogy 100 Ventilator Device Name: __

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)

Sine Page

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

510(k) Number:

Page) 0 0 0 1 6

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).