The Astral 100/150 provides continuous or intermittent ventilatory support for patients weighing more than 5kg (11 lb) who require mechanical ventilation. The Astral device is intended to be used in home, institution/hospital and portable applications for both invasive and non-invasive ventilation.

Device Description

The Astral ventilator system uses a micro-processor controlled blower, which, along with valves and pressure and flow sensors, achieves pressure, flow and time regulation of air delivery. Air is directed to the patient via one of three ventilator breathing circuits; double circuit, single circuit with expiratory valve, or single circuit with intentional leak. Supplemental oxygen can be entrained at the inlet to the main turbine. The device provides both therapeutic and technical alarms, and a user interface allowing adjustment of clinical parameters and display of monitored clinical data. The Astral can use external AC or DC power supply and contains an integrated battery.

The Astral is capable of providing the following types of ventilatory support:

Assist/Control and SIMV with either volume or pressure control
Continuous Spontaneous Ventilation in either Pressure Support or CPAP
Volume Assurance and Apnea Ventilation

AI/ML Overview

Acceptance Criteria and Study for Astral 100/150 Ventilator

The provided documentation details the non-clinical performance evaluation of the Astral 100/150 ventilator to establish its substantial equivalence to predicate devices (Respironics Trilogy 200 and Pulmonetic LTV 1200).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study Confirmation
Accuracy of Ventilation Controls & Monitoring	Accuracy of ventilation volume controls	Met predetermined acceptance criteria	Confirmed by design and verification activities
	Accuracy of ventilation pressure controls	Met predetermined acceptance criteria	Confirmed by design and verification activities
	Accuracy of ventilation volume monitoring	Met predetermined acceptance criteria	Confirmed by design and verification activities
	Accuracy of ventilation pressure monitoring	Met predetermined acceptance criteria	Confirmed by design and verification activities
Waveform Performance	Flow waveforms	Met predetermined acceptance criteria	Confirmed by side-by-side performance testing
	Pressure waveforms	Met predetermined acceptance criteria	Confirmed by side-by-side performance testing
	Volume waveforms	Met predetermined acceptance criteria	Confirmed by side-by-side performance testing
Triggering and Cycling	Accuracy of triggering	Met predetermined acceptance criteria	Confirmed by design and verification activities
	Repeatability of triggering	Met predetermined acceptance criteria	Confirmed by design and verification activities
	Accuracy of cycling	Met predetermined acceptance criteria	Confirmed by design and verification activities
	Repeatability of cycling	Met predetermined acceptance criteria	Confirmed by design and verification activities
Endurance & Environmental Testing	Endurance requirements	Met predetermined acceptance criteria	Confirmed by design and verification activities
	Environmental requirements	Met predetermined acceptance criteria	Confirmed by design and verification activities
Alarms Verification	Alarm functionality	Met predetermined acceptance criteria	Confirmed by design and verification activities
Therapy Mode & Supplementary Feature Performance	Flow, pressure, and volume waveforms for each mode/feature	Met predetermined acceptance criteria (indicated as substantially equivalent to predicates)	Confirmed by side-by-side performance testing for each mode and feature
	Ventilation control parameter accuracy for each mode/feature	Met predetermined acceptance criteria (indicated as substantially equivalent to predicates)	Confirmed by side-by-side performance testing for each mode and feature
	Patient trigger reliability for each mode/feature	Met predetermined acceptance criteria (indicated as substantially equivalent to predicates)	Confirmed by side-by-side performance testing for each mode and feature
	Patient trigger synchrony for each mode/feature	Met predetermined acceptance criteria (indicated as substantially equivalent to predicates)	Confirmed by side-by-side performance testing for each mode and feature

Note: The document states that "All tests confirmed the product met the predetermined acceptance criteria." The specific numerical or qualitative values for these criteria are not provided in this summary but are implied to have been met for substantial equivalence.

2. Sample Size and Data Provenance

Sample Size for Test Set: Not explicitly stated. The document refers to "Design and Verification activities" and "non-clinical side-by-side performance testing" for each therapy mode and supplementary feature. This suggests a comprehensive, but unquantified, series of tests.
Data Provenance: The study was conducted as part of the device's design and verification by ResMed Corp., in San Diego, CA, USA. This indicates the testing was performed internally by the manufacturer, likely in a controlled laboratory environment. The data would be prospective as it was generated specifically for the 510(k) submission to demonstrate compliance.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable as the study was a non-clinical performance evaluation of a medical device (ventilator). Ground truth in this context would refer to the established engineering specifications, performance standards, and the capabilities of the predicate devices, rather than expert interpretation of clinical data. The performance was assessed against these known standards and functional requirements.

4. Adjudication Method for the Test Set

This information is not applicable. As a non-clinical performance study, there would be no human "adjudication" in the sense of resolving disagreements among experts on clinical findings. Performance was assessed against predefined technical specifications and standards using objective measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The document explicitly states: "Clinical testing was not required." The evaluation was entirely non-clinical and focused on device performance against technical standards and comparison to predicate devices, not on human-in-the-loop performance or clinical outcomes.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done in the sense that the device's performance was evaluated independently without human intervention during the technical tests. The "Design and Verification activities" and "non-clinical side-by-side performance testing" assessed the device's inherent mechanical and software-driven functionalities (e.g., accuracy of volume/pressure controls, waveform generation, triggering, alarms). This is implicitly a standalone performance evaluation of the device as an engineered system.

7. Type of Ground Truth Used

The ground truth used was based on established engineering specifications, performance standards, and the known operational characteristics of the predicate devices. The testing confirmed that the Astral device met "predetermined acceptance criteria" and demonstrated "substantially equivalent" performance to the predicates. This encompasses:
- Applicable FDA guidance documents (e.g., Draft Reviewer Guidance for Ventilators, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices).
- International standards (e.g., ASTM F 1246-91, ASTM F 1100-90, ISO 10651-2:2004, IEC 60601-1:2005, IEC 60601-1-2:2007).
- The performance characteristics and range/accuracy of the predicate devices (Respironics Trilogy 200 and Pulmonetic LTV 1200).

8. Sample Size for the Training Set

This information is not applicable. The Astral 100/150 is a medical device (ventilator) that relies on micro-processor controlled mechanics and software for its operation. It is not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "software based pressure, flow and time regulation" is developed through engineering and control system design, not through machine learning from data.

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

This information is not applicable as there was no AI/machine learning training set. The "ground truth" for the device's design and functional parameters would have been established through established engineering principles, physics, medical requirements for ventilation, and regulatory standards.

Summary

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

JUN 0 4 2014

510(k) Summary - Astral

Date prepared

Official contact

Submitter

4 April 2014

Peter Jennings Senior Regulatory Affairs Manager

Jim Cassi V.P., Quality Assurance Americas ResMed Corp. 9001 Spectrum Center Blvd., San Diego CA 92123 USA Tel: +1 858-836-6081 Fax: +1 858-836-5519

Astral 100/150

Continuous ventilator

Proprietary name

Common name

Classification

21 CFR 868.5895 Primary product code CBK Secondary product code NOU Class II Ventilator, continuous, facility use

Respironics Trilogy 200 (K093416) Pulmonetic LTV 1200 (K060647)

Predicate Devices

Reason for submission

New device

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

Intended Use

Device Description

The Astral is capable of providing the following types of ventilatory support:

-Assist/Control and SIMV with either volume or pressure control
. -Continuous Spontaneous Ventilation in either Pressure Support or CPAP
- ー Volume Assurance and Apnea Ventilation

Substantial Equivalence

The Astral has the following similarities to the previously cleared predicate devices:

-Same intended use
Same scientific technology ﺖ
Similar performance specifications -

A comparative summary of the technological characteristics of the Astral device with the primary predicate Trilogy 200 (K093416) is presented below.

Characteristic	Astral (new device)	Trilogy 200 (K093416)	Comparison
Intended Use	Continuous or intermittentventilatory support	Continuous or intermittentventilatory support	Substantially EquivalentIntended use the same aspredicate
	Invasive & non-invasive	Invasive & non-invasive
	Adult and Pediatric (>5kg)	Adult and Pediatric (>5kg)
	Home, institution/hospital, &portable	Home, institution/hospital, &portable
Therapy ModesSupplementaryFeatures	ACVPACVV-SIMVP-SIMVPS & S/TCPAPPACSVSighApnea VentilationManual Breath	CV, ACT & PCSIMVPC-SIMVS, S/T & TCPAPPCAVAPSSighApnea Rate	Substantially EquivalentEquivalent modes can beconfigured to deliver thesame therapy.Apnea Ventilation &Manual Breathsubstantially equivalent toLTV 1200 (K060647)
VentilationControlParameters	Pressure RangeTidal VolumeRespiratory RateRise TimeTimed InspirationSensitivity	Pressure RangeTidal VolumeRespiratory RateRise TimeTimed InspirationSensitivity	Substantially EquivalentAstral provides equivalentrange and equivalent orimproved accuracy to thepredicate device

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

OperatingPrinciple
Technology	Micro-processor controlledblower as air source	Micro-processor controlledblower as air source	Substantially EquivalentSame operating principle
	Software based pressure, flowand time regulation withsecondary volume target	Software based pressure, flowand time regulation withsecondary volume target	Substantially EquivalentSame technology
CircuitInterfaces	Vented & Non-ventedInvasive & Non-invasive	Vented & Non-ventedInvasive & Non-invasive	Substantially Equivalent
Circuit Types	Double limbSingle limb with expiratoryvalveSingle limb with intentionalleak	Active FlowActive PAPPassive	Substantially EquivalentDouble limb (Astral) &Active Flow (Trilogy 200)both measure expiratoryflow. Double limb also onLTV 1200 (K060647)
User Interface	LCD screen, hard keys & LEDindicators	LCD screen, hard keys & LEDindicators	Substantially Equivalent
Power	AC, DC, & Internal battery	AC, DC, & Internal battery	Substantially Equivalent
SystemComponents	VentilatorMask, invasive patientinterfaceAir tubing, air filter, optionalantibacterial filterOptional external humidifier orHME	VentilatorMask, invasive patientinterfaceAir tubing, air filter, optionalantibacterial filterOptional external humidifier orHME	Substantially Equivalent

Non-Clinical Performance Data

Design and Verification activities were performed on the Astral as a result of the risk analysis and product requirements. Testing included accuracy of ventilation volume & pressure controls and monitoring, waveform performance (flow, pressure, volume), accuracy and repeatability of triggering and cycling, endurance and environmental testing, and alarms verification. All tests confirmed the product met the predetermined acceptance criteria. In particular non-clinical side-by-side performance testing was performed for each therapy mode and supplementary feature. Characteristics tested included flow, pressure and volume waveforms, ventilation control parameter accuracy, and patient trigger reliability and synchrony, supporting the claim that the Astral is substantially equivalent to the predicate devices.

The Astral was designed and tested in accordance with the applicable requirements in relevant FDA guidance documents and international standards including:

FDA Draft Reviewer Guidance for Ventilators (July 1995) -
FDA Guidance for the Content of Premarket Submissions for Software Contained in -Medical Devices (May 11, 2005)
ASTM F 1246-91 (2005) Standard Specification for Electrically Powered Home Care -Ventilators
ASTM F 1100-90 (1997) Standard Specification for Ventilators intended for use in -Critical Care
ISO 10651-2:2004. Lung ventilators for medical use Part 2: Home care ventilators for ventilator-dependent patients
-IEC 60601-1:2005 Medical electrical equipment. Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2:2007, Medical electrical equipment Part 1-2: Electromagnetic compatibility - Requirements and tests

Clinical testing was not required.

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

Conclusion

The indications for use, technological characteristics, and principles of operation are similar to the predicate devices. Performance data supports the claim that the new device is as safe and as effective as the predicate devices. Thus the data in this submission supports the claim of substantial equivalence to the identified predicate devices.

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

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WQ66-G609 Silver Spring, MD 20993-0002

June 4, 2014

ResMed Corporation Mr. Jim Cassi V.P. of Quality Assurance Americas 9001 Spectrum Center Blvd. San Diego, CA 92123

Re: K133868

Trade/Device Name: Astral 100/150 Regulation Number: 21 CFR 868.5895 Regulation Name: Ventilator, continuous, facility use Regulatory Class: II Product Code: CBK. NOU Dated: April 4, 2014 Received: April 7, 2014

Dear Mr. Cassi;

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. Iisting 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.

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

Page 2 - Mr. Cassi

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mary STRUNner -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known):

Device Name: Astral 100/150

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use_

(Part 21 CFR 801 Subpart D)

(Part 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)

Image /page/6/Picture/13 description: The image shows the letters "FDA" in a stylized, blocky font. The letters are arranged horizontally, with "F" on the left, "D" in the middle, and "A" on the right. The letters are composed of thick, angular lines, giving them a bold and somewhat abstract appearance. The image is in black and white.

Anya C. Harry -S 2014.06.04 03:21:15 -04'00'

Page __ of _

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).