The Astral 100/150 provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventilation.

The iVAPS mode with optional AutoEPAP is intended for patients weighing more than 66lb (30kg).

The Astral device is intended to be used in home, institution/hospital and portable applications for both invasive and noninvasive 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 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 alarms (e.g. tidal volume) and technical alarms (e.g. system fault), 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

The provided text describes a 510(k) premarket notification for the ResMed Astral 100/150 ventilator, focusing on the addition of an AutoEPAP feature within its iVAPS therapy mode. This submission argues for substantial equivalence to a previously cleared predicate device.

Here's an analysis of the acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a formal table of "acceptance criteria" for the AutoEPAP feature in the same way one might find for diagnostic accuracy (e.g., sensitivity, specificity thresholds). Instead, it discusses the performance in terms of demonstrating non-inferiority to the predicate device's manual EPAP feature.

Feature / Metric	Acceptance Criteria (Implicit)	Reported Device Performance (AutoEPAP vs. Manual EPAP)
Clinical Efficacy	Non-inferiority to manual EPAP in maintaining upper airway patency, as measured by Oxygen Desaturation Index (ODI4%).	The iVAPS with AutoEPAP algorithm was demonstrated to be non-inferior to iVAPS with manual EPAP for ODI4%.
Safety	No serious adverse events or complications related to the study device.	No serious adverse events or complications related to the study device were recorded.
Bench Testing	Met predetermined acceptance criteria for accuracy of ventilation, volume & pressure controls and monitoring, waveform performance, and alarms verification. Characterization of ventilator's response to simulated flow limitations and apneas.	All tests confirmed the product met the predetermined acceptance criteria. Bench testing for AutoEPAP included characterization of the ventilator’s response to a breathing machine that simulates patient flow limitations and apneas.

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

Test Set Sample Size: The exact number of patients in the multi-center clinical trial is not explicitly stated in the provided text.
Data Provenance: The data came from a multi-center, single-blind, randomized, cross-over clinical trial. This indicates a prospective study design. The country of origin is not specified, but the applicant (ResMed Ltd) is based in Australia, and the correspondent is in the USA.

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

The text describes a clinical trial comparing AutoEPAP to manual EPAP. For this type of study involving respiratory support, the "ground truth" isn't typically established by a panel of independent experts reviewing data for diagnostic accuracy. Instead, the ground truth is based on physiological measurements (like ODI4%) and clinical outcomes in patients under observation by medical professionals. The study design (clinical trial) itself serves as the method for assessing efficacy. Therefore, there's no mention of a specific number of experts establishing "ground truth" in the diagnostic sense, nor are their qualifications detailed in this context. Rather, the expertise lies within the medical professionals conducting and overseeing the clinical trial.

4. Adjudication Method for the Test Set

The study was a single-blind, randomized, cross-over clinical trial. In this setup, patients are switched between AutoEPAP and manual EPAP, and their outcomes (e.g., ODI4%) are compared within the same patient. The "adjudication" in this context refers to the assessment of clinical endpoints by the study investigators/medical team, rather than an independent expert review of specific cases for a diagnostic outcome. The text does not elaborate on a specific adjudication committee or process beyond the trial design itself.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. MRMC studies are typically used to evaluate the performance of diagnostic devices or algorithms where multiple readers interpret cases with and without AI assistance. This submission describes a clinical trial evaluating a therapeutic device (a ventilator with a new feature) where the performance is measured by physiological outcomes in patients.

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

Yes, the clinical trial described effectively evaluates the "standalone" performance of the AutoEPAP algorithm in conjunction with the iVAPS mode by comparing it directly to manual EPAP. While "human-in-the-loop" is always present in a therapeutic device setting (clinicians set parameters, monitor patients), the comparison focuses on the automatic adjustment provided by the AutoEPAP algorithm versus a constant manual setting, demonstrating the algorithm's performance in a real-world clinical application. Bench testing also verified the algorithm's response to simulated conditions, which is another form of standalone assessment.

7. The Type of Ground Truth Used

The primary "ground truth" or endpoint used in the clinical study was:

Oxygen Desaturation Index (ODI4%) as a measure of upper airway obstruction.
Safety outcomes (absence of serious adverse events or complications).

These are objective physiological measures and clinical safety data from patients.

8. The Sample Size for the Training Set

The text does not provide information on the sample size for the training set for the AutoEPAP algorithm. Algorithms typically undergo a development and training phase using data, but this submission focuses on the validation of the finalized algorithm through bench and clinical testing.

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

The document does not specify how the ground truth for the training set was established. Given that this is a therapeutic algorithm for a ventilator feature, the training would likely involve:

Physiological models of respiratory mechanics.
Data from patients with respiratory conditions and various levels of upper airway obstruction.
Expert clinical knowledge and engineering principles to develop the algorithm to respond appropriately to changes in flow and apnea events, aiming to maintain optimal EPAP levels.

Summary

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April 26, 2018

ResMed Ltd % Sheila Bruschi Senior Manager, Regulatory Affairs, ResMed Corp Resmed Corp (Registration Number: 3007573469) 9001 Spectrum Center Boulevard San Diego, California 92123

Re: K172875

Trade/Device Name: Astral 100/150 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK, NOU Dated: March 29, 2018 Received: March 30, 2018

Dear Sheila Bruschi:

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.

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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, 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) K172875

Device Name Astral 100/150

Indications for Use (Describe)

The Astral 100/150 provides continuous or intermittent ventilatory support for patients weighing more than 111b (5kg) who require mechanical ventilation.

The iVAPS mode with optional AutoEPAP is intended for patients weighing more than 66lb (30kg).

The Astral device is intended to be used in home, institution/hospital and portable applications for both invasive and noninvasive ventilation.

Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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K172875

510(k) SUMMARY

[As required by 21 CFR 807.92(c)]

April 26, 2018 1. Date prepared

2. Applicant information

Company Name/Owner	ResMed Ltd1 Elizabeth Macarthur DriveBella Vista NSW 2153 Australia
Submitter Name	Peter JenningsSenior Regulatory Affairs ManagerTel: + 61 2 8884 2232Fax: + 61 2 8884 2004peter.jennings@resmed.com.au
Correspondent Details/Official Contact	Miss Sheila BruschiDirector, Regulatory AffairsResMed Corp.9001 Spectrum Center BlvdSan Diego CA 92123 USATel: +1 858 836 5934Fax: +1 858 836 5519

sheila.bruschi@resmed.com

3. Device details and substantial equivalence claim [807.92(a)(3)]

Trade/Device Names Astral 100/150
Device Common Name Continuous ventilator
Regulation Number 21 CFR 868.5895
	Regulation Name Anesthesiology devices, Continuous Ventilator
Requlatory Class Class II
	Product Code Primary product code CBK
	Secondary product code NOU
	Predicate Device ResMed Astral 100/150 (K152068)
	Reference Device ResMed Juno VPAP ST-A (K161492)

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4. Indications For Use

The Astral 100/150 provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventilation.

The iVAPS mode with optional AutoEPAP is intended for patients weighing more than 66lb (30kg).

The Astral device is intended to be used in home, institution/hospital and portable applications for both invasive and non-invasive ventilation.

5. 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 -
-Volume Assurance and Apnea Ventilation

6. Predicate Comparison

The Astral 100/150 has the same intended use and similar indications, technological characteristics, and principles of operation as the previously cleared predicate Astral 100/150 (K152068). The main change to the subject 510(k) is the addition of the optional AutoEPAP feature to the iVAPS therapy mode. The purpose of EPAP (Expiratory Positive Airway Pressure) is to maintain upper airway patency. The iVAPS mode in the predicate device includes an EPAP feature which is a manually titrated fixed EPAP. The optional AutoEPAP feature automatically adjusts the EPAP pressure in response to flow limitation (partial obstruction of the upper airway) or apnea (complete obstruction of the upper airway), within pre-set limits determined by the prescribing physician. Whether EPAP is set to manual or automatic, the operating range of EPAP is the same, and the therapeutic effect is the same, i.e. maintenance of an open upper airway. The AutoEPAP feature has been previously cleared on the reference device Juno VPAP ST-A (K161492). The AutoEPAP feature is not intended for invasive use. Other technological differences between the subject device and the predicate device are:

1. Extending the Safety Volume supplementary feature to leak circuits (cleared in K152068 on valved circuits)
Duplication of ST mode as PS mode (with leak circuit) to enable clinician preference on 2) PEEP/EPAP terminology

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7. Non Clinical data

Design and Verification activities were performed on the Astral as a result of the risk analysis and product requirements. Performance testing included:

accuracy of ventilation,
volume & pressure controls and monitoring, -
waveform performance (flow, pressure, volume),
alarms verification. -

All tests confirmed the product met the predetermined acceptance criteria. In particular bench testing for the AutoEPAP feature included characterization of the ventilator's response to a breathing machine that simulates patients flow limitations and apneas.

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

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FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical -Devices (May 11, 2005)
-ISO 80601-2-72:2015, Medical Electrical Equipment – Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
IEC 60601-1:2005+AMD1:2012, Medical electrical equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014, Medical electrical equipment Part 1-2: Electromagnetic compatibility -- Requirements and tests

8. Clinical data

Clinical trial data is provided to demonstrate that the AutoEPAP algorithm performed as expected in maintaining upper airway patency in patients with respiratory failure or respiratory insufficiency. The data relates to a multi-center, single-blind, randomized, cross-over clinical trial comparing AutoEPAP algorithm in iVAPS therapy mode with manual EPAP titration in iVAPS therapy mode.

The trial demonstrated that for the primary outcome Oxygen Desaturation Index (ODI4%) as a measure of upper airway obstruction, the iVAPS with AutoEPAP algorithm is non-inferior to iVAPS with manual EPAP.

No serious adverse events or complications related to the study device were recorded.

9. Substantial Equivalence Conclusion

The indications for use, technological characteristics, and principles of operation are similar to the predicate device. Clinical data and non-clinical performance data supports that the subject device is substantially equivalent to the predicate device.

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).

Characteristic	Predicate Device:Astral 100/150(K152068)	Subject Device:Astral 100/150	SubstantiallyEquivalent?
Product code	CBK, NOU	CBK, NOU	YES
Intended Use	Continuous or intermittentventilatory supportInvasive & non-invasiveAdult and Pediatric (>5kg)Home, institution/hospital, &portable	Continuous or intermittentventilatory supportInvasive & non-invasiveAdult and Pediatric (>5kg)Home, institution/hospital, &portable	YES
Intended PatientPopulation	Patients who require mechanicalventilation (Continuous orintermittent ventilatory support)Adult and Pediatric (>5kg),iVAPS (>30kg)	Patients who require mechanicalventilation (Continuous orintermittent ventilatory support)Adult and Pediatric (>5kg),iVAPS (>30kg)	YES
Therapies
Modes	ACVPACVV-SIMVP-SIMVPS & STCPAPPACiVAPS (fixed manual EPAP)	ACVPACVV-SIMVP-SIMVPS & STCPAPPACiVAPS (optional AutoEPAP)	YESClinical and bench data forAutoEPAP on the subjectAstral device demonstrate itis substantially equivalent tomanual EPAP.Moreover, AutoEPAP iniVAPS mode has beencleared in the referencedevice K161492.PS & ST with intentional leakhave the same functionalityand clinical intent.
SupplementaryTherapyFeatures	SV (Safety Volume)SighApnea VentilationManual Breath	SV (Safety Volume)SighApnea VentilationManual Breath	YESSV on therapy modes withleak circuits has the sameclinical intent and functionalimplementation as SV onequivalent therapy modeswith valved circuits.
Ventilation Control Parameters
Pressure Range[cmH2O]	IPAP: 4-50EPAP: 2-25 sCPAP: 3-20PEEP: Off, 3 to 20Accuracy: ±(0.5 + 5% of target)	IPAP: 4-50EPAP: 2-25 sCPAP: 3-20PEEP: Off, 3 to 20Accuracy: ±(0.5 + 5% of target)	YES
Tidal Volume[mL]	100-2500 (adult)50-500 (pediatric)Accuracy ± 12 ml or 10%whichever is greater. (ValvedCircuits)	100-2500 (adult)50-500 (pediatric)Accuracy ± 12 ml or 10%whichever is greater. (ValvedCircuits)	YES
RespiratoryRate(BreathingFrequency)[bpm]	2-50 (adult)5-80 (pediatric)Accuracy ±2%	2-50 (adult)5-80 (pediatric)Accuracy ±2%	YES
Characteristic	Predicate Device:Astral 100/150(K152068)	Subject Device:Astral 100/150	SubstantiallyEquivalent?
Rise Time	Min-900 msec	Min-900 msec	YES
TimedInspiration	0.2 to 5 seconds	0.2 to 5 seconds	YES
Sensitivity	Accuracy ±(20 ms +5% ofsetting)	Accuracy ±(20 ms +5% ofsetting)
Sensitivity	InspiratoryFlow controlled0.5 to 15l/min	InspiratoryFlow controlled0.5 to 15l/min	YES
Technology & Design
OperatingPrinciple	Micro-processor controlledblower as air source	Micro-processor controlledblower as air source	YES
Technology	Software based pressure, flowand time regulation withsecondary volume target	Software based pressure, flowand time regulation withsecondary volume target	YES
Material contactstatus	Permanent contact duration,indirect dry airpathpatientcontacting materials	Permanent contact duration,indirect dry airpathpatientcontacting materials	YES
CircuitInterfaces	Vented & Non-ventedInvasive & Non-invasive	Vented & Non-ventedInvasive & Non-invasive	YES
Circuit Types	Double limbSingle limb with expiratory valveSingle limb with intentional leak	Double limbSingle limb with expiratory valveSingle limb with intentional leak	YES
User Interface	LCD screen, soft keys, mutebutton & LED indicators.	LCD screen, soft keys, mutebutton & LED indicators.	YES
SystemComponents	Ventilator	Ventilator	YES
	Mask, invasive patient interface	Mask, invasive patient interface
	Air tubing, air filter, optionalantibacterial filter	Air tubing, air filter, optionalantibacterial filter
	Optional humidifier/ HME,oximeter, nebuliser	Optional humidifier/ HME,oximeter, nebuliser
Power	AC, DC and Internal Battery	AC, DC and Internal Battery	YES
SupplementalOxygen	Labeled for use withsupplemental oxygen	Labeled for use withsupplemental oxygen	YES