The Stellar 150 is intended to provide ventilation for non-dependent, spontaneously breathing adult and pediatric patients (30 lb / 13kg and above) with respiratory insufficiency or respiratory failure, with or without obstructive sleep apnea. The device is for non-invasive use, or invasive use with an uncuffed or deflated tracheostomy. Operation of the device includes both stationary, such as in hospital or home, or mobile, such as wheelchair usage.

Device Description

The Stellar 150 is a pressure controlled ventilator using a single limb vented circuit, product code MNT. A microprocessor controlled blower generates the required airway pressure between 3-40 cm H2O. Comparing to previous ResMed devices, CPAP and Bi-level modes are implemented as in VPAP III ST-A / Kidsta mask system, which is indicated for patients above 40 lb (18 kg). With ongoing technological progress, the new device is further suitable to include a population above 30 lb (13 kg) for CPAP and Bilevel modes, which is comparable to Draeger Carina Home. The new device also includes a volume assured pressure support mode, indicated for patients above 66 lb (30 kg), which is substantially equivalent to Breas Vivo 40.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Stellar 150 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of specific numerical acceptance criteria with corresponding performance data for the Stellar 150. Instead, it states that "All tests confirmed the predetermined acceptance criteria." The performance is described in terms of compliance with established standards and substantial equivalence to predicate devices.

Acceptance Criteria Category	Description of Performance / Compliance
General Safety and Performance	- Tested to appropriate ISO and IEC standards and other applicable requirements, passing all test protocols. - Complies with IEC 60601-1:1988 (and its amendments) and IEC 60601-1-2:2007. - Complies with ISO 10651-6:2004. - Complies with FDA guidance documents: "Draft Reviewer Guidance for Ventilators (July 1995)" and "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)".
Risk Analysis Outcomes	- Design and Verification activities performed as a result of risk analysis. - All tests confirmed predetermined acceptance criteria (implying risks were mitigated and performance met safety thresholds).
Pressure Performance	- Performance testing comprises pressure performance. - Microprocessor controlled blower generates required airway pressure between 3-40 cm H2O.
Trigger and Cycling	- Performance testing comprises trigger and cycling.
Volume Assured Pressure Support Ventilation	- Performance testing comprises volume assured pressure support ventilation.
Substantial Equivalence	- Side-by-side testing demonstrated substantial equivalence to predicate devices (BREAS VIVO 40 SYSTEM, ResMed VPAP III ST-A/KIDSTA MASK SYSTEM, Draeger Carina Home) in terms of: - Same intended use - Same operating principle - Similar technologies - Same manufacturing process
Indication Expansion (CPAP/Bi-level)	- New device further suitable for patients above 30 lb (13 kg) for CPAP and Bi-level modes, comparable to Draeger Carina Home.
Indication (Volume Assured Pressure Support)	- New device includes a volume assured pressure support mode for patients above 66 lb (30 kg), substantially equivalent to Breas Vivo 40.

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

The document does not specify a "test set" in the context of clinical data or a specific cohort of patients for testing. The performance data described refers to engineering verification and validation activities conducted on the device itself.

Sample Size: Not applicable/not specified for a clinical test set. The testing refers to device units.
Data Provenance: Not applicable/not specified in terms of patient data. The provenance is from internal design, verification, and validation activities.

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

This information is not provided in the document. The study described is not a clinical study involving expert ground truth for patient outcomes.

4. Adjudication Method for the Test Set

This information is not provided in the document, as it does not describe a clinical study requiring adjudication of patient cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No MRMC comparative effectiveness study is mentioned in the document. The study described focuses on technical performance and substantial equivalence to predicate devices, not on human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device itself is a continuous ventilator, not explicitly an "algorithm" in the sense of an AI diagnostic tool. The performance described is inherent to the device's operation. Therefore, a standalone algorithm performance study is not directly applicable or described. The performance data reflects the device operating as intended without human intervention in its core functions (like pressure generation, trigger, and cycling).

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

Engineering Specifications and Design Requirements: The device was designed and tested against predetermined acceptance criteria derived from risk analysis and product design requirements.
International Standards (ISO, IEC): Compliance with these standards serves as a benchmark for safety and performance.
FDA Guidance Documents: Adherence to FDA guidelines is a form of regulatory "ground truth" for manufacturing and submission.
Predicate Device Performance: Substantial equivalence claims are based on comparing the Stellar 150's performance and characteristics to those of legally marketed predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. The Stellar 150 is a hardware-based medical device with microprocessor control, not an AI/ML algorithm that requires a "training set" of data in the typical sense. Its control logic and parameters are developed through engineering design and testing, not statistical learning from a large dataset.

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

This question is not applicable for the reasons stated in point 8.

Summary

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10316 MAR - 1 2011

510(k) Summary - Stellar 150

Date prepared	February 15, 2011
Submitter	Sandra Grünwald
Official contact	David D'CruzV.P., Clinical & Regulatory AffairsResMed Corp.9001 Spectrum Center Blvd.,San Diego CA 92123USATel: +1 858-836-5984Fax: +1 858-836-5522
Proprietary/Trade name	Stellar 150
Common name	Continuous ventilator
Classification	21 CFR 868.5895Class II
Product code	73 MNT
Predicate Devices	BREAS VIVO 40 SYSTEM (K090113)ResMed VPAP III ST-A/KIDSTA MASK SYSTEM (K060105)Draeger Carina Home (K060705).

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Indications for Use

Device Description

Performance Data

Design and Verification activities were performed on the Stellar 150 as a result of the risk analysis and product design requirements. All tests confirmed the predetermined acceptance criteria. Performance testing comprises pressure performance, trigger and cycling, as well as volume assured pressure support ventilation. In addition to system verification testing was performed using common protocols for Stellar 150 and the predicate device. The side-by-side testing demonstrated that the Stellar 150 is Substantially Equivalent to the predicate devices

This device has been tested to appropriate ISO and IEC standards and other applicable requirements passing all test protocols. The Stellar 150 was designed and tested according to:

. IEC 60601-1:1988. Medical electrical equipment - Part 1: General requirements for basic safety and essential performance and its Amendments A1:1991 and A2:1995
IEC 60601-1-2:2007, Medical electrical equipment -- Part 1-2: General requirements for basic . safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
ISO 10651-6:2004, Lung ventilators for medical use Particular requirements for basic safety and . essential performance. Part 6: Home care ventilatory support devices.

The new device complies with the applicable requirements referenced in the FDA quidance documents:

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)

Substantial Equivalence

The new device has the following similarities to the previously cleared predicate devices.

. Same intended use
Same operating principle .
Similar technologies .
Same manufacturing process .

Breas Vivo 40 is the principal predicate for the new therapy options and MNT classification. In particular this comprises volume assured pressure support ventilation for patients above 66 lb (30 kg), treatment of

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respiratory failure for non-dependent spontaneously breathing patients, non-invasive and invasive applications in hospital or home environments. Further the new device is substantially equivalent to the VPAP III ST-A / Kidsta Mask System, when looking at CPAP and Bi-level pressure support ventilation including pediatric patients above 40 lb (18 kg). Finally for CPAP and Bi-level modes the extension to patients above 30 lb (13 kg) is comparable to Draeger Carina Home.

Conclusion

The indications for use, technological characteristics, and principles of operation are similar to the predicate devices. Performance data demonstrate that the new device is as safe and effective as the predicate devices. Thus the Stellar 150 is substantially equivalent to BREAS VIVO 40 SYSTEM (K090113), ResMed VPAP III ST-A/KIDSTA MASK SYSTEM (K060105) and Draeger Carina Home (K060705).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. David D'Cruz Vice President, Clinical & Regulatory Affairs ResMed Corporation 9001 Spectrum Center Boulevard San Diego, California 92123

Re: K103167

MAR - 1 2011

Trade/Device Name: Stellar 150 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MNT Dated: February 15, 2011 Received: February 18, 2011

Dear Mr. D'Cruz:

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- Mr. D'Cruz

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Anthony D. Winton

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): K103167

Device Name:

Stellar 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)

L Schultheis
Page of

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

510(k) Number:

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).