The device is intended to provide ventilation for non-dependent, spontaneously breathing adult and pediatric patients (30 lb / 13 kg 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 the use of the ResMed Leak Valve). 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, and is substantially equivalent to the already marketed Stellar 150 device (K113640). The device contains a microprocessor controlled blower that generates the required airway pressure. CPAP and Bi-level modes are implemented and the device is suitable for patients weighing above 30 lbs (13 kg) for CPAP and Bi-level modes. The device also includes a volume assured pressure support mode (iVAPS), indicated for patients above 66 lbs (30 kg).

This submission updates the Stellar 150 to include a new Remote Alarm (optional) accessory. The Remote Alarm generates an audible and visual signal when an alarm is triggered on the ventilator. For the connection of this new Remote Alarm, the Stellar 150 requires an additional connector on the back of the device as well as electronics and software support for this additional port. This new Remote Alarm triggers this 510[k].

AI/ML Overview

This is a 510(k) premarket notification for a minor modification (addition of a remote alarm accessory) to an existing medical device, the Stellar 150 ventilator. The submission primarily relies on demonstrating substantial equivalence to predicate devices rather than conducting extensive new clinical studies to establish novel performance metrics. As a result, many of the requested elements for a study proving device acceptance criteria in a typical AI/diagnostic device context are not directly applicable or explicitly detailed in this document.

However, I can extract and infer information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For the Stellar 150 ventilator itself, the acceptance criteria are implicitly that it performs as well as the prior cleared Stellar 150 (K113640) and meets applicable standards. For the new Remote Alarm accessory and its integration, the acceptance criteria are implicitly that it performs as well as the predicate Respironics Trilogy series Remote Alarm (K111610) and functions correctly with the Stellar 150. Specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) are not presented as this is not a diagnostic device and the submission focuses on safety and performance equivalence.

Feature/Component	Acceptance Criteria (Implicit)	Reported Device Performance (Implicit)
Stellar 150	Maintain existing performance, safety, and operational characteristics of the predicate Stellar 150 (K113640) after minor modifications.	- "Stellar 150 remains unchanged from the predicate Stellar 150 (K113640) in terms of technology as well as in terms of the operation modes." - "Design and system verification testing in regards to mechanical and environmental testing according to IEC 60601-1-11:2010, electrical safety testing according to IEC 60601-1:2005, EMC testing according to IEC 60601-1-2:200, etc. was performed." - "A regression analysis identified the features which were changed and which test cases needed to be repeated. End-to-end testing on the appropriate test cases has been performed." - "The tests as well as the existing data from the K113640 submission, demonstrate that the Stellar 150 meets the predetermined acceptance criteria and is substantially equivalent to the predicate device (K113640)."
Remote Alarm	Perform comparably to the Respironics Trilogy series Remote Alarm (K111610). Interoperate safely and effectively with the Stellar 150.	- "The Remote Alarm was compared to the Respironics Trilogy series Remote Alarm (K111610). The result of this comparison is that the Remote Alarm is substantially equivalent to the Trilogy Remote Alarm (K111610)." - "The compatibility of Stellar 150 with the Remote Alarm was tested and confirmed." - "In addition verification testing for the Remote Alarm was performed and demonstrated that it met the predetermined acceptance criteria."

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

The document does not specify a "sample size" in terms of patient data for a test set. This submission relies on engineering verification and validation testing (e.g., mechanical, electrical safety, EMC, software regression testing) rather than a clinical study with patient data. Therefore, the concept of data provenance (country of origin, retrospective/prospective) related to patient data is not applicable here.

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

Not applicable. Ground truth in the context of this submission would refer to the expected performance of the device under various engineering tests, which is established by engineering specifications, regulatory standards (like IEC 60601-1), and comparison to predicate device performance, not by expert consensus on clinical cases.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a human adjudication process for interpreting test results. Device performance is determined by meeting pre-defined engineering and regulatory standards during verification and validation testing.

5. 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

Not applicable. This is not an AI-assisted diagnostic or imaging device, and no MRMC study was performed.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The Stellar 150 is a medical device, not an algorithm in the AI sense. Performance testing was done on the device (and its new accessory) as a standalone system to ensure it met its specifications and regulatory standards. The "standalone" performance here refers to the device itself operating as intended, independent of direct interaction during the test, but it's not "algorithm-only" performance as one might see in AI/ML submissions.

7. The Type of Ground Truth Used

The "ground truth" for this type of submission is established through:

Engineering specifications and design requirements: Derived from the predicate device and relevant standards.
Regulatory standards: Such as IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11.
Performance of the predicate devices: The Stellar 150 (K113640) for the main device and the Respironics Trilogy series Remote Alarm (K111610) for the new accessory.
Functional tests: Ensuring the device and accessory perform their intended functions (e.g., alarm triggers correctly, connectivity works).

There is no mention of pathology, expert consensus on clinical cases, or outcomes data as the primary ground truth for this technical verification and validation.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a "training set."

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

Not applicable, as no training set was used.

Summary

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Stellar 150 Traditional 510(k) Premarket Notification

JUN 1 7 2013

510(k) Summary - Stellar 150

Date prepared

Submitter

August 31, 2012

Sandra Grünwald Director Quality Management and Regulatory Affairs ResMed Germany Inc. Fraunhoferstr. 16 82152 Martinsried Germany Tel: +49 89 9901 -1561 Fax: +49 89 9901 -1441

Official contact	Jim CassiVice President, Quality Assurance AmericasResMed Corp.9001 Spectrum Center Blvd.,San Diego CA 92123USATel: +1 858-836-6081Fax: +1 858-836-5522
Proprietary name	Stellar 150
Common name	Continuous ventilator
Classification	21 CFR 868.5895Product code MNTVentilator, continuous, minimal ventilatory support, facility use
Predicate Devices	Stellar 150 (K113640)Respironics Trilogy series Remote Alarm (K111610)
Reason for submission	New Remote Alarm accessory

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Intended Use

Device Description

Performance Data

The Stellar 150 remains unchanged from the predicate Stellar 150 (K113640) in terms of technology as well as in terms of the operation modes. Design and system verification testing in regards to mechanical and environmental testing according to IEC 60601-1-11:2010, electrical safety testing according to IEC 60601-1:2005, EMC testing according to IEC 60601-1-2:200, etc. was performed and shows that the device is substantially equivalent to the predicate device (K113640).

A rearession analysis identified the features which were changed and which test cases needed to be repeated. End-to-end testing on the appropriate test cases has been performed. The rests as well as the existing data from the K113640 submission, demonstrate that the Stellar 150 meets the predetermined acceptance criteria and is substantially equivalent to the predicate device (K113640).

The Remote Alarm was compared to the Respironics Trilogy series Remote Alarm (K111610). The result of this comparison is that the Remote Alarm is substantially equivalent to the Trilogy Remote Alarm (K111610).

The compatibility of Stellar 150 with the Remote Alarm was tested and confirmed. In addition verification testing for the Remote Alarm was performed and demonstrated that it met the predetermined acceptance criteria.

Substantial Equivalence

The Stellar 150 is substantially equivalent to the previously cleared predicate device Stellar 150 (K113640).

· Same indication for use
Same operating principle s
A Same technologies
Similar manufacturing process A

The new optional Stellar accessory, the Remote Alarm, is substantially equivalent to the Remote Alarm of the Respironics Trilogy series in terms of operating principle and technology. (K111610).

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Conclusion

The indications for use, technological characteristics, and principles of operation are similar to the predicate devices. Performance data demonstrate that the new device Stellar 150 is substantially equivalent to our predicate device Stellar 150 (K113640) and the Remote Alarm is substantially equivalent to the Respironics Trilogy series Remote Alarm (K111610).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 17, 2013

ResMed Germany, Inc. Mr. Jim Cassi Vice President, Quality Assurance Americas ResMed Corporation 9001 Spectrum Center Boulevard SAN DIEGO CA 92123

Re: K122715

Trade/Device Name: Stellar 150 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MNT Dated: June 4, 2013 Received: June 6, 2013

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-todevices 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. Ilsting 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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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 devicerelated 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 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/Resourcesfor You/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.

Image /page/4/Picture/7 description: The image shows a letter closing with the phrase "Sincerely yours,". Below the closing is a signature and the name "Tejashri Purohit-Sheth, M.D.". The text "Clinical Deputy Director DAGRID" is also present. The word "FOR" is located at the bottom right of the image.

Kwame Ulmer, M.S. Acting Division 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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RESMED

Indications for Use

1122715 510(k) Number (if known):

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)

Page 1 of 1

Anya C.
Harry FIL
Digitally signed by Anya C. Harry
DN:C=US, O=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=Anya C. Harry,
0.9.2342.19200300.100.1.1=0011315590
Date: 2013.06.13 09:01:05 -04'00'

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

510(k) Number: K122715

August 31, 2012

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).