STELLAR 150
Device Facts
| Record ID | K103167 |
|---|---|
| Device Name | STELLAR 150 |
| Applicant | Resmed Germany, Inc. |
| Product Code | MNT · Anesthesiology |
| Decision Date | Mar 1, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5895 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
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 Story
Stellar 150 is a pressure-controlled ventilator; uses single-limb vented circuit. Microprocessor-controlled blower generates airway pressure (3-40 cm H2O). Modes include CPAP, Bi-level, and volume-assured pressure support. Used in hospital, home, or mobile (wheelchair) environments; operated by clinicians or patients. Provides respiratory support for patients with insufficiency or failure. Healthcare providers use device output to manage ventilation therapy; benefits include improved respiratory function and patient mobility. Device design incorporates pressure performance, trigger, and cycling monitoring.
Clinical Evidence
Bench testing only. Performance testing included pressure performance, trigger and cycling, and volume-assured pressure support ventilation. Side-by-side testing with predicate devices confirmed predetermined acceptance criteria. Device complies with IEC 60601-1, IEC 60601-1-2, and ISO 10651-6 standards.
Technological Characteristics
Pressure-controlled ventilator; single-limb vented circuit. Microprocessor-controlled blower; pressure range 3-40 cm H2O. Stationary and mobile form factor. Complies with IEC 60601-1, IEC 60601-1-2, and ISO 10651-6. Software-controlled ventilation modes (CPAP, Bi-level, volume-assured pressure support).
Indications for Use
Indicated for non-dependent, spontaneously breathing adult and pediatric patients (≥13 kg) with respiratory insufficiency or failure, with or without obstructive sleep apnea. For non-invasive or invasive (uncuffed/deflated tracheostomy) use in hospital, home, or mobile settings.
Regulatory Classification
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.
Predicate Devices
- BREAS VIVO 40 SYSTEM (K090113)
- ResMed VPAP III ST-A/KIDSTA MASK SYSTEM (K060105)
- Draeger Carina Home (K060705)
Submission Summary (Full Text)
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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'Cruz<br>V.P., Clinical & Regulatory Affairs<br>ResMed Corp.<br>9001 Spectrum Center Blvd.,<br>San Diego CA 92123<br>USA<br>Tel: +1 858-836-5984<br>Fax: +1 858-836-5522 |
| Proprietary/Trade name | Stellar 150 |
| Common name | Continuous ventilator |
| Classification | 21 CFR 868.5895<br>Class II |
| Product code | 73 MNT |
| Predicate Devices | BREAS VIVO 40 SYSTEM (K090113)<br>ResMed VPAP III ST-A/KIDSTA MASK SYSTEM (K060105)<br>Draeger Carina Home (K060705). |
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#### Indications for Use
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.
#### 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:
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.
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:
