(285 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard ventilator technology and a new remote alarm accessory.
Yes
The device is a ventilator, used to provide ventilation for patients with respiratory insufficiency or failure, which are conditions that require therapeutic intervention.
No
The device is described as a ventilator intended to provide ventilation for patients with respiratory insufficiency or failure, not to diagnose a condition.
No
The device description explicitly states it contains a "microprocessor controlled blower" and requires "an additional connector on the back of the device as well as electronics and software support". This indicates the device is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for providing ventilation to patients with respiratory insufficiency or failure. This is a therapeutic and life-support function, not a diagnostic one.
- Device Description: The description details a pressure-controlled ventilator with different modes of operation (CPAP, Bi-level, iVAPS). These are all related to delivering air pressure to the patient's airways, not analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
The device is a medical device, specifically a ventilator, used for respiratory support.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MNT
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].
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients (30 lb / 13 kg and above)
Intended User / Care Setting
Home, hospital, mobile (e.g., wheelchair usage)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 60601-1-2:200, etc. was performed and shows that the device is substantially equivalent to the predicate device (K113640).
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Stellar 150 (K113640), Respironics Trilogy series Remote Alarm (K111610)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 Cassi
Vice President, Quality Assurance Americas
ResMed Corp.
9001 Spectrum Center Blvd.,
San Diego CA 92123
USA
Tel: +1 858-836-6081
Fax: +1 858-836-5522 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary name | Stellar 150 |
| Common name | Continuous ventilator |
| Classification | 21 CFR 868.5895
Product code MNT
Ventilator, continuous, minimal ventilatory support, facility use |
| Predicate Devices | Stellar 150 (K113640)
Respironics Trilogy series Remote Alarm (K111610) |
| Reason for submission | New Remote Alarm accessory |
1
Intended Use
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].
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).
2
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).
3
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.
4
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
5
RESMED
Indications for Use
1122715 510(k) Number (if known):
Device Name:
Stellar 150
Indications for Use:
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.
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