(118 days)
No
The document describes a microprocessor-controlled ventilator with various modes (CPAP, Bi-level, iVAPS) and a new leak valve. It mentions performance testing and substantial equivalence to a predicate device. There is no mention of AI, ML, or related concepts like training/test sets, image processing, or specific performance metrics typically associated with AI/ML algorithms.
Yes
The device is a ventilator intended to treat respiratory insufficiency or respiratory failure, which are medical conditions that require therapeutic intervention.
No
The device is described as a pressure-controlled ventilator intended to provide ventilation for patients with respiratory insufficiency or failure, not to diagnose a condition.
No
The device description explicitly states it is a "pressure controlled ventilator using a single limb vented circuit" and includes a "microprocessor controlled blower" and a "ResMed Leak Valve," all of which are hardware components.
Based on the provided text, 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 issues. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a pressure-controlled ventilator with different modes (CPAP, Bi-level, iVAPS) and accessories for invasive use. This aligns with a respiratory support device.
- No Mention of In Vitro Activities: There is no mention of analyzing samples (blood, urine, tissue, etc.) or performing tests outside of the body, which are the hallmarks of an IVD.
- Performance Studies: The performance studies focus on the functionality of the ventilator and its components (like the leak valve) in delivering therapy, not on the accuracy of a diagnostic test.
Therefore, the Stellar 150 is a therapeutic medical device for respiratory support, not an IVD.
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
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 (K103167). For both devices as they are substantial equivalent, it is essential that a microprocessor controlled blower generates the required airway pressure. CPAP and Bi-level modes are implemented. With ongoing technological progress, the device is further suitable to include a population above 30 lbs (13 kg) for CPAP and Bilevel modes. The device also includes a volume assured pressure support mode (iVAPS), indicated for patients above 66 lbs (30 kg). The Stellar 150 in combination with the new developed ResMed Leak Valve supports the invasive use therapy. The ResMed Leak Valve incorporates a leak port as well as an integrated anti-asphyxia valve.
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, or mobile (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
Performance testing on the Stellar 150 device was performed and cleared in the previous submission of the Stellar 150 (K103167). Within this submission performance testing on the ResMed Leak Valve was accomplished. The ResMed Leak Valve performance tests comprise functionality tests according to:
- ISO 5356-1 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and o sockets
- ASTM F 1246-91 Specification for Electrically Powered Home Care Ventilators, Part 1 -O Positive-Pressure Ventilators and Ventilator Circuits
In addition to the performance testing of the new ResMed Leak Valve, system verification testing was performed as well as bench testing. The side-by-side testing demonstrated that there is no significant difference in delivering invasive therapy using the new ResMed Leak Valve (leak port with integrated anti-asphyxia valve) and therefore the Stellar 150 is Substantially Equivalent to the predicate device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design and verification activities which were performed on the previously cleared Stellar 150 as a result of the risk analysis and product requirements remain still valid. All tests confirmed the product met the predetermined acceptance criteria.
Performance testing on the Stellar 150 device was performed and cleared in the previous submission of the Stellar 150 (K103167). Within this submission performance testing on the ResMed Leak Valve was accomplished. The ResMed Leak Valve performance tests comprise functionality tests according to:
- ISO 5356-1 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and o sockets
- ASTM F 1246-91 Specification for Electrically Powered Home Care Ventilators, Part 1 -O Positive-Pressure Ventilators and Ventilator Circuits
In addition to the performance testing of the new ResMed Leak Valve, system verification testing was performed as well as bench testing. The side-by-side testing demonstrated that there is no significant difference in delivering invasive therapy using the new ResMed Leak Valve (leak port with integrated anti-asphyxia valve) and therefore the Stellar 150 is Substantially Equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
STELLAR 150 (K103167)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
APR - 5 2012
| Date prepared | February 6, 2012 |
|---|---|
| Submitter | Sandra Grünwald |
| Manager Quality Management & Regulatory Affairs | |
| ResMed Germany, Inc. | |
| Official contact | David D'Cruz |
| V.P., Clinical & Regulatory Affairs | |
| ResMed Corp. | |
| 9001 Spectrum Center Blvd., | |
| San Diego CA 92123 | |
| USA | |
| Tel: +1 858-836-5984 | |
| Fax: +1 858-836-5522 | |
| Proprietary/Trade name | Stellar 150 |
| Common name | Continuous ventilator |
| Classification | 21 CFR 868.5895 |
| Class II | |
| Product code | MNT |
| Ventilator, continuous, minimal ventilatory support, facility use | |
| Predicate Device | STELLAR 150 (K103167) |
| Reason for submission | Change of Indication for Use |
510(k) Summary – Stellar 150
i
1
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.
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 (K103167). For both devices as they are substantial equivalent, it is essential that a microprocessor controlled blower generates the required airway pressure. CPAP and Bi-level modes are implemented. With ongoing technological progress, the device is further suitable to include a population above 30 lbs (13 kg) for CPAP and Bilevel modes. The device also includes a volume assured pressure support mode (iVAPS), indicated for patients above 66 lbs (30 kg). The Stellar 150 in combination with the new developed ResMed Leak Valve supports the invasive use therapy. The ResMed Leak Valve incorporates a leak port as well as an integrated anti-asphyxia valve.
Performance Data
Design and verification activities which were performed on the previously cleared Stellar 150 as a result of the risk analysis and product requirements remain still valid. All tests confirmed the product met the predetermined acceptance criteria.
Performance testing on the Stellar 150 device was performed and cleared in the previous submission of the Stellar 150 (K103167). Within this submission performance testing on the ResMed Leak Valve was accomplished. The ResMed Leak Valve performance tests comprise functionality tests according to:
- ISO 5356-1 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and o sockets
- ASTM F 1246-91 Specification for Electrically Powered Home Care Ventilators, Part 1 -O Positive-Pressure Ventilators and Ventilator Circuits
In addition to the performance testing of the new ResMed Leak Valve, system verification testing was performed as well as bench testing. The side-by-side testing demonstrated that there is no significant difference in delivering invasive therapy using the new ResMed Leak Valve (leak port with integrated anti-asphyxia valve) and therefore the Stellar 150 is Substantially Equivalent to the predicate device.
Substantial Equivalence
The Stellar 150 is substantial equivalent to the previously cleared predicate device Stellar 150 (K103167).
- Similar indication for use A
- Same operating principle A
- A Same technologies
- A Same manufacturing process
The extension of the indication for use can be realized by combining the Stellar 150 with the new developed ResMed Leak Valve. Especially the ResMed Leak Valve with its integrated anti-asphyxia valve (AAV) ensures that safety and effectiveness of the invasive use therapy is not affected adversely. Performance and side-by-side testing demonstrated that there is no significant difference in auversely. Forromanoo and the new ResMed Leak Valve (leak port with integrated anti-asphyxia valve).
2
As the operating principle, the technology and the manufacturing process of the Stellar 150 device are identical to the Stellar 150 (K103167) design and verification activities which were performed on the previously cleared Stellar 150 as a result of the risk analysis and product requirements remain still valid. All tests confirmed the product met the predetermined acceptance criteria.
Thus the Stellar 150 with the modified indication for use is substantial equivalent to the previous cleared Stellar 150 device (K103167).
Conclusion
The indication for use is similar to the predicated device, whereas the technological characteristics, principles of operation and manufacturing process remain unchanged. Performance data of the new ResMed Leak Valve and side-by-side testing demonstrate that the new combination consisting of the ResMed Leak Valve and the Stellar 150 is as safe and effective as the Stellar 150 device (K103167). The Stellar 150 with modified indication for use is therefore substantially equivalent to the Stellar 150 device (K103167).
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ResMed Germany, Inc. C/O Mr. David D'Cruz Vice President, Clinical & Regulatory Affairs ResMed Corporation 9001 Spectrum Center Blvd. San Diego, California 92123
Re: K113640
Trade/Device Name: Stellar 150 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MNT Dated: March 14, 2012 Received: March 19, 2012
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 Eederal Register.
APR - 5 2012
4
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 vou 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 yours,
hh for
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
5
Indications for Use
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 with of milliour. Operation of the device includes both stationary, such as in hospital or home, or mobile, such as wheelchair usage.
| Prescription Use | X | 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 | ||
|---|---|---|---|
| (Division Sign-Off) | |||
| Division of Anesthesiology, General Hospital | |||
| Infection Control, Dental Devices | K113640 | ||
| 510(k) Number: | February 6, 2012 | C89440 | Page 20 |