(114 days)
Not Found
No
The summary describes a medical device for delivering nitric oxide and monitoring gas levels, focusing on hardware and software for control and safety. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as a delivery system for INOmax (nitric oxide for inhalation) therapy gas, indicating its role in providing therapy to patients.
No
The device is described as a delivery system for therapeutic gas (nitric oxide) and includes monitoring of O2, NO2, and NO levels during delivery, which are functional aspects of managing the therapy rather than diagnosing a patient's condition.
No
The device description explicitly details hardware components such as a delivery CPU, flow controller, injector module, monitoring system with a separate monitor CPU, gas cells (NO, NO2, and O2 cells), user interface including display and alarms, and a battery. It also mentions adding hardware for infrared communications. This indicates it 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 primary function of the INOmax DS is to deliver a therapeutic gas (nitric oxide) to a patient's breathing circuit. It also monitors inspired gases (O2, NO2, NO) in the breathing circuit, not in a biological sample from the patient.
- Device Description: The description focuses on the delivery and monitoring of gases within the breathing system.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples (blood, urine, tissue, etc.) from the patient. IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
The INOmax DS is a medical device used for delivering a therapeutic gas and monitoring the gas composition within the patient's breathing circuit. It does not perform in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The INOmax DS delivery system delivers INOmax® (nitric oxide of inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators.
The INOmax DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.
The INOmax DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.
The INOmax DS includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender for backup.
The target patient population is controlled by the drug labeling for INOmax and is currently neonates. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.
Product codes
MRN, MRQ, MRP
Device Description
The INOmax DS2 uses a "dual-channel" design to ensure the safe delivery of INOmax. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and O2 cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOmax delivery independent of monitoring but also allows the monitoring system to shutdown INOmax delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm.
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
neonates
Intended User / Care Setting
Primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.
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
Non-Clinical Tests: The INOmax DS and its applications comply with voluntary standards as detailed in Section 9 and 17 of this premarket submission.
The hardware changes made to the INOmax DS, to implement the INOmax DS infrared features consisted of adding additional hardware to provide infrared communications to an INOmeter mounted on the INOmax DS gas cylinders. The new hardware did not change the original hardware which controlled all the original INOmax DS functions. The additional electrical connections to the original hardware were connections to the common power source and a serial data link connected to the battery and the monitoring processor. Thus, no extensive retesting of the original INOmax DS was deemed necessary.
The SVRS testing, the summary of which is described in appendix J of this submission, thoroughly tested all requirements of the software, including the NO delivery and gas monitoring performance. The successful completion of these tests demonstrated that the INOmax DS (Version 2) met the performance requirements of the original product and the new requirements of the revised device.
The INOmax DS revision complies to "Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer" (January 24, 2000) FDA-1157.
The results of testing verified that the additional communication of patient data through Infrared transmission and additional alarms did not alter the safety or effectiveness of the INOmax DS operation.
Clinical Tests: The subject of this premarket submission, INOmax DS, did not require clinical studies to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
K061901; INOmax DS (Delivery System)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5165 Nitric oxide administration apparatus.
(a)
Identification. The nitric oxide administration apparatus is a device used to add nitric oxide to gases that are to be breathed by a patient. The nitric oxide administration apparatus is to be used in conjunction with a ventilator or other breathing gas administration system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.”
0
INO Therapeutics/Ikaria Premarket Notification
APR 1 5 2010
INOmax DS
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided: December 18, 2009 Date: Submitter: INO Therapeutics/Ikaria 2902 Dairy Drive Madison, Wisconsin 53718
Primary Contact Person: Larry Lepley Associate Director, Regulatory Affairs INO Therapeutics/Ikaria T: 608-226-3415 F: 608-226-3402
David Trueblood Secondary Contact Person: Director, Regulatory Affairs INO Therapeutics/Ikaria T: 608-395-3910 F: 608-226-3402
INOmax DS (Delivery System) Device: Trade Name:
Common/Usual Name: Nitric Oxide Administration Apparatus (primary) Nitric Oxide Administration Apparatus, Back-up System Nitric Oxide Analyzer Nitrogen Dioxide Analyzer
Apparatus, Nitric Oxide Delivery, or Apparatus, Nitric Oxide Classification Names: Backup Delivery, Class II - 21 CFR 868.5165 Product Code: MRN (primary), MRQ, MRP, MRQ
K061901; INOmax DS (Delivery System) Predicate Device(s):
Device Description: The INOmax DS2 uses a "dual-channel" design to ensure the safe delivery of INOmax. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and O2 cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOmax delivery independent of monitoring but also allows the monitoring system to shutdown INOmax delivery if it detects a fault in the delivery system such that the NO
1
concentration could become greater than 100 ppm.
Intended Use:
The INOmax DS delivery system delivers INOmax® (nitric oxide of inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators.
The INOmax DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The INOmax DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.
The INOmax DS includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender for backup.
The target patient population is controlled by the drug labeling for INOmax and is currently neonates. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.
Technology:
All revisions of NOmax DS utilize component technology to deliver Nitric Oxide gas to the patient. The components consist of the Delivery System unit, the blender, a stand/cart and the NO gas tanks. In this revision the INOmax DS technological characteristic of design has changed with the inclusion of patient data storage and additional operation alarms. This modification of design does not affect the intent of INOmax DS in the delivery of NO gas for the target population of neonatal patients. The patient data storage was included for patient administration and the additional alarms were added to aid in the safe administration of the NO gas.
The fundamental scientific technology remains the same in the concept of the INOmax DS. The proposed INOmax DS includes ergonomic changes related to two specific areas of use;
- data collection for the collection of patient parameters/device usage
- additional notifications/alerts (visual and audible) to alert । the user of operational events.
These additional functions required the INOmax DS to be modified to accommodate the additional components for data
2
transfer utilizing Infrared communication and the change in the Graphic User Interface (GUI) for visual notifications.
Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
The INOmax DS and its applications comply with voluntary standards as detailed in Section 9 and 17 of this premarket submission.
The hardware changes made to the INOmax DS, to implement the INOmax DS infrared features consisted of adding additional hardware to provide infrared communications to an INOmeter mounted on the INOmax DS gas cylinders. The new hardware did not change the original hardware which controlled all the original INOmax DS functions. The additional electrical connections to the original hardware were connections to the common power source and a serial data link connected to the battery and the monitoring processor. Thus, no extensive retesting of the original INOmax DS was deemed necessary.
The SVRS testing, the summary of which is described in appendix J of this submission, thoroughly tested all requirements of the software, including the NO delivery and gas monitoring performance. The successful completion of these tests demonstrated that the INOmax DS (Version 2) met the performance requirements of the original product and the new requirements of the revised device.
The INOmax DS revision complies to "Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer" (January 24, 2000) FDA-1157
The results of testing verified that the additional communication of patient data through Infrared transmission and additional alarms did not alter the safety or effectiveness of the INOmax DS operation.
Summary of Clinical Tests:
The subject of this premarket submission, INOmax DS, did not require clinical studies to support substantial equivalence.
Conclusion:
INO Therapeutics/Ikaria considers the INOmax DS to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol of three human figures, represented by flowing lines, suggesting unity and collaboration.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Larry Lepley Associate Director, Regulatory Affairs 2902 Dairy Drive Madison, Wisconsin 53718 United States
Re: K093922
Trade/Device Name: INOmax DS Regulation Number: 21 CFR 868.5165 Regulation Name: Nitric Oxide Administration Apparatus Regulatory Class: II Product Code: MRN, MRO, MRP, MRP, MRQ Dated: March 15, 2010 Received: March 16, 2010
Dear Mr. Larry Lepley:
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.
APR 1 5 2010
4
Page 2 - Mr. Lepley
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 yours.
h
f.r
Anthony D. Watson, B.S., M.S., M.B.A. Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INO Therapeutics/Ikaria Premarket Notification
INOmax DS
510(k) Number (if known):
INOmax DS Device Name:
Indications for Use:
The INOmax DS delivery system delivers INOmax® (nitric oxide of inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators.
The INOmax DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.
The INOmax DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.
The INOmax DS includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender for backup.
The target patient population is controlled by the drug labeling for INOmax and is currently neonates. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schult
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K093922