(117 days)
No
The summary describes a device that delivers and monitors nitric oxide based on user settings and ventilator waveforms. It uses a dual-channel system for safety and includes backup capabilities. There is no mention of AI, ML, or any learning or adaptive algorithms in the description of its functionality or testing. The testing described is standard performance and compatibility testing, not related to training or evaluating an AI/ML model.
Yes
The device delivers INOmax® (nitric oxide for inhalation) therapy gas to patients, which is a therapeutic agent. Its purpose is to deliver and manage the administration of this therapy.
No
Explanation: The device is designed to deliver nitric oxide therapy and monitor gas concentrations (O2, NO2, NO) to ensure proper delivery, not to diagnose medical conditions.
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 with display and alarms, and a battery. It also describes a backup NO delivery capability involving fixed flow and user-supplied oxygen. These are all physical hardware components, not solely software.
Based on the provided text, the INOmax DS delivery system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The device's intended use is to deliver a therapeutic gas (nitric oxide) to a patient's breathing circuit. This is a direct treatment delivery system, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description focuses on the mechanics of gas delivery, monitoring of gas concentrations within the breathing circuit, and safety features related to delivery. It does not mention any analysis of biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other bodily fluids.
- Providing diagnostic information based on biological markers.
- Performing tests for disease detection, monitoring, or prognosis.
The INOmax DS is a medical device used for the administration of a drug (INOmax) to a patient.
N/A
Intended Use / Indications for Use
The INOmax DS delivery system delivers INOmax® (nitric oxide for 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.
Product codes
MRN, MRQ, MRP
Device Description
The INOmax DSIR 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Tests:
The testing concluded all requirements necessary for the operation of the INOmax DSIR and interface to the selected respiratory care devices to be compatible:
The three respiratory care devices were set up and calibrated according to the manufacturer's recommendations, and tested using the settings established for each respiratory care device test. The INOmax DSIR was set up and calibrated according to the manufacturer's recommendations. Six INOmax DSIR settings were used [0 (baseline), 1, 5, 20, 40, and the measured values on the INOmax DSIR were also recorded along with any anomalies found. The testing concluded four requirements necessary for the operation of the INOmax DSJR and the three respiratory care devices to be compatible:
- O2 dilution
- Effect on respiratory care device
- INOmax DSB delivery accuracy
- NO2 generation
Testing Conclusion:
The INOmax DSJR performed within published specifications when used with each of the respiratory care devices.
Summary of Clinical Tests:
The subject of this premarket submission, INOmax DSIR, interfaced to each of the selected respiratory care devices, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K061901, K070867, K071516, K080484, K081691, K090958, K092545, K093922, K110344, K110635
Reference Device(s)
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
11113272
510(k) Summary
FEB 2 9 2012
In accordance with 21 CFR 807.92 the following summary of information is provided: Date: November 3, 2011
INO Therapeutics/Ikaria Submitter: 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
Secondary Contact Person: David Trueblood Director, Regulatory Affairs INO Therapeutics/Ikaria T: 608-395-3910 F: 608-226-3402
INOmax® DSIR (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
Predicate Device(s): K061901, K070867, K071516, K080484, K081691, K090958, K092545, K093922, K110344, K110635
The INOmax DSIR uses a "dual-channel" design to ensure the Device Description: 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.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
| 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 INOmax DSIR 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 proposed revision the INOmax DSIR, technological
characteristic of design has not changed with the inclusion of
three additional respiratory care devices that INO
Therapeutics/Ikaria has tested to be compatible for use with the
INOmax DSIR system.
The three additional respiratory care devices include:
(K102775) Hamilton C2
(K070513) Hamilton G5
(K100011) Fisher & Paykel Healthcare Bubble CPAP System |
| Determination of
Substantial Equivalence: | Summary of Non-Clinical Tests:
The testing concluded all requirements necessary for the
operation of the INOmax DSIR and interface to the selected
respiratory care devices to be compatible:
The three respiratory care devices were set up and calibrated
according to the manufacturer's recommendations, and tested
using the settings established for each respiratory care device test.
The INOmax DSIR was set up and calibrated according to the
manufacturer's recommendations.
Six INOmax DSIR settings were used [0 (baseline), 1, 5, 20, 40, |
،
.
2
The measured values on the INOmax DSIR were also recorded along with any anomalies found.
The testing concluded four requirements necessary for the operation of the INOmax DSJR and the three respiratory care devices to be compatible:
- O2 dilution
- Effect on respiratory care device
- INOmax DSB delivery accuracy
- NO2 generation
Testing Conclusion:
The INOmax DSJR performed within published specifications when used with each of the respiratory care devices.
Summary of Clinical Tests:
The subject of this premarket submission, INOmax DSIR, interfaced to each of the selected respiratory care devices, did not require clinical studies to support substantial equivalence.
Conclusion: INO Therapeutics/Ikaria considers the INOmax DSIR to be as safe and as effective as the predicate device, with performance substantially equivalent to the predicate device.
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 stylized eagle-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
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 INO Therapeutics / Ikaria 2902 Dairy Drive Madison, Wisconsin 53718
FEB 2 9 2012
Re: K113272 Trade/Device Name: INOmax DS Regulation Number: 21 CFR 868.5165 Regulation Name: Nitric Oxide Administration Apparatus Regulatory Class: II Product Code: MRN, MPQ, MRP Dated: January 27, 2012 Received: January 30, 2012
Dear Mr. 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.
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 vours.
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
INO Therapeutics/Ikaria Premarket Notification
510(k) Number (if known):
INOmax DS Device Name:
Indications for Use:
The INOmax DS delivery system delivers INOmax® (nitric oxide for 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 AND/OR (Part 21 CFR 801 Subpart D)
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. Schultz
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
4113272 510(k) Number: