(117 days)
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.
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.
The provided document describes the INOmax DSIR, a nitric oxide delivery system, and its compatibility with additional respiratory care devices. The submission focuses on non-clinical testing to demonstrate substantial equivalence, rather than a study involving clinical outcomes or diagnostic accuracy. Therefore, information related to observer performance studies (e.g., MRMC studies, standalone performance), ground truth establishment for diagnostic tasks, expert qualifications, and adjudication methods is not applicable to this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Requirements) | Reported Device Performance (Testing Conclusion) |
|---|---|
| O2 dilution | Performed within published specifications when used with each of the selected respiratory care devices. |
| Effect on respiratory care device | Performed within published specifications when used with each of the selected respiratory care devices. |
| INOmax DSIR delivery accuracy | Performed within published specifications when used with each of the selected respiratory care devices. |
| NO2 generation | Performed within published specifications when used with each of the selected respiratory care devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical testing involving the INOmax DSIR and three specific respiratory care devices:
The testing involved using six INOmax DSIR settings: [0 (baseline), 1, 5, 20, 40] ppm (the sixth value is cut off but implied to be another concentration in ppm). The document states, "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." This suggests a systematic testing approach across different settings for each device. However, a specific numerical "sample size" in terms of number of patient cases or repeated measurements for statistical analysis is not detailed in the provided text.
The data provenance is prospective non-clinical testing conducted by INO Therapeutics/Ikaria, likely at their facilities, to evaluate compatibility and performance. There is no indication of country of origin of patient data as no patient data was used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This was a non-clinical device compatibility and performance study, not a diagnostic accuracy study requiring expert-established ground truth. The "ground truth" was the expected performance according to published specifications and manufacturer recommendations for the devices.
4. Adjudication Method for the Test Set
Not applicable. This was a non-clinical device compatibility and performance study, not a diagnostic accuracy study requiring adjudication of expert interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. No MRMC study was conducted, as this submission concerns the hardware and software performance of a nitric oxide delivery system and its compatibility with other respiratory devices, not a diagnostic algorithm involving human readers or AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The INOmax DSIR is a medical device for delivering and monitoring nitric oxide, not a standalone diagnostic algorithm. Its performance was tested as a standalone system and in conjunction with other respiratory care devices.
7. The Type of Ground Truth Used
The "ground truth" for this non-clinical testing was based on:
- Manufacturer's specifications: The INOmax DSIR was expected to "perform within published specifications."
- Manufacturer's recommendations: The respiratory care devices were set up and calibrated "according to the manufacturer's recommendations."
- Expected compatibility: The overall aim was to conclude that the INOmax DSIR and the three respiratory care devices are compatible.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware and software system for medical gas delivery and monitoring, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set.
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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.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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| Intended Use: | The INOmax DS delivery system delivers INOmax® (nitricoxide of inhalation) therapy gas into the inspiratory limb of thepatient breathing circuit in a way that provides a constantconcentration of nitric oxide (NO), as set by the user, to thepatient throughout the inspired breath. It uses a speciallydesigned injector module, which enables tracking of the ventilatorwaveforms and the delivery of a synchronized and proportionaldose of NO. It may be used with most ventilators.The INOmax DS provides continuous integrated monitoring ofinspired O2, NO2, and NO, and a comprehensive alarm system.The INOmax DS incorporates a battery that provides up to 6hours of uninterrupted NO delivery in the absence of an externalpower source.The INOmax DS includes a backup NO delivery capability thatprovides a fixed flow of 250 mL/min of NO which along withuser supplied 10 L/min of oxygen provides 20 ppm in the gasflow to a patients breathing circuit. It may also use theINOblender for backup.The target patient population is controlled by the drug labelingfor INOmax and is currently neonates. The primary targetedclinical setting is the Neonatal Intensive Care Unit (NICU) andsecondary targeted clinical setting is the transport of neonates. |
|---|---|
| Technology: | All revisions of INOmax DSIR utilize component technology todeliver Nitric Oxide gas to the patient. The components consist ofthe Delivery System unit, the blender, a stand/cart and the NO gastanks. In this proposed revision the INOmax DSIR, technologicalcharacteristic of design has not changed with the inclusion ofthree additional respiratory care devices that INOTherapeutics/Ikaria has tested to be compatible for use with theINOmax DSIR system.The three additional respiratory care devices include:(K102775) Hamilton C2(K070513) Hamilton G5(K100011) Fisher & Paykel Healthcare Bubble CPAP System |
| Determination ofSubstantial Equivalence: | Summary of Non-Clinical Tests:The testing concluded all requirements necessary for theoperation of the INOmax DSIR and interface to the selectedrespiratory care devices to be compatible:The three respiratory care devices were set up and calibratedaccording to the manufacturer's recommendations, and testedusing the settings established for each respiratory care device test.The INOmax DSIR was set up and calibrated according to themanufacturer's recommendations.Six INOmax DSIR settings were used [0 (baseline), 1, 5, 20, 40, |
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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.
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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.
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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
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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:
§ 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.”