(120 days)
Not Found
No
The summary describes a device that delivers and monitors nitric oxide based on user settings and ventilator waveforms, using a dual-channel system for safety. There is no mention of AI or ML in the description of its functionality, control, or monitoring. The testing described is bench testing and validation against a protocol, not performance evaluation of an AI/ML algorithm.
No
The device delivers a therapy gas (INOMAX®), but it is a delivery system, not the therapeutic agent itself. It's an accessory to deliver the drug.
No
The device is primarily a delivery system for nitric oxide therapy, with integrated monitoring of gas concentrations (O2, NO2, and NO) to ensure safe and accurate delivery of the drug, rather than for diagnosing a medical 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 with display and alarms, a battery, and components like a blender, stand/cart, and NO gas tanks. It is a physical delivery system for a gas.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is to deliver a therapeutic gas (nitric oxide) to a patient's breathing circuit. This is a direct treatment or therapy delivery function.
- Device Description: The description focuses on the mechanical and electronic components for gas delivery, monitoring of gas concentrations within the breathing circuit, and safety features related to gas delivery.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. IVDs are designed for testing samples in vitro.
- Clinical Setting: The device is used directly with the patient in a clinical setting (NICU, transport). IVDs are typically used in laboratories or point-of-care settings for analyzing samples.
- Performance Studies: The performance studies described are bench testing related to gas delivery and compatibility with ventilators, not studies evaluating the accuracy or performance of diagnostic tests on biological samples.
The device is a medical device used for delivering a therapeutic gas, not for performing diagnostic tests on biological specimens.
N/A
Intended Use / Indications for Use
The INOmax® DSIR Plus 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® DSIR Plus provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.
The INOmax® DSIR Plus incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.
The INOmax® DSIR Plus includes a backup NO delivery capability that provides a fixed flow of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breath. It may also use the INOblender® for backup.
Product codes (comma separated list FDA assigned to the subject device)
MRN, MRQ, MRP
Device Description
The INOmax DSR® Plus 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
The target patient population is controlled by the drug labeling for INOMAX® and is currently neonates.
Intended User / Care Setting
The 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 Nonclinical Tests:
In the most recent predicate 510(k) [K131686], the Ventilator/Gas Delivery System Validation Test Protocol was accepted and the outcomes were used as justification on clearance of the submission and modification in labelling for compatibility with respiratory care device.
Specifically in K131686 clearance, the labelling of the INOmax DSIR was being updated to add the following compatible respiratory care devices:
- Hamilton C1 Ventilator (K120574)
- Hamilton T1 Ventilator (K120670)
The Ventilator/Gas Delivery System Validation Test Protocol was used to validated the hazards were mitigated. Since the 510(k) clearance, the protocol has had insignificant differences between validation protocol versions. Ultimately, the requirements necessary for the operation of the INOmax DSIR passed.
Mallinckrodt now has combined the data into a Summary of Bench Testing. This Bench Testing was conducted across all platforms to demonstrate that the INOmax DSIR® Plus performs within published specifications. The Hazards identified were from Risk Input that were thru Ventilator Validation based on a protocol which again was recently cleared thru K131686.
Summary of Clinical Tests:
The subject of this premarket submission, INOmax DSn® Plus with updated labeling to interface with additional ventilator and breathing devices, did not require clinical studies to support substantial equivalence.
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.
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
§ 868.5165 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
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Mallinckrodt Manufacturing LLC % Jamie Yieh Director, Global Regulatory Affairs Mallinckrodt Hospital Products Inc. 1425 U.S. Route 206 Bedminster, New Jersey 07921
Re: K200389
Trade/Device Name: INOmax DSIR Plus Regulation Number: 21 CFR 868.5165 Regulation Name: Nitric Oxide Administration Apparatus Regulatory Class: Class II Product Code: MRN, MRQ, MRP Dated: May 15, 2020 Received: May 18, 2020
Dear Jamie Yieh:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200389
Device Name INOmax® DSIR Plus
Indications for Use (Describe)
The INOmax® DSIR Plus 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® DSIR Plus provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.
The INOmax® DSIR Plus incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.
The INOmax® DSIR Plus includes a backup NO delivery capability that provides a fixed flow of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breath. 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.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
In accordance with 21 CFR 807.92 the following summary of information is provided:
Submitter Information
| Date: | February 14, 2020 | |
|---|---|---|
| Company: | Mallinckrodt Manufacturing, LLC | |
| 6603 Femrite Drive | ||
| Madison, Wisconsin 53718 | ||
| Contact Person: | Jamie Yieh | |
| Director, Regulatory Affairs, Devices | ||
| Email: | Jamie.Yieh@mnk.com | |
| Telephone: | 908-238-6738 | |
| FAX: | 908-238-6402 | |
| Secondary Contact Person: | David Trueblood | |
| Email: | David.Trueblood@mnk.com | |
| Telephone: | 608-395-3910 |
Identification of the Device
| Device Trade Name: | INOmax DSIR® Plus (Delivery System) |
|---|---|
| Common Name: | Nitric Oxide Administration Apparatus (primary) |
| Nitric Oxide Analyzer | |
| Nitrogen Dioxide Analyzer | |
| Classification Name: | Apparatus, Nitric Oxide Delivery, or Apparatus, Nitric |
| Oxide Backup Delivery | |
| Device Classification: | Class II – 21 CFR 868.5165 |
| Product Code: | MRN (Primary), MRQ, MRP |
| Predicate Device(s): | K131686 |
The INOmax DSR® Plus uses a "dual-channel" design to ensure the Description of Device 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
4
delivery system such that the NO concentration could become greater than 100 ppm.
The INOmax® DSIR Plus delivery system delivers INOMAX® (nitric Intended Use 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® DSIS Plus provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.
The INOmax® DSIR Plus incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.
The INOmax® DSIR Plus 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.
All revisions of INOmax DSm® Plus utilize component technology to Technology 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 of the INOmax DSm® Plus, the only changes to the device includes the labeling for compatibility with respiratory care device.
Determination of Substantial Equivalence
The modified INOmax DSm® Plus has the same intended use as the previously cleared INOmax DSm . All features are identical except those described in the table below.
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| Feature / Specification | INOmax DSIR® - K131686 | INOmax DSIR® Plus with additional
ventilator and breathing devices |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Labeling for
compatibility with
ventilator devices | A variety of transport,
neonatal, adult/ped, high
frequency and anesthesia
ventilators, nasal CPAP and
nasal high flow cannulas. | Additional ventilator devices include:
Covidien PB 980 (K131252) GE Healthcare Carescape R860 (K142679) Fisher & Paykel Healthcare RT330 Breathing Circuit and Optiflow Jr (Class I, 510(k) Exempt under 21 CFR 868.5340)) Bunnell Inc Life Pulse 204 (P850064) Drager Perseus A500 (K133886) Fisher & Paykel Healthcare Airvo 2 (K131895) Drager Carina (K072885) Maquet Servo u/n (K151814) Hamilton C3 (K161450) IMT Medical Bellavista (K163127) Maquet Flow-i (K160665) Bio-Med TV-100 (K173973) Phillips V60 (K102985) |
Comparison to Predicate Device
Summary of Nonclinical Tests
In the most recent predicate 510(k) [K131686], the Ventilator/Gas Delivery System Validation Test Protocol was accepted and the outcomes were used as justification on clearance of the submission and modification in labelling for compatibility with respiratory care device.
Specifically in K131686 clearance, the labelling of the INOmax DSIR was being updated to add the following compatible respiratory care devices:
The Ventilator/Gas Delivery System Validation Test Protocol was used to validated the hazards were mitigated. Since the 510(k) clearance, the protocol has had insignificant differences between validation protocol versions. Ultimately, the requirements necessary for the operation of the INOmax DSIR passed.
Mallinckrodt now has combined the data into a Summary of Bench Testing. This Bench Testing was conducted across all platforms to demonstrate that the INOmax DSIR® Plus performs within
6
published specifications. The Hazards identified were from Risk Input that were thru Ventilator Validation based on a protocol which again was recently cleared thru K131686.
Summary of Clinical Tests
The subject of this premarket submission, INOmax DSn® Plus with updated labeling to interface with additional ventilator and breathing devices, did not require clinical studies to support substantial equivalence.
Conclusion
Mallinckrodt Manufacturing, LLC considers the INOmax DSm® Plus to be as safe and as effective as the predicate device, with performance substantially equivalent to the predicate device.