(731 days)
Not Found
No
The document describes a device for delivering nitric oxide and monitoring gas levels, focusing on hardware components, safety features, and basic control mechanisms. There is no mention of AI or ML algorithms for data analysis, decision-making, or adaptive control.
Yes
The device delivers nitric oxide therapy gas to patients to treat hypoxic respiratory failure in neonates, which is a therapeutic intervention.
No
The device is primarily an nitric oxide delivery system that also monitors specific gases (O2, NO2, and NO) within the breathing circuit to ensure safe and accurate drug delivery, rather than to diagnose a medical condition.
No
The device description clearly outlines hardware components such as a delivery CPU, flow controller, injector module, monitor CPU, gas cells (NO, NO2, and O2 cells), user interface including display and alarms, a battery, and a blender. It is a physical medical device with integrated software.
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® DSIR Plus is to deliver a therapeutic gas (nitric oxide) to a patient's respiratory system. It also monitors certain gases (O2, NO2, NO) within the breathing circuit.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description focuses on the mechanical and electronic components involved in gas delivery and monitoring within the breathing circuit. It does not mention any analysis of biological samples.
The device is a therapeutic and monitoring device used directly with the patient's respiratory system, not for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
The INOmax® DSIR Plus delivers INOMAX® (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant on 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 ventilators and respiratory care devices that the INOmax DSIR Plus has been validated with.
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 INOmax® DSIR Plus must only be used in accordance with the indications, warnings and precautions described in the nitric oxide drug packaging inserts and is indicated for use in term and near-term (>34weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. INOmax DSIR Plus is indicated for a maximum of 14 days of use. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.
Product codes (comma separated list FDA assigned to the subject device)
MRN, MRO, 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
term and near-term (>34weeks gestation) 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)
The subject of this premarket submission, INOmax DSm® Plus, 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 the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 20, 2023
Mallinckrodt Manufacturing LLC % David Trueblood Senior Director, Regulatory Affairs, Devices 6603 Femrite Drive Madison, Wisconsin 53718
Re: K211153
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. MRO. MRP Dated: February 16, 2023 Received: February 21, 2023
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
1
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 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 (QS) 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 medical devices and radiation-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,
Ting Song -S
for James J. Lee, PhD Director DHT1C: Division of 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) K211153
Device Name INOmax® DSIR Plus
Indications for Use (Describe)
The INOmax® DSIR Plus delivers INOMAX® (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant on 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 ventilators and respiratory care devices that the INOmax DSIR Plus has been validated with.
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 INOmax® DSIR Plus must only be used in accordance with the indications, warnings and precautions described in the nitric oxide drug packaging inserts and is indicated for use in term and near-term (>34weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. INOmax DSIR Plus is indicated for a maximum of 14 days of use. 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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5. 510(K) SUMMARY
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
Submitter Information
| Date: | March 30, 2023 |
|---|---|
| Company: | Mallinckrodt Manufacturing, LLC |
| 6603 Femrite Drive | |
| Madison, Wisconsin 53718 | |
| Contact Person: | David M. Trueblood |
| Senior Director, Regulatory Affairs, Devices | |
| Email: | David.trueblood@sbiopharma.com |
| Telephone: | 608.320.2755 |
| FAX: | 908.238.6402 |
| Secondary Contact Person: | Erica Mullaney |
| Email: | Erica.mullaney@sbiopharma.com |
| Telephone: | 353.87.1193048 |
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) | K200389 |
Description of Device 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®
4
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.
Intended 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 ventilators and respiratory care devices that the INOmax DSIR Plus has been validated with.
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 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 INOmax® DSIR Plus must only be used in accordance with the indications, contraindications, warnings and precautions described in the nitric oxide drug packaging inserts and labeling and is indicated for use in term and near-term (>34weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. INOmax DSIR Plus is indicated for a maximum of 14 days of use. 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 DSIR® Plus, the significant changes to the device include the labeling and main circuit board.
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Determination of Substantial Equivalence
The modified INOmax DSn® Plus has the same intended use as the previously cleared INOmax DSm®. All features are identical except those described in the table below.
| Feature /
Specification | INOmax DSiR® Plus-
K131686 | INOmax DSiR® Plus Device Modification |
|----------------------------|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DSIR Head | DSIR Head | Modified DSIR head with RoHS compliant
electrical components, revised mounting
method for pneumatic pressure switch, supplier
change to LCD component in touchscreen
display, revised shroud around display for
improved ferrite fit, monitoring board changes
to eliminate potential ADC override, and
changed to an equivalent indium tin oxide
glass display |
| Injector Module | Injector Module | Modified injector module with updated
exterior color and design and RoHS compliant
electrical components |
| Power Supply | Power Supply | Modified power supply due to obsolescence
and added protection components |
| Disk Filter | Patient Sample Gas Line
Disk Filter, 0.5 mircon | 2-stage filter (coalescing media is glass fiber
1.0 micron and hydrophobic media is PTFE 0.2
micron) |
| Software | Software | Modified brand name to Mallinckrodt, added
transmission of timestamp when cylinder is
open to INOmeter, minor modifications to
troubleshooting help, and minor sustaining
changes to resolve anomalies |
| Main circuit board | Main circuit board | The INOmax DSIR main board has been
redesigned due to the obsolescence of the
sound and Ethernet chips. This includes
inclusion of new components, board layout
updates and an update in software drivers to
support the new chips. |
| Sustaining Changes | N/A | Part obsolescence and minor sustaining
changes to improve reliability and
manufacturability. |
Comparison to Predicate Device
Summary of Nonclinical Tests
The following quality assurance measures were applied to the modification of the system:
- Risk Analysis .
- Requirements Review .
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- . Design Reviews
- Testing on unit level (module verification)
- Integration testing (system verification)
- Performance testing (verification)
- Safety testing (verification) ●
- Biocompatibility testing of new materials in accordance with the FDA recognized standards in the ISO 18562 and ISO 10993 series.
Support for the substantial equivalence of the INOmax DSIR Plus was provided as a result of risk management and testing which included electrical safety, performance and software tests. This testing includes conformity to FDA recognized consensus standards as follows:
- IEC 60601-1:2005 Medical electrical equipment -- Part 1: General requirements for basic . safety and essential performance
- . IEC 60601-1-2:2014 General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
Summary of Clinical Tests
The subject of this premarket submission, INOmax DSm® Plus, 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.