(120 days)
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.
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.
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® 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.
All revisions of INOmax DSm® Plus 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 of the INOmax DSm® Plus, the only changes to the device includes the labeling for compatibility with respiratory care device.
This document, K200389, is a 510(k) premarket notification for the INOmax DSIR Plus, a nitric oxide administration apparatus. It focuses on demonstrating substantial equivalence to a predicate device (K131686), specifically by adding compatibility with new ventilator and breathing devices.
Based on the provided text, the device performance assessment relies entirely on nonclinical (bench) testing and comparison to a previously cleared predicate device. There is no evidence of clinical studies involving human subjects or AI algorithms in this document. Therefore, many of the requested points regarding AI/MRMC studies, expert ground truth adjudication, and training/test set sample sizes are not applicable to the information presented.
Here's the breakdown of what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with corresponding performance metrics like "accuracy > X%". Instead, it refers to a "Ventilator/Gas Delivery System Validation Test Protocol" used for the predicate device (K131686) and states that this same protocol, with "insignificant differences," was used for the INOmax DSIR Plus. The general acceptance criterion implied is that the device "performs within published specifications" and that "the hazards were mitigated" based on this protocol.
- Acceptance Criteria (Implied): Performance according to "published specifications" and mitigation of identified hazards, as demonstrated through the "Ventilator/Gas Delivery System Validation Test Protocol."
- Reported Device Performance: "Ultimately, the requirements necessary for the operation of the INOmax DSIR passed." and "This Bench Testing was conducted across all platforms to demonstrate that the INOmax DSIR® Plus performs within published specifications."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated as a number of patient cases or images. The "test set" in this context refers to the bench testing conducted on the device's compatibility with a list of new ventilator and breathing devices. The document lists 11 specific additional ventilator devices that were tested for compatibility:
- 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)
- Data Provenance: The data originates from bench testing (laboratory) rather than clinical patient data. Country of origin for the testing is not specified but is presumed to be associated with the manufacturer (Mallinckrodt Manufacturing, LLC, based in Madison, Wisconsin, USA). The testing is prospective in the sense of being conducted specifically for this submission, although it leverages a protocol from a previous clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This device is a hardware apparatus for administering nitric oxide, not an AI algorithm requiring expert human interpretation of medical images or data for ground truth. The "ground truth" for the nonclinical testing would be the engineering specifications and expected performance, verified through the validation protocol.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no human expert adjudication of data (like medical images or clinical outcomes) was performed. The "adjudication" of the bench test results would be whether the device passed or failed the predefined engineering/performance criteria in the validation protocol.
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
No. This document explicitly states, "The subject of this premarket submission... did not require clinical studies to support substantial equivalence." This means no human-in-the-loop performance study, MRMC study, or AI assistance was involved.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This device is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" used for this device's validation was engineering specifications and performance criteria established in the "Ventilator/Gas Delivery System Validation Test Protocol," likely determined by design requirements and regulatory standards for medical devices of this type.
8. The sample size for the training set
Not applicable. There is no AI component or training set mentioned in this submission.
9. How the ground truth for the training set was established
Not applicable. There is no AI component or training set mentioned in this submission.
{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
{2}------------------------------------------------
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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, LLC6603 Femrite DriveMadison, Wisconsin 53718 | |
| Contact Person: | Jamie YiehDirector, 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 AnalyzerNitrogen Dioxide Analyzer |
| Classification Name: | Apparatus, Nitric Oxide Delivery, or Apparatus, NitricOxide 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.
{5}------------------------------------------------
| Feature / Specification | INOmax DSIR® - K131686 | INOmax DSIR® Plus with additionalventilator and breathing devices |
|---|---|---|
| Labeling forcompatibility withventilator devices | A variety of transport,neonatal, adult/ped, highfrequency and anesthesiaventilators, nasal CPAP andnasal 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.
§ 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.”