(203 days)
Not Found
No
The summary describes a device for delivering nitric oxide based on user settings and ventilator waveforms, with no mention of AI or ML technologies for decision-making, analysis, or control.
Yes
The device delivers INOmax® (nitric oxide of inhalation) "therapy gas" and its function is described as delivering a "dose of NO" to the patient, indicating a therapeutic purpose.
No
This device is a drug delivery system used to administer nitric oxide gas, and it also provides monitoring of certain gas levels (O2, NO2, NO) to ensure proper dosage and safety, rather than diagnosing a patient's medical condition.
No
The device description explicitly mentions "reconfiguration of hardware, electronic circuitry and software" and describes physical components like an injector module, battery, and backup delivery capability, indicating it is a hardware device with integrated software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- 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 Function: The INOmax DS delivery system is designed to deliver a therapeutic gas (nitric oxide) directly to a patient's breathing circuit. It also monitors gases within that circuit.
- Lack of Sample Analysis: The description does not mention the device analyzing any biological samples taken from the patient. Its function is to deliver a substance to the patient and monitor gases in the breathing circuit, which is external to the patient's body in the context of sample collection for diagnosis.
Therefore, the INOmax DS is a therapeutic delivery system and monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
MRN, MRO, MRP, MRQ
Device Description
The INO Therapeutics INOmax DS represents the continuing evolution of the Datex-Ohmeda (now GE Healthcare) INOvent Delivery System design. Its published performance specifications are not significantly different from the INOvent. The INOmax DS design incorporates a reconfiguration of hardware, electronic circuitry and software resulting in a more compact, stylish, modern, user-friendly and easier manufactured product.
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
Neonatal Intensive Care Unit (NICU), 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 INOmax DS (Delivery System) and its applications comply with voluntary standards as detailed in Section 17-20 of this premarket submission. The following quality assurance measures were applied to the development of the system:
- . Risk Analysis
- Requirements Reviews
- . Design Reviews
- Testing on unit level (Module verification) .
- Integration testing (System verification) .
- . Final acceptance testing (Validation)
- Performance testing (Verification) .
- Safety testing (Verification) .
Summary of Clinical Tests:
The subject of this premarket submission, INOmax DS (Delivery System), did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
510(k) SummMAR 1 0 2010
In accordance with 21 CFR 807.92 the following summary of information is provided: Date: 14 August 2009
| Submitter: | INO Therapeutics
2902 Dairy Drive
Madison, Wisconsin 53718 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person: | Larry Lepley
Associate Director, Regulatory Affairs
608-226-3415 |
| Secondary Contact Person: | David Trueblood
Director, Regulatory Affairs
908-608-3910 |
| Device: Trade Name: | INOmax DS (Delivery System) |
| Common/Usual Name: | Nitric Oxide Administration Apparatus (primary)
Nitric Oxide Administration Apparatus, Back-up System
Nitric Oxide Analyzer
Nitrogen Dioxide Analyzer |
| Classification Names: | Class II - 21CFR868.5165, MRN (primary)
Class II - 21CFR868.5165, MRO |
| Product Code: | Class II - 21CFR868.2380, MRP
Class II - 21CFR868.2385, MRQ |
| Predicate Device(s): | K061901; INOmax DS (Delivery System) |
Device Description:
The INO Therapeutics INOmax DS represents the continuing evolution of the Datex-Ohmeda (now GE Healthcare) INOvent Delivery System design. Its published performance specifications are not significantly different from the INOvent. The INOmax DS design incorporates a reconfiguration of hardware, electronic circuitry and software resulting in a more compact, stylish, modern, user-friendly and easier manufactured product.
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
1
designed iniector 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 DS (Delivery System) employs the same functional
Technology:
Determination of Substantial Equivalence:
scientific technology as its predicate devices.
Summary of Non-Clinical Tests:
The INOmax DS (Delivery System) and its applications comply with voluntary standards as detailed in Section 17-20 of this premarket submission. The following quality assurance measures were applied to the development of the system:
- . Risk Analysis
- Requirements Reviews .
- . Design Reviews
- Testing on unit level (Module verification) .
- Integration testing (System verification) .
- . Final acceptance testing (Validation)
- Performance testing (Verification) .
- Safety testing (Verification) .
Summary of Clinical Tests:
The subject of this premarket submission, INOmax DS (Delivery System), did not require clinical studies to support substantial equivalence.
INO Therapeutics considers the INOmax DS (Delivery System) Conclusion: to be as safe, as effective, and performance is substantially equivalent to the predicate device.
2
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR ] 0 2010
Mr. Larry Lepley Associate Director, Regulatory Affairs INO Therapeutics 2902 Dairy Drive Madison, Wisconsin 53718
Re: K092545
Trade/Device Name: INOmax DS (Delivery System) Regulation Number: 21 CFR 868.5165 Regulation Name: Nitric Oxide Administration Apparatus Regulatory Class: II Product Code: MRN, MRO, MRP, MRP, MRQ Dated: February 5, 2010 Received: February 12, 2010
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.
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.
3
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/Centers Offices/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
ph 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
Enclosure
4
510(k) Number (if known):
INOmax DS (Delivery System) Device Name:
Indications for 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.
Prescription Use__X___________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
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 Arlin Ube
(Division Sian-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
1092541 510(k) Number: