(203 days)
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.
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.
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 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 provided text describes the INOmax DS (Delivery System), a nitric oxide administration apparatus. However, it explicitly states that clinical studies were not required to support substantial equivalence for this device. Therefore, information regarding acceptance criteria derived from clinical studies, comparative effectiveness studies, or clinical ground truth establishment is not available within the provided document.
The document primarily focuses on non-clinical tests and the device's technological equivalence to a predicate device.
Here's an analysis based only on the provided text, addressing the requested points:
Acceptance Criteria and Device Performance
Since clinical studies were not required for this 510(k) submission, there are no specific performance acceptance criteria or reported device performance metrics from clinical trials mentioned. The manufacturer's conclusion is that the INOmax DS is "as safe, as effective, and performance is substantially equivalent to the predicate device."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Clinical Performance | Not applicable; clinical studies were not required to support substantial equivalence. Device is considered "as safe, as effective, and performance is substantially equivalent to the predicate device." |
| Non-Clinical Performance | The device complies with voluntary standards and underwent internal quality assurance measures: Risk Analysis, Requirements Reviews, Design Reviews, Unit-level Testing (Module verification), Integration Testing (System verification), Final Acceptance Testing (Validation), Performance Testing (Verification), Safety Testing (Verification). |
Other Information
Due to the lack of clinical studies, much of the requested information is not present in the provided document.
- Sample sizes used for the test set and the data provenance: Not applicable, as no clinical test set for performance evaluation is mentioned. Non-clinical testing details (e.g., number of units tested, specific data provenance) are not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set requiring expert ground truth is mentioned.
- Adjudication method for the test set: Not applicable, as no clinical test set is mentioned.
- 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. This device is a nitric oxide delivery system, not an AI-assisted diagnostic tool. No MRMC study was conducted or mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device for nitric oxide delivery, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical ground truth establishment is mentioned. The primary basis for equivalence is technological similarity and compliance with voluntary standards and internal quality assurance measures, rather than a clinical ground truth.
- The sample size for the training set: Not applicable, as this is a medical device, not an AI algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.”