(696 days)
The Ulspira TS Nitric Oxide Therapy System is intended for use by healthcare professionals for the delivery of nitric oxide (NO) and the monitoring of inspired NO, NO2 and O2 concentrations for a patient undergoing inhaled Nitric Oxide (iNO) therapy.
The Ulspira TS must only be used in accordance with the indications, 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. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates. Refer to this material prior to use.
The Ulspira TS primary NO therapy system delivers NO gas in the 0-80 ppm range while in the Constant Rate or flow sensing modes. This includes:
• Continuous integrated monitoring for inspired NO, NO2 and a comprehensive alarm system.
· A touch-screen user interface with a waveform display of the ventilation device flow as measured in the inspiratory limb.
· Cylinder handling facilitated by manual or an automatic cylinder switch which is reactive to the detected gas supply state of NO cylinders, and a low O2 pressure alarm when using an oxygen cylinder.
• An automated emergency dosing activated by certain high-risk alarms, which impact patient dosing, to avoid sudden cessation of therapy.
· Compatibility with a wide inspiratory flow rate range of 0.25-120 1/min, utilizing an automatically detected low or high flow sensor.
• An internal battery which provides at least two hours of uninterrupted therapy and a 12V DC inlet for additional external battery access.
The integrated Ulspira TS pneumatic backup NO therapy system provides backup NO delivery capability that is intended to deliver a continuous flow of NO mixed with O2, for iNO therapy which allows continuous treatment during transit within hospitals.
Ulspira TS Nitric Oxide Therapy System delivers physician-prescribed NO therapy gas and monitors inspired Nitric Oxide, Nitrogen Dioxide, and Oxygen gas in combination with a respiratory device.
The main device functionalities of the Ulspira TS Nitric Oxide Therapy System include:
- A primary delivery system to administer NO gas into a respiratory device circuit.
- Monitoring of NO, NO2, and O2 gas concentrations close to the patient interface. ।
- System includes a user interface that contains all controls used to set the NO delivery and monitoring parameters. All set i parameters as well as other information are shown on the user interface screen.
- -The system will produce visual and audible alarms if vital parameters vary beyond preset or default limits.
- -The system includes an integrated pneumatic back-up system for manual hand bagging in order to the rapy in the event of a failure of the primary delivery system and during manual ventilation.
The Ulspira TS system consists of the base unit, the mobile cart and bedside rail holder, and various components and accessories, including the gas regulators and patient kits for use with validated respiratory devices.
Although the provided text describes the ULSPIRA TS Nitric Oxide Therapy System's indications for use, its technical characteristics compared to a predicate device, and the non-clinical performance data (verification and validation activities and applied standards), it does not contain explicit acceptance criteria or a study design and results that directly "prove the device meets the acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or AUC.
The document focuses on demonstrating substantial equivalence to a predicate device (INOmax DSIR Plus) based on technical comparisons and non-clinical testing. This type of submission (510(k)) generally relies on demonstrating that the new device is as safe and effective as a legally marketed predicate, often without requiring extensive new clinical efficacy studies if technological differences are minor and can be addressed through non-clinical means.
Therefore, many of the requested details about clinical studies, expert consensus, and effects on human readers are not available in the provided text.
Here's a breakdown of what can be extracted and what is not present:
1. A table of acceptance criteria and the reported device performance
The document presents a comparison to a predicate device, showing "Comparison" remarks that indicate substantial equivalence or identify differences that are still considered acceptable (e.g., meeting regulatory guidance). It does not explicitly list "acceptance criteria" as pass/fail thresholds for clinical metrics but rather as similar technical specifications or compliance with standards.
| Acceptance Criteria (Implied from predicate comparison/standards) | Reported Device Performance (ULSPIRA TS) |
|---|---|
| NO Administration Principle | NO delivery into the inspiratory limb of a ventilation device's patient circuit. |
| Range of NO gas concentration delivered | 0-80 ppm |
| NO delivery accuracy | ± 20% or 2 ppm, whichever is the greatest. |
| Operating Modes (fixed dose) | One mode for user-set NO dose based on measured respiratory device flow. |
| Backup power source | Pneumatic system |
| Backup NO delivery accuracy | Within ±20% of set value or ±2 ppm, whichever is the greatest. |
| Breathing circuit sample source location | On the inspiratory limb of the breathing circuit, after the humidifier. |
| Integrated NO Gas Analyzer | Yes |
| NO measurement accuracy | ± (0.5 ppm +20 % of actual concentration) in 0-10 ppm; ± (0.5 ppm +10 % of actual concentration) in 10-100 ppm. |
| NO Measurement range | 0 - 100 ppm |
| Integrated NO2 Gas Analyzer | Yes |
| NO2 measurement accuracy | ±(20% or 0.5 ppm), whichever is the greatest. |
| NO2 measurement range | 0 - 10 ppm |
| Integrated O2 Gas Analyzer | Yes |
| O2 measurement accuracy | ± 3% volume fraction (v/v) |
| O2 measurement range | 18 - 100 % |
| Battery backup time | 6h |
| Compliance with relevant standards | (Implied by predicate and FDA guidance adherence) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes non-clinical performance data (verification and validation activities) rather than clinical study data. It mentions "performance testing (verification including primary & backup NO delivery, gas monitoring, & compatibility with ventilators identified in labeling)" but does not specify a sample size for a test set in cases or patients, nor does it indicate data provenance (country, retrospective/prospective). This suggests the testing was bench/lab-based rather than a clinical trial with patient data.
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/Not provided. The testing described is primarily engineering/performance verification against specifications and standards, not clinical ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. This refers to a clinical study method, which is not detailed in the provided non-clinical data.
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
Not applicable/Not provided. This device is a nitric oxide therapy system, not an AI-assisted diagnostic or treatment planning tool that would typically involve "human readers" or AI assistance in that context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided in this context. The device itself performs delivery and monitoring; there isn't an "algorithm only" performance that would be separate from the integrated system's function. The performance testing is for the whole system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical performance data would be the established engineering specifications, regulatory standards, and physical measurements (e.g., gas concentrations measured by reference instruments, flow rates, alarm thresholds, battery duration). There is no mention of clinical ground truth from expert consensus, pathology, or outcomes data, as this was not a clinical efficacy study.
8. The sample size for the training set
Not applicable/Not provided. This implies a machine learning or AI context, which is not described for this device's submission.
9. How the ground truth for the training set was established
Not applicable/Not provided. As above, this is relevant for AI/ML models, not for the technical equivalence and performance verification described for this nitric oxide therapy system.
§ 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.”