(161 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, 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. 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 algorithm 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 //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:
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A primary delivery system to administer NO gas into a respiratory device circuit.
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Monitoring of NO, NO2, and O2 gas concentrations close to the patient interface.
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System includes a user interface that contains all controls used to set the NO delivery and monitoring parameters. All set parameters as well as other information are shown on the user interface screen.
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The system will produce visual and audible alarms if vital parameters vary beyond preset or default limits.
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The system includes an integrated pneumatic back-up system for manual hand bagging in order to deliver NO therapy 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.
The provided text is a 510(k) summary for the ULSPIRA TS™ Nitric Oxide Therapy System, focusing on its substantial equivalence to a predicate device after minor modifications (primarily expanded compatibility with additional respiratory devices and a minor software update). As such, it does not contain the detailed, explicit criteria and study results typically found in an AI/ML medical device submission that would precisely fit all aspects of your requested output.
The document describes a non-clinical test summary, which is designed to show the device functions as intended when connected to other equipment, rather than a clinical study evaluating diagnostic or therapeutic efficacy with human subjects.
Therefore, I will extract and infer the closest applicable information from the provided text, while also explicitly stating what information is not available based on the nature of this 510(k) submission.
Here's an attempt to answer your request based on the provided document:
Acceptance Criteria and Device Performance for ULSPIRA TS™ Nitric Oxide Therapy System
The ULSPIRA TS™ Nitric Oxide Therapy System is a Class II device (21 CFR 868.5165) intended for the delivery and monitoring of inhaled nitric oxide (iNO). This submission (K242374) is for modifications to an existing cleared device (K212409), primarily focused on expanding compatibility with additional respiratory devices and a minor software update (Version 1.6 from 1.5).
The performance evaluation in this 510(k) is a non-clinical test summary designed to demonstrate that the modified device functions within specifications when used with the newly included ventilators. This is a technical performance assessment, not a clinical study involving diagnostic accuracy, human reader performance, or patient outcomes.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this specific 510(k) are implicitly tied to the device performing "within specifications" when connected to new ventilators and maintaining the same performance characteristics as the predicate device. The document explicitly lists performance specifications for the nitric oxide delivery and gas analysis components, which were maintained.
| Acceptance Criteria (Characteristic) | Target Specification (from Predicate Device) | Reported Device Performance (with new ventilators) |
|---|---|---|
| NO Delivery | ||
| Range of NO gas concentration delivered | 0-80 ppm | Identical (0-80 ppm) |
| NO delivery accuracy | ±20% or 2 ppm, whichever is the greatest | Identical (±20% or 2 ppm, whichever is the greatest) |
| Backup NO delivery accuracy | Within ±20% of set value or ±2 ppm, whichever is the greatest | Identical (Within ±20% of set value or ±2 ppm, whichever is the greatest) |
| Gas Analysis (Monitoring) | ||
| NO measurement accuracy | +- (0.5 ppm +20 % of actual concentration) in the range 0-20 ppm; +- (0.5 ppm +10 % of actual concentration) in the range 20-120 ppm | Identical (Met specified accuracy) |
| NO Measurement range | 0 - 120 ppm | Identical (0 - 120 ppm) |
| NO2 measurement accuracy | ±(20% or 0.5 ppm), whichever is the greatest | Identical (Met specified accuracy) |
| NO2 measurement range | 0 - 30 ppm | Identical (0 - 30 ppm) |
| O2 measurement accuracy | ±(2.5 % volume fraction + 2.5 % of gas concentration) | Identical (Met specified accuracy) |
| O2 measurement range | 18 - 100 % | Identical (18 - 100 %) |
| Functional Performance | ||
| Compatibility with selected ventilators | Not explicitly stated as a numerical target, but an implicit expectation that the device performs safely and effectively with new ventilators. | "The ULSPIRA TS Nitric Oxide Therapy System performed within specifications when used with each ventilator." |
| Influence on ventilator performance | No adverse influence on ventilator function | No adverse influence reported. Tests evaluated "Influence on ventilator performance." |
| O2 dilution | Within acceptable limits | Evaluated, no issues mentioned. |
| NO2 formation | Within acceptable limits | Evaluated, no issues mentioned. |
| Alarm functionality | Alarms activate appropriately | Evaluated, no issues mentioned. |
| Connection of the systems | Seamless and functional | Evaluated, no issues mentioned. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: The test set included seven additional ventilators. The "data" are technical measurements (e.g., NO/NO2/O2 concentration, flow rates) the device exhibited when connected to these ventilators under various conditions (e.g., multiple levels of NO delivery: 0, 1, 5, 20, 40, and 80 ppm). This is a technical validation, not observational patient data.
- Data Provenance: This was a non-clinical, laboratory-based engineering test conducted to assess device compatibility and performance with specific ventilator models. The location of the testing is not specified, but it would typically be conducted by the manufacturer or a certified testing laboratory. It is retrospective in the sense that it evaluates the function of a developed device against set technical specifications, not a prospective clinical trial.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This submission details engineering and functional performance testing of a medical device, not the evaluation of an AI algorithm based on human expert annotations or diagnoses. Therefore, there was no "ground truth" derived from expert consensus on medical images or patient outcomes. The "ground truth" for this testing was the known input parameters (e.g., target NO concentration, ventilator settings) and the expected physical and chemical measurements (e.g., measured NO/NO2/O2 levels).
4. Adjudication Method for the Test Set
- Not Applicable. As there was no human expert review or labeling involved, there was no adjudication method like 2+1 or 3+1. The performance was measured against the device's technical specifications and engineering design requirements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks (e.g., radiologists reading images with and without AI assistance). This device is a nitric oxide delivery and monitoring system, and the study focused on its technical performance and compatibility with other medical equipment, not on influencing human diagnostic accuracy.
6. Standalone (Algorithm Only) Performance
- Partially Applicable / Inferred. The core of the submission effectively is a standalone performance evaluation of the device as a system. The testing evaluated the device's ability to deliver and monitor gases within its specified accuracy, independently confirmed for each of the new ventilators. While an "algorithm" is mentioned (e.g., automated emergency dosing algorithm), the performance reported is of the integrated system (hardware + software). The "algorithm only" concept usually applies more directly to AI/ML algorithms performing diagnostic tasks on data, rather than control systems for drug delivery.
7. Type of Ground Truth Used
- The "ground truth" for this non-clinical testing was based on known engineering specifications and measurable physical/chemical parameters. For example, if the device was set to deliver 20 ppm of NO, the "ground truth" for accuracy assessment would be the actual concentration measured by a highly accurate reference instrument. It was not expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
- Not Applicable/Not Provided. This document describes the premarket notification for a device change, primarily concerning hardware compatibility and a minor software update. It is not a submission for an AI/ML model where a "training set" of data would be used to develop a learned algorithm. The software changes are described as "Improvements in onscreen appearance" and "correct minor items noted during software testing," indicating traditional software development, verification, and validation, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there was no "training set" for an AI/ML algorithm in the context of this 510(k) submission, there was no establishment of ground truth for such a set.
§ 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.”