(163 days)
The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. The NKV-550 offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. The NKV-550 is intended for use in hospitals and hospital-type facilities, as well as, for in-hospital transportation.
The Nihon Kohden NKV-550 Series Ventilator System consists of a graphic user interface (GUI) and a breath delivery unit (BDU). The GUI allows clinicians to set ventilator control parameters such as tidal volume and inspiratory pressure, to set alarm limits such as high inspiratory pressure alarm, to view monitored numeric values, to view waveform and loops, and to operate various features through the apps.
The BDU contains a microprocessor that receives inputs from the electronic system and controls the pneumatic system for breath delivery to the patient. It also provides various alarms, a safety valve, and other design features.
The Nihon Kohden NKV-550 Series Ventilator System's acceptance criteria and the study proving it meets these criteria are described below.
1. Table of Acceptance Criteria and Reported Device Performance
| Technical Characteristic | Acceptance Criteria (Predicate Device: Draeger Evita Infinity V500, K093633) | Reported Device Performance (Nihon Kohden NKV-550 Series Ventilator System) | Comparison |
|---|---|---|---|
| Indication for Use | Intended for the ventilation of adult, pediatric and neonatal patients. Offers mandatory ventilation modes and ventilation modes for spontaneous breathing support and airway monitoring. Intended for use in different medical care areas (hospitals, medical rooms) or for patient transportation within the hospital. | Intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. Offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. Intended for use in hospitals and hospital-type facilities, as well as for in-hospital transportation. | Same |
| Environment of Use | Hospitals, hospital-type facilities and in-hospital transportation for patients who need ventilation therapy | Hospitals, hospital-type facilities and in-hospital transportation for patients who need ventilation therapy | Same |
| Anatomical Site | Patient airways | Patient airways | Same |
| Target Population | Adult, pediatric and neonatal patients | Adult, pediatric and neonatal patients | Same |
| Performance | Met ISO 80601-2-12 requirements on essential performance of critical care ventilator | Met ISO 80601-2-12 requirements on essential performance of critical care ventilator | Same |
| Waveform Comparison | Comparable waveform test result | Comparable waveform test result | Substantially equivalent |
| Design | Consists of a graphic user interface to set and monitor ventilation, breath delivery unit, breathing circuit; Controls air and oxygen deliveries by proportional valves through microprocessors | Consists of a graphic user interface to set and monitor ventilation, breath delivery unit, breathing circuit; Controls air and oxygen deliveries by proportional valves through microprocessors | Substantially equivalent |
| Chemicals Delivered to Patient | Medical Air and Oxygen | Medical Air and Oxygen | Same |
| Delivery method to Patient | Positive pressure | Positive pressure | Same |
| Energy Used for Device | AC Power and DC Power (battery) | AC Power and DC Power (battery) | Same |
| Control principle | Time-cycled, volume-constant, pressure-controlled | Time-cycled, volume-constant, pressure-controlled | Same |
| Therapy Types | Intubated, Non-invasive, O2 Therapy | Invasive, Non-invasive, O2 Therapy | Same |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state a "test set" in the context of clinical data for performance evaluation. Instead, the performance was demonstrated through non-clinical testing against various standards and comparisons to a predicate device. Therefore, a specific sample size for a test set of patient data is not applicable here as clinical performance data was not required for substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as clinical performance data was not required, and thus, no ground truth established by experts on patient data was utilized for the device's clearance. The "ground truth" for the non-clinical testing was established by the requirements and thresholds set by the relevant international standards (e.g., ISO 80601-2-12, ANSI AAMI ES60601-1, etc.).
4. Adjudication method for the test set:
Not applicable, as clinical performance data and expert-established ground truth were not used for the device's clearance.
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. This device is a ventilator system, not an AI-assisted diagnostic or interpretation tool that would involve human readers or MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device's performance was evaluated in a standalone manner by testing against established international standards. The listed "Summary of Non-Clinical Performance Data" includes:
- Software Verification
- Electrical Safety & EMC Testing
- Agency Testing to Applicable Standards
- Device Functionality Testing
- Performance of Therapy Types and Ventilation Modes
- Product Endurance
- Power Performance
- Environmental
- Cleaning & Disinfection
- Gas Path Biocompatibility
- Human Factors/Usability Testing
- Risk Management
- Waveform Comparison with Predicate
- Accessory Compatibility
These tests assess the device's intrinsic functions and compliance with safety and performance requirements, which can be considered standalone performance.
7. The type of ground truth used:
For the non-clinical performance evaluation, the "ground truth" was derived from:
- International Standards: e.g., ISO 80601-2-12 (essential performance of critical care ventilators), ANSI AAMI ES60601-1 (general requirements for basic safety and essential performance), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-1-6 (usability), IEC 60601-1-8 (alarm systems), IEC 62133 (batteries), ISO 80601-2-55 (respiratory gas monitor), ISO 10993-1 (biological evaluation), ISO 18562-1 to 3 (biocompatibility of breathing gas pathways).
- Predicate Device Characteristics: The Nihon Kohden NKV-550 Series Ventilator System was compared to the predicate device (Draeger Evita Infinity V500) based on its documented technical characteristics and performance, aiming for substantial equivalence.
8. The sample size for the training set:
Not applicable, as this device does not appear to involve machine learning or AI models that would require a training set of data. Its performance is based on engineering design and meeting pre-defined physical and functional specifications.
9. How the ground truth for the training set was established:
Not applicable, as there is no mention of a training set or machine learning components in the provided documentation.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).