(109 days)
The CNS-6200 Series Central Nurse Station is intended for cardiac and vital signs monitoring for multiple patients. The device will display and record physiological data from individual bedside monitors and /or telemetry received transmitters and mimics an alarm when a measured parameter falls outside a preset limit or when an arrhythmia is detected by the bedside monitor or telemetry unit.
This product will be available for use by medical personnel on all patient populations within a medical facility.
The device is intended for use by medical professionals to provide cardiac and vital signs monitoring for multiple patients within a medical facility. The CNS-6200 Series Central Nurse Station will display and record physiological data from up to forty telemetry receiver/transmitters and generates an alarm when a measured parameter falls outside a pre-set limit or when life threatening arrhythmia is detected. Arrhythmia detection and alarm determination are functions of the telemetry receivers/transmitters or individual bedside monitor.
The provided document describes a 510(k) premarket notification for the Nihon Kohden CNS-6200 Series Central Nurse Station. This device is an update to a previously cleared predicate device (CNS-9701A). The submission focuses on demonstrating substantial equivalence rather than a new performance claim, therefore, details on specific acceptance criteria for a new device's performance, a comprehensive study proving those criteria, or a standalone performance study are not explicitly included in the provided text as one might find for a novel AI/software medical device.
However, based on the information provided, we can infer some aspects related to acceptance criteria and validation.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Electrical Standards Compliance: | CNS-6200 Series Central Nurse Station complies with IEC 60601-1 subclause 56.3 (C), implemented by 21 CFR Part 868 Performance Standard for Electrode Lead Wires and Patient Cables. |
| Proper Operation according to Design Specifications: | Design validation confirmed the operation of the software and hardware of the device is in accordance to the design specifications. |
| Electromagnetic, Environmental, and Safety Performance: | The device was subjected to electromagnetic, environmental, safety and performance testing procedures. These tests verified the proper operation of the device. |
| Functional Equivalence to Predicate Device: | The technical characteristics of the CNS-9701A predicate and the new CNS-6200 Series are the same with the exception that the new device has new hardware such as CPU and LCD monitor. (This implies that the new device performs the same functions, including cardiac and vital signs monitoring, display, recording, and alarm mimicking, as the predicate.) |
| Intended Use Compliance: | The device's operation aligns with its intended use: "cardiac and vital signs monitoring for multiple patients. The device will display and record physiological data from individual bedside monitors and /or telemetry received transmitters and mimics an alarm when a measured parameter falls outside a preset limit or when an arrhythmia is detected by the bedside monitor or telemetry unit." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical study in the typical sense of a novel device requiring a test set of patient data for performance evaluation (e.g., sensitivity, specificity for arrhythmia detection algorithms). Instead, the validation is focused on engineering verification and validation (V&V) activities and demonstrating substantial equivalence to a predicate device.
- Sample Size for Test Set: Not applicable or not specified in the context of clinical performance data. The "test set" would primarily refer to the device itself undergoing various engineering and functional tests.
- Data Provenance: Not applicable, as this submission isn't based on retrospective or prospective patient data for an algorithm's performance. The validation is based on the device's adherence to design specifications and safety standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. For this type of device (a patient monitoring system that displays and relays information, rather than autonomously making a diagnosis or interpretation), "ground truth" established by clinical experts on a test set of patient cases is not a requirement for this 510(k) submission. The ground truth would reside in the functioning of the connected bedside monitors or telemetry units for arrhythmia detection.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no mention of a human-reviewed test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-driven diagnostic or interpretative aids where human reader performance is a key metric. The CNS-6200 Series Central Nurse Station is a monitoring and display system, not a diagnostic interpretation tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Standalone Study: No, a standalone performance study (in the context of an algorithm's diagnostic or interpretive accuracy) was not described or performed. The device's function is to display and record physiological data and mimic alarms from other primary devices (bedside monitors and telemetry units). The core arrhythmia detection function, for example, resides in the connected telemetry receivers/transmitters or individual bedside monitors, not the central station itself. The central station's "performance" is in accurately receiving, displaying, recording, and relaying these statuses and alarms.
7. The Type of Ground Truth Used
- Type of Ground Truth: The concept of "ground truth" as typically applied to algorithmic performance (e.g., pathology, outcomes data) is not directly relevant here. The ground truth for the CNS-6200 Series would be:
- Design Specifications: The device accurately performs according to its documented design.
- Predicate Device Functionality: The new device replicates the functions and technical characteristics of the legally marketed predicate device.
- Regulatory Standards: The device adheres to mandated safety and electrical performance standards (e.g., IEC 60601-1, 21 CFR 868).
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set of data. Its development is based on engineering design principles for hardware and software, not on machine learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as no training set was used.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.