(101 days)
The Prefense EDNS-9000 Series Central Nurse Station is intended for use by medical professionals to provide cardiac and vital signs monitoring for multiple patients within a medical facility.
The Prefense EDNS-9000 Series Central Nurse Station will display and record physiological data from up to forty telemetry receivers/transmitters and generates an alarm when a measured parameter falls outside a preset limit or when an arrhythmia is detected. Arrhythmia detection and alarm determination are functions of the telemetry receivers/transmitters or individual beside monitor.
The Prefense EDNS-9000 Series Central Nurse Station is intended for cardiac and vital signs monitoring for multiple patients. The device will display and record physiological data from telemetry receivers/transmitters and alarms when a measured parameter falls outside a preset limit or when an arrhythmia is detected by the telemetry unit.
This product will be available for use by medical personnel on all patient populations with a medical facility.
The Prefense EDNS-9000 Series Central Nurse Station is intended for use by medial professionals to provide cardiac and vital signs monitoring for multiple patients within a medical facility. The Prefense EDNS-9000 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 (Model ORG-9700 Multiple Patient Receiver, per 510K K071058 Commercial distribution certification dated June 29, 2007) transmitter (Model ZS-940PA, per 510(k) K043517 Commercial Distribution certification dated February 3, 2005).
The new device receives a small subset (non-invasive telemetry parameters) all of the same information as the predicate device, i.e., receives physiological signal from telemetry transmitters/receivers from ORG 9700 Multiple Patient Receiver signal simultaneously, receives and displays physiological information. generates audible and/or visual alarm indictors when an alarm violation is detected by the telemetry units, stores waveforms for review and printing as full disclosure, stores tabular and graphical trending data for review and printing, provides network communications using commercially available LAN/WAN products, provides remote data access through NetProse access software and records and prints physiological patient data.
I am sorry, but based on the provided text, there is no information about specific acceptance criteria or a study proving the device meets them, as requested in your prompt.
The document discusses the regulatory submission for the NIHON KOHDEN NKUS LAB PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION, focusing on its substantial equivalence to a predicate device. It briefly mentions "design validation confirmed the operation of the software and hardware of the device is in accordance to the design specifications" and that the device "was subjected to electromagnetic, environmental, safety and performance testing procedures." However, it does not provide details on:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts, or adjudication methods for any test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
- Whether a standalone performance study was done.
- The type of ground truth used for any evaluations.
- Sample size for training sets or how ground truth was established for them.
The device's description clarifies that "Arrhythmia detection and alarm determination are functions of the telemetry receivers (Model ORG-9700 Multiple Patient Receiver, per 510K K071058 Commercial distribution certification dated June 29, 2007) transmitter (Model ZS-940PA, per 510(k) K043517 Commercial Distribution certification dated February 3, 2005)." This indicates that the core arrhythmia detection logic resides in separate, previously cleared devices, and the Central Nurse Station primarily displays and records data from these units.
Therefore, I cannot fulfill your request for details on acceptance criteria and study proving their achievement from the provided text.
§ 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.