(29 days)
The Dash 2500 Patient Monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of this device is a portable (intrahospital) multiparameter unit designed for monitoring adult, pediatric, and neonate patient vital signs in a hospital subacute care environments, such as same-day surgery, emergency rooms, recovery/PACU, progressive care, interventional radiology, special care units, and GI/endoscopy.
The Dash 2500 Patient Monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), heart/pulse rate, respiration rate, ECG, temperature with an reusable electronic thermometer (predictive mode for oral and rectal temperature measurement, monitor mode for axillary temperature measurement), and functional oxygen saturation (SpO2) and pulse rate via spot checking and continuous monitoring, including monitoring during conditions of clinical patient motion or low perfusion.
The Dash 2500 Patient Monitor also detects alarm limit conditions and is capable of recording up to two waveforms. Using this monitor a clinician can view, record and recall clinical data derived from each parameter.
The Dash 2500 Patient Monitor is a portable (intra-hospital) multi-parameter monitor designed for monitoring adult, pediatric, and neonate patient vital signs.
The Dash 2500 Patient Monitor is self-contained and can be powered by batteries or AC. The Monitor has a carrying handle and can be operated on a shelf or table. It can also be mounted in a variety of ways (e.g., wall, pole, bed rail, or head/foot board) using a mounting plate located on the bottom of the Monitor. The Monitor can be used as a stand-alone monitor with the capability to interface to a central station, a server or any other device capable of receiving data using the host communications protocol.
The provided text states that no clinical studies were required or performed to support the substantial equivalence of the Dash 2500 Patient Monitor. Therefore, there is no information available to complete the requested table or answer the questions regarding acceptance criteria and performance studies.
The document explicitly states:
"The subject of this premarket submission, Dash 2500 Patient Monitor, did not require clinical studies to support substantial equivalence."
Instead of clinical studies, the manufacturer relied on:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Final acceptance testing (Validation)
- Performance testing (Verification)
- Safety testing (Verification)
These are quality assurance measures applied during the development of the system. The basis for substantial equivalence was that the Dash 2500 Patient Monitor "employs the same functional scientific technology" as its predicate device (K080157 Dash 2500 Patient Monitor) and complies with voluntary standards.
§ 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.