(154 days)
The Monitor B125/B105 is a portable multi-parameter unit to be used for monitoring, and to generate alarms for multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.
The Monitor B125/B105 is intended for use under the direct supervision of a licensed health care practitioner. The Monitor B125/B105 is not intended for use during MRI.
The Monitor B125/B105 can be a stand-alone monitor or interfaced to other devices via network.
The Monitor B125/B105 monitors and displays : ECG (including ST segment, arrhythmia detection, ECG Diagnostic Analysis and Measurement,), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring( including monitoring conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/Tympani/Rectal/ Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration rate, CO2.
The Monitor B125/B105 is able to detect and generate alarms for ECG arrhythmias: Asystole, Ventricular tachycardia, VT>2, Ventricular Bradycardia, Accelerated Ventricular Couplet, Bigeminy, Trigeminy, Trigeminy, "R on T", Tachycardia, Bradycardia, Pause, Atrial Fibrillation, Multifocal PVCs, Missing Beat, Premature Ventricular Contraction (PVC) and Ventricular fibrillation.
The Monitor B125/B105 is a multi-parameter patient monitor that is developed based on the predicate Monitor B40 (K151063) platform. The Monitor B125/B105 provides additional support for ECG full arrhythmia (has been claimed in CARESCAPE Monitor B650(K102239)), WLAN (FCC ID: OU5B1X501) and touch screen.
As with the predicate Monitor B40(K151063), the proposed Monitor B125/B105 is a multiparameter patient monitor, utilizes 12inches /10inches LCD display with an integrated keypad and a pre-configuration (hemodynamic module) which provide basic parameters: ECG, RESP, NIBP, IBP, TEMP, SPO2.
As with the predicate Monitor B40(K151063), the proposed Monitor B125/B105 has optional CO2 parameter provided by the identical E-MiniC module (K052582).
As with the predicate Monitor B40(K151063), the proposed Monitor B125/B105 has a mounting plate on the bottom of the monitor. The monitor can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.
The provided text describes a 510(k) premarket notification for the GE Monitor B125/B105. While it details various performance data related to electrical safety, EMC, software verification, environmental, mechanical stress, and packaging tests, it does not include specific acceptance criteria or a study that directly proves the device meets such criteria for parameters like arrhythmia detection accuracy.
The document states:
- "The proposed Monitor B125/B105 provides additional support for ECG full arrhythmia (has been claimed in CARESCAPE Monitor B650 (K102239))"
- "The proposed device uses the same ECG algorithm (EK-Pro V12) as predicate device B40 (K151063)"
- "The proposed device enabled full arrhythmia analysis which disabled in the predicate device B40 (K151063)."
- "Full arrhythmia analyses implemented with EK -ProV12 ECG algorithm was cleared in B650 (K102239)"
This indicates that the arrhythmia detection capabilities rely on a previously cleared algorithm (EK-Pro V12) and that the full arrhythmia analysis feature was enabled on the new device, having been previously cleared in the predicate device B650 (K102239). However, no new study data for arrhythmia detection performance or specific acceptance criteria for these functionalities are presented in this document.
Therefore, based solely on the provided text, I cannot complete the requested information regarding acceptance criteria and a study proving the device meets them for ECG arrhythmia detection. The document primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and adherence to various safety and performance standards, but not on detailed performance metrics for specific clinical functions like arrhythmia detection.
No information is available for the following points in the provided document:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance for arrhythmia detection.
- Number of experts used to establish the ground truth for the test set and their qualifications for arrhythmia detection.
- Adjudication method for the test set for arrhythmia detection.
- Multi-reader multi-case (MRMC) comparative effectiveness study information.
- Standalone (algorithm only) performance information for arrhythmia detection.
- Type of ground truth used for arrhythmia detection.
- Sample size for the training set for arrhythmia detection.
- How the ground truth for the training set was established for arrhythmia detection.
§ 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.