(53 days)
The CARESCAPE™ Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility.
The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time
The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation)), Airway Gases (Fi/Et CO2, O2, N2O and Anesthetic Agent), Spirometry, Gas Exchange (02 Consumption (VO2), CO2 production (VCO2), energy expenditure (EE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status.
The CARESCAPE Monitor B850 provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices. The CARESCAPE Monitor B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for bed to bed viewing and to data management software devices via a network.
The CARESCAPE Monitor B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. In addition to the healthcare practitioner, the CARESCAPE Monitor B850 is designed to provide configuration and troubleshooting capabilities to qualified service personnel.
The CARESCAPE Monitor B850 is not intended for use during MRI.
The CARESCAPE Monitor B850 includes both new and existing subsystems interconnected to form a high acuity, multi-parameter patient monitoring system. A typical configuration would be a CARESCAPE Monitor B850 host processing unit running the CARESCAPE Monitoring platform software, a display with integrated keyboard and a frame for the insertion of parameter measurement modules. A variety of options are available to the customer including additional displays, various input devices (keyboard, mouse, bar code reader), additional modules and frames and software options.
The new subsystems include a host processing unit (CPU), a 15 inch LCD display with an integrated keypad, 19 inch LCD display with an integrated keypad and touch panel interface, a five slot parameter module frame, a seven slot parameter module frame, a cabled remote control, a cabled remote keypad, and the CARESCAPE Monitoring platform software. Some of these new major subsystems include non-patient contact accessory items (e.g. cables and mounting hardware). The CARESCAPE Monitor B850 interfaces to a variety of existing physiological parameter measurement modules. In addition, the CARESCAPE Monitor B850 interfaces to a variety of existing OEM medical devices via the existing network infrastructure.
The provided text is a 510(k) summary for the GE CARESCAPE™ Monitor B850. It explicitly states that no clinical studies were required or performed to support substantial equivalence for this device. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment does not exist within this document for the CARESCAPE Monitor B850 itself.
The substantial equivalence determination was based on non-clinical tests and a comparison to predicate devices, asserting that the device is as safe and effective due to its fundamental technology being the same as the predicates.
Here's a breakdown of why each requested point cannot be addressed by the provided text:
- A table of acceptance criteria and the reported device performance: Not provided. The document outlines general "quality assurance measures" (e.g., Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level, Integration testing, Final acceptance testing, Performance testing, Safety testing) but no specific performance acceptance criteria or results are given.
- Sample sized used for the test set and the data provenance: Not provided, as no clinical test set was used for substantial equivalence.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no external test set requiring expert ground truth was mentioned for the substantial equivalence determination.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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. The device is a patient monitor, not an AI-assisted diagnostic tool, and no MRMC study was performed.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a "multi-parameter patient monitor," implying continuous operation with human oversight, not a standalone algorithm. Performance metrics in an "algorithm only" context are not discussed.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as no clinical ground truth data for the device was used in its pathway to substantial equivalence.
- The sample size for the training set: Not applicable, as this is a patient monitor, not an AI software/algorithm requiring a training set in the conventional sense for a 510(k) submission focused on substantial equivalence to existing predicate hardware/software.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided 510(k) document states: "The subject of this premarket submission, CARESCAPE™ Monitor B850 did not require clinical studies to support substantial equivalence." Therefore, the detailed information about acceptance criteria and clinical study results that you requested is not available in this document. The submission relied on non-clinical testing and comparison to predicate devices.
§ 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.