(259 days)
The CARESCAPE B850 is a multi-parameter patient montor intended for use in multiple areas within a professional healthcare facility.
The CARESCAPE B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B850 is indicated for monitoring of:
· hemodynamic (including ECC, ST segment, arthythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),
· respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and
· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).
The CARESCAPE B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.
The CARESCAPE B850 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B850 also shows alarms from other ECG sources.
The CARESCAPE B850 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices.
The CARESCAPE 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.
Contraindications for using the monitor
The CARESCAPE B850 is not intended for use in a controlled MR environment.
The CARESCAPE B850 is a new version of a modular multi-parameter patient monitoring system. The monitor includes a separate 19-inch touchscreen display, the central processing unit (also called CPU) and the module frame F5 or F7. CARESCAPE B850 V3 is equipped with an "ePort" interface that supports use of PDM or CARESCAPE ONE patient data acquisition modules for patient monitoring. In addition, the F5 module frame has five module slots, and the F7 module frame has seven module slots where patient data acquisition modules (E-Module type), can be connected to perform patient monitoring. The CARESCAPE B850 V3 includes features and subsystems that are optional or configurable.
The provided document, [K191323](https://510k.innolitics.com/search/K191323), is a 510(k) premarket notification for the GE Healthcare CARESCAPE B850 patient monitor. It describes the device and compares it to a predicate device ([K131414](https://510k.innolitics.com/search/K131414) CARESCAPE Monitor B850). This document outlines non-clinical testing and explicitly states that clinical studies were not required.
Therefore, I cannot fully answer your request for acceptance criteria and a study proving the device meets those criteria from this specific document, as it indicates clinical studies were not performed. The document focuses on demonstrating substantial equivalence through non-clinical bench testing, including software, hardware, and performance tests, and usability studies.
However, I can extract the information related to the device's performance and the types of tests conducted, even if they aren't presented as a structured "acceptance criteria" table with "reported device performance" against them in a clinical study context.
Here's a breakdown of what can be extracted and what cannot:
What Can Be Inferred/Extracted from the Document:
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Device Performance (as demonstrated by non-clinical testing):
- The CARESCAPE B850's hardware, software, and overall performance met specifications through bench testing.
- The device demonstrated electromagnetic compatibility, electrical safety, environmental resilience, and usability.
- Software testing covered design, development, verification, validation, and traceability.
- The device addressed patient safety, security, and privacy risks, including cybersecurity measures.
- It can withstand network storm conditions without rebooting.
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Test Set Description (for non-clinical testing):
- Data Provenance: Not explicitly stated for specific datasets, but testing was conducted on the aformentioned device, manufactured by GE Healthcare Finland Oy. This implies internal testing. The nature of "bench testing" suggests controlled environments rather than real-world patient data for performance validation against specific clinical thresholds.
- Retrospective/Prospective: Not specified. Bench testing is typically a controlled laboratory process.
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Ground Truth (for non-clinical testing):
- The "ground truth" for the technical specifications and performance of the device (e.g., accuracy of parameter measurements, robust alarms) would have been established by engineering and quality standards, internal specifications, and applicable consensus standards (e.g., IEC 60601-1-8 for alarms).
What Cannot Be Answered From the Document (specifically regarding clinical studies/acceptance criteria as implied by clinical outcomes or human reader performance):
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A table of acceptance criteria and the reported device performance (in a clinical context): The document explicitly states "CARESCAPE B850 did not require clinical studies to support substantial equivalence." Therefore, no clinical performance acceptance criteria or reported clinical performance is provided. The acceptance criteria for the non-clinical tests are implicit in the statement "demonstrating the design meets the specifications" for hardware, software, and performance.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective) for a clinical study: Not applicable, as no clinical study was performed.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable, as no clinical study was performed. Ground truth for technical performance would be against engineering benchmarks, not expert clinical assessment in a study.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical study was performed.
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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. This device is a patient monitor, not an AI-assisted diagnostic tool for image interpretation or similar. The "EK-Pro arrhythmia detection algorithm" is an internal algorithm, not a separate AI for human assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The EK-Pro V14 arrhythmia analysis algorithm operates within the device as a standalone component for its intended function. Its performance would have been validated against a set of ECG waveforms with established ground truth for arrhythmias, but details of such testing (like sample size or specific metrics) are not in this 510(k) summary. The document states "EK-Pro V14 arrhythmia analysis algorithm compared to the EK-Pro V13 used in the predicate monitors," implying internal validation of the updated algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the arrhythmia detection algorithm, the ground truth would typically be established by expert cardiologists reviewing ECG recordings. However, the details of how EK-Pro V14's ground truth was established are not provided in this 510(k). For general device performance, the ground truth is adherence to technical specifications and relevant standards.
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The sample size for the training set: Not applicable, as this is a 510(k) submission for a patient monitor, not an AI/ML device requiring a training set in the typical sense. While the EK-Pro algorithm may have been "trained" or developed using data, the document does not mention details about this.
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How the ground truth for the training set was established: Not applicable for the same reason as above.
Summary Table of Available Information (based on non-clinical context):
| Acceptance Criterion (Type of Test) | Reported Device Performance / Outcome (Non-Clinical) |
|---|---|
| Hardware Performance | Meets specifications. Includes electromagnetic compatibility, electrical safety, environmental, and usability testing. |
| Software Performance | Meets specifications. Includes software design, development, verification, validation, and traceability. The new EK-Pro V14 arrhythmia analysis algorithm is considered equivalent to the predicate's V13. |
| Usability | Extensive usability work completed, including critical task identification through use-based hazard analysis, multiple rounds of formative usability testing, and summative testing. The overall user interface layout, structure, operations, and workflow remain the same as the predicate, with only a new color scheme and slight visual adjustments aligned with a new design guideline. |
| Cybersecurity / Risks | Patient safety, security, and privacy risks addressed through design and development, including a Security Risk Assessment and Threat model (system integrity controls, access controls, audit controls, network controls, remote service controls) mapping to FDA Guidance for Cybersecurity in Medical Devices (2014). The device can withstand network storm conditions without rebooting when connected by wire to specific networks. |
| Alarm Functionality | Alarm management core functionalities (classification, notification, adjustment of settings, On/Off, audio silencing) are implemented and equivalent to the predicate. Added flexibility for users to adjust alarm priorities, criteria for additional parameter alarms, alarm delay options, critical alarm options, alarm acknowledgement, and latched alarm indicators. Supports tailored/specific alarm management schemes to reduce alarm fatigue while maintaining safety. Default settings are according to IEC 60601-1-8. The CARESCAPE RAD (new accessory for remote alarms) replaces the prior Remote Alarm Box and communicates one-way, not affecting the B850's alarm functionality. |
| Networking Capability | Supports CARESCAPE Network LAN/VLAN. New single-wire network configuration supported, simplifying installation and maintenance without impact on clinical monitoring. |
| Processor | Updated from Intel Celeron-M 423 ULV to Freescale ARM Cortex-A9, considered equivalent. |
| Modules Supported | Equivalent. Supports newer acquisition modules, covering the same parameters as the predicate, with some legacy modules removed and new ones (e.g., CARESCAPE ONE, E-EEGX, E-sCAiOVX, E-sCOVX) added. |
| General Equivalence | "The fundamental function and operation of the proposed CARESCAPE B850 V3 monitor are unchanged compared to CARESCAPE Monitor B850 with ESP V2 software (K131414). There are no new types of monitored parameters introduced compared to the predicate B850 monitor." The device is found to be substantially equivalent to the predicate device(s) for the intended users, uses and use environments based on non-clinical testing. |
Conclusion from Document:
The acceptance criteria for the CARESCAPE B850, as presented in this 510(k) submission, were met through extensive non-clinical bench testing, hardware and software verification/validation, and usability studies. The submission asserts the device's substantial equivalence to its predicate based on these non-clinical activities, stating explicitly that clinical studies were not required or performed.
§ 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.