(260 days)
The CARESCAPE B450 is a multi-parameter patient monitor intended for use in multiple areas and intra hospital transport within a professional healthcare facility.
The CARESCAPE B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B450 is indicated for monitoring of:
· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic 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 B450 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 B450 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 B450 also shows alarms from other ECG sources.
The CARESCAPE B450 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices.
The CARESCAPE B450 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.
CARESCAPE B450 V3 is a new version of a portable multiparameter patient monitoring system. The CARESCAPE B450 V3 includes the monitor itself with built-in CPU, power unit, a 12 inch touch display, the CARESCAPE Software version 3 and one or two batteries. CARESCAPE B450 V3 is equipped with so called ePort interface that supports use of PDM or CARESCAPE ONE patient data acquisition modules for patient monitoring. CARESCAPE B450 V3 is also equipped with one module slot where patient data acquisition modules (E-Modules), can be connected to perform patient monitoring. The CARESCAPE B450 V3 includes features and subsystems that are optional or configurable.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the CARESCAPE B450, based on the information provided in the 510(k) summary.
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study report with specific acceptance criteria and performance metrics for the novel aspects. Therefore, much of the requested information (like specific quantitative acceptance criteria or detailed study methodologies for new features) is not explicitly present. The summary explicitly states that no clinical studies were required to support substantial equivalence for this particular submission.
Acceptance Criteria and Device Performance for CARESCAPE B450
Given that this is a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to a predicate device. This is achieved by showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The performance outlined refers to the device's ability to maintain existing functionalities and integrate new ones without compromising safety or efficacy, primarily through non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance:
Since explicit, quantitative acceptance criteria for each individual parameter for this 510(k) are not provided in the document (as it's a "substantial equivalence" claim based on existing technology), the table below reflects what can be inferred. The "acceptance criteria" here are largely implicit: that the new device performs equivalently or better than the predicate, or that new features function as intended and safely.
| Feature/Parameter | Acceptance Criteria (Inferred from Substantial Equivalence and Bench Testing) | Reported Device Performance (from K191249 Summary) |
|---|---|---|
| Arrhythmia Detection (EK-Pro) | Performance of EK-Pro V14 algorithm to be equivalent or improved compared to EK-Pro V13 in the predicate devices while ensuring clinical safety and accuracy for detected arrhythmias (e.g., atrial fibrillation, asystole, bradycardia, V-fib/V-tach, etc.). This would typically involve meeting sensitivity and specificity targets compared to an expert-annotated ground truth. | Equivalent: "CARESCAPE B450 V3 uses an EK-ProV14 arrhythmia analysis algorithm compared to the EK-Pro V13 used in the predicate monitors." (Implies it meets or exceeds V13 performance, which was already cleared.) The document does not provide specific performance metrics for sensitivity/specificity of EK-Pro V14 itself, but rather states it's an "equivalent" change. |
| Gas Exchange Parameters (VO2, VCO2, EE, RQ) | Accurate and reliable measurement of O2 consumption (VO2), CO2 production (VCO2), energy expenditure (EE), and respiratory quotient (RQ) when utilizing the E-sCOVX or E-sCAIOVX modules. Performance should be equivalent to existing cleared devices (B850, B650) that support these parameters. | Added support for gas exchange parameters: "The gas exchange parameters and calculations are identical to the predicate CARESCAPE Monitor B850 (K131414) and CARESCAPE Monitor B650 (K131223) monitors." These modules were previously cleared (K150245); the B450 V3 now supports their integration. |
| Hardware Components (Processor, Modules) | New hardware (Freescale ARM Cortex-A9 processor) and updated module support (e.g., CARESCAPE ONE, E-EEGX, E-sCAIOVX) should maintain or improve overall system performance, reliability, and safety compared to the predicate device, without introducing new hazards. Functionality of all supported modules must be verified within the new system. | Equivalent: "The CARESCAPE Bx50 V3 monitors have an updated common CPU platform." "Removed support for several legacy... as many newer acquisition modules are included... Added support for CARESCAPE ONE and E-EEGX acquisition modules. Added support for E-sCAIOVX and E-sCOVX modules (K150245)." Implies functional equivalence or improvement. |
| Alarm Management | Enhanced flexibility in alarm settings (priorities, criteria, delays, critical alarm options, acknowledgment, latched indicators, pause monitoring) must reduce alarm fatigue while maintaining patient safety. Default settings must conform to IEC 60601-1-8. Functionality including remote alarm integration via CARESCAPE RAD must be reliable. | Equivalent: "More flexibility was added for the user to adjust alarm priorities and alarm criteria for additional parameter alarms, including additional alarm delay options, critical alarm options, alarm acknowledgement and latched alarm indicators, and a pause monitoring & central function." "Default setting are according to IEC 60601-1-8." Remote alarm functionality is "utilized for remote alarming" and "the CARESCAPE Bx50 V3 alarm functionality is unaffected." |
| Network Capability (WLAN) | Ability to support new wireless standards (IEEE 802.11n, 802.11r fast roaming, WPA2-Enterprise security) while ensuring secure, fast, and reliable data transfer during intra-hospital transport, and without impacting clinical monitoring. The device must withstand network storms without rebooting. | Equivalent: "Support wireless data transfer with support for WPA2-Enterprise security mechanisms... and support the IEEE 802.11n protocol for faster wireless data transfer, and the IEEE 802.11r fast roaming standard for fast and secure handoffs... without rebooting when connected by wire to either MC, IX, or both networks which suffer broadcast storm traffic." Testing confirmed the device can withstand network storms. |
| Overall Performance & Safety | The device must meet all specified performance requirements for its intended use (monitoring hemodynamic, respiratory, and neurophysiological status for adult, pediatric, and neonatal patients) and maintain safety and effectiveness as outlined by applicable consensus standards and regulatory requirements. | "Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the CARESCAPE B450, demonstrating the design meets the specifications." "Found to be substantially equivalent to the predicate device(s) for the intended users, uses and use environments." |
| Usability | Usability of the device, particularly with the new graphical user interface (HDX) and revised alarm management, must be maintained or improved, ensuring that critical tasks can be performed safely and effectively. | "Extensive usability work has been completed for CARESCAPE B450 and the predicate devices including critical task identification through use-based hazard analysis, multiple rounds of formative usability testing and summative testing, among other activities." The new GUI is a "new color scheme" and "slight visual adjustments," but the "overall user interface layout, structure, operations, and workflow remains the same as the predicate," ensuring equivalence. |
| Cybersecurity | Security risks related to system integrity, access control, audit control, network control, and remote services must be addressed in accordance with FDA guidance. | "Patient safety, security, and privacy risks have been addressed... including a Security Risk Assessment and Threat model. This includes system integrity controls, access controls, audit controls, network controls, and remote service controls which map to the General Principles and Security Capabilities outlined in the FDA Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in the 510(k) summary for specific performance tests. The review relies on "bench testing" and "extensive usability work" without providing specific numbers of test cases, patients, or data points.
- Data Provenance: Not explicitly stated. The nature of "bench testing" suggests a controlled, laboratory environment. For usability, it would involve participants, but their origin is not specified. The arrhythmia algorithm (EK-Pro V14) likely draws from large, existing ECG databases typically used in device development, but this is not detailed here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Number of Experts & Qualifications: Not specified in the provided text. For arrhythmia algorithms (EK-Pro), ground truth is typically established by multiple cardiologists or electrophysiologists. However, for this 510(k), since the EK-Pro V14 is considered "equivalent" to a previously cleared version, the detailed ground truth establishment for it is likely from prior submissions or internal development, not explicitly reported here.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not specified. For tasks like arrhythmia detection, typically multiple experts review and label data, and disagreements are resolved through consensus, majority vote, or a super-reader.
5. 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:
- MRMC Study: No. The document explicitly states: "The subject of this premarket submission, CARESCAPE B450 did not require clinical studies to support substantial equivalence." This means no clinical MRMC studies were conducted for this submission. The device is a patient monitor, not primarily an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance Study: The document does not explicitly present a standalone performance study for the EK-Pro V14 arrhythmia algorithm. It states that EK-Pro V14 is an update to V13 and is "equivalent." Implied is that internal validation of the algorithm's performance against ground truth would have occurred during its development, but the results are not detailed in this 510(k) summary. The gas exchange parameters are also noted as "identical" in calculation to previously cleared predicate devices, implying their standalone performance is already established.
7. The Type of Ground Truth Used:
- Ground Truth Type: Not explicitly stated for any of the tested features within this document.
- For Arrhythmia Detection (EK-Pro V14): Typically, expert-annotated ECG waveforms (clinical data) serve as ground truth.
- For Gas Exchange Parameters: Likely derived from high-precision laboratory measurements or established physiological models.
- For Hardware/Software Functional Testing: System specifications and expected behavior as defined during development serve as ground truth.
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not specified. Training sets are primarily relevant for machine learning algorithms. While the EK-Pro algorithm may have some adaptive or learning components from its development, the document doesn't detail its training set.
9. How the Ground Truth for the Training Set was Established:
- Ground Truth Establishment for Training Set: Not specified. As mentioned above, for arrhythmia detection, this would typically involve expert cardiological review and annotation of large datasets.
§ 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.