(189 days)
The CARESCAPE B850 is a multi-parameter patient monitor 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 ECG, ST segment, arthythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, 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.
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), the CARESCAPE Software, and a module frame F5 or F7. CARESCAPE B850 is equipped with the 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 includes features and subsystems that are optional or configurable.
This looks like a 510(k) summary for the GE Healthcare CARESCAPE B850 patient monitor. I will extract information related to the acceptance criteria and study that proves the device meets them.
Based on the provided text, the CARESCAPE B850 is a multi-parameter patient monitor. The 510(k) submission is for a new version with updated software and minor hardware modifications. The submission refers to a primary predicate device, also named CARESCAPE B850 (K191323), and additional predicate/reference devices for specific parameters (INVOS PM7100 and MASIMO RADICAL Y PULSE CO-OXIMETER).
The key takeaway is that the device did not require clinical studies to support substantial equivalence because it is a modified version of an already cleared device and incorporates previously cleared parameters. Therefore, the "study that proves the device meets the acceptance criteria" primarily refers to non-clinical bench testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the new CARESCAPE B850 compared to a specific threshold. Instead, it relies on the concept of substantial equivalence to a predicate device.
The "acceptance criteria" are implied to be that the performance of the new device is "as safe, as effective, and the performance to be substantially equivalent to the predicate device." The reported "device performance" is primarily that it passed various non-clinical tests.
Implied Acceptance Criteria (based on substantial equivalence concept):
| Performance Aspect | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Software | Meets specifications and validated as per design requirements. | Bench testing related to software design, development, verification, validation and traceability was conducted. |
| Hardware | Meets specifications, including safety and compatibility. | Bench testing related to electromagnetic compatibility, electrical safety, environmental, and usability was conducted. |
| Overall Safety & Effectiveness | As safe and effective as the predicate device (K191323). | The device is considered as safe, as effective, and its performance is substantially equivalent to the predicate device. |
Note: The document states that the fundamental function and operation of the proposed CARESCAPE B850 monitor are unchanged compared to its predicate (K191323), except for the addition of an E-musb Interface module and the capability to display previously cleared hemodynamic parameters from OEM devices (regional oxygen saturation and total hemoglobin concentration).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "bench testing related to software, hardware and performance." This typically involves testing prototypes or production units, but a "sample size" in the context of patient data is not applicable here as no clinical studies were performed for this submission.
- Data Provenance: Not applicable, as no external data (e.g., patient data from a specific country, retrospective or prospective) was used for this 510(k) submission to demonstrate substantial equivalence. The testing was internal bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. For bench testing of hardware and software, "ground truth" is typically established by engineering specifications, validated test protocols, and adherence to consensus standards, rather than expert clinical consensus on patient data.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This concept applies to clinical studies where discrepancies in observations or diagnoses need to be resolved. For bench testing, test results are typically compared against predefined specifications.
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 device is a multi-parameter patient monitor, not an AI-assisted diagnostic tool that would typically involve human readers. The new version mostly focuses on software updates, minor hardware changes, and display of previously cleared parameters from other OEM devices.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: The core functionality of the device (e.g., ECG, arrhythmia detection, various physiological measurements) operates in a "standalone" fashion in that the algorithms process patient data collected by the sensors. The document doesn't detail specific "algorithm-only" performance metrics as would be seen for a novel AI algorithm. Instead, it relies on the previous clearance of the predicate device and the fact that the algorithms (like EK-Pro arrhythmia detection algorithm V14) are identical. The newly added parameters (regional oxygen saturation and total hemoglobin concentration) are sourced from OEM devices that would have their own standalone performance data from their original clearances.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the non-clinical bench testing, the ground truth would be the engineering specifications of the device and adherence to relevant consensus standards (e.g., for electromagnetic compatibility, electrical safety, environmental performance). For the physiological parameters, the "ground truth" for the algorithms (e.g., arrhythmia detection) was established during the development and clearance of the predicate device (K191323) and the OEM devices for rSO2 and SpHb.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. As this is not an AI/ML device that requires a distinct "training set" for model development for this 510(k) submission, this information is not relevant here. The update involves existing algorithms and integration of existing cleared parameters.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, for the same reason as point 8.
§ 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.