(104 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 is indicated for monitoring of:
· hemodynamic (including ECG, ST segment, arrhythmia 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 Monitor B850 also 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 remote 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,
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 (in this submission the ESP V2 software) , a display with integrated keyboard and a frame for the insertion of parameter measurement modules. Many times a secondary display with keyboard is also used. The CARESCAPE Monitor B850 is designed to give the user maximum flexibility to choose the particular options for the particular care environment at the healthcare facility. 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. Some of these 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. There are also various care area specific main software options and software licenses for specific features the customer can choose from for the CARESCAPE Monitor B850. There are also various upgrade programs offered to existing customers via the CARESCAPE Life Upgrade Programs to provide new CARESCAPE Monitor B850 hardware and/or software to the customers, but offer the benefit that the customers can continue to use the majority of their parameter measurement modules.
The provided text describes the GE Healthcare CARESCAPE Monitor B850, a multi-parameter patient monitor. However, the document does not contain information related to specific acceptance criteria, device performance, or a study proving that the device meets acceptance criteria.
Instead, the document focuses on:
- 510(k) Summary: Detailing the device owner, contact information, device names, and classification.
- Predicate Device: Identifying the K092027 CARESCAPE Monitor B850 with ESP V1 software as the predicate.
- Device Description: Explaining the system's components and flexibility.
- Intended Use: Outlining the patient populations, monitoring capabilities (hemodynamic, respiratory, neurophysiological), and operational environment.
- Compliance with Standards: Listing numerous IEC and AAMI standards that the device was designed and tested for.
- Clinical Studies: Explicitly stating that "The subject of this premarket submission, CARESCAPE Monitor B850 did not require clinical studies to support substantial equivalence."
- Conclusion: Asserting substantial equivalence to the predicate device.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I describe a study proving the device meets acceptance criteria, as the document states no clinical studies were required or performed for this submission.
The document heavily relies on non-clinical testing and compliance with voluntary standards to demonstrate substantial equivalence.
Here's what can be inferred from the provided text regarding other requested points, even without a specific performance study:
- Sample size used for the test set and the data provenance: Not applicable, as no dedicated performance study is described. The non-clinical testing refers to unit, integration, final acceptance, and performance testing, but details on test sets (e.g., patient data) are not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: No, such a study is not mentioned. The document explicitly states no clinical studies were required.
- Standalone (i.e. algorithm only without human-in-the loop performance) study: Not applicable based on the provided information.
- Type of ground truth used: Not applicable, as no performance study is described. The "ground truth" for the device's functionality would be its adherence to the design specifications and compliance with the various industry standards listed.
- Sample size for the training set: Not applicable, as no algorithm training or performance study is detailed, beyond the mention of the EK-Pro Arrhythmia Detection Algorithm.
- How the ground truth for the training set was established: Not applicable.
§ 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.