(195 days)
McKesson Cardiology™ Hemo is intended for complete physiological/hemodynamic monitoring. clinical data acquisition, medical image and data processing, and analytical assessment.
McKesson Cardiology™ Hemo is also intended for patient/procedural data management, such as documentation, logging, reporting, storing, storing, carrying, carrying out clinical calculations and exporting various representations of the acquired data. Data may also be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices.
McKesson Cardiology™ Hemo is intended for use in the areas of: cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology, and other areas where patient/procedural data management is needed.
User-adjustable alarms (both visual and audible) available in the system alert the operator to anomalous occurrences and facilitate timely responses.
Use of the system is not intended for unattended patient monitoring or in situations where arrhythmia detection is required.
The McKesson Cardiology™ Hemo device is a hemodynamic monitoring system for monitoring vital signs, performing measurements and calculations, documenting procedure and patient data and interfacing to other systems and devices during and after procedures in the areas of in the areas of: cardiology, cardiac catheterization, electrophysiology, invasive radiology, and other areas where patient/procedural data management is needed.
McKesson Cardiology™ Hemo also acquires patient information from other hospital information systems and makes hemodynamic information available to them. It facilitates seamless interfacing with hospital information systems and cardiac image management, archiving and reporting systems.
McKesson Cardiology™ Hemo incorporates the FDA cleared the ARGUS PB vital signs monitoring device (K012226), manufactured by Schiller AG, which provides patient monitoring via:
- ECG leads .
- Invasive Blood Pressure (non-McKesson transducers) .
- SpO2 sensor .
- Non-invasive blood pressure (NIBP) cuff .
- . Temperature probe
- . Thermal Dilution Cardiac output temperature probe (connected to a non-McKesson Cardiac Output catheter)
- . CO2 (connected to non-McKesson cannulas or intubation tubes)
Disposables and accessories (transducers, cannulas and intubation devices) are not part of the McKesson Cardiology™ Hemo system, but are supplied by the end user facility as required.
McKesson Cardiology™ Hemo is composed of:
- A control and documentation unit (Information System) that is used for administration, . performing measurements, recording full disclosure, taking samples and entering procedure notes and overall data input and management of the patient and procedure data.
- A Clinical Unit that incorporates the 'Clinical System' and the 'Front-End' unit (which . incorporates the Schiller Argus PB device - K012226). The clinical unit is responsible for acquiring, analyzing and displaying patient vitals and other pertinent clinical data. The data is displayed on monitors.
The provided 510(k) summary for McKesson Cardiology™ Hemo does not contain detailed acceptance criteria or a specific study designed to prove the device meets such criteria in terms of analytical or clinical performance metrics. Instead, it focuses on general verification and validation and demonstrating substantial equivalence to predicate devices.
Here's an analysis based on the provided text, addressing your specific points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in the form of specific performance metrics (e.g., accuracy, sensitivity, specificity, or error rates) for the device's functions. Therefore, a table for this cannot be created from the provided text.
The closest statement regarding performance is:
"Verification and validation testing was performed on McKesson Cardiology™ Hemo to ensure it met all specifications. The device was further validated to ensure that it performs as intended. Performance testing was conducted to verify compliance with specified design requirements and relevant safety standards such as: IEC 60601-1, IEC 60601-2-49 and IEC 60601-1-8. In all instances, McKesson Cardiology™ Hemo functioned as intended and the observed results demonstrate substantial equivalence with the predicate devices."
This indicates general functional and safety compliance but does not provide quantitative performance data against specific acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify any sample sizes for test sets (e.g., number of patients, cases, or data points) or the provenance of any data used for testing (e.g., country of origin, retrospective or prospective). The performance data section broadly mentions "verification and validation testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention using experts to establish ground truth for a test set. This type of information is usually associated with clinical performance studies or algorithm validation, which are not detailed here.
4. Adjudication Method for the Test Set
Since there is no mention of experts or a specific test set requiring ground truth establishment, there is no information on any adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The document does not mention an MRMC comparative effectiveness study, nor does it discuss comparing human reader performance with or without AI assistance. The device is a physiological/hemodynamic monitoring system, not primarily an AI diagnostic tool that would typically undergo such a study for human reader improvement.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
The document does not describe a standalone performance study in terms of specific algorithm outputs. The device is described as a system for monitoring, data acquisition, processing, and analytical assessment, implying a human user interacts with and interprets the displayed information. Its core function is to present data, not to make autonomous diagnostic decisions.
7. The Type of Ground Truth Used
The document does not specify the type of ground truth used for any performance evaluation. Given the nature of the device (hemodynamic monitoring), ground truth would typically refer to validated physiological measurements, but no details are provided.
8. The Sample Size for the Training Set
The document does not mention a training set size. This indicates that the device might not heavily rely on machine learning or AI models that require distinct training and testing sets in the conventional sense for performance claims, or this information was not deemed necessary for this type of 510(k) submission focused on substantial equivalence to predicate devices that are also likely traditional monitoring systems.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, there is also no information on how ground truth for a training set was established.
Summary of Device Evaluation Approach as described in the 510(k):
The McKesson Cardiology™ Hemo 510(k) relies primarily on demonstrating substantial equivalence to existing predicate devices (Medcon Ltd.'s Windsurfer and WITT BIOMEDICAL CORP Philips Xper Flex Cardio Physiomonitoring System/ Xper Information Management System).
The "Performance Data" section states: "Verification and validation testing was performed on McKesson Cardiology™ Hemo to ensure it met all specifications. The device was further validated to ensure that it performs as intended. Performance testing was conducted to verify compliance with specified design requirements and relevant safety standards such as: IEC 60601-1, IEC 60601-2-49 and IEC 60601-1-8. In all instances, McKesson Cardiology™ Hemo functioned as intended and the observed results demonstrate substantial equivalence with the predicate devices."
This indicates that the "study" proving the device meets acceptance criteria was a general verification and validation (V&V) testing program focused on:
- Meeting design specifications.
- Functioning as intended.
- Complying with relevant safety standards (IEC 60601 series).
- Demonstrating that its technological characteristics and performance are comparable to the identified predicate devices, raising no new safety or effectiveness concerns.
Specific analytical or clinical performance metrics (e.g., accuracy of a specific measurement, diagnostic performance) and the details of studies to establish these are not provided in this summary. The FDA's clearance is based on the determination of substantial equivalence, implying that accepted methods for physiological monitoring are used and that the device performs comparably to already cleared devices.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).