(162 days)
The SphygmoCor® Cardiovascular Management System (CvMS) provides a derived ascending aortic blood pressure waveform and a range of central arterial indices. The CvMS is used with a tonometer over a radial artery calibrated with a standard cuff blood pressure measurement. It is to be used on those patients where information related to ascending aortic blood pressure is desired but in the opinion of the physician, the risks of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits.
The CvMS Heart Rate Variability (HRV) option is intended for use in obtaining HRV measurements in response to controlled exercises.
The CvMS is a modified version of the SphygmoCor Px (K012487). Like its predecessor, the CvMS is a computerized tool for the assessment of a range of central vascular parameters, including blood pressure, by peripheral pulse wave detection, callbration, and analysis that can be derived from the calibrated peripheral pressure waveform. The CvMS is used with a tonometer over the radial artery, and is calibrated with a standard blood pressure cuff measurement. The CyMS is intended for use on those patients where information related to ascending aortic blood pressure is desired but in the opinion of the physician, the risks of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits. In addition, the CvMS incorporates an option to enable users to measure Heart Rate Variability (HRV) in response to controlled exercises.
The CvMS is made up of three primary components: 1) a proprietary signal processing electronics module; 2) proprietary software; and 3) a Millar Micro-Tip Pulse Transducer tonometer (Millar tonometer).
One notable new feature incorporated into the CvMS is the addition of the capability to noninvasively measure Heart Rate Variability (HRV) data. The CvMS measures the variability in intervals between R waves ("R-R intervals") on a continuous beat-to-beat basis for a period of time to provide HRV data and to use standard analysis procedures to provide stable and evoked measures of HRV in response to certain controlled exercises. The CvMS is also capable of providing Central Blood Pressure (PWA) and Pulse Wave Velocity (PWV) measurements.
The CvMS system is available in three different configuration options based upon these measurement capabilities. These options allow the user to select a measurement system that suits their particular clinical needs. These configuration options include:
- SphygmoCor Px Pulse Wave Analysis (PWA) System (Px);
- SphygmoCor Vx Pulse Wave Velocity (PWV) System (Vx); and
- SphygmoCor Hx Heart Rate Variability (HRV) System (Hx).
All measurements may be stored and viewed on an attached computer which is attached to the CvMS's signal processing electronics module via a standard USB cable. The patient study reports are displayed on an attached computer.
Here's a breakdown of the acceptance criteria and study information for the SphygmoCor Cardiovascular Management System (CvMS), based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety Standards: | Compliance Demonstrated: |
| IEC60601-1 (Electro-Medical Equipment Safety) | Met electrical and environmental safety standards for safe use. |
| IEC60601-1-2 (Electromagnetic compatibility-Requirements and tests) | Met electrical and environmental safety standards for safe use. |
| AAMI EC13:2002 (Cardiac monitors, heart rate meters, and alarms) | Substantial compliance demonstrated. |
| Performance Requirements: | Compliance Demonstrated: |
| Hardware verification and validation testing | Complies with performance requirements. |
| Software verification and validation testing | Complies with performance requirements. |
| Ability to provide a derived ascending aortic blood pressure waveform and central arterial indices (comparison to SphygmoCor Px) | Performed substantially the same as the SphygmoCor Px. |
Note: The document primarily focuses on demonstrating substantial equivalence to predicate devices and compliance with safety and performance standards, rather than specific numerical acceptance benchmarks for clinical accuracy.
Study Information
The document describes performance testing and comparison testing rather than a formal clinical study with a specific test set.
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Sample Size Used for the Test Set and Data Provenance:
- The document states "comparison testing between the CVMS and the SphygmoCor Px demonstrated that the devices performed substantially the same." However, it does not specify the sample size for this comparison or the data provenance (e.g., country of origin, retrospective/prospective).
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable/Not specified. The testing described is a comparison against a predicate device and compliance with standards, not a ground truth established by experts on a test set in the traditional sense.
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Adjudication Method for the Test Set:
- Not applicable/Not specified.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study is not mentioned. The device is standalone, and the assessment is of its performance compared to a predicate device and safety standards, not an AI-assisted human reading task.
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Standalone Performance (Algorithm Only) Study:
- Yes. The described "hardware and software verification and validation testing" and "comparison testing between the CVMS and the SphygmoCor Px" are essentially standalone performance assessments of the device's algorithms and functionality. The comparison confirms its performance matches the predicate device.
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Type of Ground Truth Used:
- For the comparison testing of the derived ascending aortic blood pressure waveform and central arterial indices: The "ground truth" was the performance of the legally marketed predicate device, SphygmoCor Px (K012487).
- For safety and electrical standards: Compliance with recognized industry standards (IEC60601-1, IEC60601-1-2, AAMI EC13:2002) served as the "ground truth" for meeting those requirements.
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Sample Size for the Training Set:
- Not applicable/Not specified. This device is a modified version of an existing system, and the description focuses on verification and validation of the modified system, not the training of a new AI algorithm.
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How the Ground Truth for the Training Set Was Established:
- Not applicable/Not specified. (See above)
§ 870.1110 Blood pressure computer.
(a)
Identification. A blood pressure computer is a device that accepts the electrical signal from a blood pressure transducer amplifier and indicates the systolic, diastolic, or mean pressure based on the input signal.(b)
Classification. Class II (performance standards).