The V Series Monitoring System is intra hospital use under the direct supervision of a licensed healthcare practitioner. The Indications for Use for the V12/V21 Monitor include the continuous monitoring of the following human physiological parameters:
- · ECG waveform derived from 3, 5 and 12 Lead measurements
- · Heart Rate
- · ST Segment Analysis
- · Arrhythmia Detection
- 12-lead ECG interpretation
- · OT Analysis
- · Pulse Oximetry (SpO2)
- · Pulse Rate (PR)
- · Non Invasive Blood Pressure (NIBP)
- · Invasive Blood Pressure (IBP)
- · Cardiac Output (C.O.)
- · Respiratory Gases (02, CO2)
- · Respiration Rate (RESP)
- · Anesthetic Gases (Iso, Enf, Sev, Hal, Des, N2O)
- · Temperature (TEMP)
- · Bispectral Index (BIS)
The V12/V21 Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
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The target populations are adult, pediatric and neonate with the exception of:
· Arrhythmia detection, ST Segment Analysis, for which the target population are adult and pediatric only. -
· IV Drug Calculations for which the target population is adult only,
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· Cardiac Output for which the target population are adult and pediatric only, and
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· Bispectral Index(BIS) for which the target population are adult and pediatric only.
The subject V Series Monitoring System includes two monitors, one incorporating a12" display (V12 Monitor) and the other incorporating a 21" display (V21 Monitor), and includes the following system components:
- Display Control Unit (DCU) Display Control Unit (DCU) includes the system . processor, monitor display, user interface and appropriate connectors for communication to peripheral devices. The 12-inch (V12) monitor display features a touch screen display that accommodates up to 8 waveforms and corresponding numerics. It includes an internal module rack in the back which holds up to 6 modules, depending on their size. It can be removed from the docking station and used as an intra hospital transport monitor. The 21-inch (V21) monitor display features a touch screen display that accommodates up to 12 waveforms and corresponding numerics. It also includes a touch pad as an optional method to interact with the software.
- Docking Station (Model name: V Dock) The Docking Station is a physical mount ● for the DCU. The Docking Station incorporates multiple connectivity ports designed to enable quick connection and release for mobility. It provides power to the monitoring system. It features a quick release mechanism that allows the DCU to be easily and quickly removed and reattached. The docking station also provides connectivity to other external devices and systems such as remote displays or nurse call systems and mounts to a wall mount or rolling stand. The Docking Station used in the subject V Series is referred to in Mindray internal documents as "V Dock" or "Dock".
- Module Rack (Model name: V Hub) The Module Rack is a physical mount for the ● modules capable of holding up to 6 modules, depending on their size. It features a quick release mechanism that allows the Module Rack to be easily and quickly removed and reattached to a wall mount or rolling stand to be used during intra hospital transports. The Module Rack used in the subject V Series is referred to in Mindray internal documents as "V Hub" or "Hub".
- VPS Module - The VPS is the main parameter module of the subject V Series that provides the core parameters: 3/5/12-lead ECG, SpO2, Respiration, NIBP, 2 invasive pressures and 1 temperature channel. The VPS is a parameter acquisition device designed to acquire and store real-time vital sign data. Its modular design allows it to be moved with the patient between V Series Monitoring Systems.
- Modules - Modules are data acquisition devices that add parameter and interface capability to the subject V Series. These modules are parameter specific and include temperature, invasive blood pressure (IBP), cardiac output (C.O.), CO2, and strip recorder. One module, the VDI (V Device Integrator), is configurable to allow interface to other medical devices such as continuous cardiac output (CCO), regional oxymetry saturation (rSO2), respiratory gas, and DIAP (previously cleared under the
predicate V Series K132026). One module, the BIS interface module, is configurable to allow interface to BIS module (Mindray is seeking clearance for this new feature under this 510(k)). - o View 12 (12 lead ECG cable) - The View 12 will monitor 12 lead ECG and respiration through the ECG port connection on the VPS Module.
Here's an analysis of the provided text regarding the acceptance criteria and study for the V Series Monitoring System:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a distinct section with pass/fail metrics. Instead, it presents performance specifications of the subject device and compares them to those of predicate devices to demonstrate substantial equivalence. The "Acceptance Criteria" here are implicitly the existing performance characteristics and accuracy claims of the predicate devices or the device's own specifications after modifications, and the "Reported Device Performance" is stated by asserting that the subject device meets specifications and that its performance is equivalent to the predicate.
It's important to note that the document focuses on changes from the predicate device and how those changes are still "substantially equivalent." Therefore, the table below will highlight the modified features and their performance metrics. For features that are stated as "Same" as the predicate, it implies they meet the predicate's specifications.
| Feature | Implicit Acceptance Criteria / Predicate Performance (K132026) | Reported Device Performance (Subject V12/V21) |
|---|---|---|
| ECG Waveform Leads | 3-lead, 5-lead, 6-lead, or 12-lead selectable | 3-lead, 5-lead, or 12-lead selectable (6-lead removed for business reasons, declared as not affecting safety/effectiveness) |
| QRS Waveform Detection | Supported, fixed threshold 0.2mV | Supported, adjustable threshold between 0.16mV to 0.48mV |
| Arrhythmia Detection | Supported, fixed leads for arrhythmia analysis | Supported, adjustable leads for arrhythmia analysis, Added Extreme Bradycardia alarms, Extreme Tachycardia alarms, Pacer Failure to Capture alarms, Pacer Failure to Sense alarms |
| 12-lead ECG Interpretation | Supported | Supported, Added Baseline Drift Removal (BDR) filter, Muscle Artifact filter and Beat markers |
| QT Analysis | Not supported | Supported (justified by presence in predicate K101521) |
| Mortara Arrhythmia Algorithm Software Version | 3.3.5 | 4.0.0 |
| Pace Detection | Single Pace detection channel | Dual Pace detection channels |
| NIBP Pressure Range | Adult: Systolic 55-235 mmHg, Diastolic 30-200 mmHg | |
| Pediatric: Systolic 55-160 mmHg, Diastolic 30-150 mmHg | ||
| Neonate: Systolic 45-120 mmHg, Diastolic 20-100 mmHg | Adult: Systolic 55-270 mmHg, Diastolic 30-200 mmHg | |
| Pediatric: Systolic 55-170 mmHg, Diastolic 30-150 mmHg | ||
| Neonate: Systolic 45-130 mmHg, Diastolic 20-100 mmHg (Wider range is an improvement) | ||
| Bispectral Index (BIS) | Not supported | Supported (justified by presence in predicate K143195) |
| New NIBP Cuffs | None | Supported |
| Wireless Functionality | Not supported | Supported |
For parameters not listed as modified (e.g., Heart Rate Meter, SpO2 Accuracy, IBP Accuracy, CO, Capnography, Respiration Rate, Temperature), the reported device performance is implicitly the "Same" as the predicate device, meaning they meet the predicate's stated specifications and accuracy.
The document states: "The testing provided an evaluation of the performance of the device relevant to each of the modifications to the subject devices since their previous clearance. The system and performance testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective). It simply states that "Mindray conducted system and performance testing on the subject devices."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for any test sets. The nature of the device (patient monitor for physiological parameters) suggests that ground truth for performance metrics (like heart rate, blood pressure, etc.) would typically be established by established reference methods/equipment, not necessarily human expert consensus on raw data interpretation in the same way an imaging AI might.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with vs. without AI Assistance
A MRMC comparative effectiveness study was not done or reported in this documentation. The device described, a patient physiological monitor, is not an AI-assisted diagnostic tool that would typically involve human readers interpreting output in the MRMC sense. It provides measurements and alarms derived from physiological signals.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The document implies that standalone performance testing was done, as it states: "The system and performance testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate." This refers to the device's inherent ability to measure and process physiological parameters according to its own algorithms and sensors. No human-in-the-loop performance evaluation is described.
7. The Type of Ground Truth Used
Based on the type of device and parameters measured, the ground truth would likely be established using:
- Reference measurement equipment: For parameters like NIBP, IBP, SpO2, and temperature, a reference standard device or method with certified accuracy would be used.
- Simulated physiological signals: For ECG, arrhythmia detection, heart rate, QRS detection, and pace detection, standardized test signals (e.g., from an ECG simulator) representing various physiological and pathological conditions would likely be used to test the algorithm's accuracy against known inputs.
- Clinical data with expert verification: For features like 12-lead ECG interpretation, the ground truth would typically be established by a consensus of expert cardiologists or clinicians reviewing ECG tracings and relevant patient data. However, the document does not specify this for the training or testing.
The document itself does not explicitly detail the ground truth methodology beyond stating "system and performance testing" and compliance with consensus standards.
8. The Sample Size for the Training Set
The document does not specify the sample size for any training set. This is a medical device clearance document, not a detailed algorithm development paper. While internal algorithms for arrhythmia detection, QRS detection, and 12-lead ECG interpretation would involve training, this document focuses on substantial equivalence for regulatory purposes, not the detailed development process.
9. How the Ground Truth for the Training Set Was Established
The document does not describe how ground truth for any training set was established. Similar to point 8, this level of detail is typically not found in regulatory submission summaries unless it's a novel AI/ML device where the training data and ground truth methodology are critical for demonstrating safety and effectiveness. This device appears to be an iterative update to an existing monitoring system, with modifications to existing algorithms (e.g., Mortara arrhythmia algorithm version update, new NIBP range, QRS threshold adjustment).
§ 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.