(275 days)
The iMEC Series Patient Monitors, including iMEC8, iMEC10 and iMEC12, are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia detection and ST Segment analysis, heart rate (HR), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), and carbon dioxide (CO2). All the parameters can be applied to single adult, pediatric and neonatal patients with the exception of the following: C.O. monitoring is restricted to adult patients only, and PAWP monitoring, arrhythmia detection and ST Segment analysis are not intended for neonatal patients.
The iPM Series Patient Monitors, including iPM 8, iPM 10 and iPM 12, are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead, or 5-lead, or 12-lead selectable), arrhythmia detection and ST Segment analysis, heart rate (HR), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), and anesthetic gas (AG). All the parameters can be applied to single adult, pediatric and neonatal patients with the exception of the following: C.O. monitoring is restricted to adult patients only, and PAWP monitoring, arrhythmia detection and ST Segment analysis are not intended for neonatal patients. 12-lead monitoring and AG monitoring are available for iPM 10 and iPM 12 Patient Monitors only.
The BeneView T1 Patient Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead, or 5-lead, or 12-lead selectable), arrhythmia detection and ST Segment analysis, heart rate (HR), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), and carbon dioxide (CO2). All the parameters can be applied to single adult, pediatric and neonatal patients with the exception of the following: C.O. monitoring is restricted to adult patients only, and PAWP monitoring, arrhythmia detection and ST Segment analysis are not intended for neonatal patients.
The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.
The iMEC Series Patient Monitors (including iMEC10 and iMEC12), iPM Series Patient Monitors (including iPM 8, iPM 10 and iPM 12) and BeneView TI Patient Monitor are the developed new series based on the technical platform of the BeneView T Series patient monitors. The new series, much more compact and flexible with the appearance changes, are the sub-configuration models of the BeneView T Series patient monitors by reducing some parameters monitoring functions such as impedance cardiograph (ICG), bispectral index (BIS) and respiration mechanics (RM) monitoring. And comparing with the cleared BeneView T Series Patient Monitors using Mortara ECG algorithm, the subject patient monitors adopt Mindray Monitoring ECG Algorithm as an optional ECG algorithm to implement ECG monitoring, arrhythmia detection, and ST Segment Analysis.
Here's a breakdown of the acceptance criteria and the study information based on the provided text:
Key Takeaways:
- This submission focuses on patient monitors with various physiological parameters, but the core 'new' aspect seems to be the adoption of the "Mindray Monitoring ECG Algorithm" as an optional ECG algorithm. The previous predicate device used the "Mortara ECG algorithm."
- The acceptance criteria and performance data are implicitly tied to the general performance and safety requirements for patient monitors and specifically to the performance of the ECG algorithm for arrhythmia detection and ST segment analysis. However, explicit acceptance criteria values (e.g., specific accuracy percentages for arrhythmia detection) are NOT provided in the extracted text. The document states that the devices "comply with the recognized safety, performance and electromagnetic compatibility standards" and that "The results of all testing demonstrate that the iMEC Series Patient Monitors, iPM Series Patient Monitors and BeneView T1 Patient Monitor are as safe, as effective, and perform as well as the predicate devices." This implies that the performance for the Mindray algorithm met the standards expected of the predicate devices, but the precise numbers are not detailed here.
Acceptance Criteria and Reported Device Performance
| Parameter/Function | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| General Performance & Safety | Compliance with recognized safety, performance, and electromagnetic compatibility standards. | "The iMEC Series Patient Monitors... comply with the recognized safety, performance and electromagnetic compatibility standards." |
| "The results of all testing demonstrate that the iMEC Series Patient Monitors, iPM Series Patient Monitors and BeneView T1 Patient Monitor are as safe, as effective, and perform as well as the predicate devices." (Predicate device: K092449, BeneView T Series patient monitors using Mortara ECG algorithm). | ||
| ECG Monitoring | Implied to meet the performance of predicate devices and relevant standards for ECG monitoring. Specific numerical acceptance criteria (e.g., frequency response, amplitude accuracy) are not detailed in this summary. | Not detailed explicitly, but "perform as well as the predicate devices." |
| Arrhythmia Detection (Mindray ECG Alg.) | Intended for adult and pediatric patients. Implied to meet performance comparable to predicate devices for accuracy in detecting arrhythmias. Specific numerical acceptance criteria (e.g., sensitivity, specificity for various arrhythmia types) are not detailed in this summary. | Not detailed explicitly, but "perform as well as the predicate devices." The device "adopt Mindray Monitoring ECG Algorithm as an optional ECG algorithm to implement ECG monitoring, arrhythmia detection, and ST Segment Analysis." |
| ST Segment Analysis (Mindray ECG Alg.) | Intended for adult patients only. Implied to meet performance comparable to predicate devices for accuracy in ST segment analysis. Specific numerical acceptance criteria (e.g., accuracy of ST elevation/depression measurement) are not detailed in this summary. | Not detailed explicitly, but "perform as well as the predicate devices." The device "adopt Mindray Monitoring ECG Algorithm as an optional ECG algorithm to implement ECG monitoring, arrhythmia detection, and ST Segment Analysis." |
| Other Physiological Parameters (HR, Resp, Temp, SpO2, PR, NIBP, IBP, C.O., CO2, AG) | Implied to meet the performance of predicate devices and relevant standards for each parameter. Specific numerical acceptance criteria are not detailed in this summary. | Not detailed explicitly, but "perform as well as the predicate devices." |
Study Information:
The provided text describes a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive, detailed clinical study report with specific performance metrics for every algorithm. The studies mentioned are primarily validation and verification activities related to regulatory compliance and equivalence.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in the provided text.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The document mentions "Hardware and Software validation" and "Performance testing," implying internal testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not stated. The document simply mentions "Performance testing" without detailing how ground truth was established for algorithmic evaluation.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not stated.
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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:
- No, an MRMC study is not mentioned. The document focuses on the performance of the device/algorithm itself, not on human reader performance with or without AI assistance. This is a standalone patient monitor, not an AI diagnostic aid for human interpretation.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, implicitly. The document states, "And comparing with the cleared BeneView T Series Patient Monitors using Mortara ECG algorithm, the subject patient monitors adopt Mindray Monitoring ECG Algorithm as an optional ECG algorithm to implement ECG monitoring, arrhythmia detection, and ST Segment Analysis." This indicates that the Mindray ECG Algorithm itself was evaluated for its performance. The "Performance testing" listed would include evaluating the algorithm's standalone capabilities.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. For ECG algorithms, ground truth is typically derived from expert-adjudicated ECG recordings or reference databases. The summary does not provide these details.
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The sample size for the training set:
- Not stated. The document focuses on regulatory testing/validation rather than the development and training of the algorithm itself.
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How the ground truth for the training set was established:
- Not stated.
Summary of Study Type:
The provided text indicates that the submission is for new patient monitor models (iMEC, iPM, BeneView T1) that are "substantially equivalent" to an existing predicate device (BeneView T Series K092449). A key difference highlighted is the inclusion of the "Mindray Monitoring ECG Algorithm" as an optional ECG algorithm, replacing or supplementing the Mortara algorithm used in the predicate.
The studies described are therefore primarily verification and validation activities to demonstrate that these new monitors, including their Mindray ECG algorithm, are as safe and effective as the predicate device and comply with relevant standards. These studies would typically involve:
- Bench testing: To verify performance against technical specifications and recognized standards.
- Performance testing: Evaluating the accuracy and reliability of the various physiological parameter measurements, including the new ECG algorithm for arrhythmia detection and ST segment analysis. This would involve comparing the algorithm's output against a known or established "ground truth" using relevant testing datasets.
- Safety testing: Electrical safety, EMC, etc.
- Risk analysis.
The document does not include details of a large-scale clinical trial or comparative effectiveness study between different ECG algorithms, nor does it detail the specific sensitivity/specificity or other performance metrics achieved by the Mindray ECG Algorithm. The statement "perform as well as the predicate devices" is the primary evidence provided for the algorithm's effectiveness in this summary.
§ 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.