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510(k) Data Aggregation
(301 days)
This Patient Monitor is a multi-functional instrument designed for monitoring the vital physiological signs of adult and pediatric patients. With the functions of real-time recording and displaying parameters, such as ECG, heart rate, non-invasive blood pressure, functional oxygen saturation, end-tidal CO2 concentration, respiration rate, body temperature, and so on, it allows comprehensive analysis of patient's physiological conditions.
This instrument is applicable for use in hospitals and clinical institutions. The operation should be performed by qualified professionals only.
UP-7000 Patient Monitor is a modular designed patient monitor. It monitors the patient's Electrocardiograph (ECG), respiratory rate (RR) and bo dy temperature (TEMP) by measuring physical parameters with variety modules. It can also measure non-invasive blood pressure (NIBP, the pressures of systolic, diastolic and mean) by the oscillating method. It can detect the blood oxygen saturation (SpO₂) and pulse rate (PR) non-invasively by the photoelectric method. Finally, it can extend CO2 monitor which measures the End-tidal Carbon dioxide, Inspired CO2 and Respiratory Rate. The accessories and the sensors will transfer the physical parameters into electrical signal, which will be collected and amplified by the circuit in the device. After CPU analyzing and calculating, the parameters are displayed on the screen in a graphical representation and it can record and/or print if necessary. The alarm activates if the monitored parameters go over the specified limits, alerting the medical professional.
Acceptance Criteria and Device Performance for Patient Monitor, Model UP-7000
This submission for the Patient Monitor, Model UP-7000, primarily focuses on demonstrating substantial equivalence to predicate devices through adherence to recognized performance and safety standards. The provided documentation does not detail specific, quantitative acceptance criteria for device performance parameters like accuracy, sensitivity, or specificity, nor does it present detailed study results proving a device meets such criteria to the level often seen for diagnostic AI/ML devices. Instead, the submission relies on compliance with established international and medical device standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Function/Parameter | Acceptance Criteria (Standard Compliant) | Reported Device Performance |
|---|---|---|
| General Safety and Performance | Compliance with general requirements for safety and essential performance of medical electrical equipment. (e.g., IEC 60601-1: 1990+A1+A2+A13, IEC 60601-1-2: 2007 (EMC), IEC 60601-1-4: 2000 (programmable medical electrical systems), IEC 60601-1-6:2006 (usability), IEC 60601-1-8: 2006 (alarms)) | "Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1. Testing to specific ISO standards was used to validate the effectiveness and accuracy of the device. All test results were satisfactory." The device is concluded to be "safe and effective and substantially equivalent to predicate devices." This implies that the device successfully passed all tests stipulated by these general safety and performance standards. |
| ECG/Heart Rate | Compliance with particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment. (e.g., IEC 60601-2-27 :2005) | "Testing to specific ISO standards was used to validate the effectiveness and accuracy of the device. All test results were satisfactory." This confirms compliance with IEC 60601-2-27. Specific performance metrics (e.g., heart rate accuracy range, artifact rejection) are not enumerated in this summary. |
| SpO2 (Functional Oxygen Saturation) | Compliance with particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use. (e.g., ISO 9919: 2005) | "Testing to specific ISO standards was used to validate the effectiveness and accuracy of the device. All test results were satisfactory." This confirms compliance with ISO 9919. Specific performance metrics (e.g., SpO2 accuracy, perfusion index range) are not enumerated. |
| NIBP (Non-invasive Blood Pressure) | Implied compliance with relevant standards for non-invasive blood pressure measurement. (Not explicitly listed in relation to a specific NIBP standard, but "Testing to specific ISO standards was used to validate the effectiveness and accuracy of the device.") | "Testing to specific ISO standards was used to validate the effectiveness and accuracy of the device. All test results were satisfactory." NIBP is measured by the oscillating method. Specific performance metrics (e.g., accuracy against a reference method) are not enumerated. |
| CO2 (End-tidal CO2 concentration, Respiration Rate) | Compliance with particular requirements for the basic safety and essential performance of respiratory gas monitors. (e.g., ISO 21647: 2004(E)) | "Testing to specific ISO standards was used to validate the effectiveness and accuracy of the device. All test results were satisfactory." This confirms compliance with ISO 21647. Specific performance metrics (e.g., EtCO2 accuracy, respiration rate accuracy) are not enumerated. |
| Biological Evaluation (Biocompatibility) | Compliance with biological evaluation of medical devices standards. (e.g., ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010) | The device was tested for biocompatibility according to ISO 10993 series, with all test results reported as satisfactory. This means it passed tests for evaluation and testing, in vitro cytotoxicity, and irritation and delayed-type hypersensitivity. |
2. Sample Size for Test Set and Data Provenance
The provided 510(k) summary does not specify the sample size used for any performance testing or the provenance of any data (e.g., country of origin, retrospective or prospective). The submission largely relies on the declaration of compliance with recognized performance and safety standards, rather than presenting a detailed clinical study with a specific test set.
3. Number of Experts and Their Qualifications for Ground Truth
The provided document does not mention the use of experts to establish ground truth for a test set. This type of submission, pertaining to a patient monitor (a hardware device measuring physiological parameters), typically relies on established calibration standards and validated reference measurement systems for performance testing, rather than expert consensus on diagnostic interpretations.
4. Adjudication Method
Given the nature of the device and the absence of expert involvement in establishing ground truth, there is no mention of an adjudication method in the provided document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done as described in the provided summary. This type of study would be relevant for devices that assist human readers in making diagnostic interpretations, which is not the primary function of this patient monitor.
6. Standalone (Algorithm Only) Performance Study
The device itself is a standalone patient monitor that directly measures physiological parameters. Therefore, the "standalone performance" is essentially the device's ability to accurately measure these parameters. The submission indicates that "Testing to specific ISO standards was used to validate the effectiveness and accuracy of the device. All test results were satisfactory." This implies that the device's performance was evaluated independently against these standards. However, no specific detailed results of such a standalone study (e.g., accuracy metrics for each parameter) are provided in the summary.
7. Type of Ground Truth Used
The ground truth used for testing this patient monitor would generally be based on:
- Reference standard measurements: Comparison against highly accurate and calibrated reference devices or methods for each physiological parameter (e.g., a calibrated ECG simulator for ECG and heart rate testing, a reference oximeter for SpO2, a known pressure source for NIBP, calibrated gas mixtures for CO2).
- Biocompatibility testing: Laboratory assays for cytotoxicity, irritation, and hypersensitivity.
- Electrical and mechanical safety testing: Verification against defined thresholds and criteria in the relevant IEC standards.
The summary states that "Testing to specific ISO standards was used to validate the effectiveness and accuracy of the device." These standards implicitly define the required ground truth and evaluation methods.
8. Sample Size for the Training Set
This device is a hardware patient monitor that measures physiological parameters, not an AI/ML device that requires a "training set" in the conventional sense of machine learning. Therefore, the concept of a "training set" as it applies to AI/ML is not relevant to this submission and no sample size for training is provided.
9. How Ground Truth for the Training Set Was Established
As explained above, this device does not typically utilize a "training set" in the context of AI/ML. The "ground truth" for its development and validation would have been established through engineering design, component validation, and testing against physical standards and known physiological inputs, in accordance with the cited international electrical and medical device standards.
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