(211 days)
The iX series Patient Monitors including iX10, iX12, iX15 are intended to be used for monitoring, storing, and reviewing of, and to generate alarms for, multiple physiological parameters of adults and pediatics (including neonates). The monitors are intended for use by trained healthcare professionals in hospital environments.
The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.), and Anaesthesia gas (AG).
The arrhythmia detection and ST Segment analysis are intended for adult patients.
The NIBP monitoring supports iCUFS algorithm and iFAST algorithm is intended for adult, pediatric and neonatal patients. The iFAST algorithm is intended for adult and pediatic patients (≥3 years of age). Both measurement algorithms are also intended for use with pregnant women, including pre-eclamptic patients. NIBP MAP is not applicable to pregnant women.
The Spot Temp with T2A module can only measure temperature of adult and pediatric (> 1 year of age) patients. The monitors are not intended for MRI environments.
The cardiac output (C.O.) is only intended for adult patients.
The iX series Patient Monitors including iX10, iX12, iX15 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormalities so that doctors and nurses can respond to the patient's situation as appropriate.
This document describes the premarket notification (510(k)) for the Edan Instruments, Inc. Patient Monitor (iX10, iX12, iX15) and its equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the new device were generally established by compliance with various international standards for medical electrical equipment and specific performance characteristics. The reported device performance indicates that the device meets these standards and its specified accuracy.
For the Quick Temp Module (T2A), the provided text details specific clinical study results. Other parameters were tested for compliance with relevant standards through non-clinical testing.
| Parameter/Characteristic | Acceptance Criteria (Reference Standard/Specification) | Reported Device Performance |
|---|---|---|
| General Safety and Performance | ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] | Complied with the standard |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2014+A1:2020 | Complied with the standard |
| Alarm Systems | IEC 60601-1-8:2020 | Met relevant consensus standards |
| Electrocardiographs (ECG) | IEC 60601-2-25:2011 | Met relevant consensus standards |
| ECG Monitoring Equipment | IEC 60601-2-27:2011 | Met relevant consensus standards |
| Automated Non-Invasive Sphygmomanometers (NIBP) | IEC 80601-2-30:2018 | Met relevant consensus standards |
| Invasive Blood Pressure Monitoring Equipment (IBP) | IEC 60601-2-34:2011 | Met relevant consensus standards |
| Multi-function Patient Monitoring Equipment | IEC 60601-2-49:2018 | Met relevant consensus standards |
| Respiratory Gas Monitors (CO2, AG) | ISO 80601-2-55:2018 | Met relevant consensus standards |
| Clinical Thermometers (TEMP - General) | ISO 80601-2-56:2017+A1:2018 | Met relevant consensus standards |
| Pulse Oximeter Equipment (SpO2) | ISO 80601-2-61:2017 | Met relevant consensus standards |
| Wireless Coexistence | IEEE ANSI C63.27:2017 | Met relevant consensus standards |
| Cardiac Rhythm and ST Segment Measurement Algorithms | ANSI AAMI EC57:2012 | Met relevant consensus standards |
| Quick Temp Module (T2A) Predict Mode Clinical Accuracy | ISO 80601-2-56:2017/Amd.1:2018(E) - Temperature measurement requirements | Meets the requirements of the standard and acceptance criteria in clinical protocol |
2. Sample Size for Test Set and Data Provenance
For the Quick Temp Module (T2A) Predict Mode clinical accuracy study:
- Sample Size: 142 valid cases for sublingual and axillary temperature measurements.
- Data Provenance: Clinical investigation (prospective study). No country of origin is explicitly stated, but the company is based in China.
For other parameters, specific sample sizes for non-clinical (bench) testing are not provided, but the document states "Edan has conducted functional and system level testing to validate the performance of the results of the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards."
3. Number of Experts and their Qualifications for Ground Truth
The document does not specify the number or qualifications of experts used to establish ground truth for the clinical study of the Quick Temp Module (T2A). It only mentions that the study compared the new module against the "direct mode of F3000 Temp Module of M3A Vital signs monitor," implying the predicate device served as a reference for accuracy.
For other non-clinical tests, the ground truth is implicitly defined by the specifications and performance requirements outlined in the referenced international standards.
4. Adjudication Method for the Test Set
The document does not describe a specific adjudication method (e.g., 2+1, 3+1) for the clinical study or any other test sets.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text. The device is a patient monitor, and its performance evaluation typically focuses on the accuracy and reliability of its physiological parameter measurements, not on improving human reader performance with AI assistance.
6. Standalone (Algorithm Only) Performance Study
Yes, standalone performance was evaluated for the components of the device. The non-clinical data section describes extensive functional and system-level testing to validate the performance against relevant consensus standards. This includes specific tests for algorithms like cardiac rhythm and ST segment measurement. The clinical study for the Quick Temp Module (T2A) also assesses the standalone performance of that specific module.
7. Type of Ground Truth Used
- For the Quick Temp Module (T2A) clinical study: The ground truth was established by comparison to a reference device's direct temperature measurement mode ("direct mode of F3000 Temp Module of M3A Vital signs monitor"). This is a form of reference standard comparison (using a predicate device as the reference).
- For other parameters (e.g., ECG, NIBP, SpO2, CO2, AG): The ground truth for non-clinical testing is implicitly based on the specifications and performance requirements outlined in the referenced international consensus standards (e.g., IEC 60601 series, ISO 80601 series, AAMI standards).
8. Sample Size for the Training Set
The document does not provide information about a training set since this is a patient monitoring device and not a machine learning algorithm as typically understood in the context of large-scale image-based diagnostics. The "algorithms" mentioned (e.g., arrhythmia detection, NIBP algorithms) are likely engineered signal processing algorithms rather than deep learning models requiring large training datasets.
9. How Ground Truth for Training Set was Established
Not applicable, as no training set for a machine learning model is described in the provided text. The algorithms for the patient monitor's functions are developed and validated against established physiological principles and engineering standards.
§ 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.