(234 days)
iM20 Patient Monitor (hereinafter called monitor) is intended to be used for monitoring, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended for use by trained healthcare professionals in hospital environments.
The monitored physiological parameters include: ECG. respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), and invasive blood pressure (IBP), and carbon dioxide (CO2).
The arrhythmia detection and ST Segment analysis are intended for adult only.
The monitor is additionally intended for use during patient transport inside of the hospital environment.
The monitor is not intended for airplane, helicopter transport, home use and MRI environments.
The iM20 Patient Monitor System (hereinafter called iM20) can perform long-time continuous monitoring of multiple physiological parameters, including ECG, respiration (RESP), non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), temperature (TEMP), invasive pressure (IBP), Carbon Dioxide (CO2). The system capabilities include storing, displaying, analyzing and controlling such data afterwards. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. The system is intended to be used during patient transport inside and outside of the hospital environment.
iM20 can be utilized in two ways, as an independent monitor and as a module of V series Patient Monitor (including models elite V5, elite V6 and elite V8). When used as an independent monitor, it can simultaneously monitor, store, review several parameters data. And transfer patient data to V series patient monitor only under the transport mode. As a highly portable monitor, its compact design makes it particularly appropriate inside hospital and vehicle ambulance transport environments.
When as a multi-measurement module, when the iM20 is directly connected to a V series patient monitor, it can provide the measurements, trends, and patient information. When connected, the V series Patient Monitor controls the connected iM20, including all alarm functionality. So no alarms are available on iM20 in such application and iM20 takes power from the V series Patient Monitor.
This document focuses on the Edan Instruments Inc. Patient Monitor, model iM20 (K152552), and its equivalency to predicate devices. It lists performance data based on non-clinical and clinical studies to demonstrate substantial equivalence.
Here's the breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a detailed comparison table between the proposed device (iM20) and a predicate device (Philips Medizin.Systeme Boeblingen GmbH IntelliVue MP2 cleared under K102562), focusing on various physiological parameters and technical specifications. A second comparison table is provided for the reference device Edan Instruments, Inc. iM70 (K131971), specifically for PR from NIBP and CO2 function.
Since the provided text does not present a separate "acceptance criteria" table and "reported device performance" table, but rather a comparison with performance metrics of a predicate device, the following table synthesizes the information from the "Predicate Device Comparison" section to represent acceptance criteria (from the predicate) and the reported device performance (for the iM20). Differences are explicitly noted as "Different." Where the proposed device's performance aligns with the predicate, it is marked "Same."
Acceptance Criteria (Based on Predicate Device) and Reported Device Performance (iM20)
| Feature / Parameter | Acceptance Criteria (Predicate: Philips MP2) | Reported Device Performance (iM20) | Match? |
|---|---|---|---|
| ECG Function - HR Calculation | |||
| HR Range (Adult/Pedi/Neo) | Adult/pedi: 15 to 300 bpm, Neo: 15 to 350 bpm | ADU: 15 bpm to 300 bpm, PED/NEO: 15 bpm to 350 bpm | Same |
| HR Accuracy | ±1% of range | ± 1% or 1 bpm, whichever is greater | Different |
| HR Resolution | 1 bpm | 1 bpm | Same |
| Sensitivity | ≥ 200 µVpeak | ≥ 300 µVPP | Different |
| PVC Rate Range | 0 to 300 bpm | ADU: 0 to 300 PVCs/ min, PED/NEO: 0 to 350 PVCs/ min | Different |
| PVC Resolution | 1 bpm | 1 PVCs/min | Different |
| ST Numeric Range | -20 to +20 mm | -2.0 mV to +2.0 mV | Different |
| ST Accuracy | ± 0.5mm or 15%, whichever is greater | -0.8 mV to +0.8 mV: ± 0.02 mV or 10%, whichever one is greater. Beyond this range: not specified. | Different |
| ST Resolution | 0.1mm | 0.01 mV | Different |
| Range of Sinus and SV Rhythms (Brady) | Adult: 15 to 60 bpm, Pedi: 15 to 80 bpm, Neo: 15 to 90 bpm | Adult: RR interval for 5 consecutive QRS complex ≥ 1.5 s. Pediatric/neonatal: RR interval for 5 consecutive QRS complex ≥ 1 s. | Different |
| Range of Sinus and SV Rhythms (Normal) | Adult: 60 to 100 bpm, Pedi: 100 to 160 bpm, Neo: 90 to 180 bpm | Adult: 0.5s 100 bpm, Pedi: >160 bpm, Neo: >180 bpm | Adult: RR interval for 5 consecutive QRS complex ≤ 0.5 s. Pediatric/neonatal: RR interval for 5 consecutive QRS complex ≤ 0.375 s. |
| Bandwidth | Diagnosis: 0.05 to 150 Hz, Monitor: Adult: 0.5 to 40 Hz, Neo/pedi: 0.5 to 55 Hz, Filter Mode: 0.5 to 20 Hz | Diagnosis: 0.05Hz to 150Hz, Monitor: 0.5Hz to 40Hz, Surgery: 1Hz to 20Hz | Different |
| CMRR | Diagnostic mode: >86 dB, Filter mode: >106 dB | Diagnosis: >95dB (Notch filter off), Monitor: >105dB (Notch filter on), Surgery: >105dB (Notch filter on) | Different |
| Differential Input Impedance | >2 MΩ RA-LL leads (Resp), >5 MΩ at all other leads | >5MΩ | Different |
| Input Signal Range | ±5mV (peak-to-peak value) | ±10mVPP | Different |
| Electrode Offset Potential Tolerance | ±500mV | ±500mV | Same |
| Auxiliary Current (detect) | Active electrode: 1200ms. | Different | |
| Accuracy of HR Meter and Response to Irregular Rhythm | Ventricular bigeminy: 80 bpm, Slow alternating ventricular bigeminy: 60 bpm, Rapid alternating ventricular bigeminy: 120 bpm, Bidirectional systoles: 90 bpm | Ventricular bigeminy: 80 bpm±1 bpm, Slow alternating ventricular bigeminy: 60 bpm±1 bpm, Rapid alternating ventricular bigeminy: 120 bpm±1 bpm, Bidirectional systoles: 91 bpm±1 bpm | Different |
| Response time of HR Meter to Change in HR (80 to 120 bpm) | Range: [6.4 to 7.2 s], Average: 6.8 s | Within 11 s | Different |
| Response time of HR Meter to Change in HR (80 to 40 bpm) | Range: [5.6 to 6.4 s], Average: 6.0 s | Within 11 s | Different |
| RESP Function | |||
| Respiration excitation waveform | Sinusoidal signal, 260 µA, 39 kHz | Sinusoid, 62.8 kHz (±10%), 300 mmHg (40 kPa) >2 sec | 297 ± 3mmHg (EDAN), 300 mmHg (40 kPa) >2 sec |
| AwRR Accuracy | ±1 rpm | ± 1 rpm | Same |
| Sample Gas Flow rate | 50±10ml/min | 50±10 ml/min | Same |
| O2 Compensation Range | 0 ~ 100% | 0~100% | Same |
2. Sample Sizes and Data Provenance for Test Set
- Clinical Testing Sample Size: Not explicitly stated in terms of patient numbers or case count.
- Data Provenance: The NIBP clinical testing was conducted as per ISO 81060-2: 2013, "Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type." The document does not specify the country of origin for the clinical data or whether it was retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth of Test Set
The document does not provide information on:
- The number of experts used to establish ground truth for the test set.
- The qualifications of those experts.
4. Adjudication Method for the Test Set
The document does not provide information on the adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No information about a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is provided. The study focuses on the device's technical and clinical performance against standards and a predicate device, not on human reader performance with or without AI assistance.
6. Standalone Performance Study (Algorithm Only)
The document primarily describes the performance of the entire "iM20 Patient Monitor device, consisting of all the modules and accessories in the system." While it details performance parameters of various physiological monitoring algorithms (ECG, NIBP, SpO2, CO2), it does not explicitly describe a standalone (algorithm only without human-in-the-loop performance) study in the detailed sense of a specific data set applied only to the algorithm for evaluation. However, the bench testing and NIBP clinical validation are evaluations of the device's inherent measurement capabilities.
7. Type of Ground Truth Used
- For ECG, RESP, NIBP, SpO2, IBP, TEMP, CO2: The measurements of these physiological parameters are compared against the expected performance defined by international standards (e.g., ISO, IEC) or against the performance of a predicate device. For NIBP, the ground truth is established through clinical validation against "automated measurement type" as per ISO 81060-2:2013, which typically involves comparison to a reference standard measurement method (e.g., auscultatory method).
- For Biocompatibility: Compliance with ISO 10993-1, (Cytotoxicity, Skin Sensitization, Skin Irritation).
- For Electrical Safety and EMC: Compliance with IEC 60601-1:2005/A1:2012 and IEC 60601-1-2:2007.
- For General Performance (Bench Testing): Compliance with various IEC/ISO standards specific to each parameter.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set size, as it describes a medical device clearance submission based on equivalence to predicate devices and adherence to performance standards, not a machine learning model requiring a training set.
9. How Ground Truth for Training Set was Established
Not applicable, as no training set is mentioned in the context of this device's submission.
§ 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.