(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 < RR interval for 5 consecutive QRS complex < 1.5 s. Pedi/Neo: 0.375s < RR interval for 5 consecutive QRS complex < 1 s. | Different |
| Range of Sinus and SV Rhythms (Tachy) | Adult: >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. | Different |
| 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: <100nA, Reference electrode: <900nA | Active electrode: <100nA, Reference electrode: <900nA | Same |
| Pace Pulse Indicator | ±2 mV to ±700 mV and widths from 0.1 ms to 2.0 ms | Amplitude: ±2 mV to ±700 mV, Width: 0.1 ms to 2.0 ms, Ascending time: 10 us to 100 us | Different |
| Pace Pulse Rejection | ±2 mV to ±700 mV and widths from 0.1 ms to 2.0 ms | Amplitude: ±2 mV to ±700 mV, Width: 0.1 ms to 2.0 ms, Ascending time: 10 us to 100 us | Different |
| Max Start-up alarm time for Ventricular Tachycardia (1mV 206bpm) | Gain 1.0 Range 6.1 to 6.9 seconds, Average 6.5 seconds | Gain 1.0: 10 s | Different |
| Max Start-up alarm time for Ventricular Tachycardia (2mV 195bpm) | Gain 1.0, Range 5.7 to 6.5 seconds, Average 6.1 seconds | Gain 1.0: 10 s | Different |
| Tall T-wave Rejection | Exceeds ANSI/AAMI EC 13 Sect. 3.1.2.1(c) 1.2 mV T-Wave amplitude | Complied with IEC 60601-2-27: 2011, Sect. 201.12.1.101.17 minimum recommended 1.2 mV T-Wave amplitude | Same |
| HR Averaging Method | Three different methods used, typically 12 most recent RR intervals | Method 1: excluding min/max values from 12 most recent RR intervals and averaging the residual 10. Method 2: 4 most recent RR intervals if 3 consecutive > 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%), <500 µA | Different |
| RR Measuring Range | Adult/pedi: 0 to 120 rpm, Neo: 0 to 170 rpm | Adult: 0 rpm to120rpm, Pediatric/neonate: 0 rpm to 150rpm | Different |
| Accuracy | at 0 to 120 rpm ±1 rpm, at 120 to 170 rpm ±2 rpm | Adult: 6 to 120 rpm: ±2 rpm, 0 to 5 rpm: not specified. Neo/Ped: 6 to 150 rpm: ±2 rpm, 0 to 5 rpm: not specified. | Different |
| Resolution | 1 rpm | 1 rpm | Same |
| Waveform bandwidth | 0.3 to 2.5 Hz (-6 dB) | 0.2Hz to 2.5Hz (-3dB) | Different |
| Apnea Alarm Time Setup | 10 to 40 seconds 5 second steps | 10s, 15s, 20s, 25s, 30s, 35s, 40s | Different |
| NIBP Function | |||
| Principle of Operation | oscillation | oscillation (EDAN, SunTech NIBP) | Same |
| Measurement Range (Adult Systolic) | 30 to 270 mmHg | EDAN NIBP: 40 mmHg ~ 270 mmHg, SunTech NIBP: 60 mmHg ~ 250 mmHg | Different |
| Measurement Range (Adult Diastolic) | 10 to 245 mmHg | EDAN NIBP: 10 mmHg ~ 215 mmHg, SunTech NIBP: 30 mmHg ~ 190 mmHg | Different |
| Measurement Range (Adult Mean) | 20 to 255 mmHg | EDAN NIBP: 20 mmHg ~ 235 mmHg, SunTech NIBP: 40 mmHg ~ 210 mmHg | Different |
| Measurement Range (Pediatric Systolic) | 30 to 180 mmHg | EDAN NIBP: 40 mmHg ~ 230 mmHg, SunTech NIBP: 40 mmHg ~ 230 mmHg | Different |
| Measurement Range (Pediatric Diastolic) | 10 to 150 mmHg | EDAN NIBP: 10 mmHg ~ 180 mmHg, SunTech NIBP: 20 mmHg ~ 160 mmHg | Different |
| Measurement Range (Pediatric Mean) | 20 to 160 mmHg | EDAN NIBP: 20 mmHg ~ 195 mmHg, SunTech NIBP: 30 mmHg ~ 175 mmHg | Different |
| Measurement Range (Neonate Systolic) | 30 to 130 mmHg | EDAN NIBP: 40 mmHg ~135 mmHg, SunTech NIBP: 40 mmHg ~130 mmHg | Different |
| Measurement Range (Neonate Diastolic) | 10 to 100 mmHg | EDAN NIBP: 10 mmHg ~ 100 mmHg, SunTech NIBP: 20 mmHg ~ 90 mmHg | Same/Different |
| Measurement Range (Neonate Mean) | 20 to 120 mmHg | EDAN NIBP: 20 mmHg ~ 110 mmHg, SunTech NIBP: 30 mmHg ~ 100 mmHg | Different |
| Accuracy | Max. Std. Deviation: 8 mmHg, Max. Mean Error: ± 5 mmHg | Max standard deviation: 8 mmHg (EDAN, SunTech); Max mean error: ± 5 mmHg | Same |
| Pressure Resolution | 1mmHg | 1mmHg (EDAN, SunTech) | Same |
| Maximum measuring period | 180 seconds (adult/pedi), 90 seconds (neonates) | Adult/Pediatric 120s, Neonate 90s | Different |
| Overpressure protection (Adult) | >300 mmHg (40 kPa) >2 sec | 297 ± 3mmHg (EDAN), <300mmHg (SunTech) | Different |
| Overpressure protection (Pediatric) | >300 mmHg (40 kPa) >2 sec | 240 ± 3mmHg (EDAN), <300mmHg (SunTech) | Different |
| Overpressure protection (Neonate) | >150 mmHg (20 kPa) >2 sec | 147 ± 3mmHg (EDAN), <150mmHg (SunTech) | Different |
| Measuring interval in AUTO Mode | 1, 2, 2.5, 3, 5, 10, 15, 20, 30, 45, 60 or 120 minutes | 1/2/3/4/5/10/15/30/60/90/120/240/480 min (EDAN), 1/2/3/4/5/10/15/30/60/90/120/240/480 min (SunTech) | Different |
| Continuous | 5 minutes | 5min, interval is 5s | Same |
| SpO2 Function (EDAN) | |||
| Measurement Range | 0 to 100 % | 0-100% | Same |
| Accuracy | Philips Reusable Sensors: M1191A, etc. = 2 % (70 % to 100 %); M1193A, etc. = 3 % (70 % to 100 %) | Adult/Pediatric: ± 2 % (70% to 100% SpO2), Undefined (0 to 69% SpO2). Neonate: ± 3 % (70% to 100% SpO2), Undefined (0 to 69% SpO2). | Different |
| Resolution | 1 % | 1 % | Same |
| Pulse Rate Measuring Range | 30 to 300 bpm | 25 bpm to 300 bpm | Different |
| Pulse Rate Accuracy | ±2 % or 1 bpm, whichever is greater | ±2bpm | Different |
| Pulse Rate Resolution | 1 bpm | 1 bpm | Same |
| SpO2 Function (Nellcor) | |||
| Measurement Range | 1% to 100% | 1% to 100% | Same |
| Accuracy | Philips Reusable Sensors: M1193A, etc. = 3 % (70 % to 100 %) (Adult); = 4 % (70 % to 100 %) (Neonate) | DS-100A, OXI-A/N (Adult): ± 3% (70% to 100% SpO2). OXI-A/N (Neonate): ± 4% (70% to 100% SpO2). | Same |
| Resolution | 1 % | 1 % | Same |
| Pulse Rate Measuring Range | 30 to 300 bpm | 20bpm to 300bpm | Different |
| Pulse Rate Accuracy | ±2 % or 1 bpm, whichever is greater | ± 3bpm (20bpm to 250bpm) | Different |
| Pulse Rate Resolution | 1 bpm | 1 bpm | Same |
| Temperature Function | |||
| Measurement Range | -1 to +49°C (30 to 113°F) | 0 to 50°C | Different |
| Accuracy | ±0.1°C (±0.2°F) | ±0.1 °C | Same |
| Resolution | 0.1°C (±0.1°F) | 0.1 °C | Same |
| Average Time Constant | Less than 10 seconds | <30 s | Different |
| IBP Function | |||
| Measurement Range | -40 to 360 mmHg | -50 to +300 mmHg | Different |
| Accuracy | 4 % of reading or ±4 mmHg, whichever is greater | ± 2 % or ±1 mmHg, whichever is greater | Different |
| Resolution | 1 mmHg | 1 mmHg | Same |
| Transducer Load/Output Impedance | Load Impedance: 200 to 2000 Ω, Output Impedance: 3000 Ω | 5 (μV/V/mmHg) 300 to 3000 Ω | Different |
| Zero Range | ±200 mmHg | ±200 mmHg | Same |
| General Specifications | |||
| Electrical Safety Anti-electroshock type | Class II | Class II | Same |
| Working system | Continuous operation equipment | Continuous operation equipment | Same |
| Operating Temp Range | 0 to 40°C (32 to 104°F) | 0°C to +40°C | Same |
| Storage Temp Range | -20 to 60°C (-4 to 140°F) | -30°C to +70°C | Different |
| Operating Humidity Range | 15 % to 95 % RH | 15% to 95% (non-condensing) | Same |
| Storage Humidity Range | 5 % to 95 % RH | 15% to 95% (non-condensing) | Different |
| Operating Altitude Range | -500 m to 3000 m (10000 ft) | 615hPa to 1060hPa (DC-DC power supply)(-400 m to 4000 m), 680hPa to 1060hPa (AC to DC power supply)(-400m to 3000m) | Different |
| Storage Altitude Range | -500 m to 4600 m (15000 ft) | 615hPa to 1060hPa (-400 m to 4000 m) | Different |
| Weight | 1.25 kg | iM20: <1.5kg, EFM: < 0.58 kg | Different |
| Dimensions | (W x H x D) 188 x 99 x 86 mm | iM20: 185 mm (L) × 85.3 mm (W)× 116 mm (H), EFM: 207 mm (L) × 93.4 mm (W)× 116 mm (H) | Different |
| Display Description | 72 x 54 mm (2.8 x 2.1 in) | 5 inches LCD | Different |
| Display Resolution | 320 x 240 | 800x480 | Different |
| Power consumption | <12 W average, <30 W while battery is loading | <25w (Max) | Different |
| Power input | 36 to 60 V DC floating | 11.1V to 19.8VDC | Different |
| Current | 0.7 to 0.4 A | 1.27~2.3A | Different |
| AC-DC Power supply Line Voltage | 100 to 240 V ~ | 100~240Vac | Same |
| AC-DC Power supply Output Voltage | 36 to 60 V DC floating | 15V±5%dc, 24VA | Different |
| AC-DC Power supply Frequency | 50/60 Hz ~ | 50/60 Hz ~ | Same |
| DC-DC Power supply Line Voltage | N/A | 10~16Vdc | Different |
| DC-DC Power supply Output Voltage | N/A | 15V±5%dc | Different |
| Standard Compliance (General) | IEC 60601-1:1988 + A1:1991 + A2:1995 | IEC 60601-1:2005 | Different |
| Out-Of-Hospital Transport Shock Tests | According to IEC TR 60721-4-7, Class 7M3. IEC/EN 60068-2-27 (peak acceleration up to 100g). | According to IEC TR 60721-4-7, Class 7M3. IEC/EN60068-2-27 (peak acceleration up to 100g). | Same |
| Out-Of-Hospital Transport Random Vibration | According to IEC TR 60721-4-7, Class 7M3. IEC/EN 60068-2-64 (RMS acceleration 5g). | According to IEC TR 60721-4-7, Class 7M3. IEC/EN 60068-2-64 (RMS acceleration 5g). | Same |
| Out-Of-Hospital Transport Sinusoidal Vibration | According to IEC TR 60721-4-7, Class 7M3. IEC/EN 60068-2-6 (acceleration up to amplitude 2g). | According to EN1789:2007+A: 2010, 6.4.1 vibration test, IEC/EN 60068-2-6 (acceleration up to amplitude 2g). | Different |
| Out-Of-Hospital Transport Bump | -- (Not specified for predicate) | According to EN1789:2007+A: 2010, 6.4.1 Bump test, IEC/EN 60068-2-6 (acceleration up to amplitude 15g). | N/A |
| Out-Of-Hospital Transport Drop Test | According to EN1789 (covers also IEC TR 60721-4-7 and Class 7M3). IEC/EN 60068-2-32 (height 0.75 m). | according to EN1789:2007+A:2010, IEC 60068-2-32 (height 1.2 m). | Different |
| Degrees of Protection | provided by enclosures according to IEC/EN 60529: IP32 | provided by enclosures according to IEC/EN 60529: IP44 | Different |
| Medical Vehicles and Equipments | EN 1789 +A1:2003 Medical vehicles and their equipment - Road ambulances (chapter 6 - Medical Devices). | EN1789:2007+A: 2010 Medical vehicles and their equipment - Road ambulances (chapter 6 – Medical Devices). | Same |
| Radiated Susceptibility | 20 V/m according to EN ISO 9919 (SpO2) and EN ISO 21647 (CO2). | 20 V/m according to EN ISO 9919 (SpO2) and EN ISO 21647 (CO2). | Same |
| Alarm Categories | Physiological alarms, Technical alarms, Prompt information | Physiological alarms, Technical alarms, Prompt information | Same |
| Alarm Levels | High level alarms, Medium level alarms, Low level alarms | High level alarms, Medium level alarms, Low level alarms | Same |
| Alarm Modes | Visual alarms, Audible alarms, Alarm messages, Parameter flashes | Visual alarms, Audible alarms, Alarm messages, Parameter flashes | Same |
Comparison to Reference Device iM70 (Specifically for PR from NIBP and CO2 Function)
| Feature / Parameter | Acceptance Criteria (Reference: iM70) | Reported Device Performance (iM20) | Match? |
|---|---|---|---|
| PR from NIBP | |||
| Measurement range | 40 to 240 bpm | 40 to 240 bpm (EDAN), 30 bpm ~220bpm (SunTech) | Same/Different |
| Accuracy | ±3bpm or 3.5%, whichever is greater | ±3bpm or 3.5%, whichever is greater (EDAN); ±3bpm or ±2%, whichever is greater (SunTech) | Same/Different |
| CO2 Function | |||
| EtCO2 Range | 0 to 150 mmHg | 0 mmHg ~ 150 mmHg | Same |
| FiCO2 Range | 3 mmHg to 50 mmHg | 3 mmHg~50 mmHg | Same |
| AwRR Range | 2 to 150 rpm | 2 rpm ~ 150 rpm (Sidestream) | Same |
| EtCO2 Resolution | 1.0 mmHg | 1mmHg | Same |
| FiCO2 Resolution | 1mmHg | 1mmHg | Same |
| AwRR Resolution | ±1 rpm | 1 rpm | Same |
| EtCO2 Accuracy (0-40 mmHg) | ±2.0 mmHg | ± 2 mmHg | Same |
| EtCO2 Accuracy (41-70 mmHg) | ±5 % of reading | ± 5 % | Same |
| EtCO2 Accuracy (71-100 mmHg) | ±8 % of reading | ± 8 % | Same |
| EtCO2 Accuracy (101-150 mmHg)| ±10 % of reading | ± 10 % | Same | |
| RESP > 80rpm | ±12 % of actual | ± 12 % | Same |
| 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.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29, 2016
Edan Instruments. Inc. % Doug Worth Sr. Dir. US RA/QA Edan Medical 1200 Crossman Ave. Suite 200 Sunnyvale, California 94086
Re: K152552
Trade/Device Name: Patient Monitor, model iM20 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: MHX, DSI, MLD, DRT, DXN, DSK, FLL, DQA, CCK, GXY, DPS, DRG Dated: March 22, 2016 Received: March 28, 2016
Dear Doug Worth:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply
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with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mitchell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152552
Device Name Patient Monitor, model iM20
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510 (K) Summary
Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92
| 1. Submitter: | Edan Instruments, Inc3/F - B, Nanshan MedicalEquipments Park, Nanhai Rd 1019#,Shekou, Nanshan Shenzhen, |
|---|---|
| 518067 P.R. China | |
| Tel: +86(0755) 26858736 | |
| Fax: +1 (408) 418-4059 | |
| Contact person: | Queena Chen |
| Preparing date: | March 22, 2015 |
| 2. Device name andclassification: | Device Name: Patient Monitor |
| Model: iM20 | |
| Classification Name/ Product code: | |
| 870.1025 monitor, physiological, patient(with arrhythmiadetection or alarms)/ MHX | |
| 870.1025 Detector and Alarm, Arrhythmia/ DSI | |
| 870.1025 Monitor, ST Segment with Alarm/ MLD | |
| 870.2300 Cardiac monitor (including cardiotachometer and ratealarm)/ DRT | |
| 870.1130 Non-Invasive blood pressure/ DXN | |
| 870.1110 Blood pressure computer/ DSK | |
| 880.2910 Clinical Electronic Thermometers-TemperatureMonitor with Probe/ FLL | |
| 870.2700 Oximeter, Pulse/ DQA | |
| 868.1400 Carbon Dioxide Gas Analyzer/ CCK | |
| 882.1320 Cutaneous electrode/GXY | |
| 870.2340 Electrocardiograph/DPS | |
| 870.2910 Radiofrequency physiological signal transmitter andreceiver/ DRG | |
| Regulatory Class: Class II | |
| 3.PremarketNotification Class IIICertification andSummary | Not applicable, the subject device is Class II. |
| 4. Predicate Device(s): | 1) Philips Medizin.Systeme Boeblingen GmbH IntelliVue MP2 cleared under K102562. |
| 2) Edan Instruments, Inc. iM70/ K131971 | |
| 5. Reason forSubmission | Introduce new device iM20 |
| 6. Pre-Submission,IDE | Not applicable, there is no prior submission. |
| 7. Device Description: | The iM20 Patient Monitor System (hereinafter called iM20) canperform long-time continuous monitoring of multiplephysiological parameters, including ECG, respiration (RESP),non-invasive blood pressure (NIBP), oxygen saturation of theblood (SpO2), pulse rate (PR), temperature (TEMP), invasivepressure (IBP), Carbon Dioxide (CO2). The system capabilitiesinclude storing, displaying, analyzing and controlling such dataafterwards. When necessary, alarms will be produced so thatdoctors and nurses can manage patient care appropriately. Thesystem is intended to be used during patient transport inside andoutside of the hospital environment.iM20 can be utilized in two ways, as an independent monitorand as a module of V series Patient Monitor (including modelselite V5, elite V6 and elite V8). When used as an independentmonitor, it can simultaneously monitor, store, review severalparameters data. And transfer patient data to V series patientmonitor only under the transport mode. As a highly portablemonitor, its compact design makes it particularly appropriateinside hospital and vehicle ambulance transport environments.When as a multi-measurement module, when the iM20 isdirectly connected to a V series patient monitor, it can providethe measurements, trends, and patient information.Whenconnected, the V series Patient Monitor controls the connectediM20, including all alarm functionality. So no alarms areavailable on iM20 in such application and iM20 takes powerfrom the V series Patient Monitor. |
| 8. IntendedUse/Indications forUse: | iM20 Patient Monitor (hereinafter called monitor) is intended tobe used for monitoring, storing, and reviewing of, and togenerate alarms for, multiple physiological parameters ofadults, pediatrics and neonates. The monitors are intended foruse by trained healthcare professionals in hospitalenvironments.The monitored physiological parameters include: ECG,respiration (RESP), temperature (TEMP), oxygen saturation of |
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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 and outside of the hospital environment.
The monitor is not intended for airplane, helicopter transport, home use and MRI environments.
9. Predicate Device Comparison
The subject devices share the same characteristics in all items with the predicate device, concluding from using the same technology and principle. All the technological differences existed between the subject and predicate devices are only some performance parameters improvement, detailed substantial equivalence discussion are included in the following tables.
| Item | Proposed device: iM20 | Predicate device:IntelliVue MP2 | Comparison Result |
|---|---|---|---|
| 510(k)Number | Current Submission | K102562 | |
| Indications for Use | |||
| Intended Use | iM20 Patient Monitor is intended to be used for monitoring, storing, and reviewing of, and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended to be used by trained healthcare professionals in a hospital environment. The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), and carbon dioxide (CO2). The arrhythmia detection and ST-segment monitoring are intended for adult only. Neonatal and pediatric | Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording of, and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The | Different |
| patients are not clinically validated.The monitors are indicated for use byhealth care professionals or under theirdirection whenever there is a need formonitoring the physiological parametersof patients.The monitors are additionally intendedfor use during patient transport insideand outside of the hospital environment.The monitor is not intended for airplane,helicopter transport, home use or MRIenvironments. | MP2, X2, MP5,MP5T, MP20,MP30, MP40, andMP50 areadditionallyintended for use intransport situationswithin hospitalenvironments. TheMP2, X2and MP5are also intendedfor use duringpatient transportoutside of ahospitalenvironment. | ||
| ECG Function | |||
| HR Calculation | |||
| Range | ADU: 15 bpm to 300 bpmPED/NEO: 15 bpm to 350 bpm | Adult/pedi: 15 to300 bpmNeo range: 15 to350 bpm | Different |
| Accuracy | $\pm$ 1% or 1 bpm, whichever is greater | $\pm$ 1% of range | Different |
| Resolution | 1 bpm | 1bpm | Same |
| Sensitivity | $\ge$ 300 $\mu$ VPP | $\ge$ 200 $\mu$ Vpeak | Different |
| PVC Rate | |||
| Range | ADU: 0 to 300 PVCs/ minPED/NEO: 0 to 350 PVCs/ min | 0 to 300 bpm | Different |
| Resolution | 1 PVCs/min | 1 bpm | Different |
| ST Numeric | |||
| Range | -2.0 mV to +2.0 mV | -20 to +20 mm | Different |
| Accuracy | -0.8 mV to +0.8 mV: $\pm$ 0.02 mV or 10%,which ever one is greater.Beyond this range: not specified. | $\pm$ 0.5mm or 15%,which ever one isgreater | Different |
| Resolution | 0.01 mV | 0.1mm | Different |
| Range of Sinus and SV Rhythm | |||
| Brady | Adult: RR interval for 5 consecutiveQRS complex $\ge$ 1.5 s.Pediatric/neonatal: RR interval for 5consecutive QRS complex $\ge$ 1 s. | Adult: 15 to 60bpmPedi: 15 to 80 bpmNeo: 15 to 90 bpm | Different |
| Normal | Adult: 0.5s < RR interval for 5consecutive QRS complex < 1.5 s. | Adult: 60 to 100bpm | Different |
| for 5 consecutive QRS complex < 1 s. | bpm | ||
| Neo: 90 to 180 bpm | |||
| Tachy | Adult: RR interval for 5 consecutiveQRS complex ≤ 0.5 s.Pediatric/neonatal: RR interval for 5consecutive QRS complex ≤ 0.375 s. | Adult: >100 bpmPedi: >160 bpmNeo: >180 bpm | Different |
| Bandwidth(-3dB) | Diagnosis: 0.05Hz to 150HzMonitor: 0.5Hz to 40HzSurgery: 1Hz to 20Hz | Diagnosis:Adult/neo/pedi:0.05 to 150 HzMonitor: Adult: 0.5to 40 HzNeo/pedi: 0.5 to 55 HzFilter Mode:Adult/neo/pedi: 0.5to 20 Hz | Different |
| CMRR(CommonModeRejectionRatio) | Diagnosis: >95dB (the Notch filter isoff)Monitor: >105dB (the Notch filter is on)Surgery: >105dB (the Notch filter is on) | Diagnosticmode: >86 dB(with a 51 k $/$ 47nF imbalance).Filter mode: >106dB (with a 51 k/47nF imbalance). | Different |
| DifferentialInputImpedance | >5MΩ | >2 MΩ RA-LLleads (Resp)>5 MΩ at all otherleads (at 10 Hzincluding patientcable) | Different |
| Input SignalRange | ±10mVPP | ±5mV(peak-to-peakvalue) | Different |
| ElectrodeOffsetPotentialTolerance | ±500mV | ±500mV | Same |
| AuxiliaryCurrent(Leads offdetection) | Active electrode: <100nAReference electrode: <900nA | Active electrode:<100nAReferenceelectrode: <900nA | Same |
| PacePulseIndicator | Pulse is marked if the requirements ofIEC 60601-2-27: 2011, Sect.201.12.1.101.12 are met: | ±2 mV to ±700 mVand widths from0.1 ms to 2.0 ms | Different |
| Amplitude: ±2 mV to ±700 mV | |||
| Width: 0.1 ms to 2.0 ms | |||
| Ascending time: 10 us to 100 us | |||
| Pulse is marked if the requirements of | ±2 mV to ±700 mV | ||
| IEC 60601-2-27: 2011, Sect. | and widths from | ||
| Pulse | 201.12.1.101.12 are met: | 0.1 ms to 2.0 ms | |
| Rejection | Amplitude: ±2 mV to ±700 mV | ||
| Width: 0.1 ms to 2.0 ms | |||
| Ascending time: 10 us to 100 us | |||
| Maximum start-up alarm time for Tachycardia | |||
| Ventricular | Gain 1.0: 10 s | Gain 1.0 Range 6.1 | Different |
| Tachycardia | to 6.9 seconds, | ||
| 1 mV | Average 6.5 | ||
| 206bpm | seconds | ||
| Ventricular | Gain 0.5: 10 s | Gain 0.5, Range 6.5 | |
| Rhythm | to 8.4 seconds, | ||
| Ventricular | Average 7.2 | ||
| Bradycardia | seconds | ||
| Gain 2.0: 10 s | Gain 2.0, Range 5.9 | ||
| to 6.7 seconds, | |||
| Average 6.3 | |||
| seconds | |||
| Gain 1.0: 10 s | Gain 1.0, Range 5.7 | ||
| to 6.5 seconds, | |||
| Average 6.1 | |||
| seconds | |||
| Ventricular | Gain 0.5: 10 s | Gain 0.5, Range 5.4 | |
| Tachycardia | to 6.2 seconds, | ||
| 2 mV | Average 5.8 | ||
| 195bpm | seconds | ||
| Gain 2.0: 10 s | Gain 2.0, Range 5.3 | ||
| to 6.1 seconds, | |||
| Average 5.7 | |||
| seconds | |||
| Complied with IEC 60601-2-27: 2011, | Exceeds | ||
| Sect. 201.12.1.101.17 minimum | ANSI/AAMI EC | ||
| recommended 1.2 mV T-Wave | 13 Sect. 3.1.2.1(c) | ||
| Tall T-wave | amplitude | minimum | |
| Rejection | recommended 1.2 | ||
| mV T-Wave | |||
| amplitude. | |||
| Heart Rate | Method1.Heart rate is computed by | Three different | Different |
| Averaging | excluding the minimum and maximum | methods are used: | |
| Method | values from the 12 most recent RR | Normally, heart | |
| intervals and averaging the residual 10 | rate is computed by | ||
| RR intervals. | averaging the 12 | ||
| Method 2.If each of three consecutive | most Recent RR | ||
| RR intervals is greater than 1200ms, then | intervals. | ||
| the four most recent RR intervals are | For runs of PVCs, | ||
| averaged to compute the HR. | up to 8 RR | ||
| intervals are | |||
| averaged to | |||
| compute the HR. If | |||
| each of 3 | |||
| consecutive RR | |||
| intervals is greater | |||
| than 1200 ms (that | |||
| is, rate less than 50 | |||
| bpm), then the 4 | |||
| most recent RR | |||
| intervals are | |||
| averaged to | |||
| compute the HR. | |||
| Complied with IEC 60601-2-27: 2011, | Ventricular | Different | |
| Sect. 201.7.9.2.9.101 b) 4), the HR value | bigeminy: 80 bpm | ||
| Accuracy of | after 20 seconds of stabilization is | Slow alternating | |
| Heart Rate | displayed as follows: | ventricular | |
| Meter and | Ventricular bigeminy: 80 bpm±1 bpm | bigeminy: 60 bpm | |
| Response to | Slow alternating ventricular bigeminy: | Rapid alternating | |
| Irregular | 60 bpm±1 bpm | ventricular | |
| Rhythm | Rapid alternating ventricular bigeminy: | bigeminy: 120 bpm | |
| 120 bpm±1 bpm | Bidirectional | ||
| Bidirectional systoles: 91 bpm±1 bpm | systoles: 90 bpm | ||
| Response | HR range: 80 bpm to 120 bpm | HR change from 80 | Different |
| time of Heart | Range : Within 11 s | to 120 bpm: | |
| Rate Meter | HR range: 80 bpm to 40 bpm | Range: [6.4 to 7.2 | |
| to Change in | Range : Within 11 s | seconds] Average: | |
| HR | 6.8 seconds | ||
| HR change from 80 | |||
| to 40 bpm: | |||
| Range: [5.6 to 6.4 | |||
| sec] Average: 6.0 | |||
| seconds | |||
| RESP Function | |||
| Different | |||
| Respiration | Sinusoid, 62.8 kHz(= 10%), <500 μA | Sinusoidal signal, | |
| excitation | 260 µA, 39 kHz | ||
| waveform | |||
| RR | Adult: 0 rpm to120rpm | Adult/pedi: 0 to | Different |
Comparison to Primary Predicate Device MP2
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| MeasuringRange | Pediatric/neonate: 0 rpm to 150rpm | 120 rpmNeo: 0 to 170 rpm | |||
|---|---|---|---|---|---|
| Accuracy | Adult: 6 to 120 rpm: ±2 rpm, 0 to 5 rpm:not specifiedNeo/Ped: 6 to 150 rpm: ±2 rpm0 to 5 rpm: not specified | at 0 to 120 rpm ±1 rpmat 120 to 170 rpm ±2 rpm | Different | ||
| Resolution | 1 rpm | 1 rpm | Same | ||
| Waveformbandwidth | 0.2Hz to 2.5Hz (-3dB) | 0.3 to 2.5 Hz (-6 dB) | Different | ||
| Apnea AlarmTime Setup | 10s, 15s, 20s, 25s, 30s, 35s, 40s; | 10 to 40 seconds 5 second steps | Different | ||
| NIBP Function | |||||
| Principle ofOperation | oscillation(EDAN, SunTech NIBP) | oscillation | Same | ||
| Adult | Different | ||||
| EDANNIBP | 40 mmHg ~ 270 mmHg | 30 to 270 mmHg | |||
| Systolic | SunTechNIBP | 60 mmHg ~ 250 mmHg | |||
| Diastolic | EDANNIBP | 10 mmHg ~ 215 mmHg | 10 to 245 mmHg | ||
| SunTechNIBP | 30 mmHg ~ 190 mmHg | ||||
| Mean | EDANNIBP | 20 mmHg ~ 235 mmHg | 20 to 255 mmHg | ||
| SunTechNIBP | 40 mmHg ~ 210 mmHg | ||||
| Measurement Range | Pediatric | EDANNIBP | 40 mmHg ~ 230 mmHg | 30 to 180 mmHg (4 to 24 kPa) | |
| Systolic | SunTechNIBP | 40 mmHg ~ 230 mmHg | |||
| Diastolic | EDANNIBP | 10 mmHg ~ 180 mmHg | 10 to 150 mmHg | ||
| SunTechNIBP | 20 mmHg ~ 160 mmHg | ||||
| Mean | EDANNIBP | 20 mmHg ~ 195 mmHg | 20 to 160 mmHg | ||
| SunTechNIBP | 30 mmHg ~ 175 mmHg | ||||
| Neonate | |||||
| Systolic | EDANNIBP | 40 mmHg ~135 mmHg | 30 to 130 mmHg (4 to 17 kPa) | ||
| SunTech NIBP | 40 mmHg ~130mmHg | ||||
| EDANNIBP | 10 mmHg ~ 100mmHg | 10 to 100 mmHg | |||
| Diastolic | SunTech NIBP | 20 mmHg ~ 90mmHg | |||
| EDANNIBP | 20 mmHg ~ 110mmHg | 20 to 120 mmHg | |||
| Mean | SunTech NIBP | 30 mmHg ~ 100mmHg | |||
| Max. Std.Deviation: 8 mmHg(1.1 kPa) | Same | ||||
| Accuracy | Max standard deviation: 8mmHg(EDAN, SunTech);Max mean error: $\pm$ 5 mmHg | Max. Mean Error:$\pm$ 5 mmHg ( $\pm$ 0.7kPa) | |||
| PressureResolution | 1mmHg(EDAN, SunTech); | 1mmHg | Same | ||
| Maximum time:180 seconds(adult/pediatric)90 seconds(neonates) | Different | ||||
| Maximummeasuringperiod | Adult/Pediatric 120sNeonate 90s | ||||
| Adult | 297 $\pm$ 3mmHg(EDAN)<300mmHg(SunTech) | >300 mmHg (40kPa) >2 sec | Different | ||
| Overpressureprotection | Pediatric | 240 $\pm$ 3mmHg(EDAN)<300mmHg(SunTech) | >300 mmHg (40kPa) >2 sec | ||
| Neonate | 147 $\pm$ 3mmHg(EDAN)<150mmHg(SunTech) | >150 mmHg (20kPa) >2 sec | |||
| Measuringinterval inAUTO Mode | 1/2/3/4/5/10/15/30/60/90/120/240/480min(EDAN)1/2/3/4/5/10/15/30/60/90/120/240/480min(SunTech) | 1, 2, 2.5, 3, 5, 10,15, 20, 30, 45, 60or 120 minutes | Different | ||
| Continuous | 5min, interval is 5s | 5 minutes | Same | ||
| SpO2 Function (EDAN) | |||||
| Measurement Range | 0-100% | 0 to 100 % | Same | ||
| Accuracy | Adult /Pediatric : $\pm$ 2 % (70% to 100%SpO2), Undefined (0 to 69% SpO2)Neonate : $\pm$ 3 % (70% to 100% SpO2),Undefined (0 to 69% SpO2) | Philips ReusableSensors:M1191A,M1191AL,M1191ANL,M1191B, | Different |
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| M1192A,M1192AN = 2 %(70 % to 100 %)M1193A,M1193AN,M1194A,M1194AN,M1195A,M1195AN,M1196A = 3 %(70 % to 100 %)M1191T, M1192T,M1193T (Adult),M1196T = 3%(70% to 100%)M1193T (Neonate)= 4 % (70 % to100 %) | |||
|---|---|---|---|
| Resolution | 1 % | 1 % | Same |
| Pulse Rate | |||
| MeasuringRange | 25 bpm to 300 bpm | 30 to 300 bpm | Different |
| Accuracy | ±2bpm | ±2 % or 1 bpm,whichever isgreater | Different |
| Resolution | 1 bpm | 1 bpm | Same |
| SpO2 Function (Nellcor) | |||
| Measurement Range | 1% to 100% | 1% to 100% | Same |
| Accuracy | DS-100A, OXI-A/N(Adult): ± 3% (70%to 100% SpO2)OXI-A/N(Neonate): ± 4% (70% to 100%SpO2) | Philips ReusableSensors:M1193A,M1193AN,M1194A,M1194AN,M1195A,M1195AN,M1196A = 3 %(70 % to 100 %)M1191T, M1192T,M1193T (Adult),M1196T = 3%(70% to 100%)M1193T (Neonate) | Same |
| = 4 % (70 % to100 %) | |||
| Resolution | 1 % | 1 % | Same |
| Pulse Rate | |||
| MeasuringRange | 20bpm to 300bpm | 30 to 300 bpm | Different |
| Accuracy | ± 3bpm (20bpm to 250bpm) | ±2 % or 1 bpm,which eve one isgreater | Different |
| Resolution | 1 bpm | 1 bpm | Same |
| Temperature Function | |||
| Measurement Range | 0 to 50°C | -1 to +49°C (30 to113°F ) | Different |
| Accuracy(notincludingsensor) | ±0.1 °C | ±0.1°C (±0.2°F ) | Same |
| Resolution | 0.1 °C | 0.1°C (±0.1°F) | Same |
| AverageTimeConstant | <30 s | Less than 10seconds | Different |
| IBP Function | |||
| MeasurementRange | -50 to +300 mmHg | -40 to 360 mmHg | Different |
| Accuracy (notincludingsensor) | ± 2 % or ±1 mmHg, whichever isgreater | 4 % of reading or±4 mmHg (±0.5kPa), whichever isgreater | Different |
| Resolution | 1 mmHg | 1 mmHg | Same |
| Transducer | 5 (μV/V/mmHg)300 to 3000 Ω | LoadImpedance:200 to2000 ^ (resistive)OutputImpedance:"3000^ (resistive) | Different |
| Zero | Range: ±200 mmHg | ±200 mmHg (±26kPa) | Same |
| Electronic Safety | |||
| Anti-electroshock type | Class II | Class II | Same |
| Workingsystem | Continuous operation equipment | Continuousoperationequipment | Same |
| Environmental Specifications | |||
| Temperature Range | |||
| Operating | 0°C to +40°C | 0 to 40°C (32 to104°F) | Same |
| Storageincludingtransportation | -30°C to +70°C | -20 to 60°C (-4 to140°F) | Different |
| Humidity Range | |||
| Operating | 15% to 95% (non-condensing) | 15 % to 95 %Relative Humidity(RH) | Same |
| Storageincludingtransportation | 15% to 95% (non-condensing) | 5 % to 95 %Relative Humidity(RH) | Different |
| Altitude Range | |||
| Operating | 615hPa to 1060hPa (DC-DCpowersupply)(-400 m to 4000 m)680hPa to 1060hPa (AC to DC powersupply)(-400m to 3000m) | -500 m to 3000 m(10000 ft) | Different |
| Storageincludingtransportation | 615hPa to 1060hPa(-400 m to 4000 m) | -500 m to 4600m(15000 ft) | Different |
| Physical Characteristics | |||
| Weight | iM20 : <1.5kgEFM : < 0.58 kg | 1.25 kg | Different |
| Dimensions | iM20:185 mm (L) × 85.3 mm (W)× 116mm (H)EFM: 207 mm (L) × 93.4 mm (W)× 116mm (H) | (W x H x D)188 x99 x 86 mm | |
| Display Specification | |||
| Description | 5 inches LCD | 72 x 54 mm (2.8 x2.1 in) | Different |
| Resolution | 800x480 | 320 x 240 | |
| Power Supply | |||
| Powerconsumption | <25w(Max) | <12 W average<30 W whilebattery is loading | Different |
| Power input | 11.1V to 19.8VDC | 36 to 60 V DCfloating | |
| Current | 1.27~2.3A | 0.7 to 0.4 A | |
| AC-DC Power supply | |||
| Line Voltage | 100~240Vac | 100 to 240 V ~ | Same |
| OutputVoltage | 15V±5%dc, 24VA | 36 to 60 V DC floating | Different |
| Frequency | 50/60 Hz ~ | 50/60 Hz ~ | Same |
| DC-DC Power supply | |||
| Line Voltage | 10~16Vdc | N/A | Different |
| OutputVoltage | 15V±5%dc | N/A | |
| Standard Compliance | |||
| Generalrequirement | IEC 60601-1:2005 | IEC 60601-1:1988 + A1:1991 +A2:1995 | Different |
| IEC 60601-2-25: 2011 | IEC60601-2-25:1993 +A1:1999 | ||
| IEC 60601-2-27: 2011 | IEC60601-2-27:2005 | ||
| IEC 60601-2-51: 2003 | IEC60601-2-51:2003 | ||
| AAMI EC11EC13:1991/2002. | AAMI EC11EC13:1991/2002 | ||
| Specialrequirement | IEC 80601-2-30: 2009 | IEC60601-2-30:1999 | |
| IEC 60601-2-34: 2011 | IEC60601-2-34:2000 | ||
| ISO 80601-2-61: 2011 | ISO 9919:2005 | ||
| EN 12470-4: 2000+ A1: 2009 | EN 12470-4:2000 | ||
| ISO 80601-2-55: 2011 | EN ISO21647:2004+Cor.1:2005 | ||
| ISO 80601-2-56: 2009 | EN 12470-4:2000 | ||
| ISO 81060-2: 2009 | -- | ||
| IEC 60601-2-49: 2011 | IEC60601-2-49:2001). | ||
| EMC | IEC 60601-1-2:2007 | IEC60601-1-2:2001 +A1:2004. | |
| Alarm | IEC 60601-1-8:2006 | IEC60601-1-8:2003 | |
| Biocompatibility | Compliance with ISO10993-1 ISO10993-5,ISO 10993-5-10 | Compliance withISO10993-1 ISO10993-5,ISO | |
| Out-Of-Hospital Transport - Standards Compliance | 10993-5-10 | ||
| Out-Of-Hospital Transport - Standards Compliance | |||
| Shock Tests | According to IEC TR 60721-4-7, Class7M3. Test procedure according toIEC/EN60068-2-27 (peak accelerationup to 100g). | According to IECTR 60721-4-7,Class 7M3. Testprocedureaccording toIEC/EN60068-2-27 (peakacceleration up to100g). | Same |
| RandomVibration | According to IEC TR 60721-4-7, Class7M3. Test procedure according toIEC/EN 60068-2-64 (RMS acceleration5g). | According to IECTR 60721-4-7,Class 7M3. Testprocedureaccording toIEC/EN60068-2-64 (RMSacceleration 5g). | Same |
| SinusoidalVibration | According to EN1789:2007+A: 2010,6.4.1 vibration test, Test procedureaccording to IEC/EN 60068-2-6(acceleration up to amplitude 2g). | According to IECTR 60721-4-7,Class 7M3. Testprocedureaccording toIEC/EN 60068-2-6(acceleration up toamplitude 2g). | Different |
| Bump | According to EN1789:2007+A: 2010,6.4.1 Bump test, Test procedureaccording to IEC/EN 60068-2-6(acceleration up to amplitude 15g). | -- | Different |
| Drop Test | according to EN1789:2007+A:2010,Test Procedure according to EN60068-2-32 (height 1.2 m). | According toEN1789 (coversalso IEC TR60721-4-7 andClass 7M3). Testprocedureaccording to EN60068-2-32 (height0.75 m). | Different |
| Degrees ofProtection | provided by enclosures according toIEC/EN 60529: IP44 | provided byenclosuresaccording to | Different |
| IEC/EN 60529:IP32 | |||
| MedicalVehicles andEquipments | EN1789:2007+A: 2010 Medicalvehicles and their equipment - Roadambulances (chapter 6 – MedicalDevices). | EN 1789 +A1:2003Medical vehiclesand their equipment- Road ambulances(chapter 6 -Medical Devices). | Same |
| RadiatedSusceptibility | 20 V/m according to EN ISO 9919(SpO2) and EN ISO 21647 (CO2). | 20 V/m accordingto EN ISO 9919(SpO2) and ENISO 21647 (CO2). | Same |
| Alarm System | |||
| AlarmCategories | Physiological alarmsTechnical alarmsPrompt information | PhysiologicalalarmsTechnical alarmsPrompt information | Same |
| Alarm Levels | High level alarmsMedium level alarmsLow level alarms | High level alarmsMedium levelalarmsLow level alarms | Same |
| Alarm Modes | Visual alarmsAudible alarmsAlarm messagesParameter flashes | Visual alarmsAudible alarmsAlarm messagesParameter flashes | Same |
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Comparison to Reference Device iM70
| Item | Proposed device, iM20 | Predicate device, | Comparison |
|---|---|---|---|
| K# | Current Submission | iM70 | Result |
| K131971 | |||
| PR from NIBP | |||
| Measurementrange | 40 to 240 bpm(EDAN)30 bpm ~220bpm(SunTech) | 40 to 240 bpm | SameDifferent |
| Accuracy | ±3bpm or 3.5%, whichever isgreater(EDAN);±3bpm or ±2%, whichever isgreater(SunTech); | ±3bpm or 3.5%, whichever isgreater | SameDifferent |
| CO2 Function | |||
| Measuring Range | |||
| EtCO2 | 0 mmHg ~ 150 mmHg | 0 to 150 mmHg (0 to 20.0 kPa) | Same |
| FiCO2 | 3 mmHg~50 mmHg | 3 mmHg to 50 mmHg | Same |
| AwRR | 2 rpm ~ 150 rpm (Sidestream) | 2 to 150 rpm | Same |
| Resolution | |||
| EtCO2 | 1mmHg | 1.0 mmHg (0.1 kPa) | Same |
| FiCO2 | 1mmHg | 1mmHg | Same |
| AwRR | 1 rpm | ±1 rpm | Same |
| EtCO2 Accuracy | |||
| 0 to 40 mmHg | ± 2 mmHg | ±2.0 mmHg (±0.29 kPa) | Same |
| 41 to 70 mmHg | ± 5 % | ±5 % of reading | Same |
| 71 to 100 mmHg | ± 8 % | ±8 % of reading | Same |
| 101 to 150 mmHg | ± 10 % | ±10 % of reading | Same |
| RESP measurement value exceeds 80rpm (sidestream) | ± 12 % | ±12 % of actual | Same |
| AwRR Accuracy | ± 1 rpm | ± 1 rpm | Same |
| Sample Gas Flow rate (sidestream) | 50±10 ml/min | 50±10ml/min | Same |
| O2 Compensation | |||
| Range | 0~100% | 0 ~ 100% | Same |
| Resolution | 1% | 1% | Same |
| Default | 16% | 16% | Same |
| Barometric pressure compensation | User setup | User setup | Same |
| Anesthetic Gas Compensation | |||
| Range | 0~20% | 0 ~ 20% | Same |
| Resolution | 0.1% | 0.1% | Same |
| Default | 0.0% | 0.0% | Same |
| Balance Gas Compensation | Room air, N2O, helium | Room air, N2O, helium | Same |
| Stability | |||
| Short Term | Drift over 4 hours < 0.8 mmHg | Drift over 4 hours | Same |
| Drift | < 0.8 mmHg | ||
| Long Term Drift | 120 hours | 120 hours | Same |
| Total System Response Time | 4.7 s | 4.7 s | Same |
| Alarm Type | EtCO2, FiCO2, AwRR | EtCO2, FiCO2, AwRR | Same |
| Apnea Alarm Delay | 10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s; default value is 20 s. | 10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s; default value is 20 s. | Same |
| Data Sample Rate | 100 Hz | 100 Hz | Same |
| Sensor Response Time (sidestream) | < 3 seconds, including transport time and rise time | < 3 seconds, including transport time and rise time | Same |
| Interfering Gas and Vapor Effects on EtCO2 Measurement Values | |||
| Nitrous oxide 60% | Dry and Saturated Gas0 – 40 mmHg: ± 1 mmHg additional error | Dry and Saturated Gas0 – 40 mmHg: ± 1 mmHg additional error | Same |
| Halothane 4% | 41 – 70 mmHg: ± 2.5% additional error | 41 – 70 mmHg: ± 2.5% additional error | |
| Desflurane 5% | 71 – 100 mmHg: ± 4% additional error | 71 – 100 mmHg: ± 4% additional error | |
| Enflurane 5% | 101 – 150 mmHg: ± 5% additional error*Additional worst case error when compensation for PB, O2, N2O, anesthetic agents, or helium is correctly selected for the actual fractional gas constituents present. | 101 – 150 mmHg: ± 5% additional error*Additional worst case error when compensation for PB, O2, N2O, anesthetic agents, or helium is correctly selected for the actual fractional gas constituents | |
| Isoflurane 5% | |||
| Sevoflurane 80% | Desflurane:The presence of desflurane in the exhaled breath at concentrations greater than 5% will positively bias Carbon Dioxide values by up to an additional 3 mmHg at 38mmHg. | ||
| Xenon 50% | Xenon:The presence of Xenon in the exhaled breath will negatively bias Carbon Dioxide values by up to an additional 5 mmHg at 38mmHg. | ||
| Helium 15% | |||
| Desflurane:The presence ofdesflurane in theexhaled breath atconcentrationsgreater than 5%will positively biasCarbon Dioxidevalues by up to anadditional 3mmHg at38mmHg.Xenon:The presence ofXenon in theexhaled breath willnegatively biasCarbon Dioxidevalues by up to anadditional 5mmHg at38mmHg. | |||
| Barometric Pressure on EtCO2 Measurement Values | |||
| 0 – 40 mmHg | $\pm$ 1 mmHg additional error | $\pm$ 1 mmHgadditional error | Same |
| 41 – 70mmHg | $\pm$ 2.5% additional error | $\pm$ 2.5% additionalerror | Same |
| 71 – 100mmHg | $\pm$ 4% additional error | $\pm$ 4% additionalerror | Same |
| 101 - 150mmHg | $\pm$ 5% additional error | $\pm$ 5% additionalerror | Same |
| Wi-Fi | |||
| IEEE | 802.11b/g/n | 802.11b/g/n | Same |
| FrequencyBand | 2.4GHz ISM band | 2.4GHz ISM band | Same |
| Modulation | OFDM with BPSK, QPSK, 16-QAM,and 64-QAM 802.11b with CCK andDSSS | OFDM withBPSK, QPSK,16-QAM, and64-QAM802.11b with CCKand DSSS | Same |
| TypicalTransmitPower ( $\pm$ 2 | 17 dBm for 802.11b DSSS17 dBm for 802.11b CCK15 dBm for 802.11g/n OFDM | 17 dBm for802.11b DSSS17 dBm for | Same |
| dBm) | 802.11b CCK15 dBm for802.11g/n OFDM |
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As seen in the comparison tables, the subject and predicate devices have similar design features and performance specifications. The main technological differences between the subject and predicate devices are minor differences, and do not raise different questions of safety or effectiveness. As demonstrated in the non-clinical and clinical testing, the different technological characteristics do not affect the safety and effectiveness of the Edan iM20 system.
10. Performance Data:
Non-clinical data:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the iM20 Patient Monitor were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered tissue contacting for duration of less than 24 hours. And the battery of testing included the following tests:
- □ Cytotoxicity
- □ Skin Sensitization
- □ Skin Irritation
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the iM20 Patient Monitor device, consisting of all the modules and accessories in the system complies with the IEC 60601-1:2005/A1: 2012 for safety and the IEC 60601-1-2:2007 standard for EMC.
Bench Testing
Bench testing was conducted on the iM20 Patient Monitor device, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-1-8: 2006, IEC 60601-2-25: 2011, IEC 60601-2-27: 2011, IEC 80601-2-30: 2009, IEC 60601-2-34: 2011, IEC 60601-2-49: 2011, ISO 80601-2-55: 2011, ISO 80601-2-56: 2009 and ISO 80601-2-61: 2011 standards for performance effectiveness.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance
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for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
Clinical data:
Clinical testing required by FDA specific guidance on Non-Invasive Blood Pressure (NIBP) Monitor is conducted per ISO 81060-2: 2013 Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type.
Summary
Based on the non-clinical and clinical performance as documented in the system development, the subject devices were found to have a safety and effectiveness profile that is similar to the predicate device.
11. Conclusion
The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that the iM20 Patient Monitor device should perform as intended in the specified use conditions. The clinical data demonstrate that the subject devices perform comparably to the predicate device that is currently marketed for the same intended use. In other words, the subject the iM20 Patient Monitor devices are substantially equivalent to the predicate devices.
§ 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.