(60 days)
The SE-18 18-lead electrocardiograph is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.
The SE-18 acquires and displays an 18 leads waveforms, which can also be printed by an integrated thermal printer with effective recording width 216mm. Digital filtering techniques similar to those incorporated on the SE-1515 and SE-12 have been used in SE-18: including Anti-baseline drift filter, AC filter (50/60Hz), EMG Filter and Low pass Filter, which can help the user to record a higher quality ECG. The EDAN Instruments "Smart ECG Measurement and interpretation program" (SEMIP) is included in this machine. The SEMIP program is completely integrated and provides the clinician with a detailed analysis of the ECG signal to aid in the interpretation of the ECGs. The recorded ECG can be saved in flash memory or sent to a PC by Ethernet or WIFI. During the examination, there are no substances delivered to and/or extracted from the patient. SE-18's function block diagram is shown as Fig 1. It's made up of an external ECG Sampling Box, SE-18 Main Control Board with RAM, FLASH, Ethernet module, WIFI module and USB module, a thermal printer module, a power supply module, a keyboard, and 15' 1024*768 display module.
The provided text describes the 510(k) submission for the Edan Instruments, Inc. SE-18 Electrocardiograph. It establishes substantial equivalence to predicate devices (EDAN Instrument, Inc. Electrocardiograph, models SE-1515 and SE-12 Series) based on similar design features, performance specifications, and non-clinical testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria" in the format of pass/fail thresholds against which device performance is directly measured. Instead, it compares the specifications of the proposed device (SE-18) against the predicate devices (SE-1515 and SE-12 Series) in a series of tables. The acceptance criteria are implicitly met if the proposed device's performance characteristics are "Same" as or demonstrate "minor differences" that "do not raise different questions of safety or effectiveness" compared to the predicate devices.
Below is a summary drawn from the provided comparison tables, focusing on a few key performance parameters. It consolidates information from Tables 1 and 2-2.
| Performance Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (SE-18) | Outcome (compared to Predicate) |
|---|---|---|---|
| HR Recognition | |||
| HR Range | 30 bpm ~300 bpm | 30 bpm ~300 bpm | Same |
| Accuracy | ± 1 bpm | ± 1 bpm | Same |
| ECG Unit (Electrical) | |||
| Leads | 18 standard leads (SE-1515); Standard 12 leads (SE-12 Series) | 18 standard leads | Same (vs. SE-1515) / Different (vs. SE-12 Series, with explanation below) |
| Sampling Frequency | 16kHz (SE-1515); 10k Hz (SE-12 Series) | 16kHz | Same (vs. SE-1515) / Different (vs. SE-12 Series) |
| A/D | 24 bits | 24bits | Same |
| Resolution | 0.1575uV/LSB (SE-1515); 2.52uV/LSB (SE-12 Series) | 0.1575 μV/LSB | Same (vs. SE-1515) / Different (vs. SE-12 Series) |
| Frequency Response | 0.01~300Hz(-3dB) (SE-1515); 0.05 Hz ~ 150 Hz (-3 dB) (SE-12 Series) | 0.01~300Hz(-3dB) | Same (vs. SE-1515) / Different (vs. SE-12 Series) |
| Input Impedance | ≥100MΩ (10Hz) (SE-1515); ≥50 MΩ(10 Hz) (SE-12 Series) | ≥100M Ω (10Hz) | Same (vs. SE-1515) / Different (vs. SE-12 Series) |
| Noise | ≤12.5µVp-p | ≤12.5μVp-p | Same |
| Multichannel Crosstalk | ≤0.5mm | ≤0.5mm | Same |
| Filters | |||
| DFT Filter settings | 0.01Hz/0.05Hz/0.32Hz/0.67Hz (SE-1515); 0.05Hz / 0.15Hz / 0.25Hz / 0.32Hz / 0.5Hz / 0.67Hz (SE-12 Series) | 0.01Hz/0.05Hz/0.32Hz/0.67Hz | Same (vs. SE-1515) / Different (vs. SE-12 Series) |
| Lowpass Filter settings | 300Hz/270Hz/150Hz/100Hz/75Hz (SE-1515); 150Hz / 100Hz / 75Hz (SE-12 Series) | 300Hz/270Hz/150Hz/100Hz/75Hz | Same (vs. SE-1515) / Different (vs. SE-12 Series) |
| CMRR | ≥123dB (AC OFF) (SE-1515); ≥115dB (AC Off) (SE-12 Series) | ≥140dB (AC On), ≥123dB (AC Off) | Greater than (vs. SE-12 Series) / Same (vs. SE-1515 for AC Off) |
| Pacemaker Detection | |||
| Amplitude | ±750μV to ±700mV (SE-1515); ±2 to ±700 mV (SE-12 Series) | ±750μV to ±700mV | Same (vs. SE-1515) / Different (vs. SE-12 Series) |
| Width | 50us to 2.0ms (SE-1515); 0.1 to 2.0 ms (SE-12 Series) | 50µs to 2.0ms | Same (vs. SE-1515) / Different (vs. SE-12 Series) |
The document states that SE-18 has "minor differences" compared to the predicate devices and that these "do not raise different questions of safety or effectiveness." This implies that the observed differences are within acceptable limits or represent improvements that do not negatively impact safety or effectiveness.
2. Sample size used for the test set and the data provenance
The document explicitly states "Clinical data: Not applicable."
For non-clinical data, it mentions Bench Testing was conducted per IEC 60601-2-25: 2011, and "all the results show pass." However, specific sample sizes for this general bench testing are not provided. The data provenance is not mentioned beyond being part of the manufacturer's internal testing. It is retrospective, as it was submitted for a 510(k) premarket notification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical study or expert-based ground truth establishment is described for the device's performance other than that the device's interpretation statements are "offered to clinicians on an advisory basis only." For the safety and performance testing, standards like IEC 60601-1 and IEC 60601-2-25 are used, which do not typically involve human expert consensus for ground truth on device specifications like sampling frequency or input impedance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no described clinical study involving assessment by human readers requiring adjudication.
5. 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
Not applicable. The document states "Clinical data: Not applicable" and describes an electrocardiograph, not an AI-assisted diagnostic tool requiring an MRMC study. The "EMIP" program for interpretation is mentioned, but its effectiveness or impact on human readers is not studied or presented here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device includes the "EDAN Instruments 'Smart ECG Measurement and interpretation program' (SEMIP)". While this is an algorithm, the document does not describe a standalone performance study of SEMIP's diagnostic accuracy. It states that "the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only," suggesting it's not intended for standalone diagnostic use. The focus is on the device's hardware and basic signal acquisition/processing capabilities meeting predicate equivalence.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance and safety specified, the ground truth is based on engineering specifications and adherence to international standards (e.g., IEC 60601-1, IEC 60601-2-25). For the SEMIP program, no explicit ground truth methodology for its interpretive statements is provided in this submission summary. Given its "advisory basis only" role, a rigorous ground truth validation for diagnostic accuracy might not have been required for this 510(k).
8. The sample size for the training set
Not applicable. The document does not describe a machine learning model that would require a training set. The SEMIP program is mentioned, but details on its development data or training set are not provided.
9. How the ground truth for the training set was established
Not applicable, as no training set for a machine learning model is described in the document.
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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
June 2, 2017
Edan Instruments, Inc. Mr. Doug Worth Sr. Dir. US RA/OA 1200 Crossman Ave, Suite 200 Sunnyvale, California 94086
Re: K170995
Trade/Device Name: SE-18 Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: March 30, 2017 Received: April 3, 2017
Dear Mr. 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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{1}------------------------------------------------
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.
Sincerelv.
M.A. Hillemann
for.
for __________________________________________________________________________________________________________________________________________________________________________ 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 know n)
K170995
Device Name SE-18 Electrocardiograph
Indications for Use (Describe)
The SE-18 18-lead electrocardiograph is intended to acquire ECG signals fromadult and pediatric patients through body surface ECG electrodes. The electrocardiographis only intended o be used in hospitals or healthcare healthcare professionals. The cardiogramrecorded by the electrocardio graph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.
| 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, Inc#15 Jinhui Road,Jinsha Community,Kengzi Sub-District, Pingshan District,Shenzhen, 518122 P.R.China.518067 P.R. ChinaTel: +86(0755) 26858736Fax: +1 (408) 418-4059 |
|---|---|
| Contact person:Preparing date: | Alice YangMarch 30, 2017 |
| 2. Device name andclassification: | Device Name: ElectrocardiographModel: SE-18Classification Name/ Product code:870.2340 Electrocardiograph/DPSRegulatory Class: Class II |
| 3. Predicate Device(s): | 1. EDAN Instrument, Inc. Electrocardiograph, models SE-1515,K152427 (Primary)2. EDAN Instrument, Inc. Electrocardiograph, models SE-12, SE-12Express, SE-1200, and SE-1200 Express, K160876 (Reference) |
| 4. Reason forSubmission | New model |
| 5. Pre-Submission,IDE | Not applicable, there is no prior submission. |
| 6. Device Description: | The SE-18 acquires and displays an 18 leads waveforms, which canalso be printed by an integrated thermal printer with effectiverecording width 216mm. |
| Digital filtering techniques similar to those incorporated on theSE-1515 and SE-12 have been used in SE-18: including |
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Anti-baseline drift filter, AC filter (50/60Hz), EMG Filter and Low pass Filter, which can help the user to record a higher quality ECG. The EDAN Instruments "Smart ECG Measurement and interpretation program" (SEMIP) is included in this machine. The SEMIP program is completely integrated and provides the clinician with a detailed analysis of the ECG signal to aid in the interpretation of the ECGs. The recorded ECG can be saved in flash memory or sent to a PC by Ethernet or WIFI. During the examination, there are no substances delivered to and/or extracted from the patient. SE-18'sfunction block diagram is shown as Fig 1.It's made up of an external ECG Sampling Box, SE-18 Main Control Board with RAM, FLASH, Ethernet module, WIFI module and USB module, a thermal printer module, a power supply module, a keyboard, and 15' 1024*768 display module. The SE-18 18-lead electrocardiograph is intended to acquire ECG signals from adult and pediatric patients through body surface ECG
- Intended Use: electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.
8. 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 items, which are shown in the following tables in details.
| Item | Proposed device(SE-18) | Predicate device(SE-1515) | Remark | |
|---|---|---|---|---|
| 510(k) Number | Current Submission | K152427 | ---- | |
| Indications for Use | ||||
| Intended use | The SE-18 18-leadelectrocardiograph is intendedto acquire ECG signals fromadult and pediatric patientsthrough body surface ECGelectrodes. Theelectrocardiograph is onlyintended to be used inhospitals or healthcarefacilities by doctors andtrained healthcareprofessionals. The cardiogramrecorded by theelectrocardiograph can helpusers to analyze and diagnoseheart disease. However, theinterpreted ECG withmeasurements andinterpretive statements isoffered to clinicians on anadvisory basis only. | SE-1515 PC ECG is intended toacquire, process and store ECGsignals from adult and pediatricpatients undergoing stressexercise test or resting test. TheSE-1515 PC ECG is intended tobe used only in hospitals andhealthcare facilities by doctorsand trained healthcareprofessionals. The cardiogramrecorded by the SE-1515 PCECG can help users to analyzeand diagnose heart diseases.However, the ECG withmeasurements and interpretivestatements is offered to clinicianson an advisory basis only. | Different | |
| SW Algorithm | SEMIP | SEMIP | Same | |
| Sampling Box | DE18 | DE18/DE15/DX12/DP12 | Different | |
| Safety Specifications | ||||
| Safety Standards | IEC 60601-1:2005/A1:2012EN 60601-1:2006/A1:2013IEC 60601-1-2:2007EN 60601-1-2:2007/AC:2010IEC 60601-2-25:2011 | IEC 60601-1:2005/A1:2012EN 60601-1:2006/A1:2013IEC 60601-1-2:2007EN 60601-1-2:2007/AC:2010IEC 60601-2-25:2011 | Same | |
| Anti-electric-shocktype: | Class I with internal powersupply | Class II | Different | |
| Anti-electric-shockdegree: | Type CF withdefibrillation-proof | Type CF with defibrillation-proof | Same | |
| Degree of protectionagainst harmful ingressof water: | Ordinary equipment (Sealedequipment without liquidproof) | Ordinary equipment (Sealedequipment without liquid proof) | Same | |
| Disinfection/sterilization method: | Refer to the user manual for details | Refer to the user manual for details | Same | |
| Degree of safety of application in the presence of flammable gas: | Equipment not suitable for use in the presence of flammable gas | Equipment not suitable for use in the presence of flammable gas | Same | |
| Working mode: | Continuous operation | Continuous operation | Same | |
| EMC: | CISPR 11 Group 1, Class A | CISPR 11 Group 1, Class A | Same | |
| Patient Leakage Current: | NCSFC | $<10μA (AC) / <10μA (DC)<50μA (AC) / <50μA (DC)$ | $<10μA (AC) / <10μA (DC)<50μA (AC) / <50μA (DC)$ | Same |
| Patient Auxiliary Current: | NCSFC | $<10μA (AC) / <10μA (DC)<50μA (AC) / <50μA (DC)$ | $<10μA (AC) / <10μA (DC)<50μA (AC) / <50μA (DC)$ | Same |
| Environmental Specifications | ||||
| Temperature | ||||
| Operating | +5°C (+41°F) ~ +40°C (+104°F) | +5°C (+41°F) ~ +40°C (+104°F) | Same | |
| Transport/Storage | -20°C (-4°F) ~ +55°C (+131°F) | -20°C (-4°F) ~ +55°C (+131°F) | Same | |
| Humidity | ||||
| Operating | 15%RH~95%RHNon-Condensing | 25% RH~80% RHNon-Condensing | Different | |
| Transport/Storage | 15%RH~95%RHNon-Condensing | 25% RH~93% RHNon-Condensing | t | |
| Pressure | ||||
| Operating | 70 kPa ~106 kPa | 86 kPa ~106 kPa | Different | |
| Transport/Storage | 70 kPa ~106 kPa | 70 kPa ~106 kPa | t | |
| Performance Specifications | ||||
| HR Recognition | ||||
| HR Range: | 30 bpm ~300 bpm | 30 bpm ~300 bpm | Same | |
| Accuracy: | $\pm$ 1 bpm | $\pm$ 1 bpm | Same | |
| ECG Unit (only DE18 is listed for SE-1515) | ||||
| Leads: | 18 standard leads | 18 standard leads | Same | |
| Acquisition Mode: | 18 leads acquisitionsimultaneously | 18 leads acquisitionsimultaneously | Same | |
| Sampling Frequency | 16kHz | 16kHz | Same | |
| A/D: | 24bits | 24 bits | Same | |
| Resolution: | 0.1575 μV/LSB | 0.1575uV/LSB | Same | |
| Time Constant: | ≥3.2s | ≥3.2s | Same | |
| Frequency Response: | 0.01~300Hz(-3dB) | 0.01~300Hz(-3dB) | Same | |
| Gain: | 2.5, 5, 10, 20, 10/5, AGC (mm/mV) | 2.5, 5, 10, 20, 10/5, AGC (mm/mV) | Same | |
| Input Impedance: | ≥100M Ω (10Hz) | ≥100MΩ (10Hz) | Same | |
| Input Circuit Current: | ≤0.01μA | ≤0.01μA | Same | |
| Input Voltage Range | ≤±5 mVpp | ≤±5 mVpp | Same | |
| Calibration Voltage: | 1mV±2% | 1mV ± 2% | Same | |
| DC Offset Voltage: | ±600mV | ±600mV | Same | |
| Minimum Amplitude: | 20 μVp-p | 20 μVp-p | Same | |
| Noise: | ≤12.5μVp-p | ≤12.5μVp-p | Same | |
| Multichannel crosstalk | ≤0.5mm | ≤0.5mm | Same | |
| Filter | AC | 50Hz/60Hz/Off | 50Hz/60Hz/Off | Same |
| DFT | 0.01Hz/0.05Hz/0.32Hz/0.67Hz | 0.01Hz/0.05Hz/0.32Hz/0.67Hz | ||
| EMG | 25Hz/35Hz/45Hz/Off | 25Hz/35Hz/45Hz/Off | ||
| LOWPASS Filter | 300Hz/270Hz/150Hz/100Hz/75Hz | 300Hz/270Hz/150Hz/100Hz/75Hz | ||
| CMRR | ≥123dB (AC OFF) | ≥123dB (AC OFF) | Same | |
| Pacemaker Detection | ||||
| Amplitude | ±750μV to ±700mV | ±750uV ~ ±700mV | Same | |
| Width | 50us to 2.0ms | 50us ~ 2.0ms | Same |
Table 1: Comparison between SE-18 and SE-1515
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K170995 Page 3 of 10
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Table 2-2: Comparison between SE-18 and SE-12 Series
| Item | Proposed device(SE-18) | Predicate device(SE-12 Series) | Remark | |
|---|---|---|---|---|
| 510(k) Number | Current Submission | K160876 | --- | |
| Intended use | The SE-18 18-leadelectrocardiograph is intendedto acquire ECG signals fromadult and pediatric patientsthrough body surface ECGelectrodes. Theelectrocardiograph is onlyintended to be used in hospitalsor healthcare facilities by | The intended use of SE-12series electrocardiograph is toacquire ECG signals from adultand pediatric patients throughbody surface ECG electrodes.The electrocardiograph is onlyintended to be used in hospitalsor healthcare facilities bydoctors and trained healthcare | Same | |
| SW Algorithm | SEMIP | SEMIP | Same | |
| ---- | ||||
| Safety SpecificationsSafety Standards | IEC 60601-1:2005/A1:2012EN 60601-1:2006/A1:2013IEC 60601-1-2:2007EN60601-1-2:2007/AC:2010IEC 60601-2-25:2011 | IEC 60601-1:2005EN 60601-1:2006EN 60601-1-2:2007IEC 60601-1-2:2007IEC/EN60601-2-25:2011 | Different | |
| Anti-electric-shock type: | Class I with internal powersupply | Class I with internal powersupply | Same | |
| Anti-electric-shockdegree: | Type CF withdefibrillation-proof | Type CF withdefibrillation-proof | Same | |
| Degree of protectionagainst harmful ingressof water: | Ordinary equipment (Sealedequipment without liquidproof) | Ordinary equipment (Sealedequipment without liquidproof) | Same | |
| Disinfection/sterilizationmethod: | Refer to the user manual fordetails | Refer to the user manual fordetails | Same | |
| Degree of safety ofapplication in thepresence of flammablegas: | Equipment not suitable for usein the presence of flammablegas | Equipment not suitable for usein the presence of flammablegas | Same | |
| Working mode: | Continuous operation | Continuous operation | Same | |
| EMC: | CISPR 11 Group 1, Class A | CISPR 11 Group 1, Class A | Same | |
| Patient | NC | <10μA (AC) / <10μA (DC) | <10μA (AC) / <10μA (DC) | Same |
| LeakageCurrent: | SFC | <50μA (AC) / <50μA (DC) | <50μA (AC) / <50μA (DC) | Same |
| Patient | NC | <10μA (AC) / <10μA (DC) | <10μA (AC) / <10μA (DC) | Same |
| AuxiliaryCurrent: | SFC | <50μA (AC) / <50μA (DC) | <50μA (AC) / <50μA (DC) | Same |
| Ingress rating | IPX0 | IPX0 | Same | |
| Environmental Specifications | ||||
| Temperature | ||||
| Operating | +5℃ (+41°F) ~ +40°C | +5°C (+41°F) ~ +40°C (+104°F) | Same | |
| (+104°F) | ||||
| Transport/Storage | -20°C (-4°F) ~ +55°C (+131°F) | -20°C (-4°F) ~ +55°C (+131°F) | Same | |
| Humidity | ||||
| Operating | 15%RH~95%RH | 25% to 80% RH | ||
| Non-Condensing | Non-condensing | |||
| Transport/Storage | 15%RH~95%RH | 25% to 93% RH | Different | |
| Non-Condensing | Non-condensing | |||
| Pressure | ||||
| Operating | 70 kPa ~106 kPa | 86 kPa ~106 kPa | ||
| Transport/Storage | 70 kPa ~106 kPa | 70 kPa ~106 kPa | Different | |
| Power Supply Specifications | ||||
| Operating Voltage = | Operating Voltage = | Same | ||
| 100V-240V~ | 100V-240V~ | |||
| Mains Supply | Operating Frequency = | Operating Frequency = | Same | |
| 50Hz/60Hz | 50Hz/60Hz | |||
| Input Current = 0.9A ~ 0.4A | Input Current = 0.9 ~ 0.4A | Same | ||
| Rated Voltage = 14.8V | Rated voltage = 14.8V | Different | ||
| SE-12 Express&SE-1200 | ||||
| Internal Li-ion Battery | Rated Capacity = 5000mAh | Express: Rated capacity = | ||
| Pack: | 5000mAh | |||
| SE-12& SE-1200: Rated | ||||
| capacity =2500mAh | ||||
| Performance Specifications | ||||
| Recording | ||||
| Recorder: | Thermal dot-matrix recorder | Thermal dot-matrix recorder | Same | |
| 8 dots per mm / 200 dots per | 8 dots per mm / 200 dots per | Same | ||
| inch (amplitude axes) | inch (amplitude axes) | |||
| Printing Density | 40 dots per mm / 1000 dots per | 40 dots per mm / 1000 dots per | ||
| inch (time axes, @ 25 mm/s) | inch (time axes, @ 25 mm/s) | |||
| Folded thermal paper: | Same | |||
| Recorder Paper: | Folded thermal paper: | |||
| 210mm×295mm×100pages | 210mm×295mm×100pages | |||
| Folded thermal paper: | Folded thermal paper: | |||
| 215mm×280mm×100pages | 215mm×280mm×100pages | |||
| Folded thermal paper:210mm×295mm×200pages | (Optional)Rolled thermal paper:210mm×30m (Optional) | |||
| Effective Width: | 210mm | 210mm | Same | |
| Paper Speed: | 5mm/s, 6.25mm/s, 10mm/s,12.5mm/s, 25mm/s, 50mm/s(±3%) | 5mm/s, 6.25mm/s, 10mm/s,12.5mm/s, 25mm/s, 50mm/s(±3%) | Same | |
| Accuracy of data: | ±5% (x-axis), ±5%(y-axis) | ±5% (x-axis), ±5%(y-axis) | Same | |
| HR Recognition | ||||
| HR Range: | 30 bpm ~300 bpm | 30 BPM ~ 300 BPM | Same | |
| Accuracy: | ±1 bpm | ±1 bpm | Same | |
| ECG Unit | ||||
| Leads: | 18 standard leads | Standard 12 leads | Different | |
| Acquisition Mode: | 18 leads acquisitionsimultaneously | Simultaneously 12 leads | ||
| Sampling Frequency | 16kHz | 10k Hz | Different | |
| A/D | 24bits | 24 bits | Same | |
| Resolution: | 0.1575 µV/LSB | 2.52uV/LSB | Different | |
| Time Constant: | ≥3.2s | ≥ 3.2 s | Same | |
| FrequencyResponse: | 0.01~300Hz(-3dB) | 0.05 Hz ~ 150 Hz (-3 dB) | Different | |
| 2.5, 5, 10, 20, 10/5, AGC(mm/mV) | 2.5, 5, 10, 20, 10/5, AGC(mm/mV) | Same | ||
| Gain: | (mm/mV) | (mm/mV) | ||
| Input Impedance: | ≥100M Ω (10Hz) | ≥50 MΩ(10 Hz) | Different | |
| Input Circuit Current: | ≤0.01μA | ≤0.01μA | Same | |
| Input Voltage Range | ≤±5 mVpp | ≤±5 mVpp | Same | |
| Calibration Voltage: | 1mV±2% | 1 mV±2% | Same | |
| DC Offset Voltage: | ±600mV | ±600 mV | Same | |
| Noise: | ≤12.5µVp-p | ≤12.5 µVp-p | Same | |
| Multi-channel Crosstalk | ≤0.5mm | ≤0.5 mm | Same | |
| Filter | AC | 50Hz/60Hz/Off | 50Hz/60Hz/Off | Same |
| DFT | 0.01Hz/0.05Hz/0.32Hz/0.67Hz | 0.05Hz / 0.15Hz / 0.25Hz /0.32Hz / 0.5Hz / 0.67Hz | Different | |
| EMG | 25Hz/35Hz/45Hz/Off | 25Hz/35Hz/45Hz/Off | Same | |
| LOWPASS | 300Hz/270Hz/150Hz/100Hz/75Hz | 150Hz / 100Hz / 75Hz | Different |
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| CMRR | ≥140dB (AC On),≥123dB (AC Off), | ≥115dB (AC Off) | Different |
|---|---|---|---|
| Pacemaker Detection | |||
| Amplitude | ±750μV to ±700mV | ±2 to ±700 mV | Different |
| Width | 50µs to 2.0ms | 0.1 to 2.0 ms | Different |
| Sampling Frequency | 16kHz, Rhythm Lead | 10,000/sec/channel | Different |
| External Input/Output | |||
| Input | ≥100kΩ; Sensitivity10mm/V±5%;Single ended | ≥100kΩ; Sensitivity10mm/V±5%;Single ended | Same |
| Output | ≤100Ω; Sensitivity1V/mV±5%;Single ended | ≤100Ω; Sensitivity1V/mV±5%;Single ended | Same |
| WIFI Specifications (Optional) | |||
| Transmitting Frequency | 2.400-2.500GHz (2.4 GHz ISMband ) | 2400-2497MHz | Different |
| Frequency Band | 2.400-2.500GHz (2.4 GHz ISMband ) | 2400-2497MHz | |
| Modulation Type | DSSS, CCK,OFDM | DSSS, CCK,OFDM | |
| Transmitting Power | 17 dBm for 802.11b DSSS17 dBm for 802.11b CCK15 dBm for 802.11g/n OFDM | 6-17dBm | |
| Effective RadiatedPower | 17 dBm for 802.11b DSSS17 dBm for 802.11b CCK15 dBm for 802.11g/n OFDM | 6-17dBm |
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 testing, the different technological characteristics do not affect the safety and effectiveness of the Edan SE-18 electrocardiograph.
9. Performance Data:
Non-clinical data:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
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The biocompatibility evaluation for SE-18 electrocardiograph is 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 surface 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 SE-18 electrocardiograph, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-1:2005/A1: 2012 standard for safety and the IEC 60601-1-2: 2007 standard for EMC.
Bench Testing
Bench testing was conducted per IEC 60601-2-25: 2011, and all the results show pass.
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 for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software will not directly result in serious injury or death to the patient or operator, and the software device is an accessory to a medical device that has a Moderate Level of Concern.
Clinical data: Not applicable.
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.
10. Conclusion
The non-clinical data support the safety of the device and software verification and validation demonstrate that SE-18 electrocardiograph device should perform as intended in the specified use conditions, and all the 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 SE-18 electrocardiograph device is substantially equivalent to the predicate devices.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).