(210 days)
The intended use of SE-12 series electrocardiograph is to acquire ECG signals from adult and pediatric patients (beginning at birth through 21 years of age) through body surface ECG 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 disease. However, the interreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.
The SE-12/12 Express/1200/1200 Express Electrocardiograph gathers ECG signals of 12 leads simultaneously. It displays the operation menu, ECG parameters as well as electrocardiograms, and be powered by the mains supply or battery. And the system has advanced performance and high reliability due to high resolution thermal recorder, 32-bit processor and a large-capacity memorizer. Design of the system took much consideration on ergonomics so the size is suitable for clinic and hospital uses.
There are four selectable modes in the system, including manual, auto, rhythm, R-R analysis or VCG, and VCG is configured with SE-12 Express & SE-1200 Express.
SE-12 and SE-1200 share the same single-color LCD screen of which the resolution is 320×240 dot; and LCD screen of SE-12 Express and SE-1200 Express is 800×600 multicolor LCD screen.
Moreover, SE-12 Express is configured with stress ECG function, which will allow to diagnose concealed coronary heart disease and atypical angina pectoris, prescribe the workload for patients with myocardial infarction before leaving hospital, and assess the effect of the treatment.
The provided text describes a 510(k) premarket notification for an Electrocardiograph device (models SE-12, SE-12 Express, SE-1200, and SE-1200 Express). It does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/algorithm's performance. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical data and comparisons of technical specifications.
Therefore, many of the requested items related to an AI study, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not available in the provided text.
However, I can extract the acceptance criteria and performance information that is available, which pertains to the device's general technical specifications and safety/EMC standards.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the "Same" or "Different" comparison to the predicate device for various specifications, as well as compliance with relevant standards. The reported device performance is either identical to the predicate (marked as "Same") or an improved/different specification (marked as "Different").
Note: The "Comparison Result" column indicates if the proposed device's specification is "Same" or "Different" from the predicate. When "Different," the proposed device's performance is listed.
| Acceptance Criteria Category | Specific Metric | Device Performance (Proposed Device) | Comparison Result (vs Predicate) |
|---|---|---|---|
| Intended Use | Patient Age Range | Adult and pediatric patient (beginning at birth through 21 years of age) | Different |
| Safety Specifications | Safety Standards Compliance | IEC 60601-1:2005/A1:2012, EN 60601-1:2006/A1:2013, IEC 60601-1-2:2007, EN 60601-1-2:2007/AC:2010, IEC/EN 60601-2-25 | Same |
| Anti-electric-shock type | Class I with internal power supply | Same | |
| Anti-electric-shock degree | Type CF | Same | |
| Degree of protection against harmful ingress of water | Ordinary equipment (Sealed equipment without liquid proof) | Same | |
| Disinfection/sterilization method | Refer to the user manual for details | Same | |
| Degree of safety in flammable gas presence | Equipment not suitable for use in the presence of flammable gas | Same | |
| Working mode | Continuous operation | Same | |
| EMC | CISPR 11 Group 1, Class A | Same | |
| Ingress rating | IPX0 | Same | |
| Environmental Specs | Transport & Storage Temperature | -20°C (-4°F) ~ +55°C (+131°F) | Same |
| Working Temperature | +5°C (+41°F) ~ +40°C (+104°F) | Same | |
| Transport & Storage Relative Humidity | 25%~93% Non-Condensing | Same | |
| Working Relative Humidity | 25% RH ~ 80% RH Non-Condensing | Same | |
| Transport & Storage Atmospheric Pressure | 700 hPa ~1060 hPa | Same | |
| Working Atmospheric Pressure | 860 hPa ~1060 hPa | Same | |
| Power Supply Specs | Mains Supply Operating Voltage | 100V-240V~ | Same |
| Mains Supply Operating Frequency | 50 Hz / 60 Hz | Same | |
| Mains Supply Input Current | 0.9-0.4A | Same | |
| Mains Supply Input Power | 96VA | Same | |
| Battery Pack Rated Voltage | 14.8 V | Same | |
| SE-12 Express & SE-1200 Express Battery Capacity | 5000mAh | Same | |
| SE-12 & SE-1200 Battery Capacity | 2500mAh | Same | |
| Battery Work Time (Full Charge, SE-12 & SE-1200) | Approx. 4 hours normally; approx. 1.5 hours continual print (manual); approx. 300 ECG reports (auto, 3x4+1R) | Same | |
| Battery Work Time (Full Charge, SE-12 Express & SE-1200 Express) | Approx. 5 hours normally; approx. 2.5 hours continual print (manual); approx. 350 ECG reports (auto, 3x4+1R) | Same | |
| Performance Specs | Recorder Type | Thermal dot-matrix recorder | Same |
| Printing Density (amplitude axes) | 8 dots per mm / 200 dots per inch | Same | |
| Printing Density (time axes, @ 25mm/s) | 40 dots per mm / 1000 dots per inch | Same | |
| Recorder Paper (Folded Thermal) | 210mm×295mm×100pages OR 215mm×280mm×100pages (Optional) | Same | |
| Recorder Paper (Rolled Thermal) | 210mm×30m (Optional) | Same | |
| Effective Width | 210mm | Same | |
| Paper Speed | 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) | Same | |
| HR Recognition Technique | Peak-Peak Detection | Same | |
| HR Range | 30 BPM ~ 300 BPM | Same | |
| HR Accuracy | ±1 BPM | Same | |
| ECG Unit Leads | Standard 12 leads | Same | |
| Acquisition Mode | Simultaneously 12 leads | Same | |
| A/D Resolution | 24 bits | Same | |
| Resolution | 2.52uV/LSB | Same | |
| Time Constant | ≥ 3.2 s | Same | |
| Frequency Response | 0.01Hz ~ 300 Hz (-3 dB) | Different | |
| Gain | 1.25, 2.5, 5, 10, 20, 10/5, AGC (mm/mV) | Same | |
| Input Impedance | ≥100MΩ (10Hz) | Different | |
| Input Circuit Current | ≤0.01μA | Same | |
| Input Voltage Range | ≤±5 mVpp | Same | |
| Calibration Voltage | 1mV±2% | Same | |
| DC Offset Voltage | ±600 mV | Same | |
| Noise | ≤12.5 µVp-p | Same | |
| Multi-channel Crosstalk | ≤0.5 mm | Same | |
| Filter (AC Filter) | On / Off | Same | |
| Filter (DFT Filter) | 0.01Hz/0.05Hz / 0.15Hz / 0.25Hz / 0.32Hz / 0.5Hz / 0.67Hz | Different | |
| Filter (EMG Filter) | 25Hz / 35Hz / 45Hz / OFF | Same | |
| Filter (LOWPASS Filter) | 300Hz/270Hz/150Hz / 100Hz / 75Hz | Different | |
| CMRR | ≥140dB (AC ON), ≥123dB (AC OFF) | Different | |
| Sampling Frequency | 16000Hz | Different | |
| Pacemaker Detection | Amplitude | ±750uV to ±700 mV | Different |
| Width | 50µs to 2.0 ms | Different | |
| Sampling Frequency | 16,000/sec/channel | Different | |
| External Input/output | Input | ≥100 kΩ; Sensitivity 10 mm/V±5%; Single ended | Same |
Study Details (Information Not Available in the Provided Text)
The document is a 510(k) summary for a medical device (Electrocardiograph) seeking substantial equivalence to a previously cleared predicate device. It primarily focuses on hardware specifications, safety, EMC, and software verification/validation. It does not describe a study involving an AI or algorithm's diagnostic performance beyond stating that "ECG interpretation features were also validated by database testing." As such, the following requested information is not explicitly detailed in the provided text:
- Sample size used for the test set and the data provenance: Not explicitly stated for specific diagnostic performance of the interpretation features, beyond "database testing."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not stated.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not stated.
- 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: No MRMC study is mentioned. The device's interpreted ECG with statements is "offered to clinicians on an advisory basis only," indicating it's an assistive tool, but no comparative effectiveness study with human readers is described.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document mentions "ECG interpretation features were also validated by database testing," which suggests standalone algorithm testing, but details on its specific performance metrics (e.g., sensitivity, specificity, accuracy) are not provided.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not stated for the "database testing" of interpretation features.
- The sample size for the training set: Not stated.
- How the ground truth for the training set was established: Not stated.
The document primarily demonstrates that the updated hardware and software of the Electrocardiograph maintain the safety and effectiveness profile of its predicate device, rather than providing a detailed study of an AI's diagnostic performance against specific acceptance criteria.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 24, 2018
Edan Instruments, Inc. % Doug Worth Sr. Dir. US RA/QA Edan Medical 1200 Crossman Ave. Suite 200 Sunnyvale, California 94089
Re: K171942
Trade/Device Name: Electrocardiograph with models SE-12, SE-12 Express, SE-1200 and SE-1200 Express Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: December 21, 2017 Received: December 26, 2017
Dear Doug Worth:
We have reviewed vour 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 of medical device-related adverse events) (21 CFR 803); good
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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
MA Willel em
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K171942
Device Name
Electrocardiograph: SE-12, SE-12 Express, SE-1200, SE-1200 Express
Indications for Use (Describe)
The intended use of SE-12 series electrocardiograph is to acquire ECG signals from adult and pediatric patients (beginning at birth through 21 years of age) through body surface ECG 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 disease. However, the interreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
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510(k) Summary
Prepared in accordance with the 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.Tel.: (0755) 28340011Fax: +1 (408) 418-4059 |
|---|---|
| Contact Person: | Alice Yang |
| Date prepared: | June 19, 2017 |
| 2. Device nameand classification: | Device Name: Electrocardiograph |
| Model: SE-12, SE-1200, SE-12 Express, SE-1200 Express | |
| Classification Name: | |
| 870.2340 ElectrocardiographProduct code: DPS | |
| Regulatory Class: Class II | |
| 3.PremarketNotification ClassIII Certificationand Summary | Not applicable, the subject device is Class II. |
| 4. PredicateDevice(s): | 1. Edan Instruments, Inc., Electrocardiograph, models SE-12, SE-12 Express,SE-1200, and SE-1200 Express cleared under K160876 (Primary)2. Edan Instruments, Inc., PC ECG, model SE-1515 cleared underK152427(Reference) |
| 5. Reason forSubmission | Modification for previous cleared product Electrocardiograph, modelsSE-12, SE-1200, SE-12 Express, SE-1200 Express. |
| 6. Pre-Submission,IDE | Not applicable, there is no prior submission. |
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| 7. DeviceDescription: | The SE-12/12 Express/1200/1200 Express Electrocardiograph gathersECG signals of 12 leads simultaneously. It displays the operation menu,ECG parameters as well as electrocardiograms, and be powered by themains supply or battery. And the system has advanced performance andhigh reliability due to high resolution thermal recorder, 32-bit processorand a large-capacity memorizer. Design of the system took muchconsideration on ergonomics so the size is suitable for clinic andhospital uses. |
|---|---|
| There are four selectable modes in the system, including manual, auto,rhythm, R-R analysis or VCG, and VCG is configured with SE-12Express & SE-1200 Express. | |
| SE-12 and SE-1200 share the same single-color LCD screen of whichthe resolution is 320×240 dot; and LCD screen of SE-12 Express andSE-1200 Express is 800×600 multicolor LCD screen. | |
| Moreover, SE-12 Express is configured with stress ECG function, whichwill allow to diagnose concealed coronary heart disease and atypicalangina pectoris, prescribe the workload for patients with myocardialinfarction before leaving hospital, and assess the effect of the treatment. | |
| 8. Intended Use: | The intended use of SE-12 series electrocardiograph is to acquire ECGsignals from adult and pediatric patients (beginning at birth through 21years of age) through body surface ECG electrodes. Theelectrocardiograph is only intended to be used in hospitals or healthcarefacilities by doctors and trained healthcare professionals. Thecardiogram recorded by the electrocardiograph can help users to analyzeand diagnose heart disease. However, the interpreted ECG withmeasurements and interpretive statements is offered to clinicians on anadvisory basis only. |
9. Predicate Device Comparison
Comparison to the predicate devices, the subject device has the same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following tables:
| Item | Predicatedevice(SE-12, SE-12Express,SE-1200, andSE-1200Express) | Proposed device(SE-12, SE-12Express, SE-1200,andSE-1200Express) | ComparisonResult |
|---|---|---|---|
| K# | K160876 | Current Submission | — |
| Intended Use | The intended use of the12-channel electrocardiograph isto acquire ECG signals fromadult and pediatric patientsthrough body surface ECGelectrodes. Theelectrocardiograph is only | The intended use of SE-12 serieselectrocardiograph is to acquireECG signals from adult andpediatric patient (beginning atbirth through 21 years of age)through body surface ECGelectrodes. The | Different |
| 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. | 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. | ||
| 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/EN 60601-2-25 | IEC 60601-1:2005/A1:2012EN 60601-1:2006/A1:2013IEC 60601-1-2:2007EN 60601-1-2:2007/AC:2010IEC/EN 60601-2-25 | Same |
| Anti-electric-shock type: | Class I with internal power supply | Class I with internal power supply | Same |
| Anti-electric-shock degree: | Type CF | Type CF | Same |
| Degree of protection against harmful ingress of water: | Ordinary equipment (Sealed equipment without liquid proof) | Ordinary equipment (Sealed equipment 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 |
| Ingress rating | IPX0 | IPX0 | Same |
| Environment Specifications | |||
| Temperature | |||
| Transport & Storage | -20°C (-4°F) ~ +55°C (+131°F) | -20°C (-4°F) ~ +55°C (+131°F) | Same |
| Working | +5°C (+41°F) ~ +40°C (+104°F) | +5°C (+41°F) ~ +40°C (+104°F) | Same |
| Relative Humidity: | |||
| Transport & Storage | 25%~93%Non-Condensing | 25%~93%Non-Condensing | Same |
| Working | 25% RH ~ 80% RHNon-Condensing | 25% RH ~ 80% RHNon-Condensing | Same |
| Atmospheric Pressure: | |||
| Transport & Storage | 700 hPa ~1060 hPa | 700 hPa ~1060 hPa | Same |
| Working | 860 hPa ~1060 hPa | 860 hPa ~1060 hPa | Same |
| Power Supply Specifications |
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| Operating frequency = 50 Hz / 60Operating frequency = 50 Hz / 60SameHzHzMains Supply:Input Current = 0.9-0.4AInput Current = 0.9-0.4ASameOr Input power = 96VAOr Input power = 96VARated voltage = 14.8 VRated voltage = 14.8 VSameSE-12 Express&SE-1200SE-12 Express&SE-1200Express: Rated capacity =Express: Rated capacity =5000mAh5000mAhSameSE-12& SE-1200: Rated capacitySE-12& SE-1200: Rated capacity= 2500mAh= 2500mAhWhen the battery is fullyWhen the battery is fully charged,charged, SE-12&SE-1200 canworkSE-12& SE-1200can worknormally about4hours, and it cannormally about 4 hours, and itBuilt-in Lithiumcan continually print about 1.5continually print about 1.5 hoursBattery Pack:hours in the manual mode orin the manual mode or printprint about 300 ECG reports ofabout300 ECG reports of3×4+1R in the auto mode: SE-123×4+1Rin the auto mode; SE-12SameExpress &SE-1200 Express canExpress& SE-1200 Express canwork normally about 5 hours, andworkit can continually print about 2.5normally about 5 hours, and itcan continually print about 2.5hours in the manual mode or printhours in the manual mode orabout 350 ECG reports ofprint about 350 ECG reports of3×4+1Rin the auto mode.3×4+1R in the auto mode.Performance SpecificationsRecordingThermal dot-matrix recorderThermal dot-matrix recorderRecorder:Same8 dots per mm / 200 dots per inch8 dots per mm / 200 dots per inch(amplitude axes)(amplitude axes)Printing DensitySame40 dots per mm / 1000 dots per40 dots per mm / 1000 dots perinch (time axes, @, 25 mm/s)inch (time axes, (@, 25 mm/s)Folded thermal paper:Folded thermal paper:210mm×295mm×100pages210mm×295mm×100pagesFolded thermal paper:Folded thermal paper:Recorder Paper:215mm×280mm×100pages215mm×280mm×100pagesSame(Optional)(Optional)Rolled thermal paper:Rolled thermal paper:210mm×30m (Optional)210mm×30m (Optional)Effective Width:210mm210mmSame5mm/s, 6.25mm/s, 10mm/s,5mm/s, 6.25mm/s, 10mm/s,12.5mm/s, 25mm/s, 50mm/s12.5mm/s, 25mm/s, 50mm/sPaper Speed:Same(+3%)(+3%)±5% (x-axis), ±5%(y-axis)Accuracy of data:±5% (x-axis), ±5%(y-axis)Same | Operating Voltage =100V-240V~ | Operating Voltage =100V-240V~ | Same | ||
|---|---|---|---|---|---|
| HR Recognition |
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| Technique: | Peak-Peak Detection | Peak-Peak Detection | Same |
|---|---|---|---|
| HR Range: | 30 BPM ~ 300 BPM | 30 BPM ~ 300 BPM | Same |
| Accuracy: | ±1 BPM | ±1 BPM | Same |
| ECG Unit | |||
| Leads: | Standard12 leads | Standard12 leads | Same |
| AcquisitionMode: | Simultaneously12leads | Simultaneously12leads | Same |
| A/D | 24 bits | 24 bits | Same |
| Resolution: | 2.52uV/LSB | 2.52uV/LSB | Same |
| Time Constant: | ≥ 3.2 s | ≥ 3.2 s | Same |
| FrequencyResponse: | 0.05 Hz ~ 150 Hz (-3 dB) | 0.01Hz ~ 300 Hz (-3 dB) | Different |
| Gain: | 1.25,2.5, 5, 10, 20, 10/5, AGC(mm/mV) | 1.25,2.5, 5, 10, 20, 10/5, AGC(mm/mV) | Same |
| Input Impedance: | ≥50MΩ(10Hz) | ≥100MΩ(10Hz) | Different |
| Input CircuitCurrent: | ≤0.01μA | ≤0.01μA | Same |
| Input VoltageRange | ≤±5 mVpp | ≤±5 mVpp | Same |
| CalibrationVoltage: | 1mV±2% | 1mV±2% | Same |
| DC OffsetVoltage: | ±600mV | ±600 mV | Same |
| Noise: | ≤12.5µVp-p | ≤12.5 µVp-p | Same |
| Multi-channelCrosstalk | ≤0.5 mm | ≤0.5 mm | Same |
| Filter | AC Filter: On / OffDFT Filter: 0.05Hz / 0.15Hz /0.25Hz / 0.32Hz / 0.5Hz / 0.67HzEMG Filter: 25Hz / 35Hz / 45Hz/ OFFLOWPASSFilter:150Hz / 100Hz/ 75Hz | AC Filter: On / OffDFTFilter:0.01Hz/0.05Hz /0.15Hz / 0.25Hz / 0.32Hz / 0.5Hz/ 0.67HzEMG Filter: 25Hz / 35Hz / 45Hz/ OFFLOWPASSFilter: 300Hz/270Hz/150Hz / 100Hz / 75Hz | SameDifferentSameDifferent |
| CMRR | ≥115 dB | ≥140dB (AC ON)≥123dB (AC OFF) | Different |
| SamplingFrequency | 10000Hz | 16000Hz | Different |
| Pacemaker Detection | |||
| Amplitude | ±2 to ±700 mV | ±750uVto ±700 mV | Different |
| Width | 0.1 to 2.0 ms | 50µs to 2.0 ms | Different |
| SamplingFrequency | 10,000/sec/channel | 16,000/sec/channel | Different |
| External Input/output | |||
| Input | ≥100 kΩ; Sensitivity 10mm/V±5%;Single ended | ≥100 kΩ; Sensitivity 10mm/V±5%;Single ended | Same |
| Single ended | Single ended |
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The subject device has similar intended use, similar product design, and same performance effectiveness, as the predicate device. There are no significant differences between the primary predicate. There are no new questions of safety and/or effectiveness. There are no changes to the intended use, indications for use, nor fundamental scientific technology.
10. Effectiveness and Safety Considerations:
Non-clinical data:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for SE-12/12 Express/1200/1200 Express ELECTROCARDIOGRAPH device 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 and the results passed. 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-12/12 Express/1200/1200 Express ELECTROCARDIOGRAPH device, 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 and no changes conducted during the testing to comply with the standards. The results passed.
Bench Testing
Bench testing was conducted per IEC 60601-2-25: 2011 and all the results show pass. ECG interpretation features were also validated by database testing.
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.
Regression testing to previous releases was completed for existing functionality and bench testing was utilized to verify new features against documented requirements.
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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.
11. Substantially Equivalent Determination
Verification and validation testing has been conducted on the Electrocardiograph, models SE-12, SE-1200, SE-12 Express, SE-1200 Express. This premarket notification submission demonstrates that Electrocardiograph, models SE-12, SE-1200, SE-12 Express, SE-1200 Express 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).