(322 days)
The intended use of SE-12 series electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to 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 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 document is a 510(k) premarket notification for Electrocardiograph Models SE-12, SE-12 Express, SE-1200, and SE-1200 Express by Edan Instruments, Inc. It details the device comparison and performance data, but it does not describe specific acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity) for the ECG interpretation algorithm, nor does it present a study proving the device meets such criteria.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through:
- Comparison of intended use, safety specifications, environmental specifications, and performance specifications.
- Non-clinical testing, including biocompatibility, electrical safety/EMC, bench testing against IEC standards, and software verification/validation.
Here's an analysis of the requested information based on the provided text, highlighting where information is not available:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative diagnostic acceptance criteria (e.g., minimum sensitivity or specificity for detecting heart conditions) for its ECG interpretation capabilities. The closest information is comparisons of general performance specifications with predicate devices and compliance with safety and electrical standards.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Safety Standards Compliance | IEC 60601-1:2005, EN 60601-1:2006, EN 60601-1-2:2007, IEC 60601-1-2:2007, IEC/EN60601-2-25:2011 | "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 was conducted per IEC 60601-2-25: 2011, and all the results show pass." |
| Biocompatibility | ISO 10993-1 (Cytotoxicity, Skin Sensitization, Skin Irritation) | "The biocompatibility evaluation... is conducted in accordance with the International Standard ISO 10993-1... The battery of testing included... Cytotoxicity, Skin Sensitization, Skin Irritation." (Implied pass, as it supports substantial equivalence). |
| Electrical Safety & EMC | IEC 60601-1:2005/A1: 2012 standard for safety and IEC 60601-1-2: 2007 standard for EMC. Also CISPR 11 Group 1, Class A for EMC. | "Electrical safety and EMC testing were conducted on the SE-12 series electrocardiograph... The system complies with the IEC 60601-1:2005/A1: 2012 standard for safety and the IEC 60601-1-2: 2007 standard for EMC." "EMC: CISPR 11 Group 1, Class A" (Stated as a "Same" characteristic as predicate, implying compliance). |
| Software Quality | Compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance... The software for this device was considered as a 'moderate' level of concern..." (Implied pass, as it supports substantial equivalence). |
| Battery Performance | UL 2054, UL60950-1:2007 and IEC 61233:2012 standards | "Testing on battery are conducted per UL 2054, UL60950-1:2007 and IEC 61233:2012, and results show pass for all testing items." (Regarding battery capacity, the proposed device has increased capacity compared to the predicate, but this is a change, not a specific "acceptance criterion" met). |
| ECG Interpretation (Advisory Basis) | Equivalent performance to predicate devices (K102830, K131503, K060167, K152427) using "Glasgow" or "SEMIP" algorithms. | The document states, "The subject devices share the same characteristics in all items with the predicate device, concluding from using the same technology and principle." For ECG interpretation, the models use the "Glasgow" or "SEMIP" algorithms, which are stated to be the "Same" as their respective predicates. The interpreted ECG results are explicitly "offered to clinicians on an advisory basis only," indicating that the device's interpretation is not a definitive diagnosis and clinical data for diagnostic performance was "Not applicable." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified for any diagnostic performance evaluation. The document states "Clinical data: Not applicable," which implies no specific clinical test set for evaluating diagnostic accuracy was used or required for this 510(k) submission.
- Data Provenance: Not applicable, as no clinical test set data is described. The device is manufactured in China (Shenzhen, P.R. China).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No clinical test set data or expert-established ground truth is described. The device's integrated interpretation uses specific algorithms (Glasgow, SEMIP) which are compared to those in predicate devices. The interpreted ECG with measurements and interpretive statements is "offered to clinicians on an advisory basis only," suggesting that the device's output is not intended as a definitive ground truth in itself.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set and thus no adjudication method for ground truth establishment is described.
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
- No MRMC comparative effectiveness study is mentioned. The submission states, "Clinical data: Not applicable."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- While the device includes an ECG interpretation algorithm (Glasgow/SEMIP), the document does not present a standalone performance study in terms of diagnostic accuracy (e.g., sensitivity, specificity, accuracy against a clinical gold standard). The focus is on the device's technical specifications and substantial equivalence to previously cleared devices that also include such algorithms, with the understanding that the interpretation is advisory. The "Bench Testing" (IEC 60601-2-25: 2011) primarily assesses the technical performance of the electrocardiograph (e.g., frequency response, noise, gain, etc.), not the diagnostic accuracy of its interpretive algorithm against clinical outcomes or expert diagnoses.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for diagnostic performance. For the technical and safety performance, the "ground truth" is adherence to international and national standards (e.g., IEC 60601 series, ISO 10993-1, UL standards).
8. The sample size for the training set
- Not specified. The document describes the device as incorporating existing algorithms (Glasgow, SEMIP) found in predicate devices. Details about the training set for these algorithms (if they are considered "AI" in the modern sense) are not provided within this 510(k) summary.
9. How the ground truth for the training set was established
- Not specified. As noted above, details about the training of the Glasgow or SEMIP algorithms are not part of this submission.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 15, 2017
Edan Instruments, Inc. % Doug Worth Sr. Dir. US RA/QA Edan Medical 1200 Crossman Ave. Suite 200 Sunnyvale, California 94089
Re: K160876 Trade/Device Name: Electrocardiograph, 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: January 5, 2017 Received: January 9, 2017
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 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 (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.
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.
Mude Yellen
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) K160876
Device Name
Device Name: Electrocardiograph Model: SE-12, SE-12 Express, SE-1200, and 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 through body surface ECG electrodes. The electrocardiograph is only intended to 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 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, Inc3/F - B, Nanshan MedicalEquipments Park, Nanhai Rd 1019#,Shekou, Nanshan Shenzhen,518067 P.R. ChinaTel: +86(0755) 26858736Fax: +1 (408) 418-4059 |
|---|---|
| Contact person:Preparing date: | Alice YanJanuary 5, 2016 |
| 2. Device name andclassification: | Device Name: ElectrocardiographModel: SE-12, SE-12 Express, SE-1200, and SE-1200 ExpressClassification Name/ Product code:870.2340 Electrocardiograph/DPSRegulatory Class: Class II |
| 3. Predicate Device(s): | 1) EDAN Instrument, Electrocardiograph, model SE-12, SE-12Express, SE-1200, and SE-1200 Express, K1028302) EDAN Instrument, Electrocardiograph, model SE-601, K1315033) Cardiac Science Corporation, model Atria 6100, K0601674) EDAN Instrument, PC ECG, model SE-1515, K152427 |
| 4. Reason forSubmission | Technology change |
| 5. Pre-Submission,IDE | Not applicable, there is no prior submission. |
| 6. Device Description: | The SE-12/12 Express/1200/1200 Express Electrocardiographgathers ECG signals of 12 leads simultaneously. It displays theoperation menu, ECG parameters as well as electrocardiograms, andbe powered by the mains supply or battery. And the system hasadvanced performance and high reliability due to high resolutionthermal recorder, 32-bit processor and a large-capacity memorizer.Design of the system took much consideration on ergonomics so thesize is suitable for clinic and hospital uses.There are four selectable modes in the system, including manual, |
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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 intended use of SE-12 series electrocardiograph is to acquire 7. Intended Use: 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.
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 | Predicate device(SE-12, SE-12 Express,SE-1200, and SE-1200 Express) | Proposed device(SE-12, SE-12 Express,SE-1200, and SE-1200 Express) | ComparisonResult |
|---|---|---|---|
| K# | K102830 | Current Submission | — |
| Intended Use | The intended use of the12-channel electrocardiograph isto acquire ECG signals fromadult and pediatric patientsthrough body surface ECGelectrodes. Theelectrocardiograph is onlyintended to be used in hospitalsor healthcare facilities by doctorsand trained healthcareprofessionals. The cardiogramrecorded by the | The intended use of SE-12 serieselectrocardiograph is to acquireECG signals from adult andpediatric patients through bodysurface ECG electrodes. Theelectrocardiograph is onlyintended to be used in hospitalsor healthcare facilities by doctorsand trained healthcareprofessionals. The cardiogramrecorded by theelectrocardiograph can help users | Same |
| Table 1: Comparison between the current SE-12 series and previous cleared system | |||||||
|---|---|---|---|---|---|---|---|
| electrocardiograph can help usersto analyze and diagnose heartdisease. However, the interpretedECG with measurements andinterpretive statements is offeredto clinicians on an advisory basisonly. | to analyze and diagnose heartdisease. However, the interpretedECG with measurements andinterpretive statements is offeredto clinicians on an advisory basisonly. | ||||||
| Safety Specifications | |||||||
| Safety Standards | IEC 60601-1:1988+A1+A2,EN 60601-1:1990+A1+A2,IEC/EN 60601-1-2: 2001+A1,IEC/EN60601-2-25ANSI/AAMI EC11IEC/EN 60601-2-51 | 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 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 | Operating Voltage = | 700 hPa ~ 1060 hPa | Operating Voltage = | Same | ||
| Working | Mains Supply: | 860 hPa ~ 1060 hPa | 100V-240V~ | 860 hPa ~ 1060 hPa | 100V-240V~ | Same | Same |
| Operating frequency = 50 Hz /60 Hz | Operating frequency = 50 Hz / 60 Hz | Same | |||||
| Input Power = 70VA | Input Current = 0.9-0.4AOr Input power = 96VA | Different | |||||
| Rated voltage = 14.8 V | Rated voltage = 14.8 V | Same | |||||
| SE-12 Express&SE-1200Express: Rated capacity =4400mAh | SE-12 Express&SE-1200Express: Rated capacity =5000mAh | Different | |||||
| SE-12& SE-1200: Ratedcapacity =2200mAh | SE-12& SE-1200: Rated capacity= 2500mAh | ||||||
| Built-in LithiumBattery Pack: | When the battery is fullycharged, SE-12&SE-1200 canworknormally about 4 hours, and itcan continually print about 1.5hours in the manual mode orprint about 300 ECG reports of$3×4+1R$ in the auto mode; SE-12Express &SE-1200 Express canworknormally about 5 hours, and itcan continually print about 2.5hours in the manual mode orprint about 350 ECG reports of$3×4+1R$ in the auto mode. | When the battery is fullycharged, SE-12& SE-1200 canwork normally about 4 hours, andit can continually print about 1.5hours in the manual mode orprint about 300 ECG reports of$3×4+1R$ in the auto mode; SE-12Express& SE-1200 Express canwork normally about 5 hours, andit can continually print about 2.5hours in the manual mode orprint about 350 ECG reports of$3×4+1R$ in the auto mode. | Same | ||||
| Performance Specifications | |||||||
| RecordingRecorder: | Thermal dot-matrix recorder | Thermal dot-matrix recorder | Same | ||||
| 8 dots per mm / 200 dots per inch(amplitude axes) | 8 dots per mm / 200 dots per inch(amplitude axes) | ||||||
| Printing Density | 40 dots per mm / 1000 dots perinch (time axes, @ 25 mm/s) | 40 dots per mm / 1000 dots perinch (time axes, @ 25 mm/s) | Same | ||||
| Recorder Paper: | Folded thermal paper:210mm×295mm×100pages | Folded thermal paper:210mm×295mm×100pages | |||||
| Folded thermal paper:215mm×280mm×100pages(Optional) | Folded thermal paper:215mm×280mm×100pages(Optional) | Same | |||||
| Rolled thermal paper:210mm×30m (Optional) | Rolled thermal paper:210mm×30m (Optional) | ||||||
| Effective Width: | 203 mm | 203mm | Same |
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| 5mm/s, 6.25mm/s, 10mm/s, | 5mm/s, 6.25mm/s, 10mm/s, | ||
|---|---|---|---|
| Paper Speed: | 12.5mm/s, 25mm/s, 50mm/s(±3%) | 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 | |||
| 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: | Standard 12 leads | Standard 12 leads | Same |
| AcquisitionMode: | Simultaneously 12 leads | Simultaneously 12 leads | 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) | 0.05 Hz ~ 150 Hz (-3 dB) | 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: | ≥50 MΩ(10 Hz) | ≥50 MΩ(10 Hz) | Same |
| Input CircuitCurrent: | ≤0.01μA | ≤0.01μA | Same |
| Input VoltageRange | ≤±5 mVpp | ≤±5 mVpp | Same |
| CalibrationVoltage: | 1 mV±3% | 1 mV±3% | Same |
| DC OffsetVoltage: | ±600 mV | ±600 mV | Same |
| Noise: | ≤12.5 µVp-p | ≤12.5 µVp-p | Same |
| Multi-channelCrosstalk | ≤0.5 mm | ≤0.5 mm | Same |
| Filter | AC Filter: On / Off | AC Filter: On / Off | Same |
| DFT Filter: 0.05Hz / 0.15Hz /0.25Hz / 0.32Hz / 0.5Hz /0.67Hz | DFT Filter: 0.05Hz / 0.15Hz /0.25Hz / 0.32Hz / 0.5Hz / 0.67Hz | Same | |
| EMG Filter: 25Hz / 35Hz / 45Hz/ OFF | EMG Filter: 25Hz / 35Hz / 45Hz/ OFF | Same | |
| LOWPASS Filter: 150Hz /100Hz / 75Hz | LOWPASS Filter: 150Hz / 100Hz/ 75Hz | Same | |
| CMRR | ≥115 dB | ≥115 dB | |
| SamplingFrequency | 1000 Hz | 1000 Hz | |
| Pacemaker Detection | |||
| Amplitude | ±2 to ±700 mV | ±2 to ±700 mV | Same |
| Width | 0.1 to 2.0 ms | 0.1 to 2.0 ms | Same |
| SamplingFrequency | 10,000/sec/channel | 10,000/sec/channel | Same |
| External Input/ Output | |||
| Input | ≥100 kΩ; Sensitivity 10mm/V±5%;Single ended | ≥100 kΩ; Sensitivity 10mm/V±5%;Single ended | Same |
| Output | ≤100Ω; Sensitivity 1 V/mV ±5%;Single ended | ≤100Ω; Sensitivity 1 V/mV ±5%;Single ended | Same |
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Table 2: Comparison between SE-12 series and SE-601 series
| Item | Predicate device(SE-601C) | Proposed device(SE-12, SE-12 Express,SE-1200, and SE-1200 Express) | ComparisonResult |
|---|---|---|---|
| K# | K131503 | Current Submission | — |
| Intended Use | The intended use of SE-601 is toacquire ECG signals from adultand pediatric patients throughbody surface ECG electrodes.The electrocardiograph is onlyintended to be used in hospitals orhealthcare facilities by doctorsand trained healthcareprofessionals. The cardiogramrecorded by theelectrocardiograph can help usersto analyze and diagnose heartdisease. However, the interpretedECG with measurements andinterpretive statements is onlyintended to be used on adultpatients and is offered toclinicians on an advisory basisonly. | The intended use of SE-12 serieselectrocardiograph is to acquireECG signals from adult andpediatric patients through bodysurface ECG electrodes. Theelectrocardiograph is onlyintended to be used in hospitals orhealthcare facilities by doctorsand trained healthcareprofessionals. The cardiogramrecorded by theelectrocardiograph can help usersto analyze and diagnose heartdisease. However, the interpretedECG with measurements andinterpretive statements is offeredto clinicians on an advisory basisonly. | Same |
| TransmittingFrequency | 2412-2497MHz | 2400-2497MHz | |
| Frequency Band | 2412-2497MHz | 2400-2497MHz | |
| Modulation Type | DSSS, CCK | DSSS, CCK,OFDM | Different |
| TransmittingPower | 18dBm | 6-17dBm | |
| Effective | 18dBm | 6-17dBm |
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| Radiated Power | ||
|---|---|---|
| Table 3: Comparison between predicate device Atria 6100 and the proposed system | ||||
|---|---|---|---|---|
| Item | Predicate device(Atria 6100) | Proposed device(SE-12, SE-12 Express,SE-1200, and SE-1200 Express) | ComparisonResult |
|---|---|---|---|
| K# | K060167 | Current Submission | — |
| Screen Size | 640*480 | 320240 (SE-12, SE-1200)800600(SE-12Express,SE-1200Express) | Different |
| SW Algorithm | Glasgow | Glasgow | Same |
| Table 2-4: Comparison between predicate device SE-1515 (K152427) and SE-12, SE-12 Express, SE-1200. | |||
|---|---|---|---|
| and SE-1200 Express |
| Item | Predicate device(SE-1515) | Proposed device(SE-12, SE-12 Express,SE-1200, and SE-1200 Express) | ComparisonResult |
|---|---|---|---|
| K# | K152427 | Current Submission | |
| Intended Use | SE-1515 PC ECG is intended toacquire, process and store ECGsignals from adult and pediatricpatients undergoing stress exercisetest or resting test. The SE-1515 PCECG is intended to be used only inhospitals and healthcare facilities bydoctors and trained healthcareprofessionals. The cardiogramrecorded by the SE-1515 PC ECGcan help users to analyze anddiagnose heart diseases. However,the ECG with measurements andinterpretive statements is offered toclinicians on an advisory basis only.It is mainly used in the ECGOutpatient Department and PhysicalExamination Department. | The intended use of SE-12 serieselectrocardiograph is to acquire ECGsignals from adult and pediatricpatients through body surface ECGelectrodes. The electrocardiograph isonly intended to be used in hospitalsor healthcare facilities by doctors andtrained healthcare professionals. Thecardiogram recorded by theelectrocardiograph can help users toanalyze and diagnose heart disease.However, the interpreted ECG withmeasurements and interpretivestatements is offered to clinicians onan advisory basis only. | different |
| SW Algorithm | SEMIP | SEMIP | Same |
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
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demonstrated in the non-clinical testing, the different technological characteristics do not affect the safety and effectiveness of the Edan SE-12 series electrocardiograph.
9. Performance Data:
Non-clinical data:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for SE-12 series 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-12 series 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.
Battery Testing
Testing on battery are conducted per UL 2054, UL60950-1:2007 and IEC 61233:2012, and results show pass for all testing items.
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
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device.
10. Conclusion
The non-clinical data support the safety of the device and software verification and validation demonstrate that SE-12 series 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-12 series 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).