(210 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard electrocardiograph functionality and hardware.
No
Explanation: The device is described as an electrocardiograph used to acquire and analyze ECG signals for diagnostic purposes, not to treat a disease or condition. The text also mentions it can "help users to analyze and disease," which appears to be a typo and likely meant "analyze diseases," further supporting its diagnostic role.
Yes
The device acquires ECG signals to help users analyze and diagnose diseases, and it mentions a stress ECG function that allows for the diagnosis of concealed coronary heart disease and atypical angina pectoris.
No
The device description clearly outlines hardware components such as a thermal recorder, processor, memorizer, LCD screen, and the ability to be powered by mains supply or battery. It is an electrocardiograph machine, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device acquires ECG signals from the body surface. This is a measurement of electrical activity within the body, not an analysis of a sample taken from the body (like blood, urine, or tissue).
- Device Description: The description details how the device gathers and displays ECG signals, which are physiological measurements.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or performing tests on specimens outside of the body.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This electrocardiograph measures electrical signals directly from the patient's body surface.
N/A
Intended Use / Indications for Use
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 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.
Product codes
DPS
Device Description
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 320x240 dot; and LCD screen of SE-12 Express and SE-1200 Express is 800x600 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients (beginning at birth through 21 years of age)
Intended User / Care Setting
doctors and trained healthcare professionals / hospitals or healthcare facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical data:
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.
Clinical data: Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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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3
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) 28340011
Fax: +1 (408) 418-4059 |
|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Alice Yang |
| Date prepared: | June 19, 2017 |
| 2. Device name
and classification: | Device Name: Electrocardiograph |
| | Model: SE-12, SE-1200, SE-12 Express, SE-1200 Express |
| | Classification Name: |
| | 870.2340 Electrocardiograph
Product code: DPS |
| | Regulatory Class: Class II |
| 3.Premarket
Notification Class
III Certification
and Summary | Not applicable, the subject device is Class II. |
| 4. Predicate
Device(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 under
K152427(Reference) |
| 5. Reason for
Submission | Modification for previous cleared product Electrocardiograph, models
SE-12, SE-1200, SE-12 Express, SE-1200 Express. |
| 6. Pre-Submission,
IDE | Not applicable, there is no prior submission. |
4
| 7. Device
Description: | 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. |
| 8. Intended Use: | 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 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. |
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) | Comparison
Result |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| K# | K160876 | Current Submission | — |
| Intended Use | The intended use of the
12-channel electrocardiograph is
to acquire ECG signals from
adult and pediatric patients
through body surface ECG
electrodes. The
electrocardiograph is only | The intended use of SE-12 series
electrocardiograph is to acquire
ECG signals from adult and
pediatric patient (beginning at
birth through 21 years of age)
through body surface ECG
electrodes. 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/A1:2012
EN 60601-1:2006/A1:2013
IEC 60601-1-2:2007
EN 60601-1-2:2007/AC:2010
IEC/EN 60601-2-25 | 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 | 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% RH
Non-Condensing | 25% RH ~ 80% RH
Non-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 | | | |
5
6
| Operating frequency = 50 Hz / 60
Operating frequency = 50 Hz / 60
Same
Hz
Hz
Mains Supply:
Input Current = 0.9-0.4A
Input Current = 0.9-0.4A
Same
Or Input power = 96VA
Or Input power = 96VA
Rated voltage = 14.8 V
Rated voltage = 14.8 V
Same
SE-12 Express&SE-1200
SE-12 Express&SE-1200
Express: Rated capacity =
Express: Rated capacity =
5000mAh
5000mAh
Same
SE-12& SE-1200: Rated capacity
SE-12& SE-1200: Rated capacity
= 2500mAh
= 2500mAh
When the battery is fully
When the battery is fully charged,
charged, SE-12&SE-1200 can
work
SE-12& SE-1200can work
normally about4hours, and it can
normally about 4 hours, and it
Built-in Lithium
can continually print about 1.5
continually print about 1.5 hours
Battery Pack:
hours in the manual mode or
in the manual mode or print
print about 300 ECG reports of
about300 ECG reports of
3×4+1R in the auto mode: SE-12
3×4+1Rin the auto mode; SE-12
Same
Express &SE-1200 Express can
Express& SE-1200 Express can
work normally about 5 hours, and
work
it can continually print about 2.5
normally about 5 hours, and it
can continually print about 2.5
hours in the manual mode or print
hours in the manual mode or
about 350 ECG reports of
print about 350 ECG reports of
3×4+1Rin the auto mode.
3×4+1R in the auto mode.
Performance Specifications
Recording
Thermal dot-matrix recorder
Thermal dot-matrix recorder
Recorder:
Same
8 dots per mm / 200 dots per inch
8 dots per mm / 200 dots per inch
(amplitude axes)
(amplitude axes)
Printing Density
Same
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:
Folded thermal paper:
210mm×295mm×100pages
210mm×295mm×100pages
Folded thermal paper:
Folded thermal paper:
Recorder Paper:
215mm×280mm×100pages
215mm×280mm×100pages
Same
(Optional)
(Optional)
Rolled thermal paper:
Rolled thermal paper:
210mm×30m (Optional)
210mm×30m (Optional)
Effective Width:
210mm
210mm
Same
5mm/s, 6.25mm/s, 10mm/s,
5mm/s, 6.25mm/s, 10mm/s,
12.5mm/s, 25mm/s, 50mm/s
12.5mm/s, 25mm/s, 50mm/s
Paper 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 |
7
| 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 |
| Acquisition | |||
| Mode: | 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 |
| Frequency | |||
| Response: | 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 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 | ±600 mV | Same |
| Noise: | ≤12.5µVp-p | ≤12.5 µVp-p | Same |
| Multi-channel | |||
| Crosstalk | ≤0.5 mm | ≤0.5 mm | Same |
| Filter | AC Filter: On / Off |
DFT Filter: 0.05Hz / 0.15Hz /
0.25Hz / 0.32Hz / 0.5Hz / 0.67Hz
EMG Filter: 25Hz / 35Hz / 45Hz
/ OFF
LOWPASSFilter:150Hz / 100Hz
/ 75Hz | AC Filter: On / Off
DFTFilter:0.01Hz/0.05Hz /
0.15Hz / 0.25Hz / 0.32Hz / 0.5Hz
/ 0.67Hz
EMG Filter: 25Hz / 35Hz / 45Hz
/ OFF
LOWPASSFilter: 300Hz/270Hz/1
50Hz / 100Hz / 75Hz | Same
Different
Same
Different |
| CMRR | ≥115 dB | ≥140dB (AC ON)
≥123dB (AC OFF) | Different |
| Sampling
Frequency | 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 |
| Sampling
Frequency | 10,000/sec/channel | 16,000/sec/channel | Different |
| External Input/output | | | |
| Input | ≥100 kΩ; Sensitivity 10
mm/V±5%;
Single ended | ≥100 kΩ; Sensitivity 10
mm/V±5%;
Single ended | Same |
| | | | |
| | Single ended | Single ended | |
8
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.
9
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.