(60 days)
No
The description mentions a "Smart ECG Measurement and interpretation program" (SEMIP) which provides analysis and interpretation, but it does not explicitly state or imply the use of AI or ML. The filtering techniques mentioned are standard digital signal processing methods. There is no mention of AI/ML terms, training data, or performance metrics typically associated with AI/ML models.
No.
The device is used to acquire, display, and analyze ECG signals for diagnostic purposes, not to provide therapy.
Yes
The device is intended to help users "analyze and diagnose heart disease" and provides "detailed analysis of the ECG signal to aid in the interpretation of the ECGs," which are functions of a diagnostic device.
No
The device description explicitly lists multiple hardware components including an external ECG Sampling Box, Main Control Board, thermal printer, power supply, keyboard, and display module.
Based on the provided information, the SE-18 18-lead electrocardiograph is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The SE-18 acquires ECG signals directly from the patient's body surface using electrodes. It does not analyze blood, urine, tissue, or any other bodily fluid or substance.
- The intended use clearly states it acquires ECG signals from adult and pediatric patients through body surface ECG electrodes. This is a direct measurement from the patient, not an analysis of a specimen.
- The device description mentions acquiring and displaying waveforms, printing, digital filtering, and providing interpretive statements based on the ECG signal. These are all related to the electrical activity of the heart as measured directly from the body.
- The description explicitly states "During the examination, there are no substances delivered to and/or extracted from the patient." This further reinforces that it's not dealing with bodily specimens.
Therefore, the SE-18 falls under the category of a medical device used for physiological measurement and analysis, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 healthcare professionals. The cardiogram recorded 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.
Product codes
DPS
Device Description
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 SE-18 18-lead electrocardiograph is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body surface
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
hospitals or healthcare facilities by doctors and trained healthcare professionals.
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-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.
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.
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.
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/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 a stylized image of three human profiles facing to the right, stacked on top of each other.
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
2
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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3
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. China
Tel: +86(0755) 26858736
Fax: +1 (408) 418-4059 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person:
Preparing date: | Alice Yang
March 30, 2017 |
| 2. Device name and
classification: | Device Name: Electrocardiograph
Model: SE-18
Classification Name/ Product code:
870.2340 Electrocardiograph/DPS
Regulatory 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-12
Express, SE-1200, and SE-1200 Express, K160876 (Reference) |
| 4. Reason for
Submission | 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 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 |
4
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-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. | SE-1515 PC ECG is intended to
acquire, process and store ECG
signals from adult and pediatric
patients undergoing stress
exercise test or resting test. The
SE-1515 PC ECG is intended to
be used only in hospitals and
healthcare facilities by doctors
and trained healthcare
professionals. The cardiogram
recorded by the SE-1515 PC
ECG can help users to analyze
and diagnose heart diseases.
However, the ECG with
measurements and interpretive
statements is offered to clinicians
on an advisory basis only. | Differen
t | |
| SW Algorithm | SEMIP | SEMIP | Same | |
| Sampling Box | DE18 | DE18/DE15/DX12/DP12 | Differen
t | |
| 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 60601-2-25:2011 | 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 60601-2-25:2011 | Same | |
| Anti-electric-shock
type: | Class I with internal power
supply | Class II | Differen
t | |
| Anti-electric-shock
degree: | Type CF with
defibrillation-proof | Type CF with defibrillation-proof | 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 | |
| Patient Leakage Current: | NC
SFC | $