(277 days)
Not Found
No
The description mentions "Automatic analysis and diagnostic software (SEMIP)" but does not use terms like AI, ML, deep learning, or neural networks, nor does it describe characteristics typically associated with AI/ML development (training/test sets, performance metrics like AUC). The "automatic analysis" could be based on rule-based algorithms or traditional signal processing techniques.
No.
The device is used to acquire ECG signals for diagnostic purposes, not to provide therapy or treatment.
Yes
The device acquires ECG signals and provides "Automatic analysis and diagnostic software" that can "help users to analyze and diagnose heart disease." Although the interpreted ECG is advisory, the phrase "analyze and diagnose heart disease" directly indicates a diagnostic function.
No
The device description explicitly lists hardware components such as a built-in rechargeable battery, AC/DC power supply, internal thermal printer, and external printer, indicating it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The SE-601 acquires ECG signals from the body surface using electrodes. This is a non-invasive measurement of electrical activity of the heart, not a test performed on a sample taken from the body.
- Intended Use: The intended use describes acquiring ECG signals and helping users analyze and diagnose heart disease based on those signals. This is consistent with an electrocardiograph, not an IVD.
Therefore, the SE-601 is an electrocardiograph, which is a medical device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The intended use of SE-601 is 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 only intended to be used on adult patients and is offered to clinicians on an advisory basis only.
Product codes
DPS
Device Description
SE-601 series Smart ECG includes three models SE-601A, SE-601B and SE-601C.
Device features include as follows:
● Portable, lightweight design
● Easy data input and operation
● Alphanumeric keyboard and one-touch operation
● Built-in rechargeable battery, AC/DC power supply
● Automatic analysis and diagnostic software (SEMIP) for adults and pediatrics
● Two-step exercise test with periodic recording
● Heart rate variability (HRV) analysis
- . Internal thermal printer and external printer
- . Support external archiving: USB flash disk, card reader
- . Data transmission to PC via Ethernet . WIFI or serial port
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
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)
Quality assurance measures applied:
- Software testing
- Risk analysis
- Safety testing
- Performance testing
- Environmental testing
Conclusion: Verification and validation testing was done on SE-601 Series Electrocardiograph. This premarket notification submission demonstrates that the subject device SE-601 Series Electrocardiograph is substantially equivalent to the predicate device above mentioned
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
イ
510(K)Summary of Safety and Effectiveness
:
FEB 25 2014 This summary of 510k safety and effectiveness is being submitted in according with 21CFR part 807.92 The 510(k) number is (if known)_
| Submitter: | Edan Instruments, Inc
3/F - B. Nanshan Medical
Equipments Park, Nanhai Rd 1019#,
shekou. Nanshan Shenzhen,
518067 P.R. China
Tel: +86755 26882220
Fax:+86 755 26882223 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Cherry Sun
Edan Instruments, Inc. |
| Proprietary Name: | SE-601 Series Electrocardiograph |
| Classification
information: | 21 CFR 870.2340, Electrocardiograph
Class II |
| Product code: | DPS |
| Review Panel: | Cardiovascular |
| Predicate Devices: | PC ECG cleared under K092010
Manufacturer: Edan Instruments, Inc.
SE-601 series Electrocardiograph cleared under K093869
Manufacturer: Edan Instruments, Inc. |
| Device Description: | SE-601 series Smart ECG includes three models SE-601A, SE-601B
and SE-601C.
Device features include as follows: |
| | ● Portable, lightweight design
● Easy data input and operation
● Alphanumeric keyboard and one-touch operation
● Built-in rechargeable battery, AC/DC power supply
● Automatic analysis and diagnostic software (SEMIP) for adults
and pediatrics
● Two-step exercise test with periodic recording
● Heart rate variability (HRV) analysis |
1
Intended Use:
- . Internal thermal printer and external printer
- . Support external archiving: USB flash disk, card reader
- . Data transmission to PC via Ethernet . WIFI or serial port
This submission is to modify the indication for use (intended use) by adding the applicable pediatric population.
The intended use of SE-601 is 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 only intended to be used on adult patients and is offered to clinicians on an advisory basis only.
Test Summary:
The following quality assurance measures were applied to the development of the SE-601 Series Electrocardiograph:
- 0 Software testing
- 0 Risk analysis
- 0 Safety testing
- . Performance testing
- . Environmental testing
Conclusion:
Verification and validation testing was done on SE-601 Series Electrocardiograph. This premarket notification submission demonstrates that the subject device SE-601 Series Electrocardiograph is substantially equivalent to the predicate device above mentioned
24
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three wavy lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 25, 2014
Edan Instruments, Inc. Ms. Cherry Sun Certification Engineer Nanhai Road 1019# Nanshen Shenzhen, Guangdong, China 518067
Re: K131503
Trade/Device Name: SE-601 Series Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: January 21, 2014 Received: January 28, 2014
Dear Ms. Cherry Sun:
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
3
Page 2 - Ms. Cherry Sun
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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 vours.
51
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use
510(k) Number:
Device Name: SE-601 Series Electrocardiograph
The intended use of SE-601 is 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 only intended to be used on adult patients and is offered to clinicians on an advisory basis only.
Prescription Use (21 CFR Part 801 Subpart D)
Over the Counter Use _ (21 CFR Part 801 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Or
Concur for B. Zuckerman
Date:
11/01/2014 14:02:25
13:39:48:05'00'