(110 days)
Unknown
The device description mentions "Automatic analysis and diagnostic software (SEMIP) for adults" and "Heart rate variability (HRV) analysis". While these features involve algorithmic processing of ECG data, the summary does not explicitly state that AI or ML techniques are used for these analyses. The lack of mention of AI/ML terms, training/test sets, or performance metrics typically associated with AI/ML models makes it impossible to definitively confirm the presence of AI/ML.
No
Explanation: A therapeutic device is used for treatment. This device is an electrocardiograph, which is a diagnostic tool used to acquire ECG signals and help analyze heart disease. It does not provide any treatment.
Yes
The device is described as having "Automatic analysis and diagnostic software (SEMIP) for adults" and the "cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease." Although the interpretive statements are advisory, the device actively aids in the diagnostic process.
No
The device description explicitly lists hardware components such as a portable design, alphanumeric keyboard, built-in rechargeable battery, internal thermal printer, and support for external archiving via USB flash disk or card reader. These are physical components, 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 such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The electrocardiograph described acquires ECG signals from the body surface using electrodes. This is a non-invasive measurement of electrical activity within the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is to acquire ECG signals and help users analyze and diagnose heart disease based on these signals. This is a diagnostic tool that works by measuring physiological signals directly from the patient.
Therefore, while it is a diagnostic device, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface with 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
- 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 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
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)
The following quality assurance measures were applied to the development of the SE-601 Series Electrocardiograph:
- Software testing
- Risk analysis .
- Safety testing .
- Performance test
Verification and validation testing was done on SE-601 Electrocardiograph. This premarket notification Series submission demonstrates that the subject device SE-601 Series Electrocardiograph is substantially equivalent to the predicate device.
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
510 (K) Summary of Safety and Effectiveness
This summary of 510k safety and effectiveness is being submitted in according with 21CFR part 807.92
Submitter:
JUN - 3 2009
Edan Instruments, Inc 3/F - B, Nanshan Medical Equipments Park, Nanhai Rd 1019#,3x shekou, Nanshan Shenzhen, 518067 P.R. China Tel: +86755 26882220 Fax:+86 755 26882223
Contact person:
Jiang yucai Edan Instruments, Inc.
Proprietary Name:
Classification information: 21 CFR 870.2340, Electrocardiograph Class II
SE-601 Series Electrocardiograph
Product code:
Review Panel:
Cardiovascular
DPS
Predicate Devices:
Device Description:
ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES K072217 CARDIOFAX M Manufacturer: NIHON KOHDEN AMERICA, INC
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
- Heart rate variability (HRV) analysis
- Internal thermal printer and external printer 4-1
1
K090367 pg 2082
RE K090367 Se-601 series 510(k) SUBMISSION
ATTACHMENT 4
- Support external archiving: USB flash disk, card reader .
- Data transmission to PC via Ethernet or serial port .
The intended use of electrocardiograph is to acquire ECG Intended Use: signals from adult and pediatric patients through body surface with 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:
- Software testing
- Risk analysis .
- Safety testing .
- Performance test
Conclusion:
Verification and validation testing was done on SE-601 Electrocardiograph. This premarket notification Series submission demonstrates that the subject device SE-601 Series Electrocardiograph is substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Edan Instruments, Inc. c/o Mr. William Stern 1 Odell Plaza Yonkers, NY 10701
IIIN - 3 2009
Re: K090367
SE-601 Series Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Codes: DPS Dated: April 9, 2009 Received: April 29, 2009
Dear Mr. Stern:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. William Stern
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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: K090367
Device Name: SE-601 Series Electrocardiograph
The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface with 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)
Or
Over the Counter Use (21 CFR Part 801 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
At. R. Ste. fo B Zuckerman
(Division Sign-Off) 6/2/09
Division of Cardiovascular Devices
510(k) Number K090367