(108 days)
Not Found
No
The description mentions "Auto measurement and diagnosing is available" and "Supporting auto measurement and diagnosing," but it does not explicitly state that AI or ML is used for these functions. The lack of mention of AI/ML terms, training/test sets, or performance metrics typically associated with AI/ML algorithms suggests that traditional algorithms are likely employed for the auto-analysis.
No
The device is used for acquiring and analyzing ECG signals to help diagnose heart disease, but it does not directly treat or cure any condition. The interpretive statements are advisory only, indicating a diagnostic rather than therapeutic purpose.
Yes
The device acquires ECG signals and the cardiogram can help users analyze and diagnose heart disease.
No
The device description explicitly mentions "PC machine" and the acquisition of ECG signals through "body surface ECG electrodes," indicating the presence of hardware components beyond just software.
Based on the provided information, the SE-1010 PC ECG is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use explicitly states that the device is used to "acquire ECG signals from adult and pediatric patients through body surface ECG electrodes" and that the "cardiogram recorded by SE-1010 PC ECG can help users to analyze and diagnose heart disease." This involves the analysis of biological signals (electrical activity of the heart) obtained from the human body to provide information for diagnosis.
- Device Description: The description details functions like "ECG data can be sampled, displayed and stored," "Auto measurement and diagnosing is available," and "Supporting auto measurement and diagnosing." These are all activities related to the analysis and interpretation of biological data for diagnostic purposes.
- Input Imaging Modality: While it's not traditional imaging, ECG signals are a form of biological data acquired from the body for analysis.
- Anatomical Site: The device acquires signals from the "body surface," which is a common method for obtaining biological data for IVD purposes.
The fact that the interpretive statements are advisory does not negate its IVD status. The device is still providing information derived from biological samples (ECG signals) that is intended to aid in the diagnosis of heart disease.
N/A
Intended Use / Indications for Use
SE-1010 PC ECG is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. SE-1010 PC ECG is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by SE-1010 PC ECG can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.
Product codes
DPS
Device Description
PC ECG including model SE-1010 has the similar functions of an ordinary electrocardiograph. ECG data can be sampled, displayed and stored in PC machine, and they can be printed with several kinds of printing types, including PDF format, word format and JPG format. ECG wave can be frozen and reviewed. Auto measurement and diagnosing is available, and Diagnose Template can be edited. PC ECG has the features as follows: - 3/6/12-channel ECG wave display and printing simultaneously - ECG wave frozen and review - Measurement point adjustment and re-analyzing, manual measurement with high precision electronic ruler - data management and processing function - Report printing with PDF format, word format or JPG format -Multi-language supporting - Supporting auto measurement and diagnosing -- -Automatic baseline adjustment for optimal printing
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
Verification and validation testing was done on PC ECG. This premarket notification submission demonstrates that PC ECG is substantially equivalent to the predicate device.
Key Metrics
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
K092010
20 page 1 of 2
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: | 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 | OCT 22 2009 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact person: | Jiang yucai
Edan Instruments, Inc. | |
| Date: | 2009-6-29 | |
| Proprietary Name: | PC ECG | |
| Classification Name: | 21 CFR 870.2340 Electrocardiograph | |
| Product code: | DPS | |
| Predicate Devices: | Cardiosoft/case cardiac testing system
Manufacturer: GE medical systems information technologies
K031561 | |
| Device Description: | PC ECG including model SE-1010 has the similar functions
of an ordinary electrocardiograph. ECG data can be sampled,
displayed and stored in PC machine, and they can be printed
with several kinds of printing types, including PDF format,
word format and JPG format. ECG wave can be frozen and
reviewed. Auto measurement and diagnosing is available,
and Diagnose Template can be edited.
PC ECG has the features as follows:
- 3/6/12-channel ECG wave display and printing simultaneously
- ECG wave frozen and review
- Measurement point adjustment and re-analyzing, manual measurement with high precision electronic ruler | |
1
- data management and processing function |
- Report printing with PDF format, word format or JPG format
- -Multi-language supporting
- Supporting auto measurement and diagnosing --
- -Automatic baseline adjustment for optimal printing
Intended Use:
SE-1010 PC ECG is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. SE-1010 PC ECG is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by SE-1010 PC ECG can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.
Test Summary:
Conclusion:
The following quality assurance measures were applied to the development of the Fetal & Maternal Monitor
- Software testing .
- Risk analysis .
- Safety testing .
- Environment test .
Verification and validation testing was done on PC ECG .. This premarket notification submission demonstrates that PC ECG is substantially equivalent to the predicate device.
2
Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
OCT 22 2009
Edan Instruments, Inc. c/o Mr. William Stern Multigon Industries, Inc. 1 Odell Plaza Yonkers, NY 10701
Re: K092010
PC ECG Model SE-1010 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: Undated Received: September 17, 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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 (if known): K 092010
Device Name: PC ECG
SE-1010 PC ECG is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. SE-1010 PC ECG is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by SE-1010 PC ECG can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.
Prescription Use
Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(21 CFR Part 801 Subpart D)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K092 010