(155 days)
Not Found
No
The description mentions "ECG Measurement and interpretation program (SEMIP)" which provides "more detail information to diagnose heart disease," but it does not explicitly state or imply the use of AI or ML for this interpretation. The focus is on digital filtering and a standard interpretation program, not advanced learning algorithms.
No
The device is described as a "diagnostic tool" intended to "acquire, process and store ECG Signal" to "analyze and diagnose heart disease." It does not mention any therapeutic function or intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "PC-based diagnostic tool" and that the recorded cardiogram "can help users to analyze and diagnose heart disease." The "Device Description" also mentions that the ECG Measurement and interpretation program "can provide more detail information to diagnose heart disease."
No
The device description explicitly states that the device includes "data sampling modules and software," indicating the presence of hardware components in addition to the software.
Based on the provided information, the SE-1010 PC ECG is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The SE-1010 PC ECG acquires ECG signals directly from the patient's body (electrodes placed on the skin). It does not analyze blood, urine, tissue, or other bodily fluids or substances.
- The intended use describes acquiring, processing, and storing ECG signals. This is a physiological measurement, not an in vitro analysis of a specimen.
- The device description focuses on acquiring and processing electrical signals from the heart. This aligns with the function of an electrocardiograph, which is a medical device for measuring electrical activity of the heart.
Therefore, the SE-1010 PC ECG falls under the category of a medical device used for physiological monitoring and diagnosis, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SE-1010 PC ECG is a PC-based diagnostic tool intended to acquire, process and store ECG signals from adult and pediatric patients undergoing stress exercise test or resting test. SE-1010 PC ECG is intended to be used only in hospitals and 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 clinicians on an advisory basis only.
Product codes (comma separated list FDA assigned to the subject device)
DPS
Device Description
PC ECG is a kind of resting and exercising electrocardiograph based on PC. PC ECG including data sampling modules and software which can be installed on desktop or laptop PC. PC ECG can acquire 12 channel waveforms simultaneously, which can also print out 3/6/12 channel electrocardiograph wave simultaneously by a 210mm (A4) wide printer.
Advanced digital filter technique has been used in PC ECG including baseline anti-drift filter AC noise (50/60Hz) filter; EMG Filter and Low pass Filter which can help the user to record the ECG more clearly.
Moreover. the ECG Measurement and interpretation program(SEMIP) is included in this machine, this program can provide more detail information to diagnose heart disease.
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
Heart
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
hospitals and 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)
The following quality assurance measures were applied to the development of the PC ECG Electrocardiograph
- Software testing .
- Risk analysis .
- Safety testing
- Environment test
Conclusion: Verification and validation testing was done on PC ECG. This premarket notification submission demonstrates that PC ECG is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
P 1/2
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 26858736
Fax:+86 755 26882223 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Queena Chen
Edan Instruments, Inc. |
| Date: | 2013-5-16 |
| Proprietary Name: | PC ECG |
| Classification Name: | 21 CFR 870.2340 Electrocardiograph |
| Product code: | DPS |
| Predicate Devices: | PC ECG, Model SE-1010
K102854
Manufacturer: Edan Instruments, Inc.
CG-7000DX-BT ECG Recorder/Transmitter
K052556
Card Guard Scientific Survival, LTD. |
| Device Description: | PC ECG is a kind of resting and
exercising
electrocardiograph based on PC. PC ECG including data
sampling modules and software which can be installed on
desktop or laptop PC. PC ECG can acquire 12 channel
waveforms simultaneously, which can also print out 3/6/12
channel electrocardiograph wave simultaneously by a
210mm (A4) wide printer.
Advanced digital filter technique has been used in PC ECG
including baseline anti-drift filter AC noise (50/60Hz) filter;
EMG Filter and Low pass Filter which can help the user to |
1
record the ECG more clearly.
Moreover. the ECG Measurement and interpretation program(SEMIP) is included in this machine, this program can provide more detail information to diagnose heart disease.
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
Intended Use: SE-1010 PC ECG is a PC-based diagnostic tool intended to acquire, process and store ECG signals from adult and pediatric patients undergoing stress exercise test or resting test. SE-1010 PC ECG is intended to be used only in hospitals and 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 clinicians on an advisory basis only.
Test Summary:
The following quality assurance measures were applied to the development of the PC ECG Electrocardiograph
- Software testing .
- Risk analysis .
- � Safety testing
- . Environment test
Conclusion:
Verification and validation testing was done on PC ECG. This premarket notification submission demonstrates that PC ECG is substantially equivalent to the predicate devices.
2
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 22, 2013
Edan Instruments, Inc. c/o Ms. Queena Chen Certification Engineer Equipments Park, Nanhai Rd 1019 No. Shekou Nanshan Shenzhen, 518067 CH
Re: K131819
Trade/Device Name: PC ECG Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: II (two) Product Code: DPS Dated: June 17, 2013 Received: October 10, 2013
Dear Ms. Queena Chen:
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.
3
Page 2 - Ms. Queena Chen
.. .
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 (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 yours,
Owen P. Faris -S
for
Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K131819
Indication for Use
510(k) Number: K131819
Device Name: PC ECG
SE-1010 PC ECG is a PC-based diagnostic tool intended to acquire, process and store ECG Signal from adult and pediatric patients undergoing stress exercise test or resting test. SE-1010 PC ECG is intended to be used only in hospitals and 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 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
Digitally signed by
Owen P. Faris -5
Date: 2013.11.22
12:43:57-05'00'