(65 days)
Not Found
No
The description mentions "ECG and interpretation program(SEMIP)" and "auto measurement and diagnosing," but these are described as providing "advisory" information and are not explicitly stated to use AI/ML. The focus is on digital filtering and standard ECG analysis techniques. There is no mention of AI, ML, DNN, or any related concepts.
No
The device is described as a diagnostic tool used to acquire, process, and store ECG signals for analysis and diagnosis of heart disease, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states, "SE-1010 PC ECG is a PC-based diagnostic tool." It also mentions that the cardiogram can "help users to analyze and 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 text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for acquiring ECG signals from the body surface of patients. This is a direct measurement of physiological signals from a living organism, not an analysis of samples taken from the body (like blood, urine, or tissue).
- Device Description: The description focuses on acquiring, processing, and storing ECG signals, which are electrical signals from the heart. It mentions filters and measurement programs, but these are applied to the acquired physiological data, not to in vitro samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the SE-1010 PC ECG is a diagnostic device, but it operates in vivo (on the living body) rather than in vitro (in a test tube or other artificial environment).
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.
KID2854 510(k) Number (if known):
Device Name: PC ECG
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.
Measurement Moreover, the ECG 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
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
The following quality assurance measures were applied to the development of the PC ECG Electrocardiograph
- Software testing
- Risk analysis .
- . Safety testing
- Environment test
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 (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
PC ECG special 510k modification SUBMISSION
ッ
. . . .
24
DEC - 3 2010.'
510(K)Summary of Safety and Effectiveness
ミ :
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 26899197
Fax:+86 755 26882223 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Yue Qiuhong (Tracy)
Edan Instruments, Inc. |
| Date: | 2010-9-20 |
| Proprietary Name: | PC ECG |
| Classification Name: | 21 CFR 870.2340 Electrocardiograph |
| Product code: | DPS |
| Predicate Devices: | Cardiosoft/case cardiac testing system
K031561
Manufacturer: GE medical systems information technologies
PC ECG, MODEL SE-1010
K092010
Manufacturer: Edan Instruments, Inc |
| 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. |
1
Measurement Moreover, the ECG 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 ー measurement with high precision electronic ruler
data management and processing function ।
Report printing with PDF format, word format or JPG ﺳﮯ 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:
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 device.
ﺎ ﻓﻲ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
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 stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the staff and a serpent intertwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Edan Instruments, Inc. c/o Ms. Yue Qiuhong Registrar 3/F - B, Nanshan Medical Equipments Park, Nanhai Rd 1019# Shekou, Nanshan Shenzhen, 518067 P.R. China
DEC - 3 2010
Re: K102854
Trade/Device Name: PC ECG Model SE-1010 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: October 28, 2010 Received: November 8, 2010
Dear Ms. Qiuhong:
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 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. Yue Qiuhong
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 1 5809.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,
[signature]
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
KID2854 510(k) Number (if known):
Device Name: PC ECG
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.
× Prescription Use Or Over the Counter Use (21 CFR Part 801 Subpart D) (21 CFR Part 801 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
W.M.S
1 of 1
DEC - 3 2010