(211 days)
No
The summary describes a standard electrocardiograph that acquires and displays ECG signals. While it includes an "analysis program" (CardioPro), there is no mention of AI, ML, or related concepts like deep learning, neural networks, or training/test sets, which are typically associated with AI/ML-powered devices. The interpretive statements are explicitly stated as advisory, which is common in traditional ECG analysis software and doesn't necessarily indicate AI/ML.
No
The device is an electrocardiograph used for acquiring and analyzing ECG signals to help diagnose heart disease, which is a diagnostic function, not a therapeutic one.
Yes
The device acquires ECG signals and provides a cardiogram that "can help users to analyze and diagnose heart disease." Although interpretive statements are advisory, the core function includes providing information for diagnosis.
No
The device description explicitly states it consists of hardware modules (power supply, signal collection, amplification, control) and acquires signals via electrodes, indicating it is a physical device with software components, not software-only.
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. They are performed outside of the living body.
- Device Function: The description clearly states that this electrocardiograph acquires ECG signals from adult and pediatric patients through body surface ECG electrodes. This means it is measuring electrical activity directly from the patient's body, which is an in vivo (within the living body) measurement, not an in vitro measurement.
- Intended Use: The intended use is to acquire ECG signals to help analyze and diagnose heart disease. While the analysis of the acquired signal is part of the diagnostic process, the initial signal acquisition is not an in vitro test.
Therefore, this device falls under the category of medical devices that perform measurements directly on the patient's body, rather than on samples taken from the body.
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 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 ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.
Product codes
DPS
Device Description
Digital Electrocardiograph, iE 3/ iE 6/ iE 12/ iE 12A/ iE 15/ ECG-1210/ ECG-3010/ ECG-6010, are intended 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 ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.
All the proposed models, iE 3/ iE 6/ iE 12/ iE 12A/ iE 15/ ECG1210/ ECG3010/ ECG6010, follow the same design principle, main components, accessories and software; they acquire ECG electrical signals from patient body surface by ECG electrodes. After been amplified, filtered and transferred, the ECG signal waveforms are displayed on the LCD and recorded on the paper through thermal printer.
They consist of four modules, which are power supply module, signal collection module, amplification module, and control module.
They can acquire ECG signal via twelve leads simultaneously, display or print waveform of ECG signal via three channel, six channel, twelve channel or fifteen channel.
The CardioPro analysis program is the analysis program used in this proposed device.
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
IEC 60601-1:1990+ A1:1993+ A11:1993+ A12:1993+ A13:1996, Medical electrical equipment, Part 1: General requirements for safety.
IEC 60601-2-25:1993+A1:1999, Medical electrical equipment, Part 2-25: Particular requirements for the safety of electrocardiographs.
IEC 60601-1-2: 2007, Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and teats.
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
Public Health Service
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a stylized emblem. The emblem consists of three intertwined human profiles facing right, symbolizing health and human services. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 13, 2015
Shenzhen Biocare Bio-Medical Equipment Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CH
Re: K141946
Trade/Device Name: Digital electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: January 5, 2015 Received: January 15, 2015
Dear Diana Hong,
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. Isting 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
1
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 of medical devicerelated 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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Melissa A. Torres -S
For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) KJ41946
Device Name Digital Electrocardiograph
Indications for Use (Describe)
The intended use of electrocardiograph 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 ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
- Over-The-Counter Use (21 CFR 801 Subpart C)
PEEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IE NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM IO THE PRA STAEE EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect: of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staffl PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Section 3 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K141946
-
- Date of Submission: July 04, 2014
-
- Sponsor Identification
Shenzhen Biocare Bio-Medical Equipment Co.,Ltd. #A735, Shenzhen Mingyou Industrial Product Exhibition & Procurement Center, Bao'an, Shenzhen, Guangdong, 518102, China
Establishment Registration Number: 3008457078
Contact Person: Mr. Hongbo Zhong Position: R&D Director Tel: +86-0755-36615333 Fax: +86-0755-27960643 Email: hb-zhong@tom.com
-
- Submission Correspondent
Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
- Submission Correspondent
4
4. Proposed Device Identification
Proposed Device Name: Digital Electrocardiograph; Models: iE 3, iE 6, iE 12, iE 12A, iE 15, ECG-1210, ECG-3010 and ECG-6010; Proposed Device Common Name: Electrocardiograph;
Regulatory Information: Classification Name: Electrocardiograph; Classification: II; Product Code: DPS; Regulation Number: 21 CFR 870.2340; Review Panel: Cardiovascular;
Intended Use Statement:
The intended use of electrocardiograph 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 ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.
ર. Predicate Device Identification
510(k) Number: K091513 Product Name: Smart ECG (SE) Series Electrocardiograph, SE-12 Model: SE-12 Manufacturer: Edan Instruments, Inc
510(k) Number: K050858 Product Name: Ascentia HeartStation™ ECG Management System Manufacturer: Heartlab, Inc.
6. Device Description
Digital Electrocardiograph, iE 3/ iE 6/ iE 12/ iE 12A/ iE 15/ ECG-1210/ ECG-3010/ ECG-6010, are intended 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 ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.
5
All the proposed models, iE 3/ iE 6/ iE 12/ iE 12A/ iE 15/ ECG1210/ ECG3010/ ECG6010, follow the same design principle, main components, accessories and software; they acquire ECG electrical signals from patient body surface by ECG electrodes. After been amplified, filtered and transferred, the ECG signal waveforms are displayed on the LCD and recorded on the paper through thermal printer.
They consist of four modules, which are power supply module, signal collection module, amplification module, and control module.
They can acquire ECG signal via twelve leads simultaneously, display or print waveform of ECG signal via three channel, six channel, twelve channel or fifteen channel.
The CardioPro analysis program is the analysis program used in this proposed device.
- Non-Clinical Test Conclusion 7.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
IEC 60601-1:1990+ A1:1993+ A11:1993+ A12:1993+ A13:1996, Medical electrical equipment, Part 1: General requirements for safety.
IEC 60601-2-25:1993+A1:1999, Medical electrical equipment, Part 2-25: Particular requirements for the safety of electrocardiographs.
IEC 60601-1-2: 2007, Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and teats.
6
8. Substantially Equivalent (SE) Conclusion
The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.
ITEM | Proposed Device | Predicate Device | Predicate Device |
---|---|---|---|
K091513 | K050858 | ||
Model | iE 3/ iE 6/ iE 12/ iE 12A/ iE 15/ | N.A. | |
ECG-1210/ | |||
ECG-3010/ | SE-12 | ||
ECG-6010 | |||
Product Code | DPS | Same | Same |
Regulation | |||
Number | 21CFR 870.2340 | Same | Same |
Intended Use | HeartStation™ | ||
Heartlab | |||
The | |||
ECG | |||
The | |||
intended | |||
use | |||
of | intended | ||
The | |||
use | |||
of | Management System is a comprehensive data | ||
electrocardiograph is to acquire | electrocardiograph is to acquire | management solution which automates the | |
ECG signals from adult and | ECG signals from adult and | processing, | |
and | |||
storage | |||
display | |||
of | |||
pediatric patients through body | pediatric patients through body | electrocardiograms (ECGs) | |
throughout | |||
a | |||
surface ECG electrodes. The | surface ECG electrodes. The | healthcare enterprise. HeartStation™ accepts | |
electrocardiograph | |||
is | |||
only | electrocardiograph | ||
is | |||
only | standard 12-lead ECGs, which originate from | ||
intended to be used in hospitals | intended to be used in hospitals | any one of a variety of manufacturers' | |
or healthcare facilities by doctors | healthcare | ||
facilities | |||
or | |||
by | cardiographs and patient monitors, and | ||
and | |||
trained | |||
healthcare | doctors and trained healthcare | them to a common format. | |
normalizes | |||
professionals. The cardiogram | professionals. The cardiogram | ECGs are | |
then measured, | |||
interpreted, | |||
recorded | |||
by | |||
the | recorded | ||
by | |||
the | previous | ||
compared | |||
to | |||
ECGs | |||
("serial | |||
electrocardiograph | |||
can | |||
help | electrocardiograph can | ||
help | comparison"), optionally printed and stored | ||
users to analyze and diagnose | users to analyze and diagnose | with a preliminary diagnosis. A graphical user | |
heart disease. However the ECG | heart disease. However | ||
the | interface allows a physician to review these | ||
with | |||
measurements | |||
and | ECG with measurements and | computer-generated reports, modify them or | |
interpretive statements is offered | interpretive | ||
statements | |||
is | add comments as appropriate, electronically | ||
to clinician on an advisory basis | offered to clinician on | ||
an | his or her signature and trigger the | ||
apply | |||
only. | advisory basis only. | automatic distribution of final, confirmed | |
diagnostic reports to other care providers. | |||
Lead | Standard 12-lead or 15 lead | Standard 12-lead | N.A. |
Acquisition | Simultaneous 12-lead acquisition | Simultaneous | |
12-lead | N.A. | ||
mode | or 15 lead acquisition | acquisition | |
Recording | Automatic / Manual / Rhythm | Same | Unknown |
format | |||
Analysis mode | Yes | Yes | Yes |
CMRR | >60dB | Similar | Unknown |
>100 with AC filter | |||
Paper Speed | 4 levels as 6.25, 12.5, 25, | ||
50mm/s, OR | |||
6 levels as: 5, 6.25, 10, 12.5, 25 | |||
and 50mm/s | Similar | Unknown | |
Input CIR | |||
current | ≤0.1μΑ | Similar | Unknown |
Input impedance | >50ΜΩ | Same | Unknown |
Patient leak | |||
current |