K Number
K141946
Device Name
DIGITAL ELECTROCARDIOGRAPH
Date Cleared
2015-02-13

(211 days)

Product Code
Regulation Number
870.2340
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
More Information

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)

K091513, K050858

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).

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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

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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:

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"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."

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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

    1. Date of Submission: July 04, 2014
    1. 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

    1. 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

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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.

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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.

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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.

ITEMProposed DevicePredicate DevicePredicate Device
K091513K050858
ModeliE 3/ iE 6/ iE 12/ iE 12A/ iE 15/N.A.
ECG-1210/
ECG-3010/SE-12
ECG-6010
Product CodeDPSSameSame
Regulation
Number21CFR 870.2340SameSame
Intended UseHeartStation™
Heartlab
The
ECG
The
intended
use
ofintended
The
use
ofManagement System is a comprehensive data
electrocardiograph is to acquireelectrocardiograph is to acquiremanagement solution which automates the
ECG signals from adult andECG signals from adult andprocessing,
and
storage
display
of
pediatric patients through bodypediatric patients through bodyelectrocardiograms (ECGs)
throughout
a
surface ECG electrodes. Thesurface ECG electrodes. Thehealthcare enterprise. HeartStation™ accepts
electrocardiograph
is
onlyelectrocardiograph
is
onlystandard 12-lead ECGs, which originate from
intended to be used in hospitalsintended to be used in hospitalsany one of a variety of manufacturers'
or healthcare facilities by doctorshealthcare
facilities
or
bycardiographs and patient monitors, and
and
trained
healthcaredoctors and trained healthcarethem to a common format.
normalizes
professionals. The cardiogramprofessionals. The cardiogramECGs are
then measured,
interpreted,
recorded
by
therecorded
by
theprevious
compared
to
ECGs
("serial
electrocardiograph
can
helpelectrocardiograph can
helpcomparison"), optionally printed and stored
users to analyze and diagnoseusers to analyze and diagnosewith a preliminary diagnosis. A graphical user
heart disease. However the ECGheart disease. However
theinterface allows a physician to review these
with
measurements
andECG with measurements andcomputer-generated reports, modify them or
interpretive statements is offeredinterpretive
statements
isadd comments as appropriate, electronically
to clinician on an advisory basisoffered to clinician on
anhis or her signature and trigger the
apply
only.advisory basis only.automatic distribution of final, confirmed
diagnostic reports to other care providers.
LeadStandard 12-lead or 15 leadStandard 12-leadN.A.
AcquisitionSimultaneous 12-lead acquisitionSimultaneous
12-leadN.A.
modeor 15 lead acquisitionacquisition
RecordingAutomatic / Manual / RhythmSameUnknown
format
Analysis modeYesYesYes
CMRR>60dBSimilarUnknown
>100 with AC filter
Paper Speed4 levels as 6.25, 12.5, 25,
50mm/s, OR
6 levels as: 5, 6.25, 10, 12.5, 25
and 50mm/sSimilarUnknown
Input CIR
current≤0.1μΑSimilarUnknown
Input impedance>50ΜΩSameUnknown
Patient leak
current