K Number

Device Name

DIGITAL ELECTROCARDIOGRAPH

Manufacturer

SHENZHEN BIOCARE ELECTRONICS CO., LTD

Date Cleared

2011-09-22

(30 days)

Product Code

DPS

Regulation Number

870.2340

Intended Use

Digital Electrocardiographs, ECG-3020 / ECG-3030 / ECG-3060 / ECG-6020 / ECG-1220 / ECG-1260 / ECG-1215 / ECG-1216, are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

Device Description

Digital Electrocardiographs, ECG-3020 / ECG-3030 / ECG-3060 / ECG-6020 / ECG-1220 / ECG-1260 / ECG-1215 / ECG-1216, are designed to acquire, display and record ECG signals from patient body surface by ECG electrodes. After been amplified and filtered, the ECG signals waveforms are displayed in the LCD and recorded in the paper through thermal printer. ECG data result and patient information could be stored in the memory of the device. All the models, ECG-3020 / ECG-3030 / ECG-3060 / ECG-6020 / ECG-1220 / ECG-1260 / ECG-1215 / ECG-1216, of the proposed device, Digital Electrocardiographs, follow the same design principle and similar technical specifications.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K101876

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard ECG signal acquisition, display, and recording. There is no mention of AI, ML, or any advanced analytical techniques beyond basic signal processing and display. The performance studies focus on electrical safety and substantial equivalence to a predicate device, not on the performance of any AI/ML algorithm.

Therapeutic

No
The device is described as acquiring, displaying, and recording ECG signals to help analyze and diagnose heart disease. It does not provide any therapy or treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that "The obtained ECG records can help users to analyze and diagnose heart disease." This indicates its role in the diagnostic process.

SaMD (Software as a Medical Device)

The device description explicitly states that the device acquires, displays, and records ECG signals using ECG electrodes, an LCD, and a thermal printer, indicating the presence of hardware components beyond just software.

IVD (In Vitro Diagnostic)

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 such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
Device function: The description clearly states that the device "acquire[s] ECG signals from adult and pediatric patients through body surface ECG electrodes." This involves measuring electrical activity directly from the patient's body surface, not analyzing samples taken from the body.
Intended Use: The intended use is to "acquire ECG signals" and the obtained records "can help users to analyze and diagnose heart disease." This is a direct physiological measurement, not an in vitro test.

Therefore, this device falls under the category of medical devices that perform physiological measurements, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

DPS

Device Description

All the models, ECG-3020 / ECG-3030 / ECG-3060 / ECG-6020 / ECG-1220 / ECG-1260 / ECG-1215 / ECG-1216, of the proposed device, Digital Electrocardiographs, follow the same design principle and similar technical specifications.

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

healthcare facilities by doctors and/or 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)

Bench 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: 1988 +A1:1991+A2:1995, Medical Electrical Equipment - Part 1: General requirements for safety.

IEC 60601-1-2: 2001 +A1:2004, Medical Electrical Equipment - Part 1: General requirements for safety - Collateral Standard: Electromagnetic compatibility - Requirements and tests

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K101876

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

Section III 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 21 CFR 807.92.

The assigned 510(k) Number: __

1. Date of Submission: August 17, 2011
1. Sponsor

Shenzhen Biocare Electronics Co., Ltd S/F, Taohuayuan High-Tech Innovation Park, Baoan Shenzhen, Guangdong, 518102, China

Contact Person: Mr. Hongbo Zhong Position: Director Tel: +86-755-27960888 Fax: +86-755-27960643 Email: hb-zhong@tom.com

Submission Correspondent Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
Proposed Device Identification

Proposed Device Name: Digital Electrocardiographs Proposed Device Model: ECG-3020 / ECG-3030 / ECG-3060 / ECG-6020 / ECG-1220 / ECG-1260 / ECG-1215 / ECG-1216 Classification: Class II Product Code: DPS Regulation Number: 21 CFR 870.2340 Review Panel: Cardiovascular

Project #:M0122011Aa

Intended Use Statement:

1. Predicate Device Identification
  510(k) Number: K101876 Product Name: Digital Electrocardiograph Manufacturer: Shenzhen Biocare Electronics Co., Ltd
1. Device Description
  Digital Electrocardiographs, ECG-3020 / ECG-3030 / ECG-3060 / ECG-6020 / ECG-1220 / ECG-1260 / ECG-1215 / ECG-1216, are designed to acquire, display and record ECG signals from patient body surface by ECG electrodes. After been amplified and filtered, the ECG signals waveforms are displayed in the LCD and recorded in the paper through thermal printer. ECG data result and patient information could be stored in the memory of the device.

1. Non-Clinical Test Conclusion
  Bench 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: 1988 +A1:1991+A2:1995, Medical Electrical Equipment - Part 1: General requirements for safety.

IEC 60601-1-2: 2001 +A1:2004, Medical Electrical Equipment - Part 1: General requirements for safety - Collateral Standard: Electromagnetic compatibility - Requirements and tests

8. Substantially Equivalent Conclusion

The proposed device, Digital Electrocardiograph, is determined to be Substantially Equivalent (SE) to the predicate device, Digital Electrocardiograph (K101876), in respect of safety and effectiveness.

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 or bird-like figure with three curved lines representing its wings or feathers.

Public Flealth Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room WO66-G609 Silver Spring, MID 20993-0002

Shenzhen Biocare Electronics Co., Ltd. c/o Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 237-023 Shanghai 200237 CHINA

SEP 2 2 2011

રિદ: K112431

Trade/Device Name: Digital Electrocardiographs, Models ECC-3020/ECG-3030/2 ECG-3060/ECG-6020/ECG-1220/ECG-1260/ECG-1215/ECG1216 Regulatory Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: II (two) Product Code: 74 DPS Dated: August 22, 2011 Received: August 23, 2011

Dear Ms. Hong:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 210(x) premained is substantially equivalent for in indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative no regally manation date of the Medical Device Americal Caud. Days commerce prov to May 20, 1977, the oncerners with the provisions of the Federal Food, Drug. devices mat have been reclassified in acceraanse who a premarket approval application (PMA). and Cosment ACT(ACC) market the device, subject to the general controls provisions of the Act. The You may, incretore, market the dovres, babject to the manual registration, listing of general controls provisions of the rice 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 It may be subject to additional Collivols. Extrang major 1990 to 898. In addition, FDA may found in the Court of Feaching your device in the Federal Register.

Page 2 - Ms. Diana Hong

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.lda.gov/AboutFDA/CentersOfTices/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Section II Indications for Use Project #:M0122011Aa

Section II Indications for Use

510(k) Number: Device Name: Digital Electrocardiographs

Indications for Use:

OPRESCRIPTION USE (Part 21 CFR 801 Subpart D) OOVER-THE-COUNTER USE (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

RIKla, Ok

of Cardiovascular Devices

510(k) Number