(51 days)
Not Found
No
The summary describes a standard digital electrocardiograph that acquires, displays, and records ECG signals. There is no mention of AI, ML, or any advanced analytical capabilities beyond basic signal processing and display. The performance studies focus on safety and electromagnetic compatibility standards, not AI/ML performance metrics.
No
The device is used to acquire and display ECG signals for analysis and disease diagnosis, which is for diagnostic purposes, not therapeutic.
Yes
The device is described as assisting users in analyzing and diagnosing diseases using obtained ECG records.
No
The device description explicitly states that the device acquires, displays, and records ECG signals using ECG electrodes and a thermal printer, indicating the presence of hardware components beyond just software.
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.
- 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 placing electrodes on the patient's skin to measure electrical activity of the heart. This is an in vivo measurement (within the living body), not an in vitro measurement (outside the living body).
- Intended Use: The intended use is to "acquire ECG signals" and "help users to analyze and disease." This analysis is based on the electrical signals from the heart, not on testing samples from the body.
Therefore, the Digital Electrocardiographs described are medical devices used for physiological measurement, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Digital Electrocardiographs, ECG-8080/ iE 3S/ iE 12/ iE 12P, are intended to acquire ECG signals from adult and pediatic patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Product codes
DPS
Device Description
Digital Electrocardiographs, ECG-8080/ IE 3S/ iE 12/ iE 12P, 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 paperthrough thermal printer. ECG data result and patient information could be stored in the memory of the device.
All the models, ECG-8080/ iE 3S/ iE 12/ iE 12P, 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
body surface
Indicated Patient Age Range
adult and pediatic 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 Equivalem (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+ A !: 1999, Medical electrical equipment -Part 2: Particular requirements for the safety of electrocardiographs.
IEC 60601-1-2:2007, Medical electrical equipment- Part 1-2: General requirements for safety-Collateral standard: Electromagnetic compatibility- Requirements and teats.
IEC 60601-2-25:1995 +A1:1999 Clause 36, Medical electrical equipment - Part 2 Clause 36: Particular requirements for the safety of electrocardiographs - Electromagnetic compatibility.
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
K122712 pg 1 of 3
Premarket Notification 510(k) Submission
Section V 510(k) Summary
Project #:M0062012Ad
Section V 510(k) Summary
25 2012
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:
- l . Date of Submission: August 17, 2012 .
-
- Sponsor
Shenzhen Biocare Electronics Co., Ltd S/F, Taohuayuan High-Tech Innovation Park, Baoan, Shenzhen, Guangdong, 518102, China
Establishment Registration Number: 3008457078
Contact Person: 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 4.
Proposed Device Name: Digital Electrocardiographs Proposed Device Model: ECG-8080/ iE 3S/ iE 6S/ iE 12/ iE 12P Classification: Class II Product Code: DPS Regulation Number: 21 CFR 870.2340 Review Panel: Cardiovascular
1
K122712 pg 2 of 3
Premarket Notification 510(k) Submission Section V 510(k) Summary
Project #:M0062012Ad
Intended Use Statement:
Digital Electrocardiographs, ECG-8080/ iE 3S/ iE 12/ iE 12P, are intended to acquire ECG signals from adult and pediatic patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
-
- Predicate Device Identification
510(k) Number: K101876 Product Name: Digital Electrocardiograph Model: ECG-3010/ECG-6010 Manufacturer: Shenzhen Biocare Electronics Co., Ltd
- Predicate Device Identification
510(k) Number: K112431 Product Name: Digital Electrocardiograph Model: ECG-1216/ECG-1215 Manufacturer: Shenzhen Biocare Electronics Co., Ltd
Device Description 6.
Digital Electrocardiographs, ECG-8080/ IE 3S/ iE 12/ iE 12P, 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 paperthrough thermal printer. ECG data result and patient information could be stored in the memory of the device.
All the models, ECG-8080/ iE 3S/ iE 12/ iE 12P, of the proposed device, Digital Electrocardiographs, follow the same design principle and similar technical specifications.
-
- Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalem (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
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+ A !: 1999, Medical electrical equipment -Part 2: Particular requirements for the safety of electrocardiographs.
IEC 60601-1-2:2007, Medical electrical equipment- Part 1-2: General requirements for safety-Collateral standard: Electromagnetic compatibility- Requirements and teats.
IEC 60601-2-25:1995 +A1:1999 Clause 36, Medical electrical equipment - Part 2 Clause 36: Particular requirements for the safety of electrocardiographs - Electromagnetic compatibility.
2
Section V 510(k) Summary
Project #:M0062012Ad
K1227
- Substantially Equivalent Conclusion 8.
The proposed device, Digital Electrocardiograph, is determined to be Substantially Equivalent (SE) to the predicate device, Digital Electrocardiograph (K 101876 and K 112431), in respect of safety and effectiveness.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 25 2012
Shenzhen Biocare Electronics Co., LTD c/o Ms. Diana Hong Mid-Link Consulting Co., LTD P.O. Box 237-023 Shanghai, China 200237
Re: K122712
Trade/Device Name: Digital Electrocardiography models ECG-8080, iE 3S, iE 12, and iE 12P
Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiography Regulatory Class: Class II Product Code: DPS Dated: September 24, 2012 Received: October 1, 2012
Dear Ms. 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, 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.
4
Page 2 - Ms. Diana Hong
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 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/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.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Project #:M0062012Ad Section II Indications for Use Premarket Notification 510(k) Submission
Section II Indications for Use
510(k) Number: Device Name:Digital Electrocardiographs
Indications for Use:
Digital Electrocardiographs, ECG-8080/ iE 3S/ iE 12/ iE 12P, 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 disease. Digital Electrocardiographs shall be used in healtheare facilities by doctors and/or trained healthcare professionals.
ZPRESCRIPTION USE (Part 21 CFR 801 Subpart D) OVER-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
(Division Sign-Off)
on of Cardiovascular Devices
510(k) Number K122712