(154 days)
Not Found
No
The document describes standard ECG signal processing and analysis (QRS detection, heart rate, ectopic beats, ST segment deviation) without mentioning AI, ML, or related concepts. The analysis is described as "advisory basis only," which is common for automated ECG interpretation but doesn't inherently imply AI/ML. The performance studies focus on standard electrical safety and ECG performance standards, not AI/ML validation metrics.
No.
The device is used to acquire and analyze ECG signals for diagnostic purposes, with results offered on an advisory basis. It does not provide any form of therapeutic intervention or treatment.
Yes
The device is an Electrocardiograph, which is clearly stated to be "intended to acquire ECG signals from adult patients," "complete the ECG measurements of QRS detection, Heart Rate, ventricular ectopic beat (VEB), supraventricular ectopic beat (SVEB) and ST Segment Deviation," and provide "ECG with measurements" to clinicians on an advisory basis. These functions are inherently diagnostic, as they involve the acquisition and analysis of physiological data to identify specific medical conditions or characteristics.
No
The device description explicitly states it consists of hardware components (power module, control module, LCD, thermal printer) and acquires signals through physical electrodes. It is a traditional hardware-based ECG device with integrated software for analysis and display.
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 patients through body surface ECG electrodes." This is a non-invasive measurement of electrical activity of the heart on the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is to acquire and analyze ECG signals for diagnostic purposes, which is a function of a medical device, but not specifically an in vitro diagnostic device.
Therefore, this device is a medical device, specifically an electrocardiograph, but it does not fit the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Electrocardiographs, ECG-1101G(1), ECG-1103G(1), ECG-1103LW(1), ECG-1106L, ECG-1112 and ECG-1112D, are intended to acquire ECG signals from adult patients through body surface ECG electrodes. It could complete the ECG measurements of QRS detection, Heart Rate, ventricular ectopic beat (VEB), supraventricular ectopic beat (SVEB) and ST Segment Deviation. ECG with measurements is offered to clinician on an advisory basis only. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Product codes (comma separated list FDA assigned to the subject device)
DPS
Device Description
Carewell Digital Electrocardiographs, ECG-1101G(I) / ECG-1103G(I)/ ECG-1103LW(I) / ECG-1106L /ECG-1112 / ECG-1112D, are designed to acquire, analyze, display and record ECG signals from patient body surface by ECG electrodes. After been amplified, fittered and analyzed, the ECG signal waveforms and analysis results are displayed on the LCD and recorded on the paper through thermal printer. ECG data, result and patient information could be stored in the memory of the device.
All the models, ECG-1101G(1) / ECG-1103G(1) ECG-1103LW(1) / ECG-1106L /ECG-1112 / ECG-1112D of the proposed device, Carewell Digital Electrocardiographs, have difference in appearance. but follow the same design principle and similar technical specifications:
They consist of three modules, which are power module and control module, and they have three operation modes, including AUTO Mode (automatic mode), MAN Mode (manual mode) and ANA Mode (analysis mode).
They are standard twelve leads, including bipolar limb leads, augmented unipolar limb leads and unipolar chest leads. And they are using the same accessories.
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 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 A requirements for safety;
- IEC 60601-1-2:2001 +A1: 2007, Medical Electrical Equipment - Part 1: General requirements for safety - Collateral Standard: Electromagnetic compatibility - Requirements and tests;
- A IEC 60601-2-25: 1993+ A1:1999, Medical Electrical Equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers;
- ANSI/AAMI EC11:1991/(R)2007, Diagnosis electrocardiographic devices;
- ANSI/AAMI EC38:1998, Ambulatory electrocardiographs;
- ANSI/AAMI EC57:2003,Testing and Reporting performance results of cardiac rhythm and ST-segment measurement algorithms;
- AAMI EC53:1998, ECG cables and leadwieres;
- ISO 10993-5:2009 Standard, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity";
- ISO 10993-10:2002 Standard and Amendment 1:2006. "Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity AMENDMENT 1";
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
1/3
Exhibit #1510(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: K113485
-
- Date of Submission:April 5, 2012
-
- Sponsor
Shenzhen Carewell Electronics Co., Ltd 5A, Huating 3, TimeCity, Chuangye Road, Nanshan, Shenzhen 518054, P.R. China Contact Person: Jason Kang Position: General Manager Tel: +86-755-86170389 Email: standard@carewell.com.cn
-
- 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:Electrocardiograph Proposed Device Model:ECG-1101G(1), ECG-1103G(1), ECG-1103LW(1), ECG-1106L, ECG-1112 and
ECG-1112D
Classification: II Product Code: DPS Regulation Number: 21 CFR 870.2340 Review Panel: Cardiovascular
1
Premarket Notification 510(k) Submission Exhibit #1 510(k) Summary Project #:M0142011 Ac
Intended Use Statement:
Electrocardiographs, ECG-1101G(1), ECG-1103G(1), ECG-1103LW(1), ECG-1106L, ECG-1112 and ECG-1112D, are intended to acquire ECG signals from adult patients through body surface ECG electrodes. It could complete the ECG measurements of QRS detection. Heart Rate, ventricular ectopic beat (VEB), supraventricular ectopic beat (SVEB) and ST Segment Deviation. ECG with measurements is offered to clinician on an advisory basis only. 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 Manufacturer:Digital Electrocardiograph
-
- Device Description
Carewell Digital Electrocardiographs, ECG-1101G(I) / ECG-1103G(I)/ ECG-1103LW(I) / ECG-1106L /ECG-1112 / ECG-1112D, are designed to acquire, analyze, display and record ECG signals from patient body surface by ECG electrodes. After been amplified, fittered and analyzed, the ECG signal waveforms and analysis results are displayed on the LCD and recorded on the paper through thermal printer. ECG data, result and patient information could be stored in the memory of the device.
All the models, ECG-1101G(1) / ECG-1103G(1) ECG-1103LW(1) / ECG-1106L /ECG-1112 / ECG-1112D of the proposed device, Carewell Digital Electrocardiographs, have difference in appearance. but follow the same design principle and similar technical specifications:
They consist of three modules, which are power module and control module, and they have three operation modes, including AUTO Mode (automatic mode), MAN Mode (manual mode) and ANA Mode (analysis mode).
They are standard twelve leads, including bipolar limb leads, augmented unipolar limb leads and unipolar chest leads. And they are using the same accessories.
- Non-Clinical Test Conclusion 7.
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:
2
Premarket Notification 510(k) Submission Exhibit #1 510(k) Summary Project #:M0142011Ac
- IEC 60601-1:1988+A1:1991+A2:1995, Medical Electrical Equipment Part 1: General A requirements for safety;
-
IEC 60601-1-2:2001 +A1: 2007, Medical Electrical Equipment - Part 1: General requirements for safety - Collateral Standard: Electromagnetic compatibility - Requirements and tests;
- A IEC 60601-2-25: 1993+ A1:1999, Medical Electrical Equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers;
-
ANSI/AAMI EC11:1991/(R)2007, Diagnosis electrocardiographic devices;
-
ANSI/AAMI EC38:1998, Ambulatory electrocardiographs;
-
ANSI/AAMI EC57:2003,Testing and Reporting performance results of cardiac rhythm and ST-segment measurement algorithms;
- V AAMI EC53:1998, ECG cables and leadwieres;
- A ISO 10993-5:2009 Standard, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity";
- A ISO 10993-10:2002 Standard and Amendment 1:2006. "Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity AMENDMENT 1";
-
- Substantially Equivalent Conclusion
The proposed device, Electrocardiographs, is determined to be Substantially Equivalent (SE) to the predicate device, Digital Electrocardiograph, K101876, in respect of safety and effectiveness.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 2 5 2012
Shenzhen Carewell Electronics Co., Ltd c/o Diana Hong Shanghai Mid-Link Business Consulting Co., Ltd PO Box 237-023 Shanghai, 200030, China
Re: K113485
Trade/Device Name: Electrocardiograph ECG-1101G(I), ECG-1103G(I), ECG-1103LW(I), ECG-1106L, ECG-1112 and ECG-1112D Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: April 5, 2012 Received: April 9, 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.
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.
4
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.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
Premarket Notification 510(k) Submission
Exhibit #2 Indication for Use Project #:M0142011Ac
Exhibit #2Indications for Use
510(k) Number: Ki13485 Device Name: Electrocardiographs
Indications for Use:
Electrocardiographs, ECG-1101G(1), ECG-1103G(1), ECG-1103LW(1), ECG-1106L, ECG-1122 and ECG-1112D, are intended to acquire ECG signals from adult patients through body surface ECG electrodes. It could complete the ECG measurements of QRS detection, Heart Rate, ventricular ectopic beat (VEB), supraventricular ectopic beat (SVEB) and ST Segment Deviation. ECG with measurements is offered to clinician on an advisory basis only. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
&PRESCRIPTION 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)
of Cardiovascular Devices
510(k) Number K113485
1