(392 days)
No
The summary describes a standard digital electrocardiograph that acquires, filters, amplifies, 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 compliance with electrical safety and performance standards, not on the performance of any AI/ML algorithm.
No
The device is described as a Digital Electrocardiograph intended to acquire and display ECG signals for analysis and diagnosis; it does not provide therapy.
Yes
The device is intended to acquire ECG signals to "help users to analyze and diagnose heart disease," which aligns with the definition of a diagnostic device.
No
The device description explicitly states it consists of an "acquisition box," "optional accessories" (lead wires, electrodes, printer), "installation CD," and "USB dongle," in addition to the software. This indicates it is a system with both hardware and software components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Digital Electrocardiograph acquires electrical signals directly from the patient's body surface using electrodes. It does not analyze specimens taken from the body.
- Intended Use: The intended use is to acquire ECG signals to help analyze and diagnose heart disease, which is a direct measurement of physiological activity, not an analysis of a biological sample.
Therefore, this device falls under the category of a medical device that performs a physiological measurement, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Digital Electrocardiograph is intended to acquire ECG signals from adult patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiograph shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Product codes
DPS
Device Description
Digital Electrocardiograph, ECG-2000, is intended to acquire ECG signals from adult patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease.
It consists of the acquisition box, optional accessories, installation CD, and USB dongle. The acquisition box is connected with ECG electrodes, and intends to acquire ECG signals from patient. The acquired ECG signal is filtered and amplified, then transferred to the working station. The acquisition box is powered by the working station via a USB line. The working station is a Personal Computer installed with ECG-2000 Software, it intends to receive the processed ECG signal from the acquisition box, and further display and record the signals. Optional accessories include lead wires, limb electrodes and chest electrodes, and general-purpose printer (with USB interface, support PCL language, such as HP1010, P2035, and P2055d series). The CD contains Digital Electrocardiograph installer and dongle installation program module.
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)
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 60601-1:2005 + CORR.1(2006) + CORR.2(2007) +AM1(2012), Medical electrical equipment - Part 1 : General requirements for basic safety and essential performance.
EN 60601-1-2:2007+AC:2010, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
IEC 60601-2-25: 2011, Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs.
Software Verification Test was performed to verify the software functions against its intended use.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 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: K133985
Trade/Device Name: Digital Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: December 3. 2014 Received: December 5, 2014
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, 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.
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
1
related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (OS) 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
2
Indications for Use
510(k) Number (if known) K133985
Device Name
Digital Electrocardiograph ECG-2000
Type of Use (Select one or both, as applicable)
Indications for Use (Describe)
Digital Electrocardiograph is intended to acquire ECG signals from adult patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and disease. Digital Electrocardiograph 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) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF 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) Staff 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."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
Tab #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: K133985
-
- Date of Submission: 01/07/2015
-
- Sponsor Identification
Shenzhen Biocare Bio-Medical Equipment Co., Ltd Room A735, Floor 7, Tower A, Shenzhen Famous Industrial Procurement & Exhibition Center, No. 168 Baoyuan Road, Baoan, Shenzhen, 518102, P.R. China
Establishment Registration Number: 3008457078
Contact Person: Mr. Hongbo Zhong Position: Director Tel: +86-755-36615333-8856 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 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
- Submission Correspondent
4
- Proposed Device Identification 4.
Proposed Device Name: Digital Electrocardiograph Model: ECG-2000 Proposed Device Common Name: Electrocardiograph
Regulatory Information: Classification Name: Electrocardiograph Classification: II; Product Code: DPS; Regulation Number: 21 CFR part 870.2340; Review Panel: Cardiovascular;
Intended Use Statement:
Digital Electrocardiograph is intended to acquire ECG signals from adult patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiograph shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
- న్. Predicate Device Identification
Predicate Device 1 510(k) Number:K092010 Product Name: PC ECG Manufacturer: Edan Instruments, Inc.
Predicate device 2 510(k) Number: K123816 Product Name: Digital Electrocardiographs iE 12A Manufacturer: Shenzhen Biocare Electronics Co., Ltd
- Device Description 6.
Digital Electrocardiograph, ECG-2000, is intended to acquire ECG signals from adult patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease.
It consists of the acquisition box, optional accessories, installation CD, and USB dongle. The acquisition box is connected with ECG electrodes, and intends to acquire ECG signals from patient. The acquired ECG signal is filtered and amplified, then transferred to the working station. The acquisition box is
5
powered by the working station via a USB line. The working station is a Personal Computer installed with ECG-2000 Software, it intends to receive the processed ECG signal from the acquisition box, and further display and record the signals. Optional accessories include lead wires, limb electrodes and chest electrodes, and general-purpose printer (with USB interface, support PCL language, such as HP1010, P2035, and P2055d series). The CD contains Digital Electrocardiograph installer and dongle installation program module.
-
- Non-Clinical Test Conclusion
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:
- Non-Clinical Test Conclusion
IEC 60601-1:2005 + CORR.1(2006) + CORR.2(2007) +AM1(2012), Medical electrical equipment - Part 1 : General requirements for basic safety and essential performance.
EN 60601-1-2:2007+AC:2010, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
IEC 60601-2-25: 2011, Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs.
Software Verification Test was performed to verify the software functions against its intended use.
- Substantially Equivalent (SE) Conclusion 8.
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 1 | Predicate Device 2 |
|---|---|---|---|
| Product Code | DPS | Same | Same |
| Regulation Number | 21 CFR 870. 2340 | Same | Same |
| Class | Class II | Same | Same |
| Intended Use | Digital Electrocardiograph is | ||
| intended to acquire ECG signals | |||
| from adult patients through body | |||
| surface ECG electrodes. The | |||
| obtained ECG records can help | |||
| users to analyze and diagnose heart | Similar | Similar | |
| disease. Digital Electrocardiograph |
Table 3-1 Comparison of Technology Characteristics
6
| | shall be used in healthcare facilities
by doctors and/or trained healthcare
professionals. | | |
|-----------------------------|--------------------------------------------------------------------------------------------------|---------|------|
| Configuration | Chest Electrode and Limb Electrode | Same | Same |
| ECG Lead | Standard 12-lead | Same | Same |
| ECG Gain | 1.25, 2.5, 5, 10, 20, 10-5, 20-10
(mm/mV) | Similar | Same |
| Sampling rate | 1000Hz | Same | Same |
| Input circuit current | ≤0.1 μΑ | Similar | Same |
| Noise level |