(116 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 for user interpretation. The performance studies section also indicates no changes to the hardware or software from a previous submission, further suggesting a lack of new, potentially AI/ML-driven features.
No
The device is a diagnostic tool that acquires ECG signals to analyze and diagnose heart disease, rather than treating or curing it.
Yes
The 'Intended Use' section states that "The obtained ECG records can help users to analyze and disease." and the 'Device Description' section also says "The obtained ECG records can help users to analyze and diagnose heart disease." This indicates the device is used for diagnostic purposes.
No
The device description explicitly states it consists of an "acquisition box" which is a hardware component used to acquire ECG signals. It also mentions optional hardware accessories like lead wires and electrodes.
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 Digital Electrocardiograph acquires ECG signals directly from the patient's body surface using electrodes. It does not analyze samples taken from the body.
- Intended Use: The intended use is to acquire ECG signals to help users analyze and diagnose heart disease. This 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 and pediatric 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 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)
Non-Clinical Test Conclusion: This submission is filed for extension of intended use, the device, including its hardware and software, has not been changed from the one cleared in the previous submission, K133985; therefore, only the following standard was tested to verify that the device can meet its additional intended use: IEC 60601-2-25: 2011, Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs.
Clinical Test Conclusion: No clinical study is included in this submission.
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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with a flowing design element below them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2015
Shenzhen Biocare Bio-medical Equipment Co., Ltd. % Diana Hong General Manager Mid-link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CHINA
Re: K152384
Trade/Device Name: Digital Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: November 6, 2015 Received: November 9, 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, 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 of medical device
1
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 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,
Mitchell Stein
forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152384
Device Name Digital Electrocardiograph, ECG-2000
Indications for Use (Describe)
Digital Electrocardiograph is 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 Electrocardiograph shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Tab #7 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number:
-
- Date of Preparation: 08/04/2016
-
- Sponsor Identification
Shenzhen Biocare Bio-Medical Equipment Co., Ltd. Room A735, Floor 7, Tower A, Shenzhen Famous Industrial Products 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
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (Alternative Contact Person)
- Designated Submission Correspondent
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
4
4. Identification of Proposed Device
Trade 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:
Digital Electrocardiograph is 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 Electrocardiograph shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
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.
ર . Identification of Predicate Device(s)
Predicate Device 1 510(k) Number: K092010 Product Name: PC ECG Manufacturer: Edan Instruments, Inc.
5
Predicate device 2 510(k) Number: K133985 Product Name: Digital Electrocardiograph, ECG-2000 Manufacturer: Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
-
- Non-Clinical Test Conclusion
This submission is filed for extension of intended use, the device, including its hardware and software, has not been changed from the one cleared in the previous submission, K133985; therefore, only the following standard was tested to verify that the device can meet its additional intended use:
- Non-Clinical Test Conclusion
IEC 60601-2-25: 2011, Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
-
Substantially Equivalent (SE) Comparison 8.
| Item | Proposed Device | Predicate
Device1 | 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
disease. Digital Electrocardiograph
shall be used in healthcare facilities
by doctors and/or trained healthcare
professionals. | Same | Similar |
| 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 |
Table 1 Comparison of Technology Characteristics
6
| Input circuit current | $\leq$ 0.1 μA | Similar | Same |
|---|---|---|---|
| Noise level | $ |