(148 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard ECG signal acquisition and display, not advanced analytical capabilities.
Yes.
The device's intended use is to acquire ECG signals to help analyze and diagnose heart disease, which constitutes a therapeutic purpose.
Yes
The device is described as helping users to "analyze and diagnose heart disease" based on the acquired ECG records.
No
The device description explicitly states it acquires, displays, and records ECG signals through body surface by ECG electrodes and stores data in the device's memory, indicating hardware components beyond just software. The performance studies also reference IEC 60601 standards, which are for medical electrical equipment, further suggesting a hardware component.
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 acquires ECG signals from the body surface through electrodes. This is a non-invasive measurement taken directly from the patient, not a test performed on a sample in vitro (outside the body).
- Intended Use: The intended use is to acquire ECG records to help users analyze and diagnose heart disease. While this is a diagnostic purpose, it's based on physiological signals acquired directly from the patient, not on the analysis of a biological sample.
Therefore, this device falls under the category of a medical device that performs a diagnostic function in vivo (within the living body), rather than an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Digital Electrocardiographs 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.
Product codes (comma separated list FDA assigned to the subject device)
DPS
Device Description
Digital Electrocardiographs, iE 3, iE 6, are intended to acquire, display and record ECG signals from adult and pediatric patients through body surface by ECG electrodes. ECG data result and patient information could be stored in the memory of the device. The obtained ECG records can help users to analyze and diagnose heart disease.
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as vas Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- A IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; . Amendment 1. 1991-11, Amendment 2, 1995:
-
IEC 60601-1-2 Edition 3:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests.
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
JAN 30 2014
Section 10 510(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: K132758
10.1 Date of Submission: 08/30/2013
10.2 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, Bao'an, Shenzhen, Guangdong, 518102, China
Establishment Registration Number: 3008457078
Contact Person: Mr. HongboZhong Position: R&D Director Tel: +86-0755-36615333-8856 Fax: +86-0755-27960643 Email: hb-zhong@tom.com
10.3 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
1
Premarket Notification 510(k) Submission
10.4Proposed Device Identification
Proposed Device Name: Digital Electrocardiograph Models: iE 3.iE 6 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 Electrocardiographs 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.
10.5 Predicate Device Identification
510(k) Number:K 122712
Predicate Device Name: Digital Electrocardiographs, iE12
Manufacturer: Shenzhen Biocare Electronics Co., Ltd
10.6Device Description
Digital Electrocardiographs, iE 3, iE 6, are intended to acquire, display and record ECG signals from adult and pediatric patients through body surface by ECG electrodes. ECG data result and patient information could be stored in the memory of the device. The obtained ECG records can help users to analyze and diagnose heart disease.
10.7 Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as vas Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed 10-2
2
device complies with the following standards:
- A IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; . Amendment 1. 1991-11, Amendment 2, 1995:
-
IEC 60601-1-2 Edition 3:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests.
10.8 Substantially Equivalent (SE) Conclusion
The following table compares the DEVİCE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.
| Item | Proposed Device(s) | Predicate Device |
|---|---|---|
| Model | iE 3 | iE 12 |
| Product Code | DPS | DPS |
| Regulation Number | 870.2340 | 870.2340 |
| Intended Use | Digital Electrocardiographs 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. | Digital Electrocardiographs 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. | ||
| Patient Contact Material | ABS / Tin Alloy | ABS / Tin Alloy |
| Sterile | No | No |
| Single Use | No | No |
| Energy Source | AC Power / DC Power | AC Power / DC Power |
| Safety | IEC 60601-1 / IEC 60601-1-2 | IEC 60601-1 / IEC 60601-1-2 |
| Accessories | Limb Electrode | |
| Chest Electrode | ||
| Battery | Limb Electrode | |
| Chest Electrode | ||
| Battery |
Table 3-1 Comparison of Technology Characteristics between iE 3 and iE 12
10-3
3
Premarket Notification 510(k) Submission
| Item | Proposed Device(s) | Predicate Device |
|---|---|---|
| K122712 | ||
| Model | iE 6 | iE 12 |
| Product Code | DPS | DPS |
| Regulation Number | 870.2340 | 870.2340 |
| Intended Use | Digital Electrocardiographs 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. | Digital Electrocardiographs 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. | ||
| Patient Contact Material | ABS / Tin Alloy | ABS / Tin Alloy |
| Sterile | No | No |
| Single Use | No | No |
| Energy Source | AC Power / DC Power | AC Power / DC Power |
| Safety | IEC 60601-1 / IEC 60601-1-2 | IEC 60601-1 / IEC 60601-1-2 |
| Accessories | Limb Electrode | |
| Chest Electrode | ||
| Battery | Limb Electrode | |
| Chest Electrode | ||
| Battery |
Table 3-2 Comparison of Technology Characteristics between iE 6 and iE 12
10.9 SE Conclusion
.
The proposed devices, Digital Electrocardiographs, iE 3 and iE 6, are determined to be Substantially Equivalent (SE) to the predicate devices, Digital Electrocardiographs, iE 12.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Public Health Service
ood and Drug Administration 903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 30, 2014
Shenzhen Biocare Bio-Medical Equipment Co., Ltd. c/o Mid-Link Consulting Co., Ltd. Diana Hong General Manager P.O. Box 120-119 Shanghai, 200120, China
Re: K132758
Trade/Device Name: Digital electrocardiograph models iE 3 and iE 6 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: December 21, 2013 Received: January 3, 2014
Dear Ms. 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 11 (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 (2) CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-
5
Page 2 - Ms. Diana Hong
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Owen P. Faris -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Premarket Notification 510(k) Submission Section 2 Indications for Use Project #: M0602013
Section 2 Indications for Use
and/or trained healthcare professionals.
.
| 510(k) Number: | |
|---|---|
| Device Name: Digital Electrocardiograph | |
| Indications for Use: iE 3, iE 6 |
Digital Electrocardiographs 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
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| PRESCRIPTION USE | |||||
|---|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | |||||
| OR | |||||
| 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) |
Digi
Owe
Date
15-2
Digitally signed by Owen P. Faris -5 Date: 2014.01.30 1 5:21:59 -05/00/
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