(28 days)
No
The summary describes a standard digital electrocardiograph with signal processing and analysis features, but there is no mention of AI or ML technologies being used for the analysis or any other function. The analysis feature is described as providing "measurements and interpretive statements" on an "advisory basis only," which is typical for traditional ECG analysis algorithms.
No
The device is an electrocardiograph, which acquires ECG signals to help analyze and diagnose heart disease. It displays and records waveforms but does not provide any treatment or therapy. The analysis feature is advisory only.
Yes.
The device acquires ECG signals and provides an analysis feature with interpretive statements to help users "analyze and diagnose heart disease," indicating its role in diagnosis.
No
The device description explicitly states it consists of hardware modules (power supply, signal collection, amplification, control) and acquires signals via electrodes, indicating it is a physical device with integrated software, not software-only.
Based on the provided text, 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 described device, an electrocardiograph, acquires electrical 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 and help users analyze and diagnose heart disease based on these signals. This is a direct measurement of physiological activity, not an analysis of a biological sample.
Therefore, the device falls under the category of medical devices that measure physiological parameters directly from the patient, rather than in vitro diagnostics.
N/A
Intended Use / Indications for Use
The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. The proposed device has analysis feature, however the ECC with measurements and interpretive statements is offered to clinician on an advisory basis only.
Product codes
DPS
Device Description
The proposed digital electrocardiograph, iE 101 and iE 300, are designed based on the cleared digital electrocardiographs K141946 (iE 3). The proposed device has same intended use, functional modules design, working modes, analysis function and accessories. the proposed devices are different than the predicate device in that they has new printing channel for iE 101); new layout of user-machine interface; three different physical specification, such as screen size, device dimension, device weight; three different specification, such as battery capacity, noise level and CMRR; and a modified software which is modified to applicable to the proposed devices.
The proposed electrocardiographs, iE 101 and iE 300, follow the same design principle, main components, accessories and software; they acquire ECG electrical signals from patient body surface by ECG electrodes. After been amplified, filtered and transferred, the ECG signal waveforms are displayed on the LCD and recorded on the paper through thermal printer.
They consist of four modules, which are power supply module, signal collection module, amplification module, and control module.
They can acquire ECG signal via twelve leads simultaneously, display or print waveform of ECG signal via one channel (iE 101) or three channel (iE 300).
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
doctors and trained healthcare professionals, hospitals or healthcare facilities
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
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 + A 1: 2012, Medical electrical equipment, Part 1: General requirements for safety.
- IEC 60601-1-2: 2007, Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.
- A IEC 60601-2-25:2011, Medical electrical equipment, Part 2-25: Particular requirements for the safety of electrocardiographs.
No clinical study is included in this submission.
Key Metrics
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
Public Health Service
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2016
Shenzhen Biocare Bio-medical Equipment Co., Ltd. Ms. Diana Hong General Manager P.O. Box 120-119 Shanghai, 200120 CN
Re: K160092
Trade/Device Name: Digital Electrocardiograph, iE101 and iE300 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: December 29, 2015 Received: January 15, 2016
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 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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,
Mitchell Stein
for Bram 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) K160092
Device Name Digital Electrocardiograph, iE101 and iE300
Indications for Use (Describe)
The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. The proposed device has analysis feature, however the ECC with measurements and interpretive statements is offered to clinician on an advisory basis only.
| 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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K160092
Page 1 of 4
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: K160092
-
- Date of Preparation: 01/21/2016
-
- Sponsor Identification
Shenzhen Biocare Bio-Medical Equipment Co.,Ltd
#A735, Shenzhen Mingyou Industrial Product Exhibition & Procurement Center, Bao'an, Shenzhen, Guangdong, 518102, China
Establishment Registration Number: 3008457078
Contact Person: Mr. Hongbo Zhong Position: R&D Director Tel: +86-755-36615333 Fax: +86-755-27960643 Email: hb-zhong@tom.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (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
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Page 2 of 4
Identification of Proposed Device 4.
Trade Name: Digital Electrocardiograph; Common Name: Electrocardiograph Models: iE 101 and iE300
Regulatory Information Classification Name: Electrocardiograph; Classification: II: Product Code: DPS; Regulation Number: 21 CFR 870.2340; Review Panel: Cardiovascular;
Intended Use Statement:
The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. The proposed device has analysis feature, however the ECG with measurements and interpretive statements is offered to clinician on an advisorv basis only.
Device Description
The proposed digital electrocardiograph, iE 101 and iE 300, are designed based on the cleared digital electrocardiographs K141946 (iE 3). The proposed device has same intended use, functional modules design, working modes, analysis function and accessories. the proposed devices are different than the predicate device in that they has new printing channel for iE 101); new layout of user-machine interface; three different physical specification, such as screen size, device dimension, device weight; three different specification, such as battery capacity, noise level and CMRR; and a modified software which is modified to applicable to the proposed devices.
The proposed electrocardiographs, iE 101 and iE 300, follow the same design principle, main components, accessories and software; they acquire ECG electrical signals from patient body surface by ECG electrodes. After been amplified, filtered and transferred, the ECG signal waveforms are displayed on the LCD and recorded on the paper through thermal printer.
They consist of four modules, which are power supply module, signal collection module, amplification
5
K160092 Page 3 of 4
module, and control module.
They can acquire ECG signal via twelve leads simultaneously, display or print waveform of ECG signal via one channel (iE 101) or three channel (iE 300).
-
న్. Identification of Predicate Device
510(k) Number: K141946 Product Name: Digital Electrocardiograph Model: iE 3 -
- 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 + A 1: 2012, Medical electrical equipment, Part 1: General requirements for safety.
-
IEC 60601-1-2: 2007, Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.
-
A IEC 60601-2-25:2011, Medical electrical equipment, Part 2-25: Particular requirements for the safety of electrocardiographs.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
6
K160092 Page 4 of 4
8. Substantially Equivalent (SE) Comparison
| Item | Proposed Devices | Predicate Device
K141946 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Model | iE 101/ iE 300 | iE 3 |
| Product Code | DPS | DPS |
| Regulation Number | 870.2340 | 870.2340 |
| Intended Use | The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. The proposed device has analysis feature, however the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only. | SAME |
| Intended Population | Adult and pediatric patients | SAME |
| Intended Environment | Hospital, clinics | SAME |
| Configuration | ECG main unit
Chest electrodes and Limb electrode | SAME |
| Lead | Standard 12-lead | SAME |
| Acquisition mode | Simultaneous 12-lead acquisition | SAME |
| Recording format | Automatic / Manual / Rhythm | SAME |
| Analysis mode | Yes | SAME |
| Screen size | 5.0" (iE 101)
5.0" (iE 300) | 6.0" |
| Channel | 1 channel (iE 101)
3 channel (iE 101) | 3 channel |
| Biocompatibility | Comply with ISO 10993 | SAME |
| Electrical Safety | Comply with IEC 60601-1 | SAME |
| EMC | Comply with IEC 60601-1-2 | SAME |
| Particular requirements | Comply with IEC 60601-2-25 | SAME |
Table 1 Comparison of Technology Characteristics
-
- Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.
- Substantially Equivalent (SE) Conclusion