(195 days)
Not Found
No
The summary describes standard ECG signal acquisition and analysis without mentioning AI/ML techniques or providing details about training/test sets typically associated with such technologies.
Yes
The device is intended to acquire ECG signals to help users analyze and diagnose heart disease, which is a therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section states that the device can "help users to analyze and diagnose heart disease." This explicitly indicates a diagnostic purpose.
No
The device description explicitly states it consists of hardware modules (power supply, amplification, control) and includes components like an LCD and thermal printer, indicating it is a physical device, not software-only.
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 "acquire[s] ECG signals from adult and pediatric patients through body surface ECG electrodes." This involves placing electrodes on the patient's skin to measure electrical activity of the heart.
- No Sample Analysis: There is no mention of analyzing samples taken from the body (like blood or urine). The device directly interacts with the patient's body surface.
Therefore, the Digital Electrocardiographs described here are considered medical devices, but not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
Digital Electrocardiographs, IE3/ 1E12/ IE12P/ IE15, arc 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, IE3/ IE12/ IE12/ IE15, are designed to acquire, analyze, display and record ECG signals from patient body surface by ECG electrodes. After been amplified, filtered and analyzed, the ECG signals waveforms and analysis results are displayed in the LCD and recorded in the paper through thermal printer. ECG data, analysis result and patient information could be stored in the memory of the device. The device consists of three modules, which are power supply module, amplification module, and control module. The device has three recording mode, AUTO mode, MAN mode and RHY mode, They are standard twelve leads, including bipolar limb leads, augmented unipolar limb leads and unipolar chest leads.
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/or trained healthcare professionals in 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 (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 60601-1:1990+ A1:1993+ A11:1993+ A12:1993+ A13:1996, Medical electrical equipment, Part 1: General requirements for safety. IEC 60601-2-25:1993+A1:1999. Medical electrical equipment, Part 2-25: Particular requirements for the safety of electrocardiographs. 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 teats.
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
K131262
.
P 1/5
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: K131262
l . Date of Submission: Apr 22, 2013
- Sponsor Identification
SonoScape Co., Ltd Yizhe Building, Yuquan Road, Shenzhen, 518051. China
Establishment Registration Number: 3004705634
Contact Person: Toki Wu Position: Regulatory Affairs Manager Tel: +86- 755-26722890 Fax: +86-755-26722850 Email: wusq@sonoscape.net
- Submission Correspondent
Ms. Diana Hong & Mr. Tarzan Wang 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
NOV 1 4 2013
1
K 131262 p 2/5
Proposed Device Identification
Proposed Device Trade Name: Digital Electrocardiograph; Proposed Device Common Name: Electrocardiograph; Proposed Device Model: 1E3/ 1E6/ 1E12/ 1E12P/ 1E15
Regulatory Information: Classification Name: Electrocardiograph; Classification: II; Product Code: DPS: Regulation Number: 21CFR 870.2340; Review Panel: Cardiovascular:
Intended Use Statement:
Digital Electrocardiographs, IE3/ 1E12/ IE12P/ IE15, arc 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.
- Predicate Device Identification
510(k) Number: K122712 Product Name: Digital Electrocardiographs Product Model: iE 3S, iE 6S, iE 12 and iE 12P Manufacturer: Shenzhen Biocare Electronics Co., Ltd
510(k) Number: K123816 Product Name: Digital Electrocardiographs Product Model: iE 15S Manufacturer: Shenzhen Biocare Electronics Co., Ltd
Device Description ર .
Digital Electrocardiographs, IE3/ IE12/ IE12/ IE15, are designed to acquire, analyze, display and record ECG signals from patient body surface by ECG electrodes. After been amplified, filtered and analyzed, the ECG signals waveforms and analysis results are displayed in the LCD and recorded in the paper through thermal printer. ECG data, analysis result and patient information could be stored in the memory of the device.
2
| K131262 | Additional Information I | E3 510k Summary |
|---|---|---|
| K131262 | |
|---|---|
| P 3/5 |
The device consists of three modules, which are power supply module, amplification module, and control module.
The device has three recording mode, AUTO mode, MAN mode and RHY mode,
They are standard twelve leads, including bipolar limb leads, augmented unipolar limb leads and unipolar chest leads.
-
- Non-Clinical Test Conclusion
ព
- 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:
IEC 60601-1:1990+ A1:1993+ A11:1993+ A12:1993+ A13:1996, Medical electrical equipment, Part 1: General requirements for safety.
IEC 60601-2-25:1993+A1:1999. Medical electrical equipment, Part 2-25: Particular requirements for the safety of electrocardiographs.
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 teats.
-
- Substantially Equivalent (SE) Conclusion
The following table compares the Digital Electrocardiographs to the predicate devices with respect to intended use and technological characteristics, etc.
- Substantially Equivalent (SE) Conclusion
3
K 131262
P 4/5
| ITEM | Proposed Device | Predicate Device
K122712 | Predicate Device
K123816 |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-----------------------------|
| Model | IE3/IE6/IE12/IE12P/IE15 | iE 3S/iE 6S/iE 12/iE 12P | iE 15S |
| Product Code | DPS | Same | Same |
| Regulation
Number | 21CFR 870.2340 | Same | Same |
| Intended Use | Digital Electrocardiographs, IE3/IE6/IE12/IE12P/IE15, 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. | Similar | Similar |
| Main Unit Specification | | | |
| Lead | Standard 12-lead | Same | Same |
| Acquisition mode | Simultaneous 12-lead acquisition | Same | Same |
| Recording format | Automatic / Manual / Rhythm | Same | Same |
| Analysis mode | No | No | No |
| CMRR | >60dB
100 with AC filter | Same | Same |
| Paper Speed | 4 levels as 6.25, 12.5, 25, 50mm/s, OR
6 levels as: 5, 6.25, 10, 12.5, 25 and 50mm/s | Same | Same |
| Input CIR current | 50MΩ | Same | Same |
| Patient leak current | K131262 P 5/5
:
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white and appears to be a scan of a printed document.
November 14, 2013
Sonoscape Company Limited c/o Ms. Diana Hong General Manager P.o. Box 120-119 Shanghai, 237-023 CH
Re: K131262
Trade/Device Name: Digital Electrocardiographs Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: II (two) Product Code: DPS Dated: September 28, 2013 Received: October 15, 2013
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.
6
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 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, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
K131262
Indications for Use
510(k) Number: K131262 Device Name: Digital Electrocardiograph
Indications for Use:
Digital Electrocardiographs, IE3/ IE12/ IE12P/ IE15, 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.
�PRESCRIPTION USE (Part 21 CFR 801 Subpart D)
OR
OOVER-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) | |
|---|---|
| Digitally signed by Owen P. Faris -S | |
| Date: 2013.11.14 10:26:47 -05'00' | |
| Page | 1 |
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