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.

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.

AI/ML Overview

The provided 510(k) summary for K131262 does not contain information related to a clinical study or performance data against specific acceptance criteria for the device's diagnostic capabilities. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and technical specifications.

Therefore, many of the requested sections regarding acceptance criteria, study details, and performance metrics cannot be directly addressed from the provided document.

Here's a breakdown of what can be extracted and what is missing:

Description of Acceptance Criteria and Device Performance

The submission focuses on establishing substantial equivalence to predicate devices (K122712 and K123816) based on technical specifications and compliance with international standards, rather than defining specific diagnostic acceptance criteria for the device's analytical function.

The non-clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate devices. The test results demonstrated compliance 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 tests.

Table of Acceptance Criteria and Reported Device Performance (Based on Technical Specifications and Compliance to Standards):

Acceptance Criteria (from Predicate/Standard Compliance)	Reported Device Performance (K131262 Device)
Intended Use (Similar to predicates)	Acquires ECG signals, helps users analyze/diagnose heart disease
Lead (Standard 12-lead)	Standard 12-lead
Acquisition mode (Simultaneous 12-lead acquisition)	Simultaneous 12-lead acquisition
Recording format (Automatic / Manual / Rhythm)	Automatic / Manual / Rhythm
Analysis mode (No integrated analysis)	No (similar to predicates)
CMRR (>60dB, >100 with AC filter)	>60dB, >100 with AC filter
Paper Speed (4 or 6 levels)	4 levels (6.25, 12.5, 25, 50mm/s) OR 6 levels (5, 6.25, 10, 12.5, 25, 50mm/s)
Input CIR current (<0.1μA)	<0.1μA
Input impedance (>50MΩ)	>50MΩ
Patient leak current (<10μA)	<10μA
Frequency response (0.05~150Hz)	0.05~150Hz
Noise level (<15μVpp)	<15μVpp
Electrical Safety (Comply with IEC 60601-1)	Comply with IEC 60601-1
EMC (Comply with IEC 60601-1-2)	Comply with IEC 60601-1-2
Particular requirements (Comply with IEC 60601-2-25)	Comply with IEC 60601-2-25
Biocompatibility (Comply with ISO 10993)	Comply with ISO 10993

Missing Information from the Provided Document:

Sample size used for the test set and the data provenance: Not mentioned. The submission relies on non-clinical testing for compliance with standards and technical equivalency, not clinical diagnostic performance data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no diagnostic performance study with specific ground truth from experts is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an electrocardiograph, which acquires and displays ECG signals for human interpretation, it does not include AI for interpretation or an automated analysis mode (as per "Analysis mode: No" in the comparison table).
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device's "Analysis mode" is listed as "No," indicating it does not perform automated algorithmic diagnosis. It is intended for healthcare professionals to analyze and diagnose heart disease from the acquired ECG records.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no diagnostic performance study with ground truth is presented. The "ground truth" here is compliance with established safety and performance standards for an ECG device.
The sample size for the training set: Not applicable, as there is no mention of an algorithm or AI component that would require a training set.
How the ground truth for the training set was established: Not applicable.

Conclusion:

This 510(k) summary is for a traditional Digital Electrocardiograph, which is a signal acquisition and display device, not an AI-powered diagnostic system. Its approval is based on demonstrating substantial equivalence to existing legally marketed devices through compliance with industry standards and shared technical specifications. The document does not include data from a clinical performance study measuring diagnostic accuracy against specific acceptance criteria for disease detection or classification by an algorithm. The device "can help users to analyze and diagnose heart disease," implying the diagnostic responsibility remains with the human healthcare professional.

Summary

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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

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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 .

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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.

1. Non-Clinical Test Conclusion
  ព

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.

1. Substantially Equivalent (SE) Conclusion
  The following table compares the Digital Electrocardiographs to the predicate devices with respect to intended use and technological characteristics, etc.

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K 131262

P 4/5

ITEM	Proposed Device	Predicate DeviceK122712	Predicate DeviceK123816
Model	IE3/IE6/IE12/IE12P/IE15	iE 3S/iE 6S/iE 12/iE 12P	iE 15S
Product Code	DPS	Same	Same
RegulationNumber	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, OR6 levels as: 5, 6.25, 10, 12.5, 25 and 50mm/s	Same	Same
Input CIR current	<0.1μA	Same	Same
Input impedance	>50MΩ	Same	Same
Patient leak current	<10μA	Same	Same
Frequency response	0.05~150Hz	Same	Same
Noise level	<15μVpp	Same	Same
Specification of external input and external output
Electrical Safety	Comply with IEC 60601-1	Same	Same
EMC	Comply with IEC 60601-1-2	Same	Same
Particularrequirements	Comply with IEC 60601-2-25	Same	Same
Biocompatibility	Comply with ISO 10993	Same	Same

Table 3-1 Comparison of Technology Characteristics

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The proposed devices, Digital Electrocardiographs, 1E3/ 1E12P/ 1E15, are determined to be Substantially Equivalent (SE) to the predicate devices, K122712 and K123816, in respect of safety and effectiveness.

K131262 P 5/5

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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.

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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

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K131262

Indications for Use

510(k) Number: K131262 Device Name: Digital Electrocardiograph

Indications for Use:

�PRESCRIPTION USE (Part 21 CFR 801 Subpart D)

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'
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Regulation Number and Section

§ 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).