Who is the manufacturer of AI-ECG Platform?

Shenzhen Carewell Electronics., Ltd. filed the 510(k) submission for AI-ECG Platform (K180432).

What is the FDA product code for AI-ECG Platform?

DQK. It is classified under 21 CFR 870.1425 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for AI-ECG Platform?

510(k) clearance (submission type: Traditional).

Does AI-ECG Platform use AI or machine learning?

Yes. AI-ECG Platform (K180432) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for AI-ECG Platform?

Electrocardiograph (K113485); Datrix CardioServer ECG Management System (K052883).

Who can help prepare an FDA 510(k) submission like AI-ECG Platform?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like AI-ECG Platform get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

AI-ECG Platform

K180432 · Shenzhen Carewell Electronics., Ltd. · DQK · Nov 19, 2018 · Cardiovascular

Device Facts

Record ID	K180432
Device Name	AI-ECG Platform
Applicant	Shenzhen Carewell Electronics., Ltd.
Product Code	DQK · Cardiovascular
Decision Date	Nov 19, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1425
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

The AI-ECG Platform is designed to assist physicians in measuring and interpreting 12-lead resting ECG, and the interpretation by the analysis program may then be confirmed, edited, or deleted by the physician. The program is intended for use by qualified healthcare professionals in hospitals and other healthcare facilities for the assessment of common cardiac abnormalities, including arrhythmias, myocardial infarction, ventricular hypertrophy, and abnormal ST-T changes. The AI-ECG Platform interpretation results are not intended to be the sole means of diagnosis for any abnormal ECG. They are offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG. The AI-ECG Platform is qualified for use in the general adult population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities. The AI-ECG Platform is used with compatible resting ECG devices which can export ECG recordings in Carewell ECG, HL7 aECG, DICOM ECG, SCP ECG, or MFER ECG data format. The AI-ECG Platform is not to be used for: patient monitoring, on ECG signals collected using non-standard leads, ECG signals not collected using electrodes with conductive paste/gel/fluid.

Device Story

Software-based distributed ECG auto-analysis system; assists physicians in measuring/interpreting 12-lead resting ECGs. Inputs: ECG waveform data from compatible devices or manual user upload (formats: Carewell, HL7 aECG, DICOM, SCP, MFER). Processing: AI-based algorithm analyzes data on a computer server; generates automated measurements and interpretations. Output: ECG data, measurements, and interpretation statements downloaded to a PC-based client application for physician review, editing, confirmation, and report printing. Used in hospitals/healthcare facilities by qualified professionals. Benefits: provides advisory diagnostic support for arrhythmias, myocardial infarction, ventricular hypertrophy, and ST-T changes; improves clinical workflow efficiency. Original waveform data stored securely on server.

Clinical Evidence

Bench testing only. Compliance verified against AAMI/ANSI EC57:2012 (cardiac rhythm and ST-segment measurement algorithms) and IEC 60601-2-25:2011 (safety of electrocardiographs). Software lifecycle validated per IEC 62304:2015 and risk management per ISO 14971:2007.

Technological Characteristics

Software-based ECG analysis system; operates on Windows OS (XP/7/8/10, Server 2008/2012). Connectivity: local wired/wireless network, USB. Standards: IEC 60601-2-25, AAMI/ANSI EC57, IEC 62304, ISO 14971. Algorithm: Carewell ECG measurement algorithm combined with AI algorithm for automated interpretation. Software class: Major level of concern.

Indications for Use

Indicated for adult patients, ranging from healthy to those with cardiac or non-cardiac abnormalities, to assist physicians in measuring and interpreting 12-lead resting ECGs. Not for patient monitoring, non-standard leads, or signals collected without conductive paste/gel/fluid.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

Electrocardiograph (K113485)
Datrix CardioServer ECG Management System (K052883)

Related Devices

K200036 — AI-ECG Tracker · Shenzhen Carewell Electronics Co., Ltd. · Mar 20, 2020
K141963 — 12SL ECG ANALYSIS PROGRAM · Ge Medical Systems Information Technologies, Inc. · Feb 5, 2015
K052883 — CARDIOSERVER · Datrix · Nov 1, 2005
K092369 — 12SL ECG ANALYSIS PROGRAM · Ge Medical Systems Information Technologies · Feb 24, 2010
K993616 — CARDIO-CARD INTERPRETATION SYSTEM I · Nasiff Assoc., Inc. · Apr 10, 2000

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 19, 2018 Shenzhen Carewell Electronics., Ltd % Arthur Goddard President FDA Regulatory and Quality Systems Consultant 31853 Cedar Road Mayfield Heights, Ohio 44124-4445 Re: K180432 Trade/Device Name: AI-ECG Platform Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, DPS Dated: September 27, 2018 Received: October 3, 2018 Dear Arthur Goddard: 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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Arielle Drummond -S 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) K180432 Device Name AI-ECG Platform ### Indications for Use (Describe) The AI-ECG Platform is designed to assist physicians in measuring and interpreting 12-lead resting ECG, and the interpretation by the analysis program may then be confirmed, edited by the physician. The program is intended for use by qualified healthcare professionals and other healthcare facilities for the assessment of common cardiac abnormalities, including arthythmias, myocardial infarction, ventricular hypertrophy, and abnormal ST-T changes. The AI-ECG Platform interpretation results are not intended to be the sole means of diagnosis for any abnormal ECG. They are offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG. The AI-ECG Platform is qualified for use in the general adult population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities. The AI-ECG Platform is used with compatible resting ECG devices which can export ECG recordings in Carewell ECG, HL7 aECG, DICOM ECG, SCP ECG, or MFER ECG data format. The AI-ECG Platform is not to be used for: patient monitoring, on ECG signals collected using non-standard leads, ECG signals not collected using electrodes with conductive paste/gel/fluid. 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) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for Carewell Health Care. The logo features a circular graphic on the left, composed of multiple pink horizontal lines. To the right of the graphic is the company name, "carewell," in a bold, dark blue font. Below "carewell" is the text "health care" in a smaller, lighter font, also in blue. ## Section 5: 510(K) Summary This summary of 510(K) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1900 and 21 CFR 807.92. ### The assigned 510(K) Number: K180432 ### 5. 510(K) Summary #### Date of Preparation: Feb., 12th, 2018 5.1. #### 5.2. Sponsor Shenzhen Carewell Electronics Co., Ltd. Floor 4, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District 518055, Shenzhen, P.R. China Establishment Registration Number: 3010089768 Contact Person: Chang Liu Position: General Manager Tel: +86-755-86170389 Fax: +86-755-86170478 Email: standard@carewell.com.cn ### Submission Correspondent 5.3. Mr. Arthur Goddard 31853 Cedar Road, Ohio, 44124-4445, U.S.A. Tel: (216) 233-5722 Email: asjgoddard@aol.com ### 5.4. Subject Device Identification Subject Device Name: AI-ECG Platform Edition: S Edition Common name: ECG Analysis Software Classification Name(s): Programmable Diagnostic Computer / Electrocardiograph Product Code: DQK, DPS Regulation Number: 21 CFR 870.1425 Review Panel: Cardiovascular Classification: II ### 5.5. Predicate Devices 510(k) Number: K113485 (Secondary) Device Name: Electrocardiograph {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for Carewell Health Care. The logo consists of a circular graphic on the left, made up of several pink horizontal lines. To the right of the graphic is the company name, "carewell", in a dark blue, sans-serif font. Below the company name are the words "health care" in a smaller, lighter font. Shenzhen Carewell Electronics Co., Ltd. Manufacturer: Shenzhen Carewell Electronics Co., Ltd. 510(k) Number: K052883 (Primary) Device Name: Datrix CardioServer ECG Management System Manufacturer: Datrix, Inc ### 5.6. Indications for use: The AI-ECG Platform is designed to assist physicians in measuring and interpreting 12-lead resting ECG, and the interpretation by the analysis program may then be confirmed, edited, or deleted by the physician. The program is intended for use by qualified healthcare professionals in hospitals and other healthcare facilities for the assessment of common cardiac abnormalities, including arrhythmias, myocardial infarction, ventricular hypertrophy, and abnormal ST-T changes. The AI-ECG Platform interpretation results are not intended to be the sole means of diagnosis for any abnormal ECG. They are offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG. The AI-ECG Platform is qualified for use in the general adult population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities. The AI-ECG Platform is used with compatible resting ECG devices which can export ECG recordings in Carewell ECG, HL7 aECG, DICOM ECG, SCP ECG, or MFER ECG data format. The AI-ECG Platform is not to be used for: patient monitoring, on ECG signals collected using nonstandard leads, ECG signals not collected using electrodes with conductive paste/gel/fluid. ### 5.7. Device Description The AI-ECG Platform (S Edition) is a software package which is a distributed ECG auto analysis system designed to assist physician in measuring and interpreting 12-lead resting ECG with AI algorithm, the interpretation by the analysis program may then be confirmed, edited, or deleted by the physician. The program is intended for use by qualified healthcare professionals in hospitals and other healthcare facilities for the assessment of common cardiac abnormalities, including arrhythmias, myocardial infarction, ventricular hypertrophy, and abnormal ST-T changes. The AI-ECG Platform interpretation results are not intended to be the sole means of diagnosis for any abnormal ECG. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG. The Carewell AI-ECG Platform is intended to be used in conjunction with Carewell ECG device or compatible ECG can export Carewell proprietary ECG data, HL7 aECG, DICOM ECG, SCP ECG, or MFER ECG data format. The AI-ECG Platform is not to be used for: patient monitoring, on ECG signals collected using non-standard leads, ECG signals not collected using electrodes with conductive paste/gel/fluid. The program receives ECG waveform data direct from device or user {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for Carewell Health Care. The logo consists of a circular design on the left, made up of several horizontal lines. To the right of the design is the word "carewell" in a dark blue, sans-serif font. Below "carewell" are the words "health care" in a smaller, lighter font. Shenzhen Carewell Electronics Co., Ltd. manually uploaded, analyzes ECG data and automatically interprets on the computer server, the ECG measurement, interpretation and waveform data are then downloaded to a PC based physician's diagnosis client application to allow physician review, modify and confirm the analysis statements, and print the report. The original ECG waveform data is stored permanently in the server computer securely. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Carewell health care. The logo consists of a pink and white abstract image on the left, followed by the word "carewell" in blue. Below "carewell" is the phrase "health care" in a smaller, gray font. Below the logo is the text "Shenzhen Carewell Electronics Co., Ltd." ### 5.8. Predicate Devices and Subject Device Comparison | Item | Subject Device | Secondary Predicate | Primary Predicate | Remark | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | | K180432 AI-ECG Platform | K113485 Electrocardiograph | K052883 Datrix CardioServer ECG Management System | | | Product Code | DQK, DPS | DPS | DQK | Discussion 1 | | Regulation Number | 21 CFR 870.1425 | 21 CFR 870.2340 | 21 CFR 870.1425 | | | Regulation Description | Programmable diagnostic computer | Electrocardiograph | Programmable diagnostic computer | | | Discussion 1: | Predicate device Electrocardiograph, K113485 has ECG measuring functions and Datrix CardioServer ECG Management System, K052883 has ECG measuring and diagnostic functions. The subject AI-ECG Platform is a software package with automatically ECG measuring and diagnostic functions. The product codes of subject device can be covered by predicate devices K113485 and K052883. | | | | | Classification | II | II | II | Same | | Indications for use | The AI-ECG Platform is designed to assist physicians in measuring and interpreting 12-lead resting ECG, and the interpretation by the analysis program may then be confirmed, edited, or deleted by the physician. The program is intended for use by qualified healthcare professionals in hospitals and other healthcare facilities for the assessment of common cardiac abnormalities, including arrhythmias. | Electrocardiographs, ECG- 1101G(I), ECG-1103G(I), ECG- 1103LW(I), ECG-1106L, ECG- 1112 and ECG-1112D, are intended to acquire ECG signals from adult patients through body surface ECG electrodes. It could complete the ECG measurements of QRS detection, Heart Rate, ventricular ectopic beat (VEB), supraventricular ectopic beat | The CardioServer ECG Management System software is intended to be marketed to medical professionals and for point-of-care use. The software is designed to provide a database used through out the medical community to store, display, edit and print high resolution ECG data received from devices such as electrocardiographs. The CardioServer ECG Management System software allows medical | Discussion 2 | | Item | Subject Device | Secondary Predicate | Primary Predicate | Remark | | | K180432 AI-ECG Platform | K113485 Electrocardiograph | K052883 Datrix CardioServer ECG Management System | | | | myocardial infarction, ventricular hyptrophy, and abnormal ST-T changes. The AI-ECG Platform interpretation results are not intended to be the sole means of diagnosis for any abnormal ECG. They are offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG. The AI-ECG Platform is qualified for use in the general adult population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities. The AI-ECG Platform is used with compatible resting ECG devices which can export ECG recordings in Carewell ECG, HL7 aECG, DICOM ECG, SCP ECG, or MFER ECG data format. The AI-ECG Platform is not to be used for: patient monitoring, on ECG signals collected using non-standard leads, ECG signals not collected using electrodes with conductive paste/gel/fluid. | (SVEB) and ST Segment Deviation. ECG with measurements is offered to clinician on an advisory basis only. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals. | professionals responsible for the diagnosis and treatment of patients (adult and pediatric) with heart disease to: review and edit specific patient ECG data including intervals such as QT measurements and algorithm generated preliminary interpretative statements. ECG records are all associated by patient ID and other demographic data. Secure access to the database is provided. | | | Item | Subject Device | Secondary Predicate | Primary Predicate | Remark | | | K180432 AI-ECG Platform | K113485 Electrocardiograph | K052883 Datrix CardioServer ECG Management System | | | Discussion 2: | The subject device has smaller intended patient population scope, similar measuring functions, similar diagnostic functions scope and smaller supported ECG types scope. Others in the IFU are all the same. Therefore, the noted difference in indications for use does not raise any new issues of safety or effectiveness. It could be considered as substantially equivalent to that of the predicate devices. | | | | | Algorithm | Carewell ECG Measurement Algorithm + Carewell ECG AI algorithm | Carewell ECG Measurement Algorithm | Glasgow ECG analysis for 12 lead ECG | Discussion 3 | | Discussion 3: | The subject device AI-ECG Platform and the predicate device Electrocardiograph, K113485 are both produced by Shenzhen Carewell Electronics Co., Ltd. The measurement algorithm in the predicate device is also used in the subject device. AI algorithm is also used in junction with the previous algorithm. New algorithm is added into use to realize automatically interpreting ECGs and produce interpretation statement for the physician to reference. Though the subject device and predicate device K052883 use different algorithm, they are both intended to realize substantially equivalent intended use. It could be considered as substantially equivalent to that of the predicate device. | | | | | Level of Concern of the software | Major | Moderate | Not specified in 510 (K) summary | Discussion 4 | | Discussion 4: | The subject device K180432 AI-ECG Platform can provide diagnostic information about myocardial infarction (MI). The diagnostic information the software provided may result in a delayed response of appropriate medical care that would lead to serious injury or death. The Level of Concern of the software is Major. Predicate device K113485 doesn't provide diagnostic information and the software LoC is moderate. Though the level of concern of predicate device K052883 is not specified in 510 (K) summary, the predicate device K052883 can provide substantial equivalent diagnostic statement. The LoC of subject device K180432 is Major which is the highest level. So the software development is controlled as the strictest level. It could be considered as substantially equivalent to that of the predicate device. | | | | | Fundamental scientific | The AI-ECG Platform performs the following functions: | -- | CardioServer ECG Management System can realize the following | Discussion 5 | | Item | Subject Device | Secondary Predicate | Primary Predicate | Remark | | | K180432 AI-ECG Platform | K113485 Electrocardiograph | K052883 Datrix CardioServer ECG Management System | | | technology | * Receive EGGs via local wired and/or wireless network, USBs, and other standard transmission methods; * Store, archive, and display EGGs; * Export EGGs in industry standard formats to electronic health records; * Print EGGs; * Utilize Windows standards; * Secure access to patient health information; * Log patient health information; * Provide clinical access to EGG data across the users local network; * Provide automatically measurements and interpretations of ECGs * Allow user editing of ECG interpretation; * Provide tools for user to manually measure EGGs; * Generate ECG reports Operating System requirement: Windows XP/7/8/10 32bit/64bit Operating System, Windows Server 2008/2012, Internet Information | functions: | functions: * Receive EGGs via wireless LAN, LAN, USB2, and other standard transmission modes; * Store, archive, and display EGGs; * Export EGGs in industry standard formats to electronic health records; * Print EGGs; * Utilize Windows standards; * Provide secure access to patient health information; * Log all interaction with patient health information; * Provide clinical access to EGG data across the users network; * Utilize the University of Glasgow EGG Algorithm for data interpretation; * Allow user editing of ECG interpretation; * Provide EGG measurements; * Gontain calipers for user edit of EGG measurements; * Generate management reports Hardware requirements: are Windows | | | Item | Subject Device | Secondary Predicate | Primary Predicate | Remark | | | K180432 AI-ECG Platform | K113485 Electrocardiograph | K052883 Datrix CardioServer ECG Management System | | | | Server 7/8, Microsoft Sql Server 2008 The four subsystems have different hardware requirements including processor, memory (RAM), Hard drive size, Nvidia GPU (optional) , screen resolution, printer etc. | | 2000 or 2003 Server operating system; Pentium IV, 2GHz (minimum); 512 MB RAM (minimum); 10/1 00 Ethernet (minimum); RAID 5 storage; 1024x768 monitor; and standard back- up technology. | | | Discussion 5: | | | | | ### Table 3-1 Feature Comparison with Predicate Devices {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Shenzhen Carewell Electronics Co., Ltd. The logo includes a graphic of pink horizontal lines on the left. To the right of the graphic is the company name "carewell" in a dark blue font, with the words "health care" in a smaller, light gray font underneath. The full company name, "Shenzhen Carewell Electronics Co., Ltd.", is printed in black below the logo. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Carewell health care. The logo consists of a pink circular design on the left and the word "carewell" in blue on the right. Below "carewell" is the phrase "health care" in a smaller, gray font. Underneath the logo is the text "Shenzhen Carewell Electronics Co., Ltd." {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Carewell health care. The logo consists of a pink circular design on the left and the word "carewell" in dark blue on the right. Below "carewell" is the phrase "health care" in light gray. Below the logo is the text "Shenzhen Carewell Electronics Co., Ltd." {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Carewell. The logo consists of a pink circular design to the left of the word "carewell" in a dark blue font. Below "carewell" are the words "health care" in a light gray font. Below the logo is the text "Shenzhen Carewell Electronics Co., Ltd." The subject device AI-ECG Platform and the KI5283 can realize similar functions including receiving, storing, interpreting, exporting and printing ECG reports. They both have a user's interface for viewing, and interpreting ECG data, algorithms and APIs (Application Programming Interface) to access to the algorithms. They both have similar requirements for the operating system and hardware. The subject device is installed on the user's hardware and work or access through a local network. All the data processing and transmitting are in a secured local network environment. Both the devices use secured access technology. The subject device AI-ECG Platform therefore does not present any major technological innovations compared to predicate device. | Item | Subject Device K180432 AI-ECG Platform | Secondary Predicate K113485 Electrocardiograph | Primary Predicate K052883 Datrix CardioServer ECG Management System | Remark | |----------------------------------------------|-------------------------------------------|---------------------------------------------------|---------------------------------------------------------------------------|--------| | Basic safety and essential performance | Comply with IEC 60601-2-25 | Comply with IEC 60601-2-25 | -- | Same | | Measurement performance | Comply with AAMI/ANSI EC57. | Comply with AAMI/ANSI EC57. | -- | Same | | Table 3-2 Performance Comparison | | |----------------------------------|--| |----------------------------------|--| {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the Carewell Health Care logo. The logo consists of a circular graphic on the left and the text "carewell health care" on the right. The word "carewell" is in a larger, bold, dark blue font, while "health care" is in a smaller, lighter gray font and is positioned below "carewell." ### 5.9. Non-Clinical Test Conclusion Bench test were conducted to verify that the subject device met all design specifications, as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards. AAMI ANSI EC57:2012 Testing And Reporting Performance Results Of Cardiac Rhythm And ST-Segment Measurement Algorithms IEC 60601-2-25:2011, Medical Electrical Equipment -- Part 2-25: Particular requirements for the safety of electrocardiographs; IEC 62304:2015, Medical device software - Software life-cycle ISO 14971: 2007, Medical devices-Application of risk management to medical device ### 5.10. Substantially Equivalent Conclusion The subject device, AI-ECG Platform, is determined to be Substantially Equivalent (SE) to the predicate device, Electrocardiograph, K113485 and Datrix CardioServer ECG Management System, K052883.