(272 days)
Not Found
Yes
The device description explicitly states that the software package is designed to assist physicians in interpreting ECG with an "AI algorithm".
No
The device assists in diagnosing cardiac abnormalities by interpreting ECG data but does not provide or facilitate treatment. Its function is to provide advisory information to physicians, not to directly treat patients.
Yes
The device aids physicians in interpreting 12-lead resting ECGs to assess for common cardiac abnormalities, including arrhythmias, myocardial infarction, ventricular hypertrophy, and abnormal ST-T changes. Although it's not the sole means of diagnosis and offers advisory interpretation, its primary purpose is to assist in the diagnostic process.
Yes
The device description explicitly states that the AI-ECG Platform is a "software package" and a "distributed ECG auto analysis system." While it interacts with compatible ECG devices for data input, the core functionality and the device being cleared is the software itself.
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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The AI-ECG Platform analyzes ECG waveform data, which is an electrical signal measured from the body's surface. It does not analyze biological samples taken from the body.
- Intended Use: The intended use is to assist physicians in interpreting 12-lead resting ECGs for the assessment of cardiac abnormalities. This is a diagnostic aid based on physiological measurements, not laboratory testing of biological samples.
Therefore, the AI-ECG Platform falls under the category of a medical device that analyzes physiological signals, not an in vitro diagnostic device.
No
The letter does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
DQK, DPS
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Mentions AI algorithm and AI-ECG Platform multiple times.
Input Imaging Modality
ECG signals
Anatomical Site
Not Found
Indicated Patient Age Range
general adult population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities.
Intended User / Care Setting
qualified healthcare professionals in hospitals and other 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)
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, IEC 60601-2-25:2011, IEC 62304:2015, ISO 14971: 2007.
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
§ 870.1425 Programmable diagnostic computer.
(a)
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.(b)
Classification. Class II (performance standards).
0
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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) |
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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
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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
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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.
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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
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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.
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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."
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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."
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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 | |
|---|---|
| ---------------------------------- | -- |
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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.