KardiaAI

{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. March 11, 2019 AliveCor, Inc. Prabhu Raghavan Vice President of Regulatory and Quality 444 Castro Street, Suite 600 Mountain View. California 94041 Re: K181823 Trade/Device Name: KardiaAI Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK, DPS Dated: February 8, 2019 Received: February 11, 2019 Dear Prabhu Raghavan: 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. Although this letter refers to your product as a device, please be aware 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ 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 medical devices and radiation-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, Jessica E. Paulsen -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) K181823 Device Name KardiaAI Indications for Use (Describe) The KardiaAI is a software analysis library intended to assess ambulatory electrocardiogram (ECG) rhythms from adult subjects. The device supports analyzing data recorded in compatible formats from any ambulatory ECG devices such as event recorders, or other similar devices. The library is intended to be integrated into other device software. The library is not intended for use in life supporting, or sustaining systems, or cardiac alarm, or OTC use only devices. The KardiaAI library provides the following capabilities: - · ECG noise filtering. - · heart rate measurement from ECGs, - · detection of noisy ECGs, and · ECG rhythm analysis for detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia (when prescribed or used under the care of a physician). Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) X 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}------------------------------------------------ ## 510(k) Notification K181823 ## GENERAL INFORMATION [807.92(a)(1)] #### Applicant: AliveCor, Inc. 444 Castro Street, Suite 600 Mountain View, CA 94041 USA Phone: 650-396-8553 Fax: 650-282-7932 ## Applicant Contact Person: Prabhu Raghavan Vice President of Regulatory and Quality AliveCor, Inc. 444 Castro Street, Suite 600 Mountain View, CA 94041 USA Phone: 650-396-8553 Fax: 650-282-7932 Email: prabhu@alivecor.com ## Assisted by: Anna Libman Regulatory Consultant to AliveCor, Inc. Consultant, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA Date Prepared: March 06, 2019 ## DEVICE INFORMATION [807.92(a)(2)] ### Trade Name: KardiaAI ## Generic/Common Name: Programmable diagnostic computer ### Classification: 21 CFR§870.1425, Programmable diagnostic computer, Class II ## Product Code: DQK, DPS {4}------------------------------------------------ ## PREDICATE DEVICE(S) [807.92(a)(3)] - . Primary predicate: AliveCor, Inc., Kardia Band System, K171816 - Secondary predicate: CardioLogs Technologies, CardioLogs ECG Analysis . Platform, K170568 ## DEVICE DESCRIPTION [807.92(a)(4)] KardiaAI is a software library that implements various ECG processing and analysis algorithms. This Software as a Medical Device (SaMD) computes various physiologic parameters from a 30-second ECG and provides these capabilities in the form of an Application Program Interface (API) library. ECG devices can incorporate the API library into ECG device ("target device") software to enable algorithmic analysis of ECGs to provide analytical capabilities. The device provides ECG noise filtering and detection of noisy ECGs as well as identifies normal sinus rhythm, atrial fibrillation, bradycardia, and tachycardia. ## INDICATIONS FOR USE [807.92(a)(5)] KardiaAI is a software analysis library intended to assess ambulatory electrocardiogram (ECG) rhythms from adult subjects. The device supports analyzing data recorded in compatible formats from any ambulatory ECG devices such as event recorders, or other similar devices. The library is intended to be integrated into other device software. The library is not intended for use in life supporting, or sustaining systems, or ECG monitors, or cardiac alarm, or OTC use only devices. The KardiaAI provides the following capabilities: - ECG noise filtering, - heart rate measurement from ECGs, - detection of noisy ECGs, and - ECG rhythm analysis for detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, and tachycardia (when prescribed or used under the care of a physician). ## SUBSTANTIAL EQUIVALENCE KardiaAI has the same intended use as the predicate devices for the purpose of analyzing ambulatory ECG recordings. All three devices analyze ECGs for non-active patient monitoring or non-urgent clinical decision making. KardiaAI and the predicate devices all condition and analyze ECG signals from ambulatory Lead I ECG devices and provide data for display on the ECG target devices. KardiaAI shares the atrial fibrillation (AF), normal sinus rhythm (NSR), and noise algorithm with the Kardia Band System predicate device and contains the additional classifiers for bradycardia and tachycardia. Further, like the CardioLogs predicate device, KardiaAI is a SaMD with API for connecting with ECG devices and sending algorithm output for display. As such, the device has the same intended use as the predicate devices and similar technological characteristics. Differences between the subject device and the predicates have been tested to ensure that the device meets its intended use. Therefore, KardiaAI is substantially equivalent to the predicate devices. {5}------------------------------------------------ | Feature | AliveCor KardiaAI | AliveCor Kardia Band System<br>(K171816) | CardioLogs Technologies CardioLogs ECG<br>Analysis Platform<br>(K170568) | |---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | DQK, Computer, Diagnostic, Programmable<br>DPS, Electrocardiograph | DPS, Electrocardiograph<br>DXH, Transmitters And Receivers,<br>Electrocardiograph, Telephone | DQK, Computer, Diagnostic, Programmable<br>DPS, Electrocardiograph | | Regulation | 870.1425, Programmable diagnostic computer | 870.2920, Telephone electrocardiograph<br>transmitter and receiver | 870.1425, Programmable diagnostic computer | | Indications for use | KardiaAI is a software analysis library intended<br>to assess ambulatory electrocardiogram (ECG)<br>rhythms from adult subjects.<br>The device supports analyzing data recorded in<br>compatible formats from any ambulatory ECG<br>devices such as event recorders, or other similar<br>devices. The library is intended to be integrated<br>into other device software.<br>The library is not intended for use in life<br>supporting, or sustaining systems, or ECG<br>monitors, or cardiac alarm, or OTC use only<br>devices.<br>KardiaAI provides the following capabilities:<br>• ECG noise filtering,<br>• heart rate measurement from ECGs,<br>• detection of noisy ECGs, and<br>• ECG rhythm analysis for detecting the<br>presence of normal sinus rhythm, atrial<br>fibrillation, bradycardia, and tachycardia | The Kardia Band System is intended to<br>record, store and transfer single-channel<br>electrocardiogram (ECG) rhythms.<br>The Kardia Band System also displays ECG<br>rhythms and detects the presence of atrial<br>fibrillation and normal sinus rhythm (when<br>prescribed or used under the care of a<br>physician).<br>The Kardia Band System is intended for use<br>by healthcare professionals, adult patients<br>with known or suspected heart conditions<br>and health conscious individuals. | The CardioLogs ECG Analysis Platform is intended for<br>use by qualified healthcare professionals for the<br>assessment of arrhythmias using ECG data in subjects<br>over 18 years of age.<br>The product supports downloading and analyzing data<br>recorded in compatible formats from any device used<br>for the arrhythmia diagnostics such as Holter, event<br>recorder, 12 lead ambulatory ECG devices, or other<br>similar devices when assessment of the rhythm is<br>necessary. The CardioLogs ECG Analysis Platform can<br>also be electronically interfaced and perform analysis<br>with data transferred from other computer based ECG<br>systems, such as an ECG management system.<br>The CardioLogs ECG Analysis Platform provides ECG<br>signal processing and analysis, QRS and Ventricular<br>Ectopic Beat detection, QRS feature extraction,<br>interval measurement, heart rate measurement, and<br>rhythm analysis. | | Feature | AliveCor KardiaAI | AliveCor Kardia Band System<br>(K171816) | CardioLogs Technologies CardioLogs ECG<br>Analysis Platform<br>(K170568) | | | (when prescribed or used under the care of a<br>physician). | | The CardioLogs ECG Analysis Platform is not for use<br>in life supporting or sustaining systems or ECG<br>monitor and Alarm devices. | | | | | The product can be integrated into computerized ECG<br>monitoring devices. In this case, the medical device<br>manufacturer will identify the indication for use<br>depending on the application of their device. | | | | | CardioLogs ECG Analysis Platform interpretation<br>results are not intended to be the sole means of<br>diagnosis. It is offered to physicians and clinicians on<br>an advisory basis only in conjunction with the<br>physician's knowledge of ECG patterns, patient<br>background, clinical history, symptoms, and other<br>diagnostic information. | | Target population | Adults (over 18) | Adults (over 18) | Adults (over 18) | | Components | Software only | Software and ECG recording device | Software only | # Comparison of Technological Characteristics with the Predicate Devices {6}------------------------------------------------ {7}------------------------------------------------ | Feature | AliveCor KardiaAI | AliveCor Kardia Band System<br>(K171816) | CardioLogs Technologies CardioLogs ECG<br>Analysis Platform<br>(K170568) | |------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Software Functional<br>Comparisons | - An interface that provides tools to process and<br>analyze ECGs through various algorithms<br>- The automated proprietary ECG algorithms<br>provide supportive information for ECG<br>diagnosis. The library can be accessed by<br>directly connecting to the KardiaAI's<br>Application Programming Interface | - Kardia watch app software used to<br>analyze and display ECG signals<br>received from the Kardia Band hardware<br>- Kardia phone app used to create Kardia<br>account, onboard users, store, re-display<br>and transfer ECGs received from the<br>Kardia watch app | - An interface which provides tools to measure,<br>analyze and review numerous ECGs coded in java<br>language under the Angular and D3.js frameworks;<br>- An automated proprietary ECG interpretation<br>support algorithm which measures and analyzes<br>ECGs to provide supportive information for ECG<br>diagnosis,<br>This application can be accessed through an Internet<br>connection and a web browser, or is directly connected<br>to the CardioLogs' Application Programming Interface<br>(API) | {8}------------------------------------------------ ## PERFORMANCE DATA [807.92(b)] All necessary testing was conducted on the KardiaAI to support a determination of substantial equivalence to the predicate device. ## Nonclinical Testing Summary [807.92(b)(1)] Non-clinical testing was conducted to assess algorithm performance and to verify that KardiaAI performs as intended. Algorithm performance testing was assessed using ECG databases from the ANSI/AAMI EC57:2012 standard as well as AliveCor proprietary databases. The overlapping algorithms between KardiaAI and the Kardia Band System met the same performance acceptance criteria. The results of the testing demonstrate that KardiaAI performs to its specifications and meets its intended use, which is substantially equivalent to that of the predicate devices. ## CONCLUSIONS [807.92(b)(3)] The results of nonclinical testing demonstrate that the KardiaAI meets its intended use which is equivalent to that of the predicate devices. The overlapping AF, NSR, and noise algorithms for KardiaAI and Kardia Band System met the same performance criteria. Testing also ensured that differences in technological characteristics between the KardiaAI and the Kardia Band System (primary predicate) (i.e., bradycardia and tachycardia algorithms as well as multilead ambulatory ECG input) perform as intended and do not raise different questions of safety or effectiveness.