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).

Device Description

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.

AI/ML Overview

The KardiaAI device, a software analysis library for assessing ambulatory ECG rhythms, underwent non-clinical testing to demonstrate its performance and substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text states that "The overlapping AF, NSR, and noise algorithms for KardiaAI and Kardia Band System met the same performance criteria." It also mentions that "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."

However, specific numerical acceptance criteria (e.g., sensitivity, specificity thresholds for AF, NSR, bradycardia, tachycardia, or noise detection) and the corresponding reported device performance values are not explicitly detailed in the provided document. The document primarily describes that acceptance criteria were met and that the device performs as intended, rather than listing the criteria themselves with quantitative results.

2. Sample Size Used for the Test Set and Data Provenance

The document states that "Algorithm performance testing was assessed using ECG databases from the ANSI/AAMI EC57:2012 standard as well as AliveCor proprietary databases."

Sample Size: The specific sample sizes (number of ECGs or patients) from the ANSI/AAMI EC57:2012 standard databases and the AliveCor proprietary databases used for testing are not explicitly stated.
Data Provenance:
- ANSI/AAMI EC57:2012 standard databases: These are standardized databases, typically containing diverse ECG recordings established for performance evaluation of ECG devices. The country of origin is not specified but these are internationally recognized standards.
- AliveCor proprietary databases: The country of origin is not explicitly stated, nor is whether the data is retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state the number of experts used to establish the ground truth for the test set or their specific qualifications. It implicitly refers to "ECG databases from the ANSI/AAMI EC57:2012 standard" which typically have established ground truths, but the methodology for these specific tests is not detailed.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method used for the test set (e.g., 2+1, 3+1, none).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide an effect size for human readers improving with AI vs. without AI assistance. The testing described is focused on the standalone algorithm performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone study was done. The document explicitly states: "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..." This indicates a focus on the algorithm's performance in isolation.

7. The Type of Ground Truth Used

The ground truth for the test set seems to be derived from expert consensus embedded within the "ECG databases from the ANSI/AAMI EC57:2012 standard" and "AliveCor proprietary databases." While not explicitly stated, standardized ECG databases are typically annotated by cardiologists or other qualified experts, aligning with an expert consensus type of ground truth.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size used for the training set. It only mentions the databases used for testing.

9. How the Ground Truth for the Training Set Was Established

The document does not explicitly state how the ground truth for the training set was established. While it implies the use of "AliveCor proprietary databases," the method for their ground truth annotation (e.g., expert review, pathology, outcomes data) is not detailed.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K181823

Device Name KardiaAI

Indications for Use (Describe)

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)

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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

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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)]

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.

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Feature	AliveCor KardiaAI	AliveCor Kardia Band System(K171816)	CardioLogs Technologies CardioLogs ECGAnalysis Platform(K170568)
Product Code	DQK, Computer, Diagnostic, ProgrammableDPS, Electrocardiograph	DPS, ElectrocardiographDXH, Transmitters And Receivers,Electrocardiograph, Telephone	DQK, Computer, Diagnostic, ProgrammableDPS, Electrocardiograph
Regulation	870.1425, Programmable diagnostic computer	870.2920, Telephone electrocardiographtransmitter and receiver	870.1425, Programmable diagnostic computer
Indications for use	KardiaAI is a software analysis library intendedto assess ambulatory electrocardiogram (ECG)rhythms from adult subjects.The device supports analyzing data recorded incompatible formats from any ambulatory ECGdevices such as event recorders, or other similardevices. The library is intended to be integratedinto other device software.The library is not intended for use in lifesupporting, or sustaining systems, or ECGmonitors, or cardiac alarm, or OTC use onlydevices.KardiaAI provides the following capabilities:• ECG noise filtering,• heart rate measurement from ECGs,• detection of noisy ECGs, and• ECG rhythm analysis for detecting thepresence of normal sinus rhythm, atrialfibrillation, bradycardia, and tachycardia	The Kardia Band System is intended torecord, store and transfer single-channelelectrocardiogram (ECG) rhythms.The Kardia Band System also displays ECGrhythms and detects the presence of atrialfibrillation and normal sinus rhythm (whenprescribed or used under the care of aphysician).The Kardia Band System is intended for useby healthcare professionals, adult patientswith known or suspected heart conditionsand health conscious individuals.	The CardioLogs ECG Analysis Platform is intended foruse by qualified healthcare professionals for theassessment of arrhythmias using ECG data in subjectsover 18 years of age.The product supports downloading and analyzing datarecorded in compatible formats from any device usedfor the arrhythmia diagnostics such as Holter, eventrecorder, 12 lead ambulatory ECG devices, or othersimilar devices when assessment of the rhythm isnecessary. The CardioLogs ECG Analysis Platform canalso be electronically interfaced and perform analysiswith data transferred from other computer based ECGsystems, such as an ECG management system.The CardioLogs ECG Analysis Platform provides ECGsignal processing and analysis, QRS and VentricularEctopic Beat detection, QRS feature extraction,interval measurement, heart rate measurement, andrhythm analysis.
Feature	AliveCor KardiaAI	AliveCor Kardia Band System(K171816)	CardioLogs Technologies CardioLogs ECGAnalysis Platform(K170568)
	(when prescribed or used under the care of aphysician).		The CardioLogs ECG Analysis Platform is not for usein life supporting or sustaining systems or ECGmonitor and Alarm devices.
			The product can be integrated into computerized ECGmonitoring devices. In this case, the medical devicemanufacturer will identify the indication for usedepending on the application of their device.
			CardioLogs ECG Analysis Platform interpretationresults are not intended to be the sole means ofdiagnosis. It is offered to physicians and clinicians onan advisory basis only in conjunction with thephysician's knowledge of ECG patterns, patientbackground, clinical history, symptoms, and otherdiagnostic 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

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Feature	AliveCor KardiaAI	AliveCor Kardia Band System(K171816)	CardioLogs Technologies CardioLogs ECGAnalysis Platform(K170568)
Software FunctionalComparisons	- An interface that provides tools to process andanalyze ECGs through various algorithms- The automated proprietary ECG algorithmsprovide supportive information for ECGdiagnosis. The library can be accessed bydirectly connecting to the KardiaAI'sApplication Programming Interface	- Kardia watch app software used toanalyze and display ECG signalsreceived from the Kardia Band hardware- Kardia phone app used to create Kardiaaccount, onboard users, store, re-displayand transfer ECGs received from theKardia watch app	- An interface which provides tools to measure,analyze and review numerous ECGs coded in javalanguage under the Angular and D3.js frameworks;- An automated proprietary ECG interpretationsupport algorithm which measures and analyzesECGs to provide supportive information for ECGdiagnosis,This application can be accessed through an Internetconnection and a web browser, or is directly connectedto the CardioLogs' Application Programming Interface(API)

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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.

Regulation Number and Section

§ 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).