The KardiaMobile System is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The KardiaMobile System also displays ECG rhythms and output of ECG analysis from AliveCor's KardiaAl platform including detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, and others. The KardiaMobile System is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals. The device has not been tested and is not intended for pediatric use.

Device Description

The KardiaMobile System is a trans-telephonic (transmission by telephone) ECG (electrocardiogram) event recorder that records, stores and transfers single-channel electrocardiogram rhythms. The device utilizes the computing power of Apple iOS- and Google Android-based smartphones to obtain and analyze single-channel ECG. These smartphones are termed Mobile Computing Platforms (MCPs). The device consists of the hardware (that has the electrodes), and the Kardia phone app (installed on an MCP). The same software is implemented in the iOS and Android MCP. In either configuration, the same hardware is used to sense the ECG. The KardiaMobile Hardware transmits the ECG signal from the electrode to the Kardia phone app on the MCP to be analyzed and presented to the user. All ECGs are synced with the user's account.

AI/ML Overview

The provided text describes the acceptance criteria and the study conducted for the KardiaMobile System, primarily focusing on proving that the device meets special controls for Electrocardiograph Software for Over-the-Counter Use, especially after the removal of a "clinician overread" function.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a direct table of numerical "acceptance criteria" (e.g., minimum sensitivity/specificity percentages) and corresponding "reported device performance" values for the AI algorithm suite (KardiaAI SaMD). Instead, it states that the performance characteristics (sensitivity and specificity) were "tested to meet the system requirements" against ANSI/AAMI EC57:2012 databases and AliveCor's proprietary databases.

However, the "Special Control" table implicitly functions as acceptance criteria for different aspects of the device's performance and the "Summary of Conformance" column indicates the reported performance/compliance.

Acceptance Criteria (Implicit from Special Controls) and Reported Device Performance (Summary of Conformance):

Acceptance Criteria (Special Control)	Reported Device Performance (Summary of Conformance)
1. Clinical performance testing under anticipated conditions of use must demonstrate: (a) The ability to obtain an ECG of sufficient quality for display and analysis; and	The KardiaMobile device has demonstrated its ability to obtain ECGs of sufficient quality for display and analysis through both bench and clinical performance testing. (Long history of real-world use and real-world use data supports that representative users can record ECG of equivalent quality to 12-lead ECG).
(b) The performance characteristics of the detection algorithm as reported by sensitivity and either specificity or positive predictive value.	The KardiaMobile System leverages the KardiaAI SaMD (K181823) for ECG analysis. KardiaAI algorithm suite ECG detection algorithm outputs of Atrial Fibrillation, Normal, Bradycardia, Tachycardia, and Noise as well as the heart rate calculations were tested to meet the system requirements for sensitivity and specificity. Testing was conducted to ANSI/AAMI EC57:2012 databases and AliveCor's proprietary databases.
2. Software verification, validation, and hazard analysis must be performed. Documentation must include a characterization of the technical specifications of the software, including the detection algorithm and its inputs and outputs.	Software documentation for the KardiaMobile software was prepared and provided in accordance with FDA's Guidance titled, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2015). (Further specifically stated that software V&V was done per FDA's "General Principles of Software Validation," Jan 11, 2002.)
3. Non-clinical performance testing must validate detection algorithm performance using a previously adjudicated data set.	KardiaAI algorithm suite ECG detection algorithm outputs of Atrial Fibrillation, Normal, Bradycardia, Tachycardia, and Noise as well as the heart rate calculations were tested to meet the system requirements for sensitivity and specificity. Testing was conducted to ANSI/AAMI EC57:2012 databases and AliveCor's proprietary databases. These validation datasets are representative of the patient population of the proposed device.
4. Human factors and usability testing must demonstrate the following: (a) The user can correctly use the device based solely on reading the device labeling; and (b) The user can correctly interpret the device output and understand when to seek medical care.	Human factors evaluation was performed in accordance with recommendations in IEC62366-1:2015 and FDA's Guidance Document; Applying Human Factors and Usability Engineering to Medical Devices. The study found that the user can correctly use the device solely based on on-screen guidance and the users understand the device output. The study also found that users understand when to seek care regardless of the output of the device. (Specifically tested addressing the removal of "unlock overread" function).
Labeling must include specific information (hardware/OS requirements, performance limitations, clinical performance summary, device measures/outputs, guidance on interpretation).	Provided within applicable sections of the KardiaMobile Instructions for Use and User Manual documents and within on-screen instructions to the user within the software.

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

Sample Size for Algorithmic Performance (KardiaAI SaMD): The document states that the KardiaAI SaMD (K181823), leveraged by the KardiaMobile System for ECG analysis, was validated using "ANSI/AAMI EC57:2012 databases and AliveCor's proprietary databases." It also notes that these "validation datasets are representative of the patient population of the proposed device."
- Specific sample sizes are NOT provided for these databases.
- Data Provenance: Not explicitly stated regarding country of origin. The use of "ANSI/AAMI EC57:2012 databases" suggests a standardized, likely diverse, source, while "AliveCor's proprietary databases" could be from various global or specific regions. The document does not specify if the data was retrospective or prospective for the algorithmic validation, but typically such databases are compiled retrospectively.
Sample Size for Human Factors and Usability Testing: Not explicitly stated, but it refers to "representative users."

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

For Algorithmic Performance (KardiaAI SaMD): The document states that the detection algorithm performance was validated using a "previously adjudicated data set" (Special Control 3) and mentions that for the primary predicate, the "overread unlock" mechanism involved review by a "board-certified cardiologist." However, it does not explicitly state the number or specific qualifications (e.g., years of experience) of experts used to establish the ground truth for the test sets used for the KardiaAI algorithm validation. Adjudicated data implies expert review, but details are absent.

4. Adjudication Method for the Test Set

For Algorithmic Performance (KardiaAI SaMD): The document mentions "previously adjudicated data set." No specific adjudication method (e.g., 2+1, 3+1) is detailed.

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

No MRMC comparative effectiveness study, comparing human readers with AI vs. without AI assistance, is mentioned. The focus of the changes and testing described is on the device's standalone performance and human factors/usability for over-the-counter use after removing the "overread" requirement.

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

Yes. The document explicitly states: "The KardiaMobile System leverages the KardiaAI SaMD (K181823) for ECG analysis. KardiaAI algorithm suite ECG detection algorithm outputs of Atrial Fibrillation, Normal, Bradycardia, Tachycardia, and Noise as well as the heart rate calculations were tested to meet the system requirements for sensitivity and specificity." This indicates that the core AI algorithm's performance was evaluated independently (without human-in-the-loop for its direct analytical output).

7. The Type of Ground Truth Used

For Algorithmic Performance (KardiaAI SaMD): "Previously adjudicated data set." This typically implies expert consensus (e.g., cardiologists reviewing ECGs). It does not mention pathology or outcomes data as the ground truth directly for the AI algorithm's performance.

8. The Sample Size for the Training Set

Not specified. The document focuses on the validation/test sets (ANSI/AAMI EC57:2012 and AliveCor's proprietary databases) for the KardiaAI algorithm. Information regarding the training set's size is not provided.

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

Not specified. As the training set size itself is not mentioned, neither is the method for establishing its ground truth.

Summary

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January 24, 2020

AliveCor, Inc. Saket Bhatt Senior Manager, Regulatory Affairs 444 Castro Street. Suite 600 Mountain View, California 94041

Re: K191406

Trade/Device Name: KardiaMobile, KardiaStation Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone electrocardiograph transmitter and receiver Regulatory Class: Class II Product Code: DXH, DPS, QDA Dated: December 20, 2019 Received: December 23, 2019

Dear Saket Bhatt:

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Hetal Patel Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191406

Device Name KardiaMobile System

Indications for Use (Describe)

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 K191406

GENERAL INFORMATION [807.92(a)(1)]

Applicant:

AliveCor, Inc. 444 Castro Street, Suite 600 Mountain View, CA 94041 Phone: 650-396-8553 Fax: 650-282-7932

Contact Person:

Saket Bhatt Vice President, Regulatory Affairs AliveCor, Inc. 444 Castro Street, Suite 600 Mountain View, CA 94041 Phone: 650-396-8553 Email: RA@alivecor.com

Date Prepared: January 22, 2020

DEVICE INFORMATION [807.92(a)(2)]

Trade/Proprietary Name: KardiaMobile System

Generic/Common Name:

Telephone electrocardiograph transmitter and receiver

Classification:

21 CFR §870.2920, Telephone electrocardiograph transmitter and receiver, Class II

Product Code: DXH, DPS, QDA

Establishment Registration: 3009715978

PREDICATE DEVICE(S) [807.92(a)(3)]

K182396 - AliveCor KardiaMobile System (Primary predicate) DEN180044 - Apple Inc. ECG App (Secondary predicate)

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DEVICE DESCRIPTION [807.92(a)(4)]

INDICATIONS FOR USE [807.92(a)(5)]

Indications for Use:

The KardiaMobile System is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The KardiaMobile System also displays ECG rhythms and output of ECG analysis from AliveCor's KardiaAI platform including detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, and others. The KardiaMobile System is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals. The device has not been tested and is not intended for pediatric use.

Type of Use:

Over-The-Counter Use (21 CFR 801 Subpart C)

Comparison with Predicate Devices:

The proposed device and both predicate devices have the same intended use of recording, displaying, analyzing, storing, and transferring single-lead ECG rhythms in an ambulatory setting. As such, the proposed device and its predicates are substantially equivalent with respect to intended use.

The proposed device and primary predicate device have similar Indications for Use which fall within the scope of the same intended use. The Indications for Use between the proposed device and primary predicate device (K182396) are highly similar and vary solely with respect to removal of the requirement for use under supervision of a clinician. The proposed device and secondary predicate device's (DEN180044) Indications for Use statements describe the same range of functionality with respect to ECG recording, display, and analysis; and neither device includes an unlock mechanism for access to any functionality or requires use "under the care of the physician," as is the case with the primary predicate device.

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510(K) SUMMARY (CONT.)

The KardiaMobile System has undergone evaluation in accordance to the Special Controls associated with 21CFR§ 870.2345, Electrocardiograph Software for Over-the-Counter Use. Specifically, human factors usability testing was conducted, where lay users have demonstrated the ability to both correctly use the device and understand the output of the device as designed when relying on only labeling. The evidence with the study results demonstrates that the removal of overread function brings the OTC use of the proposed device to be consistent with the secondary predicate device.

TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED WITH THE PREDICATE DEVICE [807.92(a)(6)]

The proposed KardiaMobile System device is highly similar to the primary predicate device with respect to technological characteristics, in terms of principle of operation, technological and performance characteristics (mechanism of action, environmental specifications, dimensional specifications, ergonomics of patient-user interface, packaging, sterilization and shelf life), materials, software and anatomical site. No modifications were made to the device hardware or to the Kardia app software's clinical functionalities with respect to ECG acquisition, display, and analysis as a result of this change.

The minor change which prompted this 510(k) is a change in the first-use onboarding procedure when the device is used in an OTC setting for new patients. While the predicate KardiaMobile System device required ECG review by a professional (i.e., "unlock overread") prior to a consumer patient gaining access to first-time ECG data analysis, the proposed KardiaMobile System device does not require the unlock overread. This onboarding step, without unlock overread, for the proposed KardiaMobile System device is similar to the secondary predicate device, the Apple Inc. ECG App (DEN180044), with respect to the lack of any unlocking requirements prior to access of ECG display and recording functions, therefore prompting its inclusion as a secondary predicate device. Specifically:

. With respect to the OTC Use Model, the primary predicate device's OTC use requires clinician overread, whereas the proposed device does not. in order to reduce the patient's burden of onboarding prior to use of the device and to improve AliveCor's operational efficiency. The removal of overread function does not add risk or remove mitigations of risk as compared with the primary predicate device as it only required a single time clinician interpretation of the patient's ECG. after which patients use the predicate device in the same manner as they would the proposed device. This updated OTC use case is further consistent with that of the ECG app secondary predicate device with respect to direct ECG display/analysis access without any "unlock" mechanisms.
. With respect to ECG recording and display, the ECG recording procedure of the proposed device is identical to that of the predicate devices, in which the user initiates contact with the electrodes of the device's hardware (the identical KardiaMobile hardware in the case of the proposed and primary predicate device, and consumer Apple Watch hardware in the case of the secondary predicate device), upon which ECG signal is recorded and processed by software. In all three (3) devices, the ECG recording is processed and displayed regardless of the ECG analysis outcomes, which allows the ECG signal to be evaluated independently by a trained physician (e.g., via sending an e-mailed PDF report). There are minor differences between the proposed and predicate devices with respect to the specific method of ECG display. In both the proposed and secondary

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predicate devices, the ECG reading is displayed to the user via the associated software after the recording is complete. In the primary predicate device, the recording is similarly displayed for the user after recording completion under normal use, but for first-time use, the ECG recording is withheld from the user upon completion until the ECG signal recorded is reviewed by a board-certified cardiologist under the "overread unlock" mechanism.

With respect to ECG analysis, after acquisition and initial processing of ECG signals, the ● proposed device and both predicate devices also include algorithms for filtering and analysis of ECG signals for arrhythmia. Specifically, all three (3) devices detect the presence of atrial fibrillation and Normal Sinus Rhythm. The proposed and primary predicate devices also detect the presence of two additional arrythmia conditions bradycardia and tachycardia – which are within the shared intended use of the proposed and both predicate devices. All three (3) devices further provide outputs for nondeterminative cases, i.e., in which the quality of the ECG may not enable the algorithmic determination, or in cases where the ECG may exhibit an arrhythmia other than those detectable by the algorithm. As such, the ECG algorithm outputs are similar between the proposed and predicate devices.
The removal of the unlock overread function does not introduce new risks or significantly modify existing risks, nor does it remove mitigations of risk as compared with the primary predicate device. The removal of overread function brings the OTC use of the product to be consistent with the secondary predicate device. Through human factors usability testing, it is demonstrated that users can use the device correctly solely based on labeling, and that the device labeling provides sufficient information to allow users to appropriately interpret the device output with respect to understanding the analysis output as well as when to seek medical attention.

Therefore, the proposed device and the predicate device share key technological characteristics, especially in reference to those associated with the key clinical functionalities of ECG recording, display, and analysis.

PERFORMANCE DATA [807.92(b)]

Performance testing of the proposed device was conducted in compliance to the special controls associated with Electrocardiograph Software for Over-the-Counter Use (Product Code: ODA), as demonstrated further within the table below. A further discussion of the testing conducted specifically to support the removal of "unlock overread" follows this Special Controls table.

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Special Control	Summary of Conformance
1. Clinical performance testing under anticipatedconditions of use must demonstrate the following:(a) The ability to obtain an ECG of sufficientquality for display and analysis; and	The KardiaMobile device has demonstrated its ability toobtain ECGs of sufficient quality for display and analysisthrough both bench and clinical performance testing.
(b) The performance characteristics of thedetection algorithm as reported bysensitivity and either specificity or positivepredictive value.	The KardiaMobile System leverages the KardiaAI SaMD(K181823) for ECG analysis. KardiaAI is validated in adataset representative of the patient population of theproposed device. KardiaAI algorithm suite ECG detectionalgorithm outputs of Atrial Fibrillation, Normal,Bradycardia, Tachycardia, and Noise as well as the heartrate calculations were tested to meet the systemrequirements for sensitivity and specificity. Testing wasconducted to ANSI/AAMI EC57:2012 databases andAliveCor's proprietary databases.
2. Software verification, validation, and hazardanalysis must be performed.Documentation must include a characterization ofthe technical specifications of the software,including the detection algorithm and its inputsand outputs.	Software documentation for the KardiaMobile software wasprepared and provided in accordance with FDA's Guidancetitled, Guidance for the Content of Premarket Submissionsfor Software Contained in Medical Devices (May 11, 2015).
3. Non-clinical performance testing must validatedetection algorithm performance using apreviously adjudicated data set	KardiaAI algorithm suite ECG detection algorithm outputsof Atrial Fibrillation, Normal, Bradycardia, Tachycardia,and Noise as well as the heart rate calculations were testedto meet the system requirements for sensitivity andspecificity. Testing was conducted to ANSI/AAMIEC57:2012 databases and AliveCor's proprietary databases.These validation datasets are representative of the patientpopulation of the proposed device.
4. Human factors and usability testing mustdemonstrate the following:(a) The user can correctly use the device basedsolely on reading the device labeling; and	Human factors evaluation was performed in accordancewith recommendations in IEC62366-1:2015 and FDA'sGuidance Document; Applying Human Factors andUsability Engineering to Medical Devices:
(b) The user can correctly interpret the deviceoutput and understand when to seek medicalcare.	With respect to ECG acquisition, the proposed device uses the same hardware as the cleared KardiaMobile device (K182396 and prior clearances), which has a long history of real-world use. This real-world use data supports that representative users can record ECG of equivalent quality to 12-lead ECG. With respect to ECG display and analysis, AliveCor has conducted an additional human factors usability study which specifically evaluated whether users can safely and effectively use the proposed device to view ECG signals and their analysis. The study found that the user can correctly use the device solely based on on-screen guidance and the users understand the device output. The study also found that users understand
Special Control	Summary of Conformance
	when to seek care regardless of the output of the device.
Labeling must include:(a) Hardware platform and operating system requirements(b) Situations in which the device may not operate at an expected performance level(c) A summary of the clinical performance testing conducted with the device;	Provided within applicable sections of the KardiaMobile Instructions for Use and User Manual documents.
(d) A description of what the device measures and outputs to the user; and(e) Guidance on interpretation of any results.	Provided within on-screen instructions to the user within the software, as well as applicable sections of the KardiaMobile Instructions for Use and User Manual documents.

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Specifically to support the removal of "unlock overread," AliveCor has conducted software verification and validation testing in accordance to FDA's guidance titled, General Principles of Software Validation (January 11, 2002), which demonstrated that the minor software revisions to enable the change in the onboarding procedure is successfully implemented within the Kardia app. In addition, human factors usability testing was conducted to additionally confirm that representative users can use the device safely and effectively without supervision from a healthcare professional, and, furthermore, that the users understand when to seek medical help. This testing was performed in accordance with recommendations in FDA's Guidance Document titled, Applying Human Factors and Usability Engineering to Medical Devices (February 03, 2016), and IEC 62366-1:2015, Medical devices - Part 1: Application of usability engineering to medical devices.

The results of the collective testing demonstrated that the proposed KardiaMobile device is substantially equivalent to the predicate devices.

SUMMARY

AliveCor, Inc. considers the proposed KardiaMobile System device to be substantially equivalent to the legally marketed primary predicate KardiaMobile System (K182396) and the secondary predicate Apple Inc ECG App (DEN180044). Human factors usability testing, performed in agreement with recommendations in relevant FDA guidance documents and compliance standards, demonstrates that the removal of overread function brings the OTC use of the proposed device to be consistent with the secondary predicate device. The proposed KardiaMobile device is substantially equivalent to the predicate devices for its intended use.

Regulation Number and Section

§ 870.2920 Telephone electrocardiograph transmitter and receiver.

(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).