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 (when prescribed or used under the care of a healthcare professional). 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 documents describe the KardiaMobile System and its substantial equivalence to a predicate device. However, the specific acceptance criteria for the device's performance related to its AI algorithms (atrial fibrillation, normal sinus rhythm, tachycardia, bradycardia, and noise detection) and the detailed study that proves these criteria are met are NOT explicitly detailed within the provided text.

The document states:

"The KardiaMobile System... 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..."
"Available Algorithms: Atrial Fibrillation, Noise Algorithm, Normal Sinus Rhythm, Tachycardia, Bradycardia (implements the same algorithms of the KardiaAI reference device, K181823)"
"All necessary performance testing was conducted on the KardiaMobile System to support a determination of substantial equivalence to the predicate device. This testing included the following: - validation of KardiaAI integration"

While it confirms that "validation of KardiaAI integration" was part of the testing, it does not provide the specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets for each rhythm detection) or the details of the study (sample size, ground truth establishment, expert qualifications, etc.) for the AI algorithms themselves.

Therefore, for aspects related to the performance of the AI algorithms, the requested information cannot be fully extracted from the provided text. The document focuses more on the substantial equivalence of the overall system (hardware and software integration) to a predicate device, rather than a detailed performance study for the AI algorithms against specific statistical targets.

However, based on the information provided for the overall system's substantial equivalence:

1. Table of acceptance criteria and the reported device performance:

The document does not provide a table with specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy percentages) for the rhythm detection algorithms. Instead, the acceptance is based on the system demonstrating substantial equivalence to the predicate device (AliveCor Heart Monitor K142672) and the reference device's (KardiaAI K181823) algorithms, and meeting established specifications through nonclinical testing.

Reported Device Performance (General):

Validation of KardiaAI integration: Performed.
Verification of the device's specification: Performed.
Testing to software level of concern requirements: Performed.
Compliance with standards: ISO 10993-1:2009, IEC 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-11:2015, IEC 60601-2-47:2012.
Conclusion: "The collective results of the performance testing demonstrate that the KardiaMobile System meets the established specifications and complies with the aforementioned standards." and "The evaluation and testing results showed that differences between the subject and predicate device do not raise different questions of safety or effectiveness."

The following information applies to the overall system's validation and substantial equivalence as described, but not specifically to the detailed performance of the AI algorithms against quantifiable targets, which is not provided in the text.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the provided documents. The text mentions "validation of KardiaAI integration" and "verification of the device's specification" but does not detail the size of the dataset used for these tests.
Data Provenance: Not specified. It is not mentioned if the data was retrospective or prospective, or the country of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified in the provided documents. The text does not detail the process of establishing ground truth for any test sets related to the AI algorithms.

4. Adjudication method for the test set:

Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

A multi-reader multi-case (MRMC) comparative effectiveness study focusing on human readers improving with AI assistance is not described in the provided documents. The submission focuses on the substantial equivalence of the device, including its AI algorithms, rather than a comparative effectiveness study with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The document implies that the algorithms were evaluated independently as part of the "KardiaAI integration validation" and reference to "KardiaAI K181823". However, the specific details of such a standalone study (e.g., metrics, test set, ground truth) are not provided for the algorithms themselves. The overall device is described as having "output of ECG analysis from AliveCor's KardiaAI platform," suggesting that the algorithms perform analysis independently before being displayed to the user.

7. The type of ground truth used:

Not specified in the provided documents.

8. The sample size for the training set:

Not specified in the provided documents.

9. How the ground truth for the training set was established:

Not specified in the provided documents.

Summary

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Indications for Use

510(k) Number (if known)

Device Name KardiaMobile System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below the words "U.S. FOOD & DRUG".

April 12, 2019

AliveCor, Inc. % Prabhu Raghavan Vice President of Regulatory and Quality 444 Castro Street. Suite 600 Mountain View, California 94041

Re: K182396

Trade/Device Name: KardiaMobile System Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter And Receiver Regulatory Class: Class II Product Code: DXH, DPS Dated: March 12, 2019 Received: March 13, 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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,

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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510(k) Notification K182396

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

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: April 09, 2019

DEVICE INFORMATION [807.92(a)(2)]

Trade Name:

KardiaMobile System

Generic/Common Name:

Telephone electrocardiograph transmitter and receiver

Classification:

21 CFR8870.2920, Transmitters and Receivers, Electrocardiograph, Telephone, Class II

Product Code:

DXH, DPS

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

K142672 - AliveCor Heart Monitor (predicate device, currently marketed as "KardiaMobile") K181823 - AliveCor KardiaAI (reference device)

DEVICE DESCRIPTION [807.92(a)(4)]

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

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 (when prescribed or used under the care of a healthcare professional). 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.

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

	KardiaMobile SystemK182396(subject device)	AliveCor Heart MonitorK142672(predicate device)	KardiaAIK181823(reference device)
Feature
Product Code	DXH, DPS	Same	DQK, DPS
Mechanism of Action	User completes circuit withskin contact and hardwaretransmits audio signal toMCP to convert and displayECG waveform	Same	API library analyzes ECGsand provides analysis totarget application.
Where used (intended use)	Mobile/active users at rest(ambulatory)	Same	Same
Anatomical sites	Left hand fingers to righthand fingersLeft leg to right hand fingersOn or below chest	Same	N/A (SaMD)
Available Algorithms	Atrial FibrillationNoise AlgorithmNormal Sinus RhythmTachycardiaBradycardia(implements the samealgorithms of the KardiaAIreference device, K181823)	Atrial Fibrillation	Atrial FibrillationNoise AlgorithmNormal Sinus RhythmTachycardiaBradycardia
Data Acquisition:Frequency Response	0.5Hz – 40Hz	Same	Same
ECG electrodes	Dry electrodes
ECG channels	Single Channel
Resolution	16 bit
Sample Rate	300 Samples/Second
Number of ECG Leads	Single lead, 2 electrodes	Same	Single lead
Power Supply:BatteryBattery Life (typical)	1 Lithium ManganeseDioxide Coin Cells100 hours operational	Same	N/A (SaMD)
User Interface:Primary Lead	Lead I, Left to Right	Same	Application ProgramInterface (API)
Data acquisition	Ultrasonic acoustics	Same
Hardware	Two-electrode sensor	Same
Software interface	Apple iOS-based or GoogleAndroid-based software	Same
Physical Specs:Dimensions	82 x 32 x 4mm	82 x 32 x 3.5mm	N/A (SaMD)
Weight	15 grams	15 grams
Prescribed:	Prescription and OTC	Same	Prescription and OTC
Communications	Ultrasonic Acousticsacquired by phone	Same	N/A (SaMD)

SUBSTANTIAL EQUIVALENCE

The KardiaMobile System subject device has the same intended use and similar technological characteristics as the AliveCor Heart Monitor predicate device. The differences in technological

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510(k) SUMMARY

characteristics have been analyzed and addressed through performance testing. The evaluation and testing results showed that differences between the subject and predicate device do not raise different questions of safety or effectiveness.

PERFORMANCE DATA [807.92(b)]

All necessary performance testing was conducted on the KardiaMobile System to support a determination of substantial equivalence to the predicate device.

[807.92(b)(1)] Nonclinical Testing Summary:

All necessary performance testing was conducted on the KardiaMobile System to support a determination of substantial equivalence to the predicate device. This testing included the following:

validation of KardiaAI integration
verification of the device's specification -
testing to software level of concern requirements
evaluation to the following standards: -
- ISO 10993-1:2009 (CORR 2010), Biological Evaluation of Medical Devices - O Part 1: Evaluation and Testing Within a Risk Management Process
- IEC 60601-1:2012, Medical Electrical Equipment Part 1: General Requirements o For Basic Safety And Essential Performance,
- IEC 60601-1-2:2007, Medical Electrical Equipment Part 1-2: General о Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests,
- IEC 60601-1-11:2015, Medical electrical equipment -- Part 1-11: General о requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, and
- IEC 60601-2-47:2012, Medical Electrical Equipment -- Part 2-47: Particular O Requirements For The Basic Safety And Essential Performance Of Ambulatory Electrocardiographic Systems.

The collective results of the performance testing demonstrate that the KardiaMobile System meets the established specifications and complies with the aforementioned standards.

SUMMARY

The KardiaMobile System subject device has the same intended use and similar technological characteristics as the AliveCor Heart Monitor predicate device. The differences in technological characteristics have been analyzed and addressed through performance testing. The evaluation and testing results showed that differences between the subject and predicate device do not raise different questions of safety or effectiveness. The KardiaMobile System is substantially equivalent to the predicate device.

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).