KardiaMobile 6L is intended to record, store and two-channel electrocardiogram (ECG) rhythms. In single channel mode, KardiaMobile 6L can record Lead-I. In two channel mode, KardiaMobile 6L can record Lead-I and Lead-II simultaneously and derive Lead-III and unipolar limb leads aVR, aVF and aVL. KardiaMobile 6L 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. KardiaMobile 6L 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

KardiaMobile 6L is a trans-telephonic (transmission by smartphone) electrocardiogram (ECG) event recorder that records, stores, transfers, and analyzes single-channel or two channel ECG rhythm recordings. KardiaMobile 6L provides output of one or six ECG leads, including Lead I, Lead II, Lead III, aVL, aVR and aVF. The device utilizes the computing power of iOS-based or Android-based devices (referred to as "Mobile Computing Platforms" (MCP) within this 510(k)) to record and analyze ECG signals. KardiaMobile 6L consists of KardiaMobile 6L Hardware (portable small wireless hardware with electrodes) and the Kardia Core app. which is installed on an MCP (i.e., iOS or Android devices). KardiaMobile 6L Hardware uses Bluetooth to transmit the ECG signal from the electrodes to the Kardia Core app on the MCP, which then displays the recorded ECG on the MCP's screen. The device is intended to be used by patients with known or suspected heart conditions and health conscious individuals as well as by healthcare professionals (HCPs) who want to remotely monitor their patient's heart health. The device is available for Over-the-Counter (OTC) as well prescription use. The Kardia Core app provides the complete ECG recording and analysis workflow, from acquisition of the signal from the KardiaMobile 6L hardware, to the display of the ECG and analysis results, to printing of the ECG rhythm strip. The app utilizes KardiaAI (K181823, K201985) to provide ECG analysis, which includes the determinations of Normal Sinus Rhythm, Atrial Fibrillation, Bradycardia, Tachycardia, or Unclassified to OTC users and additionally, Sinus Rhythm determinations (Sinus Rhythm with Wide ORS, Sinus Rhythm with Supraventricular Ectopy, and Sinus Rhythm with Premature Ventricular Contractions) for prescription-use only users.

AI/ML Overview

The document provided is a 510(k) summary for the AliveCor KardiaMobile 6L device. It describes the device, its intended use, and its substantial equivalence to a previously cleared predicate device.

Based on the provided information, the current submission (K220350) is for a minor modification (software reorganization and API addition) to an existing device (K210753, KardiaMobile 6L). Therefore, the study described here is primarily focused on demonstrating that these software changes do not adversely affect the device's safety or effectiveness as previously established.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the subject device (K220350) is being compared to its predicate (K210753). The performance criteria are implicitly met by demonstrating that the changes do not raise new questions of safety or effectiveness, as stated in the "Nonclinical Testing Summary" and "Conclusions" sections.

Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Subject Device K220350)
Maintain all functionalities of the predicate device (KardiaMobile 6L K210753)	All functionalities (ECG acquisition, display, analysis, PDF generation) maintained.
ECG Analysis Determinations (KardiaAI K181823) for OTC and Rx Only users remain equivalent for: Atrial Fibrillation, Normal Sinus Rhythm, Tachycardia, Bradycardia, Unclassified, Unreadable.	Performances for these determinations are stated as "No difference" compared to the predicate.
ECG Analysis Determinations (KardiaAI K201985) for Rx Only users remain equivalent for: Atrial Fibrillation, Sinus Rhythm, Sinus Rhythm with Wide QRS, Sinus Rhythm with Supraventricular Ectopy, Sinus Rhythm with Premature Ventricular Contractions, Normal Sinus Rhythm, Tachycardia, Bradycardia, Unclassified, Unreadable.	Performances for these determinations are stated as "No difference" compared to the predicate.
No degradation in data acquisition specifications: Frequency Response (0.5Hz – 40Hz), Number of ECG electrodes (Three dry electrodes), Number of ECG channels (Single-channel and two-channel), Resolution (16 bits), Sample Rate (300 Samples/Second).	All data acquisition specifications are stated as "No difference" compared to the predicate.
No degradation in power supply specifications: Battery (1 Lithium Manganese Dioxide Coin Cells), Battery Life (100 hours operational typical).	All power supply specifications are stated as "No difference" compared to the predicate.
Successful integration of an Application Program Interface (API) for other mobile applications.	API for integrating with other mobile applications is a new feature. Verification activities focused on software changes were successfully passed.
All verification test methods previously used for K183319 and K210753 are successfully passed.	The subject device successfully passed the software verification test methods previously used in K183319 and K210753.

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

The document states: "No clinical testing was required for the minor changes made to the software." This implies that the current submission (K220350) did not involve a new clinical test set with human subjects to prove performance, but rather relied on nonclinical testing, specifically software verification activities.

Therefore, information on the sample size for a test set (e.g., number of ECGs, number of patients) or data provenance (country of origin, retrospective/prospective) directly related to a new clinical performance study for K220350 is not provided as it was explicitly deemed not required. The performance is being established by comparing to the predicate and ensuring the software changes did not introduce new risks. The previous predicate devices (K210753, K183319) would have had their own clinical data.

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

Not applicable, as no new clinical testing was performed for this specific submission (K220350). The performance claims are based on the substantial equivalence to the predicate, K210753, which would have established its own ground truth using experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as no new clinical testing was performed for this specific submission (K220350).

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:

Not applicable. The document states "No clinical testing was required for the minor changes made to the software." This submission is not an MRMC study and does not evaluate AI assistance for human readers. It focuses on software reorganization and API addition.

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

The device description indicates that the Kardia Core app utilizes KardiaAI (K181823, K201985) to provide ECG analysis, detecting conditions like Normal Sinus Rhythm, Atrial Fibrillation, Bradycardia, Tachycardia, or Unclassified. This implies a standalone algorithmic analysis component. However, the current submission (K220350) primarily focuses on the software reorganization and API addition and explicitly states no new clinical testing was required. The performance of these AI determinations would have been established in the previous predicate clearances (K181823 and K201985), not in this particular submission.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not directly addressed for this specific submission (K220350), as no new clinical data was collected. For the underlying KardiaAI platform (K181823, K201985), the ground truth for ECG analysis typically involves expert consensus of cardiologists reviewing the ECGs.

8. The sample size for the training set:

The document does not provide details of the training set size, as this submission is not about training a new AI model but rather a software modification to an already cleared device that utilizes existing AI algorithms (KardiaAI K181823, K201985). The training data for those AI algorithms would have been described in their respective 510(k) submissions.

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

Not directly addressed for this specific submission (K220350), as it pertains to the training of the underlying KardiaAI algorithms (K181823, K201985) rather than the software reorganization. For such algorithms, ground truth for training is typically established by expert adjudication/consensus of ECG interpretations by qualified medical professionals (e.g., cardiologists).

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

May 25, 2022

AliveCor, Inc. % Prabhu Raghavan Principal Consultant Mdar, LLC. 189 N. Bernardo Ave. Suite 100 Mountain View. California 94043

Re: K220350

Trade/Device Name: KardiaMobile 6L Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter And Receiver Regulatory Class: Class II Product Code: DXH, DPS, ODA Dated: February 24, 2022 Received: February 25, 2022

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

{1}------------------------------------------------

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 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 medical devices and radiation-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,

Jennifer Shih Kozen 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K220350

Device Name KardiaMobile 6L

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)

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}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for AliveCor. The logo is in a teal color and features the company name in a sans-serif font. A registered trademark symbol is located to the right of the name.

510(k) Summary

Prepared in accordance with the requirements of 21 CFR 807.92

Submitter Information [807.92(a)(1)]

Submitter/Applicant	AliveCor, Inc.189 N. Bernardo Ave. Suite 100Mountain View, CA 94043Phone: 650-396-8553Fax: 650-282-7932
Primary Contact Person	Prabhu RaghavanRegulatory Consultant for AliveCorPrincipal Consultant, MDQR, LLC189 N. Bernardo Ave. Suite 100Mountain View, CA 94043Phone: 408-316-5707Fax: 650-282-7932Email: prabhu@mdqr.solutions
Submitter andSecondary Contact Person	Susan NoriegaVP of Regulatory Affairs, Clinical Affairs and Quality189 N. Bernardo Ave. Suite 100Mountain View, CA 94043Phone: 650-793-1966Fax: 650-282-7932Email: snoriega630@alivecor.com
Date Prepared	February 02, 2022
Device Information [807.92(a)(2)]
Trade Name	KardiaMobile 6L
Common Name	Transmitters and Receivers, Electrocardiograph, Telephone
Classification	21 CFR§870.2920
Device Class	Class II
Product Code	DXH
Subsequent Product Code	DPS, ODA

Predicate Information [807.92(a)(3)]

AliveCor, Inc., K210753, KardiaMobile 6L Predicate(s)

Device Description [807.92(a)(4)]

{4}------------------------------------------------

510(k) Summary for KardiaMobile 6L AliveCor, Inc.

Android-based devices (referred to as "Mobile Computing Platforms" (MCP) within this 510(k)) to record and analyze ECG signals. KardiaMobile 6L consists of KardiaMobile 6L Hardware (portable small wireless hardware with electrodes) and the Kardia Core app. which is installed on an MCP (i.e., iOS or Android devices). KardiaMobile 6L Hardware uses Bluetooth to transmit the ECG signal from the electrodes to the Kardia Core app on the MCP, which then displays the recorded ECG on the MCP's screen. The device is intended to be used by patients with known or suspected heart conditions and health conscious individuals as well as by healthcare professionals (HCPs) who want to remotely monitor their patient's heart health. The device is available for Over-the-Counter (OTC) as well prescription use. The Kardia Core app provides the complete ECG recording and analysis workflow, from acquisition of the signal from the KardiaMobile 6L hardware, to the display of the ECG and analysis results, to printing of the ECG rhythm strip. The app utilizes KardiaAI (K181823, K201985) to provide ECG analysis, which includes the determinations of Normal Sinus Rhythm, Atrial Fibrillation, Bradycardia, Tachycardia, or Unclassified to OTC users and additionally, Sinus Rhythm determinations (Sinus Rhythm with Wide ORS, Sinus Rhythm with Supraventricular Ectopy, and Sinus Rhythm with Premature Ventricular Contractions) for prescription-use only users.

The Kardia Core app may be distributed as is or be incorporated into other apps ("variants"), by AliveCor or by third-parties, that can provide additional functionality such patient/user onboarding, storage and review of past data, as well as providing secondary MDDS displays of other medical devices. The main software app variant, called the Kardia App, is the default software marketed with KardiaMobile 6L. Kardia App includes workflows for OTC user account creation, integration with AliveCor's KardiaPro MDDS portal, secondary display of Bluetoothenabled blood pressure monitors, and other non-regulated or enforcement discretion features. Kardia App also provides workflows for patients to forward the recorded ECG to their HCP, who can review the ECG rhythm and measure the QT interval. An alternate software variant, called the KardiaStation App, incorporates the Kardia Core app to be used exclusively within hospitals and clinics by adding patient administration workflows. Finally, a third variant called Kardia Rx App incorporates the Kardia Core app to provide a simple workflow to transfer the data for remote patient monitoring applications.

Indications for use [807.92(a)(5)]

KardiaMobile 6L is intended to record, store and transfer one- and two-channel electrocardiogram (ECG) rhythms. In single channel mode, KardiaMobile 6L can record Lead-I. In two channel mode, KardiaMobile 6L can record Lead-I simultaneously and derive Lead-III and unipolar limb leads aVR, aVF and aVL. KardiaMobile 6L 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. KardiaMobile 6L 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.

Substantial Equivalence

The KardiaMobile 6L subject device has the same intended use, physical characteristics, and technological characteristics as the K210753, KardiaMobile 6L predicate device. The difference between the two devices is the reorganization of the software only and the addition of an

{5}------------------------------------------------

510(k) Summary for KardiaMobile 6L AliveCor, Inc.

Application Program Interface for other apps to access Kardia Core workflows. Performance testing, utilizing test methods previously used in K183319 and K210753, were employed to ensure that the device meets its requirements and that the differences between the subject and predicate device do not raise different questions of safety or effectiveness.

Performance Data [807.92(b)]

All necessary testing was conducted on KardiaMobile 6L to support a determination of substantial equivalence to the predicate device.

Nonclinical Testing Summarv [807.92(b)(1)]

Since both the subject and the predicate have the same hardware, verification activities focused on the changes related to the software reorganization. The subject device successfully passed the software verification test methods previously used in K183319 and K210753.

Clinical Testing Summary [807.92(b)(2)]

No clinical testing was required for the minor changes made to the software.

Conclusions [807.92(b)(3)]

The KardiaMobile 6L subject device has the same intended use as the predicate device, and the software changes to support the reorganization do not raise different questions of safety or effectiveness. The software changes between the subject device and the predicate device have been verified to ensure that the subject device is as safe and effective for its intended use as the predicate device. Therefore, the KardiaMobile 6L subject device is substantially equivalent to the predicate device.

Feature	AliveCor KardiaMobile 6L(Subject Device)	AliveCor KardiaMobile 6L(K210753, Predicate Device)
Product Code	DXH, DPS, QDA	No difference
Mechanism of Action	User completes circuit with skincontact and hardware transmits ECGsignal to MCP to convert and displayECG waveform	No difference
Where used (intended use)	Mobile/active users at rest (ambulatory)	No difference
Use cases for HCPs	Rhythm analysisQT Interval Measurement	No difference
Anatomical sites	Left hand fingers to right hand fingersLeft hand fingers to right hand fingersand to left leg/knee	No difference
Software applicationfunctions	Medical device functions● Acquire ECG from○ KardiaMobile 6L Hardware	Medical device functions● No difference○
Feature	AliveCor KardiaMobile 6L(Subject Device)	AliveCor KardiaMobile 6L(K210753, Predicate Device)
	Record, transfer, and display an ECG, ECG analysis of KardiaAI (K181823 or K201985), as applicable Create a PDF rhythm strip of the recorded ECG API for integrating with other mobile applications	Provides additional nonmedical device or enforcement discretion functions such as workflows for user account creation, and onboarding, connecting to Bluetooth-enabled blood pressure monitors to provide a secondary display, share previously recorded ECG and blood pressure data with healthcare professionals, etc.
ECG AnalysisDeterminations usingK181823 KardiaAI.In OTC and Rx Only type ofuse	Atrial FibrillationNormal Sinus RhythmTachycardiaBradycardiaUnclassifiedUnreadable	No difference
ECG AnalysisDeterminations usingK201985 KardiaAI.In Rx Only type of use	Atrial FibrillationSinus RhythmSinus Rhythm with Wide QRS,Sinus Rhythm with SupraventricularEctopySinus Rhythm with PrematureVentricular ContractionsNormal Sinus RhythmTachycardiaBradycardiaUnclassifiedUnreadable	No difference
Data Acquisition:
Frequency Response	0.5Hz – 40Hz	No difference
No. of ECG electrodes	Three (3) dry electrodes	No difference
No. of ECG channels	Single-channel and two-channel	No difference
Resolution	16 bits	No difference
Sample Rate	300 Samples/Second	No difference
Power Supply:
Battery	1 Lithium Manganese Dioxide CoinCells	No difference
Battery Life (typical)	100 hours operational	No difference

Comparison of Technological Characteristics with the Predicate Device [807.92(a)(6)]

{6}------------------------------------------------

Comparison of Technological Characteristics with the Predicate Device [807.92(a)(6)]

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).