KardiaMobile, KardiaStation

K182396 · AliveCor, Inc. · DXH · Apr 12, 2019 · Cardiovascular

Device Facts

• Record ID: K182396
• Device Name: KardiaMobile, KardiaStation
• Applicant: AliveCor, Inc.
• Product Code: DXH · Cardiovascular
• Decision Date: Apr 12, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2
• Attributes: AI/ML

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Atrial Fibrillation detection	—	—	—	—	—	—	—
Normal Sinus Rhythm detection	—	—	—	—	—	—	—
Bradycardia detection	—	—	—	—	—	—	—
Tachycardia detection	—	—	—	—	—	—	—

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 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 Story

KardiaMobile System is a trans-telephonic ECG event recorder; records, stores, and transfers single-channel ECG rhythms. Hardware consists of a two-electrode sensor; user completes circuit via skin contact (fingers or chest). Device transmits ECG signal to Kardia phone app on iOS/Android mobile computing platforms (MCPs) via ultrasonic acoustics. App displays ECG waveform and provides automated analysis from KardiaAI platform. Used by healthcare professionals, patients, or health-conscious individuals in ambulatory settings. Output assists clinicians in heart condition management; enables remote monitoring and patient self-assessment.

Clinical Evidence

Bench testing only. Validation included KardiaAI integration, device specification verification, and software level of concern testing. Compliance demonstrated with ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-47 standards.

Technological Characteristics

Two-electrode dry sensor; single-channel ECG; 16-bit resolution; 300 samples/second; 0.5Hz–40Hz frequency response. Powered by 1 Lithium Manganese Dioxide coin cell (100 hours typical). Connectivity via ultrasonic acoustics to iOS/Android MCPs. Standards: ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-47.

Indications for Use

Indicated for healthcare professionals, patients with known or suspected heart conditions, and health-conscious individuals to record, store, and transfer single-channel ECG rhythms and detect normal sinus rhythm, atrial fibrillation, bradycardia, and others. Not intended for pediatric use.

Regulatory Classification

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.

Predicate Devices

• AliveCor Heart Monitor (K142672)

Reference Devices

• AliveCor KardiaAI (K181823)

Submission Summary (Full Text)

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# Indications for Use

510(k) Number (if known)

Device Name KardiaMobile System

#### Indications for Use (Describe)

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.

| 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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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 ([e-mail]) or phone [phone] 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: [phone] Fax: [phone]

### Applicant Contact Person:

Prabhu Raghavan Vice President of Regulatory and Quality AliveCor, Inc. 444 Castro Street, Suite 600 Mountain View, CA 94041 USA Phone: [phone] Fax: [phone] Email: [e-mail]

### 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)]

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.

### 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 System<br>K182396<br>(subject device) | AliveCor Heart Monitor<br>K142672<br>(predicate device) | KardiaAI<br>K181823<br>(reference device) |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Feature | | | |
| Product Code | DXH, DPS | Same | DQK, DPS |
| Mechanism of Action | User completes circuit with<br>skin contact and hardware<br>transmits audio signal to<br>MCP to convert and display<br>ECG waveform | Same | API library analyzes ECGs<br>and provides analysis to<br>target application. |
| Where used (intended use) | Mobile/active users at rest<br>(ambulatory) | Same | Same |
| Anatomical sites | Left hand fingers to right<br>hand fingers<br>Left leg to right hand fingers<br>On or below chest | Same | N/A (SaMD) |
| Available Algorithms | Atrial Fibrillation<br>Noise Algorithm<br>Normal Sinus Rhythm<br>Tachycardia<br>Bradycardia<br>(implements the same<br>algorithms of the KardiaAI<br>reference device, K181823) | Atrial Fibrillation | Atrial Fibrillation<br>Noise Algorithm<br>Normal Sinus Rhythm<br>Tachycardia<br>Bradycardia |
| Data Acquisition:<br>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:<br>Battery<br>Battery Life (typical) | 1 Lithium Manganese<br>Dioxide Coin Cells<br>100 hours operational | Same | N/A (SaMD) |
| User Interface:<br>Primary Lead | Lead I, Left to Right | Same | Application Program<br>Interface (API) |
| Data acquisition | Ultrasonic acoustics | Same | |
| Hardware | Two-electrode sensor | Same | |
| Software interface | Apple iOS-based or Google<br>Android-based software | Same | |
| Physical Specs:<br>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 Acoustics<br>acquired 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.