Kardia Band System

K171816 · AliveCor, Inc. · DXH · Nov 16, 2017 · Cardiovascular

Device Facts

• Record ID: K171816
• Device Name: Kardia Band System
• Applicant: AliveCor, Inc.
• Product Code: DXH · Cardiovascular
• Decision Date: Nov 16, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Intended Use

The Kardia Band System is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The Kardia Band System also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician). The Kardia Band System is intended for use by healthcare professionals, adult patients with known or suspected heart conditions and health conscious individuals.

Device Story

Kardia Band System is a trans-telephonic ECG event recorder integrated into an Apple Watch band. User completes electrical circuit by touching electrode on watchband with opposite hand; device captures single-channel ECG signal. Signal transmitted via ultrasonic acoustics to Apple Watch and iPhone apps for analysis, display, and storage. Used by patients or healthcare professionals in ambulatory settings. Output provides ECG waveform and automated detection of atrial fibrillation or normal sinus rhythm. Data synced to user account for review by healthcare providers to assist in cardiac rhythm diagnosis and clinical decision-making.

Clinical Evidence

Clinical performance testing demonstrated that the Kardia Band System generates rhythm strip data meeting clinical quality requirements for cardiac rhythm diagnosis. Study results showed strong mathematical correlation and qualitative clinical equivalence to the predicate device, meeting all qualitative and quantitative acceptance criteria.

Technological Characteristics

Single-lead ECG system; 2 electrodes; 16-bit resolution; 300 samples/second; 0.5-40 Hz frequency response. Powered by Lithium Manganese Dioxide coin cell (100-hour life). Connectivity via ultrasonic acoustics to Apple Watch/iPhone. Form factor: 24.5 x 24.5 x 6.5 mm, 9g. Standards: IEC 60601-1:2012, IEC 60601-1-2:2014, IEC 60601-2-47:2012.

Indications for Use

Indicated for adult patients with known or suspected heart conditions, health-conscious individuals, and healthcare professionals to record, store, and transfer single-channel ECG rhythms and detect atrial fibrillation or normal sinus rhythm.

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 (Kardio Mobile) (K142743)

Submission Summary (Full Text)

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November 16, 2017

Alivecor, Inc % Anna Libman Senior Manager, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, California 95110

Re: K171816

Trade/Device Name: Kardia Band System Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II Product Code: DXH, DPS Dated: October 11, 2017 Received: October12, 2017

Dear Anna Libman:

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

M.A. Hillebrand
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)

K171816

Device Name Kardia Band System

Indications for Use (Describe)

The Kardia Band System is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The Kardia Band System also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician). The Kardia Band System is intended for use by healthcare professionals, adult patients with known or suspected heart conditions and health conscious individuals.

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 K_________________________________________________________________________________________________________________________________________________________

## GENERAL INFORMATION

#### Applicant:

AliveCor, Inc. 444 Castro Street, Suite 600 Mountain View, CA 94041 Phone: [phone] Fax: [phone]

Applicant Contact Person:

Anna Libman Regulatory Consultant to AliveCor, Inc. Senior Manager, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA Phone: [phone] Fax: [phone] Email: [e-mail]

Date Prepared:

June 16, 2017

#### DEVICE INFORMATION

Trade Name: Kardia Band System Generic/Common Name: Telephone electrocardiograph transmitter and receiver Classification: 21 CFR \$870.2920, Transmitters and Receivers, Electrocardiograph, Telephone, Class II Product Code: DXH, DPS

### PREDICATE DEVICE(S)

- K142743 AliveCor Heart Monitor (also known as Kardia Mobile) .
K171816 p.1/4

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## 510(k) SUMMARY

#### INDICATIONS FOR USE

The Kardia Band System is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The Kardia Band System also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician). The Kardia Band System is intended for use by healthcare professionals, adult patients with known or suspected heart conditions and health conscious individuals.

## DEVICE DESCRIPTION

The Kardia Band 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 the Apple, Inc. Apple Watch to obtain and analyze single-channel ECG. The Kardia Band System consists of the Kardia Band Hardware (watchband), the Kardia watch app software (installed on the Apple Watch), and the Kardia phone app software (installed on the Apple iPhone). The Kardia Band System transmits the ECG signal from its electrode to the Kardia watch app on the Apple Watch to be analyzed and presented to the user. All ECGs are synced with the user's account.

| Feature | Kardia Band System | Kardia Mobile<br>K142743 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Product Code | DXH, DPS | Same |
| Mechanism of<br>Action | User completes circuit with skin contact<br>and hardware transmits audio signal to<br>MCP to convert and display ECG<br>waveform | Same |
| Where used<br>(intended use) | Mobile/active users at rest (ambulatory) | Same |
| Anatomical sites | Left hand fingers to right wrist or vice<br>versa | Left hand fingers to right hand fingers |
| Data Acquisition: | | Same |
| Frequency<br>Response | 0.5 Hz - 40 Hz | |
| ECG channels | Single Channel | |
| Resolution | 16 bit | |
| Sample Rate | 300 Samples/Second | |
| Memory<br>Capacity: | Essentially unlimited due to real-time<br>transmission to MCP memory (size of<br>ECG file is miniscule – kilobytes<br>compared to device memory capacity -<br>gigabytes) | Same |

Physical and Technological Characteristics of the Kardia Band System

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## 510(k) SUMMARY

| Feature | Kardia Band System | Kardia Mobile<br>K142743 |
|--------------------------------------|--------------------------------------------------------------------|----------------------------------------|
| Number of ECG<br>Leads | Single lead, 2 electrodes | Same |
| Power Supply: | Same | Same |
| Battery<br>Battery Life<br>(typical) | 1 Lithium Manganese Dioxide Coin<br>Cells<br>100 hours operational | Same |
| User Interface: | | |
| Primary Lead | Lead I, Left to Right | Same |
| Data acquisition | Ultrasonic acoustics | Same |
| Hardware | Apple Watch Band and Sensor | iPhone Case and Universal Module |
| Software<br>interface | Apple iOS based software and Apple<br>WatchOS based software | Apple iOS based software |
| Physical Specs: | | |
| Dimensions | 24.5 x 24.5 x 6.5 mm | 118 x 62 x 16.5 mm |
| Weight | 9 grams | 40 grams |
| Prescribed: | Prescription and OTC | Same |
| Environmental: | | Same |
| Operating Temp | 10 to 40 degrees C | |
| Storage Temp | -20 to 60 degrees C | |
| Communications | Ultrasonic Acoustics acquired by watch | Ultrasonic Acoustics acquired by phone |

# SUBSTANTIAL EQUIVALENCE

The Kardia Band System is substantially equivalent to the previously cleared Kardia Mobile product (AliveCor Heart Monitor hardware and software (K142743), also known as Kardia Mobile). The new Kardia Band System has been redesigned to fit on an Apple Watch band and has the same intended use and similar technological characteristics as those of the predicate device. Differences in technological characteristics have been evaluated through performance testing, and therefore the proposed device is substantially equivalent to the predicate device.

## NONCLINICAL TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

All necessary performance testing was conducted on the Kardia Band System to support a determination of substantial equivalence to the predicate device. This testing included testing to the following standards: IEC 60601-1:2012 Medical Electrical Equipment -Part 1: General Requirements For Basic Safety And Essential Performance, IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests, and IEC 60601-2-47:2012 Medical Electrical Equipment --

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## 510(k) SUMMARY

Part 2-47: Particular Requirements For The Basic Safety And Essential Performance Of Ambulatory Electrocardiographic Systems. The collective results of the non-clinical testing demonstrate that the Kardia Band System meets the established specifications and complies with the aforementioned standards.

## CLINICAL TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

Clinical performance testing was conducted to demonstrate that the AliveCor Kardia Band System generates rhythm strip data that meets the clinical quality requirements for accurate cardiac rhythm diagnosis.

The presented data shows very strong mathematical correlation and qualitative clinical equivalence. The study is sufficient to draw a conclusion of substantial equivalence based on meeting qualitative and quantitative acceptance criteria.

## CONCLUSION

The results of both clinical and nonclinical testing demonstrate that the Kardia Band System is substantially equivalent to the predicate device.