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.

AI/ML Overview

The provided text describes the Kardia Band System, an ECG device, and its substantial equivalence determination based on non-clinical and clinical testing. However, it does not explicitly state specific acceptance criteria or provide a detailed study that proves the device meets specific performance criteria.

It primarily asserts "very strong mathematical correlation and qualitative clinical equivalence" to a predicate device (Kardia Mobile K142743) and that the clinical study was "sufficient to draw a conclusion of substantial equivalence based on meeting qualitative and quantitative acceptance criteria."

Therefore, based only on the provided text, I cannot provide a detailed answer to all your questions because much of the requested information (like specific numerical acceptance criteria, detailed performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment specifics for the clinical study) is not present.

However, I can extract the information that is implicitly or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: The text states, "The study is sufficient to draw a conclusion of substantial equivalence based on meeting qualitative and quantitative acceptance criteria." It also mentions "generates rhythm strip data that meets the clinical quality requirements for accurate cardiac rhythm diagnosis" and "very strong mathematical correlation and qualitative clinical equivalence" to the predicate device. However, the specific numerical values or defined qualitative benchmarks for these criteria are not provided.
Reported Device Performance: The text generally asserts that the device meets the unspecified "clinical quality requirements" and shows "very strong mathematical correlation and qualitative clinical equivalence" to the predicate. No specific performance metrics (e.g., sensitivity, specificity, accuracy for AF detection) are given in the provided document for the Kardia Band System itself.

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

Sample Size for Test Set: Not explicitly stated.
Data Provenance: Not explicitly stated. (e.g., country of origin, retrospective/prospective)

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

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated.

4. Adjudication method for the test set:

Adjudication Method: Not explicitly stated.

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:

MRMC Study: Not explicitly stated. The clinical testing section focuses on the device's ability to generate rhythm strip data meeting quality requirements and showing equivalence, rather than a comparative effectiveness study involving human readers with and without AI assistance. This device is described as detecting atrial fibrillation and normal sinus rhythm, suggesting an automated algorithm.

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

The device's description of "detects the presence of atrial fibrillation and normal sinus rhythm" implies a standalone algorithmic performance component. The clinical testing likely evaluated this standalone performance, but the details are not explicitly stated.

7. The type of ground truth used:

The text mentions the device "generates rhythm strip data that meets the clinical quality requirements for accurate cardiac rhythm diagnosis" and detects "atrial fibrillation and normal sinus rhythm." This strongly suggests the ground truth would be based on expert consensus interpretation of ECGs, likely by cardiologists, to establish the presence or absence of AF or normal sinus rhythm. However, this is an inference based on the device's function, not an explicit statement.

8. The sample size for the training set:

Not explicitly stated.

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

Not explicitly stated.

Summary of what is explicitly stated or strongly implied regarding the study:

Study Type: Clinical performance testing was conducted.
Purpose: To demonstrate that the Kardia Band System generates rhythm data meeting clinical quality requirements for accurate cardiac rhythm diagnosis and to show substantial equivalence to the predicate device (Kardia Mobile).
Outcome: The study showed "very strong mathematical correlation and qualitative clinical equivalence" to the predicate device and was deemed sufficient to conclude substantial equivalence based on meeting unspecified "qualitative and quantitative acceptance criteria."

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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510(k) Notification K_________________________________________________________________________________________________________________________________________________________

GENERAL INFORMATION

Applicant:

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

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: 408-400-0856 Fax: 408-400-0865 Email: anna@experiengroup.com

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

DEVICE DESCRIPTION

Feature	Kardia Band System	Kardia MobileK142743
Product Code	DXH, DPS	Same
Mechanism ofAction	User completes circuit with skin contactand hardware transmits audio signal toMCP to convert and display ECGwaveform	Same
Where used(intended use)	Mobile/active users at rest (ambulatory)	Same
Anatomical sites	Left hand fingers to right wrist or viceversa	Left hand fingers to right hand fingers
Data Acquisition:		Same
FrequencyResponse	0.5 Hz - 40 Hz
ECG channels	Single Channel
Resolution	16 bit
Sample Rate	300 Samples/Second
MemoryCapacity:	Essentially unlimited due to real-timetransmission to MCP memory (size ofECG file is miniscule – kilobytescompared to device memory capacity -gigabytes)	Same

Physical and Technological Characteristics of the Kardia Band System

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510(k) SUMMARY

Feature	Kardia Band System	Kardia MobileK142743
Number of ECGLeads	Single lead, 2 electrodes	Same
Power Supply:	Same	Same
BatteryBattery Life(typical)	1 Lithium Manganese Dioxide CoinCells100 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
Softwareinterface	Apple iOS based software and AppleWatchOS 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.

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).