KardiaAI

K201985 · AliveCor, Inc. · DQK · Nov 12, 2020 · Cardiovascular

Device Facts

• Record ID: K201985
• Device Name: KardiaAI
• Applicant: AliveCor, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Nov 12, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

KardiaAI is a software analysis library intended to assess ambulatory electrocardiogram (ECG) rhythms from adult subjects (when prescribed or used under the care of a physician). The device supports analyzing data recorded in compatible formats from any ambulatory ECG devices such as event recorders, or other similar devices. The library is intended to be integrated into other device software. The library is not intended for use in life supporting, or sustaining systems, or ECG monitors, or cardiac alarm, or OTC use only devices. The KardiaAl library provides the following capabilities: - Filtering ECG noise, - Reporting heart rate measurement from ECGs, - Detecting noisy ECGs. - Reporting ECG rhythm analysis for the presence of sinus rhythm, atrial fibrillation, bradycardia, for ECGs detected as sinus rhythm, detecting normal sinus rhythm with with wide QRS, sinus rhythm with premature ventricular contractions (PVC), and sinus rhythm with supraventricular ectopy; - Detecting QRS complexes in an ECG. - For ECGs detected as sinus rhythm, classifying individual beats as a PVC or non-PVC beat, and - Generating an average beat from an ECG The device is not intended for use in patients who have pacemakers, ICDs, or other implanted electronic devices.

Device Story

KardiaAI is a software-only library (SaMD) integrated into AliveCor-compatible ambulatory ECG devices (e.g., KardiaMobile, Triangle System). It processes single-channel ECG inputs to provide automated analysis via an API. Functions include noise filtering, QRS detection, heart rate measurement, and rhythm classification (sinus rhythm, AFib, bradycardia, tachycardia). For sinus rhythm, it further identifies wide QRS, PVCs, and supraventricular ectopy; generates average beat representations; and produces R-R interval tachograms. The device is operated under physician care. Outputs are stored, transferred, and displayed by the host device for review by healthcare professionals. The device provides supportive diagnostic information to assist clinical decision-making regarding arrhythmia management. It benefits patients by enabling automated, remote analysis of ambulatory ECG data.

Clinical Evidence

Bench testing only. Algorithm performance verified using proprietary AliveCor ECG databases and comparative testing against ANSI/AAMI EC57 databases. Human factors usability study conducted per IEC 62366-1:2015 and FDA guidance confirmed users understand device outputs and appropriate clinical follow-up actions.

Technological Characteristics

Software-only API library. Implements proprietary ECG processing and analysis algorithms. Operates on ambulatory ECG data. Integrated into host device software. No physical hardware components. Complies with IEC 62366-1:2015 for usability.

Indications for Use

Indicated for adult patients (18+) requiring assessment of ambulatory ECG rhythms. Contraindicated for patients with pacemakers, ICDs, or other implanted electronic devices. Not for life-supporting systems, cardiac alarms, or OTC use.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

• KardiaAI (K181823)

Reference Devices

• Triangle System (K183319)
• KardiaMobile System (K182396)
• KardiaBand System (K171816)
• Omron Model BP7900 Blood Pressure Monitor + EKG (K182579)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 12, 2020

AliveCor, Inc. % Prabhu Raghavan Principal MDQR, LLC 444 Castro Street, Suite 600 Mountain View. California 94041

Re: K201985

Trade/Device Name: KardiaAI Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK, DPS Dated: October 12, 2020 Received: October 13, 2020

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jennifer Shih 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

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## Indications for Use

# 510(k) Number (if known) K201985

Device Name

KardiaAI

#### Indications for Use (Describe)

KardiaAI is a software analysis library intended to assess ambulatory electrocardiogram (ECG) rhythms from adult subjects (when prescribed or used under the care of a physician). The device supports analyzing data recorded in compatible formats from any ambulatory ECG devices such as event recorders, or other similar devices. The library is intended to be integrated into other device software. The library is not intended for use in life supporting, or sustaining systems, or ECG monitors, or cardiac alarm, or OTC use only devices.

The KardiaAl library provides the following capabilities:

- · Filtering ECG noise,
- · Reporting heart rate measurement from ECGs,
- · Detecting noisy ECGs.

· Reporting ECG rhythm analysis for the presence of sinus rhythm, atrial fibrillation, bradycardia, for ECGs detected as sinus rhythm, detecting normal sinus rhythm with with wide QRS, sinus rhythm with premature ventricular contractions (PVC), and sinus rhythm with supraventricular ectopy;

· Detecting QRS complexes in an ECG.

- · For ECGs detected as sinus rhythm, classifying individual beats as a PVC or non-PVC beat, and
- · Generating an average beat from an ECG

The device is not intended for use in patients who have pacemakers, ICDs, or other implanted electronic devices.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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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 simple, sans-serif font. A registered trademark symbol is located to the upper right of the name.

#### 510(k) Summary for K201985

Prepared in accordance with the requirements of 21 CFR 807.92

#### Submitter Information [807.92(a)(1)]

| Submitter/Applicant | AliveCor, Inc.<br>444 Castro Street, Suite 600<br>Mountain View, CA 94041<br>Phone: [phone]<br>Fax: [phone] |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person | Prabhu Raghavan<br>Regulatory Consultant for AliveCor<br>MDQR, LLC<br>444 Castro Street, Suite 600<br>Mountain View, CA 94041<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Submitter and<br>Secondary Contact Person | Saket Bhatt<br>VP of Regulatory and Quality<br>444 Castro Street, Suite 600<br>Mountain View, CA 94041<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |

Date Prepared

July 15, 2020

#### Device Information [807.92(a)(2)]

| Trade Name | KardiaAI |
|-------------------------|----------------------------------|
| Common Name | Programmable diagnostic computer |
| Classification | 21 CFR§870.1425 |
| Device Class | Class II |
| Product Code | DQK |
| Subsequent Product Code | DPS |

### Predicate Information [807.92(a)(3)]

Predicate(s)

AliveCor, Inc., KardiaAI, K181823

#### Device Description [807.92(a)(4)]

KardiaAI is a software library that implements various ECG processing and analysis algorithms. This Software as a Medical Device (SaMD) computes various physiologic parameters from an ECG and provides these capabilities in the form of an Application Program Interface (API)

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510(k) Summary for KardiaAI AliveCor, Inc.

library. AliveCor-designed ECG devices ("target device") incorporate the API library into their device software to enable algorithmic analysis of ECGs to provide analytical capabilities. KardiaAI provides ECG processing functions, including ECG noise filtering and detection of noisy ECGs. It performs rhythm analysis on ECGs, specifically detecting atrial fibrillation, bradycardia, tachycardia and sinus rhythm, which can be further classified as normal sinus rhythm, sinus rhythm with wide QRS, sinus rhythm with premature ventricular contractions (PVCs), and sinus rhythm with supraventricular ectopy. It further provides beat-level annotations, including beat-level ORS locations, and, for sinus rhythm ECGs, PVC/not-PVC annotations. It also provides an average beat ECG representation, and the R-R interval tachogram. Recording and viewing of ECGs and the results of the KardiaAI analyses are to be provided by other AliveCor FDA-cleared devices (i.e., the target devices) into which the API library is incorporated, such as AliveCor's Triangle System (K183319) and KardiaMobile System (K182396).

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

KardiaAI is a software analysis library intended to assess ambulatory electrocardiogram (ECG) rhythms from adult subjects (when prescribed or used under the care of a physician). The device supports analyzing data recorded in compatible formats from any ambulatory ECG devices such as event recorders, or other similar devices. The library is intended to be integrated into other device software. The library is not intended for use in life supporting, or sustaining systems, or ECG monitors, or cardiac alarm, or OTC use only devices.

The KardiaAI library provides the following capabilities:

- Filtering ECG noise.
- Reporting heart rate measurement from ECGs, ●
- o Detecting noisy ECGs,
- Reporting ECG rhythm analysis for the presence of sinus rhythm, atrial fibrillation, ● bradycardia, and tachycardia; for ECGs detected as sinus rhythm, detecting normal sinus rhythm, sinus rhythm with wide QRS, sinus rhythm with premature ventricular contractions (PVC), and sinus rhythm with supraventricular ectopy,
- Detecting QRS complexes in an ECG,
- For ECGs detected as sinus rhythm, classifying individual beats as a PVC or non-PVC ● beat, and
- o Generating an average beat from an ECG

The device is not intended for use in patients who have pacemakers, ICDs, or other implanted electronic devices.

#### Substantial Equivalence

The subject device has the same intended use as the predicate devices intended are to process (e.g., filter and detect noise) and analyze a single channel ECG signal to detect the presence of arrhythmias. These ECG analysis outputs from the subject and predicate device all represent potential findings to be reviewed and interpreted by a qualified healthcare professional, and do not represent complete diagnoses. Both devices are software-only API libraries and are intended to be incorporated into other Alive Cor-designed medical devices ("target device"). Both the subject and predicate device process and analyze recorded ECGs, the output of which are stored, transferred, and displayed by the target device.

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The subject device includes all the software outputs of the predicate device with updates in algorithm design and provides several new analysis outputs which are within the general intended use shared with the predicate device. Like the predicate device, the subject device's ECG analysis functionalities with respect to arrhythmia detection are prescription features.

As such, the subject device has the same intended use and technological characteristics as the predicate device. Differences between the subject device and the predicate device do not raise different questions of safety or effectiveness from the predicate device, and performance testing has demonstrated that the subject device meets its performance specifications and is as safe and as effective as the predicate device for their intended use. Therefore, KardiaAI is substantially equivalent to the predicate device.

| Feature | AliveCor KardiaAI<br>(Subject Device) | AliveCor KardiaAI (K181823)<br>(Predicate Device) |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | DQK, Computer, Diagnostic,<br>Programmable | DQK, Computer, Diagnostic,<br>Programmable |
| | DPS, Electrocardiograph | DPS, Electrocardiograph |
| Regulation | 21 CFR§870.1425, Programmable<br>diagnostic computer | 21 CFR§870.1425, Programmable<br>diagnostic computer |
| | Class II | Class II |
| Feature | AliveCor KardiaAI<br>(Subject Device) | AliveCor KardiaAI (K181823)<br>(Predicate Device) |
| Indications for<br>use | KardiaAI is a software analysis library<br>intended to assess ambulatory<br>electrocardiogram (ECG) rhythms from<br>adult subjects (when prescribed or used<br>under the care of a physician). The<br>device supports analyzing data recorded<br>in compatible formats from any<br>ambulatory ECG devices such as event<br>recorders, or other similar devices. The<br>library is intended to be integrated into<br>other device software. The library is not<br>intended for use in life supporting, or<br>sustaining systems, or ECG monitors, or<br>cardiac alarm, or OTC use only devices.<br>The KardiaAI library provides the<br>following capabilities:<br>• Filtering ECG noise,<br>• Reporting heart rate measurement<br>from ECGs,<br>• Detecting noisy ECGs,<br>• Reporting ECG rhythm analysis for<br>the presence of sinus rhythm, atrial<br>fibrillation, bradycardia, and<br>tachycardia; for ECGs detected as<br>sinus rhythm, detecting normal sinus<br>rhythm, sinus rhythm with wide<br>QRS, sinus rhythm with premature<br>ventricular contractions (PVC), and<br>sinus rhythm with supraventricular<br>ectopy,<br>• Detecting QRS complexes in an<br>ECG,<br>• For ECGs detected as sinus rhythm,<br>classifying individual beats as a PVC<br>or non-PVC beat, and<br>• Generating an average beat from an<br>ECG<br>The device is not intended for use in<br>patients who have pacemakers, ICDs, or<br>other implanted electronic devices | KardiaAI is a software analysis library<br>intended to assess ambulatory<br>electrocardiogram (ECG) rhythms from<br>adult subjects.<br>The device supports analyzing data<br>recorded in compatible formats from<br>any ambulatory ECG devices such as<br>event recorders, or other similar devices.<br>The library is intended to be integrated<br>into other device software.<br>The library is not intended for use in life<br>supporting, or sustaining systems, or<br>ECG monitors, or cardiac alarm, or<br>OTC use only devices.<br>KardiaAI provides the following<br>capabilities:<br>• ECG noise filtering,<br>• heart rate measurement from ECGs,<br>• detection of noisy ECGs, and<br>• ECG rhythm analysis for detecting<br>the presence of normal sinus rhythm,<br>atrial fibrillation, bradycardia, and<br>tachycardia (when prescribed or used<br>under the care of a physician). |
| Target<br>population | Adults (over 18) | Adults (over 18) |
| Components | Software only | Software only |
| Feature | AliveCor KardiaAI<br>(Subject Device) | AliveCor KardiaAI (K181823)<br>(Predicate Device) |
| Software<br>Functionalities | An interface that provides tools to<br>process and analyze ECGs through<br>various algorithms The automated proprietary ECG<br>algorithms provide supportive<br>information for ECG diagnosis. The<br>library can be accessed by directly<br>connecting to the KardiaAI's<br>Application Programming Interface | An interface that provides tools to<br>process and analyze ECGs through<br>various algorithms The automated proprietary ECG<br>algorithms provide supportive<br>information for ECG diagnosis. The<br>library can be accessed by directly<br>connecting to the KardiaAI's<br>Application Programming Interface |
| Compatible<br>ECG Devices | Triangle System (K183319) KardiaMobile System (K182396) Omron Model BP7900 Blood<br>Pressure Monitor + EKG (K182579) | Triangle System (K183319) KardiaMobile System (K182396) KardiaBand System (K171816) Omron Model BP7900 Blood<br>Pressure Monitor + EKG (K182579) |

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

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

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

#### Performance Data [807.92(b)]

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

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

Nonclinical testing, similar to that conducted to support the predicate device, was conducted to assess algorithm performance and to verify that KardiaAI performs as intended.

Software testing was conducted for KardiaAI. Specifically, algorithm performance testing was assessed using an AliveCor proprietary ECG database. Additional comparative testing was also performed on databases from the ANSVAAMI EC57. All analysis outputs were found to meet their performance specifications. Specifically, for the algorithm outputs which are present in both KardiaAI and the predicate device, comparative testing was conducted, and it was found that the subject device demonstrated equivalent performance to the predicate device. The results of the testing demonstrate that KardiaAI performs to its specifications and meets its intended use, which is substantially equivalent to that of the predicate device.

In addition, a human factors usability study was conducted in accordance with recommendations in IEC 62366-1:2015, "Medical devices - Part 1: Application of usability engineering to medical devices", and FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices", issued February 3, 2016. The results of the study demonstrated that users can use the device and understands its outputs based on labeling, and further understand appropriate actions if symptoms are present, such as when to seek medical care.

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510(k) Summary for KardiaAI AliveCor, Inc.

### Conclusions [807.92(b)(3)]

KardiaAI has the same intended use as the predicate device, and any differences in technological characteristics do not raise different questions of safety or effectiveness. Differences between the subject device and the predicate device have been tested to ensure that the device meets its intended use. The results of nonclinical testing specifically demonstrate that KardiaAI meets its intended use which is equivalent to that of the predicate device. Therefore, KardiaAI is substantially equivalent to the predicate device.