(245 days)
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Yes
The device name itself, "KardiaAI", explicitly includes "AI", and the description mentions "algorithmic analysis of ECGs".
No.
The KardiaAI is a software analysis library that processes ECG data to identify certain cardiac rhythms. It is intended for diagnostic purposes (detection of normal sinus rhythm, atrial fibrillation, bradycardia) and not for treating or preventing a disease, which are characteristics of a therapeutic device.
Yes
The device performs ECG rhythm analysis for detecting various conditions like normal sinus rhythm, atrial fibrillation, bradycardia, and tachycardia, which are diagnostic functions.
Yes
The device is explicitly described as a "software analysis library" and "Software as a Medical Device (SaMD)" that provides an API for integration into other ECG device software. It does not include or require specific hardware components for its function.
Based on the provided information, the KardiaAI device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- KardiaAI's function: KardiaAI analyzes electrocardiogram (ECG) rhythms, which are electrical signals from the heart recorded externally from the body. It does not analyze biological samples taken from the body.
- Intended Use: The intended use clearly states it assesses "ambulatory electrocardiogram (ECG) rhythms from adult subjects."
Therefore, while KardiaAI is a medical device that performs analysis, it does so on physiological signals recorded externally, not on in vitro samples.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The KardiaAI is a software analysis library intended to assess ambulatory electrocardiogram (ECG) rhythms from adult subjects. 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 cardiac alarm, or OTC use only devices.
The KardiaAI library provides the following capabilities:
- ECG noise filtering.
- heart rate measurement from ECGs,
- detection of noisy ECGs, and
· ECG rhythm analysis for detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia (when prescribed or used under the care of a physician).
Product codes
DOK, DPS
Device Description
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 a 30-second ECG and provides these capabilities in the form of an Application Program Interface (API) library. ECG devices can incorporate the API library into ECG device ("target device") software to enable algorithmic analysis of ECGs to provide analytical capabilities. The device provides ECG noise filtering and detection of noisy ECGs as well as identifies normal sinus rhythm, atrial fibrillation, bradycardia, and tachycardia.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
KardiaAI is a software library that implements various ECG processing and analysis algorithms.
Input Imaging Modality
Ambulatory electrocardiogram (ECG)
Anatomical Site
Not Found
Indicated Patient Age Range
Adults (over 18)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Non-clinical testing was conducted to assess algorithm performance and to verify that KardiaAI performs as intended. Algorithm performance testing was assessed using ECG databases from the ANSI/AAMI EC57:2012 standard as well as AliveCor proprietary databases.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was conducted to assess algorithm performance and to verify that KardiaAI performs as intended. Algorithm performance testing was assessed using ECG databases from the ANSI/AAMI EC57:2012 standard as well as AliveCor proprietary databases. The overlapping algorithms between KardiaAI and the Kardia Band System met the same performance acceptance criteria. 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 devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
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.(b)
Classification. Class II (performance standards).
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March 11, 2019
AliveCor, Inc. Prabhu Raghavan Vice President of Regulatory and Quality 444 Castro Street, Suite 600 Mountain View. California 94041
Re: K181823
Trade/Device Name: KardiaAI Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK, DPS Dated: February 8, 2019 Received: February 11, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica E. Paulsen -S
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) K181823
Device Name KardiaAI
Indications for Use (Describe)
The KardiaAI is a software analysis library intended to assess ambulatory electrocardiogram (ECG) rhythms from adult subjects. 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 cardiac alarm, or OTC use only devices.
The KardiaAI library provides the following capabilities:
- · ECG noise filtering.
- · heart rate measurement from ECGs,
- · detection of noisy ECGs, and
· ECG rhythm analysis for detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia (when prescribed or used under the care of a physician).
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 K181823
GENERAL INFORMATION [807.92(a)(1)]
Applicant:
AliveCor, Inc. 444 Castro Street, Suite 600 Mountain View, CA 94041 USA Phone: 650-396-8553 Fax: 650-282-7932
Applicant Contact Person:
Prabhu Raghavan Vice President of Regulatory and Quality AliveCor, Inc. 444 Castro Street, Suite 600 Mountain View, CA 94041 USA Phone: 650-396-8553 Fax: 650-282-7932 Email: prabhu@alivecor.com
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: March 06, 2019
DEVICE INFORMATION [807.92(a)(2)]
Trade Name:
KardiaAI
Generic/Common Name:
Programmable diagnostic computer
Classification:
21 CFR§870.1425, Programmable diagnostic computer, Class II
Product Code:
DQK, DPS
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PREDICATE DEVICE(S) [807.92(a)(3)]
- . Primary predicate: AliveCor, Inc., Kardia Band System, K171816
- Secondary predicate: CardioLogs Technologies, CardioLogs ECG Analysis . Platform, K170568
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 a 30-second ECG and provides these capabilities in the form of an Application Program Interface (API) library. ECG devices can incorporate the API library into ECG device ("target device") software to enable algorithmic analysis of ECGs to provide analytical capabilities. The device provides ECG noise filtering and detection of noisy ECGs as well as identifies normal sinus rhythm, atrial fibrillation, bradycardia, and tachycardia.
INDICATIONS FOR USE [807.92(a)(5)]
KardiaAI is a software analysis library intended to assess ambulatory electrocardiogram (ECG) rhythms from adult subjects. 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 provides the following capabilities:
- ECG noise filtering,
- heart rate measurement from ECGs,
- detection of noisy ECGs, and
- ECG rhythm analysis for detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, and tachycardia (when prescribed or used under the care of a physician).
SUBSTANTIAL EQUIVALENCE
KardiaAI has the same intended use as the predicate devices for the purpose of analyzing ambulatory ECG recordings. All three devices analyze ECGs for non-active patient monitoring or non-urgent clinical decision making. KardiaAI and the predicate devices all condition and analyze ECG signals from ambulatory Lead I ECG devices and provide data for display on the ECG target devices. KardiaAI shares the atrial fibrillation (AF), normal sinus rhythm (NSR), and noise algorithm with the Kardia Band System predicate device and contains the additional classifiers for bradycardia and tachycardia. Further, like the CardioLogs predicate device, KardiaAI is a SaMD with API for connecting with ECG devices and sending algorithm output for display. As such, the device has the same intended use as the predicate devices and similar technological characteristics. Differences between the subject device and the predicates have been tested to ensure that the device meets its intended use. Therefore, KardiaAI is substantially equivalent to the predicate devices.
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| Feature | AliveCor KardiaAI | AliveCor Kardia Band System
(K171816) | CardioLogs Technologies CardioLogs ECG
Analysis Platform
(K170568) |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | DQK, Computer, Diagnostic, Programmable
DPS, Electrocardiograph | DPS, Electrocardiograph
DXH, Transmitters And Receivers,
Electrocardiograph, Telephone | DQK, Computer, Diagnostic, Programmable
DPS, Electrocardiograph |
| Regulation | 870.1425, Programmable diagnostic computer | 870.2920, Telephone electrocardiograph
transmitter and receiver | 870.1425, Programmable diagnostic computer |
| Indications for use | KardiaAI is a software analysis library intended
to assess ambulatory electrocardiogram (ECG)
rhythms from adult subjects.
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.
KardiaAI provides the following capabilities:
• ECG noise filtering,
• heart rate measurement from ECGs,
• detection of noisy ECGs, and
• ECG rhythm analysis for detecting the
presence of normal sinus rhythm, atrial
fibrillation, bradycardia, and tachycardia | 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. | The CardioLogs ECG Analysis Platform is intended for
use by qualified healthcare professionals for the
assessment of arrhythmias using ECG data in subjects
over 18 years of age.
The product supports downloading and analyzing data
recorded in compatible formats from any device used
for the arrhythmia diagnostics such as Holter, event
recorder, 12 lead ambulatory ECG devices, or other
similar devices when assessment of the rhythm is
necessary. The CardioLogs ECG Analysis Platform can
also be electronically interfaced and perform analysis
with data transferred from other computer based ECG
systems, such as an ECG management system.
The CardioLogs ECG Analysis Platform provides ECG
signal processing and analysis, QRS and Ventricular
Ectopic Beat detection, QRS feature extraction,
interval measurement, heart rate measurement, and
rhythm analysis. |
| Feature | AliveCor KardiaAI | AliveCor Kardia Band System
(K171816) | CardioLogs Technologies CardioLogs ECG
Analysis Platform
(K170568) |
| | (when prescribed or used under the care of a
physician). | | The CardioLogs ECG Analysis Platform is not for use
in life supporting or sustaining systems or ECG
monitor and Alarm devices. |
| | | | The product can be integrated into computerized ECG
monitoring devices. In this case, the medical device
manufacturer will identify the indication for use
depending on the application of their device. |
| | | | CardioLogs ECG Analysis Platform interpretation
results are not intended to be the sole means of
diagnosis. It is offered to physicians and clinicians on
an advisory basis only in conjunction with the
physician's knowledge of ECG patterns, patient
background, clinical history, symptoms, and other
diagnostic information. |
| Target population | Adults (over 18) | Adults (over 18) | Adults (over 18) |
| Components | Software only | Software and ECG recording device | Software only |
Comparison of Technological Characteristics with the Predicate Devices
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| Feature | AliveCor KardiaAI | AliveCor Kardia Band System
(K171816) | CardioLogs Technologies CardioLogs ECG
Analysis Platform
(K170568) |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software Functional
Comparisons | - An interface that provides tools to process and
analyze ECGs through various algorithms
- The automated proprietary ECG algorithms
provide supportive information for ECG
diagnosis. The library can be accessed by
directly connecting to the KardiaAI's
Application Programming Interface | - Kardia watch app software used to
analyze and display ECG signals
received from the Kardia Band hardware - Kardia phone app used to create Kardia
account, onboard users, store, re-display
and transfer ECGs received from the
Kardia watch app | - An interface which provides tools to measure,
analyze and review numerous ECGs coded in java
language under the Angular and D3.js frameworks; - An automated proprietary ECG interpretation
support algorithm which measures and analyzes
ECGs to provide supportive information for ECG
diagnosis,
This application can be accessed through an Internet
connection and a web browser, or is directly connected
to the CardioLogs' Application Programming Interface
(API) |
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PERFORMANCE DATA [807.92(b)]
All necessary testing was conducted on the KardiaAI to support a determination of substantial equivalence to the predicate device.
Nonclinical Testing Summary [807.92(b)(1)]
Non-clinical testing was conducted to assess algorithm performance and to verify that KardiaAI performs as intended. Algorithm performance testing was assessed using ECG databases from the ANSI/AAMI EC57:2012 standard as well as AliveCor proprietary databases. The overlapping algorithms between KardiaAI and the Kardia Band System met the same performance acceptance criteria. 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 devices.
CONCLUSIONS [807.92(b)(3)]
The results of nonclinical testing demonstrate that the KardiaAI meets its intended use which is equivalent to that of the predicate devices. The overlapping AF, NSR, and noise algorithms for KardiaAI and Kardia Band System met the same performance criteria. Testing also ensured that differences in technological characteristics between the KardiaAI and the Kardia Band System (primary predicate) (i.e., bradycardia and tachycardia algorithms as well as multilead ambulatory ECG input) perform as intended and do not raise different questions of safety or effectiveness.