(220 days)
K181823 - AliveCor KardiaAI
Yes
The summary explicitly mentions "AliveCor's KardiaAI platform" and describes its function in analyzing ECG rhythms to detect conditions like atrial fibrillation, indicating the use of AI.
No.
The device records, stores, and transfers ECG rhythms and provides analysis for detection of specific heart conditions; it does not provide treatment.
Yes
The device is described as detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, and other heart conditions, which indicates a diagnostic function.
No
The device description explicitly states that the KardiaMobile System "consists of the hardware (that has the electrodes), and the Kardia phone app". This indicates the device includes a physical hardware component in addition to the software.
Based on the provided text, the KardiaMobile System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The KardiaMobile System records electrical signals from the body (ECG rhythms) directly from the skin surface using electrodes. It does not analyze biological samples.
- The intended use and device description clearly state it records, stores, and transfers ECG rhythms. This is a physiological measurement, not an analysis of a biological sample.
- The analysis performed by the KardiaAI platform is based on the electrical signals of the heart, not on the composition or properties of a biological sample.
Therefore, the KardiaMobile System falls under the category of a medical device that measures physiological parameters, not an In Vitro Diagnostic device.
No
The provided text does not contain explicit language stating 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 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.
Product codes
DXH, DPS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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).
Input Imaging Modality
Not Found
Anatomical Site
Left hand fingers to right hand fingers
Left leg to right hand fingers
On or below chest
Indicated Patient Age Range
The device has not been tested and is not intended for pediatric use.
Intended User / Care Setting
healthcare professionals, patients with known or suspected heart conditions and health conscious individuals.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K142672 - AliveCor Heart Monitor
Reference Device(s)
K181823 - AliveCor KardiaAI
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
2
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
3
510(k) Notification K182396
GENERAL INFORMATION [807.92(a)(1)]
Applicant:
AliveCor, Inc. 444 Castro Street, Suite 600 Mountain View, CA 94041 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: 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
4
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.
5
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE[807.92(a)(6)]
| | KardiaMobile System
K182396
(subject device) | AliveCor Heart Monitor
K142672
(predicate device) | KardiaAI
K181823
(reference device) |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Feature | | | |
| Product Code | DXH, DPS | Same | DQK, DPS |
| Mechanism of Action | User completes circuit with
skin contact and hardware
transmits audio signal to
MCP to convert and display
ECG waveform | Same | API library analyzes ECGs
and provides analysis to
target application. |
| Where used (intended use) | Mobile/active users at rest
(ambulatory) | Same | Same |
| Anatomical sites | Left hand fingers to right
hand fingers
Left leg to right hand fingers
On or below chest | Same | N/A (SaMD) |
| Available Algorithms | Atrial Fibrillation
Noise Algorithm
Normal Sinus Rhythm
Tachycardia
Bradycardia
(implements the same
algorithms of the KardiaAI
reference device, K181823) | Atrial Fibrillation | Atrial Fibrillation
Noise Algorithm
Normal Sinus Rhythm
Tachycardia
Bradycardia |
| Data Acquisition:
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:
Battery
Battery Life (typical) | 1 Lithium Manganese
Dioxide Coin Cells
100 hours operational | Same | N/A (SaMD) |
| User Interface:
Primary Lead | Lead I, Left to Right | Same | Application Program
Interface (API) |
| Data acquisition | Ultrasonic acoustics | Same | |
| Hardware | Two-electrode sensor | Same | |
| Software interface | Apple iOS-based or Google
Android-based software | Same | |
| Physical Specs:
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
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
6
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.