(107 days)
Yes
The document explicitly mentions and references "KardiaAI" as the platform used for ECG analysis, and lists previous 510(k) submissions for "KardiaAI" as reference devices. This strongly indicates the use of AI/ML for the analysis functions.
No
The device is intended to monitor and analyze ECG rhythms for diagnostic purposes, not to provide treatment.
Yes
The device records, stores, displays, and analyzes ECG rhythms, including detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, and other conditions, which are all diagnostic functions indicating specific medical conditions.
No
The device description explicitly states that KardiaMobile 6L consists of "KardiaMobile 6L Hardware (portable small wireless hardware with electrodes) and the Kardia Core app." This indicates a hardware component is integral to the device's function.
Based on the provided information, the KardiaMobile 6L is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- KardiaMobile 6L Function: The KardiaMobile 6L records and analyzes electrical signals from the heart (ECG). It does not analyze biological specimens.
- Intended Use: The intended use describes recording, storing, displaying, and analyzing ECG rhythms to detect conditions like atrial fibrillation, bradycardia, etc. This is a physiological measurement and analysis, not an in vitro examination of a specimen.
Therefore, while the KardiaMobile 6L is a medical device used for diagnostic purposes, it falls under the category of a physiological monitoring and analysis device, not an IVD.
No
The clearance letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
KardiaMobile 6L is intended to record, store and two-channel electrocardiogram (ECG) rhythms. In single channel mode, KardiaMobile 6L can record Lead-I. In two channel mode, KardiaMobile 6L can record Lead-I and Lead-II simultaneously and derive Lead-III and unipolar limb leads aVR, aVF and aVL. KardiaMobile 6L 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. KardiaMobile 6L 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 (comma separated list FDA assigned to the subject device)
DXH, DPS, ODA
Device Description
KardiaMobile 6L is a trans-telephonic (transmission by smartphone) electrocardiogram (ECG) event recorder that records, stores, transfers, and analyzes single-channel or two channel ECG rhythm recordings. KardiaMobile 6L provides output of one or six ECG leads, including Lead I, Lead II, Lead III, aVL, aVR and aVF. The device utilizes the computing power of iOS-based or Android-based devices (referred to as "Mobile Computing Platforms" (MCP) within this 510(k)) to record and analyze ECG signals. KardiaMobile 6L consists of KardiaMobile 6L Hardware (portable small wireless hardware with electrodes) and the Kardia Core app. which is installed on an MCP (i.e., iOS or Android devices). KardiaMobile 6L Hardware uses Bluetooth to transmit the ECG signal from the electrodes to the Kardia Core app on the MCP, which then displays the recorded ECG on the MCP's screen. The device is intended to be used by patients with known or suspected heart conditions and health conscious individuals as well as by healthcare professionals (HCPs) who want to remotely monitor their patient's heart health. The device is available for Over-the-Counter (OTC) as well prescription use. The Kardia Core app provides the complete ECG recording and analysis workflow, from acquisition of the signal from the KardiaMobile 6L hardware, to the display of the ECG and analysis results, to printing of the ECG rhythm strip. The app utilizes KardiaAI (K181823, K201985) to provide ECG analysis, which includes the determinations of Normal Sinus Rhythm, Atrial Fibrillation, Bradycardia, Tachycardia, or Unclassified to OTC users and additionally, Sinus Rhythm determinations (Sinus Rhythm with Wide ORS, Sinus Rhythm with Supraventricular Ectopy, and Sinus Rhythm with Premature Ventricular Contractions) for prescription-use only users.
The Kardia Core app may be distributed as is or be incorporated into other apps ("variants"), by AliveCor or by third-parties, that can provide additional functionality such patient/user onboarding, storage and review of past data, as well as providing secondary MDDS displays of other medical devices. The main software app variant, called the Kardia App, is the default software marketed with KardiaMobile 6L. Kardia App includes workflows for OTC user account creation, integration with AliveCor's KardiaPro MDDS portal, secondary display of Bluetooth-enabled blood pressure monitors, and other non-regulated or enforcement discretion features. Kardia App also provides workflows for patients to forward the recorded ECG to their HCP, who can review the ECG rhythm and measure the QT interval. An alternate software variant, called the KardiaStation App, incorporates the Kardia Core app to be used exclusively within hospitals and clinics by adding patient administration workflows. Finally, a third variant called Kardia Rx App incorporates the Kardia Core app to provide a simple workflow to transfer the data for remote patient monitoring applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Yes, KardiaAI is mentioned. "KardiaMobile 6L 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." "The app utilizes KardiaAI (K181823, K201985) to provide ECG analysis".
Input Imaging Modality
Not Found
Anatomical Site
Left hand fingers to right hand fingers Left hand fingers to right hand fingers and to left leg/knee
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. The device is available for Over-the-Counter (OTC) as well prescription use.
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 testing was conducted on KardiaMobile 6L to support a determination of substantial equivalence to the predicate device.
Nonclinical Testing Summary: Since both the subject and the predicate have the same hardware, verification activities focused on the changes related to the software reorganization. The subject device successfully passed the software verification test methods previously used in K183319 and K210753.
Clinical Testing Summary: No clinical testing was required for the minor changes made to the software.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
AliveCor, Inc., K210753, KardiaMobile 6L
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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May 25, 2022
AliveCor, Inc. % Prabhu Raghavan Principal Consultant Mdar, LLC. 189 N. Bernardo Ave. Suite 100 Mountain View. California 94043
Re: K220350
Trade/Device Name: KardiaMobile 6L Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter And Receiver Regulatory Class: Class II Product Code: DXH, DPS, ODA Dated: February 24, 2022 Received: February 25, 2022
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer Shih Kozen 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) K220350
Device Name KardiaMobile 6L
Indications for Use (Describe)
KardiaMobile 6L is intended to record, store and two-channel electrocardiogram (ECG) rhythms. In single channel mode, KardiaMobile 6L can record Lead-I. In two channel mode, KardiaMobile 6L can record Lead-I and Lead-II simultaneously and derive Lead-III and unipolar limb leads aVR, aVF and aVL. KardiaMobile 6L 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. KardiaMobile 6L 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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510(k) Summary
Prepared in accordance with the requirements of 21 CFR 807.92
Submitter Information [807.92(a)(1)]
| Submitter/Applicant | AliveCor, Inc.
189 N. Bernardo Ave. Suite 100
Mountain View, CA 94043
Phone: 650-396-8553
Fax: 650-282-7932 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person | Prabhu Raghavan
Regulatory Consultant for AliveCor
Principal Consultant, MDQR, LLC
189 N. Bernardo Ave. Suite 100
Mountain View, CA 94043
Phone: 408-316-5707
Fax: 650-282-7932
Email: prabhu@mdqr.solutions |
| Submitter and
Secondary Contact Person | Susan Noriega
VP of Regulatory Affairs, Clinical Affairs and Quality
189 N. Bernardo Ave. Suite 100
Mountain View, CA 94043
Phone: 650-793-1966
Fax: 650-282-7932
Email: snoriega630@alivecor.com |
| Date Prepared | February 02, 2022 |
| Device Information [807.92(a)(2)] | |
| Trade Name | KardiaMobile 6L |
| Common Name | Transmitters and Receivers, Electrocardiograph, Telephone |
| Classification | 21 CFR§870.2920 |
| Device Class | Class II |
| Product Code | DXH |
| Subsequent Product Code | DPS, ODA |
Predicate Information [807.92(a)(3)]
AliveCor, Inc., K210753, KardiaMobile 6L Predicate(s)
Device Description [807.92(a)(4)]
KardiaMobile 6L is a trans-telephonic (transmission by smartphone) electrocardiogram (ECG) event recorder that records, stores, transfers, and analyzes single-channel or two channel ECG rhythm recordings. KardiaMobile 6L provides output of one or six ECG leads, including Lead I, Lead II, Lead III, aVL, aVR and aVF. The device utilizes the computing power of iOS-based or
4
510(k) Summary for KardiaMobile 6L AliveCor, Inc.
Android-based devices (referred to as "Mobile Computing Platforms" (MCP) within this 510(k)) to record and analyze ECG signals. KardiaMobile 6L consists of KardiaMobile 6L Hardware (portable small wireless hardware with electrodes) and the Kardia Core app. which is installed on an MCP (i.e., iOS or Android devices). KardiaMobile 6L Hardware uses Bluetooth to transmit the ECG signal from the electrodes to the Kardia Core app on the MCP, which then displays the recorded ECG on the MCP's screen. The device is intended to be used by patients with known or suspected heart conditions and health conscious individuals as well as by healthcare professionals (HCPs) who want to remotely monitor their patient's heart health. The device is available for Over-the-Counter (OTC) as well prescription use. The Kardia Core app provides the complete ECG recording and analysis workflow, from acquisition of the signal from the KardiaMobile 6L hardware, to the display of the ECG and analysis results, to printing of the ECG rhythm strip. The app utilizes KardiaAI (K181823, K201985) to provide ECG analysis, which includes the determinations of Normal Sinus Rhythm, Atrial Fibrillation, Bradycardia, Tachycardia, or Unclassified to OTC users and additionally, Sinus Rhythm determinations (Sinus Rhythm with Wide ORS, Sinus Rhythm with Supraventricular Ectopy, and Sinus Rhythm with Premature Ventricular Contractions) for prescription-use only users.
The Kardia Core app may be distributed as is or be incorporated into other apps ("variants"), by AliveCor or by third-parties, that can provide additional functionality such patient/user onboarding, storage and review of past data, as well as providing secondary MDDS displays of other medical devices. The main software app variant, called the Kardia App, is the default software marketed with KardiaMobile 6L. Kardia App includes workflows for OTC user account creation, integration with AliveCor's KardiaPro MDDS portal, secondary display of Bluetoothenabled blood pressure monitors, and other non-regulated or enforcement discretion features. Kardia App also provides workflows for patients to forward the recorded ECG to their HCP, who can review the ECG rhythm and measure the QT interval. An alternate software variant, called the KardiaStation App, incorporates the Kardia Core app to be used exclusively within hospitals and clinics by adding patient administration workflows. Finally, a third variant called Kardia Rx App incorporates the Kardia Core app to provide a simple workflow to transfer the data for remote patient monitoring applications.
Indications for use [807.92(a)(5)]
KardiaMobile 6L is intended to record, store and transfer one- and two-channel electrocardiogram (ECG) rhythms. In single channel mode, KardiaMobile 6L can record Lead-I. In two channel mode, KardiaMobile 6L can record Lead-I simultaneously and derive Lead-III and unipolar limb leads aVR, aVF and aVL. KardiaMobile 6L 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. KardiaMobile 6L 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.
Substantial Equivalence
The KardiaMobile 6L subject device has the same intended use, physical characteristics, and technological characteristics as the K210753, KardiaMobile 6L predicate device. The difference between the two devices is the reorganization of the software only and the addition of an
5
510(k) Summary for KardiaMobile 6L AliveCor, Inc.
Application Program Interface for other apps to access Kardia Core workflows. Performance testing, utilizing test methods previously used in K183319 and K210753, were employed to ensure that the device meets its requirements and that the differences between the subject and predicate device do not raise different questions of safety or effectiveness.
Performance Data [807.92(b)]
All necessary testing was conducted on KardiaMobile 6L to support a determination of substantial equivalence to the predicate device.
Nonclinical Testing Summarv [807.92(b)(1)]
Since both the subject and the predicate have the same hardware, verification activities focused on the changes related to the software reorganization. The subject device successfully passed the software verification test methods previously used in K183319 and K210753.
Clinical Testing Summary [807.92(b)(2)]
No clinical testing was required for the minor changes made to the software.
Conclusions [807.92(b)(3)]
The KardiaMobile 6L subject device has the same intended use as the predicate device, and the software changes to support the reorganization do not raise different questions of safety or effectiveness. The software changes between the subject device and the predicate device have been verified to ensure that the subject device is as safe and effective for its intended use as the predicate device. Therefore, the KardiaMobile 6L subject device is substantially equivalent to the predicate device.
| Feature | AliveCor KardiaMobile 6L
(Subject Device) | AliveCor KardiaMobile 6L
(K210753, Predicate Device) |
|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | DXH, DPS, QDA | No difference |
| Mechanism of Action | User completes circuit with skin
contact and hardware transmits ECG
signal to MCP to convert and display
ECG waveform | No difference |
| Where used (intended use) | Mobile/active users at rest (ambulatory) | No difference |
| Use cases for HCPs | Rhythm analysis
QT Interval Measurement | No difference |
| Anatomical sites | Left hand fingers to right hand fingers
Left hand fingers to right hand fingers
and to left leg/knee | No difference |
| Software application
functions | Medical device functions
● Acquire ECG from
○ KardiaMobile 6L Hardware | Medical device functions
● No difference
○ |
| Feature | AliveCor KardiaMobile 6L
(Subject Device) | AliveCor KardiaMobile 6L
(K210753, Predicate Device) |
| | Record, transfer, and display an ECG, ECG analysis of KardiaAI (K181823 or K201985), as applicable Create a PDF rhythm strip of the recorded ECG API for integrating with other mobile applications | Provides additional nonmedical device or enforcement discretion functions such as workflows for user account creation, and onboarding, connecting to Bluetooth-enabled blood pressure monitors to provide a secondary display, share previously recorded ECG and blood pressure data with healthcare professionals, etc. |
| ECG Analysis
Determinations using
K181823 KardiaAI.
In OTC and Rx Only type of
use | Atrial Fibrillation
Normal Sinus Rhythm
Tachycardia
Bradycardia
Unclassified
Unreadable | No difference |
| ECG Analysis
Determinations using
K201985 KardiaAI.
In Rx Only type of use | Atrial Fibrillation
Sinus Rhythm
Sinus Rhythm with Wide QRS,
Sinus Rhythm with Supraventricular
Ectopy
Sinus Rhythm with Premature
Ventricular Contractions
Normal Sinus Rhythm
Tachycardia
Bradycardia
Unclassified
Unreadable | No difference |
| Data Acquisition: | | |
| Frequency Response | 0.5Hz – 40Hz | No difference |
| No. of ECG electrodes | Three (3) dry electrodes | No difference |
| No. of ECG channels | Single-channel and two-channel | No difference |
| Resolution | 16 bits | No difference |
| Sample Rate | 300 Samples/Second | No difference |
| Power Supply: | | |
| Battery | 1 Lithium Manganese Dioxide Coin
Cells | No difference |
| Battery Life (typical) | 100 hours operational | No difference |
Comparison of Technological Characteristics with the Predicate Device [807.92(a)(6)]
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