(107 days)
No.
The device is intended for recording, storing, and analyzing ECG rhythms and detecting conditions like atrial fibrillation; it does not provide therapy or treatment.
Yes
The device records and analyzes ECG rhythms to detect conditions such as atrial fibrillation, bradycardia, and tachycardia, which are used to aid in the diagnosis of heart conditions. It also mentions comparison to a "gold standard 12-lead diagnostic ECG device" and the ability to "review and measure the QT interval reliably," which are functions of a diagnostic device.
No
The device description explicitly states that KardiaMobile 6L consists of "KardiaMobile 6L Hardware (portable small wireless hardware with electrodes) and the Kardia App". This indicates the device includes a physical hardware component in addition to the software.
Based on the provided text, the KardiaMobile 6L is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- KardiaMobile 6L Function: The KardiaMobile 6L records and analyzes electrical signals from the heart (ECG). It does not analyze biological specimens taken from the body.
Therefore, while it is a medical device used for diagnosis and monitoring, it falls under a different regulatory category than IVD devices.
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
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 aVE. 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, QDA
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 submission) to obtain and analyze ECG signals. KardiaMobile 6L consists of KardiaMobile 6L Hardware (portable small wireless hardware with electrodes) and the Kardia 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 App on the MCP. KardiaMobile 6L displays thus record their ECG and additionally provides ECG analysis using the KardiaAI (K181823, K201985) ECG analysis suite, which includes the determinations of Atrial Fibrillation, Normal Sinus Rhythm, Bradycardia, Tachycardia, or Unclassified. 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. Patients can forward the recorded ECG to their HCP, who can review the ECG for rhythm and to measure the QT interval. The device is available for Over-the-Counter (OTC) purchase and for purchase with a prescription. The Kardia App is also comes in an alternate variant, called the KardiaStation App that is exclusively used within hospitals and clinics; this app is identical to the Kardia App with the exception of incorporating patient administration workflows.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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.
additionally provides ECG analysis using the KardiaAI (K181823, K201985) ECG analysis suite, which includes the determinations of Atrial Fibrillation, Normal Sinus Rhythm, Bradycardia, Tachycardia, or Unclassified.
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
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
Clinical performance testing was conducted to validate that a healthcare professional can review and measure the QT interval reliably using an ECG recorded using KardiaMobile 6L. The clinical evaluation compared KardiaMobile 6L 6-lead measurements (recorded in a sitting position) to an FDA-cleared gold standard 12-lead diagnostic ECG device (recorded supine) in 313 subjects. Subjects included both healthy volunteers and patients suspected of long QT syndrome or other genetic heart disease. ECG recordings from both the subject device and gold standard device were taken comparison. A core lab used to provide precise OT measurements for Thorough QT studies was utilized to measure the QT and heart-rate corrected QTc in each ECGs, in a randomized and blinded order, using standard measurement techniques.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical performance testing was conducted to validate that a healthcare professional can review and measure the QT interval reliably using an ECG recorded using KardiaMobile 6L. The clinical evaluation compared KardiaMobile 6L 6-lead measurements (recorded in a sitting position) to an FDA-cleared gold standard 12-lead diagnostic ECG device (recorded supine) in 313 subjects. The comparative statistical analysis of this assessment determined that the QT interval measured using the subject device is equivalent to the interval measured from a commercial gold-standard diagnostic 12-lead ECG. The results of the testing demonstrated that the modifications to the KardiaMobile 6L labeling do not raise different questions of safety or effectiveness.
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.
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.
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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June 30, 2021
AliveCor, Inc. % Prabhu Raghavan Principal MDQR, LLC 444 Castro Street, Suite 600 Mountain View, California 94041
Re: K210753
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, QDA Dated: March 12, 2021 Received: March 15, 2021
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.
1
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 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 mediation-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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
K210753
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 aVE. 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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary for K210753
Prepared in accordance with the requirements of 21 CFR 807.92
Submitter Information [807.92(a)(1)]
| Submitter/Applicant | AliveCor, Inc.
444 Castro Street, Suite 600
Mountain View, CA 94041
Phone: 650-396-8553
Fax: 650-282-7932 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person | Prabhu Raghavan
Regulatory Consultant for AliveCor
MDQR, LLC
444 Castro Street, Suite 600
Mountain View, CA 94041
Phone: 408-316-5707
Fax: 650-282-7932
Email: prabhu@mdqr.solutions |
| Submitter and
| Secondary Contact Person | Saket Bhatt |
|---|---|
| VP of Regulatory and Quality | |
| 444 Castro Street, Suite 600 | |
| Mountain View, CA 94041 | |
| Phone: 408-701-7319 | |
| Fax: 650-282-7932 | |
| Email: ra@alivecor.com |
Date Prepared
May 27, 2021
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, QDA |
Predicate Information [807.92(a)(3)|
AliveCor, Inc., K183319, Triangle System (marketed as Predicate(s) KardiaMobile 6L)
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,
4
K210753
510(k) Summary for KardiaMobile 6L AliveCor, Inc.
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 submission) to obtain and analyze ECG signals. KardiaMobile 6L consists of KardiaMobile 6L Hardware (portable small wireless hardware with electrodes) and the Kardia 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 App on the MCP. KardiaMobile 6L displays thus record their ECG and additionally provides ECG analysis using the KardiaAI (K181823, K201985) ECG analysis suite, which includes the determinations of Atrial Fibrillation, Normal Sinus Rhythm, Bradycardia, Tachycardia, or Unclassified. 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. Patients can forward the recorded ECG to their HCP, who can review the ECG for rhythm and to measure the QT interval. The device is available for Over-the-Counter (OTC) purchase and for purchase with a prescription. The Kardia App is also comes in an alternate variant, called the KardiaStation App that is exclusively used within hospitals and clinics; this app is identical to the Kardia App with the exception of incorporating patient administration workflows.
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-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.
Substantial Equivalence
The KardiaMobile 6L subject device has the same intended use, physical characteristics, technological characteristics and software as the K183319, Triangle System (marketed as "KardiaMobile 6L") predicate device. The difference between the two devices is labeling only, in that the subject device expands the use by HCPs to measure the QT interval in addition to the rhythm analysis application in the predicate. This expanded use has been analyzed and addressed through performance testing. The testing results showed that differences between the subject and predicate device do not raise different questions of safety or effectiveness. OT interval measurement is prescription use.
5
| Feature | AliveCor KardiaMobile 6L
(Subject Device) | AliveCor KardiaMobile 6L
(K183319)
(Predicate Device) |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Product Code | DXH, DPS, QDA | DXH, DPS, QDA |
| 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 | Rhythm analysis only |
| Anatomical sites | Left hand fingers to right hand fingers
Left hand fingers to right hand fingers
and to left leg/knee | No difference |
| Available Algorithms
(through KardiaAI
K181823) | Atrial Fibrillation
Noise Algorithm
Normal Sinus Rhythm
Tachycardia
Bradycardia | 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)]
6
K210753
510(k) Summary for KardiaMobile 6L AliveCor, Inc.
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 Summary [807.92(b)(1)]
Since both the subject and the predicate have the same hardware and software, and the changes are to device labeling only, no bench testing was required.
Clinical Testing Summary [807.92(b)(2)]
Clinical performance testing was conducted to validate that a healthcare professional can review and measure the QT interval reliably using an ECG recorded using KardiaMobile 6L. The clinical evaluation compared KardiaMobile 6L 6-lead measurements (recorded in a sitting position) to an FDA-cleared gold standard 12-lead diagnostic ECG device (recorded supine) in 313 subjects. Subjects included both healthy volunteers and patients suspected of long QT syndrome or other genetic heart disease. ECG recordings from both the subject device and gold standard device were taken comparison. A core lab used to provide precise OT measurements for Thorough QT studies was utilized to measure the QT and heart-rate corrected QTc in each ECGs, in a randomized and blinded order, using standard measurement techniques. The comparative statistical analysis of this assessment determined that the QT interval measured using the subject device is equivalent to the interval measured from a commercial gold-standard diagnostic 12-lead ECG. The results of the testing demonstrated that the modifications to the KardiaMobile 6L labeling do not raise different questions of safety or effectiveness.
Conclusions [807.92(b)(3)]
KardiaMobile 6L has the same intended use as the predicate device, and the labeling differences do not raise different questions of safety or effectiveness. The labeling differences between the subject device and the predicate device have been clinically validated. Therefore, KardiaMobile 6L is substantially equivalent to the predicate device.