(161 days)
Not Found
Yes
The summary explicitly mentions "AliveCor's KardiaAI platform" for ECG analysis and arrhythmia detection.
No
The device is intended to record, store, and analyze ECG rhythms for diagnostic purposes (detecting conditions like atrial fibrillation, bradycardia, etc.), not to provide treatment or therapy.
Yes
The device explicitly states its intended use for "detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, and others" and for patients with "known or suspected heart conditions," which are diagnostic purposes based on ECG analysis.
No
The device description explicitly states that the Triangle System consists of both "the Triangle Hardware (portable small wireless hardware with electrodes)" and the Kardia app (software). This indicates it is a system with both hardware and software components, not a software-only device.
Based on the provided text, the Triangle System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Triangle System Function: The Triangle System records and analyzes electrical signals from the heart (ECG rhythms) directly from the patient's body using electrodes placed on the skin. It does not analyze specimens taken from the body.
The device is a medical device used for recording and analyzing physiological signals, specifically electrocardiograms. While it provides diagnostic information (detecting arrhythmias), it does so through direct measurement of electrical activity, not through the analysis of in vitro specimens.
No
The clearance letter does not explicitly state that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The "Control Plan Authorized (PCCP) and relevant text" section explicitly states "Not Found".
Intended Use / Indications for Use
The Triangle System is intended to record, store and two-channel electrocardiogram (ECG) rhythms. In single channel mode, the Triangle System can record Lead-I. In two channel mode, the Triangle System can record Lead-I and Lead-II simultaneously and derive Lead-II and unipolar limb leads aVR, aVF and aVL. The Triangle System also displays ECG rhythms and output of ECG analysis from AliveCor's KardiaAl platform including detecting the presence of normal sinus rhythm, atral fibrillation, bradycardia, and others. The Triangle 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, QDA
Device Description
The Triangle System 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. The Triangle System provides output of one or six ECG leads by recording Lead-I and Lead-II simultaneously and derive Lead-III and unipolar limb leads aVR, aVF, and aVL for identifying cardiac arrhythmias. The device utilizes the computing power of iOS-based or Android-based smartphones (referred to as "Mobile Computing Platforms" (MCP) within this submission) to obtain and analyze ECG signals. The device consists of the Triangle Hardware (portable small wireless hardware with electrodes) and the Kardia app, which is installed on an MCP (i.e., iPhone or Android phone). The Triangle System is a new addition to AliveCor's ambulatory ECG devices that are intended to be used by lay users to record their ECG and obtain ECG analysis of Atrial Fibrillation. Normal Sinus Rhythm, Bradycardia, Tachycardia, or unclassified file. The Triangle System hardware transmits the ECG signal from the electrodes 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. The device is available for Over-the-Counter (OTC) purchase and for purchase with clinician prescription.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
The Triangle System also displays ECG rhythms and output of ECG analysis from AliveCor's KardiaAl platform including detecting the presence of normal sinus rhythm, atral fibrillation, bradycardia, and others.
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
Not Found
Summary of Performance Studies
The performance of the Triangle System for recording a 6-lead ECG was validated in a clinical study. Overall, 44 subjects participated in the study, that included nearly equal numbers of healthy volunteers and arrhythmia patients. ECG recordings were taken simultaneously with both the Triangle device and gold standard 12-lead ECG device for comparison. Qualitative and quantitative analyses of equivalence were performed on the 44 pairs of ECGs.
For qualitative assessment, two board-certified electrophysiologists compared 6-lead ECG rhythm strips acquired from the Triangle device and the corresponding leads from the reference standard 12-lead ECG device for diagnostic equivalence. All paired recordings (100%, n=44 subjects), were deemed equivalent for assessing cardiac arrhythmias by both electrophysiologists. The results of the assessment determined that the subject device records a 6-lead ECG that is qualitatively equivalent to the recordings of corresponding leads from a commercial gold standard 12-lead ECG device.
For quantitative equivalence, median beat cross correlation for Lead I and II and RMS error for all 6 limb leads were computed between the paired ECGs for each subject. This analysis was conducted on the unfiltered ECG output as well as the enhanced filtered (EF) ECG output. Triangle ECGs had a minimum correlation of 0.96 and a maximum RMS error of 47 uV as compared to the corresponding lead of the 12-lead ECG. The results of the quantitative analysis of the ECG recordings further confirmed that the Triangle device ECG has equivalent output to that of the gold standard 12-lead ECG device.
Key Metrics
For quantitative equivalence, median beat cross correlation for Lead I and II and RMS error for all 6 limb leads were computed between the paired ECGs for each subject. This analysis was conducted on the unfiltered ECG output as well as the enhanced filtered (EF) ECG output. Triangle ECGs had a minimum correlation of 0.96 and a maximum RMS error of 47 uV as compared to the corresponding lead of the 12-lead ECG.
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
AliveCor, Inc. % Prabhu Raghavan Vice President of Regulatory Quality AliveCor 224 Airport Parkway, Suite 250 San Jose, California 95110
Re: K183319
Trade/Device Name: Triangle System Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter And Receiver Regulatory Class: Class II Product Code: DXH, DPS, QDA Dated: April 9, 2019 Received: April 10, 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
1
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/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 mediation-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.
Acting Assistant Director External Heart Rhythm and Rate Devices Team 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) K183319
Device Name Triangle System
Indications for Use (Describe)
The Triangle System is intended to record, store and two-channel electrocardiogram (ECG) rhythms. In single channel mode, the Triangle System can record Lead-I. In two channel mode, the Triangle System can record Lead-I and Lead-II simultaneously and derive Lead-II and unipolar limb leads aVR, aVF and aVL. The Triangle System also displays ECG rhythms and output of ECG analysis from AliveCor's KardiaAl platform including detecting the presence of normal sinus rhythm, atral fibrillation, bradycardia, and others. The Triangle 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. and and in the
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) Notification K183319
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
Contact Person:
Prabhu Raghavan Vice President of Regulatory and Quality Phone: 650-396-8553 Email: RA@alivecor.com.
Date Prepared:
April 8, 2019
DEVICE INFORMATION [807.92(a)(2)]
Trade Name:
Triangle System
Generic/Common Name:
Telephone electrocardiograph transmitter and receiver
Classification:
21 CFR$870.2920, Transmitters and Receivers, Electrocardiograph, Telephone, Class II
Product Code:
DXH, DPS, QDA
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PREDICATE DEVICE(S) [807.92(a)(3)]
K142672 - AliveCor Heart Monitor (currently marketed as "KardiaMobile")
K181823 - AliveCor KardiaAI
DEVICE DESCRIPTION [807.92(a)(4)]
The Triangle System 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. The Triangle System provides output of one or six ECG leads by recording Lead-I and Lead-II simultaneously and derive Lead-III and unipolar limb leads aVR, aVF, and aVL for identifying cardiac arrhythmias. The device utilizes the computing power of iOS-based or Android-based smartphones (referred to as "Mobile Computing Platforms" (MCP) within this submission) to obtain and analyze ECG signals. The device consists of the Triangle Hardware (portable small wireless hardware with electrodes) and the Kardia app, which is installed on an MCP (i.e., iPhone or Android phone). The Triangle System is a new addition to AliveCor's ambulatory ECG devices that are intended to be used by lay users to record their ECG and obtain ECG analysis of Atrial Fibrillation. Normal Sinus Rhythm, Bradycardia, Tachycardia, or unclassified file. The Triangle System hardware transmits the ECG signal from the electrodes 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. The device is available for Over-the-Counter (OTC) purchase and for purchase with clinician prescription.
INDICATIONS FOR USE [807.92(a)(5)]
The Triangle System is intended to record, store and transfer one- and two-channel electrocardiogram (ECG) rhythms. In single channel mode, the Triangle System can record Lead-I. In two channel mode, the Triangle System can record Lead-II simultaneously and derive Lead-III and unipolar limb leads aVR, aVF and aVL. The Triangle 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, tachycardia, and others. The Triangle 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)]
| Feature | Triangle System
(subject device) | AliveCor Heart Monitor
K142672 |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| 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 |
| Anatomical sites | Left hand fingers to right hand fingers
Left hand fingers to right hand fingers
and to left leg/knee | Left hand fingers to right hand fingers
Right hand fingers to left leg/knee |
| Available Algorithms | Atrial Fibrillation
Noise Algorithm
Normal Sinus Rhythm
Tachycardia
Bradycardia | Atrial Fibrillation |
| Data Acquisition:
Frequency Response | 0.5Hz - 40Hz | No difference |
| No. of ECG electrodes | Three (3) dry electrodes | Two (2) dry electrodes |
| No. of ECG channels | Single-channel and two-channel | Single channel only |
| Resolution | 16 bits | No difference |
| Sample Rate | 300 Samples/Second | No difference |
| Power Supply:
Battery
Battery Life (typical) | 1 Lithium Manganese Dioxide Coin
Cells
100 hours operational | No difference |
| Leads | Lead-I, or Lead-I, Lead-II, Lead-III,
aVL, aVR and aVF. | Lead-I or Lead-II |
| Hardware interface | Three-electrode sensor | Two-electrode sensor |
| Software interface | Apple iOS-based or Google
Android-based software | No difference |
| Communications | Bluetooth Low Energy | Ultrasonic Acoustics acquired by phone |
| Physical Specs:
Dimensions | 90 x 30 x 7mm | 82 x 32 x 3.5mm |
| Weight | 24 grams | 15 grams |
SUBSTANTIAL EQUIVALENCE
The Triangle 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 testing results showed that differences between the subject and predicate device do not raise different questions of safety or effectiveness.
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PERFORMANCE DATA [807.92(b)]
All necessary non-clinical and clinical performance testing was conducted on the Triangle 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 Triangle System with passing results supporting the determination of substantial equivalence to the predicate device. This testing included the following:
- Verification of the device's specification -
- Testing to software level of concern requirements -
- Validation of KardiaAI integration -
- Validation of BLE ECG transmission -
- -Human factors evaluation
- Evaluation to the following standards: -
- ISO 10993-1:2009 (CORR 2010), Biological Evaluation of Medical O Devices - Part 1: Evaluation and Testing Within a Risk Management Process
- IEC 60601-1:2012, Medical Electrical Equipment Part 1: General O Requirements For Basic Safety And Essential Performance,
- IEC 60601-1-2:2014, 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 O 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: O Particular Requirements For The Basic Safety And Essential Performance Of Ambulatory Electrocardiographic Systems.
[807.92(b)(2)] Clinical Study Summary:
The performance of the Triangle System for recording a 6-lead ECG was validated in a clinical study. Overall, 44 subjects participated in the study, that included nearly equal numbers of healthy volunteers and arrhythmia patients. ECG recordings were taken simultaneously with both the Triangle device and gold standard 12-lead ECG device for comparison. Qualitative and quantitative analyses of equivalence were performed on the 44 pairs of ECGs.
For qualitative assessment, two board-certified electrophysiologists compared 6-lead ECG rhythm strips acquired from the Triangle device and the corresponding leads from the reference standard 12-lead ECG device for diagnostic equivalence. All paired recordings (100%, n=44 subjects), were deemed equivalent for assessing cardiac arrhythmias by both electrophysiologists. The results of the assessment determined that
7
ALIVECOR, INC.
the subject device records a 6-lead ECG that is qualitatively equivalent to the recordings of corresponding leads from a commercial gold standard 12-lead ECG device.
For quantitative equivalence, median beat cross correlation for Lead I and II and RMS error for all 6 limb leads were computed between the paired ECGs for each subject. This analysis was conducted on the unfiltered ECG output as well as the enhanced filtered (EF) ECG output. Triangle ECGs had a minimum correlation of 0.96 and a maximum RMS error of 47 uV as compared to the corresponding lead of the 12-lead ECG. The results of the quantitative analysis of the ECG recordings further confirmed that the Triangle device ECG has equivalent output to that of the gold standard 12-lead ECG device.
During this clinical study, no adverse events were observed.
SUMMARY
The Triangle System 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 which included non-clinical and clinical testing. The testing results show that differences between the subject and predicate device do not raise different questions of safety or effectiveness. The Triangle System is substantially equivalent to the predicate device.