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AliveCor's Corvair ECG analysis system assists the healthcare professional (HCP) in measuring and interpreting resting diagnostic ECGs for rhythm and morphological information by providing an initial automated interpretation. The interpretation by the analysis program may then be confirmed, edited, or deleted by the HCP. The analysis program is intended for use in the general population ranging from healthy subjects to patients with cardiac abnormalities. Corvair is intended for use by healthcare professionals, or trained personnel in healthcare facilities (e.g. the doctor's office or hospital) and in acute settings. Corvair analyses should be used only as an adjunct to clinical history, symptoms, and the results of other non-invasive and/or invasive tests. Corvair analyses are considered unconfirmed and must be reviewed by a qualified physician. The provisional automated ECG analysis should not be used for clinical action if it has not been reviewed by a qualified healthcare professional capable of independently interpreting the ECG signal.

Corvair is Software as a Medical Device (SaMD) intended for use by healthcare professionals to analyze a diagnostic-bandwidth ECG. Corvair analyzes a 10-second ECG and provides rhythm analysis, morphological analysis, and ECG interval estimation. Corvair provides 35 separate determinations with 14 rhythm and 21 morphology determinations. Rhythm determinations include Normal Sinus Rhythm, Atrial fibrillation, Atrial flutter, Paced Rhythm, Junctional Rhythm, and Bigeminy, with the modifiers of 1* Degree AV Block, Higher Degree AV Block (including 2nd and 3rd degree AV blocks), Sinus Arrhythmia, Marked Sinus Arrhythmia, Marked Bradycardia, Sinus Tachycardia, and PVCs. Morphology determinations include Intraventricular block (RBBB, LBBB, and Other Intraventricular Block), Hypertrophy (LVH, and RVH), Atrial Enlargement (LAE and RAE), Acute Myocardial Infarction (Anterior MI, Inferior MI, Lateral MI), Old/Previous Myocardial Infarction (Anterior Old MI, Inferior Old MI, Lateral Old MI), Ischemia (Anterior, Inferior, Lateral), Prolonged QT, Paced ECG, Other Morphological Defects (Early Repolarization, Wolff-Parkinson-White Syndrome (WPW)), and Normal or Otherwise Normal. Rhythm and morphology determinations are overlapping. i.e., an ECG could receive multiple rhythm and morphology determinations (e.g., Sinus Rhythm, Acute MI). The device also provides global ECG measurements (PR, ORS, OT, OTcB, OTcF, and Heart Rate). No beat-level analysis is provided by the device. Corvair may fail to detect or misidentify conduction system pacing and demand pacing. Corvair does not detect sinus pause. While Corvair provides PR interval estimation and does detect WPW, it does not have a separate determination of abnormally short PR intervals. This SaMD provides these capabilities in the form of an Application Program Interface (API) library. Any software or device ("target device") can incorporate the Corvair API library into its device software to provide users with resting ECG analytics. The input ECG is provided by the target device to Corvair, to which the various Corvair algorithms are applied, and outputs generated accordingly. Corvair has a C++ interface and a distributed binary (library), which is used by the target device to statically link to Corvair. Viewing of Corvair's ECG analysis is handled by the target device. Corvair is intended to be used with standard diagnostic-bandwidth, resting ECG recordings collected using 'wet' Ag/AgCl electrodes with conductive gel/paste. Corvair only requires 4 ECG leads for analysis, specifically, either Leads {I, II, V2, and V4}, or Leads {I, II, V1, and V4}. Compatible devices include resting ECGs from GE Medical Systems® (e.g., K081437, MAC 1600, K110266, MAC 5500, K173830, MAC VU360, etc.), and AliveCor's Impala (K232035). Regardless of the lead configuration, Corvair provides the same set of rhythm, morphological, and interval determinations. Corvair has two modes of operation, Symptomatic Mode, which is used when the pre-test probability for a specific rhythm or morphology is high, and Asymptomatic Mode, which optimizes the PPV, by optimizing the specificity, to detect the various rhythms and morphologies. The target device can choose which lead set and which mode of determinations to utilize based on the target clinical application and the patient's clinical presentation. Corvair utilizes several deep neural networks (DNNs) for its analysis. These DNNs were trained on a dataset of approximately 1 million 12-Lead ECGs acquired from about 400K clinical patients at the Emory University Hospital over several decades between 1985 and 2010. Each ECG has a physician overread confirmed diagnosis with multiple diagnostic codes. The dataset had a 52%/48% ratio of ECGs from male and female patients, respectively. The average age of the patient was 61.3 ± 16. The dataset included 56% white, 33% African American, 2.2% Asian, 9% other races/ethnicities.

Impala is intended to record, store, and transfer a 12-lead resting electrocardiogram (ECG). Impala acquires four standard diagnostic-bandwidth leads (Leads I, II, V2, V4, or Leads I, II, V1, V4). The device derives four standard diagnosticbandwidth, Lead-III and unipolar limb leads aVR, aVF and aVL. The device also synthesizes Leads V1 or V2, V3, V5, V6, which are similar to but not identical to the same leads of a standard diagnostic 12-lead. The 4 synthesized chest leads are not intended for diagnostic use and may fail to show important findings limited to those leads. This device is not a substitute for a diagnostic 12-lead ECG and is contraindicated for use in ruling out any condition (including but not limited to certain ischemia/infarcts, Brugada syndrome) for which the diagnosis may be solely dependent on the synthesized leads. The device also provides ECG measurements and ECG analysis (rhythm and morphological interpretation) using the acquired leads. The automated ECG analysis results are provisional and should not be used for clinical action if it has not been reviewed by a qualified physician capable of interpreting the ECG signal in the context of the patient's condition. The automated analysis may then be confirmed, edited, or qualified physician. ECG analysis should be used only as an adjunct to clinical history, symptoms, and the results of other non-invasive tests. Impala is intended for use with patients aged 18 years and older. Impala is intended for use by healthcare professionals, or trained personnel in healthcare facilities (e.g. the doctor's office or hospital) and in acute settings.

Impala is a portable 12-Lead resting electrocardiograph (ECG) device that acquires 4 standard diagnostic-bandwidth ECG leads from a patient (I, II, V1 or V2, V4), derives 4 standard diagnostic-bandwidth leads (aVL, aVR, aVF, III), and using software generates the remaining leads (V2 or V1, V3, V5, V6) to create a 12-Lead ECG recording. The device can be used by healthcare professionals (HCPs) to record a reduced lead, diagnostic-bandwidth, resting ECG, where traditional 10 electrode, 12 lead ECG recorders are not practical to administer due to size, time, or need for specialized clinicians to administer. Examples may include physician offices, and remote and field locations. The Impala hardware consists of the Impala ECG Module that connects to the Patient Lead Wire. The Patient Lead Wire is a single cable that includes five snap-on electrodes. Impala also consists of a mobile software application, the Impala App that executes on a mobile computing platform (MCP), such as an Apple iPhone smartphone. To record an ECG, the user positions standard off-the-shelf (OTS) ECG gel electrodes on the patient and snaps on the connectors in the Patient Lead Wire on to the electrodes. Impala allows for two options for which set of leads are acquired: 1. Lead Set 1: Leads {I, II, V2, and V4}, with electrodes on RA, LA, LL, V2, V4; and 2. Lead Set 2: Leads {I, II, V1, and V4} with electrodes on RA, LA, LL, V1, and V4. Impala incorporates AliveCor's Corvair (K231010), a software as a medical device, to provide rhythm analysis, morphological analysis, and ECG measurements. Corvair has two modes of operation, Symptomatic Mode, which is used when the pre-test probability for a specific rhythm is high, and Asymptomatic Mode, which optimizes the PPV, by optimizing the specificity, to detect the various rhythms and morphologies. The user can choose which Impala Lead Set and which Corvair mode of determinations to utilize based on the target clinical application.

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.

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.

AliveCor QT Service analyses 30 seconds of a previously acquired electrocardiogram (ECG) from AliveCor designed 6-Lead ambulatory ECG devices analyzed as normal sinus rhythm for QT interval measurements. AliveCor OT Service is intended for use in a professional medical facility, such as a hospital, clinic, or doctor's office by a qualified health care professional, including trained ECG technician. AliveCor QT Service is indicated for use on adult patients (older than 18 years). The device has not been tested for and is not intended for pediatric use. The service is not intended for use in life supporting, or sustaining systems, or continuous ECG monitors, or cardiac alarm devices, or OTC use only devices.

AliveCor QT Service is a cloud-based Software as a Medical Device (SaMD) that is used to measure the QT and heart-rate corrected QT ("QTc") interval measurements from electrocardiograms (ECG) recorded from adult patients (older than 18 years) using AliveCordesigned 6-Lead ambulatory ECG devices. AliveCor QT Service provides QT and QTc interval measurements only on ECGs analyzed as Normal Sinus Rhythm by KardiaAI (K201985). AliveCor QT Service is a prescription (Rx) use only device intended for use by qualified healthcare professionals, including trained ECG technicians. Healthcare professionals can access AliveCor OT Service over the internet from patient management and ECG storage Medical Device Data Systems (MDDS), or from other prescription-use only medical data software devices. These devices provide a previously recorded ECG from an AliveCor-designed 6-Lead ambulatory ECG device, such as the KardiaMobile 6L (K210753), in a compatible format using the AliveCor QT Service's REST-based application program interface (API). REST or REpresentational State Transfer is a software methodology that defines rules for creating web services to access resources over Hypertext Transfer Protocol (HTTP). AliveCor QT Service responds to the analysis request with the following measurements: - QT interval, measured from the first 30 seconds of the ECG - Heart-rate corrected QT (QTc) interval based on the Bazett's formula and the Fridericia's ● formula AliveCor QT Service utilizes various internal algorithms including deep neural networks (DNN) to analyze an ECG to compute the QT interval. AliveCor QT Service also includes algorithms to compute the RR-interval, which is used to provide both the Bazett's and Fridericia corrected OTc intervals. These algorithms were trained and validated on datasets with ECGs from patients representative of the device's intended use. The training included more than 750K ECGs from over 250K patients. The training dataset included more than 200K ECGs with approximately 49% data from females, approximately 70% from subjects who were reported as whites, 3% nonwhites, and 27% from those who did not report their race The validation was conducted on two datasets. The first dataset included more than 34K ECGs with approximately 51% data from females, approximately 80% from subjects who were reported as whites, 3.6% non-whites, and 1 7% from those who did not report their race. The second dataset included 226 ECGs with approximately 60% data from females, approximately 87% from subjects who were reported as whites, 3.2% non-whites, and 10% from those who did not report their race.

The KardiaMobile Card System is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The KardiaMobile Card 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. The KardiaMobile Card 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.

The AliveCor KardiaMobile Card System is a single-channel ambulatory electrocardiogram (ECG) device that is intended to record, store, transfer, display, and analyze single-channel ECG rhythms in an ambulatory setting. The device utilizes the computing power of Apple iOS- and Google Android-based smartphones to obtain and analyze single-channel ECGs. 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 Card 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.

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.

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.

KardiaAI is a software analysis library intended to assess ambulatory electrocardiogram (ECG) rhythms from adult subjects (when prescribed or used under the care of a physician). 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 library provides the following capabilities: - Filtering ECG noise, - Reporting heart rate measurement from ECGs, - Detecting noisy ECGs. - Reporting ECG rhythm analysis for the presence of sinus rhythm, atrial fibrillation, bradycardia, for ECGs detected as sinus rhythm, detecting normal sinus rhythm with with wide QRS, sinus rhythm with premature ventricular contractions (PVC), and sinus rhythm with supraventricular ectopy; - Detecting QRS complexes in an ECG. - For ECGs detected as sinus rhythm, classifying individual beats as a PVC or non-PVC beat, and - Generating an average beat from an ECG The device is not intended for use in patients who have pacemakers, ICDs, or other implanted electronic devices.

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 an ECG and provides these capabilities in the form of an Application Program Interface (API) library. AliveCor-designed ECG devices ("target device") incorporate the API library into their device software to enable algorithmic analysis of ECGs to provide analytical capabilities. KardiaAI provides ECG processing functions, including ECG noise filtering and detection of noisy ECGs. It performs rhythm analysis on ECGs, specifically detecting atrial fibrillation, bradycardia, tachycardia and sinus rhythm, which can be further classified as normal sinus rhythm, sinus rhythm with wide QRS, sinus rhythm with premature ventricular contractions (PVCs), and sinus rhythm with supraventricular ectopy. It further provides beat-level annotations, including beat-level ORS locations, and, for sinus rhythm ECGs, PVC/not-PVC annotations. It also provides an average beat ECG representation, and the R-R interval tachogram. Recording and viewing of ECGs and the results of the KardiaAI analyses are to be provided by other AliveCor FDA-cleared devices (i.e., the target devices) into which the API library is incorporated, such as AliveCor's Triangle System (K183319) and KardiaMobile System (K182396).

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. 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.

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.

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.

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.

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.

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.