(107 days)
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.
The document provided is a 510(k) summary for the AliveCor KardiaMobile 6L device. It describes the device, its intended use, and its substantial equivalence to a previously cleared predicate device.
Based on the provided information, the current submission (K220350) is for a minor modification (software reorganization and API addition) to an existing device (K210753, KardiaMobile 6L). Therefore, the study described here is primarily focused on demonstrating that these software changes do not adversely affect the device's safety or effectiveness as previously established.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states that the subject device (K220350) is being compared to its predicate (K210753). The performance criteria are implicitly met by demonstrating that the changes do not raise new questions of safety or effectiveness, as stated in the "Nonclinical Testing Summary" and "Conclusions" sections.
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Subject Device K220350) |
|---|---|
| Maintain all functionalities of the predicate device (KardiaMobile 6L K210753) | All functionalities (ECG acquisition, display, analysis, PDF generation) maintained. |
| ECG Analysis Determinations (KardiaAI K181823) for OTC and Rx Only users remain equivalent for: Atrial Fibrillation, Normal Sinus Rhythm, Tachycardia, Bradycardia, Unclassified, Unreadable. | Performances for these determinations are stated as "No difference" compared to the predicate. |
| ECG Analysis Determinations (KardiaAI K201985) for Rx Only users remain equivalent for: 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. | Performances for these determinations are stated as "No difference" compared to the predicate. |
| No degradation in data acquisition specifications: Frequency Response (0.5Hz – 40Hz), Number of ECG electrodes (Three dry electrodes), Number of ECG channels (Single-channel and two-channel), Resolution (16 bits), Sample Rate (300 Samples/Second). | All data acquisition specifications are stated as "No difference" compared to the predicate. |
| No degradation in power supply specifications: Battery (1 Lithium Manganese Dioxide Coin Cells), Battery Life (100 hours operational typical). | All power supply specifications are stated as "No difference" compared to the predicate. |
| Successful integration of an Application Program Interface (API) for other mobile applications. | API for integrating with other mobile applications is a new feature. Verification activities focused on software changes were successfully passed. |
| All verification test methods previously used for K183319 and K210753 are successfully passed. | The subject device successfully passed the software verification test methods previously used in K183319 and K210753. |
2. Sample size used for the test set and the data provenance:
The document states: "No clinical testing was required for the minor changes made to the software." This implies that the current submission (K220350) did not involve a new clinical test set with human subjects to prove performance, but rather relied on nonclinical testing, specifically software verification activities.
Therefore, information on the sample size for a test set (e.g., number of ECGs, number of patients) or data provenance (country of origin, retrospective/prospective) directly related to a new clinical performance study for K220350 is not provided as it was explicitly deemed not required. The performance is being established by comparing to the predicate and ensuring the software changes did not introduce new risks. The previous predicate devices (K210753, K183319) would have had their own clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no new clinical testing was performed for this specific submission (K220350). The performance claims are based on the substantial equivalence to the predicate, K210753, which would have established its own ground truth using experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no new clinical testing was performed for this specific submission (K220350).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. The document states "No clinical testing was required for the minor changes made to the software." This submission is not an MRMC study and does not evaluate AI assistance for human readers. It focuses on software reorganization and API addition.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device description indicates that the Kardia Core app utilizes KardiaAI (K181823, K201985) to provide ECG analysis, detecting conditions like Normal Sinus Rhythm, Atrial Fibrillation, Bradycardia, Tachycardia, or Unclassified. This implies a standalone algorithmic analysis component. However, the current submission (K220350) primarily focuses on the software reorganization and API addition and explicitly states no new clinical testing was required. The performance of these AI determinations would have been established in the previous predicate clearances (K181823 and K201985), not in this particular submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not directly addressed for this specific submission (K220350), as no new clinical data was collected. For the underlying KardiaAI platform (K181823, K201985), the ground truth for ECG analysis typically involves expert consensus of cardiologists reviewing the ECGs.
8. The sample size for the training set:
The document does not provide details of the training set size, as this submission is not about training a new AI model but rather a software modification to an already cleared device that utilizes existing AI algorithms (KardiaAI K181823, K201985). The training data for those AI algorithms would have been described in their respective 510(k) submissions.
9. How the ground truth for the training set was established:
Not directly addressed for this specific submission (K220350), as it pertains to the training of the underlying KardiaAI algorithms (K181823, K201985) rather than the software reorganization. For such algorithms, ground truth for training is typically established by expert adjudication/consensus of ECG interpretations by qualified medical professionals (e.g., cardiologists).
§ 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).