(281 days)
The HeartCheck™ Cardi Beat ECG Monitor device with the GEMS Mobile software is an over-the-counter device to be used by patients 21 years of age or older. It is intended to record, store and transfer single channel Heart Rhythm signals and display Heart Rhythm waveforms. This 1-lead cardiac monitor allows remote users to display and transmit their ECG data to medical professionals via a communication device to a remote server.
The HeartCheck™ Cardi Beat ECG Monitor combined with GEMS Mobile software is indicated for users who are concerned about their heart rhythms and may have experienced symptoms that may suggest irregular or abnormal heart rhythms. Symptoms may include:
- · Skipped beats
- · Palpitations
- · Racing heart
- Fainting and lightheadedness
- · Irregular rate
- · History of any related heart abnormalities
The HeartCheck™ Cardi Beat ECG Monitor along with the GEMS Mobile software is not intended to substitute a hospital diagnostic ECG device. Users with an implanted pacemaker or are not recommended to use this device while the implanted device is operational. Users where their pacemaker is operational will not be able to record their ECG under normal sinus rhythm with the pacemaker on.
The HeartCheck™ CardiBeat ECG Monitor device model HC-WE-01 is an ambulatory and telemedicine based solution that is intended to enable uses to record, store, transfer, and display single channel ECG waveforms. The HeartCheck™ CardiBeat ECG Monitor combined with GEMS™ Mobile enables the user to send their ECG recordings to a medical service for review and interpretation by a qualified health service professional, such as a physician.
The 1 lead ECG Event Monitor is specifically designed to operate with GEMS™ Mobile software, a smartphone software configured to run on mobile devices such as smartphones and tablets. The device will record a pre-selected amount of user ECG activity, as directed by the user. Typical configuration is to record 30 seconds of ECG per event.
The HeartCheck™ CardiBeat ECG Monitor is activated through touch by the user whenever a recording is needed. The recorded data serves as a reliable heart rhythm record that may later be shown to physicians or other health care professionals for confirmation of the presence or absence of an arrhythmia. When a user feels that a cardiac event is occurring, the utilization of the HeartCheck™ CardiBeat ECG Monitor with GEMS™ Mobile has the feature of recording this real time data that would otherwise not be possible to capture.
While performing the recording, data is continuously sent to the smartphone or tablet by secure Bluetooth connection technology. Following an initial physician review, the ECG can be displayed for quality and observation purposes on the GEMS™ Mobile application. Users will not be able to view the waveform without a physician's pre-review from the SMART Monitoring system. This system used the HeartCheck™ ECG PEN and GEMS™ Home system (K11159) with an ECG reading service as a predicate device. The recorded data can be stored locally on the mobile device and/or not transmitted to CardioComm Solutions, Inc.'s SMART Monitoring ECG reading service (powered by GlobalCardio™ K111320) for analysis and assessment by qualified professionals.
The provided text is a 510(k) summary for the HeartCheck™ CardiBeat ECG Monitor with GEMS Mobile. It details the device's description, indications for use, and a comparison to predicate devices, but it explicitly states that no clinical testing was conducted to support this submission.
Therefore, I cannot provide a table of acceptance criteria and reported device performance (Point 1), nor can I answer questions regarding sample size for test sets (Point 2), number of experts (Point 3), adjudication methods (Point 4), MRMC studies (Point 5), standalone performance (Point 6), type of ground truth used (Point 7), sample size for training set (Point 8), or how ground truth was established for the training set (Point 9).
The document states:
- "1.3.2 Clinical Testing: No clinical testing was conducted to support this submission." (Page 7)
Instead, the submission for K181310 relies on:
- Nonclinical Testing: Performance evaluation leveraging hardware and software tests and validations, compliant with standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25, IEC 62304, ISO 10933-1, ISO 10933-5, and ISO 10993-10. (Page 7)
- Substantial Equivalence (SE) Comparison: The device's indications for use, patient population, parameters measured, and other technical characteristics are compared to a primary predicate device (HeartCheck™ ECG PEN K111159) and a reference device (ECG Check K122184) to demonstrate substantial equivalence. (Pages 7-9)
In summary, the information requested regarding acceptance criteria and a study proving the device meets that criteria through clinical performance testing is not present in the provided document, as no clinical testing was performed for this submission. The device's acceptance was based on nonclinical testing and comparison to legally marketed predicate devices.
§ 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).