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The NUVANT Mobile Cardiac Telemetry (MCT) System is intended to continuously measure, record and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but not limited to, supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias and conduction disorders.

The NUVANT system model monitors, derives and displays:

• ECG

· Heart Rate

The NUVANT MCT System is a wearable, wireless arrhythmia detection system that is used by clinicians to identify suspected cardiac arrhythmias. In combination with interpretation services provided by learned intermediaries in the Corventis Monitoring Center as well as online review of data (for prescribing physicians only), NUVANT MCT enables arrhythmia detection for up to 7.5 days for each PiiX application.

The NUVANT system components are:

• PiiX® (aka: Adherent Device) a patient-worn device which is applied to the . patient's torso. It contains the ECG electrodes for recording ECG and heart rate data.
• Patient Trigger Magnet used by the patient to manually trigger the ECG . collection when he/she experiences symptoms.
• . zLink® (aka: Gateway) – hand-held device that receives information from the PiiX and transmits it to the Corventis Server via cellular technology.
• Server The Server receives sensor data from the PiiX via zLink. ECG and . heart rate are presented to learned intermediaries, Corventis cardiographic technicians, who prepare and deliver the information to prescribing physicians

The communication between the PiiX and the zLink is enabled via BlueTooth Technology. Sensor data and ECGs collected by the PiiX are transmitted to the Server via zLink.

This document is a 510(k) premarket notification for an administrative change to the NUVANT Mobile Cardiac Telemetry (MCT) System (K113372). It details the substantial equivalence to a predicate device (K111917) and mentions performance testing for safety standards but does not present an independent study with acceptance criteria and device performance for the subject device beyond compliance with general safety and performance standards.

The document explicitly states: "This Special 510(k) proposes to add a framework that will reserve space for recording ECG strips for each event type; limiting the redundant recording of certain event types. This change does not change to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device, and does not affect the safety and effectiveness of the device when used as labeled [807.92(a){5}]. The indications for use of the subject NUVANT are unchanged from the predicate NUVANT. The modification does not impact the fundamental scientific technology of the device."

Therefore, the device's performance and acceptance criteria are considered to be met by its substantial equivalence to the predicate device and its compliance with recognized safety and performance standards. The submission doesn't include a new, independent study to "prove the device meets acceptance criteria" for arrhythmia detection performance, but rather asserts that the modification does not negatively impact the existing demonstrated safety and effectiveness.

Here’s a breakdown of the requested information based on the provided document, with an emphasis on what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria (e.g., sensitivity, specificity for arrhythmia detection) or direct performance data for arrhythmia detection of the subject NUVANT system are presented in this document. The document states that the subject NUVANT system meets the requirements of listed performance standards (IEC 60601-1, IEC 60601-1-2, AAMI/ANSI EC38, AAMI/ANSI EC57) and is substantially equivalent to its predicate. The predicate device (K111917) would have had such performance data, but it is not included in this document.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable as an independent performance study for arrhythmia detection was not conducted or reported in this 510(k) submission for the subject device. The submission focuses on a modification that does not impact the device's fundamental scientific technology or indications for use.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable as an independent performance study for arrhythmia detection was not conducted or reported in this 510(k) submission for the subject device. Compliance with AAMI/ANSI EC57 implies that ground truth would have been established by qualified experts during the development and testing of the predicate device's algorithms, but details are not in this document.

4. Adjudication Method for the Test Set

Not applicable as an independent performance study for arrhythmia detection was not conducted or reported in this 510(k) submission for the subject device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or conducted as part of this 510(k) submission.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Not explicitly presented in this document for the subject device. The document mentions compliance with AAMI/ANSI EC57, which outlines methods for testing cardiac rhythm algorithms, but no specific results from such testing for the subject device are provided here. The NUVANT system description explicitly states that "interpretation services provided by learned intermediaries in the Corventis Monitoring Center" are part of the system, indicating a human-in-the-loop component for the overall clinical use.

7. Type of Ground Truth Used

Not applicable as specific performance data from a new study is not provided. For arrhythmia detection algorithms compliant with AAMI/ANSI EC57, ground truth is typically established by expert cardiologists/electrophysiologists manually reviewing and annotating ECG recordings.

8. Sample Size for the Training Set

Not applicable as this document does not describe the development or training of new algorithms. It concerns a modification to an already cleared device.

9. How the Ground Truth for the Training Set Was Established

Not applicable as this document does not describe the development or training of new algorithms.

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