(49 days)
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 MCT System is 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.
The provided text describes an Abbreviated 510(k) submission for the NUVANT Mobile Cardiac Telemetry (MCT) System, focusing on adding clarifying language to its indications for use. It asserts that this clarification does not alter the fundamental safety and effectiveness of the device compared to its predicates. However, the document does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance criteria.
The document refers to the device meeting general performance standards, but it does not provide the specific data from a study to demonstrate this.
Therefore, I cannot fulfill all parts of your request with the provided information. I can, however, extract related details:
Missing Information:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set.
- Data provenance for the test set (country of origin, retrospective/prospective).
- Number of experts used to establish ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human reader improvement with AI vs. without AI.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for the test set.
- The sample size for the training set.
- How the ground truth for the training set was established.
Information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from regulatory standards) | Reported Device Performance (Inferred from submission statement) |
|---|---|
| Conformance to IEC 60601-1 (Safety) | Meets requirements of IEC 60601-1 |
| Conformance to IEC 60601-1-2 (EMC) | Meets requirements of IEC 60601-1-2 |
| Conformance to AAMI/ANSI EC38 (Ambulatory ECG Systems) | Meets requirements of AAMI/ANSI EC38 |
| Conformance to AAMI/ANSI EC57 (Cardiac Rhythm/ST-segment) | Meets requirements of AAMI/ANSI EC57 |
| Equivalence to Predicate Devices (Safety & Effectiveness) | "As safe and as effective as the predicate devices" |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified. The document only mentions "bench tests" for supporting the claim of safety and effectiveness.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document mentions "learned intermediaries in the Corventis Monitoring Center as well as online review of data (for prescribing physicians only)" for real-world operation, but this is not tied to establishing ground truth for a test set in the context of the device's validation for this submission.
4. Adjudication method for the test set:
- Not specified.
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 specified. The NUVANT system involves human interpretation (Corventis cardiographic technicians and prescribing physicians), but the document does not describe an MRMC study or quantify human improvement with AI assistance. The system itself is characterized as an "arrhythmia detection system" that, in combination with human interpretation services, enables arrhythmia detection.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies the algorithm performs "arrhythmia detection" and transmits data. However, the statement "In combination with interpretation services provided by learned intermediaries in the Corventis Monitoring Center as well as online review of data... NUVANT MCT enables arrhythmia detection" suggests that the full "arrhythmia detection" capability for clinical use involves a human-in-the-loop. A standalone performance study of only the algorithm is not explicitly described with metrics.
7. The type of ground truth used:
- Not specified. The document refers to meeting performance standards and "bench tests" without detailing how ground truth data for these tests were derived.
8. The sample size for the training set:
- Not specified. The document does not mention an "AI" or machine learning component in a way that suggests a distinct training set. It focuses on the device hardware and its embedded detection capabilities.
9. How the ground truth for the training set was established:
- Not specified, as a training set is not explicitly mentioned.
Summary of what the document DOES state regarding "proving" criteria:
The document relies on the following to demonstrate the device's safety and effectiveness:
- Substantial Equivalence: The primary assertion is that the "subject NUVANT" is "as safe and as effective as the predicate devices" (NUVANT K091971 and CardioNet CN1005). This is a foundational premise of 510(k) submissions.
- Conformance to Industry Standards: The device meets the requirements of:
- IEC 60601-1 (General Safety)
- IEC 60601-1-2 (Electromagnetic Compatibility)
- AAMI/ANSI EC38 (Ambulatory Electrocardiographic Systems)
- AAMI/ANSI EC57 (Cardiac Rhythm and ST-segment Measurement Algorithms)
- Bench Tests: The document states that the conclusion of safety and effectiveness is "As supported by the descriptive information and the bench tests". However, no details about these bench tests or their results are provided.
- Minor Change: The core argument for this specific 510(k) is that the proposed change (clarifying language in the indications for use) does not alter the fundamental scientific technology, intended use, safety, or effectiveness of the device.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.