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The BIOMONITOR IV is indicated to detect the following cardiac arrhythmias:

• · Atrial fibrillation
• · Bradycardia
• Sudden rate drop
• · Tachycardia
• · Pause

The BIOMONITOR IV is indicated for use in:

• Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
• · Patients who experience transient symptoms that may suggest a cardiac arrhythmia

The device has not been tested for and it is not intended for pediatric use.

BIOMONITOR IV is a programmable, subcutaneous insertable cardiac monitor able to record subcutaneous ECGs (sECGs) and other physiological parameters.

The BIOMONITOR IV is designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as atrial fibrillation (AF), bradyarrhythmia, pause, sudden rate drop, or tachycardia. In addition, the BIOMONITOR IV can be activated by the patient using the Remote Assistant III to record cardiac rhythm during symptomatic episodes. BIOMONITOR IV may be used with the current legally marketed BIOTRONIK Home Monitoring® technology, which is an automatic, wireless, remote monitoring system for management of patients with implantable cardiac monitors.

The provided text describes the 510(k) premarket notification for the BIOMONITOR IV, an implantable cardiac monitor. However, it explicitly states that "No clinical performance data was submitted or relied upon in support of the substantial equivalence determination."

Therefore, I cannot provide information regarding acceptance criteria and a study that proves the device meets them, as such data was not provided in this FDA 510(k) summary. The submission focuses on validating the device against its predicate through non-clinical testing and functional equivalence.

The available information indicates that the device has undergone "thorough validation and verification testing to ensure final device functionality," including:

• Mechanical and Electrical Verification Testing for BIOMONITOR IV

This testing aimed to demonstrate that the BIOMONITOR IV functions as intended and is substantially equivalent to the predicate devices (BIOMONITOR III and BIOMONITOR IIIm) based on its principle of operation, physical characteristics, and software features. The submission does not detail specific performance metrics, sample sizes, ground truth establishment, or expert involvement for these verification tests, as those are generally internal engineering validations rather than clinical performance studies.

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