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The BIOMONITOR III/BIOMONITOR IIIm is indicated to detect the following cardiac arrhythmias:

• atrial fibrillation
• · bradycardia
• · sudden rate drop
• · high ventricular rate (HVR)
• · asystole

The BIOMONITOR III/BIOMONITOR IIIm 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 III and BIOMONITOR IIIm are programmable, subcutaneous insertable cardiac monitors able to record subcutaneous ECGs (sECGs) and other physiological parameters.

The BIOMONITOR III and BIOMONITOR IIIm are designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as atrial fibrillation (AF), bradvarrhythmia, asystole, sudden rate drop, or high ventricular rate. In addition, the BIOMONITOR III and BIOMONITOR IIIm can be activated by the patient using the Remote Assistant III to record cardiac rhythm during symptomatic episodes. BIOMONITOR III and BIOMONITOR IIIm 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.

This FDA filing (K221856) addresses changes to the BIOMONITOR III and BIOMONITOR IIIm, rather than a new device. Therefore, a full clinical study to prove the device meets acceptance criteria as would be required for a completely novel device is not presented. The submission focuses on demonstrating substantial equivalence to the predicate device (BIOMONITOR III and BIOMONITOR IIIm, K201865) following minor hardware changes.

The document explicitly states: "No clinical performance data was submitted or relied upon in support of the substantial equivalence determination." and "The BIOMONITOR III and BIOMONITOR IIIm have undergone thorough validation and verification testing to ensure final device functionality." and "Verification Testing for BIOMONITOR III and BIOMONITOR IIIm hardware changes".

Based on this information, we cannot provide the requested details about acceptance criteria derived from a substantial new clinical study, as such a study was not performed or deemed necessary for this specific submission. The focus was on demonstrating that the minor hardware changes did not negatively impact the established performance and safety characteristics of the already cleared predicate device.

Therefore, the questions regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment (items 1-9 in your request) cannot be answered from the provided document, as these typically relate to a de novo device approval or a submission requiring new clinical evidence.

The document primarily states that the updated device maintains the same principle of operation, physical device characteristics, software features, and functionality as the predicate, with minor component changes for manufacturing optimization. The validation and verification testing mentioned (Section 7.1) would likely be engineering-focused and aimed at confirming that the hardware changes did not introduce new risks or alter the device's electrical or mechanical performance, ensuring it still meets the specifications of the predicate device.

In summary, as per the provided text, a comparative effectiveness study or a new standalone clinical performance study was NOT conducted to prove the device met acceptance criteria, because the submission was a "Special 510(k)" for hardware changes to an already cleared device, not a new device.

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