(36 days)
The BioMonitor 2 is indicated to detect the following cardiac arrhythmias:
- · Atrial fibrillation,
- · Bradycardia,
- · Sudden rate drop.
- · High ventricular rate (HVR),
- · Asystole.
The BioMonitor 2 is indicated for:
- · 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
The BioMonitor 2 senses subcutaneous electrocardiograms (SECG) using two integrated electrodes and has the capability of detecting a number of arrhythmias. The BioMonitor 2 uses BIOTRONIK's Home Monitoring to send recorded SECG and statistics to the Home Monitoring Service Center (P950037/S66, dated November 21, 2008; and P950037/S69, dated March 23, 2009) for further analysis. BioMonitor 2 is intended to aid in the diagnosis of cardiac arrhythmias that might otherwise go undetected.
BioMonitor 2 is designed to detect and trigger automatic recording of certain cardiac arrhythmias; these arrhythmias can be classified as follows:
- atrial fibrillation
- bradycardia ●
- sudden rate drop
- high ventricular rate (HVR)
- asystole. .
Patients can also manually trigger recording of the cardiac information by use of the Remote Assistant. The memory capacity of BioMonitor 2 is such that the device can record at least 66 minutes of subcutaneous electrocardiograms (SECG). The device automatically stores a maximum of 55 separately recorded SECG-episodes of 40 seconds each (60 seconds maximum), and a maximum of 4 patient triggered SECG-episodes of 7.5 minutes. The BioMonitor 2 reports the recorded episodes and related statistical data through the physician's programmer and BIOTRONIK's Home Monitoring®
I am sorry, but the provided text does not contain the detailed information necessary to complete the table and answer all the questions regarding the acceptance criteria and the study that proves the device meets them.
Specifically, the document states: "To demonstrate that the modified BioMonitor 2 meets the same performance criteria, the following tests were conducted using the same test methods and acceptance criteria as for the predicate device." However, it does not provide the specific acceptance criteria themselves, nor does it report the device's performance against those criteria in a quantifiable manner (e.g., sensitivity, specificity, accuracy for arrhythmia detection).
Therefore, I cannot populate the table or answer questions 2 through 9 based solely on this document. The document lists various types of tests conducted (e.g., mechanical system verification, usability testing, packaging validation), but these are not the performance metrics of the device's arrhythmia detection capabilities. It also explicitly states, "No clinical testing was deemed necessary or completed in the premarket notification submission for a determination of substantial equivalence," which further limits the availability of data regarding clinical performance and ground truth.
§ 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.