(259 days)
The BioMonitor 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 BioMonitor is a small, leadless, implantable device that uses three electrodes on the body of the device to continuously monitor the patient's subcutaneous ECG. The BioMonitor is designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as bradvarrhythmia. asvstole, or high ventricular rate. The device memory can store up to 13.3 minutes of ECG recordings from automatically detected arrhythmias and up to 22.5 minutes of ECG recordings from patient-triggered episodes. When a patient experiences symptoms, the ECG recordings can be manually triggered by placing a magnet over the BioMonitor.
The BioMonitor Implantable Cardiac Monitor is designed to continuously monitor a patient's subcutaneous ECG and automatically record arrhythmias. The 510(k) summary provides details about its performance and the testing conducted to establish substantial equivalence to predicate devices.
1. Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state formal acceptance criteria with specific performance thresholds (e.g., "sensitivity must be >X%"). Instead, it focuses on demonstrating technological equivalence to predicate devices and verifying various functional and safety aspects. The "Summary of Testing" section lists the types of testing performed and concludes that "No safety or effectiveness issues were identified." The device performance is implicitly established by showing that its technical characteristics are comparable to cleared predicate devices.
However, based on the context of an arrhythmia detector and the technical characteristics provided, we can infer some implied performance areas.
| Performance Characteristic (Implied Acceptance Area) | Reported Device Performance (as demonstrated by testing and comparison to predicates) |
|---|---|
| Arrhythmia Detection (General) | Automatically records arrhythmias (bradyarrhythmia, asystole, high ventricular rate). |
| QRS Detection | Functional via combination signal from 3 vectors. Analysis of clinical data to support QRS detection was performed. Implied to be comparable to predicate devices which also perform QRS detection. |
| Asystole Triggering | Triggers for asystole at 40s/episode (30s prior auto activation, 10s post auto activation). Functionality confirmed. |
| Brady/Rate Drop Triggering | Triggers for brady/rate drop at 40s/episode (30s prior auto activation, 10s post auto activation). Functionality confirmed. Similar to predicate devices that have low rate triggers. |
| High Ventricular Rate (VT-FVT) Triggering | Triggers for VT-FVT at 40s/episode (30s prior auto activation, 10s post auto activation). Functionality confirmed. Similar to predicate devices that have high rate triggers. |
| ECG Recording / Storage | Stores up to 13.3 minutes of auto-activated ECG recordings and 22.5 minutes of patient-triggered ECG recordings. Functionality confirmed and comparable to predicate devices in terms of pre/post event storage capabilities. |
| Patient Activation | Allows patient activation for 7.5 min per event (7 min prior to activation, 0.5 min following activation). Functionality confirmed and comparable to predicate devices. |
| Auto Activation Triggers | Has auto activation triggers. Functionality confirmed and comparable to predicate devices. |
| Manual (Patient) Activation Trigger | Has manual (patient) activation trigger. Functionality confirmed and comparable to predicate devices. |
| Programmable High Rate Count | Has programmable high rate count. Functionality confirmed and comparable to predicate devices. |
| Functional Performance | Functional testing performed (details not specified, but concluded no safety/effectiveness issues). |
| Mechanical Performance | Mechanical testing performed (details not specified, but concluded no safety/effectiveness issues). |
| Biocompatibility | Biocompatibility testing performed (details not specified, but concluded no safety/effectiveness issues). |
| Electrical Safety / EMC | Electrical Safety / EMC testing performed (details not specified, but concluded no safety/effectiveness issues). |
| Packaging, Sterilization & Shelf Life | Packaging, Sterilization, and Shelf life testing performed (details not specified, but concluded no safety/effectiveness issues). |
2. Sample Size for Test Set and Data Provenance:
The document mentions "Analysis of clinical data to support QRS detection" but does not specify the sample size used for this analysis, nor does it detail the data provenance (e.g., country of origin, retrospective or prospective nature). The other validation tests listed (Functional, Mechanical, Biocompatibility, Electrical Safety/EMC, Packaging, Sterilization, Shelf life) are typically bench or lab tests and do not involve "patient data" test sets in the same manner as clinical performance evaluation.
3. Number of Experts and Qualifications for Ground Truth for Test Set:
The document does not provide any information regarding the number or qualifications of experts used to establish ground truth for any clinical data analysis mentioned (e.g., QRS detection).
4. Adjudication Method for Test Set:
No information is provided regarding any adjudication method for a test set. This type of detail would typically be found in a clinical study report, which is not present in this 510(k) summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention any MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated, nor does it provide an effect size for such a study. The BioMonitor is presented as a standalone automated arrhythmia detector.
6. Standalone (Algorithm Only) Performance:
Yes, the information provided primarily describes the standalone performance of the BioMonitor algorithm. The device "automatically record the occurrence of arrhythmias" and the "Analysis of clinical data to support QRS detection" would inherently evaluate the algorithm's performance without human intervention in the detection process. The summary table comparing "Technical Data" to predicate devices focuses on the device's inherent capabilities (e.g., trigger types, storage, sampling rate), all indicative of standalone algorithmic function.
7. Type of Ground Truth Used:
The type of ground truth used for the "Analysis of clinical data to support QRS detection" is not explicitly stated. For arrhythmia detection studies, ground truth is typically established by:
- Expert Consensus: Independent review of ECGs by multiple cardiologists/electrophysiologists.
- Adjudicated ECGs: Often involving multiple experts reviewing and agreeing on arrhythmia events.
- Simulated Arrhythmias: In some functional testing, precisely controlled simulated signals might be used.
Given the context of "clinical data," it is most likely that expert consensus or adjudicated ECGs served as the ground truth, but this is not confirmed in the document.
8. Sample Size for Training Set:
The document does not provide any information about a training set or its sample size. This type of information is typically related to machine learning model development, which is not detailed in this 510(k) summary focused on hardware and basic algorithmic functionality comparison.
9. How Ground Truth for Training Set Was Established:
Since no information regarding a training set is provided, there is no information on how its ground truth was established.
§ 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.