(155 days)
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 111/BIOMONITOR Illm 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), bradyarrhythmia, 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 document, K201865, is a 510(k) Premarket Notification for the BIOMONITOR III and BIOMONITOR IIIm, which are implantable cardiac monitors. The core of this submission is about confirming substantial equivalence to an existing predicate device (K200444). The specific change addressed in this 510(k) is the enabling of the temperature sensor for data transmission and its associated alerts and display.
Based on the provided text, the device itself (BIOMONITOR III/IIIm) already had acceptance criteria and studies for its primary function (arrhythmia detection) from when its predicate (K200444) was cleared. This 510(k) focuses specifically on the newly enabled feature – the temperature sensor. Therefore, the acceptance criteria and study detailed below will relate primarily to this new feature, as "no clinical performance data was submitted or relied upon in support of the substantial equivalence determination" for the overall device.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them, specifically for the newly enabled temperature sensor feature:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria for the temperature sensor feature in terms of numerical thresholds for accuracy, precision, or other performance metrics. However, it does state the reported device performance:
| Acceptance Criteria Category (Derived) | Reported Device Performance (for Temperature Sensor) |
|---|---|
| Accuracy of Temperature Measurement | "measurement accuracy of within 0.1℃ when compared to a clinical reference" |
| Functionality | "thorough validation and verification testing to ensure final device functionality." |
| Safety and Effectiveness | "The enabling of the temperature sensor for data transmission introduces no new issues of safety or effectiveness." |
| Equivalence | "identical physical device characteristics as well as software features and functionality" (for primary device functions), and "hardware design remains unchanged" (for temperature sensor). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test Set Sample Size: "Performance of the temperature sensor was validated in swine". The exact number of swine (sample size) used is not specified in the provided text.
- Data Provenance: The study was "Animal Testing" (specifically in swine). The location of this animal testing (country of origin) is not specified in the document. It is implicitly a prospective study, as it describes a validation of the sensor.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states "when compared to a clinical reference" for the temperature sensor validation. It does not specify the number of experts, their qualifications, or how they established the "clinical reference" ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe any human adjudication method. The comparison for the temperature sensor was against a "clinical reference," which implies a direct measurement or standard, not subjective expert agreement.
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
No MRMC study was done, nor is it applicable to the specific change being addressed in this 510(k). This submission is for enabling a sensor and transmitting its data, not for an AI that assists human readers in interpreting an image or signal. The device is an "Arrhythmia Detector And Alarm," and its primary function involves automated detection. The new feature is a temperature sensor.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, for the temperature sensor, the "Performance of the temperature sensor was validated in swine for detection of fever to a measurement accuracy of within 0.1℃ when compared to a clinical reference." This is a standalone validation of the sensor's accuracy. The device's primary arrhythmia detection functionality is also largely standalone/algorithm-only, as it automatically detects arrhythmias.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the temperature sensor, the ground truth was a "clinical reference" measurement. This indicates comparison against a recognized standard or highly accurate measurement technique in a clinical setting (in this case, in swine).
8. The sample size for the training set
The document does not provide information about a training set. The device's primary function is based on established arrhythmia detection algorithms, and the temperature sensor is a direct physical measurement. There is no mention of machine learning models requiring training data for this specific 510(k) submission.
9. How the ground truth for the training set was established
Not applicable, as no training set is mentioned for the temperature sensor feature, nor is the underlying arrhythmia detection algorithm (which would have had its own training/development data) the subject of this specific 510(k) clearance.
§ 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.