(29 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 .
This document is a 510(k) premarket notification for the BioMonitor 2, a device described as an "Arrhythmia Detector and Alarm." The notification details that the device is a modified version of a previously cleared device (BIOTRONIK BioMonitor 2, K152995).
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance data. Instead, it 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." It then lists the types of tests performed.
| Test Type | Description/Purpose | Outcome |
|---|---|---|
| Compatibility testing | Not specified, but likely refers to ensuring the device components work together and with other systems (e.g., Home Monitoring). | This performance testing demonstrates that the subject device meet the same functional acceptance criteria for the same intended use. |
| Wireless communication user testing | Not specified, but likely related to the functionality and reliability of the device's wireless communication capabilities. | This performance testing demonstrates that the subject device meet the same functional acceptance criteria for the same intended use. |
| Module electrical tests | Testing of individual electrical modules within the device. | This performance testing demonstrates that the subject device meet the same functional acceptance criteria for the same intended use. |
| Device electrical tests | Electrical testing of the complete device. | This performance testing demonstrates that the subject device meet the same functional acceptance criteria for the same intended use. |
| System verification testing | Verification that the entire system, including hardware and software, functions as intended. | This performance testing demonstrates that the subject device meet the same functional acceptance criteria for the same intended use. |
| Software release testing | Testing performed on the device's software prior to release. | This performance testing demonstrates that the subject device meet the same functional acceptance criteria for the same intended use. |
| Product level validation testing | Validation of the overall product's performance against its specifications. | This performance testing demonstrates that the subject device meet the same functional acceptance criteria for the same intended use. |
| Process validation/verification for manufacturing changes | Validation and verification of manufacturing processes, particularly in light of the "minor modifications" and "manufacturing changes" mentioned. | This performance testing demonstrates that the subject device meet the same functional acceptance criteria for the same intended use. |
Important Note: The document consistently states that "This performance testing demonstrates that the subject device meet the same functional acceptance criteria for the same intended use." However, it does not provide the specific numerical acceptance criteria or the raw performance data obtained from these tests. It only lists the types of tests conducted.
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical testing was deemed necessary or completed in the premarket notification submission for a determination of substantial equivalence."
Therefore, there is no test set in the clinical sense, and thus no sample size or data provenance from clinical studies for this submission. The tests listed are likely engineering and bench-top validation tests rather than human clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no clinical testing was performed, there was no "ground truth" for a clinical test set established by experts in this submission.
4. Adjudication Method for the Test Set
As there was no clinical test set for which ground truth was established, there was no adjudication method described.
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 such study was conducted or reported in this submission, as indicated by the statement, "No clinical testing was deemed necessary or completed." The device described is an "Arrhythmia Detector and Alarm," which generally acts as a standalone detection system rather than an AI-assistance tool for human readers in the context of diagnostic image interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the BioMonitor 2 as sensing subcutaneous electrocardiograms (SECG) and having the "capability of detecting a number of arrhythmias." It also states, "The BioMonitor 2 uses BIOTRONIK's Home Monitoring to send recorded SECG and statistics to the Home Monitoring Service Center for further analysis." and "BioMonitor 2 is designed to detect and trigger automatic recording of certain cardiac arrhythmias."
This strongly implies that the device (or its integrated algorithm) operates in a standalone manner to detect arrhythmias and record data. While the "Home Monitoring Service Center" performs "further analysis," the initial detection and recording of events like atrial fibrillation, bradycardia, sudden rate drop, HVR, and asystole are described as capabilities of the BioMonitor 2 itself. The performance data section refers to "System verification testing" and "Software release testing," which would encompass standalone algorithm performance.
However, specific performance metrics (e.g., sensitivity, specificity, accuracy) for these standalone detections are not provided in this document.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The document does not detail the specific ground truth used for verifying the performance of the device's arrhythmia detection capabilities. Given that no clinical testing was performed for this submission, the "ground truth" for the predicate device's initial clearance for arrhythmia detection would have been established through a combination of simulated ECG signals, known cardiac events from existing databases, and potentially clinical studies at the time of the predicate's original submission. However, this submission relies on the "same test methods and acceptance criteria as for the predicate device" for its engineering and functional tests, rather than providing new ground truth establishment for arrhythmia detection.
8. The Sample Size for the Training Set
The document does not mention any training set or machine learning aspects for this submission. This 510(k) is for a "minor modification" to an already cleared device, and the focus is on demonstrating that the modified device meets the performance of the predicate, not on developing or training a new algorithm.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, this information is not applicable and not provided.
§ 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.