(85 days)
The LUX-Dx Insertable Cardiac Monitor (ICM) is intended to monitor and record subcutaneous electrocardiogram (S-ECG). The recorded S-ECG is used for the clinical evaluation and diagnosis of cardiac arrhythmias. The LUX-Dx is indicated for use in patients that have a known heart condition and are at risk of developing an abnormal heart rhythm, or have symptoms that may suggest a cardiac arrhythmia such as dizziness, palpitations, syncope, chest pain, and/or shortness of breath.
The LUX-Dx has not been tested specifically for pediatric use.
The LUX-Dx ICM sensor device (Model M301) evaluates S-ECG waveform data for indications of cardiac arrhythmias and "marks" the S-ECG signal for clinical presentation when the algorithm criteria are met. The device is inserted into the subcutaneous layer of the fourth intercostal space of the left chest wall. The sensor device is powered by an integrated battery. The electrodes used for detecting the S-ECG signal are located on each end of the sensor device, in the header and at the base of the battery. The LUX-Dx system includes the following main components:
- LUX-Dx™ sensor device a subcutaneously-implanted sensor device for cardiac arrhythmia event ● data collection and transmission. In addition, symptom events are collected and transmitted from the sensor device.
- . Mobile Monitor (MM) - mobile applications (myLUX™ Patient app and LUX-Dx™ Clinic Assistant app) running on an OTS mobile device that communicates with the LUX-Dx sensor device (using Bluetooth Low Energy (BLE)) and the LATITUDE Clarity™ server (using cellular/Wi-Fi) for collection and transmission of event, patient, and device data.
- . LATITUDE Clarity™ server - a server that communicates with the Mobile Monitor for bidirectional data transmission and provides web access for clinicians to perform remote monitoring activities and manage general patient and system parameters and workflow activities.
- . System Accessories- for insertion of the sensor device, an insertion tool and incision tool are provided. In addition, a magnet is provided to initiate sensor/MM app communication.
The provided text describes the 510(k) clearance for the LUX-Dx Insertable Cardiac Monitor (ICM) but does not include detailed acceptance criteria or a specific study proving device performance against those criteria.
Instead of a detailed study on device performance and acceptance criteria, the document states:
- "Boston Scientific performed safety risk management activities and design verification and validation testing to demonstrate that the LUX-Dx sensor device software is substantially equivalent to the predicate device software. The system conforms to user needs and intended use and software requirements and design specifications."
It lists the following categories of "Performance Testing - Bench":
- Software Verification
- System Verification
- Confirmatory Validation
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, sample sizes, expert details, adjudication methods, or MRMC study results because this information is not present in the provided text.
The document focuses on demonstrating substantial equivalence to a predicate device (also a LUX-Dx Insertable Cardiac Monitor, K193473) based on general performance testing and software verification, rather than presenting a detailed clinical or standalone performance study with specific metrics and acceptance thresholds.
§ 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.