Sleuth Implantable ECG Monitoring System
510(k) K063035
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK063035 | Date1 Oct 2007 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MXC
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2800
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Sleuth Implantable ECG Monitoring System is a Class II implantable cardiac recorder (without arrhythmia detection) designed to continuously monitor subcutaneous electrocardiogram (ECG) signals. It is intended for patients at risk of cardiac arrhythmias or those experiencing transient symptoms potentially linked to arrhythmic events. The device captures both symptomatic and asymptomatic ECG data for diagnostic evaluation.
The system comprises three components: the Model 2010 Implantable Monitoring Device (IMD), the Model 4000 Activator, and the Model 5000 Base Station (Bluetooth Modem). It is supplied as a reusable, implantable device with FDA 510(k) clearance under the Cardiovascular advisory committee. The IMD is anatomically shaped for subcutaneous implantation, while the Activator and Base Station facilitate patient activation and data transmission. Storage and handling follow standard sterile implant procedures, adhering to regulatory guidelines for implantable cardiac devices.
Questions
AI-generated answers, 1 Oct 2026
What is the Sleuth Implantable ECG Monitoring System used for?
The Sleuth Implantable ECG Monitoring System is designed for patients who are at risk of cardiac arrhythmias or experience transient symptoms that may be linked to arrhythmic events. It continuously monitors subcutaneous ECG signals to capture both symptomatic and asymptomatic cardiac data, aiding in diagnostic evaluation. This is particularly useful for identifying irregular heart rhythms that may not be apparent during brief clinic visits.
How is the Sleuth System supplied and what are its components?
The Sleuth System consists of three key components: the Model 2010 Implantable Monitoring Device (IMD), which is anatomically shaped for subcutaneous implantation; the Model 4000 Activator, used by patients to trigger data capture when symptoms occur; and the Model 5000 Base Station (Bluetooth Modem), which facilitates wireless data transmission to a clinician’s system. The IMD itself is reusable for implantation, while the Activator and Base Station are designed for repeated use with different patients.
Is the Sleuth Implantable ECG Monitoring System sterile and how should it be handled?
The Sleuth IMD is intended for sterile implantation, adhering to standard sterile implant procedures. Handling and storage must follow regulatory guidelines for implantable cardiac devices to ensure sterility and safety. The Activator and Base Station are not implanted and do not require sterile handling, but they should be cleaned and maintained according to manufacturer instructions to ensure proper functionality.
Can the Sleuth System be reused, and if so, how?
The Sleuth Implantable Monitoring Device (Model 2010) is designed for reuse across multiple patients, provided it is properly cleaned, inspected, and maintained according to manufacturer guidelines. The Activator and Base Station are also reusable components, intended for use with different patients. Reuse must comply with regulatory standards for implantable devices to ensure patient safety and device integrity.
What regulatory approval does the Sleuth Implantable ECG Monitoring System have?
The Sleuth Implantable ECG Monitoring System holds FDA 510(k) clearance under the Cardiovascular advisory committee, with a decision classification of Substantially Equivalent (SESE). This clearance confirms that the device meets regulatory standards for safety and effectiveness as an implantable cardiac recorder without arrhythmia detection, intended for continuous ECG monitoring.