pilot TLS
Vygon CorporationThe Pilot TLS system helps healthcare providers accurately position central venous catheters by real-time monitoring of the patient's cardiac electrical signals. This serves as an alternative to traditional chest X-ray or fluoroscopy confirmation methods, potentially reducing radiation exposure and speeding up catheter placement.
Intended Use
The Pilot TLS is indicated for use in positioning of PICCs by providing real-time catheter tip location information via patient's cardiac electrical activity, as an alternative to chest X-ray or fluoroscopy confirmation in adults.
Technology
Pilot TLS includes a medical tablet with specialized Pilot software, a TLS module, ECG cable accessory, and Vygocard saline connector accessory. It uses ECG signals transmitted via a conductive metal stylet or saline column connector to determine catheter tip location by analyzing P-wave amplitude changes in intravascular ECGs.
Performance
The device underwent extensive non-clinical testing including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), software verification and validation, human factors usability studies, and biocompatibility evaluations for the Vygocard accessory. No clinical human data was provided, but testing supports substantial equivalence to a predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/3/2024
8 months - 2
FDA Approval
2/26/2025
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