pilot TLS

The Pilot TLS is a system for guiding and confirming the tip placement of peripherally inserted central catheters (PICCs) in adult patients. It uses the patient's cardiac electrical activity (ECG waveforms) to provide real-time catheter tip location information as an alternative to chest X-ray or fluoroscopy. The device comprises a medical tablet with software, a Pilot TLS module, an ECG cable with leads, and a Vygocard accessory (a saline column connector for ECG signal transmission).

Both Pilot TLS and the predicate C3 Wave use electronic circuitry and software to acquire and display patient intravascular and external ECG waveforms for catheter tip confirmation. Key differences: Pilot TLS uses a Windows tablet versus C3 Wave's iPad; Pilot TLS transmits ECG data via USB cable while C3 Wave uses Bluetooth wireless; Pilot TLS offers dual ECG signal transmission methods (saline column connector or conductive metal stylet) whereas C3 Wave uses only conductive stylet. The fundamental technology, principle of operation, and materials/sterilization are identical.

IEC 60601-1 (3rd Edition) for electrical safety; IEC 60601-1-2 (3rd Edition) for electromagnetic compatibility; software verification and validation testing; human factors study per CDRH guidance and IEC 62366-1; biocompatibility testing per ISO 10993-1, 10993-5, 10993-4, and 10993-10; ISO 10555-1 for intravascular catheters; ISO 80369-7 and ISO 80369-20.

Pilot TLS is substantially equivalent because it shares the same intended use as C3 Wave: displaying patient ECG waveforms to provide real-time tip location information for central venous catheter placement confirmation as an alternative to radiographic methods. Both devices use identical fundamental technology (electronic circuitry and software) and principle of operation (P-wave identification). The technological differences—tablet platform, USB versus Bluetooth data transmission, and addition of a saline column connector option—do not raise new safety or effectiveness issues. The performance and biocompatibility testing data support that Pilot TLS meets its design and safety requirements, demonstrating substantial equivalence to the predicate.