Sherlock 3CG™ Tip Confirmation System
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OVERVIEW
Indications for Use
The Sherlock 3CG™ Tip Confirmation System (TCS) is indicated for guidance and positioning of
Peripherally Inserted Central Catheters (PICCs). The Sherlock 3CG™ TCS provides real-time PICC tip
location information by using passive magnet tracking and the patient's cardiac electrical activity (ECG).
When relying on the patient’s ECG signal, the Sherlock 3CG™ TCS is indicated for use as an alternative
method to chest X-ray and fluoroscopy for PICC tip placement confirmation in adult patients.
Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac
rhythm change the presentation of the P wave as in atrial fibrillation, atrial flutter, severe tachycardia,
and pacemaker driven rhythm. In such patients, who are easily identifiable prior to catheter insertion,
the use of an additional method is required to confirm PICC tip location.
Post Market Clinical Trial
The Sherlock 3CG™ Tip Confirmation System (TCS) is Bard’s next generation, fully integrated magnetic
navigation and ECG-based peripherally inserted central catheter (PICC) tip confirmation technology,
which represents the next evolution of the Sherlock™ II Tip Location System and the previously
marketed Sapiens Tip Confirmation System. The Sapiens TCS Post-Market Clinical trial was a prospective,
single arm, single center study designed to assess the efficacy of the ECG method for correctly
positioning the tip of catheters in adult patients. The primary endpoints were to assess the performance
of the Sapiens technology with respect to: (1) the accuracy of the Sapiens technology with regard to
correct positioning of the catheter tip when compared to postoperative chest x-ray, (2) safety of using
an invasive intracardiac electrode, and (3) compatibility with peripherally inserted central catheters. One
hundred fourteen (114) subjects received a PICC. Final PICC tip location was confirmed at the cavoatrial
junction or /- 1 cm in 99.1% (113/114) of the subjects. No adverse events were reported.
Sherlock 3CG™ Tip Confirmation System (TCS) Description
The Sherlock 3CG™ TCS is designed to aid in PICC tip positioning through magnet tracking and ECG
technology. It is designed to operate with Bard Access Systems’ catheter kits labeled
and
“Sherlock 3CG™ TPS Stylet”.
Note:
When used in conjunction with catheter kits labeled
the device provides magnetic
navigation information but does not allow positioning through ECG technology.
ECG Positioning
The Sherlock 3CG™ TCS displays an ECG signal detected by the intravascular and body electrodes, which
can be used for catheter tip positioning. In patients with a distinct P-wave, the P-wave will increase in