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Sherlock 3CG™ Tip Confirmation System
English
1 Overview
1.1 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.
1.2 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.
1.3 Sherlock 3CG™ TCS Description
The Sherlock 3CG™ TCS is designed to aid in PICC tip positioning through magnet navigation 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 amplitude as the catheter approaches the top of the cavoatrial junction. As the
catheter advances into the right atrium, the P-wave will decrease in amplitude and may be biphasic or invert. In addition to the ECG signal, the
magnet tracking stylet icon is augmented with the shape and color changes shown below.
Note: In instances where the P-wave is not present, not identifiable, or intermittent the stylet icon will remain a yellow circle.