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The Sherlock 3CG+™ Tip Confirmation System (TCS) is indicated for navgationing of central venous access devices (CVADs) of at least 2 Fr in size. The Sherlock 3CG+™ TCS provides real-time catheter tip location information by using catheter navigation technology along with the patient's cardiac electrical activity and is indicated for use as an alternative method to chest X-ray and fluoroscopy for CVAD tip placement confirmation of approaches from the superior vena cava.

In adult patients and in adolescents (greater than 12 through 21 years of age), the Sherlock 3CG+™ TCS can be used with CVADs such as peripherally inserted central catheters (PICCs), central venous catheters (CVCs), implantable ports, and hemodialysis catheters; in children (greater than 2 to 12 years of age), in infants (greater than 1 month to 2 years of age), and in neonates (from birth to 1 month of age), the Sherlock 3CG+™ TCS can be used with centrally inserted central catheters (CICCs). In each specific age group, the CVAD type and size must be chosen and the CVAD must be used according to the CVAD's indications and instructions for use.

Limiting but not contraindicated situations for this method are in patients where alterations of cardiac the presentation of the P-wave as in 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 catheter tip location.

The SHERLOCK 3CG+™ Tip Confirmation System (TCS) is designed to aid in central venous access device (CVAD) tip positioning through real-time navigation and electrocardiogram (ECG) technology. The SHERLOCK 3CG+™ TCS provides:

• Real-time catheter navigation information to the clinician via either: 1) ECG-based . Computed R-Peak Navigation, or 2) Sherlock™ Magnet, a technology for tracking passive magnets (when used with SHERLOCK 3CG™ TPS Stylets); and
• . Catheter tip placement confirmation via the patient's cardiac electrical activity, based upon identification of a maximum P-wave in the patient's intravascular ECG signal, with available catheter tip placement visual cues.

The subject device, SHERLOCK 3CG+™ TCS incorporates features from both of its predicate devices under a single tip confirmation system. The subject SHERLOCK 3CG+T™ TCS differs from the primary predicate device (K141634) because it incorporates features from the secondary predicate device (K140345):

• Provides real-time catheter navigation information to the clinician via Sherlock™ . Magnet Tracking, a technology for tracking passive magnets (when used with SHERLOCK 3CG™ TPS Stylets); and
• Includes optional catheter tip placement visual cues. .

The subject SHERLOCK 3CG+T™ TCS differs from the secondary predicate device (K140345) because it incorporates features from the primary predicate device (K141634):

• . Provides real-time catheter navigation information to the clinician via ECG-based Computed R-Peak Navigation; and
• . Includes optional R-wave highlighting.

The SHERLOCK 3CG+T™ TCS includes the following components:

• SHERLOCK 3CG™ TCS Sensor .
• Computing Platform .
• SHERLOCK 3CG+™ TCS Mobile Medical Application running on a computing platform .

The SHERLOCK 3CG+™ TCS also operates with the following legally-marketed accessories:

• . NAUTILUS DELTA™ E Electrical Adaptor
• SHERLOCK 3CG™ ECG Leads (Fin Assembly) ●
• SHERLOCK 3CG™ TPS Stylet .
• . Remote
• Optional Printer(s) ●
• Sensor Holster (a reusable holster to hold the SHERLOCK 3CG™ TCS Sensor between uses)
• . Remote Control Holder (a sterile, single use sheath to cover the Remote Control during a procedure)
• . Sensor Holder (a sterile, single use sheath to cover the SHERLOCK 3CG™ TCS Sensor during a procedure)

The Bard Access Systems, Inc. Sherlock 3CG+ Tip Confirmation System (TCS) (K180560) is indicated for navigation and positioning of central venous access devices (CVADs). The system uses real-time catheter tip location information by combining catheter navigation technology with the patient's cardiac electrical activity. It is indicated as an alternative to chest X-ray and fluoroscopy for CVAD tip placement confirmation from the superior vena cava.

Here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of quantitative acceptance criteria and reported device performance in terms of clinical accuracy (e.g., percentage of correct tip placements). Instead, it states that "the subject device, SHERLOCK 3CG+™ TCS, met all predetermined acceptance criteria derived from the above listed tests and demonstrated substantially equivalent performance as compared to the cited primary and secondary predicate devices."

The acceptance criteria are implicitly linked to the successful completion of various non-clinical tests and the comparison to predicate devices, focusing on areas like:

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No new human clinical data was provided to support substantial equivalence."

This indicates that new clinical test data (and thus, a test set and its sample size) for the Sherlock 3CG+ TCS itself was not used to demonstrate performance. The performance claims rely on the substantial equivalence to predicate devices and non-clinical (engineering) verification testing of new features or modified aspects.

The provenance of any data from the predicate devices (K141634 and K140345) is not detailed in this specific 510(k) summary, as it refers to "Design validation data supporting device performance was provided under K141634 and K140345." To understand the sample size and data provenance for the clinical performance, one would need to review the 510(k) submissions for those predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Given that "No new human clinical data was provided," there was no new clinical test set for which ground truth needed to be established by experts for this particular 510(k) submission. Any expert involvement would have been part of the predicate device submissions (K141634 and K140345), details of which are not in this document.

4. Adjudication Method for the Test Set

As no new clinical test set was used for this submission, there was no adjudication method applied to such a set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study was done for this submission, as indicated by the statement "No new human clinical data was provided." The device's clinical performance relies on the substantial equivalence to predicate devices, which were previously cleared.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document refers to "Sherlock 3CG TCS Standalone Software Verification" and "Magnet Tracking Accuracy" as non-clinical tests. These indicate that the software and its specific functionalities (like magnetic tracking accuracy) were evaluated in a standalone manner (without a human user in a clinical setting) as part of the engineering verification testing for the changes and combined features. However, this is not a "standalone performance study" in the clinical sense of assessing diagnostic accuracy of the algorithm itself in clinical cases. The device is intended to be used with a human in the loop (clinician interpreting the cues).

7. The Type of Ground Truth Used

For the non-clinical verification tests conducted for this submission (e.g., software verification, electromagnetic compatibility, temperature/humidity, magnet tracking accuracy), the "ground truth" would be defined by the technical specifications, engineering measurements, and established standards against which the device's performance was measured. For example, for "Magnet Tracking Accuracy," the ground truth would be the known, precise position of the magnetic components as measured by a high-precision reference system.

For the claim of "substantial equivalence" regarding clinical performance, the implicit ground truth would be derived from the clinical studies and data submitted for the predicate devices (K141634 and K140345). The specific types of ground truth used in those predicate studies (e.g., chest X-ray, fluoroscopy, direct visualization, catheter tip measurement by pathology if removed) are not detailed here but would depend on the nature of those original clinical validations. This submission relies on the established safety and effectiveness of the predicates.

8. The Sample Size for the Training Set

The document does not mention a training set, as it does not describe a new clinical study involving machine learning or AI algorithm development that would typically require a training set. The device appears to be based on established physiological principles (ECG signal analysis) and magnetic tracking, rather than a machine learning model requiring a large training dataset as understood in many AI/ML device submissions. The non-clinical testing focused on verification of engineering requirements and software function.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned or implied for a new algorithm in this submission, this question is not applicable.

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