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.

Device Description

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)

AI/ML Overview

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:

Area of Performance Examined	Implicit Acceptance Criteria	Reported Device Performance (as stated in document)
Magnetic Tracking Accuracy	Adequate accuracy for real-time catheter navigation using Sherlock™ Magnet Tracking.	"Magnet Tracking Accuracy" tests were conducted. The device met all predetermined acceptance criteria for these tests.
ECG-based Computed R-Peak Navigation	Adequate accuracy for real-time catheter navigation using ECG-based Computed R-Peak Navigation.	The device incorporates this technology from the primary predicate device (K141634). Performance is considered substantially equivalent to the predicate, which presumably met acceptance criteria.
Catheter Tip Placement Confirmation	Accurate identification of a maximum P-wave in the intravascular ECG signal for tip confirmation.	The device incorporates this technology from both predicate devices. Performance is considered substantially equivalent to the predicate devices, which presumably met acceptance criteria.
Software Verification	Software functions as intended, is free from critical defects, and meets specified requirements.	"Sherlock 3CG TCS Standalone Software Verification" and "SherlockShell Software Verification" were conducted. The device met all predetermined acceptance criteria for these tests.
Electrical Safety and EMC	Compliance with relevant electrical safety and electromagnetic compatibility standards (e.g., IEC 60601-1, IEC 60601-1-2).	"Sherlock 3CG TCS Standalone Electrical Safety and EMC - IEC 60601-1 Edition 3.1" tests were conducted. The device met all predetermined acceptance criteria for these tests.
Temperature and Humidity	Operates reliably within specified environmental conditions.	"Temperature and Humidity Testing" was conducted. The device met all predetermined acceptance criteria for these tests.
Mechanical Characteristics	No adverse changes to mechanical characteristics compared to predicate devices.	"No changes to any dimensional characteristics... under this premarket notification when compared with the primary predicate device and/or secondary predicate device." Performance is considered substantially equivalent to the predicate devices.
Biocompatibility	Device materials are biocompatible.	"Previously submitted biocompatibility data submitted under K140345 verify compatibility of the device materials."
Expanded CVAD Size Compatibility	Accurate ECG signal reconstruction with 2 Fr-compatible stylet.	"Representative nonclinical verification testing demonstrating accurate ECG signal reconstruction when a 2 Fr-compatible stylet is connected to the SHERLOCK 3CG+™ TCS" was conducted, supporting the expanded Indications for Use. Performance is considered adequate for this expanded use.
Newborn/Infant Indications for Use	Safe and effective for PICC use in infants and neonates, based on established clinical practice and predicate device data.	"Clarified to include the use of PICCs, based upon established clinical practice and upon clinical information provided in support of clearance of the primary predicate device." Implies that the data from the predicate device supported this expanded use and was deemed acceptable.
Superior Vena Cava Approach Specificity	Confirmation limited to superior vena cava approaches, as other approaches have not been qualified.	This is a clarification/limitation in the Indications for Use based on the scope of qualified performance, rather than a direct performance metric. The implied acceptance is that the device is safe and effective for the specified approach.
Overall Substantial Equivalence	Device has the same intended use and fundamental scientific technology as predicate devices, and meets all performance criteria.	The document explicitly concludes: "the subject device, SHERLOCK 3CG+™ TCS, is substantially equivalent to both the primary predicate device and the secondary predicate device."

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.

Summary

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June 18, 2018

Bard Access Systems, Inc. C.R. Bard, Inc. Christopher Phillips Regulatory Affairs Associate Manager 605 North 5600 West Salt Lake City, Utah 84116

Re: K180560

Trade/Device Name: Sherlock 3CG+ Tip Confirmation System (TCS) Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS Dated: May 18, 2018 Received: May 21, 2018

Dear Christopher Phillips:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good

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Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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Enclosure

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Indications for Use

510(k) Number (if known)

K180560

Device Name Sherlock 3CG+TM Tip Confirmation System (TCS)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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SHERLOCK 3CG+™ Tip Confirmation System (TCS) K180560 510(k) Summary 21 CFR 807.92

As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based is as follows:

1. Submitter Information

Bard Access Systems, Inc. C.R. Bard, Inc. 605 North 5600 West Salt Lake City, UT 84116 Phone: (801)522-5000 Fax: (801)522-4907

Christopher M. Phillips, Regulatory Affairs Associate Manager Contact Person: 510(k) Summary Date: June 18, 2018

2. Subject Device Name

Name of Device:	SHERLOCK 3CG+™ Tip Confirmation System (TCS)
Common or Usual Name:	SHERLOCK 3CG+™ Tip Confirmation System (TCS)
Classification Name:	Percutaneous, implanted, long-term intravascular catheter
Regulatory Class:	Class II
Regulation Number:	21 CFR 880.5970
FDA Product Code:	LJS

3. Predicate Device(s) and Reference Device(s)

Primary Predicate Device
510(k) Number:	K141634
Name of Device:	Nautilus Delta
Common or Usual Name:	Nautilus Delta
Owner/Manufacturer:	Bard Access Systems, Inc. (acquired from Romedex
	International SRL)
Classification Name:	Percutaneous, implanted, long-term intravascular catheter
Regulatory Class:	Class II
Regulation Number:	21 CFR 880.5970
FDA Product Code:	LJS
Secondary Predicate Device
510(k) Number:	K140345
Name of Device:	SHERLOCK 3CG™ Tip Confirmation System (TCS)
Common or Usual Name:	SHERLOCK 3CG™ Tip Confirmation System (TCS)

Name of Device:	SHERLOCK 3CG™ Tip Confirmation System (TCS)
Common or Usual Name:	SHERLOCK 3CG™ Tip Confirmation System (TCS)
Owner/Manufacturer:	Bard Access Systems, Inc.
Classification Name:	Percutaneous, implanted, long-term intravascular catheter
Regulatory Class:	Class II
Regulation Number:	21 CFR 880.5970
FDA Product Code:	LJS

Page 1

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4. Device Description

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.

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)

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No SHERLOCK 3CG+T™ accessories or hardware components are being changed under this submission in terms of materials, sterilization processes, cleaning methods, disinfection methods, shelf life, or packaging. All accessories and hardware components are legallymarketed devices associated with the primary predicate device and/or the secondary predicate device.

5. Indications for Use

The SHERLOCK 3CG+™ Tip Confirmation System (TCS) is indicated for navigation and positioning 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 PICCs and 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 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 catheter tip location.

6. Substantial Equivalence

Intended Use

The SHERLOCK 3CG+™ TCS and its predicate devices have the same intended use. The intended use of the SHERLOCK 3CG+™ TCS is to support navigation and tip positioning of central venous access devices. The SHERLOCK 3CG+™ TCS can be used as an alternative method to fluoroscopy and chest X-ray for central venous catheter tip placement confirmation.

Indications for Use

The SHERLOCK 3CG+™ TSC adopts the Indications for Use of its primary predicate device. with some minor changes. The Indications for Use for the subject and predicate devices are described in the table below. The differences do not change the intended use of the SHERLOCK 3CG+™ TCS when compared with the intended use of either predicate device. A summary of the differences between the Indications for Use of the subject device and the primary predicate device is included below:

1. The central venous access device (CVAD) lower size compatibility limit has been expanded to include CVADs of at least 2 Fr in size, based upon representative nonclinical verification testing demonstrating accurate ECG signal reconstruction when a 2 Fr-compatible stylet is connected to the SHERLOCK 3CG+™ TCS.
1. The SHERLOCK 3CG+™ TCS Indications for Use for infants and neonates has been clarified to include the use of PICCs, based upon established clinical practice and

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upon clinical information provided in support of clearance of the primary predicate device.

1. The phrase 'catheter navigation technology' has been added, based upon the presence of different catheter navigation technologies on the SHERLOCK 3CG+™ TCS.
1. The ability to use the SHERLOCK 3CG+™ TCS as an alternative to chest X-ray or fluoroscopy has been clarified to specify that the subject device may be used for CVAD tip placement confirmation of approaches from the superior vena cava, given that CVAD tip placement confirmation of alternative approaches (i.e., from the inferior vena cava) has not been qualified.

Technological Characteristics

The subject SHERLOCK 3CG+™ TCS has the following similarities to the Nautilus Delta primary predicate device (K141634):

Provides real-time catheter navigation information to the clinician via ECG-based ● Computed R-Peak Navigation, with available R-wave highlighting.
Provides 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.

The subject SHERLOCK 3CG+™ TCS has the following similarities to the SHERLOCK 3CG™ TCS 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).
. Provides catheter tip placement confirmation via the patient's cardiac electivity, 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 combines features from its two legally-marketed predicate devices, which both have the same intended use: catheter navigation and final catheter tip placement confirmation.

The following table summarizes the substantial equivalence comparison of the subject device with the cited predicate devices.

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	SHERLOCK 3CG+TM Tip ConfirmationSystem (TCS)(Subject Device)	Nautilus Delta(Primary Predicate Device: K141634)	SHERLOCK 3CGTM Tip ConfirmationSystem (TCS)(Secondary Predicate Device: K140345)
Indicationsfor Use	The SHERLOCK 3CG+TM Tip ConfirmationSystem (TCS) is indicated for navigation andpositioning of central venous access devices(CVADs) of at least 2 Fr in size. The SHERLOCK3CG+TM TCS provides real-time catheter tiplocation information by using catheter navigationtechnology along with the patient's cardiacelectrical activity and is indicated for use as analternative method to chest X-ray andfluoroscopy for CVAD tip placementconfirmation of approaches from the superiorvena cava.In adult patients and in adolescents (greaterthan 12 through 21 years of age), the SHERLOCK3CG+TM TCS can be used with CVADs such asperipherally inserted central catheters (PICCs),central venous catheters (CVCs), implantableports, 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 inneonates (from birth to 1 month of age), theSHERLOCK 3CG+TM TCS can be used withPICCs and with centrally inserted centralcatheters (CICCs). In each specific age group,the CVAD type and size must be chosen andthe CVAD must be used according to theCVAD's indications and instructions for use.Limiting but not contraindicated situations forthis method are in patients where alterations ofcardiac rhythm change the presentation of theP-wave as in atrial fibrillation, atrial flutter,severe tachycardia, and pacemaker drivenrhythm. In such patients, who are easilyidentifiable prior to catheter insertion, the use ofan additional method is required to confirmcatheter tip location.	The NAUTILUS DELTATM Tip Confirmation System(TCS) is indicated for navigation and positioningof central venous access devices (CVADs) of atleast 3 Fr in size. The NAUTILUS DELTATM TCSprovides real-time catheter tip locationinformation by using the patient's cardiacelectrical activity and is indicated for use as analternative method to chest X-ray andfluoroscopy for CVAD tip placementconfirmation.In adult patients and in adolescents (greaterthan 12 through 21 years of age), the NAUTILUSDELTATM TCS can be used with CVADs such asperipherally inserted central catheters (PICCs),central venous catheters (CVCs), implantableports, and hemodialysis catheters; in children(greater than 2 to 12 years of age), the NAUTILUSDELTATM TCS can be used with PICCs and withcentrally inserted central catheters (CICCs); ininfants (greater than 1 month to 2 years of age)and in neonates (from birth to 1 month of age),the NAUTILUS DELTATM TCS can be used withCICCs. In each specific age group, the CVADtype and size must be chosen and the CVADmust be used according to the CVAD'sindications and instructions for use.Limiting but not contraindicated situations forthis method are in patients where alterations ofcardiac rhythm change the presentation of theP-wave as in atrial fibrillation, atrial flutter,severe tachycardia, and pacemaker drivenrhythm. In such patients, who are easilyidentifiable prior to central venous catheterinsertion, the use of an additional method isrequired to confirm catheter tip location.	The Sherlock 3CGTM Tip Confirmation System(TCS) is indicated for guidance and positioningof Peripherally Inserted Central Catheters(PICCs). The Sherlock 3CGTM TCS providesreal-time PICC tip location information by usingpassive magnet tracking and the patient'scardiac electrical activity (EGG). When relyingon the patient's ECG signal, the Sherlock3CGTM TCS is indicated for use as analternative method to chest X-ray andfluoroscopy for PICC tip placement confirmationin adult patients.Limiting but not contraindicated situations forthis technique are in patients where alterationsof cardiac rhythm change the presentation of theP-wave as in atrial fibrillation, atrial flutter,severe tachycardia, and pacemaker drivenrhythm. In such patients, who are easilyidentifiable prior to catheter insertion, the use ofan additional method is required to confirmPICC tip location.
Software	Mobile medical application operating onqualified operating systems and on qualifiedportable computing platforms	Mobile medical application operating onqualified operating systems and on qualifiedportable computing platforms	Standalone software application operating onqualified operating systems and on qualifiedportable computing platforms
Substantial Equivalence Comparison Table
	SHERLOCK 3CG+TM Tip ConfirmationSystem (TCS)(Subject Device)	Nautilus Delta(Primary Predicate Device: K141634)	SHERLOCK 3CGTM Tip ConfirmationSystem (TCS)(Secondary Predicate Device: K140345)
Software:Methods forCatheterNavigation	Real-time catheter navigation via:SherlockTM Magnet Tracking, when usedwith SHERLOCK 3CGTM TPS Stylets (that arecompatible with 3Fr or larger CVADs)ECG-based Computed R-Peak Navigationwhen used with conductive styletscompatible with 2Fr or larger CVADs ORwhen using the saline column method with3Fr or larger CVADs	Real-time catheter navigation via:ECG-based Computed R-Peak Navigationwhen used with conductive styletscompatible with 3Fr or larger CVADs ORwhen using the saline column method with3Fr or larger CVADs	Real-time catheter navigation via:SherlockTM Magnet Tracking, when usedwith SHERLOCK 3CGTM TPS Stylets (that arecompatible with 3Fr or larger CVADs)
Software:R-waveHighlighting	Available	Available	Not available
Software:Method forCatheter TipPlacementConfirmation	Catheter tip placement confirmation via thepatient's cardiac electrical activity, based uponidentification of a maximum P-wave in thepatient's intravascular ECG signal collected viaconductive stylets compatible with 2Fr or largerCVADs OR via the saline column with 3Fr orlarger CVADs	Catheter tip placement confirmation via thepatient's cardiac electrical activity, based uponidentification of a maximum P-wave in thepatient's intravascular ECG signal collected viaconductive stylets compatible with 3Fr or largerCVADs OR via the saline column with 3Fr orlarger CVADs	Catheter tip placement confirmation via thepatient's cardiac electrical activity, based uponidentification of a maximum P-wave in thepatient's intravascular ECG signal collected viaa conductive stylet
Software:P-waveHighlighting	Available	Not available	Available
Software:AvailableCatheter TipPlacementVisual Cues	When the software detects a maximum P-wavein the patient's ECG signal and the clinician isnot using ECG-based Computed R-PeakNavigation, two different visual cues arepresented to the user (if selected):The Green Diamond Indicator is displayedon the User Interface when the softwaredetects a maximum P-wave without initialnegative deflection in the patient's ECGsignalP-wave highlighting changes from yellow togreen	Not available	When the software detects a maximum P-wavein the patient's ECG signal, two different visualcues are presented to the user (if selected):The Green Diamond Indicator is displayedon the User Interface when the softwaredetects a maximum P-wave in the patient'sECG signalP-wave highlighting changes from yellow togreen
Substantial Equivalence Comparison Table
	SHERLOCK 3CG+™ Tip ConfirmationSystem (TCS)(Subject Device)	Nautilus Delta(Primary Predicate Device: K141634)	SHERLOCK 3CG™ Tip ConfirmationSystem (TCS)(Secondary Predicate Device: K140345)
Software:ECG SignalsDisplayed onthe GraphicalUserInterface(GUI)	Comparative display of:Real-time external (skin) ECG waveform Frozen external ECG waveform (taken bythe user at a desired reference point) ALONG WITH EITHER comparative display of: Real-time intravascular ECG waveform(detected at the tip of the stylet) Frozen intravascular ECG waveform (takenby the user at a desired reference point) OR comparative display of: Real-time computed ECG navigation signal Frozen computed ECG navigation signal(taken by the user at a desired referencepoint)	Comparative display of:Real-time external (skin) ECG waveform Frozen external ECG waveform (taken bythe user at a desired reference point) ALONG WITH EITHER comparative display of: Real-time intravascular ECG waveform(detected at the tip of the stylet) Frozen intravascular ECG waveform (takenby the user at a desired reference point) OR comparative display of: Real-time computed ECG navigation signal Frozen computed ECG navigation signal(taken by the user at a desired referencepoint)	Comparative display of:Real-time external (skin) ECG waveform Frozen external ECG waveform (taken bythe user at a desired reference point) ALONG WITH comparative display of: Real-time intravascular ECG waveform(detected at the tip of the stylet) Frozen intravascular ECG waveform (takenby the user at a desired reference point)
ComputingPlatform:PowerSource	A/C power, or battery power	Battery power	A/C power, or battery power
Components	SHERLOCK 3CG™ TCS Sensor Computing platform SHERLOCK 3CG+™ TCS Mobile MedicalApplication	NAUTILUS DELTA™ ECG Cable NAUTILUS DELTA™ Patient Module Computing platform NAUTILUS DELTA™ TCS Mobile MedicalApplication	SHERLOCK 3CG™ TCS Sensor Computing platform SHERLOCK 3CG™ TCS Software Application
Accessories	NAUTILUS DELTA™ E Electrical Adaptor SHERLOCK 3CG™ ECG Leads (FinAssembly) SHERLOCK 3CG™ TPS Stylet Remote Optional Printer(s) Sensor Holster Remote Control Holder Sensor Holder	NAUTILUS DELTA™ E Electrical Adaptor SHERLOCK 3CG™ TPS Stylet Remote Optional Printer(s) Patient Module Holster Remote Control Holder Patient Module Holder	SHERLOCK 3CG™ ECG Leads (FinAssembly) SHERLOCK 3CG™ TPS Stylet Remote Optional Printer(s) Sensor Holster Remote Control Holder Sensor Holder

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7. Performance Data

Testing verifying the performance requirements of the subject device was conducted and is included in this premarket notification, the results of which support substantial equivalence. All subject device accessories and hardware components are legally marketed with the primary and secondary predicate devices. The following table lists subject device design requirements and corresponding nonclinical tests submitted, referenced, or relied on in the premarket notification for a determination of substantial equivalence. All tests listed in the following table are from this submission only for the purpose of verifying changes to the device. Previously submitted design verification and validation data from K141634 and K140345 were relied on where appropriate.

Design requirements and corresponding nonclinical tests
• User needs	Sherlock 3CG TCS Standalone Software VerificationMagnet Tracking Accuracy
• Physical characteristics• Electrical, electronic, and radiation characteristics• Thermal characteristics• Mechanical characteristics	Sherlock 3CG TCS Standalone Electrical Safety and EMC - IEC 60601-1 Edition 3.1
• Operating environment	Temperature and Humidity Testing
• Labeling characteristics	Sherlock 3CG TCS Standalone Electrical Safety and EMC - IEC 60601-1 Edition 3.1Temperature and Humidity Testing
• Equipment and device interfaces and mounting• Minimum requirements for computing platform• Usability requirements	Sherlock 3CG TCS Standalone Software VerificationSherlockShell Software Verification
• Operating requirements	Magnet Tracking AccuracySherlock 3CG TCS Standalone Software Verification
• Software requirements	Sherlock 3CG TCS Standalone Software VerificationSherlockShell Software VerificationMagnet Tracking AccuracySherlock 3CG TCS System Verification
• Dimensional characteristics• Chemical characteristics• Biological and biocompatibility characteristics• Packaging characteristics	No changes to any dimensional characteristics, chemical characteristics, biological and biocompatibility characteristics, or packaging characteristics under this premarket notification when compared with the primary predicate device and/or secondary predicate device. Previously submitted biocompatibility data submitted under K140345 verify compatibility of the device materials.

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The following quidance documents and standards were used to determine appropriate methods for evaluating the performance of the subject device:

FDA Guidance Guidance for the Content of Premarket Submissions for Software ● Contained in Medical Devices
FDA Guidance Content of Premarket Submissions for Management of Cybersecurity in . Medical Devices
FDA Guidance Postmarket Management of Cybersecurity in Medical Devices ●
. FDA Guidance - Applying Human Factors And Usability Engineering To Medical Devices
. AAMI TIR 57:2016. Principles For Medical Device Security – Risk Management
AAMI / ANSI EC12:2000/l2010. Disposable ECG Electrodes .
AAMI / ANSI HE75:2009/(R)2013, Human Factors Engineering - Design Of Medical Devices
ISO 14971 Second Edition 2007-03-01, Medical Devices Application Of Risk ● Management To Medical Devices
. AAMI / ANSI / IEC 62366:2007/(R)2013. Medical Devices - Application Of Usability Engineering To Medical Devices
. IEC 60601-1 INT 3 C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
. IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
. IEC 62133 Edition 2.0 2012-12 Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications
IEC 62304 Edition 1.1 2015-06, Medical Device Software Software Life Cycle . Processes
ISO 15223-1 Third Edition 2016-11-01 Medical Devices Symbols To Be Used With ● Medical Device Labels, Labelling, And Information To Be Supplied - Part 1: General Requirements

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.

8. Clinical Performance Data

No new human clinical data was provided to support substantial equivalence. Design validation data supporting device performance was provided under K141634 and K140345.

9. Conclusion Regarding Substantial Equivalence

The subject device, SHERLOCK 3CG+™ TCS, has the same intended use and the same fundamental scientific technology as the primary and secondary predicate devices. The subject device has the same Intended Use, similar Indications for Use and incorporates the same fundamental technology as the legally marketed predicate devices to which it was compared. Based on Intended Use, technological characteristics, and performance testing, it can be

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concluded that the subject device, SHERLOCK 3CG+™ TCS, is substantially equivalent to both
the primary predicate device and the secondary predicate device.

Regulation Number and Section

§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.

(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”