Sherlock 3CG+ T ip Confirmation System

K180560 · C.R. Bard, Inc. · LJS · Jun 18, 2018 · General Hospital

Device Facts

• Record ID: K180560
• Device Name: Sherlock 3CG+ T ip Confirmation System
• Applicant: C.R. Bard, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Jun 18, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Sherlock 3CG+ TCS aids CVAD tip positioning using real-time navigation and ECG technology. Inputs include intravascular ECG signals (via conductive stylets or saline column) and magnetic tracking (via passive magnets). System processes signals to identify maximum P-wave and compute R-peak navigation. Outputs include real-time ECG waveforms, R-wave/P-wave highlighting, and visual cues (e.g., Green Diamond Indicator) on a mobile medical application GUI. Used in clinical settings by healthcare providers to confirm catheter tip location without X-ray or fluoroscopy. Benefits include reduced radiation exposure and real-time placement confirmation.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including software verification, magnet tracking accuracy, and electrical safety/EMC testing (IEC 60601-1).

Technological Characteristics

System comprises sensor, computing platform, and mobile medical application. Navigation via ECG-based Computed R-Peak or Sherlock Magnet Tracking. Tip confirmation via intravascular ECG P-wave identification. Compatible with 2 Fr or larger CVADs. Connectivity via wired leads/stylets. Standards: IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 14971.

Indications for Use

Indicated for navigation/positioning of CVADs (≥2 Fr) in neonates, infants, children, adolescents, and adults. Used as alternative to chest X-ray/fluoroscopy for superior vena cava approaches. Contraindicated/limited in patients with cardiac rhythm alterations (atrial fibrillation, flutter, tachycardia, pacemaker-driven rhythm).

Regulatory Classification

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.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

Predicate Devices

• Nautilus Delta (K141634)
• SHERLOCK 3CG™ Tip Confirmation System (TCS) (K140345)

Submission Summary (Full Text)

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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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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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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)

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.

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

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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: [phone] Fax: [phone]

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

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)

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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.
- 2. 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.

- 3. The phrase 'catheter navigation technology' has been added, based upon the presence of different catheter navigation technologies on the SHERLOCK 3CG+™ TCS.
- 4. 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 Confirmation<br>System (TCS)<br>(Subject Device) | Nautilus Delta<br>(Primary Predicate Device: K141634) | SHERLOCK 3CGTM Tip Confirmation<br>System (TCS)<br>(Secondary Predicate Device: K140345) |
|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | The SHERLOCK 3CG+TM Tip Confirmation<br>System (TCS) is indicated for navigation and<br>positioning of central venous access devices<br>(CVADs) of at least 2 Fr in size. The SHERLOCK<br>3CG+TM TCS provides real-time catheter tip<br>location information by using catheter navigation<br>technology along with the patient's cardiac<br>electrical activity and is indicated for use as an<br>alternative method to chest X-ray and<br>fluoroscopy for CVAD tip placement<br>confirmation of approaches from the superior<br>vena cava.<br><br>In adult patients and in adolescents (greater<br>than 12 through 21 years of age), the SHERLOCK<br>3CG+TM TCS can be used with CVADs such as<br>peripherally inserted central catheters (PICCs),<br>central venous catheters (CVCs), implantable<br>ports, and hemodialysis catheters; in children<br>(greater than 2 to 12 years of age), in infants<br>(greater than 1 month to 2 years of age), and in<br>neonates (from birth to 1 month of age), the<br>SHERLOCK 3CG+TM TCS can be used with<br>PICCs and with centrally inserted central<br>catheters (CICCs). In each specific age group,<br>the CVAD type and size must be chosen and<br>the CVAD must be used according to the<br>CVAD's indications and instructions for use.<br><br>Limiting but not contraindicated situations for<br>this method are in patients where alterations of<br>cardiac rhythm change the presentation of the<br>P-wave as in atrial fibrillation, atrial flutter,<br>severe tachycardia, and pacemaker driven<br>rhythm. In such patients, who are easily<br>identifiable prior to catheter insertion, the use of<br>an additional method is required to confirm<br>catheter tip location. | The NAUTILUS DELTATM Tip Confirmation System<br>(TCS) is indicated for navigation and positioning<br>of central venous access devices (CVADs) of at<br>least 3 Fr in size. The NAUTILUS DELTATM TCS<br>provides real-time catheter tip location<br>information by using the patient's cardiac<br>electrical activity and is indicated for use as an<br>alternative method to chest X-ray and<br>fluoroscopy for CVAD tip placement<br>confirmation.<br><br>In adult patients and in adolescents (greater<br>than 12 through 21 years of age), the NAUTILUS<br>DELTATM TCS can be used with CVADs such as<br>peripherally inserted central catheters (PICCs),<br>central venous catheters (CVCs), implantable<br>ports, and hemodialysis catheters; in children<br>(greater than 2 to 12 years of age), the NAUTILUS<br>DELTATM TCS can be used with PICCs and with<br>centrally inserted central catheters (CICCs); in<br>infants (greater than 1 month to 2 years of age)<br>and in neonates (from birth to 1 month of age),<br>the NAUTILUS DELTATM TCS can be used with<br>CICCs. In each specific age group, the CVAD<br>type and size must be chosen and the CVAD<br>must be used according to the CVAD's<br>indications and instructions for use.<br><br>Limiting but not contraindicated situations for<br>this method are in patients where alterations of<br>cardiac rhythm change the presentation of the<br>P-wave as in atrial fibrillation, atrial flutter,<br>severe tachycardia, and pacemaker driven<br>rhythm. In such patients, who are easily<br>identifiable prior to central venous catheter<br>insertion, the use of an additional method is<br>required to confirm catheter tip location. | The Sherlock 3CGTM Tip Confirmation System<br>(TCS) is indicated for guidance and positioning<br>of Peripherally Inserted Central Catheters<br>(PICCs). The Sherlock 3CGTM TCS provides<br>real-time PICC tip location information by using<br>passive magnet tracking and the patient's<br>cardiac electrical activity (EGG). When relying<br>on the patient's ECG signal, the Sherlock<br>3CGTM TCS is indicated for use as an<br>alternative method to chest X-ray and<br>fluoroscopy for PICC tip placement confirmation<br>in adult patients.<br><br>Limiting but not contraindicated situations for<br>this technique are in patients where alterations<br>of cardiac rhythm change the presentation of the<br>P-wave as in atrial fibrillation, atrial flutter,<br>severe tachycardia, and pacemaker driven<br>rhythm. In such patients, who are easily<br>identifiable prior to catheter insertion, the use of<br>an additional method is required to confirm<br>PICC tip location. |
| Software | Mobile medical application operating on<br>qualified operating systems and on qualified<br>portable computing platforms | Mobile medical application operating on<br>qualified operating systems and on qualified<br>portable computing platforms | Standalone software application operating on<br>qualified operating systems and on qualified<br>portable computing platforms |
| Substantial Equivalence Comparison Table | | | |
| | SHERLOCK 3CG+TM Tip Confirmation<br>System (TCS)<br>(Subject Device) | Nautilus Delta<br>(Primary Predicate Device: K141634) | SHERLOCK 3CGTM Tip Confirmation<br>System (TCS)<br>(Secondary Predicate Device: K140345) |
| Software:<br>Methods for<br>Catheter<br>Navigation | Real-time catheter navigation via:<br>SherlockTM Magnet Tracking, when used<br>with SHERLOCK 3CGTM TPS Stylets (that are<br>compatible with 3Fr or larger CVADs)ECG-based Computed R-Peak Navigation<br>when used with conductive stylets<br>compatible with 2Fr or larger CVADs OR<br>when using the saline column method with<br>3Fr or larger CVADs | Real-time catheter navigation via:<br>ECG-based Computed R-Peak Navigation<br>when used with conductive stylets<br>compatible with 3Fr or larger CVADs OR<br>when using the saline column method with<br>3Fr or larger CVADs | Real-time catheter navigation via:<br>SherlockTM Magnet Tracking, when used<br>with SHERLOCK 3CGTM TPS Stylets (that are<br>compatible with 3Fr or larger CVADs) |
| Software:<br>R-wave<br>Highlighting | Available | Available | Not available |
| Software:<br>Method for<br>Catheter Tip<br>Placement<br>Confirmation | Catheter tip placement confirmation via the<br>patient's cardiac electrical activity, based upon<br>identification of a maximum P-wave in the<br>patient's intravascular ECG signal collected via<br>conductive stylets compatible with 2Fr or larger<br>CVADs OR via the saline column with 3Fr or<br>larger CVADs | Catheter tip placement confirmation via the<br>patient's cardiac electrical activity, based upon<br>identification of a maximum P-wave in the<br>patient's intravascular ECG signal collected via<br>conductive stylets compatible with 3Fr or larger<br>CVADs OR via the saline column with 3Fr or<br>larger CVADs | Catheter tip placement confirmation via the<br>patient's cardiac electrical activity, based upon<br>identification of a maximum P-wave in the<br>patient's intravascular ECG signal collected via<br>a conductive stylet |
| Software:<br>P-wave<br>Highlighting | Available | Not available | Available |
| Software:<br>Available<br>Catheter Tip<br>Placement<br>Visual Cues | When the software detects a maximum P-wave<br>in the patient's ECG signal and the clinician is<br>not using ECG-based Computed R-Peak<br>Navigation, two different visual cues are<br>presented to the user (if selected):<br>The Green Diamond Indicator is displayed<br>on the User Interface when the software<br>detects a maximum P-wave without initial<br>negative deflection in the patient's ECG<br>signalP-wave highlighting changes from yellow to<br>green | Not available | When the software detects a maximum P-wave<br>in the patient's ECG signal, two different visual<br>cues are presented to the user (if selected):<br>The Green Diamond Indicator is displayed<br>on the User Interface when the software<br>detects a maximum P-wave in the patient's<br>ECG signalP-wave highlighting changes from yellow to<br>green |
| Substantial Equivalence Comparison Table | | | |
| | SHERLOCK 3CG+™ Tip Confirmation<br>System (TCS)<br>(Subject Device) | Nautilus Delta<br>(Primary Predicate Device: K141634) | SHERLOCK 3CG™ Tip Confirmation<br>System (TCS)<br>(Secondary Predicate Device: K140345) |
| Software:<br>ECG Signals<br>Displayed on<br>the Graphical<br>User<br>Interface<br>(GUI) | Comparative display of:<br>Real-time external (skin) ECG waveform Frozen external ECG waveform (taken by<br>the user at a desired reference point) ALONG WITH EITHER comparative display of: Real-time intravascular ECG waveform<br>(detected at the tip of the stylet) Frozen intravascular ECG waveform (taken<br>by the user at a desired reference point) OR comparative display of: Real-time computed ECG navigation signal Frozen computed ECG navigation signal<br>(taken by the user at a desired reference<br>point) | Comparative display of:<br>Real-time external (skin) ECG waveform Frozen external ECG waveform (taken by<br>the user at a desired reference point) ALONG WITH EITHER comparative display of: Real-time intravascular ECG waveform<br>(detected at the tip of the stylet) Frozen intravascular ECG waveform (taken<br>by the user at a desired reference point) OR comparative display of: Real-time computed ECG navigation signal Frozen computed ECG navigation signal<br>(taken by the user at a desired reference<br>point) | Comparative display of:<br>Real-time external (skin) ECG waveform Frozen external ECG waveform (taken by<br>the user at a desired reference point) ALONG WITH comparative display of: Real-time intravascular ECG waveform<br>(detected at the tip of the stylet) Frozen intravascular ECG waveform (taken<br>by the user at a desired reference point)…