(109 days)
Not Found
No
The summary describes the device's functionality based on ECG analysis (P-wave identification, R-peak navigation) and magnetic tracking. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No
The device is for confirming the placement of central venous access devices, not for diagnosing, treating, or preventing a disease or condition. It aids in a procedure but is not itself therapeutic.
Yes
The device provides real-time "catheter tip location information" and "catheter tip placement confirmation" by using cardiac electrical activity and catheter navigation technology. This information is used for "CVAD tip placement confirmation," which is a diagnostic function to determine the correct positioning of a medical device within the body.
No
The device description explicitly lists hardware components such as the "SHERLOCK 3CG™ TCS Sensor" and "Computing Platform," in addition to the mobile application. The performance studies also mention testing related to electrical safety, EMC, and temperature/humidity, which are typically associated with hardware verification.
Based on the provided text, the Sherlock 3CG+™ Tip Confirmation System (TCS) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Sherlock 3CG+™ TCS Function: The Sherlock 3CG+™ TCS works by using the patient's cardiac electrical activity (ECG) and/or magnetic tracking to determine the location of a catheter tip within the patient's body. It is a navigation and confirmation system for a medical procedure performed in vivo.
- Lack of Specimen Analysis: The device does not analyze any specimens taken from the patient. It directly interacts with and monitors physiological signals and/or magnetic fields within the patient.
Therefore, the Sherlock 3CG+™ TCS falls under the category of an in vivo medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
LJS
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)
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
superior vena cava
Indicated Patient Age Range
Adult patients, Adolescents (greater than 12 through 21 years of age), Children (greater than 2 to 12 years of age), Infants (greater than 1 month to 2 years of age), Neonates (from birth to 1 month of age).
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. 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.
Specific tests conducted include:
- Sherlock 3CG TCS Standalone Software Verification
- Magnet Tracking Accuracy
- Sherlock 3CG TCS Standalone Electrical Safety and EMC - IEC 60601-1 Edition 3.1
- Temperature and Humidity Testing
- SherlockShell Software Verification
- Sherlock 3CG TCS System Verification
No new human clinical data was provided to support substantial equivalence. Design validation data supporting device performance was provided under K141634 and K140345.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
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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
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Enclosure
2
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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
4
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)
5
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:
-
- 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.
-
- 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
6
upon clinical information provided in support of clearance of the primary predicate device.
-
- The phrase 'catheter navigation technology' has been added, based upon the presence of different catheter navigation technologies on the SHERLOCK 3CG+™ TCS.
-
- 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.
7
| | SHERLOCK 3CG+TM Tip Confirmation
System (TCS)
(Subject Device) | Nautilus Delta
(Primary Predicate Device: K141634) | SHERLOCK 3CGTM Tip Confirmation
System (TCS)
(Secondary Predicate Device: K140345) |
|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The SHERLOCK 3CG+TM 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+TM 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+TM 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+TM 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. | The NAUTILUS DELTATM Tip Confirmation System
(TCS) is indicated for navigation and positioning
of central venous access devices (CVADs) of at
least 3 Fr in size. The NAUTILUS DELTATM TCS
provides real-time catheter tip location
information by using 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.
In adult patients and in adolescents (greater
than 12 through 21 years of age), the NAUTILUS
DELTATM 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), the NAUTILUS
DELTATM TCS can be used with PICCs and with
centrally inserted central catheters (CICCs); in
infants (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 with
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 central venous catheter
insertion, the use of an additional method is
required to confirm catheter tip location. | The Sherlock 3CGTM Tip Confirmation System
(TCS) is indicated for guidance and positioning
of Peripherally Inserted Central Catheters
(PICCs). The Sherlock 3CGTM TCS provides
real-time PICC tip location information by using
passive magnet tracking and the patient's
cardiac electrical activity (EGG). When relying
on the patient's ECG signal, the Sherlock
3CGTM 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. |
| Software | Mobile medical application operating on
qualified operating systems and on qualified
portable computing platforms | Mobile medical application operating on
qualified operating systems and on qualified
portable computing platforms | Standalone software application operating on
qualified operating systems and on qualified
portable computing platforms |
| Substantial Equivalence Comparison Table | | | |
| | SHERLOCK 3CG+TM Tip Confirmation
System (TCS)
(Subject Device) | Nautilus Delta
(Primary Predicate Device: K141634) | SHERLOCK 3CGTM Tip Confirmation
System (TCS)
(Secondary Predicate Device: K140345) |
| Software:
Methods for
Catheter
Navigation | Real-time catheter navigation via:
SherlockTM Magnet Tracking, when used
with SHERLOCK 3CGTM TPS Stylets (that are
compatible with 3Fr or larger CVADs)ECG-based Computed R-Peak Navigation
when used with conductive stylets
compatible with 2Fr or larger CVADs OR
when using the saline column method with
3Fr or larger CVADs | Real-time catheter navigation via:
ECG-based Computed R-Peak Navigation
when used with conductive stylets
compatible with 3Fr or larger CVADs OR
when using the saline column method with
3Fr or larger CVADs | Real-time catheter navigation via:
SherlockTM Magnet Tracking, when used
with SHERLOCK 3CGTM TPS Stylets (that are
compatible with 3Fr or larger CVADs) |
| Software:
R-wave
Highlighting | Available | Available | Not available |
| Software:
Method for
Catheter Tip
Placement
Confirmation | 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 collected via
conductive stylets compatible with 2Fr or larger
CVADs OR via the saline column with 3Fr or
larger CVADs | 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 collected via
conductive stylets compatible with 3Fr or larger
CVADs OR via the saline column with 3Fr or
larger CVADs | 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 collected via
a conductive stylet |
| Software:
P-wave
Highlighting | Available | Not available | Available |
| Software:
Available
Catheter Tip
Placement
Visual Cues | When the software detects a maximum P-wave
in the patient's ECG signal and the clinician is
not using ECG-based Computed R-Peak
Navigation, two different visual cues are
presented to the user (if selected):
The Green Diamond Indicator is displayed
on the User Interface when the software
detects a maximum P-wave without initial
negative deflection in the patient's ECG
signalP-wave highlighting changes from yellow to
green | Not available | When the software detects a maximum P-wave
in the patient's ECG signal, two different visual
cues are presented to the user (if selected):
The Green Diamond Indicator is displayed
on the User Interface when the software
detects a maximum P-wave in the patient's
ECG signalP-wave highlighting changes from yellow to
green |
| Substantial Equivalence Comparison Table | | | |
| | SHERLOCK 3CG+™ Tip Confirmation
System (TCS)
(Subject Device) | Nautilus Delta
(Primary Predicate Device: K141634) | SHERLOCK 3CG™ Tip Confirmation
System (TCS)
(Secondary Predicate Device: K140345) |
| Software:
ECG Signals
Displayed on
the Graphical
User
Interface
(GUI) | Comparative display of:
Real-time external (skin) ECG waveform Frozen external ECG waveform (taken by
the 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 (taken
by 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 reference
point) | Comparative display of:
Real-time external (skin) ECG waveform Frozen external ECG waveform (taken by
the 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 (taken
by 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 reference
point) | Comparative display of:
Real-time external (skin) ECG waveform Frozen external ECG waveform (taken by
the 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 (taken
by the user at a desired reference point) |
| Computing
Platform:
Power
Source | 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 Medical
Application | NAUTILUS DELTA™ ECG Cable NAUTILUS DELTA™ Patient Module Computing platform NAUTILUS DELTA™ TCS Mobile Medical
Application | SHERLOCK 3CG™ TCS Sensor Computing platform SHERLOCK 3CG™ TCS Software Application |
| Accessories | NAUTILUS DELTA™ E Electrical Adaptor SHERLOCK 3CG™ ECG Leads (Fin
Assembly) 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 (Fin
Assembly) 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 Verification |
| Magnet 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 3.1 |
| Temperature and Humidity Testing | |
| • Equipment and device interfaces and mounting | |
| • Minimum requirements for computing platform | |
| • Usability requirements | Sherlock 3CG TCS Standalone Software Verification |
| SherlockShell Software Verification | |
| • Operating requirements | Magnet Tracking Accuracy |
| Sherlock 3CG TCS Standalone Software Verification | |
| • Software requirements | Sherlock 3CG TCS Standalone Software Verification |
| SherlockShell Software Verification | |
| Magnet Tracking Accuracy | |
| Sherlock 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.