K Number

Device Name

Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly

Manufacturer

Bard Access Systems, Inc.

Date Cleared

2022-08-24

(30 days)

Product Code

LJS

Regulation Number

880.5970

Intended Use

Catheter stylets provide internal reinforcement to aid in catheter placement. When used with the Sherlock 3CG® Tip Confirmation System (TCS), the Sherlock 3CG® TPS Stylet/T-Lock Assembly also provides the placer rapid feedback on catheter tip location and orientation through the use of passive magnets and cardiac electrical signal detection.

Device Description

Bard Access Systems, Inc.'s Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly is a sterile, single use device 0.49 mm (0.019 in) outer diameter x 78.5 cm, made of specially-formulated materials designed to aid in the placement of specific Bard catheters, as well as any open ended, non-valved, polyurethane, peripherally inserted central catheters (PICCs) that meet the dimensional specifications of the stylet. The Sherlock 3CG® TPS Stylet/T-Lock Assembly is designed to work with catheters containing a minimum lumen diameter of 0.51mm (0.020 in). The stylet provides internal reinforcement to aid in catheter placement. The Sherlock 3CG® TPS Stylet/T-Lock Assembly may be used with the Sherlock 3CG® Tip Confirmation System (TCS) to provide catheter tip placement information during the procedure.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K142267

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on passive magnets and cardiac electrical signal detection for tip location, with no mention of AI or ML.

Therapeutic

No
The device is a catheter stylet that provides internal reinforcement and aids in catheter placement and tip location/orientation confirmation. It does not exert a therapeutic effect on the patient.

Diagnostic

Yes
The device provides "rapid feedback on catheter tip location and orientation through the use of passive magnets and cardiac electrical signal detection" and is designed to "provide catheter tip placement information during the procedure," which are diagnostic functions.

SaMD (Software as a Medical Device)

The device description clearly states it is a sterile, single-use device made of specially-formulated materials, with specific dimensions and physical properties, designed to aid in catheter placement. It also mentions verification and validation tests related to physical characteristics like clamp/flow rate, leak/pressure, tensile strength, etc., which are indicative of a hardware device. While it can be used with a system that involves electrical signal detection (Sherlock 3CG® TCS), the stylet/T-Lock Assembly itself is a physical component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to aid in catheter placement and provide feedback on catheter tip location and orientation within the body using passive magnets and cardiac electrical signal detection. This is a procedure performed directly on a patient.
Device Description: The device is a stylet designed to be inserted into a catheter for placement within the body.
Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of bodily specimens.
Anatomical Site: The anatomical site mentioned (superior vena cava, near the cavoatrial junction) is within the patient's body, not a location for in vitro testing.
Performance Studies: The performance studies listed focus on the physical properties and functionality of the device itself (clamp/flow rate, leak/pressure, tensile strength, etc.), not on the accuracy of diagnostic results from analyzing specimens.

The device is a medical device used in vivo (within the body) to assist in a medical procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

LJS

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

superior vena cava, near the cavoatrial junction.

Indicated Patient Age Range

Not Found

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)

Applicable verification and validation tests have been performed in accordance with Design Controls as per 21 CFR §820.30. The following standards in conjunction with in-house protocols were used to determine appropriate methods for evaluating the performance of the device:
Clamp/ Flow rate Test (BD Internal Test Method)
Leak /Pressure Test (BD Internal Test Method)
Reseal Test (BD Internal Test Method)
Stylet Removal Force (BD Internal Test Method)
Joint Tensile (BD Internal Test Method)
Gauging (ISO 594-2)
Liquid Leakage (ISO 594-2)
Air Leakage (ISO 594-2)
Separation Force (ISO 594-2)
Unscrewing Torque (ISO 594-2)
Ease of Assembly (ISO 594-2)
Resistance to Overriding (ISO 594-2)
Stress Cracking (ISO 594-2)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K142267

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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

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.”

Summary

Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 24, 2022

Bard Access Systems, Inc. Teresa Do-Mccage Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116

Re: K222232

Trade/Device Name: Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS Dated: July 22, 2022 Received: July 25, 2022

Dear Teresa Do-Mccage:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K22232

Device Name

Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly

Indications for Use (Describe)

Catheter stylets provide internal reinforcement to aid in catheter placement. When used with the Sherlock 3 CG® Tip Confirmation System (TCS), the Sherlock 3CG® TPS Stylet/T-Lock Assembly also provides the placer rapid feedback on catheter tip location and orientation through the use of passive magnets and cardiac electrical signal detection.

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

he-Counter Use (21 CFR 801 Subpart C)

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K222232 510(k) Summary 21 CFR 807.92(a)

As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (1)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based is as follows:

General Provisions	Submitter Name:	Bard Access Systems, Inc. (Bard has joined BD)
	Submitter Address:	605 North 5600 West
Salt Lake City, UT 84116
	Contact Person:	Teresa Do-McCage
Regulatory Affairs Specialist
	Telephone Number:	801.522.5959
	Email:	teresa.do-mccage@bd.com
	Date of Preparation:	8/24/2022
	Subject Device	Trade Name:
Common Name:		Long-Term Greater Than 30 Days Therapeutic Intravascular Catheter
Regulation Number:		21 CFR §880.5970
Regulation Classification Name:		Percutaneous, Implanted Long-Term Intravascular Catheter
Regulatory Class:		II
Product Code:		LJS
Classification Panel:		General Hospital
Predicate Device	Trade Name:	Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly
	Common Name:	Long-Term Greater Than 30 Days Therapeutic Intravascular Catheter
	Regulation Number:	21 CFR §880.5970

Regulation	Classification Name:	Percutaneous, Implanted Long-Term Intravascular Catheter
	Regulatory Class:	II
	Product Code:	LJS
	Classification Panel:	General Hospital
	510(k) Status:	K142267 (Concurrence date October 17, 2014)
Device Description	Bard Access Systems, Inc.'s Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly is a sterile, single
use device 0.49 mm (0.019 in) outer diameter x 78.5 cm, made of specially-formulated materials designed to aid in the
placement of specific Bard catheters, as well as any open ended, non-valved, polyurethane, peripherally inserted central
catheters (PICCs) that meet the dimensional specifications of the stylet. The Sherlock 3CG® TPS Stylet/T-Lock
Assembly is designed to work with catheters containing a minimum lumen diameter of 0.51mm (0.020 in). The stylet
provides internal reinforcement to aid in catheter placement. The Sherlock 3CG® TPS Stylet/T-Lock Assembly may be
used with the Sherlock 3CG® Tip Confirmation System (TCS) to provide catheter tip placement information during the
procedure.
Intended Use	The Sherlock 3CG® TPS Stylet/T-Lock Assembly provides real time catheter tip location information through the use of
passive magnet and cardiac electrical signal detection.
Indications for Use	Catheter stylets provide internal reinforcement to aid in catheter placement. When used with the Sherlock 3CG® Tip
Confirmation System (TCS), the Sherlock 3CG® TPS Stylet/T-Lock Assembly also provides the placer rapid feedback
on catheter tip location and orientation through the use of passive magnets and cardiac electrical signal detection.
Technological
Characteristics	Technological characteristics of the subject Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly
device are substantially equivalent to those of the cited predicate device with respect to intended use, indications for
use, target patient population, operating principle, fundamental scientific technology, packaging configurations, sterility
assurance level, and method of sterilization. The differences of the subject device from the predicate device are limited
to the T-Lock Extension Set Assembly, a primary device component used in the subject/predicate device.
The following tables provides a summary comparison between the subject and predicate device component (T-Lock
Extension Set Assembly):
	Attribute	Subject Device	Predicate device	Testing Conducted to
Demonstrate
Substantial
Equivalence
Owner	Bard Access Systems, Inc.	Same
510(k) status	Subject of this 510(k)	K142267
Device
Configuration	Same	Sherlock 3CG® Procedure Kit
• Sterile Components:
Uncoated Tyvek® double
pouch.
• Non-sterile Components: Foil
Pouch
Indications for
use	Same	Catheter stylets provide internal
reinforcement to aid in catheter
placement. When used with the
Sherlock 3CG® Tip Confirmation
System (TCS), the Sherlock 3CG®
TPS Stylet also provides the placer
rapid feedback on catheter tip
location and orientation through the
use of passive magnets and cardiac
electrical signal detection.
Duration of
use	Same	Limited (.
	MATERIAL	MATERIAL
	Female Luer Lock Connector: PVC with colorants	Female Luer Lock Connector: Rigid PVC with colorant	Biocompatibility testing
per ISO 10993-4, ISO
10993-5, ISO 10993-10,
and ISO 10993-11.
	Slide Clamp – Polypropylene, white	Slide Clamp – ABS, white
	T-Fitting (T-Connector) – MABS, clear	T-Fitting (T-Connector) – PVC, clear
	Spin Lock (Rotating Collar) – MABS, clear	Spin Lock (Rotating Collar) – Polycarbonate, clear
	Same	Tubing: PVC
	Same	Injection Stopple (Septum) –
Polyisoprene
Stylet Pull
Tab Material	Same	Polypropylene
Stylet Tether
Material and
Length	Same	Medical grade Santoprene TPV wire insulation Copper tinsel wire Tin coated brass crimp 72 cm length
Stylet
Connector
Material	Same	Acetal connector Stainless Steel connector pin
Stylet Distal
Tip
Configuration	Same	Atraumatic tip
Magnetic
Field	Same	Passive
Connection
to sensor	Same	The Sherlock 3CG® TPS Sensor is
connected to the Sherlock 3CG®
TPS Stylet via the Sherlock 3CG®
TPS Fin Assembly. This connection
can be made through a sterile drape.
ECG
Detectable	Same	Yes, the stylet serves as an
intravascular ECG signal sensing
wire.
Fin Assembly	Same	The fin assembly consists of two off-
the-shelf pre-wired ECG electrodes
that terminate within the "fin". The fin
houses three corresponding stainless
steel contacts, one each for
applicable ECG lead and one for the
Sherlock 3CG® Stylet, representing
a 3-electrode ECG system.
ECG
Electrodes	Same	The Sherlock 3CG® TPS System
uses a 3-electrode ECG system for
ECG signal detection. The three (3)
leads consist of two (2) standard off-
the-shelf body electrodes and one
intravascular electrode (Sherlock
3CG® TPS Stylet). The three
electrodes are connected to the ECG
detection circuitry in the Sherlock
3CG® TPS Sensor through the
Sherlock 3CG® Fin Assembly.
Tip Placement
Location	Same	In the superior vena cava, near the
cavoatrial junction.
Catheter
Material	Same	Polyurethane
Catheter Sizes	Same	Specific Bard catheters, any open-
ended, non-valved, polyurethane
PICC catheter that meets the
dimensional specifications of the
stylet (0.020 inch minimum lumen
diameter)
Stylet
Dimensions	Same	0.019 inch outer diameter x 78.5 cm
	Sterility	Same	Provided Sterile
The technological differences listed above were evaluated using industry consensus standards, and as defined in the
Risk Assessment. Therefore, these differences in technological characteristics between the subject and predicate
devices do not raise new or different questions of safety or effectiveness.
Applicable verification and validation tests have been performed in accordance with Design Controls as per 21 CFR
§820.30. The following standards in conjunction with in-house protocols were used to determine appropriate methods for
evaluating the performance of the device:
		Test Description	Test Method
		Clamp/ Flow rate Test	BD Internal Test Method
		Leak /Pressure Test	BD Internal Test Method
		Reseal Test	BD Internal Test Method
		Stylet Removal Force	BD Internal Test Method
		Joint Tensile	BD Internal Test Method
Performance Tests		Gauging	ISO 594-2
		Liquid Leakage	ISO 594-2
		Air Leakage	ISO 594-2
		Separation Force	ISO 594-2
		Unscrewing Torque	ISO 594-2
		Ease of Assembly	ISO 594-2
		Resistance to Overriding	ISO 594-2
		Stress Cracking	ISO 594-2

| Summary of
Substantial
Equivalence | Based on the risk management activities, intended use, technological characteristics, and performance testing, the
subject Sherlock 3CG® TPS Stylet/T-Lock Assembly demonstrated to be substantial equivalent for its intended use and
is as safe and as effective as the cited predicate device. |

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