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.

AI/ML Overview

I am sorry, but the provided documentation does not contain details about acceptance criteria, device performance, or specific study results for the Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly.

The document is a 510(k) summary for the device, focusing on demonstrating substantial equivalence to a predicate device (K142267). It lists various performance tests conducted (e.g., Clamp/Flow rate Test, Leak/Pressure Test, Reseal Test, Stylet Removal Force, Joint Tensile, Gauging, Liquid Leakage, Air Leakage, Separation Force, Unscrewing Torque, Ease of Assembly, Resistance to Overriding, Stress Cracking), along with the test methods (BD Internal Test Method or ISO 594-2). However, it does not disclose the specific acceptance criteria for these tests or the reported results that would allow for a comparison.

Therefore, I cannot provide the requested table of acceptance criteria and reported device performance or other details regarding a study that proves the device meets acceptance criteria.

Summary

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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

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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

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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 WestSalt Lake City, UT 84116
	Contact Person:	Teresa Do-McCageRegulatory 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

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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, singleuse device 0.49 mm (0.019 in) outer diameter x 78.5 cm, made of specially-formulated materials designed to aid in theplacement of specific Bard catheters, as well as any open ended, non-valved, polyurethane, peripherally inserted centralcatheters (PICCs) that meet the dimensional specifications of the stylet. The Sherlock 3CG® TPS Stylet/T-LockAssembly is designed to work with catheters containing a minimum lumen diameter of 0.51mm (0.020 in). The styletprovides internal reinforcement to aid in catheter placement. The Sherlock 3CG® TPS Stylet/T-Lock Assembly may beused with the Sherlock 3CG® Tip Confirmation System (TCS) to provide catheter tip placement information during theprocedure.
Intended Use	The Sherlock 3CG® TPS Stylet/T-Lock Assembly provides real time catheter tip location information through the use ofpassive 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® TipConfirmation System (TCS), the Sherlock 3CG® TPS Stylet/T-Lock Assembly also provides the placer rapid feedbackon catheter tip location and orientation through the use of passive magnets and cardiac electrical signal detection.
TechnologicalCharacteristics	Technological characteristics of the subject Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assemblydevice are substantially equivalent to those of the cited predicate device with respect to intended use, indications foruse, target patient population, operating principle, fundamental scientific technology, packaging configurations, sterilityassurance level, and method of sterilization. The differences of the subject device from the predicate device are limitedto 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-LockExtension Set Assembly):
	Attribute	Subject Device	Predicate device	Testing Conducted toDemonstrateSubstantialEquivalence
Owner	Bard Access Systems, Inc.	Same
510(k) status	Subject of this 510(k)	K142267
DeviceConfiguration	Same	Sherlock 3CG® Procedure Kit• Sterile Components:Uncoated Tyvek® doublepouch.• Non-sterile Components: FoilPouch
Indications foruse	Same	Catheter stylets provide internalreinforcement to aid in catheterplacement. When used with theSherlock 3CG® Tip ConfirmationSystem (TCS), the Sherlock 3CG®TPS Stylet also provides the placerrapid feedback on catheter tiplocation and orientation through theuse of passive magnets and cardiacelectrical signal detection.
Duration ofuse	Same	Limited (<24 hours)

GeneralDeviceDescription	Same	Bard Access Systems, Inc.'sSherlock 3CG® Tip PositioningSystem (TPS) Stylet is a sterile,single use device 0.49 mm (0.019 in)outer diameter x 78.5 cm, made ofspecially-formulated materialsdesigned to aid in the placement ofspecific Bard catheters, as well asany open ended, non-valved,polyurethane, peripherally insertedcentral catheters (PICCs) that meetthe dimensional specifications of thestylet. The Sherlock 3CG® TPSStylet is designed to work withcatheters containing a minimumlumen diameter of 0.51mm (0.020in). The stylet provides internalreinforcement to aid in catheterplacement. The Sherlock 3CG® TPSStylet may be used with the Sherlock3CG® Tip Confirmation System(TCS) to provide catheter tipplacement information during theprocedure.
Means ofinsertion	Same	Percutaneous
Insertion site	Same	Peripheral
StyletMaterials	Same	Stainless steel core wire Polyimide casing Hydrophilic coating Magnets (Neodymium-Iron-Boron) Conductive epoxy UV adhesive
T-LockConnectorExtension	DESIGN	DESIGN
	Female Luer Lock Connector with wings	Female Luer Lock Connector without wings	Functional, Dimensionaltesting per ISO 594-2.
SetAssembly	Septum captured in plastic cap Cap removed from rotating collar	Septum placed in shrink wrap ring Cap provided on rotating collar	Particulate Matter testingper USP <788>.
	MATERIAL	MATERIAL
	Female Luer Lock Connector: PVC with colorants	Female Luer Lock Connector: Rigid PVC with colorant	Biocompatibility testingper ISO 10993-4, ISO10993-5, 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 PullTab Material	Same	Polypropylene
Stylet TetherMaterial andLength	Same	Medical grade Santoprene TPV wire insulation Copper tinsel wire Tin coated brass crimp 72 cm length
StyletConnectorMaterial	Same	Acetal connector Stainless Steel connector pin
Stylet DistalTipConfiguration	Same	Atraumatic tip
MagneticField	Same	Passive
Connectionto sensor	Same	The Sherlock 3CG® TPS Sensor isconnected to the Sherlock 3CG®TPS Stylet via the Sherlock 3CG®TPS Fin Assembly. This connectioncan be made through a sterile drape.
ECGDetectable	Same	Yes, the stylet serves as anintravascular ECG signal sensingwire.
Fin Assembly	Same	The fin assembly consists of two off-the-shelf pre-wired ECG electrodesthat terminate within the "fin". The finhouses three corresponding stainlesssteel contacts, one each forapplicable ECG lead and one for theSherlock 3CG® Stylet, representinga 3-electrode ECG system.
ECGElectrodes	Same	The Sherlock 3CG® TPS Systemuses a 3-electrode ECG system forECG signal detection. The three (3)leads consist of two (2) standard off-the-shelf body electrodes and oneintravascular electrode (Sherlock3CG® TPS Stylet). The threeelectrodes are connected to the ECGdetection circuitry in the Sherlock3CG® TPS Sensor through theSherlock 3CG® Fin Assembly.
Tip PlacementLocation	Same	In the superior vena cava, near thecavoatrial junction.
CatheterMaterial	Same	Polyurethane
Catheter Sizes	Same	Specific Bard catheters, any open-ended, non-valved, polyurethanePICC catheter that meets thedimensional specifications of thestylet (0.020 inch minimum lumendiameter)
StyletDimensions	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 theRisk Assessment. Therefore, these differences in technological characteristics between the subject and predicatedevices 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 forevaluating 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

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