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

K222232 · Bard Access Systems, Inc. · LJS · Aug 24, 2022 · General Hospital

Device Facts

• Record ID: K222232
• Device Name: Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly
• Applicant: Bard Access Systems, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Aug 24, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5970
• Device Class: Class 2

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.

Device Story

Sterile, single-use stylet (0.49 mm OD x 78.5 cm) provides internal reinforcement for PICC placement; used with Sherlock 3CG® Tip Confirmation System (TCS). Input: passive magnetic field and cardiac electrical signals detected via intravascular sensing wire. Operation: stylet acts as an intravascular ECG electrode; connects to TCS sensor via fin assembly (3-electrode system). Output: real-time catheter tip location/orientation feedback to clinician. Used in clinical settings during catheter insertion to ensure tip placement in superior vena cava near cavoatrial junction. Benefits: aids accurate placement, reduces need for post-procedure confirmation imaging.

Clinical Evidence

Bench testing only. Performance evaluated via ISO 594-2 (leakage, force, torque, stress cracking), biocompatibility (ISO 10993-4, -5, -10, -11), and USP <788> particulate matter testing. No clinical data presented.

Technological Characteristics

Stylet: stainless steel core, polyimide casing, hydrophilic coating, Neodymium-Iron-Boron magnets, conductive epoxy. T-Lock: PVC, MABS, polypropylene, polyisoprene. Sensing: passive magnetic and 3-electrode ECG (intravascular + 2 body electrodes). Connectivity: wired connection to TCS sensor. Sterilization: sterile.

Indications for Use

Indicated for catheter stylet internal reinforcement to aid in catheter placement. When used with the Sherlock 3CG® Tip Confirmation System (TCS), it provides rapid feedback on catheter tip location and orientation via passive magnets and cardiac electrical signal detection.

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

• Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly (K142267)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 West<br>Salt Lake City, UT 84116 |
| | Contact Person: | Teresa Do-McCage<br>Regulatory Affairs Specialist |
| | Telephone Number: | 801.522.5959 |
| | Email: | [e-mail] |
| | 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, single<br>use device 0.49 mm (0.019 in) outer diameter x 78.5 cm, made of specially-formulated materials designed to aid in the<br>placement of specific Bard catheters, as well as any open ended, non-valved, polyurethane, peripherally inserted central<br>catheters (PICCs) that meet the dimensional specifications of the stylet. The Sherlock 3CG® TPS Stylet/T-Lock<br>Assembly is designed to work with catheters containing a minimum lumen diameter of 0.51mm (0.020 in). The stylet<br>provides internal reinforcement to aid in catheter placement. The Sherlock 3CG® TPS Stylet/T-Lock Assembly may be<br>used with the Sherlock 3CG® Tip Confirmation System (TCS) to provide catheter tip placement information during the<br>procedure. | | | |
| Intended Use | The Sherlock 3CG® TPS Stylet/T-Lock Assembly provides real time catheter tip location information through the use of<br>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<br>Confirmation System (TCS), the Sherlock 3CG® TPS Stylet/T-Lock Assembly also provides the placer rapid feedback<br>on catheter tip location and orientation through the use of passive magnets and cardiac electrical signal detection. | | | |
| Technological<br>Characteristics | Technological characteristics of the subject Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly<br>device are substantially equivalent to those of the cited predicate device with respect to intended use, indications for<br>use, target patient population, operating principle, fundamental scientific technology, packaging configurations, sterility<br>assurance level, and method of sterilization. The differences of the subject device from the predicate device are limited<br>to the T-Lock Extension Set Assembly, a primary device component used in the subject/predicate device.<br>The following tables provides a summary comparison between the subject and predicate device component (T-Lock<br>Extension Set Assembly): | | | |
| | Attribute | Subject Device | Predicate device | Testing Conducted to<br>Demonstrate<br>Substantial<br>Equivalence |
| Owner | Bard Access Systems, Inc. | Same | | |
| 510(k) status | Subject of this 510(k) | K142267 | | |
| Device<br>Configuration | Same | Sherlock 3CG® Procedure Kit<br>• Sterile Components:<br>Uncoated Tyvek® double<br>pouch.<br>• Non-sterile Components: Foil<br>Pouch | | |
| Indications for<br>use | Same | Catheter stylets provide internal<br>reinforcement to aid in catheter<br>placement. When used with the<br>Sherlock 3CG® Tip Confirmation<br>System (TCS), the Sherlock 3CG®<br>TPS Stylet also provides the placer<br>rapid feedback on catheter tip<br>location and orientation through the<br>use of passive magnets and cardiac<br>electrical signal detection. | | |
| Duration of<br>use | Same | Limited (<24 hours) | | |
| | | | | |
| General<br>Device<br>Description | Same | Bard Access Systems, Inc.'s<br>Sherlock 3CG® Tip Positioning<br>System (TPS) Stylet is a sterile,<br>single use device 0.49 mm (0.019 in)<br>outer diameter x 78.5 cm, made of<br>specially-formulated materials<br>designed to aid in the placement of<br>specific Bard catheters, as well as<br>any open ended, non-valved,<br>polyurethane, peripherally inserted<br>central catheters (PICCs) that meet<br>the dimensional specifications of the<br>stylet. The Sherlock 3CG® TPS<br>Stylet is designed to work with<br>catheters containing a minimum<br>lumen diameter of 0.51mm (0.020<br>in). The stylet provides internal<br>reinforcement to aid in catheter<br>placement. The Sherlock 3CG® TPS<br>Stylet may be used with the Sherlock<br>3CG® Tip Confirmation System<br>(TCS) to provide catheter tip<br>placement information during the<br>procedure. | | |
| Means of<br>insertion | Same | Percutaneous | | |
| Insertion site | Same | Peripheral | | |
| Stylet<br>Materials | Same | Stainless steel core wire Polyimide casing Hydrophilic coating Magnets (Neodymium-Iron-Boron) Conductive epoxy UV adhesive | | |
| T-Lock<br>Connector<br>Extension | DESIGN | DESIGN | | |
| | Female Luer Lock Connector with wings | Female Luer Lock Connector without wings | Functional, Dimensional<br>testing per ISO 594-2. | |
| Set<br>Assembly | Septum captured in plastic cap Cap removed from rotating collar | Septum placed in shrink wrap ring Cap provided on rotating collar | Particulate Matter testing<br>per USP <788>. | |
| | MATERIAL | MATERIAL | | |
| | Female Luer Lock Connector: PVC with colorants | Female Luer Lock Connector: Rigid PVC with colorant | Biocompatibility testing<br>per ISO 10993-4, ISO<br>10993-5, ISO 10993-10,<br>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) –<br>Polyisoprene | | |
| Stylet Pull<br>Tab Material | Same | Polypropylene | | |
| Stylet Tether<br>Material and<br>Length | Same | Medical grade Santoprene TPV wire insulation Copper tinsel wire Tin coated brass crimp 72 cm length…