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.

Device Description

The Sherlock 3CG® TPS Stylet has been developed to aid in the placement of Bard Access Systems' catheters using current placement techniques. The stylets are designed to give the catheters added support and stiffness while traversing the patient's venous system. Also, should the clinician choose to do so, the stylets have been designed to be used in conjunction with Sherlock 3CG® Tip Confirmation System to allow for rapid feedback of catheter tip placement.

AI/ML Overview

The provided text is a 510(k) summary for the Sherlock 3CG® Tip Positioning System (TPS) Stylet. It describes the device, its intended use, and the performance testing conducted to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance tests for the device, specifically focusing on "Ship Testing" and "Tip Tracking Testing."

Test Category	Acceptance Criteria	Reported Device Performance
Ship Testing	- Visual inspection and Integrity testing of header bag.- Visual inspection of components.- Visual inspection of trays.	"The verification method for ship testing was executed in accordance with ISO 11607-1:2006... All testing passed the predetermined acceptance criteria."
Tip Tracking Testing	- Normal: $\overline{x} + k * s \le 1 \text{ cm or } 10^\circ$ - Non-Normal: $Ppk \ge k/3$	"The Tip Tracking testing was executed per internal test methods and protocols. All testing passed the predetermined acceptance criteria."

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size used for either the "Ship Testing" or "Tip Tracking Testing." It also does not provide details on the data provenance (e.g., country of origin, retrospective or prospective). It simply states that "internal test methods and protocols" were used.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

The document does not mention the use of experts or any process for establishing ground truth for the test set in the context of human-centric evaluation. The tests described are primarily device performance (engineering) verification tests.

4. Adjudication Method for the Test Set:

Not applicable, as the tests described are engineering verification tests, not clinical studies requiring human adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

No, an MRMC comparative effectiveness study was not mentioned or implied. The focus of this 510(k) submission is on demonstrating substantial equivalence through technical and performance testing of the device itself, not on evaluating human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The device described, the Sherlock 3CG® Tip Positioning System (TPS) Stylet, is a physical medical device (a stylet with integrated technology for tip confirmation). It is not an "algorithm" in the sense of an AI/ML software. Therefore, the concept of "standalone performance" for an algorithm doesn't directly apply in the typical AI/ML context. The "Tip Tracking Testing" would be considered the standalone performance of the device's ability to track the tip.

7. The Type of Ground Truth Used:

For "Tip Tracking Testing," the ground truth would likely be established by a precisely measured, known physical position and orientation of the stylet tip. This is a technical (engineering) ground truth, not a clinical ground truth like pathology or outcome data. For "Ship Testing," the ground truth is simply meeting the defined visual and integrity criteria.

8. The Sample Size for the Training Set:

Not applicable, as this is a physical medical device and not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as this is a physical medical device and not an AI/ML algorithm requiring a training set.

Summary of Study Proof:

The document indicates that the Sherlock 3CG® TPS Stylet underwent verification testing to demonstrate its performance and substantial equivalence to a predicate device. The key tests reported are:

Ship Testing: Evaluated the packaging integrity and component visual quality after simulated shipping. This was done in accordance with ISO 11607-1:2006.
Tip Tracking Testing: Assessed the device's ability to accurately track the tip's location and orientation. This was conducted using internal test methods and protocols.

For both types of tests, the document explicitly states that "All testing passed the predetermined acceptance criteria." This statement is the proof that the device meets its established acceptance criteria. However, detailed data (e.g., specific values for mean, standard deviation, Ppk, or raw pass/fail rates beyond "all testing passed") and the sample sizes used for these tests are not provided in this summary. The ground truth for these tests is based on engineering measurements and established physical standards rather than clinical expert consensus or patient outcomes.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 29, 2017

C.R. Bard, Inc. Ms. Mona Shahrebani Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116

Re: K172397

Trade/Device Name: Sherlock 3CG Tip Positioning System (TPS) Stylet Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, implanted, long-term intravascular catheter Regulatory Class: Class II Product Code: LJS Dated: August 30, 2017 Received: August 31, 2017

Dear Ms. Mona Shahrebani:

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. Isting 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.

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Tina Kiang
-s

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Change Control Table, Change History

Change Control Table

Version	Document Author	Document Approver	Date Approved
1.00	Name, Title, Office	Name, Title, Office	MM/DD/YYYY

Complete Change Control Table (all versions) retained in SWIFT Docs.

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Indications for Use

510(k) Number (if known)

K172397

Device Name

Sherlock 3CG® Tip Positioning System (TPS) Stylet

Indications for Use (Describe)

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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ACCESS SYSTEMS

K172397

510(k) Summary

21 CFR 807.92(a)

GeneralProvisions	Submitter Name:	Bard Access Systems, Inc.
	Submitter Address:	605 North 5600 WestSalt Lake City, UT 84116
	Contact Person:	Mona ShahrebaniRegulatory Affairs Specialist
	Telephone Number:	(801) 522-5967
	Fax Number:	(801) 522-4907
	Date of Preparation:	September 27, 2017
Subject Device	Trade Name(s):	Sherlock 3CG® Tip Positioning System (TPS) Stylet
	Common Name:	Peripherally Inserted Central Catheter (PICC)
	Classification Name:	Percutaneous, Implanted, Long-term Intravascular Catheter
	Product Code/Regulation:	LJS/21 CFR §880.5970
PredicateDevices	Predicate Trade Name:	Sherlock 3CG® Tip Positioning System (TPS) Stylet
	Classification Name:	Percutaneous, Implanted, Long-term Intravascular Catheter
	Premarket Notification:	K091324
	Manufacturer:	Bard Access Systems, Inc.

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DeviceDescription	The Sherlock 3CG® TPS Stylet has been developed to aid in the placement of Bard Access Systems' catheters using currentplacement techniques. The stylets are designed to give the catheters added support and stiffness while traversing thepatient's venous system. Also, should the clinician choose to do so, the stylets have been designed to be used in conjunctionwith Sherlock 3CG® Tip Confirmation System to allow for rapid feedback of catheter tip placement.
Indications ForUse	Catheter stylets provide internal reinforcement to aid in catheter placement. When used with the Sherlock 3CG® TipConfirmation System (TCS), the Sherlock 3CG® TPS Stylet also provides the placer rapid feedback on catheter tip locationand orientation through the use of passive magnets and cardiac electrical signal detection.
	Technological characteristics of the subject Sherlock 3CG® TPS Stylet are substantially equivalent with respect to basicdesign and function to those of the cited predicate device.
TechnologicalCharacteristics		Subject Device:Sherlock 3CG® Tip Positioning System Stylet	Predicate Device:Sherlock 3CG® Tip Positioning System Stylet
	PrimaryDeviceMaterials	Stylet outer casingSame as predicateCore WireSame as predicateDistal TipSame as predicate	Stylet outer casing• PolyimideCore Wire• Stainless SteelDistal Tip• Magnets: Neodymium-Iron-Boron• Tip Adhesive: Dymax UV Thermal Epoxy 1184-M-VT• Conductive Epoxy: EpoTek H20E
	Stylet DistalTipConfiguration	Same as predicate	Atraumatic tip
	Stylet	0.019 in outer diameter x 78.5 cm	0.019 in outer diameter x 78.5 cm
Dimensions	0.019 in outer diameter x 62.5 cm
PackagingConfiguration	PETG tray with degaussing magnets, sized at13mm x 5mm x 3.5mm and 13mm x 5mm x1.5mm, placed in a cavity created within the tray,wrapped in CSR wrap, sealed in header bagLLDPE/Nylon film sealed to HCW27 coated 1073BTyvek®Note: Tyvek® is a registered trademark of E. I. du Pont deNemours or an affiliate	PETG tray, wrapped in CSR wrap, sealed inheader bag LLDPE/Nylon film sealed to HCW27coated 1073B Tyvek®Note: Tyvek® is a registered trademark of E. I. du Pont deNemours or an affiliate
The only modification made to the subject device when compared to the predicate device is a change in the packaging trayand the addition of a second size offering for the stylet. The packaging tray was modified to include a cavity recess containingtwo magnets below where the preloaded stylet and catheter rest. No other changes were made to the Sherlock 3CG® TPSStylet or packaging. Additionally, the stylet will now be offered in the following sizes: 0.019 in outer diameter x 78.5 cm and0.019 in outer diameter x 62.5 cm.The technological differences listed above were evaluated using the same test requirements as the predicate devices, asdefined in the Risk Assessment. Therefore, the difference in packaging design between the subject and predicate device doesnot raise different questions of equivalence.
PerformanceTests	Verification tests were designed and performed in accordance with Design Controls per 21 CFR §820.30. The onlymodification made to the subject device when compared to the predicate device is a change in the packaging tray and theaddition of a second size offering for the stylet. The packaging tray was modified to include a cavity recess containing twomagnets beneath the preloaded stylet and catheter. No other changes were made to the Sherlock 3CG® TPS Stylet orpackaging. Additionally, the sylet will now be offered in the following sizes: 0.019 in outer diameter x 78.5 cm and 0.019 inouter diameter x 62.5 cm.The following tests were conducted per guidance documents and standards in conjunction with in-house protocols to establishthe performance of the device:
	VerificationMethod	Risk Acceptability Criteria (Acceptance Criteria of Test)
	Ship Testing	- Visual inspection and Integrity testing of header bag.- Visual inspection of components.- Visual inspection of trays.
	Tip TrackingTesting	- Normal: $\overline{x} + k * s \le 1 \text{ cm or } 10^\circ$ , Non-Normal: $Ppk \ge k/3$
	The verification method for ship testing was executed in accordance with ISO 11607-1:2006, Packaging for terminallysterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems. The TipTracking testing was executed per internal test methods and protocols. All testing passed the predetermined acceptancecriteria.
	The subject device met all design requirements derived from the above listed references and demonstrated substantialequivalence as compared to the cited predicate device.
	Risk management, including a failure modes and effects analysis (FMEA), of the subject device was conducted in accordancewith BS EN ISO 14971:2012, Medical Devices – Application of Risk Management to Medical Devices.
Summary ofSubstantialEquivalence	Based on the indications for use, technological characteristics, and results of performance testing, the subject Sherlock 3CG®Tip Positioning System Stylet met the requirements that are considered sufficient for its intended use and demonstratessubstantial equivalence to 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.”