Catheter stylets provide internal reinforcement to aid in catheter placement. The Sherlock™ TLS Stylet contains passive magnets that generate a magnetic field. This field can be detected by the Sherlock™ TLS Detector to provide the placer rapid feedback on catheter tip location.

The Sherlock™ TLS Detector quickly locates and confirms the position of specially designed. magnet-tipped Peripherally Inserted Central Catheters (PICCS) and Central Venous Catheters (CVCs) during and after initial placement. This device may be used by appropriate caregivers in hospitals, long-term care facilities or home-care settings. The Sherlock™ TLS Detector provides rapid feedback to the caregiver, but was not designed to replace conventional methods of placement verification. Users are urged to confirm correct placement according to their established institutional protocol and clinical judgment.

Device Description

The Sherlock™ Tip Location System (TLS) consists of the Sherlock™ TLS Detector and Sherlock™ TLS Stylet. The Sherlock™ TLS 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 venotomy. Also, should the clinician choose to do so, the stylets have been designed to be used in conjunction with Sherlock™ TLS Detector to allow for rapid feedback of catheter tip placement. The information provided by the Sherlock™ TLS is not meant to replace conventional methods of catheter placement verification. Clinicians are urged to confirm correct catheter placement according to their established institutional protocol and clinical judgment.

AI/ML Overview

Here's an analysis of the provided text regarding the Sherlock™ (TLS) Stylet 510(k) Modifications:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list specific numerical acceptance criteria for performance metrics (e.g., accuracy, precision) for the Sherlock™ TLS Stylet. Instead, it states that:

"The modified devices met the acceptance criteria for the tests performed."
"Performance data demonstrated that the modified Sherlock™ TLS Stylets are substantially equivalent to the predicate devices and/ or met pre-determined acceptance criteria..."
"The modified Sherlock™ TLS Stylets met predetermined performance acceptance criteria of testing performed..."

The type of tests performed focused on:

Acceptance Criteria Type	Reported Device Performance
Safety - Risk Management (based on ISO 14971:2000)	A Failure Modes and Effects Analysis (FMEA) was conducted. "The analysis did not raise any new types of safety or effectiveness questions." Risks were found "acceptable."
Effectiveness - Design Validation	"The need for design validation was assessed and no additional validation was required." "The modification to the design did not necessitate the need for additional design validation activities."
Verification - Tensile Integrity	"Verification testing demonstrated the ability of the modified design to maintain tensile integrity under extreme kink conditions." (Specific numerical criteria for tensile strength or kink resistance are not provided).
Safety - Biocompatibility (ISO 10993-1 and FDA-Modified ISO 10993 Test Profile)	"Biocompatibility requirements... were met. No materials are used in the manufacture of the modified device that have not already been cleared for similar applications by Bard Access Systems."
Overall Performance / Substantial Equivalence (to predicate K060341)	Modified devices met predetermined acceptance criteria and demonstrated substantial equivalence to the predicate devices. The basic fundamental scientific technology of the stylet has not changed.

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

The document does not specify the sample size used for any of the verification or validation tests. It only states that "testing was performed according to protocols."

Regarding data provenance:

The study was conducted by Bard Access Systems, Inc. in Salt Lake City, UT, USA.
The nature of the testing described (tensile integrity, biocompatibility, FMEA) suggests that this was primarily prospective testing conducted on the modified Sherlock™ TLS Stylets themselves, rather than analysis of retrospective patient data.

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

This information is not provided in the document. The tests described (tensile integrity, biocompatibility, FMEA) typically involve engineering and material science expertise, and risk assessment specialists, rather than clinical experts establishing a ground truth based on patient outcomes or imaging.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the described tests, traditional clinical adjudication methods (like 2+1 reader adjudication) are not applicable. The FMEA would have involved expert review and consensus on potential risks and mitigations, but the specific adjudication process is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. The document focuses on the technical verification and biocompatibility of the modified stylet and its substantial equivalence to a predicate device. It explicitly states that the Sherlock™ TLS system "was not designed to replace conventional methods of placement verification," and "Clinicians are urged to confirm correct catheter placement according to their established institutional protocol and clinical judgment." This suggests the device provides feedback but isn't intended as a standalone diagnostic or primary confirmation tool that would necessitate an MRMC study comparing human performance with and without its aid.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Since the "Sherlock™ TLS Stylet" described here is a physical component (a stylet containing passive magnets) designed to be used with a "Sherlock™ TLS Detector" (the detector being the "algorithm" equivalent to provide feedback), a standalone test of only the stylet in isolation for diagnostic or performance metrics wouldn't be meaningful.

The "algorithm only" performance would reside in the Detector, which is part of the overall Sherlock™ TLS system. The summary implies the Detector provides "rapid feedback on catheter tip location," but its standalone diagnostic accuracy (without human interpretation or confirmation from conventional methods) is not quantified. The document emphasizes the system "was not designed to replace conventional methods of placement verification."

7. The Type of Ground Truth Used

The ground truth for the verification testing conducted on the stylet itself (e.g., tensile integrity) would be based on engineering specifications and quantifiable physical measurements. For biocompatibility, the ground truth would be established by validated biological assays and compliance with ISO 10993 standards.

For the intended function of detecting catheter tip location, the implicit ground truth for the overall Sherlock™ TLS system's function (not specifically detailed in this document for this modification, but likely part of the predicate's clearance K060341) would likely be conventional imaging methods (e.g., X-ray, fluoroscopy) used for catheter tip verification. However, this 510(k) is for modifications to the stylet, and confirms it maintains its characteristics relative to the predicate, rather than re-proving the entire system's accuracy against a clinical ground truth.

8. The Sample Size for the Training Set

This information is not applicable / not provided. The Sherlock™ TLS Stylet is a passive medical device containing magnets. It does not employ machine learning or artificial intelligence algorithms that require a "training set" in the conventional sense. The "detection" occurs in the Sherlock™ TLS Detector, but the stylet itself is a physical component.

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

This information is not applicable / not provided for the same reasons as point 8.

Summary

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Sherlock™ (TLS) Stylet 510(k) Modifications

K063240

Section 6

NOV 2 1 2006

510(k) Summary Sherlock™ Tip Location System (TLS) Stylet

510(k) Summary of Safety and Effectiveness Information 21 CFR 807.92

1. Submitter Information:

Submitter Name:	Bard Access Systems, Inc.[Subsidiary of C. R. Bard, Inc.]
Address:	5425 W. Amelia Earhart DriveSalt Lake City, UT 84116
Telephone Number:	(801) 595-7136
Fax Number:	(801) 595 5425
Contact Person:	Lynn M. Kirchoff
Date of Preparation:	October 25, 2006

2. Subject Device Information:

Device Name:	Sherlock™ Tip Location System Stylet
Trade Name:	Sherlock™ Tip Location System (TLS) Stylet
Common/Usual Name:	Vascular Access Catheter Accessories
Classification Name:	80 LJS - Accessory to Percutaneous, Implanted, Long-TermIntravascular Catheter
	21 CFR 880.5970- Class II
Classification Panel:	General Hospital

Predicate Device Information: 3.

Device Name:	Sherlock™ Tip Location System
Trade Name:	Sherlock™ Tip Location System (TLS)
Common/Usual Name:	Vascular Access Catheter Accessories
Classification Name:	80 LJS - Accessory to Percutaneous, Implanted, Long-Term Intravascular Catheter21 CFR 880.5970- Class II
Classification Panel:	General Hospital
Premarket Notification:	K060341, concurrence date April 14, 2006

Device Name:	Sherlock™ Tip Location System (TLS) Detector
Trade Name:	Sherlock™ Tip Location System (TLS) Detector
Common/Usual Name:	Vascular Access Catheter Accessories
Classification Name:	80 LJS- Accessory to Percutaneous, Implanted, Long-Term Intravascular Catheter21 CFR 880.5970- Class II
Classification Panel:	General Hospital
Premarket Notification:	K061240, concurrence date June 2, 2006

4. Device Description

The Sherlock™ Tip Location System (TLS) consists of the Sherlock™ TLS Detector and Sherlock™ TLS Stylet.

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The Sherlock™ TLS 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 venotomy. Also, should the clinician choose to do so, the stylets have been designed to be used in conjunction with Sherlock™ TLS Detector to allow for rapid feedback of catheter tip placement. The information provided by the Sherlock™ TLS is not meant to replace conventional methods of catheter placement verification. Clinicians are urged to confirm correct catheter placement according to their established institutional protocol and clinical judgment.

5. Intended Use

Summary of Technological Characteristics in relation to Predicate Device: 6.

Does the new device have the same indication statement?

Yes.

Does the new device have the same technological characteristics, e.g. design, material, etc.?

Not in all regards. The Sherlock™ TLS Stylet has some minor differences from the predicate Sherlock™ TLS Stylet. However, the basic fundamental scientific technology of the stylet has not changed.

Could the new characteristics affect safety or effectiveness?

Yes. The new characteristics could affect safety and effectiveness of the device,

Do the new characteristics raise new types of safety and effectiveness questions?

No. A failure modes and effects analysis (FMEA) of the modified device was conducted in accordance with an internal protocol based on ISO 14971:2000, Medical Devices - Risk Management for Medical Devices, to assure that risks posed by the subject device are acceptable. The analysis did not raise any new types of safety or effectiveness questions.

Do accepted scientific methods exist for assessing effects of the new characteristics?

Yes. Testing was based on FDA guidance document and standards to evaluate the devices' performance:

. Coronary and Cerebrovascular Guidewire FDA Guidance, dated 1/95
. ISO 11070:1998, Sterile, single-use intravascular catheter introducers
AAMI/ANSI/ISO 11135:1994, Medical Devices Validation and Routine Control of . Ethylene Oxide Sterilization

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The need for design validation was assessed and no additional validation was required. The modification to the design did not necessitate the need for additional design validation activities. There is no change in how the clinician will use the device in placement procedures, only additional clarification in the IFU for the safe and effective use of the device. Verification testing demonstrated the ability of the modified design to maintain tensile integrity under extreme kink conditions.

Biocompatibility requirements of ISO-10993, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing, and the FDA-Modified ISO 10993 Test Profile for externally communicating, blood-contacting, long-term devices, were met. No materials are used in the manufacture of the modified device that have not already been cleared for similar applications by Bard Access Systems.

Are performance data available to assess effects of new characteristics?

Yes. Verification and validation testing was performed according to protocols based on the above-referenced guidance document recommendations and standards, as well as in accordance with in-house protocols. The modified devices met the acceptance criteria for the tests performed.

Do performance data demonstrate equivalence?

Yes. Performance data demonstrated that the modified Sherlock™ TLS Stylets are substantially equivalent to the predicate devices and/ or met pre-determined acceptance criteria, and the risks associated with use of the new device were found acceptable when evaluated by FMEA.

7. Conclusion

The modified Sherlock™ TLS Stylets met predetermined performance acceptance criteria of testing performed and are substantially equivalent to the predicate Sherlock™ TLS Stylets, cleared under K060341.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

C.R. Bard, Incorporated Ms. Lynn M. Kirchoff Regulatory Affairs Specialist Bard Access Systems, Incorporated 5425 West Amelia Earhart Drive Salt Lake City, Utah 84116

NOV 2 1 2006

Re: K063240

Trade/Device Name: Sherlock™ Tip Location System (TLS) Regulation Number: 880.5970 Regulation Name: Percutaneous, Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: October 25, 2006 Received: October 26, 2006

Dear Ms. Kirchoff:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Ms. Kirchoff

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K063240

Device Name: SherlockTM Tip Location System (TLS)

Indications For Use:

AND/OR Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ald C. Ager for now 11/27/2006

eneral Hospital.

K063240

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.”