Catheter stylets provide internal reinforcement to aid in catheter placement. The Sherlock™ TLS Stylet contains passive magnets that generate a magnetic 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

The provided text is a 510(k) summary for the Sherlock™ TLS (Tip Location System). It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain detailed information about specific acceptance criteria or the study that proves the device meets those criteria in a quantitative sense.

The document states that "The Sherlock™ Tip Location System (TLS) met all the performance criteria of the tests performed" and that "Bench testing was based on the above referenced guidance document and standards. All test results confirm that the modified device is substantially equivalent to the predicate devices." However, it does not explicitly list these "performance criteria" as acceptance metrics (e.g., accuracy +/- X mm, sensitivity, specificity, etc.) nor does it provide the detailed results of those tests.

Therefore, many of the requested details cannot be extracted directly from the provided text.

Here's an attempt to answer based on the available information, with clear indications where information is not present:

Acceptance Criteria and Study Details for Sherlock™ TLS

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Specific quantitative acceptance criteria (e.g., accuracy, precision, sensitivity, specificity, etc.) are not explicitly stated in the provided document.	The document broadly states that "The Sherlock™ Tip Location System (TLS) met all the performance criteria of the tests performed." No specific performance metrics or their values are provided. The device aims to provide "rapid feedback on catheter tip location" and quickly locate and confirm position.
Compliance with FDA guidance and ISO standards (e.g., Coronary and Cerebrovascular Guidewire FDA Guidance, ISO 11070:1998, AAMI/ANSI/ISO 11135:1994, AAMI/ANSI/ISO 10993-1:1997)	"All test results confirm that the modified device is substantially equivalent to the predicate devices."

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified in the provided document. The document refers to "Bench testing," but no details on the number of samples or tests conducted are given.
Data Provenance: Not specified. As it refers to "Bench testing," it implies laboratory-based testing rather than clinical data from specific countries. It does not mention retrospective or prospective studies for performance evaluation beyond bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified.
Ground Truth Establishment: Given that the testing was "bench testing," the "ground truth" would likely be established by precise measurements and engineering standards rather than expert clinical judgment (e.g., precise physical measurement of magnet location).

4. Adjudication method for the test set

Adjudication Method: Not specified. This detail is typically relevant for studies involving human interpretation or subjective measurements, which is not clearly described here for the performance testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not described or indicated in the provided document. The Sherlock™ TLS is a device to provide "rapid feedback on catheter tip location" and "quickly locates and confirms the position" of catheters. It is not an AI system designed to assist human readers in image interpretation.
The document states, "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." This suggests the device is an aid, not a standalone diagnostic or interpretive tool that would typically be evaluated in an MRMC study regarding "human reader improvement with AI."

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

The performance evaluation described ("Bench testing") would inherently be a standalone evaluation of the device's ability to detect and locate the magnetic tip. The document indicates the device "provides the placer rapid feedback on catheter tip location" and "quickly locates and confirms the position." The "performance criteria" that were met were for the device itself.

7. The type of ground truth used

For the reported "Bench testing," the ground truth would likely be based on precise physical measurements of the actual magnetic tip location, using calibrated equipment. The document doesn't provide explicit details but points to engineering and biocompatibility standards.

8. The sample size for the training set

The Sherlock™ TLS described here appears to be a hardware device (detector and stylet with magnets) based on physical principles of magnetic detection, not a software algorithm that would typically require a "training set" in the context of machine learning or AI. Therefore, this concept does not apply to the described device.

9. How the ground truth for the training set was established

As the device does not appear to be an AI/machine learning system requiring a training set, the question of establishing ground truth for a training set does not apply.

Summary

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Sherlock™ TLS Traditional 510(k)

Section 5 Sherlock™ Tip Location System 510(k) Summary of Safety and Effectiveness 21 CFR 807.92(a)

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5.1 General Information

Submitter Name:	Bard Access Systems, Inc. (BAS)
	[Wholly owned Subsidiary of C. R. Bard, Inc.]
Address:	5425 W. Amelia Earhart Drive
	Salt Lake City, UT 84116
Telephone Number:	(801) 595-0700 ext. 7136
Fax Number:	(801) 595-5425
Contact Person:	Lynn M. Kirchoff
Date of Preparation:	February 9, 2006
Registration Number:	1720496
Additional Registration Numbers:
C.R. Bard:	2212754

5.2 Subject Device Information

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-TermIntravascular Catheter21 CFR 880.5970— Class II
Classification Panel:	General Hospital

5.3 Predicate Device Information

Device Name(s):	5 Fr Dual Lumen Groshong® nXt PICC Catheter
	Poly Per-Q-Cath PICC
Trade Name(s):	Groshong® nXt, Poly Per-Q-Cath®
Common/Usual Name:	Peripherally Inserted Central Catheter (PICC)
Classification Name:	80 LJS - Percutaneous, Implanted, Long-Term Intravascular Catheter
	21 CFR 880.5970—Class II
Classification Panel:	General Hospital

Predicate Device Name	510(k)	Clearance Date
5 Fr DL Groshong® nXt PICC Catheter	K023374	12/18/2002
Poly Per-Q-Cath® PICC	K034019	1/21/2004

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Device Name:	Sensor Stylet and Sensor Guidewire
Trade Name:	Catheter Locator System
Common/Usual Name:	Vascular Access Catheter Accessories
Classification Name:	80 LJS – Accessory to Percutaneous, Implanted, Long-TermIntravascular Catheter21 CFR 880.5970– Class II
Classification Panel:	General Hospital

Predicate Device Name	510(k)	Clearance Date
Sensor Stylet and Sensor Guidewire	K935380	2/17/1995

Device Name:	Zortran Detector
Trade Name:	Zortran Detector
Common/Usual Name:	Vascular Access Catheter Accessories
Classification Name:	FOZ - Accessory to Percutaneous, Implanted, Intravascular Catheter21 CFR 880.5970- Class II
Classification Panel:	General Hospital

Predicate Device Name	510(k)	Clearance Date
Zortran Detector	K000997	9/7/2000

5.4 Intended Use

The intended use of the subject device is the same as the intended use of the predicate devices.

ર્ડ Indications for Use

The Indications for Use for the Sherlock™ Tip Location System (TLS) is as follows:

Summary of Changes 5.6

The following are modifications made to the currently marketed predicate PICC stylet and Sensor Stylet:

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. The addition of encapsulated passive magnetic material in the distal portion of the stylet to allow for detection when used with a magnetic sensor.

5.7 Device Description

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

ని.8 Technological Comparison to Predicate Devices

The technological characteristics of the Sherlock TLS are substantially equivalent to those of the predicate devices in terms of intended use, application, user population, basic design, performance, labeling, packaging and sterilization method.

ર્સ જે 510(k) Substantial Equivalence Decision Tree

New device is compared to Marketed Device? Yes.

Does the new device have the same indication statement and intended use as the predicate? Yes. However, there are minor modifications to the indication verbiage.

Does the new device have the same technological characteristics, e.g. design, materials, etc.? Not in all regards. The principles of operation and basic design are the same as the predicate devices. The main changes in design are the addition of passive magnetic material encapsulated in the distal portion of the stylet.

Could the new characteristics affect safety or effectiveness?

Yes. The design changes may affect safety or effectiveness of the device.

Do the new characteristics raise new types of safety and effectiveness questions? No. Safety and effectiveness questions are the same as for the predicate devices.

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
. AAMI/ANSI/ISO 10993-1:1997, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile

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Are performance data available to assess effects of new characteristics?

Yes. Bench testing was based on the above referenced guidance document and standards. All test results confirm that the modified device is substantially equivalent to the predicate devices.

5.10 Conclusion

The Sherlock™ Tip Location System (TLS) met all the performance criteria of the tests performed and, based on FDA's decision tree, is substantially equivalent to its predicate devices covered by: K023374, K034019, K935380, and K000997.

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Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The eagle is encircled by the text "U.S. Department of Health and Human Services, USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 2006

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

Re: K060341

Trade/Device Name: Sherlock™ Tip Location System (TLS) Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: February 9, 2006 Received: February 10, 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 vour 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 (OS) 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-fice 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.

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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Section 4 Indications for Use

510(k) Number (if known): job6()341

Device Name: SherlockTM Tip Location System (TLS)

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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KClO341

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).