The Sherlock 3CG™ Tip Confirmation System (TCS) is indicated for guidance and positioning of Peripherally Inserted Central Catheters (PICCs). The Sherlock 3CG™ TCS provides real-time PICC tip location information by using passive magnet tracking and the patient's cardiac electrical activity (ECG). When relying on the patient's ECG signal, the Sherlock 3CG™ TCS is indicated for use as an alternative method to chest X-ray and fluoroscopy for PICC tip placement confirmation in adult patients. Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial fibrillation, atrial flutter, severe tachycardia, and pacemaker driven rhythm. In such patients, who are easily identifiable prior to catheter insertion, the use of an additional method is required to confirm PICC tip location.

Device Description

The Sherlock 3CGTM TCS is indicated for guidance and positioning of PICCs during insertion and placement. The Sherlock 3CGTM TCS provides real-time catheter tip location information by using passive magnet tracking and the patient's cardiac electrical activity (ECG). The Sherlock 3CGTM TCS displays the location of the PICC tip using a magnetic stylet and magnetic sensors. The Sherlock 3CGTM TCS also displays ECG waveforms received from the patient's skin (baseline ECG) and from the tip of the catheter (intravascular ECG) on the graphical user interface.

AI/ML Overview

The Sherlock 3CG Tip Confirmation System (TCS) is indicated for guiding and positioning Peripherally Inserted Central Catheters (PICCs) by using passive magnet tracking and the patient's cardiac electrical activity (ECG). When relying on the ECG signal, it provides an alternative to chest X-ray and fluoroscopy for PICC tip placement confirmation in adult patients.

Here's an analysis of the acceptance criteria and study information provided:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list specific numerical acceptance criteria (e.g., a specific accuracy percentage for tip placement). Instead, it states that the device "met all pre-determined acceptance criteria" and "demonstrated substantial equivalence as compared to the predicate device." The overall conclusion from the testing is that the subject device "is as safe, as effective, and performs as well as or better than the predicate device."

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Stated)	Reported Device Performance
Device met predetermined performance specifications.	Met all pre-determined acceptance criteria.
Demonstrate substantial equivalence to predicate device.	Demonstrated substantial equivalence as compared to the predicate device.
As safe as predicate device.	Performs as well as or better than the predicate device.
As effective as predicate device.	Performs as well as or better than the predicate device.
As well as or better than predicate device in performance.	Performs as well as or better than the predicate device.

2. Sample Size and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It refers to "verification and validation activities" and "in-house protocols" for determining the appropriate methods for evaluating performance.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used or their qualifications to establish the ground truth for the test set.

4. Adjudication Method

The document does not mention any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The focus is on the device itself and its equivalence to a predicate device, rather than comparing human reader performance with and without AI assistance.

6. Standalone Performance Study

The information suggests that a standalone performance evaluation of the algorithm and device without a human-in-the-loop was conducted. The "verification and validation activities" and the statement that the device "met all pre-determined acceptance criteria" imply testing of the device's functionality and accuracy on its own. The primary claim is about the device's ability to locate the PICC tip, rather than its enhancement of human interpretation.

7. Type of Ground Truth Used

The type of ground truth used is not explicitly stated in the provided text. However, given the device's function of confirming PICC tip location as an alternative to chest X-ray and fluoroscopy, it is highly probable that the ground truth for tip location was established using imaging methods like X-ray or fluoroscopy, which are considered the conventional and definitive methods for confirming PICC tip placement at the time of the submission. It could also potentially involve direct visualization or measurement during a medical procedure.

8. Sample Size for the Training Set

The document does not provide information on the sample size for the training set. The submission focuses on verification and validation testing for market clearance, not on the development or training of an AI model in detail.

9. How Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established, as it does not detail the development or training phases of the device.

Summary

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Sherlock 3CG Tip Confirmation System (TCS)

Bard Access Systems, Inc.

510(k) Summary 21 CFR 807.92

Sherlock 3CG Tip Confirmation System

	Submitter Name:Address:	Bard Access Systems, Inc.605 North 5600 WestSalt Lake City, UT 84116
GeneralProvisions	Contact Person	James R. DavisRegulatory Affairs Specialistjames.davis2@crbard.com801.522.5000 ext 5456801.522.5425
	Date of Preparation:	07 February 2014
SubjectDevice	Trade Name:Common/Usual Name:Classification Name:	Sherlock 3CGTM Tip Confirmation SystemSherlock 3CGTM Tip Confirmation SystemPercutaneous, implanted, long-term intravascularcatheter
	Product Code/Regulation:	LJS - 21 CFR 880.5970
PredicateDevice	Trade Name:Classification Name:	Sherlock 3CGTM Tip Confirmation SystemPercutaneous, implanted, long-term intravascularcatheter
	Premarket Notification:Manufacturer:	K113808Bard Access Systems, Inc.
DeviceDescription	The Sherlock 3CGTM TCS is indicated for guidance and positioning of PICCsduring insertion and placement. The Sherlock 3CGTM TCS provides real-timecatheter tip location information by using passive magnet tracking and thepatient's cardiac electrical activity (ECG). The Sherlock 3CGTM TCS displays thelocation of the PICC tip using a magnetic stylet and magnetic sensors. TheSherlock 3CGTM TCS also displays ECG waveforms received from the patient'sskin (baseline ECG) and from the tip of the catheter (intravascular ECG) on thegraphical user interface.
Indications forUse / IntendedUse	The Sherlock 3CG™ Tip Confirmation System (TCS) is indicated for guidance andpositioning of Peripherally Inserted Central Catheters (PICCs). The Sherlock 3CG™TCS provides real-time PICC tip location information by using passive magnet trackingand the patient's cardiac electrical activity (ECG). When relying on the patient's ECGsignal, the Sherlock 3CG™ TCS is indicated for use as an alternative method to chestX-ray and fluoroscopy for PICC tip placement confirmation in adult patients.Limiting but not contraindicated situations for this technique are in patients wherealterations of cardiac rhythm change the presentation of the P-wave as in atrialfibrillation, atrial flutter, severe tachycardia, and pacemaker driven rhythm. In suchpatients, who are easily identifiable prior to catheter insertion, the use of an additionalmethod is required to confirm PICC tip location.
TechnologicalCharacteristics	Technological characteristics of the subject Sherlock 3CG™ TCS are equivalent withrespect to the basic system design and function to that of the predicate Sherlock 3CGTCS. Differences do not raise any new questions regarding safety and effectiveness.
Safety &PerformanceTests	Verification and validation activities were designed and performed to demonstratethat the subject Sherlock 3CG™ TCS met predetermined performancespecifications. The following guidance documents in conjunction with in-houseprotocols were used to determine appropriate methods for evaluating theperformance of the device. Design Control Guidance for Medical Device Manufacturers, March 11, 1997 Draft Guidance - Applying Human Factors and Usability Engineering toOptimize Medical Device Design, June 22, 2011 The subject device met all pre-determined acceptance criteria and demonstratedsubstantial equivalence as compared to the predicate device.
TestingConclusion	The results of the testing performed demonstrate the subject device is as safe, aseffective, and performs as well as or better than the predicate device.
Summary ofSubstantialEquivalence	Based on the indications for use, technological characteristics, and safety andperformance testing, the subject Sherlock 3CG™ TCS met the minimumrequirements that are considered adequate for its intended use and issubstantially equivalent in design, materials, principles of operation andindications for use to the predicate Sherlock 3CG™ TCS.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

March 14, 2014

Bard Access Systems, Incorporated Mr. James Davis Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, UT 84116

Re: K140345

Trade/Device Name: Sherlock 3CGTM Tip Confirmation System Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: February 7, 2014 Received: February 14, 2014

Dear Mr. Davis:

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. 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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Page 2 - Mr. Davis

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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 yours,

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Erin 1. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K140345

Device Name

Sherlock 3CG Tip Confirmation System (TCS)

Indications for Use (Describe)

The Sherlock 3CG Tip Confirmation System (TCS) is indicated for guidance and positioning of Peripherally Inserted Central Catheters (PICCs). The Sherlock 3CGTM TCS provides real-time PICC tip location information by using passive magnet tracking and the patient's cardiac electrical activity (ECG). When relying on the patient's ECG signal, the Sherlock 3CGTM TCS is indicated for use as an alternative method to chest X-ray and fluoroscopy for PICC tip placement confirmation in adult patients.

Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial fibrillation, atrial flutter, severe tachycardia, and pacemaker driven rhythm. In such patients, who are easily identifiable prior to catherer insertion, the use of an additional method is required to confirm PICC tip location.

Type of Use (Select one or both, as applicable)

2 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 A SEPARATE PAGE IF NEEDED.

FOR FOR FOR FOR FOR FOR THE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Digitally signed by Richard C. Chapman Date: 2014.03.12 18:00:56 -04′00″

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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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.”