THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)

K140345 · C.R. Bard, Inc. · LJS · Mar 14, 2014 · General Hospital

Device Facts

• Record ID: K140345
• Device Name: THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)
• Applicant: C.R. Bard, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Mar 14, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5970
• Device Class: Class 2

Intended Use

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 Story

Sherlock 3CG TCS provides real-time guidance and positioning for PICC insertion. Inputs: passive magnetic tracking signals and patient cardiac electrical activity (ECG). Device uses magnetic stylet and sensors to track catheter tip location; processes baseline ECG from skin and intravascular ECG from catheter tip. Outputs: real-time tip location and ECG waveforms displayed on graphical user interface. Used in clinical settings by healthcare providers to confirm PICC tip placement. Serves as alternative to chest X-ray and fluoroscopy for adult patients. Benefits: reduces reliance on ionizing radiation for tip confirmation.

Clinical Evidence

Bench testing only. Verification and validation activities demonstrated the device met predetermined performance specifications and was substantially equivalent to the predicate device.

Technological Characteristics

System utilizes passive magnet tracking and ECG signal acquisition. Includes magnetic stylet and sensors. Graphical user interface displays real-time location and ECG waveforms. System design and function are equivalent to the predicate device.

Indications for Use

Indicated for guidance and positioning of PICCs in adult patients. Contraindicated/limited use in patients with cardiac rhythm alterations affecting P-wave presentation (e.g., atrial fibrillation, atrial flutter, severe tachycardia, pacemaker-driven rhythm); requires additional confirmation method in these cases.

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 Confirmation System (K113808)

Submission Summary (Full Text)

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Sherlock 3CG Tip Confirmation System (TCS)

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Bard Access Systems, Inc.

# 510(k) Summary 21 CFR 807.92

## Sherlock 3CG Tip Confirmation System

| | Submitter Name:<br>Address: | Bard Access Systems, Inc.<br>605 North 5600 West<br>Salt Lake City, UT 84116 |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| General<br>Provisions | Contact Person | James R. Davis<br>Regulatory Affairs Specialist<br>[e-mail]<br>801.522.5000 ext 5456<br>801.522.5425 |
| | Date of Preparation: | 07 February 2014 |
| Subject<br>Device | Trade Name:<br>Common/Usual Name:<br>Classification Name: | Sherlock 3CGTM Tip Confirmation System<br>Sherlock 3CGTM Tip Confirmation System<br>Percutaneous, implanted, long-term intravascular<br>catheter |
| | Product Code/<br>Regulation: | LJS - 21 CFR 880.5970 |
| Predicate<br>Device | Trade Name:<br>Classification Name: | Sherlock 3CGTM Tip Confirmation System<br>Percutaneous, implanted, long-term intravascular<br>catheter |
| | Premarket Notification:<br>Manufacturer: | K113808<br>Bard Access Systems, Inc. |
| Device<br>Description | The Sherlock 3CGTM TCS is indicated for guidance and positioning of PICCs<br>during insertion and placement. The Sherlock 3CGTM TCS provides real-time<br>catheter tip location information by using passive magnet tracking and the<br>patient's cardiac electrical activity (ECG). The Sherlock 3CGTM TCS displays the<br>location of the PICC tip using a magnetic stylet and magnetic sensors. The<br>Sherlock 3CGTM TCS also displays ECG waveforms received from the patient's<br>skin (baseline ECG) and from the tip of the catheter (intravascular ECG) on the<br>graphical user interface. | |
| Indications for<br>Use / Intended<br>Use | The Sherlock 3CG™ Tip Confirmation System (TCS) is indicated for guidance and<br>positioning of Peripherally Inserted Central Catheters (PICCs). The Sherlock 3CG™<br>TCS provides real-time PICC tip location information by using passive magnet tracking<br>and the patient's cardiac electrical activity (ECG). When relying on the patient's ECG<br>signal, the Sherlock 3CG™ TCS is indicated for use as an alternative method to chest<br>X-ray and fluoroscopy for PICC tip placement confirmation in adult patients.<br>Limiting but not contraindicated situations for this technique are in patients where<br>alterations of cardiac rhythm change the presentation of the P-wave as in atrial<br>fibrillation, atrial flutter, severe tachycardia, and pacemaker driven rhythm. In such<br>patients, who are easily identifiable prior to catheter insertion, the use of an additional<br>method is required to confirm PICC tip location. | |
| Technological<br>Characteristics | Technological characteristics of the subject Sherlock 3CG™ TCS are equivalent with<br>respect to the basic system design and function to that of the predicate Sherlock 3CG<br>TCS. Differences do not raise any new questions regarding safety and effectiveness. | |
| Safety &<br>Performance<br>Tests | Verification and validation activities were designed and performed to demonstrate<br>that the subject Sherlock 3CG™ TCS met predetermined performance<br>specifications. The following guidance documents in conjunction with in-house<br>protocols were used to determine appropriate methods for evaluating the<br>performance of the device. Design Control Guidance for Medical Device Manufacturers, March 11, 1997 Draft Guidance - Applying Human Factors and Usability Engineering to<br>Optimize Medical Device Design, June 22, 2011 The subject device met all pre-determined acceptance criteria and demonstrated<br>substantial equivalence as compared to the predicate device. | |
| Testing<br>Conclusion | The results of the testing performed demonstrate the subject device is as safe, as<br>effective, and performs as well as or better than the predicate device. | |
| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, technological characteristics, and safety and<br>performance testing, the subject Sherlock 3CG™ TCS met the minimum<br>requirements that are considered adequate for its intended use and is<br>substantially equivalent in design, materials, principles of operation and<br>indications 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 [phone] or [phone] 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 [phone] or [phone] 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)

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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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