THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)

K113808 · C.R. Bard, Inc. · LJS · Mar 19, 2012 · General Hospital

Device Facts

• Record ID: K113808
• Device Name: THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)
• Applicant: C.R. Bard, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Mar 19, 2012
• Decision: SESE
• Submission Type: Traditional
• 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

Device provides real-time guidance and positioning for PICC insertion. Inputs: passive magnetic tracking signals and patient cardiac electrical activity (ECG) via skin electrodes and intravascular catheter tip. System processes these inputs to display catheter tip location and ECG waveforms on a graphical user interface. Used by clinicians during PICC placement procedures. Output allows clinicians to confirm catheter tip location, serving as an alternative to chest X-ray or fluoroscopy. Benefits include reduced radiation exposure and immediate confirmation of tip placement.

Clinical Evidence

Bench testing only. Verification and validation activities demonstrated the device met predetermined performance specifications in accordance with IEC 60601-1 and IEC 60601-1-2 standards.

Technological Characteristics

System utilizes passive magnet tracking and ECG signal processing. Components include magnetic stylet, magnetic sensors, and ECG electrodes. Operates as medical electrical equipment; complies with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for guidance and positioning of PICCs in adult patients. Provides real-time tip location via passive magnet tracking and ECG. Contraindicated/limited in patients with cardiac rhythm alterations affecting P-wave presentation (e.g., atrial fibrillation, atrial flutter, severe tachycardia, pacemaker-driven rhythm); requires additional confirmation methods 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

• Sapiens* Tip Confirmation System (K112744)
• Sherlock 3CG* Tip Positioning System (K091324)

Submission Summary (Full Text)

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K113808 page. 1 of 2

Bard Access Systems, Inc. Sherlock 3CG* Tip Confirmation System (TCS) Traditional 510(k) Premarket Notification

MAR 1 9 2012

:

## 510(k) Summary 21 CFR 807.92

## Sherlock 3CG* Tip Confirmation System

| General<br>Provisions | Submitter Name:<br>Submitter Address: | Bard Access Systems, Inc.<br>605 North 5600 West<br>Salt Lake City, UT 84116 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Henry Boland<br>Regulatory Affairs Specialist<br>[e-mail]<br>801.522.5000 ext. 5428<br>801.522.5425 fax |
| | Date of Preparation: | 22 December 2011 |
| Subject Device | Trade Name: | Sherlock 3CG* Tip Confirmation System |
| | Classification Name: | 21 CFR 880.5970 - Class II<br>LJS - Percutaneous, implanted, long-term<br>intravascular catheter |
| Predicate<br>Device | Trade Name: | Sapiens* Tip Confirmation System |
| | Classification Name: | 21 CFR 880.5970 - Class II<br>LJS - Percutaneous, implanted, long-term<br>Intravascular catheters |
| | Premarket Notification: | K112744, concurrence date 20 October 2011 |
| | Manufacturer: | Bard Access Systems, Inc. |
| Predicate<br>Device | Trade Name: | Sherlock 3CG* Tip Positioning System |
| | Classification Name: | 21 CFR 880.5970 - Class II<br>LJS - Percutaneous, implanted, long-term<br>Intravascular catheters |
| | Premarket Notification: | K091324, concurrence date 07 August 2009 |
| | Manufacturer: | Bard Access Systems, Inc. |
| Device<br>Description | The Sherlock 3CG* TCS is indicated for guidance and positioning of PICCs<br>during insertion and placement. The Sherlock 3CG* TCS provides real-time<br>catheter tip location information by using passive magnet tracking and the | |
| patient's cardiac electrical activity (ECG). The Sherlock 3CG* TCS displays<br>the location of the PICC tip using a magnetic stylet and magnetic sensors.<br>The Sherlock 3CG* TCS also displays ECG waveforms received from the<br>patient's skin (baseline ECG) and from the tip of the catheter (intravascular<br>ECG) on the 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<br>tracking and the patient's cardiac electrical activity (ECG). When relying on the<br>patient's ECG signal, the Sherlock 3CG TCS is indicated for use as an alternative<br>method to chest X-ray and fluoroscopy for PICC tip placement confirmation in<br>adult patients. | |
| | 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<br>additional method is required to confirm PICC tip location. | |
| Technological<br>Characteristics | Technological characteristics of the subject Sherlock 3CG* TCS are equivalent<br>with respect to the basic system design and function to that of the predicate<br>devices, Sapiens* Tip Confirmation System and Sherlock 3CG* Tip Positioning<br>System. Differences do not raise any new questions regarding safety and<br>effectiveness. | |
| Safety &<br>Performance<br>Tests | Verification and validation activities were designed and performed to<br>demonstrate that the subject Sherlock 3CG* TCS met predetermined<br>performance specifications. The following standards in conjunction with in-<br>house protocols were used to determine appropriate methods for evaluating<br>the performance of the device: | |
| | IEC 60601-1:1988/1991/1995 | Medical Electrical Equipment - Part 1:<br>General Requirements for Safety |
| | IEC 60601-1-2:2007 | Medical electrical equipment - Part 1-2:<br>General requirements for basic safety<br>and essential performance - Collateral<br>standard: Electromagnetic compatibility<br>- Requirements and tests |
| | The subject device met all pre-determined acceptance criteria and<br>demonstrated substantial equivalence as compared to 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 devices, Sapiens* Tip Confirmation System<br>and Sherlock 3CG* Tip Positioning System. | |

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K113808 page

ge 2 of 2

Bard Access Systems, Inc.
Sherlock 3CG* Tip Confirmation System (TCS)
Traditional 510(k) Premarket Notification

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle, depicted with flowing lines to represent its wings and body.

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

MAR 1 9 2012

Mr. Henry Boland Regulatory Affairs Specialist C.R. Bard, Inc. 605 North 5600 West Salt Lake City, Utah 84116

Re: K113808

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: December 22, 2011 Received: December 23, 2011

Dear Mr. Boland:

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 Eederal Register.

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Page 2 - Mr. Boland

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

Anthony D. Watson, B.S., M.S., M.B.A. 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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K113808

Bard Access Systems, Inc. Sherlock 3CG* Tip Confirmation System (TCS) Traditional 510(k) Premarket Notification

## Indications for Use Statement

510(k) Number (if known): __

## Device Name: Sherlock 3CG™ Tip Confirmation System

Indications for 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.

Over-The-Counter Use Prescription Use × AND/OR (Part 21 CFR 801 Subpart D) (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)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K113808

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