SHERLOCK TIP LOCATION SYSTEM (TLS) DETECTOR AND ACCESSORIES

K061240 · Lucent Medical Systems · LJS · Jun 2, 2006 · General Hospital

Device Facts

• Record ID: K061240
• Device Name: SHERLOCK TIP LOCATION SYSTEM (TLS) DETECTOR AND ACCESSORIES
• Applicant: Lucent Medical Systems
• Product Code: LJS · General Hospital
• Decision Date: Jun 2, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5970
• Device Class: Class 2

Intended Use

The Sherlock™ Tip Location System (TLS) Detector quickly locates and confirms the position of specially designed, magnet-tipped Peripherally Inserted Central Catheters (PICCs) and Central Venous Catheters (CVCs) during initial placement. This device may be used by appropriate caregivers in hospitals, long-term care facilities or home-care settings. The Sherlock™ Tip Location System (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 Story

Handheld, battery or line-powered detector; uses passive field sensors to detect magnetic fields from magnet-tipped catheter stylets; does not emit energy. Used by caregivers during initial PICC/CVC placement to provide real-time feedback on catheter tip location and orientation. Output displayed to caregiver; intended to supplement, not replace, conventional placement verification methods (e.g., institutional protocols). Benefits include rapid feedback during procedure, potentially aiding accurate placement.

Clinical Evidence

Bench testing only. Accuracy and user interface performance met requirements.

Technological Characteristics

Handheld, battery or line-powered device. Passive magnetic field sensing technology. No energy emission into patient. Compatible with magnet-tipped PICC/CVC stylets.

Indications for Use

Indicated for locating and confirming the position of magnet-tipped PICCs and CVCs during initial placement in patients requiring central venous access. Used by caregivers in hospitals, long-term care, or home-care settings.

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

• Zortran Detector (K00099)

Submission Summary (Full Text)

{0}------------------------------------------------

K06/240

## Sherlock™ Tip Location System (TLS) Detector 510(k) Summary (Page 1 of 1)

| Device trade name: | Sherlock™ Tip Location System (TLS) Detector | | | JUN - 2 2006 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|----------------------|--------------|
| Common name: | Catheter Placement Verification Device | | | |
| Device class and panel: | 880.5970, Accessory to intravascular catheter, Class II | | | |
| Applicant name: | Cynthia Pestka<br>Lucent Medical Systems, Inc.<br>811 Kirkland Ave, Suite 100<br>Kirkland, WA 98033<br>[phone], x33 (phone) | | | |
| Predicate device(s): | K00099, Zortran Detector | | | |
| Device description: | The Sherlock™ Tip Location System (TLS) Detector is a battery or line powered hand held device which detects the location of a magnet-tipped catheter stylet. A battery charger is also provided. The Sherlock™ Tip Location System (TLS) Detector uses only passive field sensors, and does not emit energy of any sort into the patient.<br><br>The Sherlock™ Tip Location System (TLS) Detector is designed (and labeled) to be used only with a compatible PICC or CVC intravascular catheter stylet which contains one or more small, specially oriented magnets encapsulated at the distal end. It provides rapid feedback to a caregiver about the location and orientation of these magnet-tipped devices during initial placement. | | | |
| Premarket Testing: | Type | Characteristics Tested | Results | |
| | Bench | Accuracy | Meets accuracy claim | |
| | Bench | User interface | Meets requirements | |

™ Sherlock is a registered trademark of Bard Access Systems

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Cindy Pestka Director, Regulatory Affairs and Quality Assurance Lucent Medical Systems Incorporated 811 Kirkland Avenue, Suite 100 Kirkland, Washington 98033

Re: K061240

Trade/Device Name: Sherlock™ Tip Location System (TLS) Detector Regulation Number: 880.5970 Regulation Name: Percutaneous, Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: May 2, 2006 Received: May 3, 2006

Dear Ms. Pestka:

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.

JUN - 2 2006

{2}------------------------------------------------

Page 2 - Ms. Pestka

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 vour 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

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

{3}------------------------------------------------

## Attachment #3 Statement of Intended Use

## Indications for Use Statement

510(k) Number
(f known) K061240

Sherlock™ Tip Location System (TLS) Detector Device Name

Indications The Sherlock™ Tip Location System (TLS) Detector quickly locates and confirms the For Use position of specially designed, magnet-tipped Peripherally.Inserted Central Catheters (PICCs) and Central Venous Catheters (CVCs) during initial placement. This device may be used by appropriate caregivers in hospitals, long-term care facilities or home-care settings.

> The Sherlock™ Tip Location System (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.

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) Contray, General Hospital, on Control, Dontal Devices

**** Lucent Medical Systems Confidential ****