LUMENVU CATHETER GUIDANCE SYSTEM

K093510 · Sonosite,Inc. · OMF · Aug 23, 2010 · General Hospital

Device Facts

• Record ID: K093510
• Device Name: LUMENVU CATHETER GUIDANCE SYSTEM
• Applicant: Sonosite,Inc.
• Product Code: OMF · General Hospital
• Decision Date: Aug 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2

Intended Use

The LumenVu™ Catheter Guidance System is intended to aid in the placement of peripherally inserted central catheters (PICC) by providing real-time visual navigation of the catheter tip. The system may be used by trained caregivers in hospitals or other healthcare facilities.

Device Story

LumenVu™ Catheter Guidance System aids PICC placement via real-time visual navigation of catheter tip. System components: control box, display screen, camera, sterile optical stylet. Optical stylet replaces traditional stiffening wire; transmits near-infrared (NIR) light to catheter tip. NIR light provides immediate visual feedback to user regarding tip location. Used in hospitals/healthcare facilities by trained caregivers. Output displayed on screen allows clinician to visualize catheter path and tip position during insertion, facilitating accurate placement and potentially reducing complications associated with malpositioned catheters.

Clinical Evidence

Bench testing only. Performance testing and engineering analysis characterized system components. Testing confirmed system functions as intended and meets IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), and IEC 60825-1 (laser safety) standards.

Technological Characteristics

System includes control box, display, camera, and sterile optical stylet. Uses near-infrared (NIR) light source for visual feedback. Optical stylet serves as stiffening wire and light guide. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60825-1 standards.

Indications for Use

Indicated for use by trained caregivers in hospitals or healthcare facilities to aid in the placement of peripherally inserted central catheters (PICC) by providing real-time visual navigation of the catheter tip.

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

• NEO MAPcath Sensor Stylet (K083121)
• FlowPICC Stylet (K081625)
• InfraReDx NIR Imaging System (K052908)

Submission Summary (Full Text)

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Koa 3510

# AUG 2 3 2010

:

.

#### 510(k) SUMMARY

#### SonoSite LumenVu™ Catheter Guidance System

#### Submitter Information

| Name and Address: | SonoSite, Inc. |
|-------------------|-------------------------------------------|
| | 21919 30th Drive SE |
| | Bothell, WA 98021 |
| Contact Person: | Mary K. Moore, V.P. of Regulatory Affairs |
| Date Prepared: | November 10, 2009 |

#### Device Identification

| Proprietary Name: | LumenVu™ Catheter Guidance System |
|-------------------|----------------------------------------------------------------------------------|
| Common Name: | Percutaneous, Implanted, Long-Term Intravascular |
| Catheter: | Accessory for Catheter Position |
| Classification: | General Hospital and Personal Use Therapeutic<br>Devices<br>21 C.F.R. § 880.5970 |

Product Codes: OMF

#### Predicate Device Information

NEO MAPcath Sensor Stylet (Corpak MedSystem) - K083121

FlowPICC Stylet (VasoNova, Inc.) – K081625

InfraReDx NIR Imaging System (InfraReDx, Inc.) - K052908

#### Intended Use / Indications for Use

The LumenVu™ Catheter Guidance System is intended to aid in the placement of peripherally inserted central catheters (PICC) by providing real-time visual navigation of the catheter tip. The system may be used by trained caregivers in hospitals or other healthcare facilities.

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#### Technological Characteristics

The SonoSite LumenVu™ Catheter Guidance System consists of a control box, a display screen, a camera, and a sterile optical stylet. The system uses a near-infrared light source to provide immediate visual feedback to the user on the location of a peripherally inserted central catheter tip. The optical stylet replaces traditional stiffening wire and provides a path for NIR light to its tip.

#### Performance Data

Performance testing and engineering analysis was performed and submitted to characterize the components of the SonoSite LumenVu™ Catheter Guidance System. Test results demonstrated that the LumenVu™ System functioned as intended. The observed test results demonstrate that the Lumen Vu™ System is as safe and effective as the predicate devices. Testing demonstrated that the system meets the requirements of IEC 60601-1 for electrical safety, IEC 60601-1-2 for electromagnetic compatibility, and IEC 60825-1 for laser safety.

#### Substantial Equivalence

The SonoSite LumenVu™ Catheter Guidance System has the same intended use and similar indications as the predicate devices. Any minor differences in technological characteristics and principles of operation do not raise any new issues of safety or effectiveness. Thus, the SonoSite LumenVuTM Catheter Guidance System is substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of three curved lines that converge at the bottom.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Ms. Mary K. Moore Vice President of Regulatory Affairs SonoSite, Incorporated 21919 30th Drive SE Bothell, WA 98021

AUG 2 3 2010

Re: K093510

Trade/Device Name: Lumen Vu™ Catheter Guidance System Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: OMF Dated: August 19, 2010 Received: August 20, 2010

Dear Ms. Moore:

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- Ms. Moore

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susan Pearce

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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# 14093510

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# Indications for Use Statement

510(k) Number (if known):

LumenVu™ Catheter Guidance System Device Name:

Indications for Use:

The LumenVu™ Catheter Guidance System is intended to aid in the placement of peripherally inserted central catheters (PICC) by providing real-time visual navigation of the catheter tip. The system may be used by trained caregivers in hospitals or other healthcare facilities.

Prescription Use X

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(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

5-510(k) Number: K093510