VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS

K052475 · Vygon Us, LLC · LJS · Sep 14, 2006 · General Hospital

Device Facts

• Record ID: K052475
• Device Name: VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS
• Applicant: Vygon Us, LLC
• Product Code: LJS · General Hospital
• Decision Date: Sep 14, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

An intravascular catheter, inserted peripherally for long-term administration of solutions for parenteral nutrition and/or administration of drugs

Device Story

Vygon Nutriline and Nutriline Twinflo Catheters are percutaneously implanted long-term intravascular catheters. Used for peripheral access to deliver parenteral nutrition and medications. Operated by clinicians in hospital or clinical settings. Device facilitates venous access for patients requiring extended therapy.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design comparison.

Technological Characteristics

Percutaneous long-term intravascular catheter; Class II device (21 CFR 880.5970); Product Code LJS.

Indications for Use

Indicated for patients requiring long-term peripheral administration of parenteral nutrition solutions and/or drugs.

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

• K633473

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle design with three stylized wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 1 4 2006

Ms. Courtney Smith Regulatory Affairs Manager Vygon US LLC 2495 General Armstead Avenue Norristown, Pennsylvania 19403

Re: K052475

Trade/Device Name: Vygon Nutriline and Nutriline Twinflow Catheters Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous Implant Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: August 14, 2006 Received: August 15, 2006

Dear Ms. Smith:

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.

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Page 2 - Ms. Smith

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 your 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 yours,

Clair X.

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 .

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K052475

## Indications for Use

K052475 510(k) Number:

Vygon Nutriline and Nutriline Twinflo Catheters Device Name:

Indications For Use:

An intravascular catheter, inserted peripherally for long-term administration of solutions for parenteral nutrition and/or administration of drugs

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Number: K633473