VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR, AND 5FR)

K993442 · Vygon Corp. · LJS · Aug 3, 2000 · General Hospital

Device Facts

• Record ID: K993442
• Device Name: VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR, AND 5FR)
• Applicant: Vygon Corp.
• Product Code: LJS · General Hospital
• Decision Date: Aug 3, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vygon LIFECATH-PICC (PUR) Catheter is intended for use in patients who require mid-long term I.V. therapy. It may be used to administer hyperalimentation, drug therapy or intravenous fluids.

Device Story

Vygon LIFECATH-PICC (PUR) is a peripherally inserted central catheter (PICC) designed for mid-to-long term venous access. Device consists of a polyurethane catheter available in single and double lumen configurations (3 FR, 4 FR, 4.5 FR, and 5 FR). Inserted peripherally by a clinician to provide central venous access for administration of fluids, medications, or hyperalimentation. Device facilitates therapy management by reducing need for repeated venipuncture. Benefits include reliable venous access for patients requiring extended treatment durations.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Polyurethane (PUR) catheter; available in single and double lumen configurations; sizes 3 FR, 4 FR, 4.5 FR, and 5 FR. Device is a peripherally inserted central catheter (PICC) for venous access.

Indications for Use

Indicated for patients requiring mid-to-long term intravenous therapy, including administration of hyperalimentation, drug therapy, or intravenous fluids.

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.”

Submission Summary (Full Text)

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## AUG 3 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert Schiff President Schiff & Company 1129 Bloomfield Avenue West Caldwell, New Jersey 07006

Re : K993442 Vygon Lifecath-PICC (PUR) Catheters & Single Trade Name: and Double Lumen, 3 FR, 4 FR, 4.5 FR, and 5 FR) Regulatory Class: II Product Code: LJS May 23, 2000 Dated: May 24, 2000 Received:

Dear Mr. Schiff:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Schiff

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your sia ... mur alence of your device to a legally Finding or bubbeanstal organisation a classification for your marketta predicate are ts your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in regulacion (stic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact che promotion and [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance

obcarned its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

othy A. Ulatowski Tim Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) PREMARKET NOTIFICATION VYGON, EAST RUTHERFORD, NJ LIFECATH-PICC (PUR) CATHETER

## INDICATIONS FOR USE STATEMENT

12993442

510(k) Number (if known): Device Name:

Not assigned yet Vygon LIFECATH-PICC (PUR) Catheter.

Indications for Use:

The Vygon LIFECATH-PICC (PUR) Catheter is intended for use in patients who The Vygon Life Corrern I.V. therapy. It may be used to administer hyperalimentation, require mid-long term f.V. thorapy - remay a management or intravenous fluids.

(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 CFER 801.109)

(Optional Format 1-2-96)

Patricio Escobete

(Division Sign-Off) Division of Dental, Infection Control, - General Hospital Devices 499 (k) Number ___________________________________________________________________________________________________________________________________________________________________

SUBMITTED BY SCHIFF & COMPANY, WEST CALDWELL, NJ

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