PREMICATH, 1261.205

K041468 · Vygon Corp. · LJS · Sep 9, 2004 · General Hospital

Device Facts

• Record ID: K041468
• Device Name: PREMICATH, 1261.205
• Applicant: Vygon Corp.
• Product Code: LJS · General Hospital
• Decision Date: Sep 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Premicath is a peripherally inserted central (PIC) catheter for central venous catheterization. The catheter is used for mid- to long-term infusion of TPN or intravenous medications.

Device Story

Premicath is a peripherally inserted central (PIC) catheter designed for central venous catheterization. It facilitates mid- to long-term infusion of total parenteral nutrition (TPN) or intravenous medications. The device is intended for clinical use by healthcare professionals. It functions as a conduit for fluid delivery into the central venous system. The device provides a stable access point for patients requiring extended intravenous therapy, potentially reducing the need for repeated peripheral venipuncture.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device description and intended use.

Technological Characteristics

Peripherally inserted central catheter (PIC) for central venous access. Product code LJS; Regulation 880.5970. Class II device.

Indications for Use

Indicated for patients requiring mid- to long-term central venous access for the administration of total parenteral nutrition (TPN) or intravenous medications via a peripherally inserted central catheter.

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)

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, consisting of three curved lines representing the eagle's body and wings. The emblem is black and appears to be a symbol of the U.S. Department of Health and Human Services.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP = 9 2004

Ms. Courtney Smith Regulatory Affairs Consultant Vygon Corporation 2495 General Armistead Avenue Norristown, Pennsylvania 19403-3685

Re: K041468

Trade/Device Name: Premicath, 1261.205 Regulation Number: 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: May 21, 2004 Received: June 15, 2004

Dear Mr. 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 r ou may a 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 If your de roo 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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r read be act nove 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 or any 1 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

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

Page 2 - Ms. Smith

Please be advised that FDA's issuance of a substantial equivalence determination does not r least 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 and tisting (2) - set forth in the quality systems (QS) regulation (21 CFR Part 820); and if roquicable, 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/dsma/dsmamain.html

Sincerely yours,

Chih-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

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

## Indications for Use

510(k) Number (if known):

Premicath Device Name:

Indications For Use:

Premicath is a peripherally inserted central (PIC) catheter for central venous catheterization.

The catheter is used for mid- to long-term infusion of TPN or intravenous medications.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

K04-1468

Page 1 of 1

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: