VYGON DOUBLE LUMEN UMBILICAL CATHETER

K981630 · Schiff & Co. · FOS · Oct 1, 1998 · General Hospital

Device Facts

• Record ID: K981630
• Device Name: VYGON DOUBLE LUMEN UMBILICAL CATHETER
• Applicant: Schiff & Co.
• Product Code: FOS · General Hospital
• Decision Date: Oct 1, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Venous/arterial umbilical access in infants for infusion through one lumen and monitoring/blood sampling through the second lumen. May also be used for the infusion of incompatable solutions, through separate lumens.

Device Story

Double lumen umbilical catheter designed for neonatal vascular access. Device provides two distinct lumens for simultaneous infusion, blood sampling, or pressure monitoring. Enables delivery of incompatible medications through separate channels. Used in clinical settings by healthcare professionals for infant care. Facilitates management of critically ill neonates requiring multiple intravenous therapies.

Clinical Evidence

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

Technological Characteristics

Double lumen catheter configuration for umbilical access. Materials and sterilization methods are consistent with standard umbilical catheter requirements for neonatal use.

Indications for Use

Indicated for venous or arterial umbilical access in infants requiring infusion, monitoring, or blood sampling. Allows for simultaneous infusion of incompatible solutions via separate lumens.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Submission Summary (Full Text)

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

Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol consisting of three stylized human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 1998

Anne Marie Cesario, R.A.C. Director of Requlatory Affairs Schiff & Company® 1129 Bloomfield Avenue West Caldwell, New Jersey 07006

Re : K981630 Trade Name: Vygon Double Lumen Umbilical Catheter Requlatory Class: II Product Code: FOS Dated: August 11, 1998 Received: August 14-1998 ..

Dear Ms. Cesario:

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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, 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 regulation (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 action. In addition, FDA may publish further announcements 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

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

Page 2 - Ms. Cesario

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. - Also, please note works of the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address -- .

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

Sincerely yours,

Susan Runne

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

Enclosure ·

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

510(k) Number (if known):

12981630 Not assigned yet

Device Name:

Double Lumen Umbilical Catheter

Indications for Use:

Venous/arterial umbilical access in infants for infusion through one lumen and monitoring/blood sampling through the second lumen. May also be used for the infusion of incompatable solutions, through separate lumens.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)

or

Over-The-Counter Use

(Optional Format 1-2-96)

Susa Russer

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

Prepared by Schiff & Company, West Caldwell, NJ ۰۰ - ۱۰۰۰ - ۱۰۰ Page 10