COOK FIVE LUMEN CENTRAL VENOUS CATHETER

K032274 · Cook, Inc. · FOZ · Feb 26, 2004 · General Hospital

Device Facts

• Record ID: K032274
• Device Name: COOK FIVE LUMEN CENTRAL VENOUS CATHETER
• Applicant: Cook, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Feb 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Five Lumen Central Venous Catheter is used for the intravenous administration of nutrient fluids, chemotherapeutic agents and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring. The catheter is intended for short-term vascular access.

Device Story

The Five Lumen Central Venous Catheter is a 10-French radiopaque polyurethane coaxial catheter designed for short-term (less than 30 days) vascular access. It features five round, noncommunicating lumens with numbered, color-coded hubs to facilitate simultaneous delivery of fluids, drugs, blood products, and pressure monitoring. The device is intended for use by healthcare professionals in clinical settings. By providing multiple independent access points, the catheter allows for complex therapeutic regimens and monitoring without requiring multiple venipunctures, thereby reducing patient trauma and improving clinical efficiency.

Clinical Evidence

Bench testing only. Testing included biocompatibility, tensile strength, vacuum and pressure testing, leakage, and flow rate verification to ensure safety and effectiveness.

Technological Characteristics

10-French radiopaque polyurethane coaxial catheter; five round noncommunicating lumens; numbered, color-coded hubs; 15-30 cm lengths. Intended for short-term (<30 days) intravascular use.

Indications for Use

Indicated for short-term vascular access in patients requiring intravenous administration of nutrient fluids, chemotherapeutic agents, or other drugs, as well as for blood sampling, blood delivery, and venous pressure monitoring.

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.

Predicate Devices

• Central Venous Catheter (Pre-Amendment)
• Argon Multi-Lumen CVC (K984189)
• Medcomp Quad Lumen CVC (K010021)
• Arrow International Multi-Lumen Central Venous Catheter (K904404)

Submission Summary (Full Text)

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FEB 2 € 2004

Image /page/0/Picture/1 description: The image shows the word "COOK" in a bold, serif font. A small registered trademark symbol is located to the upper right of the letter "K". The letters are black and the background is white.

Cook Incorporated P.O. Box 489 Bloomington, IN 47402-0489 Phone: [phone] www.cookgroup.com

## 510(k) Summary

| Submitted by: | Cook Incorporated<br>750 Daniels Way, P.O. Box 489<br>Bloomington, IN 47402 |
|--------------------------|--------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer Bosley, MBA, RAC<br>Ph: [phone]<br>Fax: [phone] |
| Date Prepared: | February 13, 2004 |
| 510(k) #: | K032274 |
| Device:<br>Trade Name: | Five Lumen Central Venous Catheter |
| Common/Usual Name: | Central Venous Catheter |
| Proposed Classification: | Intravascular Catheter, Therapeutic, Short-Term, Less than 30 Days<br>21 CFR Part 880.5200 (80 FOZ) Class II |

#### Device Description:

Doe Five Lumen Central Venous Catheter is a 10-French radiopaque polyurethane coaxial catheter for short-term use. The catheter is available in lengths of 15 to 30 cm incorporating five round noncommunicating vascular access lumens with numbered, colored-coded hubs.

#### Intended Use:

The Five Lumen Central Venous Catheter is used for the intravenous administration of nutrient fluids, chemotherapeutic agents and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring. The catheter is intended for short-term vascular access.

| Manufacturer | Device | 510(k) Number |
|---------------------|-------------------------------------|---------------|
| Cook Incorporated | Central Venous Catheter | Pre-Amendment |
| Maxxim Medical | Argon Multi-Lumen CVC | K984189 |
| Medical Components | Medcomp Quad Lumen CVC | K010021 |
| Arrow International | Multi-Lumen Central Venous Catheter | K904404 |

In terms of section 510(k) substantial equivalence, the Five Lumen Central Venous Catheter is similar in terms of materials, design, intended use and technological characteristics to predicate multi-lumen intravascular catheters used to sample blood, administer fluids intravenously, and to monitor venous pressure.

#### Test Data:

The Five Lumen Central Venous Catheter has undergone testing which provide reasonable assurance of safety and effectiveness for its intended use. Testing includes Biocompatibility, Tensile, Vacuum and Pressure, Leakage and Flow Rate.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jennifer Bosley, MBA, RAC Regulatory Affairs Coordinator Cook, Incorporated 750 Daniels Way P.O. Box 489

Bloomington, Indiana 47402

Re: K032274

Trade/Device Name: Cook Five Lumen Central Venous Catheter Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: December 12, 2003 Received: December 15, 2003

Dear Ms. Bosley:

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.

FEB 2 € 2004

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### Page 2 - Ms. Bosley

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/dsma/dsmamain.html

Sincerely yours.

Cls

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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## Indications For Use Statement

510(k) Number (if known):

K032274

Device Name: Five Lumen Central Venous Catheter

Indications for Use:

The Five Lumen Central Venous Catheter is used for the intravenous administration of nutrien: fluids, chemotherapeutic agents and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring. The catheter is intended for short-term vascular access.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

free for William Burslick

Division Sign-Off Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: 032274

Prescription Use
(Per 21 CFR 801.109)

OR

Over-the-Counter Use (Optional Format 1-2-96)