SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING

K033843 · Cook, Inc. · FOZ · Aug 12, 2004 · General Hospital

Device Facts

• Record ID: K033843
• Device Name: SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING
• Applicant: Cook, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Aug 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

The Spectrum® 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 impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheter-related bloodstream infections (CRBSI). It is not intended to be used as a treatment for existing infections. The device is a short-term use catheter, supplied sterile and intended for one-time use.

Device Story

Spectrum® Central Venous Catheter is a 7-French triple-lumen polyurethane catheter; features antimicrobial impregnation (minocycline and rifampin) to reduce risk of catheter-related bloodstream infections (CRBSI); includes optional hydrophilic coating (polyacrylamide and polyvinylpyridone) to facilitate insertion. Used by clinicians for short-term venous access; enables fluid/drug delivery, blood sampling, and pressure monitoring. Device is supplied sterile for single-use. Antimicrobial agents provide prophylactic protection; not intended for therapeutic treatment of established infections.

Clinical Evidence

Bench testing only. Testing included biocompatibility, tensile strength, vacuum and pressure integrity, flow rate, HPLC analysis, and zone of inhibition assays.

Technological Characteristics

7-French triple-lumen polyurethane catheter. Antimicrobial impregnation: minocycline (avg 520 ug/cm) and rifampin (avg 470 ug/cm). Hydrophilic coating: polyacrylamide and polyvinylpyridone. Sterile, single-use.

Indications for Use

Indicated for patients requiring short-term intravenous access for nutrient fluid administration, chemotherapy, drug therapy, blood sampling, blood delivery, and venous pressure monitoring. Not indicated for treatment of existing infections.

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

• Cook ABRM Central Venous Catheter (K950118)

Submission Summary (Full Text)

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

AUG 1 2 2004

# COOK®

K033843

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 J. Bosley, MBA, RAC<br>Ph: [phone]<br>Fax: [phone] |
| Date Prepared: | August 5, 2004 |
| 510(k) #: | K033843 |
| Device: | |
| Trade Name: | Spectrum® Central Venous Catheter with or without Hydrophilic Coating |
| Common/Usual Name: | Central Venous Catheter |
| Proposed Classification: | Intravascular Catheter, 21 CFR Part 880.5200 (80 FOZ) Class II |

#### Device Description:

The nominal 7-French Triple Lumen Spectrum® Central Venous Catheter with Hydrophilic Coating is a polyurethane catheter with three non-communicating vascular access lumens. The cothing is impregnated with the antimicrobials minocycline and rifamping (avg. concentration 520 ug/clin and 470 ug/cm respectively) and has a hydrophilic coating consisting of polyacrylamide and polyvinylpyridone to enhance insertion.

#### Intended Use;

The Spectrum® 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 impregnated with the animorobials minocycline and relieves to help provide protection against catheter-related bloodstream infections (CRBSI). II is not intended to be used as a treatment for existing infections. The device is a short-term use catherer, supplied to and intended for one-time use.

### Substantial Equivalence:

| Manufacturer | Device |
|---------------------------------------------------------------------------------------|------------------------------|
| the consideration of the program and the first of the first of the first of the first | And Property of Concession, |
| Cook Incorporated | ABRM Central Venous Catheter |

#### 510(k) Number K950118

In terms of section 510(k) substantial equivalence, the device is identical in terms of design, intended use and technological characteristics to the predicate Cook ABRM Catheter except for the addition of the hydrophilic coating.

#### Test Data:

The device has undergone testing that provides reasonable assurance of safety and effectiveness for its intended use. Testing includes: biocompatibility, tensile, vacuum and pressure, flow rate, HPLC and zone of inhibition.

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

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 1 2 2004

Ms. Jennifer Bosley, MBA, RAC Regulatory Affairs Coordinator Cook, Incorporated 750 Daniels Way P.O. Box 489 Bloomington, Indiana 47402-0489

Re: K033843

Trade/Device Name: Spectrum® Central Venous Catheter with or without Hydrophilic Coating Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: June 22, 2004 Received: June 23, 2004

Dear Ms. Bosley:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your ed your extermined the device is substantially equivalent (for the itsienced above and nave acteringlosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate conmisered pror to that have been reclassified in accordance with the provisions of Allendinents, or to devroos that in tic Act (Act) that do not require approval of a premarket the rodelar F ood, Drag, and Comments , therefore, market the device, subject to the general approval application (1 Million ) . The general controls provisions of the Act include condors provisions of an 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 If your device is classified (see associety) in a controls. Existing major regulations affecting g (FMA), it may of Subject to Bach ademic and Regulations, Title 21, Parts 800 to 898. In your device can be found in the Seas nouncements concerning your device in the Federal Register.

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

#### Page 2 - Ms. Bosley

Please be advised that FDA's issuance of a substantial equivalence determination does not Frease be advisod that I Dri o issualites on that your device complies with other requirements mean that I DA nas made a decemmand regulations administered by other Federal agencies. of the Act of ary I outhal bates requirements, including, but not limited to: registration You must comply with an me Hee s roq 21 CFR Part 801); good manufacturing practice allo listing (21 CF RT att 007), laoulity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are qt 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) ITILS felt will anow you to objall finding of substantial equivalence of your device to a premarket notified.com - The PDF 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), If you desire specific at no for your as [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 may obtain 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,

Clus

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

{3}------------------------------------------------

# Indications for Use Statement

K033843 510(k) Number:

Spectrum® Central Venous Catheter with or without Hydrophilic Coating Device Name:

Indications for Use:

The Spectrum Central Venous Catheter is used for the intravenous administration of nutrient The Spectrum® Central Venous Catheter is used for therapy, blood sampling, blood delivery, and
fluids, chemothers in the sether is impremated with the animicrobials minorobia fluids, chemotherapeutic and other drigs intressmed with the antipics of the open to the courses of the opening the minocyclines (CRBS).
Venous pressure monities and stimes venous pressure monitoring. The extention against catherer-related bloodstream forctions (CRBS).
and rifampin to help provide protection against catheter-related bloodstream and rifampin to help provide protection against cated blooders. The device is a short-term use
It is not intended to be used as treatment for existing use It is not intended to be used as a creading.
catheter, supplied sterile and intended for one-time use.

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

Over-The Counter Use (Part 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)

Arata V. nxt

Oivision Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: Ky3384)