SPECTRUM SILICONE CATHETER

K021557 · Cook, Inc. · FOZ · May 30, 2003 · General Hospital

Device Facts

• Record ID: K021557
• Device Name: SPECTRUM SILICONE CATHETER
• Applicant: Cook, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: May 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The COOK Spectrum® Silicone 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. Catheters are available in single and double lumen PICC, and single, double and triple lumen CVC. The device is supplied sterile and intended for one-time use.

Device Story

COOK Spectrum® Silicone Catheter; single, double, or triple lumen central venous catheter (CVC) or peripherally inserted central catheter (PICC). Impregnated with minocycline and rifampin to reduce risk of catheter-related bloodstream infections (CRBSI). Used for intravenous fluid/drug administration, blood sampling, and venous pressure monitoring. Sterile, single-use device. Clinical benefit: reduction in CRBSI incidence. Evaluated via prospective, randomized clinical trial comparing treatment (antimicrobial) vs. control cohorts; primary outcome definite CRBSI; secondary safety metrics included catheter-related complications (leak, bleeding, thrombosis).

Clinical Evidence

Prospective, randomized clinical trial comparing antimicrobial-impregnated catheter to control. Primary endpoint: definite CRBSI occurrence. Results demonstrated significant reduction in CRBSI rate for treatment cohort. Safety evaluated by comparing complication rates (leak, bleeding, thrombosis) and repositioning incidence. Post-removal evaluation included zone of inhibition testing against MRSA and culture techniques (roll plate/sonication) for colonization.

Technological Characteristics

Silicone intravascular catheter; single, double, or triple lumen configurations; 4Fr to 12Fr sizes; 8-60 cm lengths. Impregnated with minocycline and rifampin. Sterile, single-use. Biocompatibility, tensile, vacuum/pressure, flow, and shelf-life testing performed. HPLC and zone of inhibition testing used for antimicrobial verification.

Indications for Use

Indicated for patients requiring intravenous therapy, including nutrient fluid administration, chemotherapy, drug delivery, blood sampling, and venous pressure monitoring via central venous or peripherally inserted central catheters. 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

• Silicone Catheter (A137605)
• Single Lumen Urethane PICC (K992198)
• Double Lumen Urethane PICC (K010034)
• Spectrum® Catheter (K950118)
• Spectrum® Ventricular Catheter (K011812)
• Spectrum® Silicone Foley Catheter (K000251)
• ARROWgard Blue PlusTM Multi-Lumen CVC (K993691)

Submission Summary (Full Text)

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K021557

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

# MAY 3 0 2003

# 510(k) Summary

Page 1 of 2

| Submitted by: | Cook Incorporated |
|--------------------------|------------------------------------------------------------------------------------|
| Contact Person: | Jennifer Bosley, MBA<br>Ph: [phone] x2093<br>Fax: [phone] |
| Date Prepared: | March 26, 2003 |
| 510(k) #: | K021557 |
| Device: | COOK Spectrum® Silicone Catheter |
| Trade Name: | Intravascular Catheter, Central Venous Catheter |
| Common/Usual Name: | Intravascular Catheter, Therapeutic, Long-term and Short-term |
| Proposed Classification: | 21 CFR Part 880.5970 (80 LJS), Class II<br>21 CFR Part 880.5200 (80 FOZ), Class II |

### Device Description:

The COOK Spectrum® Silicone Catheters are single, double or triple lumen central venous catheters; and single and double lumen peripherally inserted central catheters available in sizes ranging from 4Fr single lumen to 12Fr double lumen. including an 8Fr triple lumen device. Catheter lengths range from 8 to 60 cm. The catheter is impregnated with an antimicrobial combination of minocycline and rifampin. The device is supplied sterile and intended for one-time use.

# Intended Use:

The COOK Spectrum® Silicone 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. Catheters are available in single and double lumen PICC, and single, double and triple lumen CVC.

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# Predicate Devices:

The COOK Spectrum® Silicone Catheter is comparable in terms of intended use and technological characteristics to predicate intravascular catheters used to sample blood, administer fluids intravenously, and to monitor venous pressure.

| Manufacturer | Device | 510(k) Number |
|---------------------------|---------------------------------------|---------------|
| COOK Incorporated | Silicone Catheter | A137605 |
| COOK Incorporated | Single Lumen Urethane PICC | K992198 |
| COOK Incorporated | Double Lumen Urethane PICC | K010034 |
| COOK Incorporated | Spectrum® Catheter | K950118 |
| COOK Incorporated | Spectrum® Ventricular Catheter | K011812 |
| COOK Urological/OB/GYN | Spectrum® Silicone Foley Catheter | K000251 |
| Arrow International, Inc. | ARROWgard Blue PlusTM Multi-Lumen CVC | K993691 |

### Substantial Equivalence:

The device will be manufactured according to specified process controls, adhering to Good Manufacturing Practices and Quality System Regulations, undergoing processing, sterilization and packaging procedures similar to devices currently manufactured and marketed by Cook Incorporated. This device is similar with respect to indications for use and design to predicate devices in terms of section 510(k) substantial equivalence.

### Test Data:

The COOK Spectrum® Silicone Catheter has undergone biocompatibility, performance, and clinical testing which provide reasonable assurance of safety and effectiveness for its intended use. Testing includes:

- Biocompatibility
- . Tensile Testing
- Vacuum and Pressure Testing
- HPLC and Zone of Inhibition Testing ●
- Flow Testing .
- Shelf-Life Testing .

# Clinical Evaluation:

In this prospective, randomized clinical trial with well matched treatment and control cohorts, results indicate that the COOK Spectrum® Silicone Catheter can significantly reduce the rate of catheter-related bloodstream infection (CRBSI). Clinical safety was evaluated by comparing rates of each complication (other than CRBSI) for the treatment cohort versus the control cohort. To determine effectiveness, the occurrence of definite CRBSI was evaluated as the primary outcome measure. When available, catheters were evaluated after removal from patients by zone of inhibition testing against MRSA (CI4371). Determination of catheter colonization was based on results of any culture from the subcutaneous and tip segment of the catheter using roll plate and sonication culture techniques. Performance was evaluated by comparing the incidence of catheter removal due to catheter leak, bleeding around the catheter thrombosis between the two study groups and by comparing the incidence of catheter repositioning.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 0 2003

Ms. Jennifer Bosley, MBA Regulatory Affairs Coordinator Cook. Incorporated 925 South Curry Pike P.O. Box 489 Bloomington, Indiana 47402-0489

Re: K021557

Trade/Device Name: COOK Spectrum® Silicone Catheter Regulation Number: 880.5200, 880.5970 Regulation Name: Intravascular Catheter, Percutaneous, Implanted, Long-term Intravascular Catheter Regulatory Class: II Product Code: FOZ, LJS Dated: March 26, 2003 Received: March 27, 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 vour 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.

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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 vour 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

Susan Runse

Susan Runner, DDS, MA Interim 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):

K021557

Device Name:

COOK Spectrum® Silicone Catheter

#### Indications for Use:

The COOK Spectrum® Silicone 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 catheterrelated bloodstream infections (CRBSI). It is not intended to be used as a treatment for existing infections. Catheters are available in single and double lumen PICC: and single, double and triple lumen CVC. The device is supplied sterile and intended for one-time use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Salvatore Cucenti

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

510(k) Number: K021557

V Prescription Use (Per 21 CFR 801.109)

OR

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