SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.0-ABRM

K060174 · Cook, Inc. · FOZ · Feb 17, 2006 · General Hospital

Device Facts

• Record ID: K060174
• Device Name: SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.0-ABRM
• Applicant: Cook, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Feb 17, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indicated for use in vascular access to intravenously administer nutrients, fluids, chemotherapeutic agents, and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring.

Device Story

Spectrum Five Lumen Central Venous Catheter Set; 10 Fr diameter; 15, 20, 25, and 30 cm lengths. Catheter impregnated with minocycline and rifampin to reduce infection risk. Used for intravenous administration of nutrients, fluids, chemotherapeutic agents, and drugs; blood sampling; blood delivery; venous pressure monitoring. Operated by clinicians in clinical settings. Provides vascular access via central venous placement. Benefits patient by facilitating multi-lumen therapy and reducing catheter-related infections through antimicrobial impregnation.

Clinical Evidence

Bench testing only. Testing included tensile testing, shaft flexibility, shaft flexural fatigue, gravity flow rate, air leakage, collapsibility under vacuum, liquid leakage, burst pressure, biocompatibility, and verification of minocycline/rifampin impregnation levels.

Technological Characteristics

10 Fr central venous catheter; lengths 15-30 cm. Impregnated with minocycline (683.3 ug/cm) and rifampin (564.1 ug/cm). Sterile, single-use. Standard intravascular catheter design.

Indications for Use

Indicated for patients requiring vascular access for intravenous administration of nutrients, fluids, chemotherapeutic agents, and other drugs, 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

• Cook Incorporated Five Lumen Central Venous Catheter Set (K032274)
• Cook Incorporated Spectrum and Spectrum Glide Central Venous Catheter Set (K033843)
• Arrow International Arrowgard Blue Quad-Lumen Central Venous Catheter (K962577)
• Medical Components Medcomp Quad Lumen (K010021)

Submission Summary (Full Text)

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Ko60174

33

### 510(k) Summary

#### Submitted By:

FEB 1 7 2006

Evangeline D. Loh, Ph.D., RAC Regulatory Affairs Scientist Cook Incorporated 750 Daniels Way (PO Box 489) Bloomington, IN 47404 (47402) 812-339-2235 January 23, 2006

### Device:

| Trade Name: | Cook Incorporated Spectrum Five Lumen Central Venous<br>Catheter Set |
|--------------------------|----------------------------------------------------------------------|
| Proposed Classification: | Intravascular Catheter<br>FOZ (21 CFR§880.5200) |

### Indications for Use

Indicated for use in vascular access to intravenously administer nutrients, fluids, chemotherapeutic agents, and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring.

# Predicate Devices:

The Spectrum Five Lumen Central Venous Catheter Set is similar in terms of intended use, principles of operation, materials of construction and technological characteristics to predicate devices reviewed as devices for venous access to intravenously administer solutions needed in medical treatment.

# Device Description:

The Spectrum Five Lumen Central Venous Catheter Set is a central venous catheter designed to intravenously administer nutrients, fluids, chemotherapeutic agents and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring through the vasculature. The Spectrum Five Lumen Central Venous Catheter will be 10 Fr. available in lengths of 15, 20, 25, and 30 cm. The Spectrum Five Lumen Catheter will be impregnated with an average of 683.3 ug/cm minocycline and 564.1 ug/cm rifampin. This device will be supplied sterile and is intended for one-time use.

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K060174 34

### Substantial Equivalence:

The Spectrum Five Lumen Central Venous Catheter is similar to many devices in commercial distribution for venous access. These devices include the Cook Incorporated Five Lumen Central Venous Catheter Set (D.C. # K032274), Cook Incorporated Spectrum and Spectrum Glide Central Venous Catheter Set (D.C. #K033843), the Arrow International Arrowgard Blue Quad-Lumen Central Venous Catheter (D.C. #K962577), and the Medical Components Medcomp Quad Lumen (D.C.#K010021).

The similar indications for use, principles of operation, technological characteristics, and performance testing results of the Spectrum Five Lumen Central Venous Catheter as compared to the predicate devices support a determination of substantial equivalence.

### Test Data:

The Spectrum Five Lumen Central Venous Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters.

- 1 . Tensile Testing
- Shaft Flexibility Testing in
- Shaft Flexural Fatigue Tolerance Testing ﻢ ﺍﻟﻤﺴﺘﻘﺒﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ
- 4. Gravity Flow Rate Testing
- న్, Air Leakage Testing
- Collapsibility under Vacuum Testing ().
- Liquid Leakage Testing 7.
- Burst Pressure Testing oc
- Biocompatibility Testing ().
- Tensile Testing after Aging 】().
- Amount of Minocycline and Rifampin Impregnated | | .

The results of these tests provide reasonable assurance that the device conforms to the requirements necessary for its use as a central venous catheter.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 7 2006

Evangeline D. Loh, Ph.D., RAC Regulatory Affairs Scientist Cook, Incorporated 750 Daniels Way Bloomington, Indian 47404

Re: K060174

K000174
Trade/Device Name: Cook Incorporated Spectrum® Five Lumen Central Venous Catheter Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: January 23, 2006 Received: January 24, 2006

Dear Dr. Loh:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowed your sected by 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 mendments, 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 approvial appressions of the Act. The general controls provisions of the Act include controls provisions of 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 (1 WA), it har ob subject in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device to rear roublish further announcements concerning your device in the Ecderal Register.

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Page 2 - Dr. Loh

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s Issualice of a substantials with other requirements
mean that FDA has made a determination that your device Fodard assessios mean that FDA has made a decemination until Josefinistered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by posignity of the Act of any Federal statutes and registerents, including, but not limited to: registration You must comply with an the Act 3 requirement 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gEP Rat 800); and i and listing (21 CFR Fall 807), labeling (21 CFR Pat 820), and if and 820); and if requirements as set form in the quality systems (Sections 531-542 of the Act);
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 5 10(k) I his letter will anow you to begin marketing your alence of your device to a premarket notification. The PDA miding of babbaan of 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), a If you desire specific advice for your device of your device Also, please note the regulation please contact the Other or Comphanes and in (21CFR Part 807.97). You entitled, "Misoranding by reserved to problems on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Binas 2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely wours,

Susan Yunae

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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510(k) Number (if known):

K060174

Device Name:

Cook Incorporated Spectrum™ Five Lumen Central Venous Catheter Set

The Spectrum™ Five Lumen Central Venous Catheter Set is Indications for Use: indicated for the intravenous administration of nutrient fluids, chemotherapeutic agents, and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring.

Prescription Use X (Per 21 CFR 801 Subpart D) ાર

Over-the-Counter Use (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)

Anton Viny

They, General Hospital,

K060174