AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE

K032962 · Arrow Intl., Inc. · FOZ · Oct 29, 2003 · General Hospital

Device Facts

• Record ID: K032962
• Device Name: AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE
• Applicant: Arrow Intl., Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Oct 29, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

The Arrow Three-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation. The ARROWg+ard antimicrobial surface is intended to help provide protection against access device-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use.

Device Story

Venous access catheter with three segregated internal pathways; includes ARROWg+ard Blue antimicrobial surface. Hemostasis valve and distal lumen accommodate 7-8 Fr thermodilution catheters or similar devices; remaining space functions as flow lumen. Used in clinical settings for central circulation access; operated by healthcare professionals. Antimicrobial surface provides protection against device-related infections; does not treat existing infections. Benefits include reduced risk of catheter-related infections during short-term central venous access.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing: flow rate, leak, tensile, fatigue, and flex modulus tests.

Technological Characteristics

Three-lumen central venous access catheter; includes ARROWg+ard Blue antimicrobial surface. Mechanical design features hemostasis valve and distal lumen for 7-8 Fr catheter accommodation. Non-electronic, non-software device.

Indications for Use

Indicated for patients requiring venous access and catheter introduction to the central circulation. Not indicated for treatment of existing infections or long-term use.

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

• Arrow MAC™ 2 Lumen Central Venous Access Kit with ARROWg+ard Blue® Antimicrobial Surface (K011761)
• Baxter Multiple-Lumen Access Products (K981909)

Submission Summary (Full Text)

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# K032962

## OCT 2 9 2003

| 510(k) Summary | |
|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | ARROW International, Inc.<br>2400 Bernville Road<br>Reading, PA 19605-9607 USA |
| Contact person: | Elizabeth Price, Regulatory Associate<br>Phone: [phone], ext. 3220<br>Fax: [phone]<br>Email: [e-mail] |
| Date summary prepared: | 9/22/03 |
| Device trade name: | MAC™ 3 Lumen Central Venous Access Kit with ARROWg+ard<br>Blue® Antimicrobial Surface. |
| Device common name: | Catheter introducer; intravascular catheter |
| Device classification<br>name: | DYB, Class II, 21 CFR 870.1340, Catheter, introducer, short term.<br>FOZ, Class II, 21 CFR 880.5200, Catheter, Intravascular, short term |
| Legally marketed<br>devices to which the<br>device is substantially<br>equivalent: | Arrow MAC™ 2 Lumen Central Venous Access Kit with<br>ARROWg+ard Blue® Antimicrobial Surface (K011761).<br>Baxter Multiple-Lumen Access Products (K981909). |
| Description of the<br>device: | The Arrow MAC™ with ARROWg+ard Blue® is a venous access<br>catheter with the functionality of three segregated internal<br>pathways. The hemostasis valve and distal lumen can<br>accommodate a thermodilution catheter, or similar device, 7 to 8 Fr<br>in size while the remaining space is utilized as a flow lumen through<br>the distal port. |
| Intended use of the<br>device: | The Arrow Three-Lumen Central Venous Access device permits<br>venous access and catheter introduction to the central circulation.<br>The ARROWg+ard antimicrobial surface is intended to help provide<br>protection against access device-related infections. It is not<br>intended to be used as a treatment for existing infections nor is it<br>indicated for long-term use. |
| Technological<br>characteristics: | The proposed device has the same technological characteristics as<br>the predicate device(s). |
| Performance tests: | Tests were performed to demonstrate substantial equivalence in the<br>following areas:<br>- Flow rate<br>- Leak test<br>- Tensile test<br>- Fatigue test<br>- Flex modulus test |
| Conclusions: | The results of the laboratory tests demonstrate that the device is as<br>safe and effective as the legally marketed predicate devices. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### OCT 2 9 2003

Ms. Elizabeth Price Regulatory Affairs ARROW International, Incorporated 2400 Bernville Road Reading, Pennsylvania 19605

Re: K032962

Trade/Device Name: MAC™ 3 Lumen Central Venous Access Kit with ARROWg ard Blue® antimicrobial surface Regulation Number: 880.5200, 870.1340 Regulation Name: Intravascular Catheter, Catheter Introducer Regulatory Class: II Product Code: FOZ, DYB Dated: September 22, 2003 Received: September 29, 2003

Dear Ms. Price:

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.

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#### Page 2 - Ms. Price

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 (OS) 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.

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):

Device Name:

Indications for Use:

K, 032962

MAC™ 3 Lumen Central Venous Access Kit with ARROWg*ard Blue® antimicrobial surface

The Arrow Central Venous Access Product permits venous access and catheter introduction to the central circulation. The ARROWg+ard Blue® antimicrobial surface is intended to help provide protection against access device-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Patrica Cuenite

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

**510(k) Number.** K032962