ARGON MULTI-LUMEN CENTRAL VENOUS CATHETER

K984189 · Maxxim Medical · FOZ · May 5, 1999 · General Hospital

Device Facts

• Record ID: K984189
• Device Name: ARGON MULTI-LUMEN CENTRAL VENOUS CATHETER
• Applicant: Maxxim Medical
• Product Code: FOZ · General Hospital
• Decision Date: May 5, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is used to measure central venous pressure, to infuse fluids, to sample venous blood and to infuse parenteral nutrition (TPN) or medications.

Device Story

Polyurethane multi-lumen central venous catheter; 2-5 lumens; 4-7 French diameter; 10-30 cm length. Device inserted via guide wire; lumens used for central venous pressure measurement, blood sampling, and infusion of fluids/medications/TPN. Features radiopaque body (30% Barium Sulfate) for placement verification; depth markings; atraumatic distal tip. Extension hubs labeled for identification. Used in clinical settings by healthcare professionals. Design improvements over predicate include deeper insert-molding of main tube into bifurcation hub to reduce cross-flow; solvent-bonded extension tubes for increased break force; extension line identification printed on hubs for improved readability.

Clinical Evidence

No clinical data.

Technological Characteristics

Polyurethane construction; 30% Barium Sulfate for radiopacity; 2-5 lumens; 4-7 French; 10-30 cm length. Insert-molded main tube; solvent-bonded extension tubes. Radiopaque. No software or electronic components.

Indications for Use

Indicated for patients requiring central venous access for the measurement of central venous pressure, infusion of fluids, sampling of venous blood, and administration of parenteral nutrition (TPN) or medications.

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

• Medex Safe-Cath (K960764)

Submission Summary (Full Text)

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5/5/98

# 510(k) Number:__K984189

## 510(k) SUMMARY

- Argon Multi-Lumen Central Venous Catheter Trade Name:
- Common Name: Multi-lumen Catheter

Classification Name: Intravascular Catheter (per CFR 21 Part 880.5200)

Product Code: FOZ

Classification: Class II

- Maxxim Medical Submitted by: Argon Division 1445 Flat Creek Road Athens. Texas 75751 Phone: [phone] Fax:
Eddie Monroe, VP QA/RA Contact person:

Date prepared:

November 17, 1998

Legally marketed device to which equivalence is claimed:

Medex Safe-Cath K960764

#### Description of Device:

The Argon multi-lumen central venous catheter has a polyurethane body with multiple The right in and be from two through five lumens. Diameters will be from 4 French 7 he 5 / 2 2 at hand lengths 10 cm through 30 cm through 30 cm. Each lumen extends from the vicinity of the distal tip to the main (bifurcation) hub, where it branches into dedicated

v.m.E

the size

NAULIN DIVISIUIN 1445 FLAT CREEK ROAD • ATHENS, TEXAS 75751 • 903/675-9321 • FAX: [phone] £ - 1

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extension lines. The largest lumen extends all the way to the distal tip. It is used for device placement using a guide wire and then to infuse fluids. The other lumens exit the catheter body at side ports that are near the distal tip but are at varying distances proximal to the tip. Functionally, the lumens are used to measure central venous pressure, to sample venous blood and to infuse parenteral nutrition (TPN) or medications. With multiple lumens more than one function can be accomplished for the patient at the same time.

When a side port is not actively being used a saline drip is run to prevent thrombosis in the lumen. The extension hub for each lumen is labeled to provide positive identification of lumen size and location. The body has depth markings, measured in cm from the distal end, that facilitate correct placement of the tip. The device is radiopaque to allow verification of location in the patient. The atraumatic distal tip minimizes patient trauma during insertion.

#### Scientific concepts that form the basis for the device:

The multi-lumen catheter is made of polyurethane to safely perform the functions described above. Thirty-percent Barium Sulfate is included in the main tube to cause radiopacity. The device has been tested to international standards to demonstrate biocompatibility. The lumens are sized to perform their individual functions.

### Intended Use of Device:

The device is used to measure central venous pressure, to infuse fluids, to sample venous blood and to infuse parenteral nutrition (TPN) or medications.

#### Comparison of Technological Characteristics to legally marketed device:

Both devices have a main (multiple lumen) tube made of polyurethane. The colorants are assumed to be different. Maxxim Medical does not know the colorant used in the legally marketed device. This includes the colorants used in the body, tip and hubs and the ink used for marking. This difference does not affect the safety and effectiveness of the device. The Argon catheter has been completely tested for biocompatibility.

Both devices have clear extension tubes made of polyurethane.

In the legally marketed device the multiple lumen tube and the extension tubes are all insert-molded into the bifurcation hub. In the Maxxim Medical device only the multiple lumen tube is insert molded into the bifurcation hub. The multiple lumen tube is molded deeper into the hub than it is in the legally marketed device. This is an improvement in the device in that the possibility of cross-flow between lumens is significantly reduced. Instead of being insert-molded into the bifurcation hub the extension tubes are solventbonded on the Maxxim Medical device. The break forces of the Maxxim Medical extension tubes are much stronger than those of the legally marketed device. Thus for

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both reasons, safety and effectiveness of the device is improved over the legally marketed device.

On the legally marketed device the extension tubes have the extension lines identified by printing on the lines themselves. The Maxxim Medical device has the extension line identification printed on the extension hubs instead of on the lines. This is an improvement in safety and effectiveness. If a clear line is full of blood the printing will be harder to read than with a line having the printing on the hub.

#### Clinical data:

Clinical data are not needed for this device.

#### CONCLUSIONS:

Maxxim Medical concludes that the Argon Multi-Lumen Central Venous Catheter is substantially equivalent to the legally marketed device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

5 1099 MAY

Mr. Eddie Monroe, VP QA/RA Maxxim Medical Argon Division 1445 Flat Creek Road Athens, Texas 75751

K984189 Re : Argon Multi-Lumen Central Venous Catheter Trade Name: Requlatory Class: II Product Code: FOZ March 31, 1999 Dated: Received: April 5, 1999

Dear Mr. Monroe:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Reqister. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Monroe

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-20#1 or [phone] or at its internet address "http://www.fdal.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: 139 841189

Device Name: Argon Multi-Lumen Central Venous Catheter

Indications for Use:

Multi-lumen central venous catheters are used to measure central venous pressure, to infuse fluids, to sample venous blood and to infuse parenteral nutrition (TPN) or medications.

X Prescription Use

Patricia Cusenite

(Division Sign Off) Division of Cardiovascular, Res and Neurological Devices 510(k) Number -