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.

Device Description

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

AI/ML Overview

The provided text is a 510(k) summary for the Argon Multi-Lumen Central Venous Catheter, which is a medical device. This type of document is a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

It does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the way described in your request.

Instead, the document focuses on:

Comparison to a legally marketed predicate device (Medex Safe-Cath K960764): It highlights similarities in materials (polyurethane) and intended use.
Demonstration of improvements: The document claims improvements in the manufacturing process (deeper molding of the multiple lumen tube into the bifurcation hub, solvent-bonded extension tubes leading to stronger break forces, and identification printing on extension hubs instead of lines).
Biocompatibility testing: It mentions the device has been tested to international standards for biocompatibility.
Radiopacity: It states that Barium Sulfate is included in the main tube to cause radiopacity.
Clinical Data: Explicitly states "Clinical data are not needed for this device."

Therefore, I cannot extract the information required for your detailed request because the document does not contain the type of study data, acceptance criteria, or ground truth establishment relevant to performance metrics like sensitivity, specificity, or AUC, which are typically found in AI/ML medical device studies.

Here's a summary of why the requested information cannot be provided based on the input:

Table of acceptance criteria and reported device performance: Not present. The document focuses on substantial equivalence based on technological characteristics and intended use, not on specific performance metrics with acceptance criteria benchmarks.
Sample size for the test set and data provenance: Not applicable. No test set for performance evaluation is mentioned.
Number of experts and qualifications for ground truth: Not applicable. No ground truth establishment for a performance study is described.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: Not done/mentioned. The document explicitly states clinical data are not needed.
Standalone performance study: Not done/mentioned.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable. The device is a physical catheter, not an AI/ML algorithm requiring a training set.
How ground truth for the training set was established: Not applicable.

Summary

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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: 903-675-9321 903-677-9397 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: 903/677-9397 £ - 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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (301) 443-6597 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 -

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
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.(b)
Classification. Class II (performance standards).