The Hickman® TriFusion™ Triple Lumen Long-Term Central Venous Catheter is indicated for use in attaining short term or long term vascular access for intravenous infusion therapy and blood sampling via the internal jugular vein, external jugular vein, and subclavian vein. All Hickman® TriFusion™ catheters are designed for apheresis, and the administration of I.V. fluids, blood products, drugs, and parenteral nutrition solutions, as well as blood withdrawal. The Hickman® TriFusion™ catheter incorporates three large, equal size lumens appropriate for apheresis procedures.

Device Description

The Hickman TriFusion™ Catheters are open-ended triple lumen radiopaque polyurethane catheters. The Hickman TriFusion™ Catheters are 12 Fr triple lumen with up to 27 cm insertion length. The Hickman TriFusion™ Catheters have three equal sized lumens with the distal lumen extending beyond the proximal lumens. The proximal end of the TriFusion™ Catheter consists of three luer connectors, occlusion clamps, and priming volume ID tags. Catheters are provided sterile in two kit configurations, an Intermediate Tray and a Microintroducer (MI) Tray.

AI/ML Overview

The provided text describes the 510(k) summary for the Hickman® TriFusion™ Catheter. It outlines the device, its intended use, and substantial equivalence to a predicate device based on nonclinical performance testing. However, it does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the context of diagnostic performance or AI effectiveness.

The document relates to a medical device (intravascular catheter), not an AI/ML-driven diagnostic device. Therefore, many of the requested categories like "test set," "ground truth," "experts," "adjudication," "MRMC study," and "training set" are not applicable to the information provided.

Based on the provided text, here's what can be answered:

1. A table of acceptance criteria and the reported device performance:

The document refers to adherence to recognized standards and in-house protocols rather than specific numerical acceptance criteria for each test with corresponding performance results. It generally states that "test results met the requirements" and "performance data demonstrate equivalence."

Aspect Tested	Referenced Standard / Protocol	Reported Device Performance
Dimensions	FDA Guidance, ISO 10555-1, ISO 10555-3	Met requirements
Flow rate	FDA Guidance, ISO 10555-1, ISO 10555-3	Met requirements
Tensile, Elongation, Stiffness	FDA Guidance, ISO 10555-1, ISO 10555-3	Met requirements
Tensile strength (catheter to hub)	FDA Guidance, ISO 10555-1, ISO 10555-3	Met requirements
Catheter tip attachment strength	FDA Guidance, ISO 10555-1, ISO 10555-3	Met requirements
Leakage at hub	FDA Guidance, ISO 10555-1, ISO 10555-3	Met requirements
Catheter burst pressure	FDA Guidance, ISO 10555-1, ISO 10555-3	Met requirements
Catheter collapse pressure	FDA Guidance, ISO 10555-1, ISO 10555-3	Met requirements
Catheter flexural fatigue	FDA Guidance, ISO 10555-1, ISO 10555-3	Met requirements
Hemolysis	In-House Protocols	Met requirements
Priming volume	In-House Protocols	Met requirements
PET cuff bond tensile strength	In-House Protocols	Met requirements
Radiopacity	In-House Protocols	Met requirements
Tunneler security test	In-House Protocols	Met requirements
Recirculation	In-House Protocols	Met requirements
Biocompatibility	FDA Guidance	Met requirements

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This is a medical device (catheter) submission, not an AI/ML diagnostic. The testing involved nonclinical performance tests of the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. Ground truth in the context of diagnostic imaging or AI is not relevant here. The "ground truth" for the catheter's performance is determined by established engineering and material science standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are typically used for expert review of images or data in diagnostic studies.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No. This is a submission for a physical medical device (catheter), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is established by recognized international standards (e.g., ISO 10555-1, ISO 10555-3, ISO 594-1, ISO 594-2) and FDA guidance, as well as in-house validation protocols. These standards define acceptable physical, chemical, and mechanical properties.

8. The sample size for the training set:
Not applicable. There is no AI/ML training set for this device.

9. How the ground truth for the training set was established:
Not applicable. There is no AI/ML training set for this device.

Summary

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NOV - 1 2004

K041088 Additional Information

Section 5 510(k) Summary of Safety and Effectiveness Information

Hickman® TriFusion™ Catheters

5.1 Submitter Information:

Submitter Name:	Bard Access Systems, Inc. (BAS)(Wholly owned Subsidiary of C.R. Bard, Inc.)
Address:	5425 W. Amelia Earhart DriveSalt Lake City, UT 84116
Telephone Number:	(801) 595-0700, Ext. 7136
Fax Number:	(801) 595-5425
Contact Person:	Lynn M. Kirchoff
Date of Preparation:	August 17, 2004

5.2 Device Name:

Device Name:	Hickman® TriFusion™ Catheter
Trade Name:	TriFusion™
Common/Usual Name:	Long-Term Intravascular Catheter
Classification Name:	80 LJS – Long-Term Intravascular Catheter21 CFR 880.5970 - Class IIImplanted Blood Access Device
Classification Panel:	General Hospital

5.3 Predicate Device:

Device Name:	Hickman® Long-Term Central Venous Catheter
Trade Name:	Hickman®
Common/Usual Name:	Long-Term Intravascular Catheter
Classification Name:	80 LJS – Long-Term Intravascular Catheter21 CFR 880.5970 – Class IIImplanted Blood Access Device
Classification Panel:	General Hospital
Premarket Notification:	K830233, cleared for marketing on February 28, 1983

5.4 Device Description:

The device description of the subject Hickman TriFusion™ Catheter is as follows:

The Hickman TriFusion™ Catheters are open-ended triple lumen radiopaque polyurethane . catheters.
The Hickman TriFusion™ Catheters are 12 Fr triple lumen with up to 27 cm insertion length. .
The Hickman TiFusion™ Catheters have three equal sized lumens with the distal lumen extending . beyond the proximal lumens.
The proximal end of the TriFusion™ Catheter consists of three luer connectors, occlusion . clamps, and priming volume ID tags.
Catheters are provided sterile in two kit configurations, an Intermediate Tray and a . Microintroducer (MI) Tray.

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ર્સ્ડ Intended Use:

5.6

The Hickman® TriFusion™ Triple Lumen Long-Term Central Venous Catheter is indicated for use in attaining short term or long term vascular access for introvenons influsion them blood sampling va the internal jugular vent external pagare vent and subclani van

All Hickman® TriFusion™ catheters are designed for apheresis, and the administration of I.V. fluids, blood products, drugs, and parenteral nuritions, as well as blood withdrawal The Hickman® Trif usion™ catheter incorporates three large, equal size lumens appropriate for apheresis procedures.

This is the same intended use as the currently marketed 12.5 Fr T/L Hickman catheter covered by K830233, concurrence date 02/28/1983.

Technological Characteristics Summary:

510(k) Substantial Equivalence Decision Tree:

New device is compared to Marked Device?

Yes.

Does the new device have the same indication statement as the predicate?

Yes, with minor modifications to the indication verbiage.

Does the new device have the same technological characteristics, e.g. design, material, etc.?

Not in all regards. The TriFusion™ Catheters have some minor differences from the predicate T/L Hickman Catheters. However, the basic fundamental scientific technology of the catheter has not changed.

Could the new characteristics affect safety or effectiveness?

Yes. The new characteristics could affect the safety or effectiveness of the device.

Do the new characteristics raise new types of safety and effectiveness questions?

No. There are no new types of safety and effectiveness questions.

Do accepted scientific methods exist for assessing effects of the new characteristics?

Yes. Reliance was placed on recognized standards to evaluate the device's performance.

Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-. Term Intravascular Catheters, dated 3/16/95
ISO 10555-1:1997, Sterile, single-use intravascular catheters, Part 1. General ● requirements
ISO 10555-3:1997, Sterile, single-use intravascular catheters, Part 3. Central . venous catheters
ISO 594-1:1986, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment-Part 1: General Requirements
ISO594-2:1986, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment-Part 2:Luer Fittings

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Image /page/2/Picture/0 description: The image shows handwritten text on a white background. The text at the top appears to be a code or identifier, possibly "KC2/1088". Below this, there's the word "Kocijuss" and "p.3". The phrase "Additional Information" is at the bottom of the image.

Are performance data available to assess effects of new characteristics"

Yes. Ventication testing was preformed according to the referenced standards, as well as in accordance with in-house protocols. The test results met the requirements and were compared to the predicate devices.

Do performance date demonstrate equivalence?

Yes. Performance data demonstrate that the TriFusion™ Catheters are substantially equivalent to the predicate 12.5 Fr T/L Hickman® Catheters.

5.7 Nonclinical Performance Testing

Testing was performed per FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95:

Biocompatibility

Guidance Testing Performed

1. Dimensions
1. Flow rate
Tensile, Elongation and Stiffness (modulus) of catheter body 3)
1. Tensile strength of catheter body to hub [connector] attachment (Assembly)
1. Catheter tip (distal) attachment strength
Leakage at hub 6)
Catheter burst pressure (positive internal pressure) 7)
1. Catheter collapse (negative internal pressure)
1. Catheter flexural fatigue tolerance (Body & Tip)

In-House Protocols

Additional Tests to Establish Safety & Effectiveness:

1. Hemolysis
1. Priming volume
1. PET cuff bond tensile strength
1. Radiopacity
1. Tunneler security test
1. Recirculation

ર-8 Conclusion:

The Hickman TriFusion™ catheter is substantially equivalent to the legally marketed predicate device, the 12.5 Fr T/L Hickman Long-Term Catheter, covered by K830233, concurrence date 02/28/1983.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 1 2004

Ms. Lynn M. Kirchoff Regulatory Affairs Specialist Bard Access Systems, Incorporated 5425 West Amelia Earhart Drive Salt Lake City, Utah 84116

Re: K041088

Trade/Device Name: Hickman® TriFusion™ Catheter Regulation Number: 880.5970 Regulation Name: Percutaneous Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: August 17, 2004 Received: August 18, 2004

Dear Ms. Kirchoff:

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. Kirchoff

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 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Carl
Chin-Lin, Ph.D.

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

510(k) Number (if known): K041088_____________________________________________________________________________________________________________________________________

Device Name: Hickman® TriFusion™ Catheter___________________________________________________________________________________________________________________________________

Indications for Use:

The Hickman® TriFusion™ Triple Lumen Long-Term Central Venous Catheter is indicated for use in attaining short term or long term vascular access for intravenous infusion therapy and blood sampling via the internal jugular vein, external jugular vein, mader morap your . All Hickman® TriFusion™ catheters are designed for apheresis, and the administration of I.V. fluids, blood products, drugs, and parenteral nutrition solutions, as well as blood withdrawal. The Hickman® TriFusion™ catheter incorporates three large, equal size lumens appropriate for apheresis procedures.

Prescription Use /
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Antony V. me

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K414988

Page of

Regulation Number and Section

§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.

(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”