The BardPort®, SlimPort™ and X-Port™ Implanted Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.

Device Description

The X-Port duo™ port has the same basic, fundamental scientific technology as the predicate MRI® Dual port. Access to the port is made percutaneously with a non-coring needle that enters the port reservoir via the silicone rubber septum. The access path to the vascular system is provided through a catheter attached to the base of the port. The port system serves as a conduit for fluids into, and out of, the central venous system.

The port body consists of an oblong shaped plastic base and top. The silicone septa are compressed between the port base and top. The port body profile incorporates smooth transitions. There are two suture holes adjacent to the stem and a third suture hole placed opposite the stem on the tapered nose. All suture holes are filled with silicone plugs.

All catheters and catheter/port connection systems used on the X-Port duo port are previously qualified legally marketed configurations covered by the predicate device.

AI/ML Overview

The provided text describes the 510(k) Pre-Market Notification for the X-Port duo™ Implanted Port. This submission relies on substantial equivalence to a predicate device, rather than performance against specific acceptance criteria derived from a clinical study. Therefore, traditional acceptance criteria and study details as might be found for a new diagnostic or AI device are not present.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific acceptance criteria with corresponding performance data in the manner typically seen for clinical trials or new device evaluations. Instead, it relies on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Acceptance Criteria Category	Specific Criteria (Implicitly Met by Predicate Equivalence)	Reported Device Performance
Mechanical Integrity	Withstand material stresses, fluid pressure, connection integrity.	"Performance data gathered in design verification and validation testing demonstrated that the X-Port duo™ port is substantially equivalent to the predicate MRI® Dual port and/or met predetermined acceptance criteria."
Biocompatibility	Non-toxic, non-irritating, non-allergenic to body tissues.	Implied by use of similar materials and design to the legally marketed predicate device.
Material Properties	Appropriate strength, durability, inertness.	Implied by use of similar materials and design to the legally marketed predicate device.
Sterility	(Not explicitly mentioned as a test, but assumed for implantable devices)	Implied by regulatory requirements for implantable devices and the substantial equivalence pathway.
Functional Equivalence	Serve as a conduit for fluids into/out of the central venous system, provide long-term repeated vascular access.	"The X-Port duo™ port has the same basic, fundamental scientific technology as the predicate MRI® Dual port." and "The port system serves as a conduit for fluids into, and out of, the central venous system."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable in the context of this 510(k) submission. The "test set" refers to the nonclinical performance testing. The text states "appropriate design verification tests were performed," but does not specify sample sizes for these tests.
Data Provenance: The testing was "performed in accordance with Guidance on 510(k) Submission for Implanted Infusion Ports, dated October 1990" and "Design Control Guidance for Medical Device Manufacturers, dated March 11, 1997." This indicates internal testing by Bard Access Systems, Inc. The nature of the tests (design verification and validation) suggests laboratory-based, non-clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This device is an implanted port, not a diagnostic device requiring expert interpretation for ground truth establishment. The evaluation is based on engineering and material performance.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication process as would be used for subjective assessments or diagnostic interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not a diagnostic device or AI-assisted system that would involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this submission is established through engineering performance specifications and comparison to the predicate device's known performance and safety record. The non-clinical performance testing validated that the device met these specifications and was substantially equivalent, ensuring its safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This refers to the training of an algorithm, which is not relevant for this physical device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no "training set" in the context of this device.

Summary

{0}------------------------------------------------

K032044

JUL 1 0 2003

X-Port duo™ Implanted Port Premarket Notification [510(k)]

Section 6 510(k) Summary X-Port duo™ Implanted Port

510(k) Summary of Safety and Effectiveness Information 21CFR 807.92

6.1 Submitter Information

Submitter Name:	Bard Access Systems, Inc. (BAS)[Subsidiary of C. R. Bard, Inc.]
Address:	5425 W. Amelia Earhart DriveSalt Lake City, UT 84116
Telephone Number:	(801) 595-0700, Ext. 5439
Fax Number:	(801) 595-5425
Contact Person:	John Knorpp
Date of Preparation:	1 July 2003

Device Name 6.2

Device Name:	Plastic Dual Port
Trade Name:	X-Port duo™ Port
Common/Usual Name:	Plastic Subcutaneous Port & Catheter
Classification Name:	80LJT - Port & Catheter, Implanted, Subcutaneous, Intravascular21 CFR 880.5965 - Subcutaneous, Implanted, Intravascular InfusionPort and Catheter, Class II
Classification Panel:	General Hospital

6.3 Predicate Device Name

Device Name:	Plastic Attachable Dual Port
Trade Name:	MRI® Dual Port
Common/Usual Name:	Plastic Subcutaneous Port & Catheter
Classification Name:	80LJT - Port & Catheter, Implanted, Subcutaneous, Intravascular
	21 CFR 880.5965 - Subcutaneous, Implanted, Intravascular Infusion
	Port and Catheter, Class II
Premarket Notification:	K912702, concurrence date - 18 September 1991.

6.4 Device Description

Principles of Operation

There are no new operating principles. The X-Port duo™ port has the same basic, fundamental scientific technology as the predicate MRI® Dual port. Access to the port is made percutaneously with a non-coring needle that enters the port reservoir via the silicone rubber septum. The access path to the vascular system is provided through a catheter attached to the base of the port. The port system serves as a conduit for fluids into, and out of, the central venous system.

{1}------------------------------------------------

Port Body

The port body consists of an oblong shaped plastic base and top .
The silicone septa are compressed between the port base and top. .
The port body profile incorporates smooth transitions. .
There are two suture holes adjacent to the stem and a third suture hole placed opposite the stem . on the tapered nose. All suture holes are filled with silicone plugs.

Catheters, Stems and Catheter Locks

All catheters and catheter/port connection systems used on the X-Port duo port are previously ● qualified legally marketed configurations covered by the predicate device.

6.5 Intended Use

The X-Port duo™ Implanted Port is a totally implantable vascular access device designed to provide long term repeated access to the vascular system.

This is the identical intended use for the predicate MRI® Dual port.

Summary of Technological Characteristics in Relation to the Predicate Device 6.6

The X-Port duo™ port design has some minor differences from the predicate MRI® Dual port, however the basic fundamental scientific technology of the port has not changed. The primary differences include the following: Larger separate two-piece septa, a lower profile port body with smooth transitions and three silicone filled suture holes.

6.7 Nonclinical Performance Testing

The appropriate design verification tests were performed in accordance with Guidance on 510(k) Submission for Implanted Infusion Ports, dated October 1990. Design validation was also performed to meet the recommendations of the FDA guidance document, Design Control Guidance for Medical Device Manufacturers, dated March 11, 1997.

Performance data gathered in design verification and validation testing demonstrated that the X-Port duo™ port is substantially equivalent to the predicate MRI® Dual port and/or met predetermined acceptance criteria, and the risks associated with use of the new device were found acceptable when evaluated by FMEA.

6.8 Clinical Performance Testing

Clinical performance testing was not required.

6.9 Conclusion

Based on FDA's decision tree, the X-Port duo™ port is substantially equivalent to the predicate device MRI® Dual port, K912702, cleared September 18, 1991.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping lines that resemble an abstract human figure.

JUL 1 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John Knorpp Senior Regulatory Affairs Specialist Bard Access Systems, Incorporated 5425 W. Amelia Earhart Drive Salt Lake City, Utah 84116

Re: K032044

Trade/Device Name: BardPort®, SlimPort™ and X-Port™ Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: July 1, 2003 Received: July 2, 2003

Dear Mr. Knorpp:

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.

{3}------------------------------------------------

Page 2 - Mr. Knorpp

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 vour 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 (301) 594-4618. 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 yours.

Sasa Ruano

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Section 1.2

INDICATION(S) FOR USE STATEMENT*

Signature of 510(k) Submitter:

Printed Name of Submitter:

John L. Knapp

John C. Knorpp Senior Regulatory Affairs Specialist

Date:

6-19-03

*Suggested language and format to meet the requirements of sections 513(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and sections 807.92(a)(5) and 801.4 of the Code of Federal Regulations, Title 21.

Concurrence of Office of Device Evaluation

510(k) Number: K032044

Division Sign-Off: Office of Device Evaluation

Patricia Crescenti

v. General Hospital

510(k) Number: K032044

OR - Over-The-Counter Use: _______________________________________________________ Prescription Use: ____________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.

(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.