PORT-A-CATH® Systems with Dual Layer Catheter are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.

PORT-A-CATH® II Systems with Dual Layer Catheter are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.

ProPort® Systems with Dual Layer Catheter are indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

P.A.S. PORT® Systems with Dual Layer Catheter are indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

Device Description

The PORT-A-CATH® Implantable Venous Access Systems with Dual Layer Catheter are totally implantable access systems and are designed to permit repeated access to the venous system for the parenteral delivery of medications, fluids nutritional solutions and for the sampling of venous blood. The PORT-A-CATH® venous systems can be placed in the chest.

The PORT-A-CATH® Implantable Venous Access Systems with Dual Layer Catheter are totally implantable access systems consisting of the following components; a portal. catheter and connector. The components are assembled during implantation. The portals are available in titanium standard or Low Profile", and the ULTRA-LOCK® catheter connector is utilized in the PORT-A-CATH® systems. The catheter is a Polyether block amide outer lining and an aliphatic polyurethane inner lining. This catheter will replace the current single layer polyurethane catheters on the equivalent Smiths Medical MD, Inc. PORT-A-CATH® Implantable Venous Access Systems, The systems are offered in either a kit or a tray configuration.

The PORT-A-CATH® II Implantable Venous Access Systems with Dual Layer Catheter are totally implantable access systems and are designed to permit repeated access to the venous system for the parenteral delivery of medications, fluids nutritional solutions and for the sampling of venous blood. The PORT-A-CATH® II venous systems can be placed in the chest.

The PORT-A-CATH® II Implantable Venous Access Systems with Dual Laver Catheter are totally implantable access systems consisting of the following components: a portal, catheter and connector. The components are assembled during implantation. The portals are available in polysulfone/titanium standard or Low Profile", and the ULTRA-LOCK® catheter connector is utilized in the PORT-A-CATH® II systems. The catheter is a Polyether block amide outer lining and an aliphatic polyurethane inner lining. This catheter will replace the current single layer polyurethane catheters on the equivalent Smiths Medical MD, Inc. PORT-A-CATH® II Implantable Venous Access Systems. The systems are offered in either a kit or a tray configuration.

The ProPort® Implantable Venous Access Systems with Dual Layer Catheter are totally implantable access systems and are designed to permit repeated access to the venous system for the parenteral delivery of medications, fluids nutritional solutions and for the sampling of venous blood. The ProPort venous systems can be placed in the chest.

The ProPort® Implantable Venous Access Systems with Dual Layer Catheter are totally implantable access systems consisting of the following components: a portal, catheter and connector. The components are during implantation. The portals are available in plastic standard or Low Profile", and the SlideLock connector is utilized in the ProPort® systems. The catheter is a Polyether block amide outer lining and an aliphatic polyurethane inner lining. This catheter will replace the current single layer polyurethane catheters on the equivalent Smiths Medical MD, Inc. ProPort® Implantable Venous Access Systems. The systems are offered in either a kit or a tray configuration.

The P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter are totally implantable access systems and are designed to permit repeated access to the venous system for the parenteral delivery of medications, fluids nutritional solutions and for the sampling of venous blood. The P.A.S. PORT® venous systems can be placed in the arm or chest.

The P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter are totally implantable access systems consisting of the following components: a portal, catheter and connector. The components are assembled during implantation. The portals are available in titanium or plastic/titanium standard or Low Profile™, and the ULTRA-LOCK® catheter connector is utilized in the P.A.S. PORT® systems. The catheter is a Polyether block amide outer lining and an aliphatic polyurethane inner lining. This catheter will replace the current single layer polyurethane catheters on the equivalent Smiths Medical MD, Inc. P.A.S. PORT® Implantable Venous Access Systems. The systems are offered in either a kit or a tray configuration.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the PORT-A-CATH® and related implantable venous access systems:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Functional Testing: Met product specification (in accordance with FDA guidance "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters," dated March 16, 1995)	All testing met product specification.
In-vivo Testing: Evaluated product performance of the new catheter material.	All testing met product specification.
Biocompatibility Testing: Conducted on system components.	All testing passed.
Packaging and Sterilization Systems: Unchanged from predicate devices. (Implied acceptance: continued safe and effective based on predicate device performance)	Unchanged from predicate devices. (No new specific performance reported, but this implies equivalency to the predicate).
Substantial Equivalence: To predicate devices (PORT-A-CATH®, PORT-A-CATH® II, ProPort®, and P.A.S. PORT® Implantable Venous Access Systems) with respect to indications for use and performance features. (This is the overarching acceptance criterion for 510(k) clearance).	The devices were found to be substantially equivalent to their respective predicate systems.

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

The provided document describes in-vitro and in-vivo testing. It refers to these as studies, but the nature of the data is not patient-specific in the way a clinical trial would be.

Sample Size for Test Set: Not explicitly stated as a number of "samples" in a clinical human subject sense. The testing involved "functional testing," "in-vivo testing of the new catheter material," and "biocompatibility testing." The sample size would be related to the number of devices or components tested in these laboratory and animal (implied by "in-vivo" for material evaluation) environments.
Data Provenance:
- In-vitro Testing: Performed in accordance with FDA guidance, suggesting laboratory testing.
- In-vivo Testing: Conducted to evaluate product performance of the new catheter material. This typically refers to animal studies for material biocompatibility and performance, not human clinical data.
- Retrospective or Prospective: These tests are inherently prospective as they are conducted specifically for the purpose of demonstrating device safety and effectiveness.

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

Not applicable in the context of this device and study. The "ground truth" for this type of medical device clearance (510(k)) is established through adherence to engineering and clinical performance standards, and comparison to legally marketed predicate devices, rather than through expert consensus on medical image interpretation or diagnosis. The "experts" involved would be the engineers, scientists, and regulatory professionals conducting and evaluating the tests against established specifications.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical data (e.g., imaging) to establish a consensus ground truth. This is not a clinical study, but rather a set of functional and biological performance tests.

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

Was an MRMC study done? No.
Effect size of human reader improvement with AI vs. without AI assistance: Not applicable, as this device is an implantable venous access system, not an AI-powered diagnostic tool.

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

Was a standalone study done? Not applicable. This device is not an algorithm or AI system. Its performance is inherent in its physical and material properties when implanted.

7. Type of Ground Truth Used

The ground truth for this submission is based on:

Product Specifications: The device was tested to ensure it met pre-defined product specifications for functional performance, material properties, and biocompatibility.
Predicate Device Performance: The primary "ground truth" for 510(k) clearance is demonstrated substantial equivalence to legally marketed predicate devices in terms of indications for use and performance features. This means the new device performs at least as safely and effectively as the existing, approved devices.
Industry Standards/Guidance: Adherence to FDA guidance for intravascular catheters (e.g., "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters").

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or artificial intelligence device that requires a training set.

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

Not applicable, as there is no training set for this device.

Summary

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PORT-A-CATH®, PORT-A-CATH® II, ProPort®, and P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter Summary of Safety and Effectiveness

MAY 17 2006

GENERAL INFORMATION

Applicant's Name and Address:	Smiths Medical MD, Inc.1265 Grey Fox RoadSt. Paul, MN 55112
Contact Person:	Melanie Hess RN, BSNRegulatory and Clinical Affairs Associate
Common/Usual Name:	Implantable Access System
Proprietary Name:	PORT-A-CATH®, PORT-A-CATH® II,ProPort®, and P.A.S. PORT® ImplantableVenous Access Systems with Dual LayerCatheter
Equivalence Device Comparison:	PORT-A-CATH®, PORT-A-CATH® II,ProPort®, and P.A.S. PORT® ImplantableVenous Access Systems

II. DEVICE DESCRIPTION

PORT-A-CATH® Implantable Venous Access Systems with Dual Layer Catheter

Confidential

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1999 18

January 03, 2006

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PORT-A-CATH®, PORT-A-CATH® II, ProPort®, and P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter Summary of Safety and Effectiveness

PORT-A-CATH® II Implantable Venous Access Systems with Dual Layer Catheter

ProPort® Implantable Venous Access Systems with Dual Layer Catheter

P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter

Confidential

Page 2 of 5

January 03, 2006

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Image /page/2/Picture/1 description: The image shows the text "page 3 of 5" on the top line and "K0600036" on the second line. The text is handwritten in black ink on a white background. The handwriting is somewhat messy, but the text is still legible.

PORT-A-CATH®, PORT-A-CATH® II, ProPort®, and P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter Summary of Safety and Effectiveness

are available in titanium or plastic/titanium standard or Low Profile™, and the ULTRA-LOCK® catheter connector is utilized in the P.A.S. PORT® systems. The catheter is a Polyether block amide outer lining and an aliphatic polyurethane inner lining. This catheter will replace the current single layer polyurethane catheters on the equivalent Smiths Medical MD, Inc. P.A.S. PORT® Implantable Venous Access Systems. The systems are offered in either a kit or a tray configuration.

III. INTENDED USE OF THE DEVICE

PORT-A-CATH® Implantable Venous Access Systems with Dual Layer Catheter

PORT-A-CATH® Systems with Dual Layer Catheter are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.

PORT-A-CATH® II Implantable Venous Access Systems with Dual Layer Catheter

PORT-A-CATH® II Systems with Dual Layer Catheter are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.

ProPort® Implantable Venous Access Systems with Dual Layer Catheter

ProPort® Systems with Dual Layer Catheter are indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter

P.A.S. PORT® Systems with Dual Layer Catheter are indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

IV. DEVICE COMPARISON

PORT-A-CATH® Implantable Venous Access Systems with Dual Layer Catheter

The PORT-A-CATH® Implantable Venous Access Systems with Dual Layer Catheter was compared to and found to be substantially equivalent to the following commercially available predicate systems with respect to indications for use and performance features PORT-A-CATH® Implantable Venous Access Systems.

Confidential

Page 3 of 5

January 03, 2006

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page 4 of 5
K060036

PORT-A-CATH®, PORT-A-CATH® II, ProPort®, and P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter Summary of Safety and Effectiveness

PORT-A-CATH® II Implantable Venous Access Systems with Dual Layer Catheter

The PORT-A-CATH® II Implantable Venous Access Systems with Dual Layer Catheter was compared to and found to be substantially equivalent to the following commercially available predicate systems with respect to indications for use and performance features: PORT-A-CATH® II Implantable Venous Access Systems.

ProPort® Implantable Venous Access Systems with Dual Layer Catheter

The ProPort® Implantable Venous Access Systems with Dual Layer Catheter was compared to and found to be substantially equivalent to the following commercially available predicate systems with respect to indications for use and performance features: ProPort® Implantable Venous Access Systems.

P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter

The P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter was compared to and found to be substantially equivalent to the following commercially available predicate systems with respect to indications for use and performance features: P.A.S. PORT® Implantable Venous Access Systems.

SUMMARY OF STUDIES V.

A. Functional Testing

In-vitro testing was conducted in accordance with the FDA guidance, "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters," dated March 16, 1995. All testing met product specification.

In-vivo testing of the new catheter material of the PORT-A-CATH®, PORT-A-CATH® II, ProPort®, and P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter was conducted to evaluate product performance. All testing met product specification.

Biocompatibility testing was conducted on system components. All testing passed.

Packaging and Sterilization systems are unchanged from predicate devices.

B. Clinical Studies

Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the PORT-A-CATH®, PORT-A-CATH® II, ProPort®, and P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter.

Confidential

Page 4 of 5

・・・

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SMITHS MEDICAL MD, INC.
510(k) Premarket Notification

PORT-A-CATH®, PORT-A-CATH® II, ProPort®, and P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter Summary of Safety and Effectiveness

C. Conclusions Drawn from the Studies

Based upon the information provided, the PORT-A-CATH®, PORT-A-CATH® II, ProPort®, and P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter is safe, effective and performs to established specifications.

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Confidential

January 03, 2006

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized graphic of three abstract human figures connected by flowing lines, arranged in a triangular shape. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the graphic.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 17 2006

Ms. Melanie Hess Regulatory and Clinical Affairs Associate Smiths Medical MD, Incorporated 1265 Grey Fox Road St. Paul. Minnesota 55112

Re: K060036

Trade/Device Name: PORT-A-CATH® Systems with Dual Layer Catheter, PORT-A-CATH® II Systems with Dual Layer Catheter, ProPort ® Systems with Dual Layer Catheter, P.A.S. Port® Systems with Dual Layer Catheter Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: January 3, 2006 Received: January 5, 2006

Dear Ms. Hess:

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. Hess

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/industry/support/index.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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PORT-A-CATH®, PORT-A-CATH® II, ProPort®, and P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter Indications for Use

510(k) Number (if known): TBD

Device Name: PORT-A-CATH® Systems with Dual Layer Catheter

Indications for Use:

"PORT-A-CATH® Systems with Dual Layer Catheter are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling."

Prescription Use X 21 CFR 801.109)

Over-The Counter Use Per

Device Name: PORT-A-CATH® II Systems with Dual Layer Catheter

Indications for Use:

"PORT-A-CATH" II Systems with Dual Layer Catheter are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling."

Prescription Use X 21 CFR 801.109)

Over-The Counter Use Per

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anthony D. Vincent

an Sign-City) of sion of Anesthesiology, General Hospital,

action Control, Dental Devices

: * * (x) Number: _ Kybopp 36

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PORT-A-CATH®, PORT-A-CATH® II, ProPort®, and P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter Indications for Use

510(k) Number (if known): TBD

Device Name: ProPort® Systems with Dual Layer Catheter

Indications for Use:

"ProPort® Systems with Dual Layer Catheter are indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling."

Prescription Use X 21 CFR 801.109)

Over-The Counter Use Per

Device Name: P.A.S. Port® Systems with Dual Layer Catheter

Indications for Use:

"P. A.S. PORT Systems with Dual Layer Catheter are indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling."

Prescription Use X 21 CFR 801.109)

Over-The Counter Use Per

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clutos Vime

on of Anesthesiology, General Hospital, Control, Dental Devices

Number: K 469936

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.