The Catheter Innovations Implantable Port is designed for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. They are also indicated for blood specimen withdrawal.

Device Description

Catheter Innovations. Inc. Implantable Ports are constructed using a combination of traditional implanted port/catheter technology and materials which are well known and proven in the art (over fifteen years of successful use), Bard Access Systems BardPort™ Implanted Ports with Groshong® catheters-hereafter referred to as BardPorts™ (over eleven years in use) and our own previously approved 510(k) technology. The Catheter Innovations ports, like the BardPorts™ and other traditional ports are implanted within the body. They are used for access to the circulatory system for repeatable or periodic infusion of fluids and/or aspiration of blood. Like many currently marketed ports the Catheter Innovations ports have smooth, contoured titanium (or proposed polysulfone plastic) port bodies with either one (single-lumen) or two (dual-lumen) independent reservoirs.

A radiopaque silicone catheter with one or two lumens is provided with each port body. The catheter may come attached to the port body by the manufacturer or unattached depending on user preference. If the catheter comes attached to the port, at the time of use the health practitioner measures and cuts off the distal end of the catheter to the desired length. If the catheter is not attached to the port when it is purchased, the catheter is placed, then cut off at the proximal end to the desired length and attached to the port by the practitioner. The port is then placed in a small pocket made just under the skin. The port bodies are designed to facilitate secure seating and anchoring in the port pocket.

The ports are accessed by inserting a non-coring needle through the skin and into the self-sealing silicone septum which caps the port body reservoirs.

Both BardPorts™ and Catheter Innovations ports contain a thin silicone membrane within their construction. In both cases these membranes have a small slit or cut through them that acts as a valve. In the BardPorts™ this valve is located at the distal end of the attached catheter. In the Catheter Innovations ports the valve is located in a small plastic polysulfone housing which comes attached to the port body. The catheter is connected to this port through this housing. In both examples the valve is used to control the flow of fluids both into and out of the blood stream. The valve remains closed when the ports are not in use and when subjected to normal central venous pressures. When positive fluid pressure is applied through the reservoir, the valve opens, allowing infusion through the catheter. When negative pressure (aspiration) is applied, the valve opens, allowing for withdrawal of blood into a syringe.

AI/ML Overview

This submission describes a special 510(k) device modification for Intravascular Implanted Ports (K993860). The modification involves changing the material of the port body from titanium to polysulfone plastic.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to the "FDA Guidance on 510(k) Submissions for Implanted Infusion Ports" (October 1990) for all performance characteristics. While specific numerical acceptance criteria are not explicitly stated in the provided text, the overall conclusion is that the modified device meets or exceeds the performance of the predicate devices.

Acceptance Criteria (from FDA Guidance on 510(k) Submissions for Implanted Infusion Ports, October 1990)	Reported Device Performance (Polysulfone body vs. Predicate Devices)
Physical characteristics (e.g., design, intended use, instructions for use)	Identical to predicate devices (K991897 and BardPorts™ with Groshong® and Hickman® catheters).
Performance characteristics related to port and valve function	Equivalent to or better than predicate devices (Catheter Innovation's titanium-bodied ports and BardPort™ with Groshong® catheters).
All other port catheter performance characteristics	Equivalent to or better than the range of values found for BardPort™ with Hickman® and Groshong® catheters.
Safety, efficacy, and performance issues	Poses no new safety, efficacy, or performance issues compared to predicate devices.
MRI Compatibility (absence of ferrous materials)	MRI Compatible as it contains no ferrous materials.

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

Sample Size: Not explicitly stated. The document mentions "performance test results" and "comparison of all other Catheter Innovations port catheter performance characteristics were made to the range of values found for the performance of the predicate BardPort™ with Hickman® and Groshong® catheters." However, the specific number of units tested for the modified device is not provided.
Data Provenance: Not explicitly stated. The study was conducted by Catheter Innovations, Inc. The data is likely internal performance testing data. It is not specified if the data is retrospective or prospective, or from which country.

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

This information is not applicable to this type of device modification submission. Device performance was assessed through physical and functional testing against established FDA guidance, not through expert-evaluated "ground truth" labels.

4. Adjudication Method for the Test Set:

This information is not applicable. Device performance was assessed through physical and functional testing against established FDA guidance, not through human adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. without AI Assistance:

This information is not applicable. This is a device modification for an implantable port, not an AI-assisted diagnostic or treatment device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:

This information is not applicable. This is a device modification for an implantable port, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for evaluating the modified device's performance was the established physical and performance characteristics of predicate devices as outlined in the "FDA Guidance on 510(k) Submissions for Implanted Infusion Ports" (October 1990). This involved comparing the new device's test results to the known performance and specifications of approved similar devices already on the market.

8. The Sample Size for the Training Set:

This information is not applicable. This is a device modification, and the "training set" concept is not relevant in this context. Device performance is evaluated through testing against established standards and predicate devices, not through a machine learning model.

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

This information is not applicable for the reasons stated in point 8.

Summary

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DEC - 3 1999

SPECIAL 510(k): DEVICE MODIFICATION Catheter Innovations, Inc. Single and Dual-Lumen Implantable Ports - Plastic

K993860

SUMMARY Prepared November 8, 1999

1. Submitted By:

Catheter Innovations, Inc. 3598 West 1820 South Salt Lake City, UT 84104-4959 (801) 954-8444 Tel: (801) 954-8484 Fax:

2. Contact Person:

Roger L. Richins V. P. Technology and Regulatory Affairs

3. Device Establishment Registration No .: 1723743 Owner/Operator No .: 9025151

4. Device Identification:

Trade Name:	Implantable Port - Plastic
Common Name:	Intravascular Implanted Port
Classification Name:	Port & Catheter, Implanted, Subcutaneous, Intravascular
Classification:	Unclassified
FDA Classification Advisory Committee:	80 - General Hospital
Product Code:	LJT - The specific guidelines for Premarket Notification in the LJT product classification are detailed in the "Guidance on 510(k) Submissions for Implanted Infusion Ports" by the CDRH, ODE, Division of Gastroenterology/Urology and General Use Devices (October 1990)
Predicate Device(s):	K 991897 - Catheter Innovations. Inc. Single and Dual-Lumen

Innovations, Inc. Single Implantable Ports (Approved to Market - October 21, 1999)

K880571 - Originally submitted as Catheter Technologies Port Implantable Vascular Access System (Approved to Market -March 4, 1988) - Currently marketed by Bard Access Systems as "BardPort™ Implanted Ports with Groshong® catheters"

K873213 - Hickman® Subcutaneous Port currently marketed by Bard Access Systems

6. Description of Device Modification:

Traditionally, implantable port bodies have been constructed using the same basic biocompatible materials. Port bodies are commonly manufactured from either titanium metal or polysulfone plastic. THIS SPECIAL 510(K) DEVICE MODIFICATION IS SUBMITTED TO GAIN APPROVAL FOR THE ADDITION OF A POLYSULFONE BODIED PORT TO OUR EXISTING PORT PRODUCT LINE. There is no difference whatsoever between this product and the predicate K991897 product, other than the use of polysulfone plastic material in the port body! There are no changes in design, intended use, and instructions for use or performance when compared to the approved device.

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SPECIAL 510(k): DEVICE MODIFICATION Catheter Innovations. Inc. Single and Dual-Lumen Implantable Ports - Plastic

SUMMARY (Continued)

7. Device Description:

The ports are accessed by inserting a non-coring needle through the skin and into the self-sealing silicone septum which caps the port body reservoirs.

8. Statement of Indications for Use:

The Catheter Innovations ports are designed for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. They are also indicated for blood specimen withdrawal.

The Catheter Innovations ports, the BardPorts™ (both with and without valve), and the numerous other approved intravascular port and catheter combinations have the same indications for use: long-term access to the central venous system for administration of fluids and for blood specimen withdrawal.

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SPECIAL 510(k): DEVICE MODIFICATION Catheter Innovations, Inc. Single and Dual-Lumen Implantable Ports - Plastic

SUMMARY (Continued)

1. Summary of Technological Characteristics of Device in Relation to Predicate Device(s):
  Catheter Innovations currently markets ports which use titanium metal for their port bodies. This proposed device modification would add to our product line a group of ports that use polysulfone plastic as their body material. Both materials have been used for many years in this application by numerous medical device manufacturers, and are commonly used to help improve patient care.

Physical characteristics of Catheter Innovations ports using both titanium and polysulfone port bodies, compared to BardPorts™ with Groshong® and Hickman® catheters, demonstrate that the physical characteristics of the Catheter Innovations ports are identical to the predicate devices for all items listed in the "FDA Guidance on 510(k) Submissions for Implanted Infusion Ports". (October 1990)

Physically, the Catheter Innovations ports differ from the BardPorts™ with Groshong® catheters, only in that the valve in the Catheter Innovations port is located in the catheter-to-port adapter housing, instead of close to the catheter as in the Groshong® catheter.

Additionally, in the BardPorts™ with Groshong® catheters the catheters are supplied in shorter lengths. This length difference is only apparent when the product is removed from the package. In actual use, the catheters are trimmed to length so that their distal tips are located in the distal 1/3 of the Superior Vena Cava (SVC). Thus, the difference in length of catheters, as supplied, is insignificant in relation to end-use of the product.

Both BardPorts™ with Hickman® catheters and Catheter Innovations ports are openended, and the distal end is trimmed by the health professional in order to obtain the desired length. Because the Groshong® catheter is close-ended and removal of a distal seqment would remove the valve, these catheters are trimmed at the proximal end and subsequently fitted over their port-connecting adapter. Placement and trimming of Catheter Innovations catheters, because they are open-ended, is identical to that of BardPort™ with Hickman® catheters.

Catheter Innovations three-way valve is located in the port-to-catheter adapter housing at the proximal end of the catheter, immediately adjacent to the port body, while the Groshong® three-way valve is located in the distal tip of the catheter in the distal third of the SVC, and directly in the fluid stream path. There are no new safety or effectiveness issues posed by the difference in location of these valves within the body.

Conclusion:

Based on these physical characteristic comparisons, we consider the Catheter Innovations Implantable Ports, using a polysulfone plastic body, to be substantially equivalent to the Catheter Innovations Implantable Ports using a titanium metal body. We also consider this product substantially equivalent to BardPort™ with Groshong® and Hickman® catheters as well as other currently marketed ports in their physical characteristics.

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SPECIAL 510(k): DEVICE MODIFICATION Catheter Innovations, Inc. Single and Dual-Lumen Implantable Ports - Plastic

SUMMARY (Continued)

10. Assessment of Performance Data:

Performance test results indicate Catheter Innovations ports, using polysulfone bodies, are substantially equivalent to predicate device port/catheter combinations for all performance characteristics itemized in the "FDA Guidance on 510(k) Submissions for Implanted Infusion Ports". (October 1990)

Catheter Innovations performance characteristics related to port and valve function were compared to the predicate Catheter Innovation's ports and BardPort™ with Groshong® catheters. Comparison of all other Catheter Innovations port catheter performance characteristics were made to the range of values found for the performance of the predicate BardPort™ with Hickman® and Groshong® catheters. These comparisons indicate that the Catheter Innovations polysulfone port body with catheters performed equivalent to, or better than, the predicate devices for all performance characteristics studied.

Conclusion:

Data indicates that the performance characteristics of the Catheter Innovations ports (using both titanium and polysulfone bodies), are equivalent or superior to the currently marketed BardPort™ Implanted Ports with Groshong® and Hickman® catheters while posing no new safety, efficacy, or performance issues.

11. MRI - Compatible:

The Catheter Innovations Implantable Ports contain no ferrous materials; therefore they are not susceptible to magnetic influence and are "MRI Compatible".

12. Risk Analysis:

A risk analysis was completed on the products covered by this "SPECIAL" 510(k) DEVICE MODIFICATION. This analysis showed that the product constructed with polysulfone plastic used as the port body has the same inherent risks of use as predicate devices and all other central venous access porticatheter products. Their use should be carefully considered before placement. Their placement and care should only be performed by persons knowledgeable of the risks involved and qualified in the procedures required.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure. The figure is composed of three curved lines that form the shape of a person's head and torso. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2001

Mr. Roger L. Richins V.P. Technology and Regulatory Affairs Catheter Innovations, Incorporated 3598 West 1820 South 84104-4959 Salt Lake City, Utah

K993860 Re: Single and Dual-Lumen Implantable Ports-Trade Name: Plastic Unclassified Requlatory Class: Product Code: LJT Dated: November 8, 1999 Received: November 15 , 1999

Dear Mr. Richins:

This letter corrects our substantially equivalent letter of December 3, 1999 regarding the Product Code.

We have reviewed your Section 510(k) notification of intent to we have reviewed your beloed above and we have determined the market the device ially 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 or the ficalour roccordance with the provisions of the Federal reclassifica in accordains "" (Act). "You may, therefore, Food, Drug, and Copment to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of Incides, 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 (Spoorar o such additional controls. Existing major bublice of Back ating your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਖੇ reacrantially equivalent determination assumes compliance with Subblancially Oquiring Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic (OMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, the Food and Drug Administration (FDA) action. may publish further announcements concerning your device in the Federal Register. Please note: this response to your

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Page 2 - Richins

premarket notification submission does not affect any premarket noctrication baxible sections 531 through 542 of obligation you might have the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as This recei will aremarket notification. The FDA described in your 510 k, promance of your device to a legally Linding of subbeancear oquired in a classification for your marketed predicate device results in the to proceed to the market.

If you desire specific advice for your device on our labeling of II you desire bpcoirie additionally 809.10 for in regulation (21 or orices), please contact the Office of VILIO draghosere at (301) 594-4692. Additionally, for questions on Compilance at (501) beertising of your device, please contact the Dromocion and adversibility of July 594-4639. Also, please note the Office or compriance led, "Misbranding by reference to that the regulation encreices, "Mibblanang the Ast may premation on your responsibilities under the Act may be information on your responsibilities and Manufacturers Assistance obtained from the bivision of Bilair Hass on at (301) 443-6597 or at its internet address

"http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Stance Cucentiffor

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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વેવ 510(k) Number (if known):

Device Name: Catheter Innovations Implantable Ports - Plastic

Indications For Use:

The Catheter Innovations Implantable Port is designed for patients who require and first of first of the The Catheler Innovations implanable For householding but not limited to access to the central venous bycloin reroy annalgesics, nutritional therapy, and blood nyulation nuludy, andbreated for blood specimen withdrawal.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Palixce Cuencte

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number .

Perscription Use
(Per 21 CFR 801.108

Over -The-Counter

vi.1

(Optional Format 1-2-96) 3

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.