PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM

K033686 · Smiths Medical MD, Inc. · LJT · Jan 23, 2004 · General Hospital

Device Facts

• Record ID: K033686
• Device Name: PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM
• Applicant: Smiths Medical MD, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Jan 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PORT-A-CATH® II Regional Arterial Portal System is indicated when patient therapy requires prolonged or repeated intra-arterial access for injection or infusion regimes.

Device Story

Implantable access system for intra-arterial drug delivery; consists of portal with self-sealing silicone septum, silicone catheter, hemostasis assembly, and micro-catheter. Accessed via percutaneous needle puncture. Used in clinical settings by healthcare providers to facilitate prolonged or repeated arterial infusions. System provides secure, long-term access point for therapeutic agents, reducing need for repeated arterial punctures and improving patient comfort during treatment regimens.

Clinical Evidence

No clinical studies were conducted. Evidence consists of bench testing (tensile strength, flow-rate, catheter stiffness, flexural fatigue, leakage, guidewire removal) and in-vivo feasibility testing for implantation and post-implant performance in target arteries using image-guided techniques. Biocompatibility testing was performed on all components.

Technological Characteristics

Portal housing: Polysulfone/Titanium; Septum: Silicone; Connector: Polypropylene/Titanium; Catheter: Pebax/PTFE/Stainless Steel. System includes hemostasis assembly and micro-catheter. Dimensions: 15.2mm height, 30.5mm base, 11.4mm septum diameter. Non-electronic, mechanical implantable device.

Indications for Use

Indicated for patients requiring prolonged or repeated intra-arterial access for injection or infusion therapy.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.

Predicate Devices

• PORT-A-CATH® II Trans-Arterial Percutaneous System (K992697)
• PORT-A-CATH® II Implantable Venous Access System (K932840)

Submission Summary (Full Text)

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### JAN 2 3 2004

K033686

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

### PORT-A-CATH® II Regional Arterial System

### November 21, 2003

#### I. GENERAL INFORMATION

| Applicant's Name and Address: | Deltec, Inc.<br>1265 Grey Fox Road<br>St. Paul, MN 55112 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patricia LaForte<br>Regulatory Affairs Associate |
| Common/Usual Name: | Implantable Access System |
| Proprietary Name: | Regional Arterial Port/Catheter System for<br>Local/Regional Drug Delivery |
| Equivalence Device Comparison: | PORT-A-CATH® II Trans-Arterial Percutaneous<br>System<br>PORT-A-CATH® II Implantable Venous Access<br>System |

#### II. DEVICE DESCRIPTION

A system consists of a portal with a self-sealing silicone septum, accessible by percutaneous needle puncture, a single lumen silicone catheter, a hemostasis sy assembly, and a micro-catheter assembly

### III. INTENDED USE OF DEVICE

The PORT-A-CATH® II Regional Arterial Portal System is indicated when patient therapy requires prolonged or repeated intra-arterial access for injection or infusion regimes.

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### 510(k) Summary of Safety and Effectiveness Page 2 of 4

### IV. DEVICE COMPARISON

| | PORT-A-CATH® II<br>Regional Arterial<br>Drug Delivery System | PORT-A-CATH® II<br>Trans-Arterial<br>Percutaneous System | PORT-A-CATH® II<br>Implantable Venous<br>Access System |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER | Deltec, Inc. | Deltec, Inc. | Deltec, Inc. |
| 510(K) NUMBER | Subject Device | K992697 | K932840 |
| INDICATION FOR USE | A system is indicated<br>when patient therapy<br>requires prolonged or<br>repeated intra-arterial<br>infusions. | A system is indicated<br>when patient therapy<br>requires prolonged or<br>repeated intra-arterial<br>infusions. | A system is indicated<br>when patient therapy<br>requires repeated access<br>to the venous system for<br>the parenteral delivery of<br>medications, fluids, and<br>nutritional solutions, and<br>for the sampling of<br>venous blood. |
| PORTAL AND<br>CONNECTOR<br>MATERIALS | | | |
| Housing | Polysulfone/Titanium | Polysulfone/Titanium | Polysulfone/Titanium |
| Septum | Silicone | Silicone | Silicone |
| Connector | Polypropylene/Titanium | Polypropylene/Titanium | Polypropylene/Titanium |
| PORTAL DIMENSIONS<br>(Nominal) | | | |
| Height<br>Portal Base<br>Septum Diameter | 15.2 mm<br>30.5 mm<br>11.4 mm | 11.5 mm<br>25.0 mm<br>9.5 mm | 15.2 mm<br>30.5 mm<br>11.4 mm |
| PORTAL<br>CONNECTING<br>CATHETER | | | |
| OD/ID | 2.8mm/1.0mm | 1.9mm/1.0mm | 2.8mm/1.0mm |
| | PORT-A-CATH® II<br>Regional Arterial<br>Drug Delivery System | PORT-A-CATH® II<br>Trans-Arterial<br>Percutaneous System | PORT-A-CATH® II<br>Implantable Venous<br>Access System |
| LENGTH<br>MATERIAL | 38cm<br>Silicone | 76cm<br>Polyurethane | 76cm<br>Silicone |
| PORTAL TUBE<br>CONNECTOR | CATH-SHIELD®<br>Connector | ULTRA-LOCK®<br>Connector | CATH-SHIELD®<br>Connector |
| INTRA-VASCULAR<br>CATHETER<br>OD/ID<br>Length<br>Material | 1.0mm/0.72mm<br>100cm<br>Pebax/PTFE/Stainless<br>Steel | All same as above<br>(same catheter connects<br>to portal and to vascular<br>system) | All same as above<br>(same catheter connects<br>to portal and to vascular<br>system) |
| CATHETER TO<br>CATHETER<br>CONNECTOR | Boot- Silicone<br>Clamp - Acetal<br>Sleeve - Tecoflex 93A<br>Bushing - Polyvinyl Chloride<br>(TOTM plasticized) | n/a1 | n/a |
| ACCESSORIES<br>Needles | 1 blunt / 1 huber | 1 blunt / 1 huber | 1 blunt / 1 huber |
| Sharps Safety | 1 Point Lok® | n/a | n/a |
| Portal Access | 1 GRIPPER PLUS® | n/a | n/a |
| Other | n/a | Guidewire, introducer<br>needle, introducer,<br>syringe | Vein Pick |

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### 510(k) Summary of Safety and Effectiveness Page 3 of 4

### DELTEC, INC.

### Comparison Chart (Continued)

1 n/a = not applicable

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#### III. SUMMARY OF STUDIES

#### A. Functional Testing

In-vitro testing was conducted in accordance with the FDA "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters," dated March 16, 1995. The testing included tensile strength, flow-rate, catheter stiffness, catheter flexural fatigue, system leakage, and guidewire removal testing.

In-vitro Simulated Life Testing to document performance of the PORT-A-CATH® II Regional Arterial System under simulated, but accelerated, in-use conditions was performed.

In-vivo testing of the PORT-A-CATH® II Regional Arterial System to evaluate the feasibility of the implantation and immediate post-implant performance of an arterial port-catheter system into the hepatic or other target arteries using minimally invasive, image-guided techniques was conducted.

Biocompatibility testing was conducted on system components.

#### B. Clinical Studies

Clinical studies were not deemed necessary regarding PORT-A-CATH® II Regional Arterial System due to their similarity in materials, design and function to current Deltec systems.

#### C. Conclusions Drawn from the Studies

The results of the testing indicated that the PORT-A-CATH® II Regional Arterial Portal System functions according to specifications and the materials used in the system are biocompatible. Therefore, these systems are considered acceptable for human use.

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Image /page/4/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The overall design is simple and conveys a sense of government authority and public service.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 3 2004

Ms. Patricia LaForte Regulatory Affairs Associate Smiths Medical MD, Incorporated 1265 Grey Fox Road Saint Paul, Minnesota 55112

Re: K033686

Trade/Device Name: PORT-A-CATH® II Regional Arterial Portal System Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Codc: LJT Dated: November 21, 2003 Received: November 24, 2003

Dear Ms. LaForte:

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 cither 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. LaForte

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 (OS) 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Cls
SG. Liu, 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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510(k) Number (if known): _____________________

Device Name: PORT-A-CATH® II Regional Arterial Portal System

Indications for Use:

"The PORT-A-CATH® II Regional Arterial Portal System will be indicated when patient therapy requires prolonged or repeated intra-arterial access for injection or infusion regimes."

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Zork Dillard, Interim Branch Chief

(Division Sian-Off) Division of Anesthesiology, Ge Infection Control, Dental De

510(k) Number: K0331

Prescription Use (Per 21 CFR 801.109)

OR

Over-The Counter Use

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