PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM

K992697 · Sims Deltec, Inc. · LJT · Nov 18, 1999 · General Hospital

Device Facts

• Record ID: K992697
• Device Name: PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM
• Applicant: Sims Deltec, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Nov 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A system is indicated when a patient requires prolonged or repeated intra-arterial infusion.

Device Story

Implantable access system for intra-arterial infusion; consists of portal with self-sealing silicone septum and single lumen polyurethane catheter. Accessories include access needle, blunt needle, introducer needle, dilator/sheath assembly, guidewire, and syringe. Used in clinical settings by healthcare professionals to provide vascular access for infusion therapy. Device allows percutaneous needle puncture to access the portal, facilitating delivery of infusates directly into the arterial system. Benefits include reliable, repeated access for patients requiring long-term arterial therapy.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is based on design, material, and functional similarity to the predicate PORT-A-CATH® II Low Profile™ Venous System. Biocompatibility testing was conducted to confirm material safety.

Technological Characteristics

Portal: Polysulfone/Titanium; Septum: Silicone; Catheter: Polyurethane. Features ULTRA-LOCK® connector. Dimensions: 11.5 mm portal height, 25.0 mm base, 9.5 mm septum diameter; 1.9 mm catheter I.D., 1.0 mm O.D., 100 cm length. Implantable, non-powered, mechanical access system.

Indications for Use

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

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 Low Profile™ Venous Implantable Access System (K942024)
• PORT-A-CATH® Arterial Implantable Access System (K830730B)

Submission Summary (Full Text)

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

PORT-A-CATH® II Trans-Arterial Percutaneous System

K 992697

August 9, 1999

# I. GENERAL INFORMATION

| Applicant's Name and Address: | SIMS Deltec, Inc.<br>1265 Grey Fox Road<br>St. Paul, MN 55112 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lisa Stone<br>Manager, Regulatory Affairs |
| Common/Usual Name: | Implantable Access System |
| Proprietary Name: | PORT-A-CATH® II Trans-Arterial Percutaneous<br>System |
| Equivalence Device Comparison: | PORT-A-CATH® II Low Profile™ Venous<br>Implantable Access System<br>PORT-A-CATH® Arterial Implantable Access<br>System |

# II. DEVICE DESCRIPTION

A PORT-A-CATH® II Trans-Arterial Percutaneous System consists of a portal with a self-sealing silicone septum, accessible by percutaneous needle puncture, and single lumen catheter. The following accessories are provided with the portal and catheter: PORT-A-CATH® access needle, blunt needle, extra-thin wall introducer needle, dilator/sheath assembly, guidewire and syringe.

# III. INTENDED USE OF DEVICE

A system is indicated when a patient requires prolonged or repeated intra-arterial infusion.

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# DEVICE COMPARISON IV.

| | PORT-A-CATH® II<br>Trans-Arterial<br>Percutaneous System | PORT-A-CATH® II<br>Low Profile™ System | PORT-A-CATH®<br>Arterial System |
|-------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER | SIMS Deltec, Inc. | SIMS Deltec, Inc. | SIMS Deltec. Inc. |
| 510(K) NUMBER | Subject Device | K942024 | K830730B |
| INDICATIONS FOR<br>USE | A system is indicated<br>when a patient requires<br>prolonged or repeated<br>intra-arterial infusion. | A system is indicated<br>when a patient requires<br>repeated vascular access<br>for injection or infusion<br>therapy and/or venous<br>blood sampling. | A system is indicated<br>when a patient requires<br>repeated vascular access<br>for injection or infusion<br>therapy and/or venous<br>blood sampling. |
| PORTAL<br>DIMENSIONS<br>(nominal) | | | |
| Height<br>Base<br>Septum Diameter | 11.5 mm<br>25.0 mm<br>9.5 mm | 11.5 mm<br>25.0 mm<br>9.5 mm | 13.5 mm<br>25.4 mm<br>11.4 mm |
| CATHETER<br>DIMENSIONS<br>(nominal) | | | |
| I.D.<br>O.D.<br>Length | 1.9 mm<br>1.0 mm<br>100 cm | 1.9 mm<br>1.0 mm<br>76 cm | 2.3 mm<br>0.8 mm<br>76 cm |
| MATERIALS | | | |
| Portal<br>Septum<br>Catheter | Polysulfone/Titanium<br>Silicone<br>Polyurethane | Polysulfone/Titanium<br>Silicone<br>Polyurethane | Titanium<br>Silicone<br>Silicone |
| CATHETER<br>CONNECTOR | ULTRA-LOCK®<br>Connector | ULTRA-LOCK®<br>Connector | CATH-SHIELD®<br>Connector |

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### V. SUMMARY OF STUDIES

### Functional Testing A.

Functional testing was not performed because the PORT-A-CATH® II Trans-Arterial Percutaneous System is functionally the same as the PORT-A-CATH® II Low Profile™ Venous System.

Biocompatibility testing was conducted on the device.

## B. Clinical Studies

Clinical studies were not deemed necessary regarding the PORT-A-CATH® II Trans-Arterial Percutaneous System due to its similarity in materials, design and function to the current PORT-A-CATH® II Low Profile™ Venous System.

## C. Conclusion Drawn from the Studies

As noted above, no functional testing or clinical studies were deemed necessary regarding the PORT-A-CATH® II Trans-Arterial Percutaneous System. Biocompatibility testing showed that the device materials were biocompatibile. Therefore, the device is considered acceptable for human use.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 1999

Ms. Lisa J. Stone Manager, Requlatory Affairs Smiths Industries Medical Systems SIMS, Deltec 1265 Grey Fox Road St. Paul, Minnesota 55112

K992697 Re :

> PORT-A-CATH® II Trans-Arterial Percutaneous Trade Name: System Unclassified Requlatory Class: Product Code: LJT Dated: October 18, 1999 Received: October 19, 1999

Dear Ms. Stone:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially 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 reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 - Ms. Stone

the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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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K992697 wmo
K442647

510(k) Number (if known):

Device Name: PORT-A-CATH® II Trans-Arterial Percutaneous System

Indications for Use:

" A system is indicated when a patient requires prolonged or repeated intra-arterial infusion. "

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The Counter Use __________

Patric Cucenti