P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM

K992880 · Sims Deltec, Inc. · LJT · Oct 19, 1999 · General Hospital

Device Facts

• Record ID: K992880
• Device Name: P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM
• Applicant: Sims Deltec, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Oct 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A P.A.S. PORT® system is indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

Device Story

P.A.S. PORT® Elite is a subcutaneously implanted venous access system; provides repeated access to vascular system for infusion of medications, parenteral nutrition, blood products, or blood sampling. System consists of a portal housing, silicone septum, and polyurethane catheter. Device implanted subcutaneously by physician; accessed percutaneously via needle through septum. Modifications from previous P.A.S. PORT include altered portal shape, increased septum diameter, and use of acetal and titanium housing materials. Device facilitates long-term venous access, reducing need for repeated venipuncture; benefits patient by providing reliable, repeatable access point for therapy.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including in-vitro functional testing (septum puncture, system leakage, clearance) per FDA guidance and biocompatibility testing of system components.

Technological Characteristics

Portal housing: Acetal and Titanium; Septum: Silicone; Connector: Titanium; Catheter: Polyurethane. Features ULTRA-LOCK® catheter connector. Dimensions: 9.5mm height, 25mm length, 17.2mm width, 9.7mm septum diameter. Catheter: 1.0mm ID, 1.9mm OD, 76cm length. Implantable, non-powered, mechanical device.

Indications for Use

Indicated for patients requiring repeated venous access for injection, infusion therapy, or venous blood sampling.

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

• P.A.S. PORT® Implantable Venous Access System (K875276)
• M.R.I.® Low Profile Implanted Port

Submission Summary (Full Text)

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K99 2880

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

# P.A.S. PORT® Elite Implantable Venous Access System

August 25, 1999

## GENERAL INFORMATION 1.

| 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: | Subcutaneously Implanted Intravascular<br>Infusion Port and Catheter |
| Proprietary Name: | P.A.S. PORT® Elite Implantable Venous<br>Access System |
| Equivalence Device Comparison: | P.A.S. PORT® Implantable Venous Access System<br>(manufactured by SIMS Deltec, Inc.)<br><br>M.R.I.® Low Profile Implanted Port<br>(manufactured by Bard Access Systems) |

### II. DEVICE DESCRIPTION

The P.A.S. PORT® Elite System is similar to the current commercially available P.A.S. PORT System. The systems have the identical outlet tube, catheter connector and catheter.

The P.A.S. PORT® Elite System differs from the current commercially available P.A.S. PORT System as follows: modified portal shape, increased septum diameter, new portal housing material, and a pierceable rear suture hole.

The P.A.S. PORT® Elite System will be made available with a sensor assembly and/or introducer set.

### III. INTENDED USE OF DEVICE

A P.A.S. PORT® system is indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

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# 510(k) Summary of Safety and Effectiveness Page 2 of 3

# IV. DEVICE COMPARISON

| | P.A.S. PORT® Elite<br>Systems | P.A.S. PORT®<br>Systems | M.R.L. Low Profile<br>Implanted Port |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER | SIMS Deltec, Inc. | SIMS Deltec, Inc. | Bard Access Systems |
| 510(K) NUMBER | Subject Device | K875276 | — |
| INDICATION FOR<br>USE | A P.A.S. PORT® system<br>is indicated when patient<br>therapy requires<br>repeated venous access<br>for injection or infusion<br>therapy and/or venous<br>blood sampling. | A system is indicated<br>when patient therapy<br>requires repeated venous<br>access for injection or<br>infusion therapy and/or<br>venous blood sampling. | The M.R.I. Low Profile<br>Implanted Port is indicated<br>for patient therapy requir-ing<br>repeated access to the<br>vascular system in pedia-tric<br>cases or where a small port<br>profile is desired or required.<br>The port system can be used<br>for infusion of medications,<br>parenteral nutrition solution,<br>blood products or imaging<br>solutions and for the<br>withdrawal of blood samples. |
| PORTAL<br>DIMENSIONS<br>(Nominal) | | | |
| Height<br>Length<br>Width<br>Septum Diameter | 9.5 mm<br>25 mm<br>17.2 mm<br>9.7 mm | 10.0 mm<br>26.7 mm<br>16.5 mm<br>6.6 mm | 10.0 mm<br>24.8 mm (diameter)<br>—<br>10.8 mm |
| CATHETER<br>DIMENSIONS<br>(Nominal) | | | |
| I.D.<br>O.D.<br>Length | 1.0 mm<br>1.9 mm<br>76 cm | 1.0 mm<br>1.9 mm<br>76 cm | 1.0 mm<br>—<br>76 cm |
| MATERIALS | | | |
| Portal Housing<br>Septum<br>Connector<br>Catheter | Acetal and Titanium<br>Silicone<br>Titanium<br>Polyurethane | Titanium<br>Silicone<br>Titanium<br>Polyurethane | Acetal<br>Silicone<br>—<br>Silicone |
| CATHETER<br>CONNECTOR | ULTRA-LOCK®<br>Connector | ULTRA-LOCK®<br>Connector | Strain relief connection |

--- Information is unknown.

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

# SUMMARY OF STUDIES V.

#### Functional Testing A.

In-vitro testing was conducted in accordance with the FDA "Guidance on 510(k) Submissions for Implanted Infusion Ports," dated October 1990. The testing included septum puncture, system leakage and clearance testing.

Biocompatibility testing was conducted on system components.

### B. Clinical Studies

Clinical studies were not deemed necessary regarding the P.A.S. PORT® Elite Implantable Venous Access System due to its similarity in materials, design and function to current SIMS Deltec systems and other commercially available systems.

### C. Conclusions Drawn from the Studies

The results of the testing indicated that the P.A.S. PORT® Elite Implantable Venous Access System functions according to specification and the materials used in the system are biocompatible. Therefore, the system is considered acceptable for human use.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 1999

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

Re : K992880

> Trade Name: P.A.S.PORT® Elite Implantable Venous Access System Class: Unclassified Product Code: LJT August 25, 1999 Dated: Received: August 27, 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, Druq, 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbrandinq 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) regulation (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 regulation may result in regulatory 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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,

Kollatrik

Timothy A. Ulatowski

hy A. Ulatowski Timot Diredtor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ K 992880

Device Name: P.A.S. PORT® Elite Implantable Venous Access System

Indications for Use:

"A P.A.S. PORT® system is indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling."

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ OR (Per 21 CFR 801.109) (Division Sign-Off) Division of Dental, Infection C ntrol/

510(k) Number

and General Hospital Devices

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________