PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM

K994216 · Sims Deltec, Inc. · LJT · Jan 27, 2000 · General Hospital

Device Facts

• Record ID: K994216
• Device Name: PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM
• Applicant: Sims Deltec, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Jan 27, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A Plastic Port System is indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

Device Story

Implantable venous access system consisting of plastic portal (standard or low-profile), silicone or polyurethane catheter, and access needles. Device provides subcutaneous access to vascular system for infusion of medications, fluids, parenteral nutrition, blood products, or blood withdrawal. Used in clinical settings by healthcare professionals. Portal housing made of acetal; septum made of silicone. System functions as a reservoir for repeated needle punctures to access the venous circulation. Benefits include reduced trauma from repeated venipuncture and reliable long-term venous access.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including in-vitro functional testing (catheter-to-port connection, septum puncture, system leakage, clearance) and biocompatibility testing in accordance with FDA guidance.

Technological Characteristics

Portal housing: Acetal. Septum: Silicone. Connector: Polypropylene/Acetal or Silicone. Catheter: Silicone or Polyurethane. Dimensions: Standard (14.0mm height, 30.5mm base) or Low Profile (10.0mm height, 25.0mm base). Connectivity: None. Energy source: None (mechanical). Sterilization: Not specified.

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

• PORT-A-CATH® Implantable Venous Access Systems (K830730B, K875276, K932840, K942024)
• M.R.I.® Implanted Ports (Unknown)

Submission Summary (Full Text)

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# 'JAN 2 7 2000

K994216

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## Plastic Port Implantable Venous Access Systems

### December 14, 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: | Subcutaneously Implanted Intravascular Infusion<br>Port and Catheter |
| Proprietary Name: | Plastic Port Implantable Venous Access System |
| Equivalence Device Comparison: | PORT-A-CATH® Implantable Venous Access<br>Systems<br>(manufactured by SIMS Deltec, Inc.)<br><br>M.R.I.® Implanted Ports<br>(manufactured by Bard Access Systems) |

### IL DEVICE DESCRIPTION

Plastic Port Implantable Venous Access Systems consist of a plastic portal (standard or Low Profile™ size), silicone or polyurethane catheter connector, PORT-A-CATH® access needle, blunt needle, and vein pick. The systems will be made available with and without introducer sets.

### III. INTENDED USE OF DEVICE

A Plastic 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 4

| | Plastic Port Systems | PORT-A-CATH®<br>Systems | M.R.I.® Implanted<br>Port |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER | SIMS Deltec, Inc. | SIMS Deltec, Inc. | Bard Access System |
| 510(K) NUMBER | Subject Device | K830730B<br>K875276<br>K932840<br>K942024 | Unknown |
| INDICATION FOR USE | 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. | 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 BardPort Implanted<br>Ports are indicated for<br>patient therapies<br>requiring repeated access<br>to the vascular system.<br>The port system can be<br>used for infusion of<br>medications, I.V. fluids,<br>parenteral nutrition<br>solutions, blood products<br>and for the withdrawal of<br>blood samples. |
| PORTAL AND<br>CONNECTOR<br>MATERIALS | | | |
| Housing | Acetal | Polysulfone/Titanium or<br>Titanium | Acetal |
| Septum | Silicone | Silicone | Silicone |
| Connector | Polypropylene/Acetal or<br>Silicone | Polypropylene/Titanium<br>or Titanium | Unknown |
| PORTAL DIMENSIONS<br>- STANDARD SIZE<br>(Nominal) | | | |
| Height<br>Portal Base<br>Septum Diameter | 14.0 mm<br>30.5 mm<br>12.7 mm | 14.7 mm<br>30.5 mm<br>11.4 mm | 13.5 mm<br>32.0 mm<br>12.7 mm |
| PORTAL DIMENSIONS<br>- LOW PROFILE SIZE<br>(Nominal) | | | |
| Height<br>Portal Base<br>Septum Diameter | 10.0 mm<br>25.0 mm<br>10.5 mm | 11.5 mm<br>25.0 mm<br>9.5 mm | 10.0 mm<br>24.8 mm<br>10.8 mm |
| | Plastic Port Systems | PORT-A-CATH®<br>Systems | M.R.I.® Implanted<br>Port |
| CATHETER<br>MATERIAL AND<br>DIMENSIONS<br>(Nominal) | | | |
| SILICONE<br>I.D.<br>O.D.<br>Length | 1.0 mm<br>2.8 mm<br>76 cm | 1.0 mm<br>2.8 mm<br>76 cm | 1.0 mm<br>Unknown<br>76 cm |
| POLYURETHANE<br>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 | n/a1<br>n/a<br>n/a |
| I.D.<br>O.D.<br>Length | 1.6 mm<br>2.6 mm<br>76 cm | 1.6 mm<br>2.6 mm<br>76 cm | n/a<br>n/a<br>n/a |
| CATHETER<br>CONNECTOR | SLIDE-LOCK® or<br>CATH-SHIELD®<br>Connector | CATH-SHIELD® or<br>ULTRA-LOCK®<br>Connector | Strain relief connection |

### IV. DEVICE COMPARISON

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

### III. SUMMARY OF STUDIES

#### A. Functional Testing

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 catheter to port connection, septum puncture, system leakage and clearance testing.

Biocompatibility testing was conducted on system components.

### Clinical Studies B.

Clinical studies were not deemed necessary regarding Plastic Port Implantable Venous Access Systems due to their similarity in materials, design and function to current SIMS Deltec systems and other commercially available systems.

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### C. Conclusions Drawn from the Studies

The results of the testing indicated that the Plastic Port Implantable Venous Access Systems function 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 stylized eagle with three curved lines representing its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 7 2000

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

Re : K994216 Deltec Plastic Port Implantable Venous Trade Name: Access System Requlatory Class: Unclassified Product Code: LJT December 14, 1999 Dated: Received: December 15, 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 Regulations, Title 21, Parts 800 to 895. ਬ 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Ms. Stone

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 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

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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510(k) Number (if known):

Device Name: Plastic Port Implantable Venous Access Systems

Indications for Use:

" A 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 (Per 21 CFR 801.109)

OR

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

Patricio Guereida

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 1: 0(k) Number_K 99 4-210