PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS

K973862 · Sims Deltec, Inc. · LJT · Dec 29, 1997 · General Hospital

Device Facts

• Record ID: K973862
• Device Name: PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS
• Applicant: Sims Deltec, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Dec 29, 1997
• 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 repeated vascular access for injection (bolus) or infusion therapy and/or venous blood sampling.

Device Story

Implantable access system consisting of a portal and catheter; provides repeated vascular access for infusion therapy or blood sampling. Device implanted subcutaneously; allows clinician access via needle puncture through a septum. Enables delivery of medications, fluids, or blood products and withdrawal of blood samples. Modified to support peripheral placement in large or obese patients. No changes to design or function compared to existing systems; no new clinical or functional testing required.

Clinical Evidence

No clinical data or functional testing performed; device is identical in design and function to predicate devices.

Technological Characteristics

Implantable vascular access port and catheter system. Portal dimensions: 11.5 mm height, 25.0 mm length, 25.0 mm width, 9.5 mm septum diameter. Materials and design are identical to existing commercially available PORT-A-CATH® systems.

Indications for Use

Indicated for patients requiring repeated vascular access for bolus injection, infusion therapy, or venous blood sampling. Includes peripheral placement in large or obese patients.

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® P.A.S. PORT® II Implantable Access System
• BardPort™ SlimPort™ Low Profile Port

Submission Summary (Full Text)

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# 19973862

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

DEC 2 9 1997

## PORT-A-CATH® Low-Profile™ Implantable Access Systems

October 6, 1997

#### 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<br>Tel. [phone] |
| Common/Usual Name: | Subcutaneously Implanted Intravascular<br>Infusion Port and Catheter |
| Proprietary Name: | PORT-A-CATH® Low-Profile™<br>Implantable Access Systems |
| Equivalence Device Comparison: | PORT-A-CATH® P.A.S. PORT® II<br>Implantable Access System<br>(manufactured by SIMS Deltec, Inc.)<br><br>BardPort™ SlimPort™ Low Profile Port<br>(manufactured by Bard Access Systems) |

#### II. DEVICE DESCRIPTION

The modified PORT-A-CATH® Low-Profile™ Systems are exactly the same in design and function as the current commercially available systems. No change to the product has been made.

#### INTENDED USE OF DEVICE III.

The indications for this device will not change [i.e. A system is indicated when a patient requires repeated vascular access for injection (bolus) or infusion therapy and/or venous blood sampling]. However, the intended use of the device will be modified to include peripheral placement of the device in large or obese patients.

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#### IV. DEVICE COMPARISON

| | PORT-A-CATH®<br>Low-Profile™<br>Systems | PORT-A-CATH®<br>P.A.S. PORT® II<br>Systems | BardPort™<br>SlimPort™ Low<br>Profile Port |
|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER | SIMS Deltec, Inc. | SIMS Deltec, Inc. | Bard Access Systems |
| INDICATIONS FOR USE | A system is indicated when a<br>patient requires repeated<br>vascular access for injection<br>(bolus) or infusion therapy<br>and/or venous blood<br>sampling. | Because of its low profile,<br>the P.A.S. PORT system is<br>intended for peripheral<br>placement in the arm. The<br>portal can be implanted in<br>the upper arm above the<br>antecubital space below the<br>axilla, or below the ante-<br>cubital space in the upper<br>part of the forearm. A<br>system is indicated when<br>patient therapy requires<br>repeated venous access for<br>injection or infusion therapy<br>and/or venous blood<br>sampling. | The BardPort Implanted<br>Ports are indicated for<br>patient therapies requiring<br>repeated access to the<br>vascular system. The port<br>system can be used for<br>infusion of medications,<br>I. V. fluids, parenteral<br>nutrition solutions, blood<br>products and for the<br>withdrawal of blood<br>samples. |
| INTENDED USE | - Chest placement<br>- Arm placement | - Arm placement | - Chest placement<br>- Arm placement |
| PORTAL DIMENSIONS<br>(Nominal)<br>Height<br>Length<br>Width<br>Septum Diameter | 11.5 mm<br>25.0 mm<br>25.0 mm<br>9.5 mm | 8.9 mm<br>23.9 mm<br>16.5 mm<br>9.7 mm | 9.8 mm<br>24.7 mm<br>19.0 mm<br>9.0 mm |

#### SUMMARY OF STUDIES V.

#### Functional Testing A.

Functional testing was not deemed necessary, since no changes were made to the product.

#### Clinical Studies B.

Clinical studies were not deemed necessary regarding the PORT-A-CATH® Low-Profile™ Implantable Access Systems due to their similarity in materials, design and function to current commercially available product (i.e. PORT-A-CATH® P.A.S. PORT® II Implantable Access System and BardPort™ SlimPort™ Low Profile Port).

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#### Conclusion Drawn from the Studies C.

As noted above, no functional testing or clinical studies were deemed necessary regarding the PORT-A-CATH® Low-Profile™ Implantable Access Systems.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 29 1997

Ms. Lisa Stone Manager Requlatory Affairs Sims Deltec, Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112

K973862 Re : Port-A-Cath Low Profile Implantable Access Trade Name: Systems Requlatory Class: Unclassified Product Code: LTS October 6, 1997 Dated: Received: October 9, 1997

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 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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obliqation you might have under sections 531

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Page 2 - Ms. Stone

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketinq your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 Other qeneral 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.qov/cdrh/dsmamain.html".

Sincerely yours,

Us. Childrust

Timothy A. Ulatowski Directbr 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: PORT-A-CATH® Low-Profile™ Implantable Access Systems

Indications for Use:

"A system is indicated when a patient requires repeated vascular access for injection (bolus) 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)


| (Division Sign-Off) | |
|---------------------------------------------------------------------|---------|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K973862 |

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