PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A

K974471 · Sims Deltec, Inc. · LJT · Jan 22, 1998 · General Hospital

Device Facts

• Record ID: K974471
• Device Name: PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A
• Applicant: Sims Deltec, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Jan 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PORT-A-CATH® II Dual-Lumen Low Profile™ Systems are indicated when a patient requires repeated venous access for injection (bolus) or infusion therapy and/or venous blood sampling.

Device Story

Subcutaneously implanted vascular access system; provides repeated venous access for infusion therapy or blood sampling. System comprises low-profile dual-lumen portal (titanium/polysulfone housing, silicone septum) and radiopaque polyurethane catheter. Implanted surgically; accessed percutaneously by clinician using access needle. Smaller portal dimensions compared to previous models; dual-lumen design allows simultaneous or separate access to two venous pathways. Benefits include reduced profile for patient comfort while maintaining functionality for repeated therapy delivery or blood withdrawal.

Clinical Evidence

No clinical data. Bench testing only, including in-vitro mechanical testing per 1990 FDA guidance and biocompatibility testing on all components.

Technological Characteristics

Portal housing: Titanium/Polysulfone; Septum: Silicone; Catheter: Polyurethane. Dual-lumen design. Dimensions: 11.0 mm height, 38.7 x 23.5 mm base. Mechanical sensing/actuation via needle access. Non-electronic, passive implantable device.

Indications for Use

Indicated for patients requiring repeated venous access for bolus 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® II Dual-Lumen Systems (SIMS Deltec, Inc.)
• LifePort® Low Profile Dual Lumen System (Strato/Infusaid)

Submission Summary (Full Text)

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS JAN 22 1998
PORT-A-CATH® II Dual-Lumen Low Profile™ Systems
November 25, 1997

I. GENERAL INFORMATION

Applicant's Name and Address: SIMS Deltec, Inc.
1265 Grey Fox Road
St. Paul, MN 55112

Contact Person: Lisa Stone
Manager, Regulatory Affairs
Tel. [phone]

Common/Usual Name: Subcutaneously Implanted Intravascular Infusion Port and Catheter

Proprietary Name: PORT-A-CATH® II Dual-Lumen Low Profile™ Implantable Access Systems

Equivalence Device Comparison: PORT-A-CATH® II Dual-Lumen Implantable Access Systems
(manufactured by SIMS Deltec, Inc.)

LifePort® Low Profile Dual Lumen System
(manufactured by Strato/Infusaid)

II. DEVICE DESCRIPTION

PORT-A-CATH® II Dual-Lumen Low Profile™ Systems are similar in design and function to the current commercially available PORT-A-CATH® II Dual-Lumen Systems.

These systems differ from current commercially available PORT-A-CATH® systems in that the portal is dimensionally smaller and a dual-lumen polyurethane catheter is being offered.

These systems consist of one low profile dual-lumen portal (titanium/polysulfone), one radiopaque catheter (polyurethane), one catheter connector, one access needle, one blunt needle and one vein pick. Introducer sets and a Fluoro-Free™ system will also be made available.

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

## III. INTENDED USE OF DEVICE

The PORT-A-CATH® II Dual-Lumen Low Profile™ Systems are indicated when a patient requires repeated venous access for injection (bolus) or infusion therapy and/or venous blood sampling.

## IV. DEVICE COMPARISON

| | PORT-A-CATH® II Dual-Lumen Low Profile™ Systems | PORT-A-CATH® II Dual-Lumen Systems | LifePort® Low Profile Dual Lumen System |
| --- | --- | --- | --- |
| MANUFACTURER | SIMS Deltec, Inc. | SIMS Deltec, Inc. | Strato/Infusaid Inc. |
| INDICATION FOR USE | A system is indicated when a patient requires repeated venous access for injection (bolus) or infusion therapy and/or venous blood sampling. | A system is indicated when a patient requires repeated venous access for injection (bolus) or infusion therapy and/or venous blood sampling. | The LifePort system is indicated for patient therapy that requires repeated entry to the vascular system for the delivery of medications, fluids, nutritional solutions and blood products or the withdrawal of venous blood samples. |
| PORTAL DIMENSIONS (Nominal) | | | |
| Height | 11.0 mm | 16.0 mm | 10.8 mm |
| Base | 38.7 (L) mm x 23.5 (W) mm | 50.0 (L) mm x 30.0 (W) mm | 40.8 (L) mm x 26.5 (W) mm |
| Septum Diameter | 9.5 mm | 11.4 mm | 10.2 mm |
| MATERIALS | | | |
| Portal Housing | Titanium/Polysulfone | Titanium/Polysulfone | Acetal |
| Septum | Silicone | Silicone | Silicone |
| Catheter | Polyurethane | Silicone | Polyurethane |
| CATHETER DIMENSIONS (Nominal) | | | |
| I.D. | 1.0 mm/1.0 mm or 1.4 mm/1.4 mm | 1.1 mm/1.1 mm | 1.0 mm/1.0mm |
| O.D. | 2.2 mm or 3.2 mm | 3.4 mm | 2.2 mm |
| Length | 76 cm | 76 cm | 76 cm |

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

# V. SUMMARY OF STUDIES

## A. Functional Testing

*In-vitro* mechanical testing was conducted according to the "Guidance on 510(k) Submissions for Implanted Infusion Ports," October 1990.

Biocompatibility testing was conducted on all system components.

## B. Clinical Studies

Clinical studies were not deemed necessary regarding PORT-A-CATH® II Dual-Lumen Low Profile™ Systems due to their similarity in materials, design and function to current SIMS Deltec commercially available systems.

## C. Conclusions Drawn from the Studies

The results of the testing indicated that PORT-A-CATH® II Dual-Lumen Low Profile™ Systems function according to specification and the materials used in the system are biocompatible. Therefore, these systems are considered acceptable for human use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

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

Re: K974471
Trade Name: PORT-A-CATH® II Dual-Lumen Low Profile™ Implantable Access Systems
Regulatory Class: Unclassified
Product Code: LJT
Dated: November 25, 1997
Received: November 26, 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. However, you are responsible to determine that the medical devices you use as components in the PORT-A-CATH® II Dual-Lumen Low Profile™ Implantable Access Systems have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your PORT-A-CATH® II Dual-Lumen Low Profile™ Implantable Access Systems. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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

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Page 2 - Ms. Stone

Federal Regulations, 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, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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 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 the 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 "[e-mail]".

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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510(k) Number (if known): K924471

Device Name: PORT-A-CATH® II Dual-Lumen Low Profile™ Implantable Access Systems

Indications for Use:

"A system is indicated when a patient requires repeated venous 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 K924471

Prescription Use ☑

(Per 21 CFR 801.109)

OR

Over-The Counter Use