K952435 · B.Braun Medical, Inc. · LJT · Apr 17, 1996 · General Hospital
Device Facts
Record ID
K952435
Device Name
CELSITE PEDIATRIC VENOUS SYSTEM
Applicant
B.Braun Medical, Inc.
Product Code
LJT · General Hospital
Decision Date
Apr 17, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 880.5965
Device Class
Class 2
Attributes
Therapeutic, Pediatric
Indications for Use
The CELSITE® Pediatric Venous Port is a implanted catheter system which allows safe, repeated access to the patient’s bloodstream. The chamber and catheter design can be used for the administration of medications and fluids.
Device Story
Implantable venous access system; consists of port chamber and catheter. Used for repeated administration of medications and fluids into patient bloodstream. Intended for pediatric population. Device implanted surgically; allows clinician access via percutaneous needle puncture of port septum. Facilitates long-term therapy; reduces need for repeated venipuncture. Design similar to existing adult ports but scaled for pediatric use.
Clinical Evidence
No clinical data provided. Safety and effectiveness supported by established clinical history of implanted ports, literature review, and MDR analysis indicating low risk profile relative to high implantation volume.
Technological Characteristics
Implantable port and catheter system. Materials tested per Tripartite Guidance for Plastics. Design features a chamber and catheter for intravascular infusion. Sterilization method not specified.
Indications for Use
Indicated for pediatric patients requiring safe, repeated access to the bloodstream for the administration of medications and fluids.
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
CELSITE™ Implantable Drug Delivery System (K902401)
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K952435
K952435
II 510(k) Summary
B. Braun Medical, Inc
824 Twelfth Avenue
Bethlehem, PA 18018
(610)691-5400
APR 17 1996
May 18, 1995
CONTACT: Mark S. Alsberge, Regulatory Affairs Associate
PRODUCT NAME: Celsite® Pediatric Venous Port
TRADE NAME: Celsite® Pediatric Venous Port
CLASSIFICATION NAME: General Hospital Devices
Class III, 80 LJT,
Implanted Port & Catheter,
Intravascular, Infusion
SUBSTANTIAL EQUIVALENCE¹ TO:
| 510(k) number | Name | Applicant |
| --- | --- | --- |
| K902401 | CELSITE™ Implantable Drug Delivery System | Burron Medical Inc. (previous title of B. Braun Medical Inc.) |
| K942024 | PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS | PHARMACIA DELTEC INC. |
DEVICE DESCRIPTION:
The CELSITE® Pediatric Venous Port is a implanted catheter system which allows safe, repeated access to the patient’s bloodstream. The chamber and catheter design can be used for the administration of medications and fluids. B. Braun Medical, Inc. intends to introduce into interstate commerce Celsite® Pediatric Venous Port.
¹ The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. Such a determination is not intended to be applicable to patent infringement suits or any other patent matter related to this product or the technology used to manufacture the product.
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# MATERIAL:
The CELSITE® Pediatric Venous Port is composed of materials have been tested in accordance with Tripartite Guidance for Plastics and determined to be suitable for the intended use of this product.
# SUBSTANTIAL EQUIVALENCE:
B.Braun has marketed the single port CELSITE® since it's clearance by the FDA in 1991 (K902401). This device has the same materials and is similar in design to the previously cleared CELSITE® port.
The modification to the design is the size of the port. The ports cited as substantially equivalent to the other manufacturers pediatric port design. A review of the current literature and MDRs indicate that there are no additional risks or concerns associated with pediatric port designs.
# SAFETY AND EFFECTIVENESS:
The manufacturing site, B.Braun Celsa LG in France, has passed FDA inspection during this year.
Implanted ports for intravascular access have become quite common with tens of thousands implanted yearly. Considering the number of ports implanted yearly verses the number of MDRs, implanted ports have demonstrated themselves on the whole to be safe and effective devices.
