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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 use for the administration of medications and fluids. B. Braun Medical, Inc. intends to introduce into interstate commerce Celsite Pediatric Venous Port.
The provided 510(k) summary for the Celsite® Pediatric Venous Port does not include the type of detailed information requested regarding acceptance criteria and a study proving device performance.
The document focuses on demonstrating substantial equivalence to previously cleared devices (K902401 and K942024) and highlights material safety based on Tripartite Guidance for Plastics. It also mentions that the manufacturing site passed an FDA inspection and generally states that implanted ports "have demonstrated themselves on the whole to be safe and effective devices."
Therefore, I cannot provide the requested information in the structured format because it is not present in the given text.
Specifically, the document lacks:
- A table of acceptance criteria and reported device performance: No specific performance metrics or acceptance thresholds are mentioned.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth type for any study: There is no description of any specific study conducted to establish performance criteria or demonstrate efficacy.
- Training set sample size or how its ground truth was established: No training data is mentioned as no specific study is described.
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K9528435
Image /page/0/Picture/1 description: The image contains a sequence of handwritten characters and numbers. The sequence appears to be 'K952431'. The characters are written in black ink on a white background. The handwriting is somewhat messy and uneven.
ll 510(k) Summary
B. Braun Medical, Inc 824 Twelfth Avenue Bethlehem, PA 18018 (610)691-5400
APR 1 7 1996
May 18, 1995
CONTACT: Mark S. Alsberge, Requlatory 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™ ImplantableDrug Delivery System | Burron Medical Inc.(previous title of B.Braun Medical Inc.) |
| K942024 | PORT-A-CATH LOWPROFILE IMPLANTABLEVENOUS ACCESS | PHARMACIA DELTECINC. |
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 use 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 pediatirc port designs.
SAFETY AND EFFECTIVENESS:
The manufacturing site, B.Braun Celsa LG in France, has passed FDA inspection during this year.
lmplanted 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.
§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.
(a)
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.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.