(189 days)
The Celsite™ Port with Preconnected Catheter is an implanted port with a catheter system attached which allows safe , repeated access to the patient's bloodstream. The port chamber and catheter design can be used for the administration of medications and fluids.
The Celsite™ Port with Preconnected Catheter is an implanted port with a catheter system attached which allows safe , repeated access to the patient's bloodstream. The port chamber and catheter design can be used for the administration of medications and fluids.
This 510(k) summary does not contain the information required to populate the requested table and sections regarding acceptance criteria and device performance studies. The document describes a medical device (Celsite™ Port with Preconnected Catheter) and focuses on demonstrating substantial equivalence to a previously cleared device (CELSITE™ Venous Access System, K952548).
Here's why the information is not present:
- Acceptance Criteria and Device Performance: The document does not define specific performance metrics (e.g., accuracy, sensitivity, specificity, throughput) with corresponding acceptance thresholds. Instead, it argues for substantial equivalence based on identical intended use, function, and materials, and a general statement that implanted ports "have demonstrated themselves on the whole to be safe and effective devices."
- Study Details: There are no details of a formal study (clinical trial, standalone performance study, MRMC study) designed to measure the device's performance against predefined acceptance criteria. The "evidence" presented for safety and effectiveness is largely based on the established safety record of similar devices and the manufacturing site's inspection history.
Therefore, I cannot provide a table or address the specific questions from sections 1-9 based on the provided text.
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K96230
DEC 1 6 1996
11 510(k) Summary
B. Braun Medical, Inc 824 Twelfth Avenue Bethlehem, PA 18018 (610) 691-5400
May 30, 1996
CONTACT: Mark S. Alsberge, Regulatory Affairs Manager
PRODUCT NAME: Celsite™ Port wit Preconnected Catheter
TRADE NAME: Celsite™ Implanted Ports & Catheters
CLASSIFICATION NAME: General Hospital Devices Class (III/ 80 LJT Implanted Port & Catheter, Intravascular, Infusion
SUBSTANTIAL EQUIVALENCE, TO:
| 510(k) number | Name | Applicant |
|---|---|---|
| K952548 | CELSITE™ VenousAccess System | B. Braun Medical |
DEVICE DESCRIPTION:
The Celsite™ Port with Preconnected Catheter is an implanted port with a catheter system attached which allows safe , repeated access to the patient's bloodstream. The port chamber and catheter design can be used for the administration of medications and fluids.
MATERIAL:
The Celsite™ Port with Preconnected Catheter is composed of materials that have been tested in accordance with Tripartite Guidance for Plastics and determined to be suitable for the intended use of this product.
The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from a FDA -regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and does
not diminish any patent claims related to this product or the technology used to manufacture the product.
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SUBSTANTIAL EQUIVALENCE:
B.Braun has marketed the CELSITE™ Venous Access System since it's clearance by the FDA in 1995 (K952548). The Celsite™ Port with preconnected catheter has the same intended use and functions in the same manner as the previous celsite™ ports. Connecting the catheter during insertion or having the catheter preconnected is a matter of physician preference and has no impact on the safety or effectiveness of the device.
The implant bodies and catheters of the system are made of materials identical to those available in the original submission.
Currently marketed ports incorporate features and are available from a number of manufacturers. A review of the current literature and MDRs indicate that there are no additional risks or concerns associated with this modification to the port designs.
SAFETY AND EFFECTIVENESS:
The manufacturing site, B.Braun Celsa in France, is scheduled to be inspected by the FDA in early June of this year and has passed its previous inspection in 1995.
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.
§ 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.