K Number
K962230
Device Name
CELSITE PORT WITH PRECONNECTED CATHETER
Date Cleared
1996-12-16

(189 days)

Product Code
Regulation Number
880.5965
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
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.
More Information

Not Found

No
The provided text describes a standard implanted port and catheter system for administering medications and fluids. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the physical components and intended use for repeated bloodstream access.

No.
The device is used for administering medications and fluids, which is a supportive rather than a therapeutic function.

No
Explanation: The device is described as an implanted port with a catheter system for administration of medications and fluids, not for diagnosing conditions.

No

The device description clearly states it is an "implanted port with a catheter system attached," which are physical hardware components.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for "safe, repeated access to the patient's bloodstream" for the "administration of medications and fluids." This describes a device used in vivo (within the body) for therapeutic purposes.
  • Device Description: The description reinforces the intended use, describing an "implanted port with a catheter system."
  • Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body).
    • Providing diagnostic information about a patient's condition.
    • Using reagents or assays.

Therefore, the Celsite™ Port with Preconnected Catheter is a medical device used for direct patient treatment, not for in vitro diagnostic testing.

N/A

Intended Use / Indications for Use

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.

Product codes

LJT

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patient's bloodstream

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K952548

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

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) numberNameApplicant
K952548CELSITE™ Venous
Access SystemB. 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.

1

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.