(329 days)
Not Found
No
The device description is for a physical implantable catheter system and there is no mention of software, algorithms, or any terms related to AI/ML.
No
The device is described as an implanted catheter system for safe, repeated access to a patient's bloodstream and for the administration of medications and fluids. While it facilitates the administration of therapies, it does not itself perform a therapeutic function by treating or curing a disease.
No
The device description states its use is for "administration of medications and fluids," indicating a therapeutic rather than diagnostic function.
No
The device description clearly states it is an "implanted catheter system," which is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is an "implanted catheter system" for "safe, repeated access to the patient's bloodstream" for "administration of medications and fluids." This describes a device used in vivo (within the body) for therapeutic or diagnostic purposes, not in vitro (outside the body) for examining specimens.
- Device Description: The description focuses on the physical components and function of an implanted port and catheter, consistent with an in vivo device.
- Lack of IVD Indicators: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis, which are hallmarks of IVD devices.
Therefore, the CELSITE® Pediatric Venous Port is an implanted medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Not Found
Product codes
LJT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Pediatric
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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™ 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 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.
1
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.