CELSITE IMPLANTABLE PORT WITH VALVED CATHETER

K993024 · B. Braun of America, Inc. · LJT · Mar 13, 2000 · General Hospital

Device Facts

• Record ID: K993024
• Device Name: CELSITE IMPLANTABLE PORT WITH VALVED CATHETER
• Applicant: B. Braun of America, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Mar 13, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5965
• Device Class: Class 2

Intended Use

The Celsite® Implantable Port with Valved Catheter is used intravenously over a long period of time for the administration of drugs for chemotherapy, anti-biotics, anti-viral drugs, and for parenteral nutrition. They are also used for blood transfusions or blood sampling in small quantities.

Device Story

The Celsite® Implantable Port with Valved Catheter is an intravascular access device designed for long-term administration of medications and parenteral nutrition, as well as blood sampling and transfusions. The system consists of an implantable port and a valved catheter. It is intended for use by healthcare professionals in clinical settings. The device functions as a conduit for fluid delivery into the venous system. By providing a secure, long-term access point, it facilitates repeated therapeutic interventions, reducing the need for frequent venipuncture and potentially improving patient comfort and treatment adherence. The device is implanted surgically; the healthcare provider accesses the port percutaneously to deliver therapy or withdraw blood samples.

Clinical Evidence

Bench testing only. The device underwent physical testing and visual examination in accordance with established Quality Control Test Procedures and cGMP requirements to ensure it meets release specifications. Materials were tested for biocompatibility per ISO 10993-1.

Technological Characteristics

Implantable port and valved catheter system. Materials tested per ISO 10993-1. Mechanical device for venous access. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients requiring long-term intravenous access for chemotherapy, antibiotics, anti-viral medications, parenteral nutrition, blood transfusions, or blood sampling.

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 Venous Access System (K952548)

Submission Summary (Full Text)

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993024

September 7, 1999

#### II 510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90

B. Braun Medical, Inc 901 Marcon Boulevard Allentown, PA 18103 [phone] ext. 2261

Contact: Mark S. Alsberge, Regulatory Affairs Director Product Name: Celsite® Implantable Port with Valved Catheter Trade Name: Catheter, Intravascular, Long Term

Unclassified, LJT

# SUBSTANTIAL EQUIVALENCE1 TO:

| 510(k) number | Name | Applicant |
|---------------|------------------------------|------------------------|
| K952548 | Celsite Venous Access System | B. Braun Medical, Inc. |

## Device Description:

Classification name:

In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce the Celsite® Implantable Port with is used intravenously over a long period of time for the administration of drugs for chemotherapy, anti-biotics, anti-viral drugs, and for parenteral nutrition. They are also used for blood transfusions or blood sampling in small quantities.

### Material:

The Celsite® Implantable Port with Valved Catheter is composed of materials that have been tested in accordance with the ISO Standard 10993-1 and have been determined to be suitable for the intended use of this product.

¹ The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an 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:

The Celsite® Implantable Port with Valved Catheter is similar in materials, form and intended use to the Celsite® Venous Access System, K952548 cleared by B. Braun Medical Inc. formally known as Burron Medical. We have not made any modifications to the port or the port connector. This submission is to introduce a new valved catheter that may be offered as an option to the predicate catheter in K952548. There are no new issues of safety or effectiveness raised by the Celsite® Implantable Port with Valved Catheter.

### Safety And Effectiveness:

All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product).

The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications.

The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control cGMP"s.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 2000

Mr. Mark S. Alsberge Requlatory Affairs Director B. Braun Medical, Inc. 901 Marcon Boulevard Allentown, Pennsylvania 18103

Re : K993024 Celsite® Implantable Port with Valved Trade Name: Catheter Unclassified Regulatory Class: Product Code: LJT Dated: January 26, 2000 Received: January 27, 2000

Dear Mr. Alsberge:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 – Mr. Alsberge

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fdap.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ K9G302 4 Device Name: Celsife Implantable Port with Valved Catheter

### Indications For Use:

ling period of time the Over a Used intravenously for chemother apy , anti-biotics ; drugs of administration for parenter at nutrition. I hey anti - Viral gruys, and transfusions or blood sampline also used for olood quanti ties Small

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE

Viola Holland for Pat Cucerti

(Division Sign-Off) Division of Dental, Infection Contr and General Hospital Devi 99302 510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)