CLOSED FLUID COLLECTION SYSTEM

K961147 · B.Braun Medical, Inc. · GBX · May 31, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K961147
• Device Name: CLOSED FLUID COLLECTION SYSTEM
• Applicant: B.Braun Medical, Inc.
• Product Code: GBX · General, Plastic Surgery
• Decision Date: May 31, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Closed Fluid Collection System is used for acute and longterm abscess drainage, pleura drainage, and chest drainage.

Device Story

Closed Fluid Collection System; facilitates drainage of abscesses, pleural space, or chest cavity; device consists of fluid delivery tubing; used in clinical settings for acute or long-term patient management; operates via passive or active drainage collection; healthcare providers manage fluid output to monitor patient status and therapeutic progress; benefits include controlled fluid removal and reduced risk of contamination.

Clinical Evidence

Bench testing only. Finished products undergo physical testing and visual examination per Quality Control Test Procedures and GMP standards to ensure compliance with design specifications.

Technological Characteristics

Fluid delivery tubing; materials tested per Tripartite Guidance for Plastics; device design conforms to established physical testing parameters and release specifications.

Indications for Use

Indicated for patients requiring acute or long-term abscess, pleural, or chest drainage.

Regulatory Classification

Identification

An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

Predicate Devices

• Collection Protection Station (NAMIC)
• Disposal Depot (Merit Medical)

Submission Summary (Full Text)

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K961147
MAY 31 1996

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

B. Braun Medical, Inc
824 Twelfth Avenue
Bethlehem, PA 18018
[phone]

March 19, 1996

CONTACT: Mark S. Alsberge, Regulatory Affairs Manager

PRODUCT NAME: Closed Fluid Collection System

TRADE NAME: Fluid Delivery Tubing

CLASSIFICATION NAME:

General Hospital
Class II, 80 FPK, Fluid Delivery Tubing
21 CFR 880.5440

SUBSTANTIAL EQUIVALENCE¹ TO:

| 510(k) number | Name | Applicant |
| --- | --- | --- |
| | Collection Protection Station | NAMIC |
| | Disposal Depot | Merit Medical |

DEVICE DESCRIPTION:

In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce Closed Fluid Collection System. The Closed Fluid Collection System is used for acute and longterm abscess drainage, pleura drainage, and chest drainage.

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.

MATERIAL:

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The Closed Fluid Collection System 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.

## SUBSTANTIAL EQUIVALENCE:

The Closed Fluid Collection System is equivalent in materials, form, and intended use to Closed Fluid Collection Systems currently marketed by Merit Medical and NAMIC. There are no new issues of safety or effectiveness raised by the Closed Fluid Collection System.

## 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 GMP's.