CONTRAST MEDIA SET

K955179 · B.Braun Medical, Inc. · IZI · Mar 12, 1997 · Radiology

Device Facts

• Record ID: K955179
• Device Name: CONTRAST MEDIA SET
• Applicant: B.Braun Medical, Inc.
• Product Code: IZI · Radiology
• Decision Date: Mar 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1600
• Device Class: Class 2

Intended Use

The Contrast Media Set is for reducing contrast waste by allowing one bottle of contrast to be used on more than one patient.

Device Story

Contrast Media Set; intravascular administration set; designed to reduce contrast media waste; enables multi-patient use from single contrast bottle; used in clinical settings; operated by healthcare professionals; physical components include tubing and connectors; device facilitates fluid delivery; reduces hospital costs/waste; safety ensured through established quality control testing procedures.

Clinical Evidence

Bench testing only. Finished products undergo physical testing and visual examination per Quality Control Test Procedure documents and GMP standards.

Technological Characteristics

Materials tested per Tripartite Guidance for Plastics. Intravascular administration set form factor. Standard physical testing and visual inspection protocols applied.

Indications for Use

Indicated for use in clinical settings to facilitate the administration of contrast media while reducing waste by enabling the use of a single contrast bottle across multiple patients.

Regulatory Classification

Identification

An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Administration Set (K915678)
• Dispensing Pin W/One Way Valve (K943181)
• Contrast Savings Delivery System (K903493B)

Submission Summary (Full Text)

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K955/79

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

B. Braun Medical, Inc

MAR 12 1997

October 31, 1995

824 Twelfth Avenue
Bethlehem, PA 18018
[phone]

CONTACT: Mark S. Alsberge, Regulatory Affairs Manager

PRODUCT NAME: Contrast Media Set

TRADE NAME: Intravascular I.V. Administration Set

CLASSIFICATION NAME:

General Hospital
Class II, 80 FPA, Intravascular IV Administration Set
21 CFR 880.5440

SUBSTANTIAL EQUIVALENCE¹ TO:

| 510(k) number | Name | Applicant |
| --- | --- | --- |
| K915678 | Administration Set | Merit Medical |
| K943181 | Dispensing Pin
W/One Way Valve | B. Braun of America |
| K903493B | Contrast Savings
Delivery System | NAMIC |

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 Contrast Media Set. The Contrast Media Set is for reducing contrast waste by allowing one bottle of contrast to be used on more than one patient.

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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MATERIAL:

The Contrast Media Set 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.

NON 150

SUBSTANTIAL EQUIVALENCE:

The Contrast Media Set is equivalent in materials, form, and intended use to Contrast Management Systems currently marketed by Merit Medical and NAMIC. There are no new issues of safety or effectiveness raised by the Contrast Media Set.

SAFETY AND EFFECTIVENESS:

Merit Medical doesn't claim
Mulipati use in their 510V's.

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.