LogoFDA 510(k) Search
K Number
K955179
Device Name
CONTRAST MEDIA SET
Manufacturer
B. BRAUN MEDICAL, INC.
Date Cleared
1997-03-12

(485 days)

Product Code
IZI
Regulation Number
892.1600
Type
Traditional
Panel
RA
Reference & Predicate Devices
K915678,K943181
Predicate For
K052252
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Contrast Media Set". This submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving a device meets specific acceptance criteria through a clinical study.

Therefore, the requested information components regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not applicable to the provided document.

The document primarily focuses on:

  • Device Description: A Contrast Media Set designed to reduce contrast waste by allowing one bottle of contrast to be used on multiple patients.
  • Materials: Composed of materials tested according to Tripartite Guidance for Plastics and deemed suitable.
  • Substantial Equivalence: Claiming equivalence in materials, form, and intended use to existing Contrast Management Systems by Merit Medical and NAMIC, and stating no new issues of safety or effectiveness are raised.
  • Safety and Effectiveness (Manufacturing Release): All finished products undergo testing to meet required release specifications, including physical testing and visual examination, as defined by Quality Control Test Procedure documents.

In summary, this 510(k) submission is about regulatory clearance based on substantial equivalence to existing devices, not about demonstrating performance against specific clinical acceptance criteria through a study with patient data and expert adjudication.

§ 892.1600 Angiographic x-ray system.

(a)
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.(b)
Classification. Class II.