(485 days)
The Contrast Media Set is for reducing contrast waste by allowing one bottle of contrast to be used on more than one patient.
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.
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.
{0}------------------------------------------------
K955/79
II 510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90
October 31, 1995
B. Braun Medical, Inc MAR | 2 1997
824 Twelfth Avenue Bethlehem, PA 18018 (610) 691-5400
Regulatory Affairs Manager CONTACT: Mark S. Alsberge,
Contrast Media Set PRODUCT NAME :
Intravascular I.V. Administration Set TRADE NAME :
CLASSIFICATION NAME:
General Hospital Class II, 80 FPA, Intravascular IV Administration Set 21 CFR 880.5440
SUBSTANTIAL EQUIVALENCE, TO:
| 510 (k) number | Name | Applicant |
|---|---|---|
| K915678 | Administration Set | Merit Medical |
| K943181 | Dispensing PinW/One Way Valve | B. Braun of America |
| K903493B | Contrast SavingsDelivery 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.
{1}------------------------------------------------
MATERIAL :
The Contrast Media Set is composed of materials that have Now 150 been tested in accordance with Tripartite Guidance for Plastics and determined to be suitable for the intended use of this product.
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 Method does not claim
Multiple use in Heir Slots.
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.
§ 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.