(485 days)
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No
The summary describes a medical device focused on reducing contrast waste through a physical set of components, with no mention of software, algorithms, or AI/ML terms.
No.
The device is described as a "Contrast Media Set" used for "reducing contrast waste by allowing one bottle of contrast to be used on more than one patient," which suggests it's for administrative or dispensing purposes rather than directly treating a disease or condition.
No
The device is described as a "Contrast Media Set" for "reducing contrast waste by allowing one bottle of contrast to be used on more than one patient." This function is related to the administration of contrast media, not the diagnosis of a condition. Its predicate devices also suggest it's an administration or dispensing system.
No
The device description explicitly states "Contrast Media Set" and describes a physical product ("one bottle of contrast") and its use in a physical process ("used on more than one patient"). The predicate devices are also physical administration and dispensing sets. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reduce contrast waste by allowing one bottle of contrast to be used on multiple patients. This is a device used in the administration of a substance to a patient, not for testing a sample taken from the body to diagnose a condition.
- Device Description: The description reinforces the intended use related to contrast administration.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is related to the delivery of a contrast agent into the body, not the analysis of samples from the body.
N/A
Intended Use / Indications for Use
The Contrast Media Set is for reducing contrast waste by allowing one bottle of contrast to be used on more than one patient.
Product codes
FPA
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 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.
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.