(132 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML models. The device description and performance studies focus on physical processes and standard quality control.
No
The device is described as being used for "preparing and dispensing medications from rubber stoppered vials," which is a functional role in medication handling, not a direct therapeutic intervention on a patient.
No
The device is described as "used for preparing and dispensing medications from rubber stoppered vials," which is a functional role for medication handling, not for diagnosing medical conditions.
No
The device description explicitly states it is used for "preparing and dispensing medications from rubber stoppered vials," which implies a physical device handling vials and dispensing medication, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "preparing and dispensing medications from rubber stoppered vials." This describes a process related to drug preparation and administration, not the diagnosis of a disease or condition using in vitro methods (testing samples like blood, urine, or tissue outside the body).
- Device Description: The description reinforces the intended use of preparing and dispensing medications.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring analytes (substances in a sample).
- Providing information for diagnosis, monitoring, or prognosis of a disease.
- Predicate Device: The predicate device (K792227 Multi-Ad Fluid Dispensing System) also appears to be a device for handling fluids, consistent with medication preparation, not an IVD.
Therefore, this device falls under the category of a medical device used for drug preparation and dispensing, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Formulation Device is used for preparing and dispensing medications from rubber stoppered vials.
Product codes
LHI
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 the Formulation Prepration Device. The Formulation Device is used for preparing and dispensing medications from rubber stoppered vials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Not Found
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 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
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
November 20, 1995
II 510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90
B. Braun Medical, Inc
APR - 4 1996
824 Twelfth Avenue Bethlehem, PA 18018 (610) 691-5400
APR - 4 1996
CONTACT: Mark S. Alsberge, Requlatory Affairs Manager
PRODUCT NAME: Formulation Preparation Device
CLASSIFICATION NAME: General Hospital Devices Class II, 80 LHI, I.V. Fluid Transfer Set
SUBSTANTIAL EQUIVALENCE, TO:
| 510 (k) number | Name | Applicant |
|---|---|---|
| K792227 | Multi-Ad Fluid | |
| Dispensing System | National Patent | |
| Development | ||
| Corporation |
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 the Formulation Prepration Device. The Formulation Device is used for preparing and dispensing medications from rubber stoppered vials.
MATERIAL :
The Formulation Preparation Device 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 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, Land 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 cloes not diminish any patent claims related to this product or the technology used to manufacture the product.
1
SUBSTANTIAL EQUIVALENCE:
The Formulation Preparation Device is equivalent in materials, form, and intended use to the Multi-Ad Fluid Dispensing System currently marketed by B. Braun Medical formerly National Patent Development. There are no new issues of safety or effectiveness raised by the Formulation Preparation Device.
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.