(132 days)
The Formulation Device is used for preparing and dispensing medications from rubber stoppered vials.
The Formulation Prepration Device. The Formulation Device is used for preparing and dispensing medications from rubber stoppered vials.
The provided text describes a medical device called the "Formulation Preparation Device" and its substantial equivalence to another device. However, it does not contain the information requested in the prompt regarding acceptance criteria, device performance metrics, study details, or ground truth establishment.
The document is a 510(k) summary for a relatively old device (1995) and focuses on demonstrating substantial equivalence to a predicate device based on materials, form, and intended use. It mentions that "All finished products are tested and must meet all required release specifications before distribution" and refers to "physical testing" and "visual examination," but it does not specify what those specifications or the results of those tests are.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth that you've asked for. The information simply isn't present in the provided text.
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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 FluidDispensing System | National PatentDevelopmentCorporation |
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.
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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.
§ 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.