FORMULATION PREPARATION DEVICE

K955398 · B.Braun Medical, Inc. · LHI · Apr 4, 1996 · General Hospital

Device Facts

• Record ID: K955398
• Device Name: FORMULATION PREPARATION DEVICE
• Applicant: B.Braun Medical, Inc.
• Product Code: LHI · General Hospital
• Decision Date: Apr 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Formulation Device is used for preparing and dispensing medications from rubber stoppered vials.

Device Story

Formulation Preparation Device; used for medication preparation and dispensing from rubber-stoppered vials; manual operation; facilitates fluid transfer; used in clinical/hospital settings; ensures safe medication handling; benefits patient by enabling accurate, sterile medication preparation.

Clinical Evidence

Bench testing only. Finished products undergo physical testing and visual examination per established Quality Control Test Procedures and GMP standards prior to release.

Technological Characteristics

Materials tested per Tripartite Guidance for Plastics. Manual fluid transfer device. Form factor designed for rubber-stoppered vial access.

Indications for Use

Indicated for use in clinical settings for the preparation and dispensing of medications from rubber-stoppered vials.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Multi-Ad Fluid Dispensing System (K792227)

Submission Summary (Full Text)

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K955398

K955398

II 510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90

B. Braun Medical, Inc

November 20, 1995

824 Twelfth Avenue

Bethlehem, PA 18018

[phone]

APR - 4 1996

CONTACT: Mark S. Alsberge, Regulatory Affairs Manager

PRODUCT NAME: Formulation Preparation Device

CLASSIFICATION NAME: General Hospital Devices Class II, 80 LHI, I.V. Fluid Transfer Set

SUBSTANTIAL EQUIVALENCE¹ 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 Preparation 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.

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.

SUBSTANTIAL EQUIVALENCE:

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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.