V2 INJECTION SITE

K955585 · B.Braun Medical, Inc. · FPA · May 15, 1996 · General Hospital

Device Facts

• Record ID: K955585
• Device Name: V2 INJECTION SITE
• Applicant: B.Braun Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: May 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The V2 Injection Site is designed to provide needle-free access on I.V. and Extension Sets as an alternative to latex injection sites or other needle-free access systems. It may be accessed with standard male luer connectors and requires no special accessory devices.

Device Story

V2 Injection Site; needle-free access port for I.V. and extension sets. Input: standard male luer connectors. Operation: mechanical access port replacing latex sites; requires no special accessories. Output: fluid path connection. Used in clinical settings by healthcare providers. Benefit: needle-free access reduces needlestick risk.

Clinical Evidence

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

Technological Characteristics

Needle-free injection site; materials tested per Tripartite Guidance for Plastics. Compatible with standard male luer connectors.

Indications for Use

Indicated for patients requiring intravenous access via I.V. or extension sets, providing a needle-free alternative to traditional injection sites.

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

• Filtered Extension Sets (K942988)

Submission Summary (Full Text)

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

K955585

B. Braun Medical, Inc November 21, 1995

824 Twelfth Avenue

Bethlehem, PA 18018

[phone]

MAY 15 1996

CONTACT: Mark S. Alsberge, Regulatory Affairs Manager

PRODUCT NAME: V2 Injection Site

TRADE NAME: Intravascular Administration Set

CLASSIFICATION NAME:

General Hospital

Class II, 80 FPA, Intravascular Administration Set

21 CFR 880.5860

SUBSTANTIAL EQUIVALENCE TO:

| 510(k) number | Name | Applicant |
| --- | --- | --- |
| K942988 | Filtered Extension Sets | B. Braun of America |

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 V2 Injection Site. The V2 Injection Site is designed to provide needle-free access on I.V. and Extension Sets as an alternative to latex injection sites or other needle-free access systems. It may be accessed with standard male luer connectors and requires no special accessory devices.

) 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.

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MATERIAL:

The V2 Injection Site 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 V2 Injection Site is equivalent in materials, form, and intended use to Filtered Extension Sets currently marketed by B. Braun of America. There are no new issues of safety or effectiveness raised by the V2 Injection Site.

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.