← Product Code [LHI](/productcode/LHI) · K970359

# COMBIPROT EMERGENCY ENFUSION DEVICE (K970359)

_B.Braun Medical, Inc. · LHI · Mar 18, 1997 · General Hospital · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K970359

## Device Facts

- **Applicant:** B.Braun Medical, Inc.
- **Product Code:** [LHI](/productcode/LHI.md)
- **Decision Date:** Mar 18, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5440
- **Device Class:** Class 2
- **Review Panel:** General Hospital
- **Attributes:** Therapeutic

## Indications for Use

The CombiPort Emergency Infusion Device is equivalent to an IV set and is utilized to transfer fluids from a container to a patient’s intravascular access catheter. The device offers the capability of high flow rates which may be desirable in emergency trauma treatment.

## Device Story

Device functions as IV fluid transfer set; facilitates fluid delivery from container to patient intravascular access catheter; enables high flow rates for emergency trauma treatment; operated by clinicians in hospital settings; provides physical conduit for fluid administration; benefits patients by ensuring rapid fluid resuscitation.

## Clinical Evidence

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

## Technological Characteristics

Materials tested per ISO 10993. Device functions as a fluid transfer conduit. No electronic, software, or energy-based components.

## Regulatory 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

- IV Fluid Transfer Pin ([K925401](/device/K925401.md))

## Submission Summary (Full Text)

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K970359

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

B. Braun Medical, Inc
824 Twelfth Avenue
Bethlehem, PA 18018
(610)691-5400

January 27, 1997

MAR 18 1997

Contact: Mark S. Alsberge, Regulatory Affairs Manager

Product Name: CombiPort Emergency Infusion Device

Trade Name: I.V. Fluid Transfer Set

Classification name:

Hospital
Class II, 80LHI
21 CFR 880.5440

SUBSTANTIAL EQUIVALENCE¹ TO:

|  510(k) number | Name | Applicant  |
| --- | --- | --- |
|  K925401 | IV Fluid Transfer Pin | B. Braun Medical Inc.  |

## 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 CombiPort Emergency Infusion Device. This device is equivalent to an IV set and is utilized to transfer fluids from a container to a patient’s intravascular access catheter. The device offers the capability of high flow rates which may be desirable in emergency trauma treatment.

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

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applicable to and does not diminish any patent claims related to this product or the technology used to manufacture the product.

## Material:

The CombiPort Emergency Infusion Device is composed of materials that have been tested in accordance with the ISO Standard 10993 and have been determined to be suitable for the intended use of this product.

## Substantial equivalence:

The CombiPort Emergency Infusion Device is similar in materials, form, and intended use to I.V. Fluid Transfer Pin cleared by B. Braun Medical Inc. There are no new issues of safety or effectiveness raised by The Emergency Infusion 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.

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**Source:** [https://fda-staging.innolitics.com/device/K970359](https://fda-staging.innolitics.com/device/K970359)

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