KIPP MED I.V. MANIFOLD

K970255 · The Kipp Group · FPA · Apr 14, 1997 · General Hospital

Device Facts

• Record ID: K970255
• Device Name: KIPP MED I.V. MANIFOLD
• Applicant: The Kipp Group
• Product Code: FPA · General Hospital
• Decision Date: Apr 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Indications for Use

This device is intended to be used as a conduit for the delivery of I.V. fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. Additionally, this device is intended to serve as an injection site for other infusion fluids. This device is intended to be used only by trained professionals in a clinical or hospital environment.

Device Story

KippMed I.V. Manifold; multi-port connector with female luer-lock adapter; three normally closed backcheck valves; connection adapter with free-spinning hub/luer lock. Used as conduit for IV fluid delivery from container to patient vascular system; serves as injection site for additional fluids. Used in clinical/hospital settings by trained professionals. Sterile, nonpyrogenic device.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 and FDA G95-1. Sterilization validated to SAL 10^-6 via Gamma radiation.

Technological Characteristics

Multi-port connector; three normally closed backcheck valves; female luer-lock adapter; free-spinning hub/luer lock inlet. Sterile, nonpyrogenic. Sterilization: Gamma radiation (SAL 10^-6). Biocompatibility: ISO 10993 compliant.

Indications for Use

Indicated for use in clinical or hospital environments by trained professionals for the delivery of IV fluids and as an injection site for infusion fluids in patients requiring intravenous therapy.

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

• Safesite - Anesthesia Tripple Valve Manifold; #AET-3000 (K942391)

Submission Summary (Full Text)

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K970255

# PREMARKET NOTIFICATION SUMMARY

APR 14 1997

| Classification Name: | Set, Administration, Intravascular |
| --- | --- |
| Common Name: | I.V. Manifold |
| Trade Name: | KippMed I.V. Manifold |
| Predicate Device: | |

The predicate device is marketed B. Braun Medical Inc. and is named the Safesite - Anesthesia Tripple Valve Manifold; #AET-3000; 510(k) K942391.

## Device Description:

The KippMed I.V. Manifold is substantially equivalent to the Braun Safesite Manifold. Minor differences in design specifications have been listed in Table One. Both devices are intended to provide connections to an I.V. Administration Set. Both devices provide a multi-port connector with a female leur-lock adapter, three normally closed backcheck valves and a connection adapter. The inlet connection adapter for both devices includes a free-spinning hub/leur lock to connect to I.V. lines. Both devices are sterile and nonpyrogenic.

## Intended Use:

This device is intended to be used as a conduit for the delivery of I.V. fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. Additionally, this device is intended to serve as an injection site for other infusion fluids. This device is intended to be used only by trained professionals in a clinical or hospital environment.

## Comparison of Technical Characteristics to Predicate Device(s):

Table 1, included on the last page of this summary, provides a comparison of the technological characteristics of the KippMed device to the Braun Safesite.

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## Sterilization:

The KippMed manifold is sterilized by Gamma radiation. The sterilization process has been validated to provide a SAL of $10^{-6}$.

## Biocompatibility:

Biocompatibility for the components used in the KippMed device have been tested in accordance with ISO 10993 and FDA General Program Memorandum G95-1. Tested components were subjected to the maximum number of sterilization cycles specified in the Device Master Record. All tested components were biocompatible.

## Reviewed and Approved By (Contact Person):


Tim Truitt
R&D Manager
The KippGroup
909 Wanamaker
Ontario, CA 91761
[phone] FAX: [phone]