MODEL D-290P ADMINISTRATION SET

K964384 · Patient Solutions, Inc. · FPA · Jan 27, 1997 · General Hospital

Device Facts

• Record ID: K964384
• Device Name: MODEL D-290P ADMINISTRATION SET
• Applicant: Patient Solutions, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jan 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Model D-290P Check Valve administration set is targeted for use with those applications where a piggyback infusion is specified. The Model D-290P set is used in conjunction with a commercially available secondary infusion line inserted in the upper Y-Site and with the Invacare Model 1200 pump.

Device Story

Administration set for piggyback IV infusion; utilizes standard medical-grade PVC tubing and non-fluid path pumping cartridge; incorporates check valve to facilitate transition from primary to secondary fluid containers. Used in clinical settings with Invacare Model 1200 pump; operated by healthcare professionals. Device enables automated switching between primary and secondary infusion lines; ensures fluid delivery to patient's vascular system. No changes to pump hardware required.

Clinical Evidence

No clinical data; nonclinical tests deemed unnecessary for substantial equivalence claim. USP Biological Tests compliance certificate provided for check valve component.

Technological Characteristics

Medical-grade PVC tubing; non-fluid path pumping cartridge; integrated check valve. Standard off-the-shelf IV set components. Mechanical fluid delivery system.

Indications for Use

Indicated for patients requiring piggyback infusion therapy via the Invacare Model 1200 pump.

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

• Block Medical, Inc. Model V021014
• IVAC Model 59093

Submission Summary (Full Text)

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INVACARE
JAN 27 1997
K964384

# 510(k) SUMMARY

Submitter's Name: Invacare Infusion Systems

Address: 13220 Evening Creek Dr. So. Suite #114 San Diego, California 92128

Phone: [phone]

Contact: Tom Kane

Date of Summary: November 1, 1996

Name of Device: Model D-290P Administration Set with Check Valve

Legally Marketed Device to Which Substantially Equivalency Is Claimed:

Block Medical, Inc. Model V021014 and IVAC Model 59093 Administration Sets with Check Valve.

## Description of Device:

The Model D-290P is an administration set that incorporates standard, off-the-shelf, I.V. set components (including a check valve), Medical Grade PVC tubing and a non-fluid path pumping cartridge.

## Intended Use:

The Model D-290P Check Valve administration set is targeted for use with those applications where a piggyback infusion is specified. The Model D-290P set is used in conjunction with a commercially available secondary infusion line inserted in the upper Y-Site and with the Invacare Model 1200 pump.

## Technological Characteristics:

The Invacare Infusion Systems, Block Medical, Inc. and IVAC administration sets with check valves have the same general design and incorporate similar technologies, materials, and components.

The primary function of the Invacare, Block and IVAC check valve sets is to administer fluids initially from a primary container until empty and then from a secondary container to a patient's vascular system. The technological characteristics of the devices are the

INVACARE INFUSION SYSTEMS
1000 E. 10th St., Suite #114 San Diego, CA 92128 USA
619-679-3840 1 p.m. 9 6 9 1994

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same and raise no new questions of safety and effectiveness. Invacare concludes that the Model D-290P is substantially equivalent to the Block Model V011014 and IVAC Model 59093 in providing primary and secondary infusion therapy that require the use of administration sets with a check valve.

## Nonclinical Tests and Results

No changes in the Invacare Infusion Systems Model 1200 Infusion Pump were necessary to add the Model D-290 administration set.

Nonclinical tests were deemed not necessary to support the claim of substantial equivalence to the Block Medical and IVAC administration sets.

A certificate of compliance for USP Biological Tests has been furnished by Medex, the check valve supplier, for their check valve that is being used in the Model D-290P administration set.