NIPRO DISPOSABLE SOLUTION INFUSION SET

K970076 · Nipro Medical Corp. · FPA · Mar 27, 1997 · General Hospital

Device Facts

• Record ID: K970076
• Device Name: NIPRO DISPOSABLE SOLUTION INFUSION SET
• Applicant: Nipro Medical Corp.
• Product Code: FPA · General Hospital
• Decision Date: Mar 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Solution Infusion Sets are intended to be used for the administration of intravenous fluid solution into the body.

Device Story

Disposable solution infusion set; facilitates delivery of IV fluids to patient. Components: PVC tubing, roller clamp, male luer lock or cone luer slip connector, optional Y-connector with injection site. Used in clinical settings by healthcare professionals. Device connects fluid source to patient vascular access; flow regulated via roller clamp. Benefits: provides reliable, sterile fluid delivery path.

Clinical Evidence

No clinical data; safety and effectiveness established through historical clinical use and identical design to legally marketed predicate.

Technological Characteristics

Materials: Polyethylene (PE), polyvinylchloride (PVC) with DEHP, polypropylene (PP), acrylonitrile butadiene styrene (ABS). Components: Tubing, roller clamp, luer connectors, Y-connector. Non-vented, non-filtered. Sterilization method not specified.

Indications for Use

Indicated for patients requiring intravenous fluid administration.

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

• I.V. Administration Set, Gainor Medical U.S.A., Inc. (K926448)

Submission Summary (Full Text)

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K970076

MAR 27 1997

NIPRO

NIPRO MEDICAL CORPORATION

10877 N.W. 33rd Street

Miami, Florida 33172

Tel.: [phone]

Fax: [phone]

SUMMARY OF SAFETY AND EFFECTIVENESS FOR NIPRO® DISPOSABLE SOLUTION INFUSION SET

§807.92 (a)(1)

Contact Person: Luis Candelario
General Manager

Address: Nipro Medical Corporation
10877 NW 33rd Street
Miami, Florida 33172
[phone] (telephone)
[phone] (fax)

Date of Summary Preparation: March 19, 1997

§807.92 (a)(2)

Trade Name: Nipro® Disposable Solution Infusion Set

Common Name: Disposable Solution Infusion Set or I.V. Administration Set

Classification Name: Intravascular administration set (21 CFR §880.5440)

§807.92 (a)(3)

Legally Marketed Substantially Equivalent Device: I.V. Administration Set, Gainor Medical U.S.A., Inc. (K926448)

§807.92 (a)(4)

Description of Device: Intravascular administration sets are described in 21 CFR §880.5440. The Disposable Solution Infusion Sets that we intend to market include 4 types of designs. The sets consist of a length of polyvinylchloride tubing with a clamp roller along it and a male luer lock at one end and a non-vented infusion subassembly without filter at the other end. Model number NNC-3L has a male luer-lock conector (without injection site) and NNC-3CL has the male luer-

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lock connector and Y-connector with injection site. Model
NNC-3CS has the cone luer slip and Y-connector with
injection site and NNC-3C has the cone slip connector
(without injection site).

The materials used for the components include
polyethylene (PE), polyvinylchloride (PVC) (contains
DEHP), polypropylene (PP) and acrylonitrile butadiene
styrene (ABS). Cyclohexanone and adhesive bond are used
and are present in trace amounts.

§807.92 (a)(5)

Intended Use:
The Solution Infusion Sets are intended to be used for the
administration of intravenous fluid solution into the body.

§807.92 (a)(6)

Comparison of Technical Characteristics:
The Nissho and Gainor Medical devices are exactly the
same devices, therefore, all technical characteristics are
identical.

As these sets have been marketed for several years, safety
and effectiveness has been established through years of
clinical use. There have not been problems reported during
use of the sets.