NIPRO DISPOSABLE SOLUTION INFUSION SET

K972493 · Nipro Medical Corp. · FPA · Sep 18, 1997 · General Hospital

Device Facts

• Record ID: K972493
• Device Name: NIPRO DISPOSABLE SOLUTION INFUSION SET
• Applicant: Nipro Medical Corp.
• Product Code: FPA · General Hospital
• Decision Date: Sep 18, 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. They are also intended for use in administering intravenous fluids to a dialysis set in conjunction with hemodialysis.

Device Story

Disposable solution infusion set for intravenous fluid administration; also used for hemodialysis priming. Device consists of PVC tubing, roller clamp, and connectors (male luer lock or cone luer slip, with or without Y-connector/injection site). Operated by clinicians in clinical settings to deliver fluids to patients. Device functions as a passive conduit for fluid flow; no active components or software. Benefits include reliable fluid delivery for hydration or dialysis support.

Clinical Evidence

No clinical data; safety and effectiveness established through historical clinical use and substantial equivalence to legally marketed devices.

Technological Characteristics

Materials: Polyethylene (PE), polyvinylchloride (PVC) with DEHP, polypropylene (PP), acrylonitrile butadiene styrene (ABS). Components: Tubing, roller clamp, luer connectors. Non-vented, non-filtered. Passive fluid administration set.

Indications for Use

Indicated for patients requiring intravenous fluid administration or hemodialysis fluid delivery.

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)
• Medistystems Dialysis Priming Set

Submission Summary (Full Text)

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K97 2493

Image /page/0/Picture/1 description: The image shows the logo for Nipro Medical Corporation. The logo consists of a stylized, intertwined ribbon-like symbol on the left, followed by the word "NIPRO" in bold, sans-serif capital letters. The logo is simple and modern, with a focus on the company name.

PRO MEDICAL CORPORATION 10877 N.W. 33rd Street Miami. Florida 33172 Tel .: [phone] Fax: [phone]

SEP 1 8 1997

## "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:

July 1, 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) and Medistystems Dialysis Priming Set

\$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 nonvented 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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K972493

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. They are also intended for use in administering intravenous fluids to a dialysis set in conjunction with hemodialysis

\$807.92 (a)(6)

Comparison of Technical Characteristics:

The Nipro 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.

The Medisystems Dialysis Priming Set includes similar indications for use in hemodialysis.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Luis Candelario General Manager Nipro Medical Corporation 10877 N.W. 33rd Street Miami. Florida 33172

SFP 18 1997

Re: K972493 Nipro® Disposable Solution Infusion Set Dated: July 2, 1997 Received: July 3, 1997 Regulatory class: II 21 CFR §876.5820/Product code: 78 KOC

Dear Mr. Candelario:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalion assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Pailure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours.

Wiliau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## KY72493

## Indications for Use

510(k) Number (if known): Unknown Device Name: Nipro Disposable Solution Infusion Set

## Indications for Use:

The Solution Infusion Sets are intended to be used for the administration of intravenous fluid solution into the body. They are also intended for use in administering intravenous fluids to a dialysis set in conjunction with hemodialysis.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

Robert R Ratliff
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K972493