SOLUTION ADMINISTRATION SET

K981792 · Baxter Healthcare Corp · FPA · Aug 17, 1998 · General Hospital

Device Facts

• Record ID: K981792
• Device Name: SOLUTION ADMINISTRATION SET
• Applicant: Baxter Healthcare Corp
• Product Code: FPA · General Hospital
• Decision Date: Aug 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The solution adminstration set will be used to administer fluids to a patient's vascular system from a container through a needle or catheter inserted into a vein. The proposed solution set will be primarily used to administer solutions containing the chemotherapeutic drug paclitaxel, but can also be used for general solution administration.

Device Story

Solution administration set designed for delivery of intravenous fluids, specifically paclitaxel; features polyethylene-lined tubing and in-line 0.22 µm filter to prevent DEHP leaching from PVC components; used in clinical settings for parenteral drug administration; operated by healthcare professionals; ensures compatibility with paclitaxel requirements; facilitates safe chemotherapy delivery by minimizing plasticizer exposure.

Clinical Evidence

Bench testing only. Functional performance data and paclitaxel compatibility testing provided. Results indicate the device meets or exceeds all functional requirements.

Technological Characteristics

Polyethylene-lined tubing; in-line 0.22 µm filter; PVC components plasticized with TEHTM; modified spike design; no DEHP plasticized PVC in contact with solution. Materials are identical to those in legally marketed devices.

Indications for Use

Indicated for patients requiring intravenous fluid administration, specifically for delivery of paclitaxel or general solutions via needle or catheter into the vascular system.

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

• Nitroglycerin Set Solution Administration Sets with 0.22 Micron Filter (K83284A)

Reference Devices

• Baxter Flo-Gard (6200 and 6300 series)
• Colleague volumetric infusion pumps

Submission Summary (Full Text)

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K981792

510(k) Premarket Notification Solution Administration Set

AUG 1 4 1998

# 510(k) Summary

#### Solution Adminstration Set

## Submitted by:

Mary Ellen Snyder Manager, Regulatory Affairs Baxter Healthcare Corporation I.V. Systems Division Rt. 120 and Wilson Road Round Lake, IL 60073

# Date Prepared:

May 20, 1998

## Proposed Device:

Solution Administration Set

#### Predicate Device:

Nitroglycerin Set Solution Administration Sets with 0.22 Micron Filter

#### Proposed Device Description:

The proposed solution set will be used for the administration of intravenous solutions containing the chemotherapeutic drug paclitaxel. The package insert for paclitaxel recommends that the drug be administered parenterally through a polyethylene-lined set because of the concern with diethyl-2-hexylphthalate (DEHP) leaching from DEHP plasticized polyvinyl chloride (PVC). The proposed set is designed to meet the package insert recommendations in that it contains polyethylene-lined tubing, an in-line 0.22 um filter, and no DEHP plasticized PVC in contact with the solution.

#### Statement of Intended Use

The solution adminstration set will be used to administer fluids to a patient's vascular system from a container through a needle or catheter inserted into a vein. The proposed solution set will be primarily used to administer solutions containing the chemotherapeutic drug paclitaxel, but can also be used for general solution administration.

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# Summary of Technological Characteristics of New Device to Predicate Devices

The product is similar to the currently marketed Baxter nitroglycerin set, cleared under K83284A on December 29, 1983. The principal differences between the proposed solution set and the predicate nitroglycerin set include a modified spike design, addition of a 0.22 µm filter, and use of TEHTM to plasticize the PVC components. There are no new materials involved in the proposed device. All solution contact materials to be used in the proposed set are identical to materials used in legally marketed devices under comparable conditions of use.

# Discussion of Nonclinical Tests and Referenced Studies Reported in Published Literature

Data regarding the functional performance of the proposed solution administration set including its compatibility with paclitaxel have been generated. A description of the functional testing along with test results has been provided. All data indicate that the proposed paclitaxel device meets or exceeds all functional requirements and thus support its suitability for use.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 17 1998

Ms. Mary Ellen Synder Requlatory Affairs Manager Baxter Healthcare Corporation I.V. Systems Division Route 120 and Wilson Road Round Lake, Illinois 60073

Re: K981792 Solution Administration Set Trade Name: Requlatory Class: II Product Code: FPA Dated: May 20, 1998 Received: May 21, 1998

Dear Ms. Synder:

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 legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 II (Special Controls) or 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. ਸਾ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. 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

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Page 2 - Ms. Snyder

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 predicate device results in a classification 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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

S. Dutman for

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure ..........

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K981792

510(k) Premarket Notification Solution Administration Set

## Indication for Use

510(k) Number: Not Available

Device Name: Solution Administration Set

Indication for Use: The solution adminstration set will be used to administer fluids to a patient's vascular system from a container through a needle or catheter inserted into a vein. The proposed solution set will be primarily used to administer solutions containing the chemotherapeutic drug paclitaxel, but can also be used for general solution administration with Baxter Flo-Gard® (6200 and 6300 series) and Colleague" volumetric infusion pumps.

(Division Sign-Off)/3.
Division of Dental, Infection Control,

and General Hospital Devices 14981792 510(k) Number _