EXEL I.V. ADMINISTRATION SET

K963659 · Exel Intl. · FPA · Dec 16, 1997 · General Hospital

Device Facts

• Record ID: K963659
• Device Name: EXEL I.V. ADMINISTRATION SET
• Applicant: Exel Intl.
• Product Code: FPA · General Hospital
• Decision Date: Dec 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

THIS DEVICE IS USED FOR INFUSION OF SOLUTIONS AND MEDICATION INTRAVENOUSLY INTO THE PATIENT.

Device Story

Exel I.V. Administration Set facilitates delivery of intravenous fluids and medications. Device consists of tubing and connectors designed to connect fluid source to patient's venous access site. Operated by clinicians in clinical settings to regulate flow of therapeutic solutions. Provides pathway for fluid administration; supports patient hydration and medication delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

I.V. administration set consisting of medical-grade tubing and connectors. Standard gravity-fed infusion design. Sterilized for single-use application.

Indications for Use

Indicated for intravenous infusion of solutions and medications in patients requiring fluid or drug 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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

DEC 16 1997

Mr. Armand Hamid
Exel International
P.O. Box 3194
Culver City, California 90231-3194

Re: K963659
Trade Name: Exel I.V. Administration Set
Regulatory Class: II
Product Code: FPA
Dated: October 10, 1997
Received: October 28, 1997

Dear Mr. Hamid:

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 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 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

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Page 2 - Mr. Hamid

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product 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 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" (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 yours,

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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K 963659

# Indications For Use

510(k) Number (if known) K963659

Device Name: **EXEL I.V. ADMINISTRATION SET**

Indications For Use:

**THIS DEVICE IS USED FOR INFUSION OF SOLUTIONS AND MEDICATION INTRAVENOUSLY INTO THE PATIENT.**

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia C. C. (Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K963659

Prescription Use ☑ OR Over-The-Counter Use ☐

(Optional Format 1-2-96)