INTRAVASCULAR ADMINISTRATION SET

K991932 · The Kipp Group · FPA · Aug 20, 1999 · General Hospital

Device Facts

• Record ID: K991932
• Device Name: INTRAVASCULAR ADMINISTRATION SET
• Applicant: The Kipp Group
• Product Code: FPA · General Hospital
• Decision Date: Aug 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intravascular Administration Set and Extension Set is a device used to serve as a conduit for delivery of I.V. fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. Additional indications for use of this device is to provide multiple secondary sterile injection sites for other infusion fluids. The device may include a drip chamber with a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container, an infusion line filter, a 2 or 3 port manifold or I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a Y-site injection site, a PRN injection site, a Y-site with integral check valve, a Spin-Loc connector and one or more Roller/Slide/Pinch clamps.

Device Story

Intravascular administration set and extension set; serves as conduit for I.V. fluid delivery from container to patient vascular system via needle or catheter. Provides multiple secondary sterile injection sites. Components include drip chamber with hollow spike, infusion line filter, manifold or stopcock, tubing, connectors (including Spin-Loc), Y-sites (with or without check valves), PRN sites, and flow control clamps. Used in clinical settings by healthcare professionals to facilitate fluid therapy. Device connects to I.V. bags or containers to enable controlled fluid administration.

Clinical Evidence

Bench testing only.

Technological Characteristics

Consists of fluid delivery tubing, drip chamber with hollow spike, infusion line filter, manifold/stopcock, Y-site injection sites, PRN sites, Spin-Loc connectors, and flow control clamps (roller/slide/pinch).

Indications for Use

Indicated for the delivery of I.V. fluids from a container to a patient's vascular system via a needle or catheter, and to provide secondary sterile injection sites for infusion fluids.

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 20 1999

Mr. Gary Werschmidt Vice President The Kipp Group 930 Wanamaker Avenue Ontario, California 91761

K991932 Re : Intravascular Administration set Trade Name: Requlatory Class: II Product Code: FPA Dated: June 01, 1999 Received: June 08, 1999

Dear Mr. Werschmidt:

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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP 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 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.

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Page 2 - Mr. Werschmidt

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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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510(k) Number (if known):

510(k) Number (if known): K991932

Device Name: Intravascular Administration Set/Extension Set

Indications for Use:

Intravascular Administration Set and Extension Set is a device used to serve as a conduit for delivery of I.V. fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. Additional indications for use of this device is to provide multiple secondary sterile injection sites for other infusion fluids. The device may include a drip chamber with a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container, an infusion line filter, a 2 or 3 port manifold or I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a Y-site injection site, a PRN injection site, a Y-site with integral check valve, a Spin-Loc connector and one or more Roller/Slide/Pinch clamps.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

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Over-The-Counter Use

(Optional Format 1-2-96)

Patricio Creciente

Division Sian Off Division of T. Cal, Infection Control, and (. Genera tal Devices 516