HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y

K981683 · Venusa , Ltd. · FPA · Jul 28, 1998 · General Hospital

Device Facts

• Record ID: K981683
• Device Name: HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y
• Applicant: Venusa , Ltd.
• Product Code: FPA · General Hospital
• Decision Date: Jul 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Venusa, Ltd. Huber Needle Infusion Set is intended to be used to deliver solutions and drugs into vascular implant ports.

Device Story

The Venusa, Ltd. Huber Needle Infusion Set is a vascular access device used to access implanted ports for drug and solution delivery. The device consists of a 90-degree bent 314 stainless steel Huber point non-coring needle, non-DEHP PVC tubing, an on/off clamp, and a female Luer lock adapter. A winged hub is included to facilitate insertion, securement, and removal. The device is used in clinical settings by healthcare professionals to provide venous access. It functions as a standard infusion set, allowing for the administration of fluids or medications directly into the patient's implanted port system.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: 314 stainless steel (needle), non-DEHP PVC (tubing). Design: 90-degree bent non-coring Huber needle with winged hub and female Luer lock. Sterilization: AAMI guidelines. Packaging: Tyvek/Mylar or Tyvek/polyethylene pouches.

Indications for Use

Indicated for the delivery of solutions and drugs into vascular implant ports. Prescription use only.

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

• Pfizer Strato (K921674)
• Douglas Medical Products (K932638)
• Marquette Medical (K884212)

Submission Summary (Full Text)

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K 98/683

January 18, 1998

To whom it may concern:

This summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

Trade Name - Venusa, Ltd. Huber Needle Infusion Set Common Name -Huber Needle Set, Vascular Access Device Classification Name - Intravascular Administration Set

The Venusa, Ltd. Huber Needle Infusion Set is intended to be used access an implanted port for the purpose of delivering drugs and solutions. The device consists of female Luer lock adapter, Non-DEHP PVC tubing, an onloff clamp, 314 stainless steel Huber point non-coring needle bent to 90 degrees. The device includes a winged hub that surrounds the needle to aid in the insertion, securement, and removal of the device. The components and the processes used to manufacture these Huber needle infusion sets are substantially equivalent to like products currently legally marketed by Pfizer Strato (K921674), Douglas Medical Products (K932638), and Marquette Medical (K884212). Venusa, Ltd. Huber Needle Infusion Sets will be packaged in tyvek\mylar pouches or tyvek and polyethylene form\fillseal container and sterilized per AAMI quidelines.

Based on the fact that the Venusa, Ltd. Huber Needle Infusion Sets utilize similar and equivalent designs, components, manufacturing processes, and have the same intended use as the currently legally marketed products, the Venusa, Ltd. Huber Needle Infusion Sets are safe and effective when used as intended.

Sincerely.

Neil Kulkarni

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 28 1998

Mr. Neil Kulkarni ·Product Development Engineer Venusa Ltd. 31 Butterfield Trail, Suite C El Paso, Texas 79906

K981683 Re : Huber Needle Infusion Set Model Number Trade Name: 20601, Huber Needle Infusion Set w/y-site Model Number 20601y Requlatory Class: II Product Code: FPA Dated: May 8, 1998 Received: May 13, 1998

Dear Mr. Kulkarni:

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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 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 - Mr. Kulkarni

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 The FDA described in your 510(k) premarket notification. 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 requlation (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 requlation 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. Aitken 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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Page

510(k) Number (if known):_

Device Name: Huber Nieedle Infosion Se t

Indications For Use:

The Venusa, Ltd. Huber Needle Infusion Set is intended to be used to deliver solutions and drugs into vascular implant ports.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_

Prescription Use V (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)