VENUSA, LTD. EXTENSION SET WITH FILTER

K994429 · Venusa , Ltd. · FPA · Mar 3, 2000 · General Hospital

Device Facts

• Record ID: K994429
• Device Name: VENUSA, LTD. EXTENSION SET WITH FILTER
• Applicant: Venusa , Ltd.
• Product Code: FPA · General Hospital
• Decision Date: Mar 3, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Venusa, Ltd. Extension Set with Filter is intended to be used with an indwelling catheter for the purpose of delivering drugs and solutions. The filter assures that particulate matter greater than .2 micron is removed from the solution and insures that air is not infused.

Device Story

Extension set for IV fluid/drug delivery; connects to indwelling IV catheter. Components include female Luer lock, TOTM (non-DEHP) plasticized PVC tubing, 0.22 micron air-eliminating filter, on/off clamp, and male Luer lock adapter. Filter removes particulates >0.2 micron and prevents air infusion. Used in clinical settings by healthcare providers. Device configuration excludes Y-injection site. Sterilized via AAMI guidelines; packaged in Tyvek/Mylar pouches.

Clinical Evidence

Bench testing only. Data provided by filter manufacturer (Millipore) includes: Reverse Pressure Filter Integrity, Unit Venting, Gravity Flow, Inlet Axial Stress, Forward Pressure Filter Integrity, Downstream Particle Count, Accelerated Endurance, Bioburden Evaluation, Inline Filter Wettability, Burst Strength, and MVI Resistance.

Technological Characteristics

TOTM (non-DEHP) plasticized PVC tubing; 0.22 micron air-eliminating filter (Millipore); female/male Luer lock connectors; on/off clamp. Sterilization per AAMI guidelines. No software or electronic components.

Indications for Use

Indicated for IV fluid administration in patients requiring delivery of drugs and solutions via indwelling IV catheter, where 0.2 micron filtration is desired to remove particulate matter and prevent air infusion.

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

• Abbott Laboratories (K960466)
• Baxter Healthcare (K964850)

Submission Summary (Full Text)

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K994429

MAR - 3 2000

Image /page/0/Picture/2 description: The image shows the logo for VENUS A LTD MEDICAL INDUSTRIES. The text is in bold, black letters. There are two pill-shaped objects behind the text.

December 27, 1999

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., Extension Set with Filter Common Name - Extension Set with .2 micron Air Eliminating Filter Classification Name - Intravascular Administration Set

The Venusa, Ltd. Extension Set with filter is intended to be used with an indwelling catheter for the purpose of delivering drugs and solutions. The filter assures that particulate matter greater than .2 micron is removed from the solution and insures that air is not infused. The device consists of female Luer lock, TOTM (non-DEHP) plasticised PVC tubing, a Millipore 0.22 micron air eliminating filter, an on\off clamp, and a male Luer lock adapter. The components and the processes used to manufacture these solution sets with filter are substantially equivalent to like products currently legally marketed by Abbott Laboratories, under K960466 and Baxter Healthcare under K964850. The Venusa, Ltd. Extension Set with Filter will be packaged in tyvek\mylar pouches and sterilized per AAMI guidelines.

The Venusa, Ltd. Extension Set with Filter is similar to the above named predicate devices in following ways:

1. It has the same intended use.

2. It uses the same components..

3. The device configuration is the same, with the exception the Venusa, Ltd. device will not

utilize a y-injection site.

4. The composition of the raw materials is similar if not identical.

5. The processes used to manufacture the devices are similar if not identical.

Venusa will purchase the 0.22 micron filter from Millipore and will incorporate it into an extension set. Venusa is making no

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changes to the design, components or materials of the Millipore filter. Millipore generated data regarding the functional performance of the 0.22 micron filter. Testing included Reverse Pressure Filter Integrity, Unit Venting, Gravity Flow, Inlet Axial Stress, Forward Pressure Filter Integrity, Downstream Particle Count, Accelerated Endurance, Bioburden Evaluation, Inline Filter Wettability, Burst Strength, and MVI Resistance. The data indicates that the filter meets of exceeds all functional requirements for the devices intended use.

Based on the fact that the Venusa, Ltd. Extension Set with Filter utilizes similar and equivalent designs, components, manufacturing processes as currently legally marketed products, the Venusa, Ltd. Extension Set with Filter is safe and effective when used as intended.

Sincerely,

[signature]

31C BUTTERFIELD TRAIL, EL PASO, TX 79906 [phone] FAX: [phone]

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 3 2000

Mr. Ross Magladry Venusa, Ltd. 31C Butterfield Trail El Paso, Texas 79906

Re : K994429 Venusa, Ltd. Extension Set with Filter Trade Name: Regulatory Class: II Product Code: FPA December 27, 1999 Dated: Received: December 30, 2000

Dear Mr. Magladry:

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 The general controls provisions of the Act 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Magladry

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 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 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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K994429

510 (k) number: K994429 Device name: Extension Set with Filter

## Indications for Use:

The Venusa, Ltd. Extension Set with Filter is used for IV fluid administration where The Velusa, Do. Dxtention Dot, Mai 22 mirron is desired. Use of the device helps assure the delivery of a bacteria-free product. The device is used in conjunction with an IV administration set and in-dwelling IV catheter.

Patricia Cuscenti

(Division Sign-Off) Division of Dental, Infection Control, and General Hospit 510(k) Number