V SET

K020424 · Hennig Enterprises Europe Srl · FPA · Aug 29, 2003 · General Hospital

Device Facts

• Record ID: K020424
• Device Name: V SET
• Applicant: Hennig Enterprises Europe Srl
• Product Code: FPA · General Hospital
• Decision Date: Aug 29, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The V Set is suitable for intravenous infusion of drug solutions and fluids and has been designed to connect multiple infusion lines, functioning in the administration of intravenous fluids from a number of sources into one cannula.

Device Story

V Set is an intravascular administration set designed to connect multiple infusion lines. It allows the administration of intravenous fluids from various sources into a single cannula. Used in clinical settings by healthcare professionals to manage fluid delivery. The device facilitates multi-line infusion, simplifying the connection process for the clinician and ensuring efficient fluid delivery to the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intravascular administration set; multi-line connector; Class II device; Product Code FPA; Regulation 880.5440.

Indications for Use

Indicated for patients requiring intravenous infusion of drug solutions and fluids from multiple sources into a single cannula.

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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Public Health Service

AUG 2 9 2003

od and Drug Administration Corporate Boulevard lockville MD 20850

Dr. George O'Neil Henning Enterprises Europe S.R.L. 25 Shann Street Floreat Perth, 6014 Western Australia

Re: K020424

Trade/Device Name: V Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: July 28, 2003 Received: August 11, 2003

Dear Mr. O'Neil:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. O' Neil

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susa Ruoen

Susan Runner, DDS, MA, Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K020424

510 (k) Application - V Set

## INDICATIONS FOR USE STATEMENT

K020429 510 (k) Number:

Trade Name: V Set

Indications For Use:

The V Set is suitable for intravenous infusion of drug solutions and fluids and has been designed to connect multiple infusion lines, functioning in the administration of intravenous fluids from a number of sources into one cannula.

Sativa Cuceniti

eneral Hospit Infection Control, Der

510(k) Number. K020474