IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES

K980992 · Venetec Intl., Inc. · FPA · May 28, 1998 · General Hospital

Device Facts

• Record ID: K980992
• Device Name: IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES
• Applicant: Venetec Intl., Inc.
• Product Code: FPA · General Hospital
• Decision Date: May 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

An extension set to be used as an extension to the Intravascular administration set to be used in the IV extension set will connect the administration set to a catheter or needle inserted into a vessel. The IV extension set incorporates needleless access devices to protect the users from needle stick injuries.

Device Story

Statlock IV Extension Sets with Needleless Access Devices function as an interface between IV administration sets and vascular access catheters/needles. The device incorporates needleless access technology to mitigate the risk of accidental needle stick injuries to healthcare providers during IV therapy. Used in clinical settings by medical professionals, the device facilitates secure fluid delivery while maintaining a closed system. It serves as a physical extension to standard IV tubing, ensuring compatibility between administration sets and patient access points.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

IV extension set featuring integrated needleless access ports. Designed for connection between standard IV administration sets and vascular catheters/needles. Materials and construction are consistent with standard medical-grade IV tubing and access components. Non-electronic, mechanical device.

Indications for Use

Indicated for use as an extension to intravascular administration sets to connect the administration set to a catheter or needle inserted into a vessel, incorporating needleless access to protect users from needle stick injuries.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 8 1998

Venetec International, Incorporated C/O Ms. Grace Holland Requlatory Consultant Promedica 3722 Avenue Sausalito Irvine, California 92606

K980992 Re :

> Statluck® IV Extension Sets with Needleless Trade Name: Access Devices Requlatory Class: II Product Code: FPA Dated: March 17, 1998 Received: March 17, 1998

Dear Ms. Holland:

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. ਰ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 not affect any obligation you might have under sections 531

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Page 2 - Ms. Holland

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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"(21CFR 807.97). Other qeneral 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,

Timothy A. Ulatowski

Directdr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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K 980992 510(k) Number (if known): __

IV Extension Sets with Needleless Access Devices Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

An extension set to be used as an extension to the Intravascular administration set to be assul in the IV extension set will connect the administration set to a catheter or needle inserted into a vessel. The IV IV administration bet to a calleless access devices to protect the users from needle stick injuries.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over The-Counter Use ... .......

(Optional Format 1-2-96)

Date of Application - Mach 17, 1998 Revised on May 22, 1998

Patrizio Cusande

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

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