6 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INCH MIN-BONE EXTENSION SET WITH LUER SLIP, NES02S, 6 INCH STAT

K980127 · Catheter Innovations, Inc. · FPA · Mar 11, 1998 · General Hospital

Device Facts

• Record ID: K980127
• Device Name: 6 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INCH MIN-BONE EXTENSION SET WITH LUER SLIP, NES02S, 6 INCH STAT
• Applicant: Catheter Innovations, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Mar 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These extension sets are indicated for needle-free use in the intravenous delivery of fluids, including but not limited to, hydration fluids, chemotherapy, antibiotics, analgesics, and nutritional therapy. The sets are commonly connected to the external portion of indwelling vascular access catheters.

Device Story

Extension sets with PASV™ valve; used for needle-free intravenous fluid delivery. Connects to external portion of indwelling vascular access catheters. Valve mechanism facilitates fluid flow while maintaining closed system. Used in clinical settings by healthcare professionals. Benefits include reduced needle-stick risk and maintenance of catheter patency.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Extension set with integrated PASV™ valve; needle-free design; sterile; single-use.

Indications for Use

Indicated for needle-free intravenous delivery of fluids (hydration, chemotherapy, antibiotics, analgesics, nutritional therapy) via connection to indwelling vascular access catheters.

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

Mr. Roger L. Richins Vice President Technology and Requlatory Affairs MAR 11 1998 Catheter Innovations, Incorporated 3598 West 1820 South Salt Lake City, Utah 84104

Re : K980127 Trade Name: Catheter Innovations, Inc. Extension Sets with PASV™ Valve Regulatory Class: II Product Code: FPA Dated: January 12, 1998 Received: January 14, 1998

Dear Mr. Richins:

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 809 to-895. A ---------substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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

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## Page 2 - Mr. Richins

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 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 regulation (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 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/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Timot Ulatowski A. 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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*980127

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## 510(k) Number (if known): K980127

Device Name: Catheter Innovations, Inc. Extension Sets with PASV™ Valve

Indications For Use:

These extension sets are indicated for needle-free use in the intravenous delivery of fluids, including but not limited to, hydration fluids, chemotherapy, antibiotics, analgesics, and nutritional therapy. The sets are commonly connected to the external portion of indwelling vascular access catheters.

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Concurrence of CHRH, Office of Device Evaluation (ODE) Division Sign-

Division of Dontal, In and General Hos 510(k) Numbe

Prescription Use V

OR

Over-The-Counter Use

(Optional Format 1-2-96)