IV ADMINISTRATION SET

K992266 · New Alliance of Independent Medical Distributors, · FPA · Oct 27, 1999 · General Hospital

Device Facts

• Record ID: K992266
• Device Name: IV ADMINISTRATION SET
• Applicant: New Alliance of Independent Medical Distributors,
• Product Code: FPA · General Hospital
• Decision Date: Oct 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

IV administration set used to administer fluids from a container to a patient's venous system through a needle or catheter inserted into a vein.

Device Story

IV administration set; facilitates fluid delivery from container to patient venous system. Used in clinical settings; operated by healthcare professionals. Device consists of tubing and connectors; provides pathway for intravenous therapy. Benefits patient by enabling controlled fluid administration.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

IV administration set; consists of tubing and connectors for fluid delivery. No specific materials, energy sources, or software components described.

Indications for Use

Indicated for the administration of fluids from a container to a patient's venous system via a needle or catheter inserted into a vein.

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

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OCT 2 7 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Edward Thibon Official Correspondent New Alliance of Independent Medical Distributors 99 W. Sandra Avenue Arcadia, California 91007

Re : K992266 Trade Name: Intravenous Administration Set Regulatory Class: II Product Code: FPA Dated: Auqust 30, 1999 Received: September 1, 1999

Dear Mr. Thibon:

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), Jit 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 895. ਧੋ 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 the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Mr. Thibon

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 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 R. Walatkus

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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K992266

Page of

510(k) NUMBER (IF KNOWN) :

DEVICE NAME: IV Administration Set

INDICATIONS FOR USE:

IV administration set used to administer fluids from a container to a patient's venous system through a needle or catheter inserted into a vein.

Attachment 4

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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)

i :

taitucio Cicente

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