GRAVITECH TM FLOW CONTROLLER PRIMARY SET/GRAVITECH FLOW CONTROLLER EXTENSION SET

K030467 · Iv Medical, Inc. · FPA · Mar 14, 2003 · General Hospital

Device Facts

• Record ID: K030467
• Device Name: GRAVITECH TM FLOW CONTROLLER PRIMARY SET/GRAVITECH FLOW CONTROLLER EXTENSION SET
• Applicant: Iv Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Mar 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GraviTech™ is a single use, disposable gravity-driven flow regulator used in conjunction with I.V. administration sets and extension sets for controlling the flow rate of I.V. solutions into the human body. GraviTech™ Primary Sets are for use in controlling the infusion rate of I.V. fluids from the solution bag to a patient catheter, which is inserted into a human vein. GraviTech™ Extension Sets are intended for use in conjunction with commonly used I.V. primary sets for controlling the infusion rate of I.V. fluids into the human body.

Device Story

GraviTech™ is a single-use, disposable gravity-driven flow regulator; designed for integration with standard I.V. administration and extension sets. Device functions by mechanically regulating flow rate of I.V. solutions from a fluid bag to a patient's venous catheter. Operated by healthcare professionals in clinical settings to manage infusion rates. Provides manual control of fluid delivery; benefits patient by ensuring consistent, regulated administration of intravenous fluids. Does not utilize electronic components or software.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Single-use, disposable gravity-driven flow regulator. Mechanical design for I.V. administration sets and extension sets. No electronic components, software, or energy source.

Indications for Use

Indicated for patients requiring controlled gravity-driven intravenous infusion of fluids via catheter 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

MAR 1 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael G. Simon President IV Medical, Incorporated 7854 Sitio Coco Carlsbad, California 92009

Re: K030467

Trade/Device Name: GraviTech™ Flow Controller Primary Set/ GraviTech™ Flow Controller Extension Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: January 27, 2003 Received: February 12, 2003

Dear Mr. Simon:

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. Simon

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.

Susan Raono

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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K030467

IV MEDICAL INC. 510(k) NOTIFICATION

## INDICATIONS FOR USE:

## Device Name:

GraviTech™ Flow Controller Primary Set GraviTech™ Flow Controller Extension Set

## Indications For Use:

GraviTech™ is a single use, disposable gravity-driven flow regulator used in conjunction with I.V. administration sets and extension sets for controlling the flow rate of I.V. solutions into the human body.

GraviTech™ Primary Sets are for use in controlling the infusion rate of I.V. fluids from the solution bag to a patient catheter, which is inserted into a human vein.

GraviTech™ Extension Sets are intended for use in conjunction with commonly used I.V. primary sets for controlling the infusion rate of I.V. fluids into the human body.

Note: The use of any Needleless connector may aid in the prevention of needle stick injuries.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Per 21 CFR Section §801.109

Patricia Cussonitz

. General Hosnital

510(k) Number: K030467