STABLE FLOW

K981157 · Cmed · FPA · Jun 16, 1998 · General Hospital

Device Facts

• Record ID: K981157
• Device Name: STABLE FLOW
• Applicant: Cmed
• Product Code: FPA · General Hospital
• Decision Date: Jun 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A device used to regulate the flow of fluids from a container, such as an I.V. bag, to a patient's vascular system, through a needle or catheter inserted into a vein. For single use.

Device Story

Stable Flow IV Flow Controller is a mechanical device designed to regulate fluid delivery from IV bags to a patient's vascular system. It operates via manual adjustment to control flow rates through IV tubing connected to a needle or catheter. Used in clinical settings by healthcare professionals to manage fluid administration. The device provides a physical mechanism to restrict or permit flow, assisting clinicians in maintaining prescribed infusion rates. It is intended for single-use applications.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical IV flow controller; single-use; manual adjustment mechanism for fluid flow regulation.

Indications for Use

Indicated for regulating fluid flow from IV containers to patient vascular systems via needle or catheter. For single use.

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

JUN 1 6 1998

Mr. Greg Holland ·Principal Computer Medical Diagnostics (CMeD) 3722 Avenue Sausalito Irvine, California 92606

Re : K981157 Trade Name: Stable Flow IV Flow Controller Regulatory Class: II Product Code: FPA March 27, 1998 Dated: Received: March 31, 1998

Dear Mr. 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 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 Requlations, Title 21, Parts 800 to 895. A 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 obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Holland

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 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. Valentine

Tim 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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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): K981157

Stable Flow, I.V. Flow Controller Device Name:

Indications For Use:

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A device used to regulate the flow of fluids from a container, such as an I.V. bag, to a patient's vascular system, through a needle or catheter inserted into a vein. For single use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sand Salata La La Millio Samura Persona mana a comments and manus and manus and (Division . . . . . . . . . Division - 19- - 1. enfection Control, and Goneral Terrains and ces-

\$10(k) = 11:100 = ____________________________________________________________________________________________________________________________________________________________

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use_ ________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Date of Application March 27, 1998