SAGE CONTRAST MANAGEMENT SYSTEM

K991112 · Sage Laboratories, Inc. · FPA · Sep 2, 1999 · General Hospital

Device Facts

• Record ID: K991112
• Device Name: SAGE CONTRAST MANAGEMENT SYSTEM
• Applicant: Sage Laboratories, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Sep 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Sage Contrast Management System is recommended for controlled IV administration of contrast media.

Device Story

Sage Contrast Management System facilitates controlled intravenous delivery of contrast media. Device operates as an automated or semi-automated infusion system to regulate flow rates and volumes during diagnostic imaging. Used in clinical settings (radiology/imaging suites) by physicians, nurses, or technicians. Output consists of precise contrast media delivery to the patient's vascular system. System ensures consistent contrast enhancement, aiding clinicians in obtaining high-quality diagnostic images. Benefits include improved procedural control, reduced risk of manual administration errors, and optimized contrast utilization.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and technological comparison.

Technological Characteristics

System designed for controlled IV administration of contrast media. Mechanical infusion control mechanism. Intended for clinical use in diagnostic imaging environments. Compliance with 21 CFR Part 820 (GMP) required.

Indications for Use

Indicated for controlled intravenous administration of contrast media in patients requiring diagnostic imaging procedures.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three curved lines that resemble a human figure, possibly representing health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP : 2 1999

Mr. David Chen President Sage Laboratories, Incorporated 5408 Interstate Drive Shreveport, Louisiana 71109

Re : K991112 Sage Contrast Management System Trade Name: Regulatory Class: II Product Code: FPA Dated: June 18, 1999 Received: June 22, 1999

Dear Mr. Chen:

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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation 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

{1}------------------------------------------------

Page 2 - Mr. Chen

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 A. Ulatowski

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

Enclosure

{2}------------------------------------------------

K991112

Page 1 of 1

510(k) Number (if known):

Device Name: Sage Contrast Management System

Indications For Use:

The Sage Contrast Management System is recommended for controlled IV administration of contrast media.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricio Vicente

ion of Dental, Infection Control. General Hospital Devices

510(k) Number K991112

Prescription Use_ (Per 21 CFR 801.109)

. "

OR

Over-The-Counter Use

(Optional Format 1-2-96)

- Attachment I, page 1 -