ISSYS DRUG FLOW MONITOR

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the wings or feathers. The symbol is enclosed within a circular border. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is written around the border of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 2 2 2006 Mr. Stephen Goldner, JD, RAC Vice President, Regulatory Affairs Integrated Sensing Systems, Incorporated 391 Airport Industrial Drive Ypsilanti, Michigan 48198 Re: K050783 Trade/Device Name: ISSYS Drug Flow Monitor® Regulation Number: 21 CFR 880.2420 Regulation Name: Electronic monitor for gravity flow infusion systems Regulatory Class: Class II Product Code: FLN Dated: Februrary 13, 2006 Received: February 16, 2006 Dear Mr. Goldner: 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. {1}------------------------------------------------ ## Page 2 – Mr. Stephen Goldner, JD, RAC Please be advised that FDA's issuance of a substantial equivalence determination does not Please be auvisod that 1 DX 3 issualled of a bases and issues complies with other requirements mean that ITDA has made a deceminations administered by other Federal agencies. of the Act of ally I ederal states and systements, including, but not limited to: registration 1 ou must comply with an the Piebeling (21 CFR Part 801); good manufacturing practice allo fishing (21 CFR Part 007), labeling (21 cm (QS) regulation (21 CFR Part 820); and if requirements as set forth in the quality by seems (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 This letter will anow you to ough himsing of substantial equivalence of your device 510(K) predicate notification: "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), If you desire specific advice for your do recolor of the 311-5. Also, please note the regulation in 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 may obtain other general meethallers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Clues Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital , Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name:__________________________________________________________________________________________________________________________________________________________________ Indications For Use: The ISSYS Drug Flow Monitor is a passive monitoring device for rravity infusion. The unit uses a flow sensor to measure the amount of liquid through the infusion line and displays the flow rate and total volume administered to the patient. Flow rates and volumes are recorded, and if the flow rate or volume falls outside the preset range, both a visible and audible alarm is triggered. This monitor is indicated for use in range, both a the flow rates are between 5 and 200 mL/hr. The accuracy of the monitor is +/- 20% at 5 mL/hr and +/- 5% at 200 mL/hr. For use with IV drug solutions administered by gravity. WARNING: DO NOT USE WITH BLOOD OR BLOOD PRODUCTS. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) > Concurrence of CDRH, Office of Device Evaluation (ODE) Case D.m. > > - Perfection Circus (Peneral Hospical, Tophol Dunlal Davices ... .- -- ------------------ K4547D2 ----------------------------------------------------------------------------------------------------------------------------------------------------------------------