UNDER BUTTOCKS DRAPE

{0}------------------------------------------------ K04-2893 MAR 1 1 7:005 #### SUMMARY OF THE SAFETY AND EFFECTIVENESS 10.0 # International Medsurg Connection Fluid Collection Under Buttocks Drape | Manufacturer: | International Medsurg Connection, Inc.<br>935 N Plum Grove Road, Suite F<br>Schaumburg, Illinois 60173-4770 | |-----------------------|-------------------------------------------------------------------------------------------------------------| | Regulatory Contact: | Teodoro Santiago<br>TRS Consultant, Inc.<br>P.O. Box 100624<br>Cudahy, WI 53110 | | Telephone: | 414-861-2178 | | Date Summary Prepared | October 5, 2004 | | Product Trade Name: | Fluid Collection Under Buttocks Drape | | Common Name: | Under Buttocks Drape. | | Classification: | Class II | | Predicate: | Under Buttocks Drapes, Reference<br>K845112 owned by Kimberly Clark<br>Corporation. | | Description: | The International Medsurg Connection<br>Fluid Collection Under Buttocks Drape. | #### Intended Use: International Medsurg Connection's Fluid Collection Under Buttocks Drape is intended to be used as Fluid Collection and by placing under a patient's buttocks in obstetrics procedure (with absorbent pad). ### Substantial Equivalence: The International Medsurg Connection Fluid Collection Under Buttocks Drapes are substantially equivalent to the Kimberly Clark Fluid Collection Under Buttocks Drape (catalog number 89414) sold by Kimberly Clark, Reference K842115. INTERNATIONAL MEDSURG CONNECTION, INC. 510K NOTIFICATION {1}------------------------------------------------ # Summary of testing: International Medsurg Connection Fluid Collection Under Buttocks Drape were tested for: | Test | Standard | |-------------------|---------------------| | Cytotoxicity | ISO 10993-Part 5 | | Skin Sensitivity | ISO 10993 - Part 10 | | Skin Irritation | ISO 10993 - Part 10 | | Systemic Toxicity | ISO 10993 - Part 11 | {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. In the center of the seal is a stylized caduceus, which is a symbol of medicine. The caduceus has three lines that represent the three branches of government: the executive, legislative, and judicial branches. MAR 1 1 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 International Medsurg Connection, Incorporated C/O Mr. Teodoro Santiago Regulatory Consultant Total Regulatory Systems Consultant, Incorporated P.O. Box 100624 Cudahy, Wisconsin 53110 Re: K042893 Trade/Device Name: International Nedsurg Connection's Fluid Collection Under Buttocks Drape Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: February 22, 2005 Received: February 24, 2005 Dear Mr. Santiago: 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 cnactment date of the Mcdical Device Amendie ecomments, 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 the Federal FUGU, ITCag, in Cay, therefore, market the device, subject to the general approvisions 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. {3}------------------------------------------------ Page 2 - Mr. Santiago Please be advised that FDA's issuance of a substantial equivalence determination does not r lease be act recommation that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or 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 and fishing (21 CF read on 1), and 100 million (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) Fins reter will and in J . The FDA finding of substantial equivalence of your device to a premarket tication on - - device results in a classification for your device and thus, permits your device to proceed to the market. If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. 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 Inter of Small Manufacturers, 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, Carls 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 {4}------------------------------------------------ ## Indications for Use 510K Number : K042893 # Device name: International Medsurg Connection's Fluid Collection Under Buttocks Drape Indication For Use: International Medsurg Connection's Fluid Collection Under Buttocks Drape is intended to be used in obstetric procedure to collect fluid and by placing under a patient's buttocks (with absorbent pad). Prescription Use______________________________________________________________________________________________________________________________________________________________ (Partb21 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) Shale A. Murphy, KG (Division Sign-off) Division of anesthesiology, General Hospital. Infection Control Dental Devices