CPR FILTERSHIELD

{0}------------------------------------------------ 1111 1 6 1998 』MORRISON DRIVE ・ GURNEE ILLINOIS 60031 ・ (847) 662-4400 ・ FAX (847) 662-1084 510(k) Summarv K1980066 Submitted By and Contact Person: Gary S. Botsford 4080 Morrison Dr. Gurnee, IL 60031 847-662-4400 Ext. 218 Fax: 847-662-1084 Date Prepared: 115/98 Name of Device: Proprietary Name: Classification Name: Common/Usual Name: CPR FILTERSHIELD™ Ventilator, Emergency, Manual (868.5915) FACE SHIELD Equivalent device: Laerdal Resusci ™ Face Shield 46 00 01 (K880450) Device description: The configuration of this device is a plastic PVC sheet with a hole in the center. Sealed around the hole is two plastic molded supports. An electret fiberous media filter is sealed to the proximal molded support. Device use: The CPR FILTERSHIELD is a highly portable, single use, physical barrier for use in performing mouth resuscitation on adults and children by personnel train in CPR techniques. The CPR FILTERSHIELD performs the same function and is technologically equivalent to the Laerdal Resusci ™ Face Shield. The CPR FILTERSHIELD was found equivalent to the Laerdal shield for the following: FLOW RESISTANCE EFFECTS OF TEMPERATURE BARRIER EFFECTIVENESS The material compounds used for the patient/rescuer contact components comply with ISO 10993 -1 1992 Biological evaluation of medical devices (surface device, mucosal membrane, contact duration A). {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Jul 1 6 1998 Mr. Gary S. Botsford Plasco, Inc. 4080 Morrison Drive Gurnee, IL 60031 K980066 Re: CPR Filtershield Regulatory Class: II (two) Product Code: 73 BTM Dated: April 22, 1998 Received: April 23, 1998 Dear Mr. Botsford: 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 leqally 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). 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 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {2}------------------------------------------------ Page 2 - Mr. Gary S. Botsford 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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Sincerely yours, Thomas J. Callahan Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ The CPR FILTERSHIELD is a highly portable, single use, physical barrier for use in performing mouth-to mouth resuscitation on adults and children by personnel train in CPR techniques. . 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