BIOSHIELD EXPRESS STERILIZATION WRAP

{0}------------------------------------------------ AUG. 5.1999 3:41PM P.3/5 NO. OSA K9837/9 AUG 25 - # legiance Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, IL 60085 847.473.1500 FAX: 847.785.2461 ## ATTACHMENT F ## SUMMARY OF SAFETY AND EFFECTIVENESS Manufacturer: Regulatory Affairs Contact Telephone: Date Summary Prepared: Product Trade Name: Common Name: Classification: Predicate Device: (K770933) Description: Intended Use: Allegiance Healthcare Corporation V. Mueller Business Unit 1435 Lake Cook Road Deerfield. IL 60015 Patricia Sharpe-Gregg 1500 Waukegan Road McGaw Park, Illinois 60085 (847) 578-3636 October 16, 1998 Allegiance BjoShield® Express™ Sterilization Wrap CSR Wrap or Sterilization Wrap Sterilization Wrap Allegiance BioShield® Sterilization Wrap The Allegiance BioShield® Express™ Sterilization Wrap is composed of a wet formed non-woven cellulose fiber with acrylic binders. The Allegiance BioShield® Express™ Sterilization Wrap is a single-use, non-sterile device. It is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. This wrap is intended for use in prevacuum steam sterilization processes. {1}------------------------------------------------ Image /page/1/Picture/2 description: The image shows the word "Allegiance" in a stylized, bold, black font. To the left of the word is a graphic of a plus sign made up of small squares. The word is slightly slanted to the right, giving it a dynamic appearance. Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, IL 60085 847.473.1500 FAX: 847.785.2461 #### ATTACHMENT F Page 2 of 2 Substantial Equivalence: The Allegiance Allegiance BioShield® Express™ Sterilization Wrap is substantially equivalent to the Dextex II Sterilization Wrap and the Kimguard™ Sterilization in that the: - intended use is the same - performance attributes are the same The Allegiance BioShield® Express™ Sterilization Wrap is substantially equivalent to the Allegiance BjoShield® Sterilization Wrap in that the: - intended use is the same - material composition is the same - performance attributes are the same The material used in the composition of this sterilization wrap was evaluated and tested as required in ISO Standard 10993 Part 1. The material was subjected to skin sensitization, intracutaneous reactivity and cytotoxicity testing. Physical and performance testing was completed including sterilization performance testing. This product is in compliance with established standards, where applicable, and is deemed acceptable for its intended use. #### Summary of Testing: {2}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 25 1999 Patricia Sharpe-Gregg Ms. Manager, Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukegan Road, Building MP-WM McGaw Park, Illinois 60085 Re : K983719 ... BioShield® Express™ Sterilization Wrap Trade Name: Requlatory Class: II Product Code: FRG Dated: July 15, 1999 Received: July 16, 1999 Dear Ms. Sharpe-Gregg: 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 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). 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 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 General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: {3}------------------------------------------------ Page 2 - Ms. Sharpe-Gregg 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 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 (301) 594-4692. 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" (21CFR 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, Timo y A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ . .•. : Allegiance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Alleglance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085 USA 847-473-1500 FAX: 847-785-2461 510(k) Notification Express Sterlilzation Wrap V. Mueller Business Unit Page 1 of 1 | 510(k) Number (if known): | Unknown K983719 | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | Bioshield® Express™ Sterilization Wrap | | Indications For Use: | The Bioshield® Express™ Sterilization Wrap is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. <p>This wrap is intended for use in prevacuum steam sterilization processes.</p> | (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use (Per 21 CFR 801.109) | | |-----------------------------------------------------------------------------------------|----------------------| | | Over-The Counter Use | | (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices | | | 510(k) Number | K983719 |