BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP

{0}------------------------------------------------ ### Allegiance Healthcare Corporation 510(k) Premarket Notification: Allegiance BioShield® Express™ Heavy & Super Duty Sterilization Wrap APR 2 1 2000 V. Mueller Business Unit 93871 # ATTACHMENT F # Summary of Safety & Effectiveness {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the word "Allegiance" in a stylized font. To the left of the word is a symbol that looks like a plus sign made up of small dots. The word "Allegiance" is in bold, black letters. The font is slightly italicized. Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, IL 60085 847.473.1500 FAX: 847.785.2461 Image /page/1/Picture/3 description: The image shows a handwritten string of characters. The string appears to be a combination of letters and numbers. The string reads 'K993871'. ## ATTACHMENT F ### SUMMARY OF SAFETY AND EFFECTIVENESS | Manufacturer: | Allegiance Healthcare Corporation<br>V. Mueller Business Unit<br>1430 Waukegan Road<br>McGaw Park, IL 60085 | |--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulatory Affairs Contact | Patricia Sharpe-Gregg<br>1500 Waukegan Road<br>McGaw Park, Illinois 60085 | | Telephone: | (847) 578-3636 | | Date Summary Prepared: | November 11, 1999 | | Product Trade Name: | Allegiance BioShield® Express™ Heavy Duty &<br>Super Duty Sterilization Wrap | | Common Name: | CSR Wrap or Sterilization Wrap | | Classification: | Sterilization Wrap | | Predicate Device:<br>(K983719) | Allegiance BioShield® Express™ Sterilization Wrap | | Description: | The Allegiance BioShield® Express™ Sterilization<br>Wrap is composed of a wet formed non-woven<br>cellulose fiber with acrylic binders. | | Intended Use: | The Allegiance BioShield® Express™ Sterilization<br>Wrap is a single-use, non-sterile device. It is<br>intended to be used to enclose another medical<br>device that is to be sterilized by a healthcare<br>provider. It is intended to allow sterilization of the<br>enclosed medical device and also to maintain sterility<br>of the enclosed device until used. This wrap is<br>intended for use in Ethylene Oxide and Gravity<br>Steam Sterilization processes. | {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a graphic of a plus sign made up of small dots. The word is in black and the background is white. 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 Kimguard™ Sterilization in that the: - intended use is the same - performance attributes are the same The Allegiance BioShield® Express™ Heavy Duty & Super Duty Sterilization Wrap is substantially equivalent to the Allegiance BioShield® Express™ Sterilization Wrap in that the: - material composition is the same - performance attributes are the same Summary of Testing: 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 use. applicable, and is deemed acceptable for its intended {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping lines that resemble a person. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 2 1 2000 Ms. Patricia Sharpe-Gregg Manager, Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukegan Road, Building MPWM McGaw Park, Illinois 60085-6787 Re: K993871 Trade Name: Bioshield® Express™ Heavy & Super Duty Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: March 13, 2000 Received: March 14, 2000 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 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 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 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 requlatory 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 {4}------------------------------------------------ #### Page 2 - Ms. Sharpe-Gregg 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. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acberrood in your 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) 594-4690. 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/dsmamain.html". Sincerely yours, Timothy A. Ulatowski y A. Ulat Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "Allegiance" in a bold, stylized font. To the left of the word is a symbol that resembles a plus sign made up of small dots. The word is written in black and is slightly slanted to the right. **Allegiance Healthcare Corporation** 1500 Waukegan Road McGaw Park, Illinois 60085 USA 847-473-1500 FAX: 847-785-2461 510(k) Notification BioShield Express Heavy & Super Duty Sterilization Wrap Addition of Ethylene Oxide & Gravity Steam Indications For Use V. Mueller Business Unit Page 1 of 1 510(k) Number (if known): Unknown Device Name: Indications For Use: Bioshield® Express™ Heavy & Super Duty Sterilization Wrap The Bioshield® Express™ Heavy Duty & Super Duty 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. This wrap is intended for use in Ethylene Oxide and Gravity Steam sterilization processes. #### (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 X ivision Sign-Off Division of Dental, Infectio 510(k) Numbe