TIDI BRAND STERILIZATION WRAP

{0}------------------------------------------------ NOV 1 7 2004 510(k) SUMMARY Image /page/0/Picture/2 description: The image shows a handwritten string of characters. The string appears to be "K042580". The characters are written in a dark ink on a white background. The handwriting is somewhat messy, but the characters are still legible. | Submission Correspondent:<br>Address: | Emergo Group, Inc.<br>2454 McMullen Booth Road<br>Suite 427<br>Clearwater, FL 33759 | |---------------------------------------|-------------------------------------------------------------------------------------| | Phone: | (727) 797-4727 | | Fax: | (727) 797-4757 | | Contact: | Mr. Ian Gordon | | Submission Sponsor: | Banta Healthcare Group<br>570 Enterprise Drive<br>Neenah, WI 54957 | | Date Prepared: | September 7, 2003 | | Trade Name: | Tidi Brand Sterilization/CSR Wrap | | Common Name: | Sterilization Wrap | | Classification: | FRG, Wrap, Sterilization<br>Class II, Regulation No. 880.6850 | ## Description: The Banta Healthcare Group Tidi Brand Sterilization/CSR Wrap is suitable for both medical and dental facilities as a wrapping material for sterilizing instruments and equipment. The Sterilization/CSR Wrap is made from a blue, wet formed nonwoven fabric comprised of natural wood pulp fibers bonded with a synthetic resin binder and is available in numerous sheet sizes. Sterilization/CSR Wrap is a single-use product intended for use in steam and ethylene oxide sterilization applications. ## Intended Use: Tidi brand Sterilization/CSR Wrap is suitable for both medical and dental facilities as a wrapping material for sterilizing instruments and equipment. Available in numerous sizes, CSR wrap is a single-use product intended for use in steam and ethylene oxide sterilization applications. The wraps maintain their wrapped integrity after sterilization to maintain contents' sterility before use. CSR Wraps can also be used for many needs that do not require sterilization, such as draping a tray and acting as a protective sheet between a surface and instruments. {1}------------------------------------------------ Predicate Devices: The predicate device referenced in this submission is: Ahlstrom Dexter - Dextex II Sterilization Wrap, 510(k) # K800123 ### Safety and Effectiveness: The differences between the Banta Healthcare Group Tidi Brand Sterilization/CSR Wrap specifications and the predicate device specifications do not result in different performance or raise new questions regarding safety and effectiveness. #### Summary and Conclusion Regarding Substantial Equivalence: By definition, a device is substantially equivalent when the device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device. The differences between the Banta Healthcare Group Tidi Brand Sterilization/CSR Wrap and the predicate device cited do not raise any different questions regarding safety and effectiveness. There are no differences in the technological characteristics and the associated procedures are nearly identical. The intended use is identical to the intended use of the previously cleared predicate device, and the indications are equivalent. The device, as designed, is as safe and effective as the predicate device, and the device is determined to be substantially equivalent to the referenced predicate device. {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. NOV 1 7 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Banta Healthcare Group, Limited C/O Mr. Tamas Borsai Responsible Third Party Official T ÜV Rheinland of North America 12 Commerce Road Newton, Connecticut 06470 Re: K042580 Trade/Device Name: Tidi Brand Sterilization/CSR Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: November 3, 2004 Received: November 4, 2004 Dear Mr. Borsai 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 appear 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 (1 Mr.), it a 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 Eederal Register. {3}------------------------------------------------ Page 2 - Mr. Borsai Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or me For of any 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 requirements as set forth in the quality systems (QS) regulation (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) 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), nlease 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 Division 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/dsma/dsmamain.html Sincerely yours. Clares 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 STATEMENT KO42580 310(k) Number (if known): _ Tidi Brand Sterilization/CSR Wrap Device Name: Indications for Use: Tidi brand Sterilization/CSR Wrap is suitable for both medical and dental facilities as a wrapping material for sterilizing instruments and equipment. Available in numerous sizes, CSR wrap is a single-use product intended for use in steam and ethylene oxide sterilization applications. The wraps maintain their wrapped integrity after sterilization to maintain contents' sterility before use. (PLEASE DO NOT: WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED) 510(k) Number ________________________________________________________________________________________________________________________________________________________________ Prescription Use . (Per 21 CFR 801.109) OR Over the Counter Use_ x Ques (Division Sign-Off) (Division Sign-Off) Division of Anesthesiology, General Hospital. Division Control Dental Devices Division of Anesthouldress Infection Control. Dental Devices 510(k) Number: K042580