Sterisheet Sterilization Wrap

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 1, 2017 Andersen Sterilizers,inc. William Andersen President 3154 Caroline Drive Haw River, North Carolina 27258 Re: K170437 Trade/Device Name: Sterisheet Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: September 28, 2017 Received: October 6, 2017 ### Dear William Andersen: 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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. 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. You 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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, # Michael J. Ryan -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) #### K170437 Device Name Sterisheet® Sterilization Wrap Indications for Use (Describe) Sterisheet Sterilization Wraps are single use non-woven sterilization wraps intended to enclose mat are to be sterlized at a healthcare facility. They are used in the 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer. Critical process parameters for the cycle are summarized below in Table 1. | Table 1. Critical sterilization cycle parameters in the Anprolene AN75 Ethylene Oxide Gas Sterilizer | | | | | |------------------------------------------------------------------------------------------------------|-------------|-------------------|------------------|------------------| | EO Amount | Temperature | Relative Humidity | EO Exposure Time | Total Cycle Time | | 17.6 g ± 5% | 20-29°C | 35-90% | 12 hours | 14 hours | The product code for Sterisheet Sterilization Wraps is listed in Table 2. | Table 2. Product code for Sterisheet Sterilization Wraps | | |----------------------------------------------------------|----------------------------------------------------------------------------------------------| | Product Designation | Sterisheet S88 Blue | | Product Code | 0129 | | Sizes | 18"x18", 20"x20", 24"x24", 30"x30", 36"x36", 40"x40", 45"x45", 48"x48", 54"x54", and 54"x72" | The 12 hour cycle in the Anprolene Oxide Gas Sterilizer has been validated to sterilize a load of up to 24 bs of metal surgical instruments, 3 lbs of fabric, or 3.5 lbs of plastic devices (combined weight of wrapped devices and tray). Sterility was maintained for at least 3 months after processing in an Anprolene sterilization cycle. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) |X Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) {3}------------------------------------------------ # 510(k) Summary K170437 | 5.1 Applicant's Name and Address | Andersen Sterilizers, Inc.<br>Establishment Registration Number 3004634710<br>3154 Caroline Drive<br>Haw River, NC 27258 | | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------| | 5.2 Contact Person | William K. Andersen, BE, MD, FAAOS<br>President<br>Phone: 336-376-8622, Fax: 336-376-5428 | | | 5.3 Date of Preparation | October 20, 2017 | | | 5.4 Device | | | | | Proprietary Name | Sterisheet® Sterilization Wrap | | | Common Name | Sterilization Wrap | | | Classification | Class II (21 CFR 880.6850) | | | Product Code | FRG | | 5.5 Predicate Device | | | | | Device Name | Sterisheet® Sterilization Wrap | | | 510(k) number | K152291 | | | Manufacturer | Ariowiggins Medical Inc | The predicate Sterisheet Sterilization Wrap (K152291) is approved for use in the EOGas 4 Ethylene Oxide Gas Sterilization system manufactured by Andersen Sterilizers, Inc. This 510(k) submission modifies the indications for use of the predicate device in order to include it as a component in the Anprolene® AN75 Ethylene Oxide Gas Sterilization system manufactured by Andersen Sterilizers, Inc. No modifications were made to the manufacturing method, technology, or intended use. #### 5.6 Device Description Sterisheet Sterilization Wraps are single use, non-sterile sterilization wraps constructed from cellulose, synthetic fibers (polypropylene), and synthetic binders, with the addition of pigmentation. They are used to enclose medical devices that are to be sterilized by a healthcare provider in the 12 hour sterilization cycle at 20-29°C in an Anprolene AN75 Ethylene Oxide Gas Sterilizer. Devices must be wrapped following manufacturer's instructions. After completion of {4}------------------------------------------------ the sterilization process, Sterisheet Sterilization Wraps maintain sterility of the enclosed medical devices for at least 3 months. AN85/AN86 EO Indicators, when placed on the outside of the sterilization wraps, may be used to secure the wrapping material on the devices and to indicate ethylene oxide exposure, offering a convenient way to verify processing in the sterilization cycle. The color of the AN85/AN86 EO Indicators changes from vellow-green to blue after exposure to ethylene oxide. #### 5.7 Indications for Use Sterisheet Sterilization Wraps are single use non-woven sterilization wraps intended to enclose medical devices that are to be sterilized at a healthcare facility. They are used in the 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer. Critical process parameters for the cycle are summarized in Table 5-1. Table 5-1. Critical sterilization cycle parameters in the Anprolene AN75 Ethylene Oxide Gas Sterilizer | Ethylene Oxide | Temperature | Relative<br>Humidity | Ethylene Oxide<br>Exposure Time | Total Cycle Time | |----------------|-------------|----------------------|---------------------------------|------------------| | 17.6 g ± 5% | 20-29°C | 35-90% | 12 hours | 14 hours | The product code for Sterisheet Sterilization Wraps is listed in Table 5-2. | Product Designation | Sterisheet S88 Blue | |---------------------|-------------------------------------------------------------------------------------------------| | Product Code | 0129 | | Sizes | 18"x18", 20"x20", 24"x24", 30"x30", 36"x36",<br>40"x40", 45"x45", 48"x48", 54"x54", and 54"x72" | Table 5-2. Product code for Sterisheet Sterilization Wraps The 12 hour cycle in the Anprolene AN75 Ethylene Oxide Gas Sterilizer has been validated to sterilize a load of up to 24 lbs of metal surgical instruments. 3 lbs of fabric, or 3.5 lbs of plastic devices (combined weight of wrapped devices and tray). Sterility was maintained for at least 3 months after processing in an Anprolene AN75 sterilization cycle. ## 5.8 Device Comparison The technological characteristics of the subject Sterilization Wraps are identical to the predicate device (K152291) - both are intended for the same use, use the same technology, and are designed in the same way. The only difference between the subject Sterisheet Sterilization Wrap and the predicate device is the sterilization cycle for which the subject Sterilization Wrap is indicated. The {5}------------------------------------------------ difference raises no issues related to safety or effectiveness of the subject device in the sterilization cycle. A comparison between the devices is listed in Table 5-3. | Elements | Predicate Sterisheet Sterilization<br>Wraps (K152291) | Subject Sterisheet Sterilization<br>Wraps | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Arjowiggins Healthcare | Arjowiggins Healthcare | | Intended Use | To enclose medical devices, allow<br>sterilization of the enclosed devices,<br>and maintain sterility of the enclosed<br>devices | Identical | | Indications for<br>Use | Sterisheet Sterilization Wraps are single<br>use non-woven sterilization wraps<br>intended to enclose medical devices that<br>are to be sterilized at a healthcare<br>facility. They are used in the 3 hour<br>sterilization cycle at 50°C in the EOGas<br>4 Ethylene Oxide Gas Sterilizer. | Sterisheet Sterilization Wraps are single<br>use non-woven sterilization wraps<br>intended to enclose medical devices that<br>are to be sterilized at a healthcare<br>facility. They are used in the 12 hour<br>sterilization cycle at 20-29°C in the<br>Anprolene AN75 Ethylene Oxide Gas<br>Sterilizer. | | Materials | Cellulose, synthetic fibers<br>(polypropylene), and synthetic binders | Identical | | Design | Cellulose allows EO to pass through the<br>wrap but prevents microorganisms from<br>crossing through the wrap, providing a<br>microbial barrier for the wrapped<br>devices after sterilization;<br>Synthetic fibers increase mechanical<br>resistance;<br>Synthetic binders enhance drapeability,<br>strength, softness, and fluid repellency | Identical | | Wrap Shape | Square or rectangular | Identical | | Configuration in<br>Load | Double sequential envelope wrap is<br>recommended | Identical | | Shelf Life | 5 years from date of manufacture | Identical | | Aeration Time | ≥ 6 hours | ≥ 6 hours | Table 5-3. Device Comparison {6}------------------------------------------------ ## 5.9 Performance Testing Sterisheet Sterilization Wraps conform to all applicable requirements for packaging for terminally sterilized medical devices for EO sterilization, based on ISO 11607-1. Performance testing was conducted to show that Sterisheet Sterilization Wraps perform as intended to allow sterilization and maintain sterility of the enclosed medical device. Sterilization efficacy testing demonstrated a sterility assurance level of 10-6 using the half dose validation method under worst-case conditions. Shelf life studies demonstrated after completion of the Anprolene AN75 sterilization process, sterility is maintained for at least 3 months. The performance of Sterisheet Sterilization Wraps is summarized in Table 5-4. | Table 5-4. Summary of bench tests performed to demonstrate safety and effectiveness of | | | | | |----------------------------------------------------------------------------------------|--|--|--|--| | Sterisheet Sterilization Wraps | | | | | | | | | | | | Test | Description | Results | |-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------| | Compliance to ISO 11607-1 | | | | Package Integrity | Porous material providing a microbial barrier;<br>Physical and chemical properties are maintained | Meets requirements | | Material Compatibility | Compatibility with respect to forming and sealing<br>process-suitable folding and drapeability;<br>Suitable for use in EO sterilization processes | Meets requirements | | Biocompatibility | Not direct patient-contacting devices;<br>Materials are non-toxic and meet ISO 11607-1<br>requirements;<br>Biological evaluation meets acceptable criteria;<br>Bio-burden control;<br>Provides reasonable assurance for safety | Pass | | Shelf Life | Physical properties and microbial barrier of the<br>processed Sterisheet Sterilization Wraps were<br>verified at the end of the claimed shelf life of 5<br>years:<br>Stability demonstrates reasonable assurance for<br>effectiveness | Pass | | Performance in the Anprolene AN75 Cycle | | | | Sterilant Penetration | EO penetrated the wraps under worst-case half-<br>dose conditions or an extreme biological<br>challenge scenario, and inactivated 6-Log<br>biological indicators | Allow a sterility<br>assurance level of 10-6<br>for the sterilization cycle | | Maintenance of<br>Package Sterility | Sterility was maintained for at least 3 months after<br>processing in an Anprolene AN75 sterilizer. | Pass | ## 5.10 Conclusion Based on the intended use, technological characteristics, and nonclinical tests performed, the subject device Sterisheet Sterilization Wrap (K170437) is as safe and effective as the legally marketed predicate device, Sterilization Wrap (K152291) intended for used in the EOGas4 sterilization system.