Standard Supreme Sterilization Wrapper

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three human profiles facing to the right. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 25, 2017 Standard Textile Co., Inc. % Jonathan Kahan Partner Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, District of Columbia 20004-1109 Re: K172207 Trade/Device Name: Standard Supreme Sterilization Wrapper Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: July 21, 2017 Received: July 21, 2017 Dear Jonathan Kahan: 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 {1}------------------------------------------------ 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 (reporting of medical devicerelated 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. 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, # Tara A. Ryan -S Lori Wiggins, MPT, CLT 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}------------------------------------------------ 510(k) Number (if known) K172207 #### Device Name Standard Supreme Sterilization Wrappers #### Indications for Use (Describe) Standard Supreme Sterilization Wrappers are intended to enclose another medical device that is to be sterilized by a health care provider. They are intended to allow sterilization of the enclosed medical device and also to maintain steriity of the enclosed device until used. Standard Supreme Sterilization Wrappers will function as a sterlization wrap when processed according to instructions. Standard Supreme Sterilization Wrappers are reusable through 75 wash, dry, and sterilization cycles. They are manufactured and distributed as non-sterily sterilization wraps that are intended to be sterlized and processed by heath care facilities and/or contract sterilization/laundry companies. #### Pack Assembly: Pack assembly should follow established folding, assembly and wrapping procedures as defined by the clinical staff for aseptic presentation of the pack and its contents. The oblorg and envelope folds have been validated for use on textile packs. Closure can include autoclave tape and elastomer closures. #### Sterilization: A prevacuum steam sterilization cycle (4 minute exposure at 270°F) has been validated for use on textile packs. The maximum pack size validated for use was 0.58 cubic feet with a pack weight of 12.9 pounds – pack density of 22.4 lbs./cu.ft. The maximum chamber loading configuration included 85.6 pounds of packs in a 9.1 cubic foot chamber – load density of 10.4 lbs./cu.ft. | Sizes | Misty | Jade | Ceil | |---------|----------|----------|----------| | 12"x12" | 21520502 | -- | -- | | 18"x18" | 21521502 | 21531502 | 21541502 | | 23"x23" | 21522002 | 21532002 | 21542002 | | 27"x27" | -- | 21532302 | -- | | 30"x30" | 21522802 | 21532802 | 21542802 | | 35"x35" | 21523002 | 21533002 | 21543002 | | 45"x45" | 21525002 | 21535002 | 21545002 | | 54"x54" | 21526002 | 21536002 | 21546002 | | 54"x72" | 21528202 | 21538202 | 21548202 | | 70"x70" | 21528802 | 21538802 | 21548802 | 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. {3}------------------------------------------------ ## 510K SUMMARY STANDARD SUPREME STERILIZATION WRAPPERS (K172207) ## Contact Information | Standard Textile Co., Inc. | Contact Person: Brad Bushman | |----------------------------|---------------------------------------------------| | One Knollcrest Drive | Phone (513) 761-9255 Ext 2455; Fax (513) 679-8389 | | Cincinnati, Ohio 45237 | Summary Prepared on 8/24/2017 | ## Device Information | Device Name: | Standard Supreme Sterilization Wrappers | |----------------------|----------------------------------------------| | Class: | Class II | | Common/Usual Name: | Non-sterile Sterilization Wrappers | | Classification Name: | Sterilization Wrap | | | Regulation 21 CFR 880.6850, Product Code FRG | ## Device Description Standard Supreme Sterilization Wrappers are made from Standard Supreme fabric. This fabric uses intimately blended cotton and polyester yarns, is woven into fabric and then dyed. The fabric comes in three colors - misty, ceil and jade. The dyes used to achieve the three shades include Teresil Navy, Novasol Blue, VatGreen1, Vat Yellow1, and Vat Red31. | Standard Supreme Wrapper Product Line Table | | | |---------------------------------------------|---------------------------------|-------------| | Item | Description | Size (inch) | | 21520502 | Standard Supreme Wrapper, Misty | 12x12 | | 21521502 | Standard Supreme Wrapper, Misty | 18x18 | | 21522002 | Standard Supreme Wrapper, Misty | 23x23 | | 21522802 | Standard Supreme Wrapper, Misty | 30x30 | | 21523002 | Standard Supreme Wrapper, Misty | 35x35 | | 21525002 | Standard Supreme Wrapper, Misty | 45x45 | | 21526002 | Standard Supreme Wrapper, Misty | 54x54 | | 21528202 | Standard Supreme Wrapper, Misty | 54x72 | | 21528802 | Standard Supreme Wrapper, Misty | 70x70 | | 21531502 | Standard Supreme Wrapper, Jade | 18x18 | | 21532002 | Standard Supreme Wrapper, Jade | 23x23 | | 21532302 | Standard Supreme Wrapper, Jade | 27x27 | | 21532802 | Standard Supreme Wrapper, Jade | 30x30 | | 21533002 | Standard Supreme Wrapper, Jade | 35x35 | | 21535002 | Standard Supreme Wrapper, Jade | 45x45 | | 21536002 | Standard Supreme Wrapper, Jade | 54x54 | | 21538202 | Standard Supreme Wrapper, Jade | 54x72 | | 21538802 | Standard Supreme Wrapper, Jade | 70x70 | | 21541502 | Standard Supreme Wrapper, Ceil | 18x18 | | 21542002 | Standard Supreme Wrapper, Ceil | 23x23 | | 21542802 | Standard Supreme Wrapper, Ceil | 30x30 | | 21543002 | Standard Supreme Wrapper, Ceil | 35x35 | | 21545002 | Standard Supreme Wrapper, Ceil | 45x45 | | 21546002 | Standard Supreme Wrapper, Ceil | 54x54 | | 21548202 | Standard Supreme Wrapper, Ceil | 54x72 | | 21548802 | Standard Supreme Wrapper, Ceil | 70x70 | {4}------------------------------------------------ # Intended Use/Indications for Use Standard Supreme Sterilization Wrappers are intended to enclose another medical device that is to be sterilized by a health care provider. They are intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. Standard Supreme Sterilization Wrappers will function wrap when processed according to instructions. Standard Supreme Sterilization Wrappers are reusable through 75 wash, dry, and sterilization cycles. They are manufactured and distributed as non-sterile sterilization wraps that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies. # Pack Assembly: Pack assembly should follow established folding, assembly and wrapping procedures as defined by the clinical staff for aseptic presentation of the pack and its contents. The oblong and envelope folds have been validated for use on textile packs. Closure can include autoclave tape and elastomer closures. # Sterilization: A prevacuum steam sterilization cycle (4 minute exposure at 270°F) has been validated for use on textile packs. The maximum pack size validated for use was 0.58 cubic feet with a pack weight of 12.9 pounds – pack density of 22.4 lbs./cu.ft. The maximum chamber loading configuration included 85,6 pounds of packs in a 9,1 cubic foot chamber - load density of 10,4 lbs./cu.ft. ## Performance Standard Supreme Sterilization Wrappers have successfully completed the non-clinical performance tests listed below. - a. Whole Package Challenge and 30 Day Shelf Life Study Standard Supreme Sterilization Wrappers demonstrated their ability in these tests to be an effective sterile barrier after 75 cycles of soiling, washing, drying and sterilization when used as a sequential double wrap for textile packs. - b. Strength through 75 wash, dry and sterilization cycles ASTM #D-5034-2013 >50 psi - c. Linting < 5.0 log IPM. Resists the rigors of linting associated with flexing and abrasion. - d. Cytotoxicity MEM Elution (MG023) Non-Toxic - e. Sterilization Sterilization efficiency/penetration for the Standard Supreme Sterilization Wrappers was demonstrated with a half-cycle exposure condition showing no growth of the indicator organism in worst case challenge load configurations. A pre-vacuum steam sterilization cycle (4 minute exposure at 270°F) has been validated for use on textile packs. The maximum pack size validated for use was 0.58 cubic feet with a pack weight of 12.9 pounds - pack density of 22.4 Ibs./cu.ft. The maximum chamber loading configuration included 85.6 pounds of packs in a 9.1 cubic foot chamber - load density of 10.4 lbs./cu.ft. - f. Use Life - 75 processing (wash, dry and sterilization). - g. Colorfastness to Commercial Laundering AATCC #61-1993(4A) >3.5. {5}------------------------------------------------ # Substantial Equivalence Comparison Standard Supreme Sterilization Wrappers have been shown to be substantially equivalent to WrapPel "T" sterilization wraps K923408. All fabrics used are woven, dyed and treated with a fluoropolymer finish. Fabrics are spread, cut and sewn into the similar if not the exact wrapper size. All products can use color coded thread around the edges to provide easy size identification. Performance through 75 processing demonstrated that Standard Supreme Sterilization Wrappers and WrapPel "T" Sterilization Wrappers have the strength for reuse. Both subject and predicate wrappers can be steam sterilized. In practice Standard Supreme Sterilization Wrappers differ from WrapPel "T" Sterilization Wrappers in that it is a 55/45 blended cotton/polyester fabric versus WrapPel "T" Sterilization Wrappers which are 100% polyester. | Substantial Equivalence Table<br>Standard Supreme Sterilization Wrappers (K172207)<br>vs.<br>WrapPel "T" Sterilization Wrappers (K923408) | | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|----------------------------------------| | | Standard Supreme Sterilization<br>Wrappers | WrapPel "T" Sterilization<br>Wrappers | | <b>Manufacturing</b> | | | | Quality System | 21 CFR 820 | 21 CFR 820 | | Fabric | Woven (1:1) | Woven (1:1) | | Finishing | Vat Dyed | Disperse Dyed &<br>Flurocarbon Treated | | Cut-n-Sew | Yes | Yes | | Finished Dimensions | Similar/Same | Similar/Same | | <b>Performance</b> – Non-clinical tests were used to evaluate the physical and performance characteristics<br>of Standard Supreme Sterilization Wrappers. Performance through 75 processing demonstrated that<br>Standard Supreme Sterilization Wrappers and WrapPel "T" Sterilization Wrappers have the strength<br>for reuse. Both wrappers can be steam sterilized, are colorfast, low lint and non-toxic. | | | | Strength | >20 psi | >20 psi | | Colorfastness | Yes | Yes | | Linting | Completed | Completed | | Toxicity | Non-Toxic | Non-Toxic | | Use Life | 75 wash, dry, & sterilizations | 75 wash, dry, & sterilizations | | <b>Sterilization - Pre-vacuum Steam Cycles</b> | | | | Cycle - 4 minute<br>exposure at 270°F. | Yes | Yes | | <b>Intended Use, i.e., traditional wrapping practices using oblong and envelope folds</b> | | | | Fabric Packs | Yes | Yes | {6}------------------------------------------------ # Substantial Equivalence Conclusion Statement Based on intended use, bench testing and technological characteristics, Standard Supreme Sterilization Wrappers are substantially equivalent to the predicate device. The non-clinical tests demonstrate that Standard Supreme Sterilization Wrappers are substantially equivalent to the predicate device.