Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator

{0}------------------------------------------------ Public Health Service Image /page/0/Picture/2 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 human profiles facing to the right, with flowing lines representing hair or a stream. July 31, 2017 Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Advanced Sterilization Products Ms. Laurie Cartwright Associate Director, Regulatory Affairs 33 Technology Drive Irvine. CA 92618 Re: K163598 Trade/Device Name: Tyvek® Pouch/Roll with STERRAD® Chemical Indicator Regulation Number: 21 CFR 880.6850 /21 CFR 880.2800 Regulation Name: Sterilization Wrap/Sterilization Process Indicator Regulatory Class: Class II Product Code: KCT, JOJ Dated: July 05, 2017 Received: July 07, 2017 Dear Laurie Cartwright: 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 {1}------------------------------------------------ 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 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 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. # Mark S. Fellman -S for 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}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K163598 Device Name Tyvek® Pouch/Roll with STERRAD® Chemical Indicator #### Indications for Use (Describe) Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are intended to enclose medical devices that are to be terminally sterilized in the STERRAD Sterilization Systems and Cycles, in a single or double pouch configuration, and to indicate, by color change, that the pouch has been exposed to sterilant. After completion of the sterilization process, the pouch/roll is intended to maintain sterility of the enclosed device until used. The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2014 [Type I]) that changes from red to the color indicated on the comparator bar included on the shelf pack (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD Sterilization Systems. The pouches and rolls can be used in the STERRAD Sterilization Systems and Cycles shown in Table 1. | Table 1- Indications for Use | | | | | |-----------------------------------------------------------|----------|-------------------------------------------------------------------------------|--------------------------------------------------|--------------------------------------------------------------------------------| | STERRAD® / Cycle | | Single-channel stainless<br>steel lumens | Other lumens | Load requirements | | STERRAD® 100S | | ≥1 mm ID x ≤125 mm long<br>≥2 mm ID x ≤250 mm long<br>≥3 mm ID x ≤400 mm long | Metal and nonmetal<br>≥6 mm ID x ≤310 mm<br>long | ≤10 lumens per load | | STERRAD NX®<br>with or without<br>ALLClear™ Technology | STANDARD | ≥1 mm ID x ≤150 mm long<br>≥2 mm ID x ≤400 mm long | N/A | ≤10 lumens per load ≤10.7<br>lbs | | | ADVANCED | ≥1 mm ID x ≤500 mm long | N/A | ≤10 lumens per load ≤10.7<br>lbs | | STERRAD® 100NX<br>with or without<br>ALLClear™ Technology | STANDARD | ≥0.7 mm ID x ≤500 mm long | N/A | ≤10 lumens per load ≤21.4<br>lbs | | | EXPRESS | N/A | N/A | ≤10.7 lbs on bottom shelf<br>only | | | DUO | N/A | N/A | Accessory devices (e.g.,<br>cameras and light cords) only<br>2 cameras maximum | 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. 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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}------------------------------------------------ Image /page/3/Picture/0 description: The image features a logo with a stylized design. The logo consists of a triangle and the letters 'SP' integrated into a single, continuous line. The entire design is enclosed within a rounded, pill-shaped border, and there is a circled 'R' symbol in the upper right corner, indicating a registered trademark. The logo is presented in a light blue color. # 510(k) Summary ### Advanced Sterilization Products Tyvek® Pouch/Roll with STERRAD® Chemical Indicator with Extended Post-Processing Shelf-Life #### General Information | Submitter Name: | Advanced Sterilization Products<br>Division of Ethicon, Inc., a Johnson & Johnson company | |----------------------|------------------------------------------------------------------------------------------------------------------------| | Address: | 33 Technology Drive<br>Irvine, CA 92618 | | Contact Person: | Laurie Cartwright<br>Associate Director, Regulatory Affairs<br>Telephone: (949) 789-3877<br>Email: lcartwr@its.jnj.com | | Date Prepared: | July 26, 2017 | | 510(k) Number: | K163598 | | Device Name | | | Proprietary Name: | Tyvek® Pouch/Roll with STERRAD® Chemical Indicator | | Common Name: | Sterilization Pouch/Roll with Chemical Indicator | | Classification Name: | Sterilization Wrap/Sterilization Process Indicator | | Device Class: | Class II | | Product Code: | KCT<br>JOJ | | CFR Section: | 21 CFR 880.6850<br>21 CFR 880.2800 | #### Predicate Device Tyvek Pouch/Roll with STERRAD Chemical Indicator cleared under K141693. #### Device Description The modified Tyvek Pouch/Roll with STERRAD Chemical Indicator is constructed from Tyvek plastic films, with the STERRAD Chemical Indicator printed onto the Tyvek film. The self-seal pouch permits sealing of the pouch without need of heat-sealing equipment, while the heat sealed pouches and rolls are heat sealed prior to processing in the STERRAD Sterilization Systems. The modified Tyvek Pouch/Roll with STERRAD Chemical Indicator is intended to enclose medical devices to be terminally sterilized in the STERRAD Sterilization Systems in a single or double pouch configuration. The medical devices are inserted into the pouch/roll, sealed, and then sterilized in the STERRAD Sterilization System. The only difference between the modified device and the predicate device, is the increased post-processing shelf-life to 12 months. The STERRAD Chemical Indicator offers an additional way to verify processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. STERRAD {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a logo with the letters ASP in a stylized font. The letters are white and are set against a light blue background. There is a registered trademark symbol in the upper right corner of the logo. Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the hydrogen peroxide. The color of the Chemical Indicator changes from red to the color indicated by the comparator bar included on the shelf pack (or lighter) when exposed to hydrogen peroxide. The product codes for all Tyvek Pouches and Rolls with STERRAD Chemical Indicator are shown in the following table: | Product Type | Product Codes | |--------------------------------------------------------------------|--------------------------------------------------------------------------------------| | Tyvek Self-Seal Pouches with STERRAD Chemical<br>Indicator (123XX) | 12320, 12326, 12335, 12332, 12342, 12340, 12348,<br>12356 | | Tyvek Rolls with STERRAD Chemical Indicator<br>(124XX) | 12407, 12410, 12415, 12420, 12425, 12435, 12442,<br>12450 | | Tyvek Heat-Seal Pouches with STERRAD<br>Chemical Indicator (125XX) | 12521, 12526, 12532, 12541, 12548, 12543*, 12544*,<br>12557*, 12558*, 12559*, 12560* | * Indicates Product Codes exclusively for markets outside the USA. #### Intended Use/Indications for Use The intended use of the Tyvek Pouch/Roll with STERRAD Chemical Indicator, as described in the 21 CFR 880.6850/21 CFR 880.2800, has not changed as a result of the proposed modification. The Tyvek Pouch/Roll with STERRAD Chemical Indicator (predicate and modified device) is intended to enclose a medical device that is to be sterilized in the STERRAD Sterilization System, and to indicate that the pouch/roll has been exposed to hydrogen peroxide during the sterilization process. The modified device indication for use is provided below: Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are intended to be used to enclose medical devices that are to be terminally sterilized in the STERRAD Sterilization Systems and Cycles, in a single or double pouch configuration, and to indicate, by color change, that the pouch has been exposed to sterilant. After completion of the sterilization process, the pouch/roll is intended to maintain sterility of the enclosed(s) device until used. The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2014 [Type I]) that changes from red to the color indicated on the comparator bar included on the shelf pack (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD Sterilization Systems. The pouches and rolls can be used in the STERRAD Sterilization Systems and Cycles shown in Table 1. | STERRAD® / Cycle | Single-channel stainless steel lumens | Other lumens | Load requirements | | |-----------------------------------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------|---------------------|------------------------------------------------------------------------------------| | STERRAD® 100S | ≥1 mm ID x ≤125 mm long<br>≥2 mm ID x ≤250 mm long<br>≥3 mm ID x ≤400 mm long | Metal and nonmetal<br>≥6 mm ID x<br>≤310 mm long | ≤10 lumens per load | | | STERRAD NX® with or<br>without ALLClear™<br>Technology | STANDARD | ≥1 mm ID x ≤150 mm long<br>≥2 mm ID x ≤400 mm long | N/A | ≤10 lumens per load<br>≤10.7 lbs | | | ADVANCED | ≥1 mm ID x ≤500 mm long | N/A | ≤10 lumens per load<br>≤10.7 lbs | | STERRAD® 100NX<br>with or without<br>ALLClear™ Technology | STANDARD | ≥0.7 mm ID x ≤500 mm long | N/A | ≤10 lumens per load<br>≤21.4 lbs | | | EXPRESS | N/A | N/A | ≤10.7 lbs on bottom<br>shelf only | | | DUO | N/A | N/A | Accessory devices (e.g.,<br>cameras and light cords).<br>only 2 cameras<br>maximum | Table 1- Indications for Use {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a logo with the letters ASP in a stylized font. The letters are white and outlined in a light blue color. The logo is enclosed in a rounded rectangle, also in light blue. There is a small registered trademark symbol in the upper right corner of the logo. #### Non-Clinical Data Verification testing was conducted in support of the extended post-processing shelf-life to the Tyvek Pouch/Roll with STERRAD Chemical Indicator that is the subject of this submission; all testing yielded passing results. This testing is summarized in the following table. | Verification<br>Testing | Description | Results<br>(Pass/Fail) | |----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------| | Maintenance of<br>Package<br>Integrity | 12 Months Sterility Maintenance of the Tyvek Pouches/Rolls with<br>STERRAD Chemical Indicator Post Processing using the<br>STERRAD 100S Sterilization System | Pass | | Maintenance of<br>Package<br>Integrity | 12 Months Sterility Maintenance of the Tyvek Pouches/Rolls with<br>STERRAD Chemical Indicator Post Processing in the STERRAD<br>100S Sterilization System using LONG Cycle | Pass | | Maintenance of<br>Package<br>Integrity | 12 Months Sterility Maintenance of the Tyvek Pouches/Rolls with<br>STERRAD Chemical Indicator Post Processing in the STERRAD<br>NX Sterilization System using ADVANCED Cycle | Pass | | Maintenance of<br>Package<br>Integrity | 12 Months Sterility Maintenance of the Tyvek Pouches/Rolls with<br>STERRAD Chemical Indicator Post Processing in the STERRAD<br>NX Sterilization System using STANDARD Cycle | Pass | | Maintenance of<br>Package<br>Integrity | 12 Months Sterility Maintenance of the Tyvek Pouches/Rolls with<br>STERRAD Chemical Indicator Post Processing in the STERRAD<br>100NX Sterilization System using STANDARD Cycle | Pass | | Maintenance of<br>Package<br>Integrity | 12 Months Sterility Maintenance of the Tyvek Pouches/Rolls with<br>STERRAD Chemical Indicator Post Processing in the STERRAD<br>100NX Sterilization System using EXPRESS Cycle | Pass | | Maintenance of<br>Package<br>Integrity | 12 Months Sterility Maintenance of the Tyvek Pouches/Rolls with<br>STERRAD Chemical Indicator Post Processing in the STERRAD<br>100NX Sterilization System using DUO Cycle | Pass | #### Summary of Performance Testing #### Clinical Data No clinical data was submitted in support of this Premarket Notification. #### Summary The Tyvek Pouch/Roll with STERRAD Chemical Indicator with Extended Post-Processing Shelf-Life and its predicate device, the Tyvek Pouch/Roll with STERRAD Chemical Indicator cleared under K141693, have the same intended use, technological characteristics, design, materials, and principles of operation. Results of maintenance of package integrity verification studies demonstrated that after completion of the sterilization process, the modified device maintains sterility of enclosed medical device(s) for a period of 12 months compared to period of 30 days for the predicate device. Furthermore, the modified device indication for use statement has been updated for clarity (including moving of the post processing shelflife dating to the description section of the Instruction for Use). Refer to the following tables for comparisons between the modified and the predicate device characteristics. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a logo with the letters "ASP" in white against a light blue background. The "A" is represented by a triangle, and the "S" and "P" are stylized and connected. A small registered trademark symbol is visible in the upper right corner of the logo. | | Predict Tyvek® Pouch/Roll with | Modified Device: Tyvek® Pouch/Roll with STERRAD®<br>Chemical Indicator with Extended Post-Processing Shelf-Life | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | STERRAD® Chemical Indicator (K141693) | (K163598) | | Intended Use | The Tyvek Pouch/Roll with STERRAD Chemical Indicator is<br>intended to enclose a medical device that is to be sterilized in<br>the STERRAD Sterilization System, and to indicate that the<br>pouch/roll has been exposed to hydrogen peroxide during the<br>sterilization process. | Same | | Indications for<br>Use | Tyvek® Pouches and Rolls with STERRAD® Chemical<br>Indicator are intended to be used to enclose medical devices<br>that are to be terminally sterilized in the STERRAD<br>Sterilization Systems and Cycles, in a single or double pouch<br>configuration, and to indicate, by color change, that the pouch<br>has been exposed to sterilant. After completion of the<br>sterilization process, the pouch/roll maintains sterility until<br>the pouch/roll is used; in the United States, this is for a period<br>of 30 days.<br>The STERRAD Sterilization Systems and Cycles that can be<br>used are shown in Table 1. The product codes for all Tyvek<br>Pouches and Rolls with STERRAD Chemical Indicator are<br>listed in Table 2.<br>The pouches and rolls are printed with a chemical indicator<br>bar which is a process indicator (ISO 11140-1:2005) that<br>changes from red to yellow (or lighter) when exposed to<br>hydrogen peroxide vapor during processing in the STERRAD<br>Sterilization Systems. | Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator<br>are intended to be used to enclose medical devices that are to be<br>terminally sterilized in the STERRAD Sterilization Systems and<br>Cycles, in a single or double pouch configuration, and to indicate,<br>by color change, that the pouch has been exposed to sterilant.<br>After completion of the sterilization process, the pouch/roll is<br>intended to maintain sterility of the enclosed device(s) until used.<br>The pouches and rolls are printed with a chemical indicator bar<br>which is a process indicator (ISO 11140-1:2014 [Type I]) that<br>changes from red to the color indicated on the comparator bar<br>included on the shelf pack (or lighter) when exposed to hydrogen<br>peroxide vapor during processing in the STERRAD Sterilization<br>Systems.<br>The pouches and rolls can be used in the STERRAD Sterilization<br>Systems and Cycles shown in Table 1. | # Comparison of Device Characteristics {7}------------------------------------------------ Image /page/7/Picture/0 description: The image is a logo for ASP. The logo is a rounded rectangle with the letters "ASP" in white inside. The "A" is a triangle, and the "P" is a backwards "P". There is a registered trademark symbol in the upper right corner of the logo. | Predict Tyvek® Pouch/Roll with STERRAD® Chemical Indicator (K141693) | | | Modified Device: Tyvek® Pouch/Roll with STERRAD® Chemical Indicator with Extended Post-Processing Shelf-Life (K163598) | | | |----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | | | | STERRAD® / Cycle | Single-channel stainless steel lumens | Other lumens<br>Load requirements | STERRAD® / Cycle | Single-channel stainless steel lumens | Other lumens<br>Load requirements | | STERRAD® 100S | ≥1 mm ID x ≤125 mm long<br>≥2 mm ID x ≤250 mm long<br>≥3 mm ID x ≤400 mm long | Metal and nonmetal<br>≥6 mm ID x ≤310 mm long<br>≤10 lumens per load | STERRAD® 100S | ≥1 mm ID x ≤125 mm long<br>≥2 mm ID x ≤250 mm long<br>≥3 mm ID x ≤400 mm long | Metal and nonmetal<br>≥6 mm ID x ≤310 mm long<br>≤10 lumens per load | | STERRAD® 50 | ≥1 mm ID x ≤125 mm long<br>≥2 mm ID x ≤250 mm long<br>≥3 mm ID x ≤400 mm long | Metal and nonmetal<br>≥6 mm ID x ≤310 mm long<br>≤10 lumens per load | STERRAD NX® with or without ALLClear™ Technology | STANDARD<br>≥1 mm ID x ≤150 mm long<br>≥2 mm ID x ≤400 mm long<br>ADVANCED<br>≥1 mm ID x ≤500 mm long | N/A<br>≤10 lumens per load<br>≤10.7 lbs<br>N/A<br>≤10 lumens per load<br>≤10.7 lbs | | STERRAD® 200 | ≥1 mm ID x ≤125 mm long<br>≥2 mm ID x ≤250 mm long<br>≥3 mm ID x ≤400 mm long | Teflon® and polyethylene<br>≥6 mm ID x ≤310 mm long<br>≤12 lumens per load<br>≤36.48 lbs | STERRAD® 100NX with or without ALLClear™ Technology | STANDARD<br>≥0.7 mm ID x ≤500 mm long<br>EXPRESS<br>N/A<br>DUO<br>N/A | N/A<br>≤10 lumens per load<br>≤21.4 lbs<br>N/A<br>≤10.7 lbs on bottom shelf only<br>N/A<br>Accessory devices (e.g., cameras and light cords) only 2 cameras maximum | | STERRAD NX® | Standard<br>≥1 mm ID x ≤150 mm long<br>≥2 mm ID x ≤400 mm long<br>Advanced<br>≥1 mm ID x ≤500 mm long | N/A<br>≤10 lumens per load<br>≤10.7 lbs<br>N/A<br>≤10 lumens per load<br>≤10.7 lbs | | | | | STERRAD 100NX® | Standard<br>≥0.7 mm ID x ≤500 mm long<br>EXPRESS<br>N/A<br>DUO<br>N/A | N/A<br>≤10 lumens per load<br>≤21.4 lbs<br>N/A<br>≤10.7 lbs on bottom shelf only<br>N/A<br>Accessory devices (e.g., cameras and light cords) only 2 cameras maximum | | | | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows a logo with the letters "ASP" in a stylized font. The "A" is represented by a triangle, and the "S" and "P" are connected with a single line. The logo is enclosed in a rounded rectangle with a light blue background. There is a registered trademark symbol in the upper right corner of the logo. | | Predict Tyvek® Pouch/Roll with<br>STERRAD® Chemical Indicator (K141693) | Modified Device: Tyvek® Pouch/Roll with STERRAD®<br>Chemical Indicator with Extended Post-Processing Shelf-Life<br>(K163598) | |--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------| | Design Features | Two films which are heat sealed together on three sides for<br>individual pouches and on two sides for roll form pouches.<br><br>A Chemical Indicator (CI) bar is printed onto the Tyvek side<br>of the pouch. For the self-seal pouch, the CI is printed onto<br>back surface of the Tyvek. For the heat-seal pouch and roll,<br>the CI is printed onto the Tyvek, but is encased in the seam of<br>the pouch between the Tyvek and transparent film. | Same | | Chemical Indicator | STERRAD indicator ink | Same | | Chemical Indicator Device Design | The color of the Chemical Indicator changes from red to color indicated by comparator bar (or lighter) when exposed to hydrogen peroxide vapor during the sterilization process in the STERRAD Sterilization Systems. | Same | | Post-Processing Sterility Shelf-Life | 30 days | 12 months | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows a logo with the letters "ASP" in a stylized font. The letters are white and are set against a light blue background. The logo is enclosed in a rounded rectangle shape. There is a registered trademark symbol in the upper right corner of the logo. | | Predict Tyvek® Pouch/Roll with<br>STERRAD® Chemical Indicator (K141693) | Modified Device: Tyvek® Pouch/Roll with STERRAD®<br>Chemical Indicator with Extended Post-Processing Shelf-Life | |---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------| | Biocompatibility | In vivo testing demonstrated that the pouch samples, after<br>STERRAD processing, met the acceptance criteria per ISO<br>10993-11 and 10993-10 and can be safely used. | No new testing. Predicate Device testing applies to modified<br>device; no change to device materials | | End Point / Post<br>Processing Color<br>Stability | Tyvek Pouches/Rolls, after STERRAD processing,<br>maintained the endpoint CI color reaction. | No new testing. Predicate Device testing applies to modified<br>device; no change to device materials | | Material<br>Compatibility | Seal strength test, microbial barrier properties, burst test,<br>and peel open test demonstrated acceptable material<br>compatibility characteristics of the Tyvek Pouches/Rolls<br>after STERRAD processing | No new testing. Predicate Device testing applies to modified<br>device; no change to device materials | | Sterilant Penetration<br>Efficacy | The sterilant penetrated through the "double pouch"<br>configuration under the worst case half-cycle conditions<br>and the sterility assurance level (SAL) of 10-6 was<br>demonstrated. | No new testing. Predicate Device testing applies to modified<br>device; no change to device materials | | Seal Strength | Seal strength of the processed Tyvek Pouches/Rolls is<br>maintained at the end of pre-processing shelf life. | No new testing. Predicate Device testing applies to modified<br>device; no change to device materials | | Chemical Indicator<br>(CI) Functionality | CI functionality of the processed Tyvek Pouches/Rolls is<br>maintained at the end of pre-processing shelf life. | No new testing. Predicate Device testing applies to modified<br>device; no change to device materials | | Maintenance of<br>Package<br>Integrity | 30 days sterility maintenance post processing in<br>STERRAD Sterilizers | 12 months sterility maintenance post processing in STERRAD<br>Sterilizers | # Comparison of Biocompatibility and Performance Testing {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows a logo with the letters ASP inside of a rounded rectangle. The letters are white, and the rectangle is a light blue color. There is a registered trademark symbol in the upper right corner of the rectangle. In conclusion, the intended use, operating principle, performance specification, material and design of the modified device are same as the predicate device and the minor differences between the modified device and its predicate device do not raise any new questions of safety or effectiveness. Thus, the Tyvek Pouch/Roll with STERRAD Chemical Indicator with Extended Post-Processing Shelf-Life is substantially equivalent to the predicate device cleared in K141693.