SterilContainer S System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in blue, followed by the words "U.S. Food & Drug Administration" in blue. December 21, 2018 Aesculap, Inc. Paul Amudala Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034 Re: K182032 Trade/Device Name: SterilContainer S System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: November 20, 2018 Received: November 23, 2018 Dear Paul Amudala: 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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Elizabeth F. Claverie -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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K182032 Device Name SterilContainer™ S System #### Indications for Use: The SterilContainer S System is a reusable sterilization container system (consisting of perforated bottoms and perforated lids with filter retention plates, and single use polypropylene filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. This container system has been validated with flexible endoscopes and accessories, cables, and camera heads. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use with the STERRAD 100NX DUO Cycle. The SterilContainer S System includes accessories such as silicone mats, baskets, trays, racks, filters, indicator cards, locks, and instrument holders. Validation testing for event related sterility maintenance has been conducted for up to 365 days. | Load Configuration | Container # 1 | Container # 2 | |--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | • 135mm Full Size Container Bottom<br>• Full Size Container Lid<br>• Full Size Basket<br>• Full Size Mat<br>• Flexible Endoscope (1.2 mm x 785 mm)<br>• Guide Cable (1x) | • 135mm Full Size Container Bottom<br>• Full Size Container Lid<br>• Full Size Basket<br>• Full Size Mat<br>• Flexible Endoscope (1.2 mm x 785 mm)<br>• Guide Cable (2x) | | 2 | • 187mm Full Size Container Bottom<br>• Full Size Container Lid<br>• Full Size Basket<br>• Full Size Mat<br>• Flexible Endoscope (1.2 mm x 785 mm)<br>• Guide Cable (2x) | • N/A – Top shelf is removed to allow the container to fit in the chamber | | 3 | • 90mm Full Size Container Bottom<br>• Full Size Container Lid<br>• Full Size Basket<br>• Full Size Mat<br>• Flexible Endoscope (1.2 mm x 785 mm)<br>• Guide Cable (2x) | • 135mm Half Size Container Bottom<br>• Half Size Container Lid<br>• Half Size Basket<br>• Half Size Mat<br>• Camera Head for Endoscope | #### Table 1: Validated STERRAD 100NX DUO Cycle Load Configurations {3}------------------------------------------------ | Lid | Bottom | Description | Container Load Weight * | |-------|--------|------------------------|---------------------------------------------------------------| | JM489 | JM440 | Full Size 90mm (4 ¼") | | | | JM441 | Full Size 120mm (5 ½") | | | | JM442 | Full Size 135mm (6") | | | | JM444 | Full Size 187mm (8") | | | JM789 | JM740 | ¾ Size 90mm(4 ¼") | 13.2 lbs total weight. (1 or 2<br>shelves based on container) | | | JM741 | ¾ Size 120mm (5 ½") | | | JM389 | JM340 | ½ Size 90mm (4 ¼") | | | | JM341 | ½ Size 120mm (5 ½") | | | | JM342 | ½ Size 135mm (6") | | | | JM344 | ½ Size 187mm (8") | | #### Table 2: STERRAD 100NX DUO Compatible SterilContainer S Container Systems *Loads containing a flexible endoscope or bronchoscope should follow Table 1 recommendations #### Table 3: STERRAD 100NX DUO Cycle Compatible Accessories | Accessories | STERRAD 100NX DUO<br>Cycle | |--------------------------------------------------------------------------------------------------------------------------|----------------------------| | Stainless Steel baskets, basket lids, and dividers | Yes | | Instrument Organization System (Silicone and Stainless Steel racks,<br>brackets, instrument holders, and clamps) | Yes | | Silicone mats | Yes | | Stainless Steel racks, trays, instrument holders, clamps, brackets,<br>tamper-proof locks, indicator cards and platforms | Yes | Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) > 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." {4}------------------------------------------------ #### 510(k) SUMMARY (as required by 21 CFR 807.92) SterilContainer" S System for use in the STERRAD 100NX DUO Cycle Dec 13, 2018 | COMPANY: | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 2916714 | |----------------------|--------------------------------------------------------------------------------------------------------------------| | CONTACT: | Paul Amudala<br>Regulatory Affairs Specialist<br>610-984-9303 (phone)<br>610-791-6882 (fax) | | TRADE NAME: | SterilContainer S System | | COMMON NAME: | Sterilization Container Wrap | | CLASSIFICATION NAME: | Sterilization Wrap | | REGULATION NUMBER: | 21 CFR 880.6850 | | PRODUCT CODE: | KCT | | DEVICE CLASS: | Class II | ## PREDICATE DEVICE K093493 - SterilContainer™ S System for use in STERRAD 200, STERRAD NX (STANDARD (Std.) & ADVANCED (Adv.) and STERRAD 100NX (Std. & FLEX) #### REFERENCE DEVICE K142970- SterilContainer™ S for use in STERRAD 100NX EXPRESS Cycle via K142970. ## DEVICE DESCRIPTION The SterilContainer™S System is a container system that will allow for sterilization and storage of medical devices. This container system can be used in the STERRAD 100NX DUO Sterilization System. The SterilContainer" S System rigid containers are made from nonanodized Aluminum and utilize disposable (single use) polypropylene filters. The SterilContainer" S System includes accessories such as mats, baskets, trays, instrument holders, organizers, filters, indicator cards and tamper proof locks. #### Indications for Use: The SterilContainer S System is a reusable sterilization container system (consisting of perforated bottoms and perforated lids with filter retention plates, and single use polypropylene filters) intended to be used to enclose another medical device that is to be sterilized by a {5}------------------------------------------------ healthcare provider. This container system has been validated with flexible endoscopes and accessories, cables, and camera heads. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use with the STERRAD 100NX DUO Cycle. The SterilContainer S System includes accessories such as silicone mats, baskets, trays, racks, filters, indicator cards, locks, and instrument holders. Validation testing for event related sterility maintenance has been conducted for up to 365 days. | Load<br>Configuration | Container # 1 | Container # 2 | |-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | • 135mm Full Size Container<br>Bottom<br>• Full Size Container Lid<br>• Full Size Basket<br>• Full Size Mat<br>• Flexible Endoscope (1.2 mm x 785 mm)<br>• Guide Cable (1x) | • 135mm Full Size Container<br>Bottom<br>• Full Size Container Lid<br>• Full Size Basket<br>• Full Size Mat<br>• Flexible Endoscope (1.2 mm x 785 mm)<br>• Guide Cable (2x) | | 2 | • 187mm Full Size Container<br>Bottom<br>• Full Size Container Lid<br>• Full Size Basket<br>• Full Size Mat<br>• Flexible Endoscope (1.2 mm x 785 mm)<br>• Guide Cable (2x) | • N/A – Top shelf is removed to<br>allow the container to fit in the<br>chamber | | 3 | • 90mm Full Size Container<br>Bottom<br>• Full Size Container Lid<br>• Full Size Basket<br>• Full Size Mat<br>• Flexible Endoscope (1.2 mm x 785 mm)<br>• Guide Cable (2x) | • 135mm Half Size Container<br>Bottom<br>• Half Size Container Lid<br>• Half Size Basket<br>• Half Size Mat<br>• Camera Head for Endoscope | Table 1: Validated STERRAD 100NX DUO Cycle Load Configurations #### Table 2: STERRAD 100NX DUO Compatible SterilContainer S Container Systems | Lid | Bottom | Description | Container Load Weight * | |-------|--------|------------------------|---------------------------------------------------------------| | JM489 | JM440 | Full Size 90mm (4 ¼") | 13.2 lbs total weight. (1 or 2<br>shelves based on container) | | | JM441 | Full Size 120mm (5 ½") | | | | JM442 | Full Size 135mm (6") | | | | JM444 | Full Size 187mm (8") | | | JM789 | JM740 | ¾ Size 90mm(4 ¼") | | | | JM741 | ¾ Size 120mm (5 ½") | | | JM389 | JM340 | ½ Size 90mm (4 ¼") | | | | JM341 | ½ Size 120mm (5 ½") | | | | JM342 | ½ Size 135mm (6") | | | | JM344 | ½ Size 187mm (8") | | *Loads containing a flexible endoscope or bronchoscope should follow Table 1 recommendations {6}------------------------------------------------ | Accessories | STERRAD 100NX DUO<br>Cycle | |--------------------------------------------------------------------------------------------------------------------------|----------------------------| | Stainless Steel baskets, basket lids, and dividers | Yes | | Instrument Organization System (Silicone and Stainless Steel racks,<br>brackets, instrument holders, and clamps) | Yes | | Silicone mats | Yes | | Stainless Steel racks, trays, instrument holders, clamps, brackets,<br>tamper-proof locks, indicator cards and platforms | Yes | #### Table 3: STERRAD 100NX DUO Compatible Accessories # TECHNOLIGICAL CHARACTERISTICS COMPARISON TABLE The SterilContainer S System for proposed use in the STERRAD 100NX DUO is the same container system that was cleared in K093493 & K142970. The materials and design have not changed. | System | SterilContainer S<br>System (K182032) | SterilContainer S System<br>(K093493) Primary<br>Predicate | SterilContainer S<br>System (K142970)<br>Reference Device | Comparison | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Sterilization<br>process | STERRAD 100NX<br>DUO | STERRAD 200 ,<br>STERRAD NX &<br>Adv. , STERRAD<br>100 NX Std. &<br>FLEX Cycle | STERRAD 100NX<br>EXPRESS | Different | | Material | Non-<br>anodized<br>aluminum | Non-anodized aluminum | Non-anodized<br>aluminum | Same | | Container<br>type | Perforated | Perforated | Perforated | Same | | Filter type | Polypropylene | Polypropylene | Polypropylene | Same | | Gasket | Silicone | Silicone | Silicone | Same | | Sizes | Full, 1/2, 3/4 | Full, ½, ¾, ¼, XL Mini | Full,1/2 | Similar | | Accessories | Stainless Steel<br>baskets, basket lids,<br>dividers, racks, trays,<br>holders clamps;<br>instrument<br>organization systems;<br>silicone mats; tamper<br>proof locks; indicator<br>cards | Stainless Steel baskets,<br>basket lids, dividers,<br>racks, trays, holders<br>clamps; instrument<br>organization systems;<br>silicone mats; tamper<br>proof locks; indicator<br>cards | Stainless Steel<br>baskets, basket lids,<br>dividers, racks,<br>trays, holders<br>clamps; instrument<br>organization<br>systems; silicone<br>mats; tamper proof<br>locks; indicator<br>cards | Same | | Reuse | Reusable | Reusable | Reusable | Same | {7}------------------------------------------------ ## NON-CLINICAL PERFORMANCE DATA The Aesculap SterilContainer S System has been validated for the STERRAD 100NX DUO Cycle. These validations were conducted by a qualified testing laboratory. The performance testing demonstrates that the device meets the acceptance criteria for each test. | Performance Testing | Results | |--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sterilization Efficacy/<br>Lethality Study | Testing demonstrated a 12 log reduction and a sterility assurance<br>level (SAL) of $10^{-6}$ using the biological (BI) overkill method and<br>half-cycle validation. | | Maintenance of<br>Sterility | Maintenance Sterility for the proposed devices remains<br>unchanged and continues to provide an effective barrier for<br>maintaining sterility of the contents after sterilization for 365<br>days event related storage under conditions which simulate<br>hospital sterile package handling and storage conditions still<br>applies for the DUO cycle. | | Simulated Use | Testing demonstrated that a 6-log reduction of G.<br>stearothermophilus suspended in artificial soil medium is<br>achieved for the Aesculap, Inc. SterilContainer S Containers<br>when processed through a full cycle in the STERRAD 100NX<br>DUO Cycle in healthcare facilities. | | Inactivation Kinetics | No growth was observed from three different injection<br>doses for load configuration 1, 2 and 3 respectively. | | Aerosol Challenge | The Aerosol challenge remains unchanged from the predicates as<br>the container as well as the gaskets of the container remain the<br>same as cleared in predicates.<br>Predicate device data is still relevant for the proposed device. | | Material Compatibility | Material Compatibility test data has not changed and remains<br>the same as cleared in predicate. | | Biocompatibility | The biocompatibility of the container remains unchanged from<br>the predicates as the materials of the container remains the<br>same as cleared in the predicate. | ## CONCLUSION The non-clinical testing demonstrates that the SterilContainer S System for use in the STERRAD 100NX DUO Cycle is as safe, as effective and performs as well as or better than the legally marketed predicate device, the Aesculap SterilContainer S System for use in the STERRAD 200, STERRAD NX (Std. & Adv.) and STERRAD 100NX (Std. and Flex) Cycles (K093493) .