SterilContainer with PrimeLine Pro Lid

{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 17, 2017 Aesculap, Inc. Lisa Boyle Regulatory Affairs Manager 3773 Corporate Parkway Center Valley, Pennsylvania 18034 Re: K172850 Trade/Device Name: SterilContainer with PrimeLine Pro Lid Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: October 24, 2017 Received: October 25, 2017 Dear Lisa Boyle: 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); {1}------------------------------------------------ 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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, 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) K172850 #### Device Name SterilContainer with PrimeLine Pro Lid #### Indications for Use (Describe) The Aesculap Sterilcontainer System is a reusable sterilization container system (consisting of solid & perforated bottoms, a perforated lid w/ filter retention plates, and reusable polytetrafluoroethylene (PTFE) filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. 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 in pre-vacuum steam and IUSS (Immediate Use Steam Sterilization modalities. The SterilContainer System for includes accessories such as silicone mats, baskets, trays, and racks. | A combined maximum load validated for all container configurations is 25lbs. | | | | |--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------| | Sterilization Cycle Parameters | PrimeLime Pro Container<br>Lid with JP050 - Lid Size | Solid Base to be used<br>with Lid | Max No. of Lumens<br>Lumen Configuration | | Immediate Use (Non porous)<br>270°F Temp, 3 min. Exposure<br>No stacking recommended | 1/2 size Lid<br>(298 x281 x36)<br>Art. No. JP121 - JP125 | JK340 (4-1/4 in height)<br>JK341 (5-1/2 in height)<br>JK342 (6 in height)<br>JK344 (8 in height)<br>JK346 (10-1/2 in height) | Immediate Use - Non Porous:<br>No lumens, a hinged device,<br>and a knurled (irregular<br>surface) device. | | Immediate Use (porous)<br>270°F Temp, 4 min. Exposure<br>No stacking recommended | 3/4 size Lid<br>(465 x 281 x 36)<br>Art. No. JP111 - JP115 | JK740 (4-1/4 in height)<br>JK741 (5-1/2 in height)<br>JK742 (6 in height)<br>JK744 (8 in height) | Immediate Use - Porous:<br>1 SS lumen with 3mm I.D. x<br>400mm L and a hinged device. | | Prevacuum Dry Time Study<br>270°FTemp, 4min.Exposure, 30 min.<br>Dry Time<br>Stacking should not exceed 16-18"<br>height | Full size Lid<br>(588 x 281 x 36)<br>Art. No. JP101 - JP105 | JK440 (4-1/4 in height)<br>JK441 (5-1./2 in height)<br>JK442 (6 in height)<br>JK444 (8 in height)<br>JK446 (10-1/2 in height) | | | Sterilization Cycle | Lid Size | Perforated Base to be<br>used with Lid | | | | 1/2 size Lid<br>(298 x281 x36)<br>Art. No. JP121 - JP125 | JN340 (41/2 in height)<br>JN341 (51/2 in height)<br>JN342 (6 in height)<br>JN344 (8 in height)<br>JN346 (101/2 in height) | | | Prevacuum Dry Time Study<br>270°FTemp, 4min.Exposure, 30 min.<br>Dry Time<br>Stacking should not exceed 16-18"<br>height | 3/4 size Lid<br>(465 x 281 x 36)<br>Art. No. JP111 - JP115 | JN740 (4-1/4 in height)<br>JN741 (5-1/2 in height)<br>JN742 (6 in height)<br>JN744 (8 in height) | | | | Full size Lid<br>(588 x 281 x 36)<br>Art. No. JP101 - JP105 | JN440 (4-1/4 in height)<br>JN441 (5-1/2 in height)<br>JN442 (6 in height)<br>JN444 (8 in height)<br>JN446 (10-1/2 in height) | | ### Table 2: Steam and IUSS Cycle Compatible Accessories | Accessories | Steam and IUSS | |-------------------------------------------------------------------------------------------------------|----------------| | Stainless Steel baskets,<br>basket lids, and dividers | Yes | | Instrument Organization System (Silicone and Stainless Steel racks,<br>brackets, holders, and clamps) | Yes | | Silicone mats | Yes | | Stainless Steel racks, trays, holders, clamps, brackets, and platforms | Yes | {3}------------------------------------------------ ■ Prescription Use (Part 21 CFR 801 Subpart D) #### 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) 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 with PrimeLine Pro Lid November 10, 2017 | COMPANY: | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 291671- | |----------------------|--------------------------------------------------------------------------------------------------------------------| | CONTACT: | Lisa Boyle<br>610-984-9274 (phone)<br>610-791-6882 (fax) | | TRADE NAME: | SterilContainer with PrimeLine Pro Lid | | COMMON NAME: | Sterilization Container | | CLASSIFICATION NAME: | Wrap, Sterilization | | REGULATION NUMBER: | 880.6850 | | PRODUCT CODE: | KCT | ## PREDICATE DEVICES Primary Predicate : Primeline Lid (K073168) Reference Devices: Sterilcontainer System (K792558), Rigid Container System (K944864), and the SterilContainer System for Flash Indications (K053389), and SterilContainer System for Pre-Vac Steam. Immediate Use Steam, and EtO Sterilization (K112671). ## DEVICE DESCRIPTION The SterilContainer with PrimeLine Pro Lid is used in conjunction with Aesculap's Sterilcontainer Systems (K792558/K944864/K053389/K112671). The SterilContainer with PrimeLine Pro Lid is designed to be compatible for use with pre-vacuum steam and IUSS sterilization. The lid is manufactured from anodized aluminum and utilizes a reusable polytetrafluoroethylene (PTFE) filter. The SterilContainer with PrimeLine Pro Lid is offered in a various colors and range of sizes as the predicates including full, ¾, and half sizes lids. ## INDICATIONS FOR USE The Aesculap Sterilcontainer System is a reusable sterilization container system (consisting of solid & perforated bottoms, a perforated lid w/ filter retention plates, and reusable polytetrafluoroethylene (PTFE) filters) intended to enclose another medical device that is to be sterilized by a healthcare provider. 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 in pre-vacuum steam and IUSS {5}------------------------------------------------ (Immediate Use Steam Sterilization) sterilization modalities. The SterilContainer System includes accessories such as silicone mats, baskets, trays, and racks. | A combined maximum load validated for all container configurations is 25lbs. | | | | |--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------| | Sterilization Cycle Parameters | PrimeLime Pro Container<br>Lid with JP050 - Lid Size | Solid Base to be used<br>with Lid | Max No. of Lumens<br>Lumen Configuration | | Immediate Use (Non porous)<br>270°F Temp, 3 min. Exposure<br>No stacking recommended | ½ size Lid<br>(298 x281 x36)<br>Art. No. JP121 - JP125 | JK340 (4-1/4 in height)<br>JK341 (5-1/2 in height)<br>JK342 (6 in height)<br>JK344 (8 in height)<br>JK346 (10-1/2 in height) | Immediate Use - Non Porous:<br>No lumens, a hinged device,<br>and a knurled (irregular<br>surface) device. | | Immediate Use (porous)<br>270°F Temp, 4 min. Exposure<br>No stacking recommended | ¾ size Lid<br>(465 x 281 x 36)<br>Art. No. JP111 - JP115 | JK740 (4-1/4 in height)<br>JK741 (5-1/2 in height)<br>JK742 (6 in height)<br>JK744 (8 in height) | Immediate Use - Porous:<br>1 SS lumen with 3mm I.D. x<br>400mm L and a hinged device. | | Prevacuum Dry Time Study<br>270°FTemp, 4min.Exposure, 30 min.<br>Dry Time<br>Stacking should not exceed 16-18"<br>height | Full size Lid<br>(588 x 281 x 36)<br>Art. No. JP101 - JP105 | JK440 (4-1/4 in height)<br>JK441 (5-1./2 in height)<br>JK442 (6 in height)<br>JK444 (8 in height)<br>JK446 (10-1/2 in height) | | | Sterilization Cycle | Lid Size | Perforated Base to be<br>used with Lid | | | Prevacuum Dry Time Study<br>270°FTemp, 4min.Exposure, 30 min.<br>Dry Time<br>Stacking should not exceed 16-18"<br>height | ½ size Lid<br>(298 x281 x36)<br>Art. No. JP121 - JP125 | JN340 (41/2 in height)<br>JN341 (51/2 in height)<br>JN342 (6 in height)<br>JN344 (8 in height)<br>JN346 (101/2 in height) | | | | ¾ size Lid<br>(465 x 281 x 36)<br>Art. No. JP111 - JP115 | JN740 (4-1/4 in height)<br>JN741 (5-1/2 in height)<br>JN742 (6 in height)<br>JN744 (8 in height) | | | | Full size Lid<br>(588 x 281 x 36)<br>Art. No. JP101 - JP105 | JN440 (4-1/4 in height)<br>JN441 (5-1/2 in height)<br>JN442 (6 in height)<br>JN444 (8 in height)<br>JN446 (10-1/2 in height) | | ### Table 1: Steam and IUSS Compatible SterilContainer with PrimeLine Pro Lid ## Table 2: Steam and IUSS ### Cycle Compatible Accessories | Accessories | Steam and IUSS | |-------------------------------------------------------------------------------------------------------|----------------| | Stainless Steel baskets,<br>basket lids, and dividers | Yes | | Instrument Organization System (Silicone and Stainless Steel racks,<br>brackets, holders, and clamps) | Yes | | Silicone mats | Yes | | Stainless Steel racks, trays, holders, clamps, brackets, and platforms | Yes | # TECHNOLIGICAL CHARACTERISTICS (compared to predicates) The SterilContainer with PrimeLine Pro Lid is made from anodized aluminum (AMg1). The only difference between the subject device and the predicate lid is material of the lid. The original Primeline Lid (K073168) is constructed of a plastic polymer, but uses the exact same integrated PTFE filter and retention plate system of the subject SterilContainer with PrimeLine Pro Lid. This new lid is manufactured from the same aluminum type material that is used for other Aesculap SterilContainer Lids (K112671/K053389/K792258). {6}------------------------------------------------ The SterilContainer with PrimeLine Pro Lid is compatible for use with pre-vacuum steam and IUSS sterilization which are the cycles that the Primeline Lid (K073168) was cleared for use with (steam and flash). Aesculap's Sterilization Container System was cleared for use in pre-vacuum steam and pre-vacuum IUSS among other sterilization modalities. The SterilContainer with PrimeLine Pro Lid is offered in variety of colors and sizes (full, 3/4, and half). | Device/<br>System | Aesculap<br>SterilContainer<br>w/ PrimeLine<br>Pro Lid | Aesculap<br>SterilContainer<br>w/Aluminum<br>Lid and<br>PrimeLine Lid | Aesculap<br>SterilContainer<br>with Primeline<br>Lid | Aesculap<br>SterilContainer<br>(Flash) | Aesculap<br>PriMed Rigid<br>Container<br>System | Aesculap<br>Container<br>System | |---------------------------------------|--------------------------------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------|----------------------------------------|-------------------------------------------------|---------------------------------| | 510(k) | Pending | K112671 | K073168 | K053389 | K944864 | K792558 | | Sterilization<br>Modalities | Pre-vac steam,<br>Immediate<br>Use Pre-vac<br>steam | Pre-vac steam,<br>Immediate Use<br>steam | Pre-vac steam,<br>Immediate Use<br>Pre-vac steam | Immediate Use<br>steam | Gravity<br>steam, High-<br>vacuum<br>steam, EO | Pre-vac,<br>Steam, EtO | | Material | Anodized<br>Aluminum | Anodized<br>Aluminum/Radel<br>R | Anodized<br>Aluminum/Radel<br>R | Anodized<br>Aluminum | Anodized<br>Aluminum/<br>JADEX | Anodized<br>Aluminum | | Worst case<br>Vent to<br>Volume Ratio | .50 | .41 | .49 | .68 | .59 | Not Available | | Filter | Reusable filter | Single Use<br>Paper Filter,<br>Single Use<br>Polypropylene<br>Filter, Reusable<br>filter | Reusable filter | Single Use<br>Paper Filter | Single Use<br>Paper filter | Single Use<br>Paper Filter, | | Shelf-life/<br>Barrier | 30,180, and<br>365 days<br>(event related) | 360 days (event<br>related) | 360 days (event<br>related) | N/A (24 hr<br>barrier) | Not defined | Not defined | | Reuse testing | 2,200 uses (lid<br>and filter) | 2,200 uses (lid<br>and filter) | 2,200 uses (lid<br>and filter) | 100 cycles<br>minimum | 100 cycles<br>minimum | 100 cycles<br>minimum | | Max total<br>weight | 25 pounds | 25 pounds | 35 pounds | 35 pounds | 25 pounds | 35 pounds | # PERFORMANCE DATA The SterilContainer with PrimeLine Pro Lid was fully validated for pre-vacuum steam and IUSS sterilization cycles. The validations were conducted in accordance with FDA guidance and available AAMI standards by a qualified testing laboratory. The performance testing demonstrates substantial equivalence to the predicate devices. The following performance testing has been completed to ensure substantial equivalence. Test were performed in best/mid/worst case sized regarding vent to volume ratio and container size. {7}------------------------------------------------ | Performance Properties | Results | |--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sterilization Efficacy | Testing demonstrated a 6 log reduction and a sterility<br>assurance level (SAL) of 10-6 using the biological (BI)<br>overkill method and half-cycle validation. | | Whole Package Microbial<br>Aerosol Challenge | After exposure to a defined amount of aerosol<br>microorganisms contents maintained sterility. | | Event Related Sterility<br>Maintenance (30, 180, and<br>365 days). | The test reports demonstrated that the SterilContainer with<br>PrimeLine Pro Lid consistently maintained sterility of the<br>contents after processing followed by a 30, 180, and 365<br>day event related storage under conditions which simulate<br>hospital sterile package handling and storage conditions as<br>long as the barrier is not compromised. | | Mechanical Cleaning<br>(Protein Analysis) | The study results validate that the mechanical cleaning<br>instructions were effective in removing gross amounts of<br>soil from the SterilContainer with PrimeLine Pro Lid to a<br>protein level of less than 6.4µg/cm² per device. | | Mechanical Cleaning<br>(Hemoglobin Analysis) | The study results validate that the mechanical cleaning<br>instructions were effective in removing gross amounts of<br>soil from the SterilContainer with PrimeLine Pro Lid to a<br>hemoglobin level of less than 2.2 µg/cm² per device. | | Manual Cleaning (Protein<br>Analysis) | The study results validate that the manual cleaning<br>instructions were effective in removing gross amounts of<br>soil from the SterilContainer with PrimeLine Pro Lid to a<br>protein level of less than 6.4µg/cm² per device. | | Manual Cleaning<br>(Hemoglobin Analysis) | The study results validate that the manual cleaning<br>instructions were effective in removing gross amounts of<br>soil from the SterilContainer with PrimeLine Pro Lid to a<br>protein level of less than 2.2 µg/cm² per device. | # CONCLUSION The SterilContainer with PrimeLine Pro Lid is substantially equivalent to the predicate device. The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well or better than the legally marketed predicate device.