SterilContainer S

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of a human figure in profile, with three faces overlapping to suggest a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 18, 2015 Aesculap, Inc. Denise R. Adams, RAC Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, PA 18034 Re: K143729 Trade/Device Name: SterilContainer™ S Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap containers, trays, cassettes & other accessory Regulatory Class: II Product Code: KCT Dated: July 22, 2015 Received: July 23, 2015 Dear Ms. Adams: 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. {1}------------------------------------------------ Page 2 - Ms. Adams 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 (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. 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 yours, *Tejashri Purohit-Sheth, M.D.* Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR Erin I. Keith, M.S. 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 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K143729 Device Name SterilContainer S Indications for Use (Describe) The SterilContainer S is a reusable sterilization container system (consisting of perforated lids with filter retention plates, and single use polypropylene filters) intended to enclose another medical device that is to be sterilized by a healthcare provider. This container system has been validated with stainless steel and Teflon lumens, hinged, and knurled instruments. 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 V-PRO 60 Low Temperature Sterilization System's Lumen and Flexible Cycles. The SterilContainer S includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders. The Steril Container S was demonstrated to maintain the sterility of its contents for 180 days following successful sterilization. | Lid | Bottom | Description | Total<br>loaded<br>container<br>weight (lbs) | Intended Container Load | |-------|--------|--------------------------------|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------| | JM440 | JM440 | Full Size 90mm (4 ½")* | 21.46 | • Lumened and non-lumened devices with<br>diffusion-restricted spaces such as the hinged<br>portion of forceps and scissors | | JM489 | JM441 | Full Size 120mm (5 ½")* | 21.46 | | | | JM442 | Full Size 135mm (6")* | 21.46 | • Medical devices, including single, dual and<br>triple channeled rigid and semi-rigid<br>endoscopes, with the following configurations: | | JM789 | JM740 | ¾ Size 90mm (4 ¼")* | 13.85 | • single or dual lumen devices with stainless<br>lumen(s) that is (are) ≥ 0.77 mm internal<br>diameter (ID) and ≤ 410 mm length | | | JM741 | ¾ Size 120mm (5 ½")* | 13.85 | • triple lumen devices with stainless steel<br>lumens that are | | | JM742 | ¾ Size 135mm (6")* | 13.85 | ≥ 1.2 mm ID and ≤ 275 mm length | | JM389 | JM340 | ½ Size 90mm (4 ¼")* | 13.85 | | | | JM341 | ½ Size 120mm (5 ½")* | 13.85 | ≥ 1.8 mm ID and ≤ 310 mm length | | | JM342 | ½ Size 135mm (6")* | 13.85 | ≥ 2.8 mm ID and ≤ 317 mm length | | JM020 | JM021 | Extra Long Mini 73mm<br>(3")** | 7.65 | | | JM174 | JM188 | Mini 67mm<br>(2 ⅝")** | 7.65 | | ## V-PRO 60 Sterilizer Lumen Cycle * The validation chamber load consisted of one containing a basket iid, mat, accessories, 12 lumens, and metal and non-metal medical devices ** The validation chamber load consisted of two containing a basket and basket lid, mat, accessories, and metal and non-metal medical devices for a total chamber load weight of 15.30 lbs. Each container held six (6) lumens for a total of 12 total lumens per load. {3}------------------------------------------------ ### V-PRO 60 Sterilizer Non Lumen Cycle | Lid | Bottom | Description | Total<br>loaded<br>container<br>weight (lbs) | Intended Container Load | |-------|--------|-----------------------------|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------| | JM489 | JM440 | Full Size 90mm (4 ¼”)* | 20.0 | | | JM489 | JM441 | Full Size 120mm (5 ½”)* | 20.0 | | | JM489 | JM442 | Full Size 135mm (6”)* | 20.0 | | | JM789 | JM740 | ¾ Size 90mm (4 ¼”)* | 13.85 | Non-lumened devices including<br>devices with stainless steel or<br>titanium diffusion-restricted spaces<br>such as the hinged portion of forceps<br>and scissors. | | JM789 | JM741 | ¾ Size 120mm (5 ½”)* | 13.85 | | | JM789 | JM742 | ¾ Size 135mm (6”)* | 13.85 | | | JM389 | JM340 | ½ Size 90mm (4 ¼”)* | 13.85 | | | JM389 | JM341 | ½ Size 120mm (5 ½”)* | 13.85 | | | JM389 | JM342 | ½ Size 135mm (6”)* | 13.85 | | | JM020 | JM021 | Extra Long Mini 73mm (3")** | 7.64 | | | JM174 | JM188 | Mini 67mm (2 ⅝")** | 7.64 | | * The validation chamber load consisted of one container with a basket lid, mat, accessories, and metal and nonmetal medical devices ** The validation chamber load consisted of two containers with a basket lid, mat, accessories, and metal and nonmetal medical devices for a total chamber load weight of 15.30 lbs. | Lid | Bottom | Description* | Total<br>loaded<br>container<br>weight<br>(lbs) | Intended Container Load | |-------|--------|------------------------|-------------------------------------------------|-------------------------------------------------| | JM489 | JM440 | Full Size 90mm (4 ¼") | 21.46 | One flexible surgical endoscope or | | | JM441 | Full Size 120mm (5 ½") | 21.46 | bronchoscope with a light cord (if not integral | | | JM442 | Full Size 135mm (6") | 21.46 | to the endoscope) and mat without any | | JM789 | JM740 | ¾ Size 90mm (4 ¼") | 13.85 | additional load. The flexible endoscopes may | | | JM741 | ¾ Size 120mm (5 ½") | 13.85 | contain: | | | JM742 | ¾ Size 135mm (6") | 13.85 | · single or dual lumen devices with lumens | | JM389 | JM340 | ½ Size 90mm (4 ¼") | 13.85 | that are ≥ 1 mm ID and ≤ 990 mm length | | | JM341 | ½ Size 120mm (5 ½") | 13.85 | | | | JM342 | ½ Size 135mm (6") | 13.85 | | ### V-PRO 60 Sterilizer Flexible Cycle * The validation chamber load consisted of one container with a basket and lid, mat, accessories, three (3) 1 x 1000mm lumens, one flexible endoscope, and one light cable. {4}------------------------------------------------ | Accessories | V-PRO 60 | |----------------------------------------------------------------------------------------------------------------|----------| | Stainless Steel baskets,<br>basket lids, and dividers | Yes | | Instrument Organization<br>System (Silicone and<br>Stainless Steel racks,<br>brackets, holders, and<br>clamps) | Yes | | Silicone mats | Yes | | Stainless Steel racks, trays,<br>holders, clamps, brackets<br>and platforms | Yes | #### V-PRO 60 Sterilizer Compatible SterilContainer S Accessories 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." {5}------------------------------------------------ # AESCULAP # 510(k) SUMMARY (as required by 21 CFR 807.92) K143729 | SPONSOR: | Aesculap, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 2916714 | |----------------------|-------------------------------------------------------------------------------------------------------------------| | CONTACT: | Denise R. Adams, RAC<br>610-984-9076 (phone)<br>610-791-6882 (fax)<br>denise.adams@aesculap.com (email) | | DATE: | July 7, 2015 | | TRADE NAME: | SterilContainer™ S | | COMMON NAME: | Sterilization container | | CLASSIFICATION NAME: | Sterilization wrap containers, trays, cassettes & other accessories<br>(21 CFR 880.6850, Product Code KCT) | | DEVICE CLASS: | Class II per 21 CFR 880.6850 | | PREDICATE: | K093649, Aesculap SterilContainer S cleared for use in V-PRO 1<br>and V-PRO 1 Plus | #### DEVICE DESCRIPTION The SterilContainer S is a container system that will allow for sterilization and storage of medical devices. This container system is for use in low-temperature sterilization technology such as with the Steris V-PRO 60 Sterilization System. The SterilContainer Srigid containers are made from non-anodized Aluminum and utilize disposable (single use) polypropylene filters. The SterilContainer S includes accessories such as mats, baskets, trays, holders, organizers, filters, indicator cards and tamper-evident locks. ### INDICATIONS FOR USE The SterilContainer S 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 stainless steel and Teflon lumens, hinged, and knurled instruments. 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 V-PRO 60 Low Temperature Sterilization System's Lumen, Non Lumen and Flexible Cycles. The SterilContainer Sincludes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders. Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 Phone: 800-258-1946 www.aesculapusa.com {6}------------------------------------------------ # AESCULAP The SterilContainer S was demonstrated to maintain the sterility of its contents for 180 days following successful sterilization. | Lid | Bottom | Description | Total<br>loaded<br>container<br>weight (lbs) | Intended Container Load | |-------|--------|--------------------------------|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------| | | JM440 | Full Size 90mm (4 ¼")* | 21.46 | Lumened and non-lumened devices with | | JM489 | JM441 | Full Size 120mm (5 ½")* | 21.46 | diffusion-restricted spaces such as the hinged<br>portion of forceps and scissors | | | JM442 | Full Size 135mm (6")* | 21.46 | • Medical devices, including single, dual and | | JM789 | JM740 | ¾ Size 90mm (4 ¼")* | 13.85 | triple channeled rigid and semi-rigid<br>endoscopes, with the following configurations: | | | JM741 | ¾ Size 120mm (5 ½")* | 13.85 | • single or dual lumen devices with stainless<br>lumen(s) that is (are) ≥ 0.77 mm internal<br>diameter (ID) and ≤ 410 mm length | | | JM742 | ¾ Size 135mm (6")* | 13.85 | | | JM389 | JM340 | ½ Size 90mm (4 ¼")* | 13.85 | • triple lumen devices with stainless steel<br>lumens that are | | | JM341 | ½ Size 120mm (5 ½")* | 13.85 | ≥ 1.2 mm ID and ≤ 275 mm length | | | JM342 | ½ Size 135mm (6")* | 13.85 | ≥ 1.8 mm ID and ≤ 310 mm length<br>≥ 2.8 mm ID and ≤ 317 mm length | | JM020 | JM021 | Extra Long Mini 73mm<br>(3")** | 7.65 | | | JM174 | JM188 | Mini 67mm<br>(2 ⅝")** | 7.65 | | # V-PRO 60 Sterilizer Lumen Cycle * The validation chamber load consisted of one containing a basket and basket lid, mat, accessories, 12 lumens, and metal and non-metal medical devices **The validation chamber load consisted of two containers containing a basket lid, mat, accessories, and metal and non-metal medical devices for a total chamber load weight of 15.30 lbs. Each container held six (6) lumens for a total of 12 total lumens per load | Lid | Bottom | Description | Total<br>loaded<br>container<br>weight (lbs) | Intended Container Load | |-------|--------|-----------------------------|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | JM440 | Full Size 90mm (4 ¼”)* | 20.0 | | | JM489 | JM441 | Full Size 120mm (5 ½”)* | 20.0 | | | | JM442 | Full Size 135mm (6”)* | 20.0 | | | | JM740 | ¾ Size 90mm (4 ¼”)* | 13.85 | Non-lumened devices including<br>devices with stainless steel or<br>titanium diffusion-restricted spaces<br>such as the hinged portion of forceps<br>and scissors. | | JM789 | JM741 | ¾ Size 120mm (5 ½”)* | 13.85 | | | | JM742 | ¾ Size 135mm (6”)* | 13.85 | | | | JM340 | ½ Size 90mm (4 ¼”)* | 13.85 | | | JM389 | JM341 | ½ Size 120mm (5 ½”)* | 13.85 | | | | JM342 | ½ Size 135mm (6”)* | 13.85 | | | JM020 | JM021 | Extra Long Mini 73mm (3”)** | 7.64 | | | JM174 | JM188 | Mini 67mm (2 ⅝” )** | 7.64 | | ### V-PRO 60 Sterilizer Non Lumen Cycle * The validation chamber load consisted of one container with a basket lid, mat, accessories, and metal and non-metal medical devices ** The validation chamber load consisted of two containers with a basket lid, mat, accessories, and metal and non-metal medical devices for a total chamber load weight of 15.30 lbs. Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 Phone: 800-258-1946 www.aesculapusa.com {7}------------------------------------------------ # AESCULAP. | Lid | Bottom | Description* | Total<br>loaded<br>container<br>weight<br>(lbs) | Intended Container Load | |-------|--------|------------------------|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | JM489 | JM440 | Full Size 90mm (4 ¼") | 21.46 | One flexible surgical endoscope or<br>bronchoscope with a light cord (if not integral<br>to the endoscope) and mat without any<br>additional load. The flexible endoscopes may<br>contain: | | | JM441 | Full Size 120mm (5 ½") | 21.46 | | | | JM442 | Full Size 135mm (6") | 21.46 | | | JM789 | JM740 | ¾ Size 90mm<br>(4 ¼") | 13.85 | additional load. The flexible endoscopes may<br>contain:<br>• single or dual lumen devices with lumens<br>that are ≥ 1 mm ID and ≤ 990 mm length | | | JM741 | ¾ Size 120mm<br>(5 ½") | 13.85 | | | | JM742 | ¾ Size 135mm (6") | 13.85 | | | JM389 | JM340 | ½ Size 90mm<br>(4 ¼") | 13.85 | | | | JM341 | ½ Size 120mm<br>(5 ½") | 13.85 | | | | JM342 | ½ Size 135mm (6") | 13.85 | | # V-PRO 60 Sterilizer Flexible Cycle * The validation chamber load consisted of one container with a basket and lid, mat, accessories, three (3) 1 x 1000mm lumens, one flexible endoscope, and one light cable. # V-PRO 60 Sterilizer Compatible SterilContainer S Accessories | Accessories | V-PRO 60 | |----------------------------------------------------------------------------------------------------------|----------| | Stainless Steel baskets, basket lids,<br>and dividers | Yes | | Instrument Organization System<br>(Silicone and Stainless Steel racks,<br>brackets, holders, and clamps) | Yes | | Silicone mats | Yes | | Stainless Steel racks, trays, holders,<br>clamps, brackets, and platforms | Yes | 1 . . {8}------------------------------------------------ # AESCULAP. # TECHNOLIGICAL CHARACTERISTICS (compared to predicates) The SterilContainer S is for use in low-temperature sterilization technology such as the Steris V-PRO 60. The SterilContainer S is the same container system as was cleared in K093649. The materials and design have not changed. | System | SterilContainer S<br>(K143729) | SterilContainer S<br>(K093649) | |----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The SterilContainer S is a reusable<br>sterilization container system<br>(consisting of perforated bottoms<br>and perforated lids with filter<br>retention plates, and single use<br>polypropylene filters) intended to be<br>used to enclose another medical<br>device that is to be sterilized by a<br>healthcare provider. This container<br>system has been validated with<br>stainless steel and Teflon lumens,<br>hinged, and knurled instruments. It<br>is intended to allow sterilization of<br>the enclosed device and also<br>maintain sterility of the enclosed<br>device until used. This container<br>system is compatible for use with the<br>V-PRO 60 Low Temperature<br>Sterilization System's Lumen, Non<br>Lumen and Flexible Cycles. The<br>SterilContainer S includes<br>accessories such as silicone mats,<br>baskets, trays, racks, eyepiece<br>holders and sleeve holders. | The Aesculap Sterilcontainer S is a<br>reusable sterilization container<br>system intended to be used to<br>enclose another medical device that<br>is to be sterilized by a healthcare<br>provider. It is intended to allow<br>sterilization of the enclosed device<br>and also maintain sterility of the<br>enclosed device until used. This<br>container system is compatible for<br>use with the V-PRO 1<br>and V-PRO Plus Systems. | | Sterilizer | Steris V-PRO 60 | Steris V-PRO 1 and V-PRO 1 Plus | | Material | Non-anodized aluminum | Non-anodized aluminum | | Container type | Perforated | Perforated | | Filter type | Polypropylene | Polypropylene | Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 Phone: 800-258-1946 www.aesculapusa.com {9}------------------------------------------------ # AESCULAP. ## PERFORMANCE DATA The SterilContainer S has been fully validated for the Steris V-PRO 60 Sterilizer. These validations were conducted by a qualified testing laboratory. The performance testing demonstrates substantial equivalence to the predicate devices. | Performance Properties | Results | |----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sterilization Efficacy | Testing demonstrated a 6 log reduction to no growth in a half<br>cycle validation. This testing supports a sterility assurance level<br>(SAL) of 10-6 in a full 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 | Testing demonstrated the ability to provide an effective<br>barrier for maintaining sterility of the contents after<br>processing followed by a 180 day event related storage<br>under conditions which simulate hospital sterile package<br>handling and storage conditions. | | Material Compatibility | After 100 cycles of processing no visible or functional<br>changes were observed | | Simulated Use | A worst case dual channel flexible endoscope was<br>reproducibly sterilized under worst case simulated use<br>testing conditions in the Flexible Cycle. | ### CONCLUSION Based on the nonclinical tests performed the subject device is as safe, as effective and performs at least as safely and effectively as the legally marketed predicate device (K093649), Class II (21 CFR 880.6850), product code KCT.