Instrument tray, for semi-rigid ureteroscope

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products. September 15, 2021 Olympus Winter & Ibe GmbH % Dolan Mills Principal Specialist. Regulatory Affairs Olympus Surgical Technologies America 118 Turnpike Road Southborough, Massachusetts 01772 Re: K203492 Trade/Device Name: Instrument tray, for semi-rigid ureteroscope Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: August 9, 2021 Received: August 10, 2021 Dear Dolan Mills: 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. Although this letter refers to your product as a device, please be aware 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 {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Clarence W. Murray III -S Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K203492 Device Name Instrument tray, for semi-rigid ureteroscope #### Indications for Use (Describe) The instrument tray is intended to be used to enclose and protect one Olympus semi-rigid ureteroscope, models WA2UR11A, WA2UR12A, WA2UR14A, WA2UR21A, WA2UR22A, WA2UR22A, WA2UR23A WA2UR31A, and WA2UR32A (K200369), and accessories during sterilization in a prevacuum steam sterilizer using the following parameters or cycles: Prevacuum steam sterilization | - Exposure time at a temperature of 132 °C (269.6 °F:) | | |--------------------------------------------------------|--------| | Wrapped instruments | 4 min. | | Unwrapped non-porous instruments | 3 min. | - Exposure time at a temperature of 135 °C (275 °F:) Wrapped instruments .......................................................................................................................................................... Unwrapped non-porous instruments ................................ 3 min. - Drying time.........................................................................................................................30 min. After steam sterilization, let the instrument tray cool down at room temperature. - Cool-down time...............................................................................................................................30 min. The instrument tray is also intended for the enclosure of Olympus semi-rigid ureteroscopes and accessories during transport and storage within the reprocessing cycle. The instrument tray is not compatible with flexible ureteroscopes. The instrument tray is to be used in conjunction with a FDA cleared sterilization wrap. Maintenance of sterility depends on the sterilization wrap. Worst case load: The instrument tray containing a ureteroscope, attachments, light-guide cable adapters, sealing caps and stopcocks must not exceed a weight of 3300 grams (7.27 lb) altogether. 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. {3}------------------------------------------------ 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}------------------------------------------------ #### 2 510(k) Summary, K203492 ### 2.1 General Information | Manufacturer: | Olympus Winter & Ibe GmbH<br>Kuehnstr. 61<br>22045 Hamburg<br>Germany | |-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Establishment Registration Number: 9610773 | | Official Correspondent: | Dolan Mills<br>Program Manager, Regulatory Affairs<br>Gyrus ACMI, Inc.<br>800 West Park Drive<br>Westborough, MA 01581<br>Phone: (901) 373-0236<br>Email: dolan.mills@olympus.com | | | Establishment Registration Number: 3003790304 | | Date Prepared: | Sept 15, 2021 | # 2.2 Device Identification | Proprietary name: | Instrument tray, for semi-rigid ureteroscope | |-------------------------------|---------------------------------------------------------------------------------------| | Device Classification name: | Sterilization Wrap Containers, Trays, Cassettes &<br>Other Accessories | | Regulation Medical Specialty: | General Hospital | | Regulation Number; Name: | 21CFR 880.6850; Sterilization wrap. | | Product code; name; class: | KCT; Sterilization Wrap Containers, Trays, Cassettes<br>& Other Accessories; class II | ### 2.3 Predicate Device The applicant device, Instrument tray, for semi-rigid ureteroscope, is considered substantially equivalent to legally marketed device of K171692, KCT, 21CFR 880.6850: #### Instrument basket, for ENDOEYE No reference devices were used in this submission. {5}------------------------------------------------ # 2.4 Product Description The instrument tray, for semi-rigid ureteroscope is specifically designed for enclosure of Olympus ureteroscopes and accessories during sterilization and storage of Olympus ureteroscopes and accessories after sterilization, as well as enclosure during transport within the reprocessing cycle. A loaded instrument tray cannot be used for automated cleaning of the contained devices. The Olympus instrument tray is autoclavable and delivered in non-sterile condition to the customer. It is reusable and has to be reprocessed before first and each subsequent use according to defined reprocessing methods in the Instructions for Use. # 2.5 Indications for Use The instrument tray is intended to be used to enclose and protect one Olympus semirigid ureteroscope, models WA2UR11A, WA2UR12A, WA2UR13A, WA2UR14A, WA2UR21A, WA2UR22A, WA2UR23A, WA2UR31A, and WA2UR32A (K200369), and accessories during sterilization in a prevacuum steam sterilizer using the following parameters or cycles: Prevacuum steam sterilization - Exposure time at a temperature of 132 °C (269.6 °F:) Wrapped instruments .......................................................................................................................................................... Unwrapped non-porous instruments ......................................3 min. - Exposure time at a temperature of 135 °C (275 °F:) Wrapped instruments .......................................................................................................................................................... Unwrapped non-porous instruments ..................................3 min. - Drying time..........................................................................................................................30 min. After steam sterilization, let the instrument tray cool down at room temperature. - Cool-down time....................................................................................................................30 min. The instrument tray is also intended for the enclosure of Olympus semi-rigid ureteroscopes and accessories during transport and storage within the reprocessing cycle. The instrument tray is not compatible with flexible ureteroscopes. The instrument tray is to be used in conjunction with a FDA cleared sterilization wrap. Maintenance of sterility depends on the sterilization wrap. Worst case load: {6}------------------------------------------------ The instrument tray containing a ureteroscope, attachments, light-guide cable, lightguide cable adapters, sealing caps and stopcocks must not exceed a weight of 3300 grams (7.27 lb) altogether. # 2.6 Technological Characteristic Comparison with Predicate Provided below is a technological comparison of the subject device with the predicate device. | Item of<br>Comparison | Subject Device,<br>K203492 | Predicate Device,<br>K171692 | Evaluation of Differences | |------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------| | General<br>technology | Perforated rigid<br>enclosure designed to<br>enclose Olympus<br>telescopes and<br>accessories while<br>allowing for sufficient<br>penetration of<br>reprocessing agents. | Perforated rigid<br>enclosure designed to<br>enclose Olympus video<br>telescopes and<br>accessories while<br>allowing for sufficient<br>penetration of<br>reprocessing agents. | Same | | Indications for<br>Use | The instrument tray is<br>intended to be used to<br>enclose and protect one<br>Olympus semi-rigid<br>ureteroscope, models<br>WA2UR11A,<br>WA2UR12A,<br>WA2UR13A,<br>WA2UR14A,<br>WA2UR21A,<br>WA2UR22A,<br>WA2UR23A,<br>WA2UR31A, and<br>WA2UR32A<br>(K200369), and<br>accessories during<br>sterilization in a<br>prevacuum steam<br>sterilizer using the<br>following parameters or<br>cycles:<br><br>Prevacuum steam<br>sterilization<br>- Exposure time at a<br>temperature of 132 °C<br>(269.6 °F:)<br>Wrapped instruments<br>....................4 min. | The instrument basket is<br>intended to be used to<br>enclose and protect one<br>Olympus video telescope<br>for sterilization in a<br>prevacuum steam<br>sterilizer or STERRAD®<br>sterilizer using the<br>following parameters or<br>cycles:<br><br>• Prevacuum steam<br>sterilization<br>- Exposure time at a<br>temperature of 132 °C<br>(269.6 °F:)<br>Wrapped instruments<br>....................4 min.<br>Immediate-use non-<br>porous instruments<br>........3 min.<br><br>- Exposure time at a<br>temperature of 135 °C<br>(275 °F:)<br>Wrapped instruments<br>........3 min.<br>Immediate-use non-<br>porous instruments<br>3 min | Similar | | Item of<br>Comparison | Subject Device,<br>K203492 | Predicate Device,<br>K171692 | Evaluation of Differences | | | Unwrapped non-porous<br>instruments .............3<br>min.<br>- Exposure time at a<br>temperature of 135 °C<br>(275 °F:)<br>Wrapped instruments<br>............3<br>min.<br>Unwrapped non-porous<br>instruments ............3<br>min.<br>- Drying<br>time............30 min.<br>After steam sterilization,<br>let the instrument tray<br>cool down at room<br>temperature.<br>- Cool-down<br>time............30 min.<br>The instrument tray is<br>also intended for the<br>enclosure of Olympus<br>semi-rigid ureteroscopes<br>and accessories during<br>transport and storage<br>within the reprocessing<br>cycle. The instrument<br>tray is not compatible<br>with flexible<br>ureteroscopes.<br>The instrument tray is to<br>be used in conjunction<br>with a FDA cleared<br>sterilization wrap.<br>Maintenance of sterility<br>depends on the<br>sterilization wrap.<br>Worst case load: The<br>instrument tray<br>containing a<br>ureteroscope,<br>attachments, light-guide<br>cable, light-guide cable | - Drying time<br>............30 min.<br>After steam sterilization,<br>let the instrument basket<br>cool down at room<br>temperature.<br>- Cool-down time<br>............30 min.<br>• STERRAD®<br>sterilization<br>- STERRAD® 100S<br>cycle<br>- STERRAD®<br>100NX™: standard cycle<br>and express cycle<br>The instrument basket is<br>not intended to maintain<br>sterility. It is intended to<br>be used in conjunction<br>with a 510K cleared<br>sterilization wrap to<br>maintain sterility of the<br>enclosed Olympus video<br>telescope and<br>accessories.<br>Validated worst-case<br>load<br>The instrument basket<br>which is double-wrapped<br>in a sterilization wrap<br>with one enclosed<br>Olympus video telescope<br>and accessories must not<br>exceed 8.708 lb (3950 g). | | | Item of | Subject Device, | Predicate Device, | Evaluation of Differences | | Comparison | K203492 | K171692 | | | | and stopcocks must not<br>exceed a weight of 3300<br>grams (7.27 lb)<br>altogether. | | | | Intended to be<br>reused | Yes | Yes | Same | | Device Setup | Consists of base with lid<br>(lid can be fastened by a<br>latching mechanism) | Consists of base with lid,<br>lid can be fastened by a<br>latching mechanism | Same | | Percentage of<br>surface<br>perforation | About 39% | About 72% | Different | | Microbial<br>barrier<br>properties | To be used with FDA<br>cleared sterilization<br>wrap | To be used with FDA<br>cleared sterilization<br>wrap | Same | | Toxicological<br>properties | Under conditions of<br>the study, the<br>materials are non-<br>cytotoxic | Under conditions of<br>the study, the<br>materials are non-<br>cytotoxic | Same | | Autoclavability<br>(steam<br>sterilization) of<br>empty<br>basket/tray | yes | yes | Same | | Validated<br>Drying time<br>(steam<br>sterilization) | 30 minutes | 30 minutes | Same | | Material | Stainless steel,<br>Silicone | Stainless steel,<br>Silicone | Same | {7}------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {8}------------------------------------------------ #### 2.7 Summary of Non-clinical Testing The following performance data were provided in support of the equivalence determination. All standards applied are FDA recognized international standards. | Name | Purpose | Acceptance Criteria | Results | |---------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|---------| | ISO 10993-5:2009 | Demonstration of biocompatibility for materials that contact the loaded devices | Non-cytotoxic under the conditions of the study | Pass | | ISO 10993-12:2012 | Chemical analysis, and sample preparation | Non-cytotoxic under the conditions of the study | Pass | | Cleaning validation | Demonstration of the efficacy of the cleaning procedure | Visibly clean<br>Residual protein content less than 3 microgram/cm2<br>Residual TOC less than 12 microgram/cm2 | Pass | {9}------------------------------------------------ | Name | Purpose | Acceptance Criteria | Results | |------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---------| | Half-cycle<br>sterilization<br>validation | Demonstration of 6 log<br>reduction of<br>stearothermophilus<br>Geobacillus under half cycle<br>conditions | No viable growth | Pass | | Verification of tray<br>durability after<br>repeated sterilization<br>cycles | Demonstration of tray<br>durability over 400<br>sterilization cycles | No visible degradation<br>No corrosion<br>Legibility of markings | Pass | | Evaluation of residual<br>moisture | Demonstrate adequate drying<br>time | No visible condensation or<br>pooling on the wrap and<br>contents free of visible<br>condensation | Pass | #### 2.7.1 Applied standards | Standard No. | Standard Title | FDA-Recognition<br>no + date | |-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------| | ISO<br>10993-1<br>Fourth Edition<br>2009 | Biological evaluation of medical devices - Part 1:<br>Evaluation and testing within a risk management process<br>[Including: Technical Corrigendum 1 (2010)] | 2-220<br>07/26/2016 | | ISO<br>10993-5<br>Third Edition<br>2009 | Biological evaluation of medical devices -- Part 5: Tests<br>for In Vitro cytotoxicity | 2-245<br>12/23/2016 | | ISO<br>10993-12<br>Fourth Edition<br>2012 | Biological evaluation of medical devices - Part 12:<br>Sample preparation and reference materials | 2-191<br>07/26/2016 | | IEC<br>62366-1<br>Edition 1.0<br>2015-02 | Medical devices - Part 1: Application of usability<br>engineering to medical devices [Including<br>CORRIGENDUM 1 (2016)] | 5-114<br>12/23/2016 | | ANSI AAMI<br>ST77<br>2013/(R)2018 | Containment devices for reusable medical device<br>sterilization | 14-396<br>01/14/2019 | | ISO<br>14971<br>Second edition<br>2007 | Medical devices - Application of risk management to<br>medical devices | 5-40<br>06/27/2016 | Table 2.1: Applied standards # 2.8 Conclusion The conclusions drawn from the nonclinical tests demonstrate that the subject Instrument tray, for semi-rigid ureteroscope, is as safe, as effective and performs as {10}------------------------------------------------ well as or better than the legally marketed predicate device, Instrument basket, for ENDOEYE (K171692).