Karl Storz Radel Sterilization Trays

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May 7, 2021 Karl Storz Endoscopy America Inc % David Furr Consultant Toscano Consulting Group Inc. 8708 Capeheart Cove Austin, Texas 78733 Re: K203572 Trade/Device Name: Karl Storz Radel Sterilization Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: April 15, 2021 Received: April 19, 2021 Dear David Furr: 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 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 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-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, Ph.D. Acting 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) K203572 Device Name KARL STORZ RADEL Sterilization Trays #### Indications for Use (Describe) The KARL STORZ RADEL Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in pre-vacuum steam sterilization cycles (132°C 4 minutes). The KARL STORZ RADEL Sterilization Trays are intended to protect medical device instrumentation. When used in conjunction with an FDA cleared sterilization wrap. KARL STORZ has validated the KARL STORZ RADEL Sterilization Trays for use in pre-vacuum steam sterilizers. The system was validated with a miniature scope with an irrigation chameter of 0.25mm and a length of 240mm and a semi-rigid ureteroscope with a channel lumen diameter of 0.77mm and a length of 420mm. | Tray Catalog Number | Intended Load Maximum Weight<br>(Karl Storz Instruments Only) | |---------------------|---------------------------------------------------------------| | 27717A | Trocar/Cannula 5.0 lbs. | | 27717B | Take-Apart Instruments 5.0 lbs. | | 39231XA | Karl Storz General Instruments 5.0 lbs. | | 39301A | Two Rigid Telescopes 2.71lbs. | | 39301C | Two Rigid Telescopes 3.21lbs. | | 39301C1 | One Rigid Telescope/One Light Cable 3.17 lbs. | | 39311A | Four Telescopes/One Light Cable 6.86 lbs. | | 39317A | Three Telescopes/One Light Cable 6.86 lbs. | 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." {3}------------------------------------------------ # 510(k) Summary K203572 ## Date: May 5, 2021 | 1. | Submitted By: | KARL STORZ Endoscopy-America, Inc.<br>2151 E. Grand Ave.<br>El Segundo, California 90245<br>424-218-8376 | |----|-----------------------------|-------------------------------------------------------------------------------------------------------------| | 2. | Contact: | David C. Furr<br>Toscano Consulting Group Inc.<br>8708 Capehart Cove<br>Austin, Texas 78733<br>512-906-9654 | | 3. | Product: | KARL STORZ RADEL Sterilization Trays (K203572)<br>Product code: KCT - Class II (21 CFR 880.6850) | | 4. | Common/Classification Name: | Sterilization wrap/container | | | Predicate devices: | Symmetry Medical Polyvac Surgical Instrument Delivery<br>System K012105 | ## Description: The KARL STORZ-ENDOSCOPE RADEL Sterilization Trays are intended only for use to encase various KARL STORZ reusable medical devices for sterilization in steam cycles. The sterilization trays are not intended to maintain sterility by themselves. Prior to sterilization, the trays must be double-wrapped with an appropriate FDA-cleared sterilization wrap to provide a microbial barrier which allows sterilant to permeate throughout the interior of the loaded tray. The tray configurations, available in various sizes, are designed to encase KARL STORZ medical devices, such as light cables, instruments, rigid telescopes, semi-rigid telescopes, etc. All systems consist of a RADEL plastic base and lid. Lids are attached to the trays with assembled hardware. Some trays have a RADEL inner tray and/or silicone rubber mat. The sterilization trays are constructed with perforated/ventilated sides and lids to allow for permeation of sterilant during sterilization. The trays have latches designed to fasten the lid onto the base. Other tray components include silicone instrument holders to secure instruments and silicone mats to provide protection of the medical devices in the sterilization tray. {4}------------------------------------------------ Intended Use: The KARL STORZ RADEL Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in pre-vacuum steam sterilization cycles (132℃ 4 minutes). The trays are to be used in conjunction with an FDA cleared sterilization wrap. KARL STORZ has validated the KARL STORZ RADEL Sterilization Trays for use in pre-vacuum steam sterilizers. The system was validated with a miniature scope with an irrigation channel lumen diameter of 0.25mm and a length of 240mm and a semi-rigid ureteroscope with a channel lumen diameter of 0.77mm and a length of 420mm. | Tray Catalog Number | Intended Load Maximum Weight<br>(Karl Storz Instruments Only) | |---------------------|---------------------------------------------------------------| | 27717A | Trocar/Cannula 5.0 lbs. | | 27717B | Take-Apart Instruments 5.0 lbs. | | 39231XA | Karl Storz General Instruments 5.0 lbs. | | 39301A | Two Rigid Telescopes 2.71lbs. | | 39301C | Two Rigid Telescopes 3.21lbs. | | 39301C1 | One Rigid Telescope/One Light Cable 3.17 lbs. | | 39311A | Four Telescopes/One Light Cable 6.86 lbs. | | 39317A | Three Telescopes/One Light Cable 6.86 lbs. | Technological Characteristics Comparison Table: Provided below is the comparison of the technological differences and similarities of the subject device and the predicate device. {5}------------------------------------------------ | Element of<br>Comparison | 510(k) Device:<br>KARL STORZ<br>RADEL Sterilization<br>Trays | Predicate Device:<br>Symmetry Medical<br>Polyvac Surgical<br>Instrument Delivery<br>System (K012105) | Comparison | |--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Regulation and<br>Product Classification<br>Code | 21 CFR 880.6850<br>KCT | 21 CFR 880.6850<br>KCT | Same | | Indications for Use | The KARL STORZ<br>RADEL Sterilization<br>Trays are intended only<br>for use to encase and<br>protect specific KARL<br>STORZ reusable medical<br>devices for sterilization in<br>pre-vacuum steam<br>sterilization cycles (132°C<br>4 minutes).<br>When used in conjunction<br>with an FDA cleared<br>sterilization wrap, sterility<br>of the enclosed medical<br>device is maintained until<br>used.<br>KARL STORZ has<br>validated the KARL<br>STORZ RADEL<br>Sterilization Trays for use<br>in pre-vacuum steam<br>sterilizers. The system<br>was validated with a<br>miniature scope with an<br>irrigation channel lumen<br>diameter of 0.25mm and a<br>length of 240mm and a<br>semi-rigid ureteroscope<br>with a channel lumen<br>diameter of 0.77mm and a<br>length of 420mm. | Polyvac's Delivery<br>Systems consist of<br>perforated trays with<br>lids, which are<br>intended to enclose and<br>protect medical device<br>instrumentation, and to<br>facilitate the<br>sterilization processing<br>by allowing steam<br>penetration and air<br>removal, when used in<br>conjunction with an<br>approved sterilization<br>wrap. Sterility of the<br>enclosed medical<br>devices maintained<br>until used. Polyvac's<br>Delivery Systems are<br>to be sterilized in one<br>of the following cycles:<br>pre vacuum steam,<br>132ºC 4 minutes<br>minimum, gravity<br>steam 132°C 30<br>minutes minimum and<br>gravity steam 121℃ 55<br>minutes minimum. | Similar | | Principal Material of<br>Construction | Thermoformed Radel<br>Polyphenylsulfone, | Thermoformed Radel<br>Polyphenylsulfone,<br>stainless steel or<br>aluminum | Different | | KARL STORZ Model<br>Numbers | 8 models | N/A | Different | | Dimensional<br>Configuration Range | Approximate sizes<br>available in inches:<br>21.2x9.8x4.3 21.2x9.8x1.9 19.8x8.9x1.8 12.18x3.22x1.2 21.48 x 3.53x 1.75 21.48 x 3.53x 1.75 13.36 x 9.31x 1.9 20.24x9.30x3.1 | Approximate sizes<br>available in inches:<br>7x2x1 7x3x1 8x4x1 11x7x1 21x10x4 17x10x4 17x8x2 15x10x1.5 20.5x9.7x5 20x10x3 26x9x6 17x3.5x1.5 And others | Similar | | Device Manufacturer | Manufactured by<br>Tecomet (formerly<br>Symmetry Medical) | Manufactured by<br>Tecomet (formerly<br>Symmetry Medical) | Same | | Sterilization Cycles | Prevacuum Steam 4<br>minute cycle 132°C | Prevacuum steam and<br>gravity steam | Similiar | | Load | Trays are to be loaded<br>with KARL STORZ<br>instruments; maximum<br>weights as indicated | Various loads up to 25<br>lbs. | Similar | {6}------------------------------------------------ {7}------------------------------------------------ ## Summary of Non-Clinical Testing: Shown below is the non-clinical testing performed with the subject device and the standards and test method used to demonstrate the subject device met the acceptance criteria of each standard.. | Type of Testing | Purpose | Acceptance<br>Criteria | Result | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|---------------------------------------------------------------------------------------|----------------------------------| | Pre-vacuum sterilization<br>efficacy<br>AAMI ST77 Containment<br>Devices for Reusable Medical<br>Device Sterilization<br>ISO 17665-1 Sterilization of Health<br>Care Products - Moist Heat - Part 1<br>Requirements for the Development,<br>Validation, and Routine Control of a<br>Sterilization Process for Medical<br>Devices | Demonstrate sterilization<br>capabilities. | 10-6 SAL | PASSED | | Pre-vacuum dry time<br>AAMI ST77 Containment Devices for<br>Reusable Medical Device Sterilization<br>ISO 17665-1 Sterilization of Health<br>Care Products - Moist Heat - Part 1<br>Requirements for the Development,<br>Validation, and Routine Control of a<br>Sterilization Process for Medical<br>Devices | To establish minimum dry<br>time. | Pre and Post<br>Sterilization weight<br>difference <3% after<br>drying | PASSED<br>30 minutes dry<br>time | | Manual Cleaning – Protein,<br>Hemoglobin<br>AAMI TIR 30 A<br>Compendium of Processes,<br>Materials, Test Methods,<br>and Acceptance Criteria for<br>Cleaning Reusable Medical<br>Devices | To demonstrate manual cleaning | < 6.4 µg/cm2<br>protein and<br>< 2.2 µg/cm2<br>hemoglobin on device<br>after cleaning | PASS | | Mechanical Cleaning - Protein,<br>Hemoglobin<br>AAMI TIR 30 A Compendium<br>of Processes, Materials, Test<br>Methods, and Acceptance<br>Criteria for Cleaning Reusable<br>Medical Devices | To demonstrate mechanical<br>cleaning | < 6.4 µg/cm²<br>protein and<br>< 2.2 µg/cm²<br>hemoglobin on device<br>after cleaning | PASS | | Material biocompatibility | To demonstrate no | Cytotoxicity – No | PASS | | ISO 10993-5 Biological Evaluation<br>of Medical Devices – Part 5: Tests for<br>in vitro cytotoxicity | Cytotoxic properties | evidence of lysis | | {8}------------------------------------------------ ## Conclusion: The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performed as well as or better than the legally marketed predicate devices.