Instrument Case P1340904

{0}------------------------------------------------ March 21, 2023 Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Cochlear Denis Dimartino Senior Regulatory Affairs Specialist 10350 Park Meadows Drive Lone Tree. Colorado 80124 Re: K223672 Trade/Device Name: Instrument Case P1340904 Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: February 23, 2023 Received: February 23, 2023 Dear Denis Dimartino: 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 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 {1}------------------------------------------------ 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. Colin O'neill -S Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K223672 Device Name Instrument Case Indications for Use (Describe) The Instrument Case is intended for staff involved in reprocessing of reusable instruments, and for surgical teams. The product shall only be used: - · in a controlled surgical environment under sterile conditions such as a hospital, - · in reprocessing environment at sterilization departments or reprocessing centers, - · and for transport of surgical instruments. Sterilization parameters: Pre-Vacuum Steam at 132 °C (270 °F) for 4 min with a 20 minutes dry time The worse-case validated load for the Instrument Case, including instruments, is 1700 g. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X 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." {3}------------------------------------------------ K223672 # 510(k) Summary Image /page/3/Picture/2 description: The image is the logo for Cochlear, a company that specializes in hearing solutions. The logo features three curved shapes stacked on top of each other, resembling sound waves. Below the shapes is the word "Cochlear" in a bold, sans-serif font, and underneath that is the tagline "Hear now. And always" in a smaller font. The logo is in a yellow color. | A. Submitter Information | | |-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------| | Submitted by: | Cochlear Americas<br>10350 Park Meadows Drive<br>Lone Tree, CO 80124 | | On behalf of the manufacturer: | Cochlear Bone Anchored Solutions AB<br>Konstruktionsvägen 14,<br>SE-435 33 Mölnlycke<br>Sweden<br>(Establishment Number 9616024) | | Contact: | Denis DiMartino<br>Senior Regulatory Specialist<br>Cochlear Americas<br>C: 508-304-4356<br>E: ddimartino@cochlear.com | | B. Date Prepared | 21-March-2023 | | C. Device Name and Classification | | | Device Names: | Instrument Case | | Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & Other<br>Accessories<br>21 CFR 880.6850, Class II | | Classification Panel: | Orthopedic | | Product Code: | KCT | | D. Predicate Device | | | Device Names: | Surgical Trays | | Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & Other<br>Accessories<br>21 CFR 880.6850, Class II | | Classification Panel: | Orthopedic | | Product Code: | KCT | | Primary Predicate: | K212281 | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, golden-yellow symbol resembling three overlapping sound waves or cochlear spirals, positioned above the company name. Below the name "Cochlear" is the tagline "Hear now. And always." # E. Purpose of Submission This Traditional 510(k) seeks clearance for an Instrument Case that is intended to hold reusable instruments used during surgical procedures for Osia® and Baha® bone conduction implants. Outside of surgery, the Instrument Case is designed to hold the reusable instruments during the sterilization process and for transportation of the instruments. # F. Device Description The Instrument case, Figure 1, is a reusable sterilization container intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization. The specific use for the Instrument case is to hold reusable instruments during transport, the sterilization process, and during surgery. The Instrument case consists of tray and lid made of stainless steel with a small box included, a component tray. The grommets, strips and holders that keep the instruments in place are made of silicone or stainless steel, and the latches in the lid are made of a Thermoplastic resin, Santoprene. The packaging materials are made of polyethylene and polyolefin. The device dimensions are 265 x 160 x 42 mm (length x width x height) and the worst case recommended load is 1700 g. ### Figure 1: Instrument Case Image /page/4/Picture/8 description: The image shows a Cochlear brand surgical kit. The kit includes a perforated metal tray with a lid, and a small perforated metal block. The Cochlear logo is visible on the lid and the tray. The kit appears to be designed for sterilizing and organizing surgical instruments. # G. Intended Use The Instrument Case is a medical device accessory intended to hold reusable surgical instruments during transportation, sterilization process and during surgery. # H. Indications for Use This product is intended for staff involved in reprocessing of reusable instruments, and for {5}------------------------------------------------ surgical teams. Image /page/5/Picture/2 description: The image shows the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized graphic of three curved shapes nested within each other, resembling the inner ear. Below the graphic, the company name "Cochlear" is written in a clear, sans-serif font, followed by the tagline "Hear now. And always" in a smaller font. The product shall only be used: - in a controlled surgical environment under sterile conditions such as a hospital, ● - in reprocessing environment at sterilization departments or reprocessing centers, ● - and for transport of surgical instruments. . Sterilization parameters: Pre-Vacuum Steam at 132 °C (270 °F) for 4 min with a 20 minutes dry time The worse-case validated load for the Instrument Case, including instruments, is 1700 g. ### I. Technological Characteristics and Comparison to Predicate Table 1 summarizes a comparison of the technological characteristics of the currently available Surgical Trays (predicate device) with the Instrument Case (subject device). | Feature | Instrument Case (Subject Device) | K212281 (Predicate device) | Comparison Notes | |--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Cochlear | Sirona Dental Systems GmbH | Different Manufacturers | | Class | II | II | Same | | Product Code | KCT | KCT | Same | | Indications for Use | The Instrument Case is intended for staff involved in reprocessing of reusable instruments, and for surgical teams. | The Surgical Trays are intended for organizing, sterilizing and storing of instruments. | Similar – While the wording is slightly different both devices are used for the same processes. | | | The product shall only be used:<br>• in a controlled surgical environment under sterile conditions such as a hospital,<br>• in reprocessing environment at sterilization departments or reprocessing centers,<br>• and for transport of surgical instruments. | The Surgical Trays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch.<br><br>Sterilization parameters: Pre-Vacuum Steam at 132 °C (270 °F) for 4 min with a 20 minutes dry time | The sterilization parameters are identical.<br><br>The maximum load for sterilization is | | Feature | Instrument Case (Subject Device) | K212281 (Predicate device) | Comparison Notes | | | Sterilization parameters:<br>Pre-Vacuum Steam at 132 °C (270 °F) for 4 min with<br>a 20 minutes dry time<br><br>The worse-case validated<br>load for the Instrument<br>Case, including<br>instruments, is 1700 g. | The tested Surgical Tray<br>represents the worst-case<br>validated load of 513.7g. | different, based<br>on the total<br>weight of<br>reusable<br>instruments<br>included in the<br>sterilization<br>case.<br><br>The Instrument<br>Case is as safe<br>and effective as<br>the predicate<br>device. | | General Design | Stainless steel instrument<br>tray with a stainless steel<br>locking lid and removable<br>stainless steel component<br>tray. Silicone instrument<br>holders. | Plastic tray with locking<br>lid. Co-molded silicone<br>and silicone grommet<br>supports | Tray is<br>different, but<br>instrument<br>support<br>(silicone) is the<br>same | | Dimensions | Length x Width x Height,<br>mm<br><br>265 x 160 x 42 | Length x Width x Height,<br>inches<br><br>7.3 x 5.5 x 2.4<br>(185.4 x 139.7 x 61 mm) | Similar | | Materials | Base Tray – Stainless steel<br>Lid – Stainless steel<br>Case tray – Stainless steel<br><br>Tooling Support – Silicone | Base – Radel 5000<br>Lid – Radel 5000 Overlay<br>– Radel 5000 Tooling<br>support - Silicone | Tray material<br>is different, but<br>tooling support<br>is the same | | Sterility | Non-sterile | Non-sterile | Same | | Sterilization<br>Method | Dynamic air removal steam<br>sterilization (prevacuum) to<br>a Sterility Assurance Level<br>(SAL) of ≤10-6 | Moist heat (steam) and<br>has been validated to SAL<br>of 10-6 | Same | | Sterilization<br>Parameters | Pre vacuum, 132°C for 4<br>minutes with a 20 minutes<br>drying time | Pre vacuum,<br>At 132°C for 4 minutes<br>with a 20 minutes dry<br>time | Same | | Reusable | Yes | Yes | Same | | Useful Life | 25 Cycles | 200 Cycles | Different,<br>based on | | Feature | Instrument Case (Subject Device) | K212281 (Predicate device) | Comparison Notes | | Biocompatibility | Planning and testing have been carried out according to ISO 10993-1.<br><br>The Instrument Case is biocompatible due to the testing with pass results. | Biocompatibility evaluation assessment for the Surgical Tray was performed according to ISO 10993- 1:2018<br><br>The test results confirm that the Surgical Trays are biocompatible for their intended use. | Same | | Perforated | Yes | Yes | Same | | Sterile Barrier | FDA cleared sterilization pouch | FDA cleared sterilization pouch | Same | | Maximum Load for Sterilization | 1700g | 513.7g | Different, based on total weight of reusable instruments included in the sterilization case. | Table 1: Predicate Comparison {6}------------------------------------------------ Image /page/6/Picture/1 description: The image is the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, abstract representation of the inner ear, depicted as three concentric, curved shapes in a golden color. Below the ear symbol, the company name "Cochlear" is written in a sans-serif font, also in the same golden color. Underneath the company name, the tagline "Hear now. And always" is present in a smaller font size. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, golden-yellow symbol resembling three overlapping sound waves or cochlear shapes. Below the symbol, the company name "Cochlear" is written in a matching golden-yellow sans-serif font. Underneath the name, the tagline "Hear now. And always" is displayed in a smaller, lighter font, emphasizing the company's commitment to long-term hearing support. ### J. Performance Data Bench testing was conducted to demonstrate substantial equivalence to the predicate device, Surgical Trays. Substantial equivalence to the predicate device was accomplished through nonclinical data related to performance testing, biocompatibility testing, and reprocessing information. The results demonstrated the Instrument Case is substantially equivalent to the predicate device. Table 2 identifies the performance tests that were conducted on the subject device. All of the testing yielded PASS results, as shown in the table below. For the sterilization validation, both the predicate and subject device utilized the ISO 17665 standard as the test methodology. For the remaining performance data, similar or the same test methodology were used to show that the subject device is as safe and effective as the predicate device as shown in the table below: | Test | Test<br>Methodology | Test Description | Acceptance<br>Criteria | Results | |------------------------------------------------------------|------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Automated<br>cleaning (with | AAMI<br>TIR12:2010 | 6 simulated use cycles | No visible soil<br>should remain | PASS: All<br>units met the | | Test | Test Methodology | Test Description | Acceptance Criteria | Results | | enzymatic detergent) | AAMI<br>TIR30:2011 | 5 accumulation cycles<br>3 efficacy cycles<br>Visual inspection for any residual test soil, residual protein and hemoglobin levels and cytotoxicity testing for presence of detergent residuals. | on the test articles.<br>Protein level should be <6.4 µg/cm2 for the test articles.<br>Hemoglobin level should be <2.2 µg/cm2 for the test articles.<br>No cytotoxic potential. | acceptance criteria.<br>Positive and negative controls performed as anticipated.<br>The Instrument case did not have a cytotoxic potential. | | Automated cleaning (with alkaline detergent) | AAMI<br>TIR12:2010<br>AAMI<br>TIR30:2011 | 6 simulated use cycles (same simulated use as for the enzymatic detergent).<br>5 accumulation cycles<br>3 efficacy cycles<br>Visual inspection for any residual test soil, residual protein and hemoglobin levels and cytotoxicity testing for presence of detergent residuals. | No visible soil should remain on the test articles.<br>Protein level should be <6.4 µg/cm2 for the test articles.<br>Hemoglobin level should be <2.2 µg/cm2 for the test articles.<br>No cytotoxic potential. | PASS: All units met the acceptance criteria.<br>Positive and negative controls performed as anticipated.<br>The Instrument case did not have a cytotoxic potential. | | Steam Sterilization<br>132°C for 4 min and 20 min dry time | AAMI<br>TIR12:2010<br>ANSI/AAMI<br>ST79:2017<br>ISO 17664:2017<br>ISO 17665-1:2006 | Devices were inoculated with at least 106 Geobacillus stearothermophilus spores, placed in the test item and sterilized in double 510(k) approved wraps in a cold spot of the sterilizer. | All positive controls for SAL testing must result in growth of the indicator organism and all negative controls must result in no growth. | PASS: Positive and negative controls performed as anticipated.<br>All devices were sterile and a SAL of ≤10-6 was achieved. | | Test | Test Methodology | Test Description | Acceptance Criteria | Results | | | ISO 11737-<br>2:2009 | For Sterility Assurance<br>Level (SAL) the steam<br>sterilization procedure<br>was repeated for 3 half-<br>cycles. After<br>incubation of the<br>devices and controls<br>for 7 days, SAL was<br>evaluated, and growth<br>was compared with<br>positive controls.<br><br>For dry time evaluation<br>the steam sterilization<br>was repeated for 3 full<br>cycles and the test<br>article, devices and<br>sterilization wraps were<br>visually inspected for<br>moisture. | There should be<br>no bacterial<br>growth on the<br>devices.<br><br>There should be<br>no visible<br>moisture present<br>on the test<br>article, devices<br>or sterilization<br>wraps after the<br>full cycle<br>exposure. | No moisture<br>was observed<br>on the test<br>article, devices<br>or sterilization<br>wraps. | | Lifecycle<br>testing Visual<br>inspection | Internal Test<br>Method | Validation of 25 cycles<br>of reprocessing<br>including manual pre-<br>cleaning, automated<br>cleaning with thermal<br>disinfection and<br>sterilization.<br><br>Visual inspections after<br>each cycle and pictures<br>taken every 5 cycle or<br>if any damage is<br>observed. | No visual<br>corrosion,<br>damage, or<br>impurities on<br>the Instrument<br>Case. | PASS: The<br>visual<br>inspection did<br>not detect any<br>damage.<br>Pictures that<br>were taken<br>after every 5<br>cycles<br>confirmed this<br>and showed<br>that the laser<br>markings were<br>fully readable<br>after up to 25<br>cycles of<br>reprocessing. | | Lifecycle<br>testing<br>Biocompatibili<br>ty | ISO 10993-<br>1:2018 | Chemical<br>characterization using<br>GC-MS and ICP-MS | Any residuals<br>hazards detected<br>should be below<br>levels of<br>toxicological<br>concern (Margin | PASS: The<br>semi-volatile<br>and inorganic<br>substances that<br>were detected<br>and that were of | | Test | Test<br>Methodology | Test Description | Acceptance<br>Criteria | Results | | | | | of safety;<br>MOS>1) | toxicological<br>concern had a<br>MOS>1 | | Biocompatibility | ISO 10993-5;<br>2009 | Cytotoxicity | Non-<br>Cytotoxic | PASS: The<br>instrument<br>case is not<br>cytotoxic | #### Table 2: Performance Data {8}------------------------------------------------ Image /page/8/Picture/1 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, golden-yellow symbol resembling three nested 'C' shapes, stacked on top of each other. Below the symbol, the company name "Cochlear" is written in a similar golden-yellow color, with the registered trademark symbol '®' next to it. Underneath the company name, the tagline "Hear now. And always" is displayed in a smaller font, completing the logo. {9}------------------------------------------------ Image /page/9/Picture/1 description: The image is the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, golden-yellow symbol resembling three overlapping "C" shapes, stacked on top of each other. Below the symbol, the company name "Cochlear" is written in a similar golden-yellow color, with the trademark symbol "®" next to it. Underneath the company name, the tagline "Hear now. And always" is displayed in a smaller font, completing the logo. {10}------------------------------------------------ Image /page/10/Picture/1 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, golden-yellow symbol resembling three overlapping sound waves or cochlear spirals. Below the symbol, the company name "Cochlear" is printed in a matching golden-yellow color, with the registered trademark symbol to the right. Underneath the company name, the tagline "Hear now. And always" is displayed in a smaller font, emphasizing the company's commitment to long-term hearing support. ### K. Conclusion Based on the indications for use, technological characteristics, and substantial equivalence comparison to the predicate device, supported by non-clinical data, the Instrument Case has been shown to be as safe, as effective, and performs as well as or better than the legally marketed predicate device, K212281.