Neodent Instrument Kit Cases

{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 seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below it. The logo is simple and professional, and it is easily recognizable. December 23, 2019 JJGC Industria e Comercio de Materiais Dentarios S.A. % Jennifer Jackson Director of Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810 Re: K190665 Trade/Device Name: Neodent Instrument Kit Cases Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: Class II Product Code: KCT Dated: October 11, 2019 Received: October 15, 2019 Dear Jennifer Jackson: 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. {1}------------------------------------------------ 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 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. Sreekanth Gutala, Ph.D. Acting Assistant Director for the Sterility Devices Team 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) K190665 Device Name Neodent Instrument Kit Cases Indications for Use (Describe) Indications for Use for GM Zygomatic Surgical Kit Case: Neodent Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases require the use of FDA cleared wrap to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles: Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20 minute dry time Neodent Instrument Kit Cases are intended for sterilization of non-porous loads. The GM Zygomatic Surgical Kit Case maximum load weight is 220 grams. Neodent Instrument Kit Cases should not to be stacked during sterilization. | 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K190665 Device Name Neodent Instrument Kit Cases Indications for Use (Describe) Indications for Use for GM Helix LG Compact Surgical Kit Case: Neodent Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases require the use of FDA cleared wrap to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles and moist heat (steam) sterilized using one of the following cycles: Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20-minute dry time Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time Neodent Instrument Kit Cases are intended for sterilization of non-porous loads. The combined weight of the GM Helix LG Compact Kit Case and the instruments is 297.3 g. The weight of the empty kit case is 236 g. Neodent Instrument Kit Cases should not to be stacked during sterilization. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 20px;">☑</span> | |----------------------------------------------|-----------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="font-size: 20px;">□</span> | ### 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." {4}------------------------------------------------ # 510(k) Summary ## K190665 ## ADMINISTRATIVE INFORMATION | Sponsor | JJGC Indústria e Comércio de Materiais Dentários SA<br>Av. Juscelino Kubitschek de Olivera, 3291<br>Curitiba, Parana, Brazil 81270-200<br>Registration No.: 3008261720<br>Owner/Operator No.: 10031702 | |------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Jennifer M. Jackson, MS<br>Director of Regulatory Affairs<br>Straumann USA<br><a href="mailto:jennifer.jackson@straumann.com">jennifer.jackson@straumann.com</a><br>Telephone (978) 747-2509 | | Date Prepared | 17/Dec/2019 | | Preparer / Alternate Contact | Luiza Vaccari Toppel<br>Regulatory Affairs Coordinator<br><a href="mailto:luiza.toppel@neodent.com">luiza.toppel@neodent.com</a> | DEVICE NAME AND CLASSIFICATION | Trade/ Proprietary Name | Neodent Instrument Kits | |----------------------------|---------------------------------------------------------------------| | Common Name | Instrument Sterilization Trays | | Classification Name | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | | Classification Regulations | 21 CFR 880.6850, Class II | | Product Code | KCT | | Classification Panel | General Hospital | | Reviewing Branch | Infection Control Devices Branch | PREDICATE DEVICE INFORMATION | Primary Predicate Device | K171713 – Neodent Instrument Kits, JJGC Indústria e Comércio de<br>Materiais Dentários AS | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | Reference Devices | K142529, Genesis™ Reusable Rigid Sterilization Container System,<br>CareFusion 2200 Inc.<br>K180915, Sonicision Reusable Sterilization Tray, Covidien | {5}------------------------------------------------ ### INDICATIONS FOR USE ### Indications for Use for GM Zygomatic Surgical Kit Case: Neodent Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases require the use of FDA cleared wrap to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles: Fractionated vacuum (pre-vacuum) – Exposure at 132 °C for 4 minutes, 30-minute dry time Neodent Instrument Kit Cases are intended for sterilization of non-porous loads. The combined weight of the GM Zygomatic Surgical Kit Case and the instruments is 738.1 g. The weight of the empty kit case is 515 g. Neodent Instrument Kit Cases should not to be stacked during sterilization. ### Indications for Use for GM Helix LG Compact Surgical Kit Case: Neodent Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases require the use of FDA cleared wrap to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles: Fractionated vacuum (pre-vacuum) – Exposure at 132 °C for 4 minutes, 20-minute dry time Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time Neodent Instrument Kit Cases are intended for sterilization of non-porous loads. The combined weight of the GM Helix LG Compact Kit Case and the instruments is 297.3 g. The weight of the empty kit case is 236 g. Neodent Instrument Kits should not to be stacked during sterilization. ### SUBJECT DEVICE DESCRIPTION The subject device kit cases are reusable rigid containers, comprising a case bottom (or base), a removable inner tray, and tray lid (lid). The subject device kits are to be used to organize and protect instruments and accessories that are to be sterilized by the healthcare provider. The subject devices include two (2) such kit cases. The lids are manufactured from injection molded polyphenylsulfone resin, the tray and base are manufactured from injection molded polysulfone resin. The designs include grommets and inserts of various geometries manufactured from molded silicone that retain the instruments within the tray and base. The subject device kit cases are provided nonsterile to the end-user. The dimensions for each part of the model and the overall dimensions are presented in the table below: {6}------------------------------------------------ | Assembled<br>Kit Case | Description | Assembled Kit<br>Case Dimension<br>(L x W x H) | Component Number | Component Dimension<br>(L x W x H) | |-----------------------|------------------------------------------|------------------------------------------------|------------------|------------------------------------| | 110.299 | GM Zygomatic Surgical<br>Kit Case | 264 x 163 x 58<br>mm | 212.327 (Lid) | 264 x 163 x 49, mm | | | | | 212.345 (Tray) | 248 x 149 x 16, mm | | | | | 212.347 (Base) | 256 x 155 x 20.5, mm | | 110.300 | GM Helix LG Compact<br>Surgical Kit Case | 195 x 90 x 64<br>mm | 212.293 (Lid) | 195 x 90 x 36, mm | | | | | 212.346 (Tray) | 180 x 76 x 26.5, mm | | | | | 212.348 (Base) | 188 x 84 x 42, mm | Note: The instrument and accessory devices that are sterilized and stored within the subject Kit Cases are not the subject devices of this submission. {7}------------------------------------------------ # TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE | | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | COMPARISON | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------| | | K190665<br>Neodent Instrument Kit Cases<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | K171713<br>Neodent Instrument Kits<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | | | Indications for<br>Use Statement | Indications for Use for GM Zygomatic<br>Surgical Kit Case: | Neodent Instrument Kits are intended to<br>be used to enclose other medical devices | Similar | | | Neodent Instrument Kit Cases are intended<br>to be used to enclose other medical devices | that are to be sterilized by a health care | | | | that are to be sterilized by a health care<br>provider. Neodent Instrument Kit Cases are | provider. Neodent Instrument Kits are | | | | intended to allow sterilization of the | intended to allow sterilization of the | | | | enclosed medical devices. Neodent | enclosed medical devices. Neodent | | | | Instrument Kit Cases require the use of FDA | Instrument Kits require the use of FDA | | | | cleared wrap to maintain the sterility of the | cleared wrap to maintain the sterility of | | | | enclosed devices. | the enclosed devices. | | | | The kits are to be enclosed in a sterilization<br>wrap that is FDA-cleared for the indicated | The kits are to be enclosed in a<br>sterilization wrap that is FDA-cleared for | | | | cycles, and moist heat (steam) sterilized | the indicated cycles, and moist heat<br>(steam) sterilized using one of the | | | | using one of the following cycles: | following cycles: | | | | Fractionated vacuum (pre-vacuum) -<br>Exposure at 132 °C for 4 minutes, 30-minute | Fractionated vacuum (pre-vacuum) -<br>Exposure at 132 °C for 4 minutes, 20- | | | | dry time | minute dry time | | | | Neodent Instrument Kit Cases are intended<br>for sterilization of non-porous loads. | Gravity displacement - Exposure at 132 °C<br>for 15 minutes, 20-minute dry time<br>Neodent Instrument Kits are intended for | | | | The combined weight of the GM Zygomatic<br>Surgical Kit Case and the instruments is | sterilization of non-porous loads. | | | | $738.1 g$ . The weight of the empty kit case is | The GM/WS Surgical Kit Case maximum | | | | $515 g$ . | load weight is 125 grams. | | | | Neodent Instrument Kit Cases are | The GM Surgical Kit Case maximum load | | | | recommended not to be stacked during | weight is 113 grams. | | | | sterilization.<br>Indications for Use for GM Helix LG<br>Compact Surgical Kit Case: | Neodent Instrument Kits are<br>recommended not to be stacked during<br>sterilization. | | | | Neodent Instrument Kit Cases are intended<br>to be used to enclose other medical devices | | | | | that are to be sterilized by a health care | | | | | provider. Neodent Instrument Kit Cases are | | | | | intended to allow sterilization of the<br>enclosed medical devices. Neodent | | | | | Instrument Kit Cases require the use of FDA | | | | | cleared wrap to maintain the sterility of the | | | | | enclosed devices. | | | | | The kits are to be enclosed in a sterilization<br>wrap that is FDA-cleared for the indicated<br>cycles, and moist heat (steam) sterilized | | | | | using one of the following cycles: | | | | | Fractionated vacuum (pre-vacuum) -<br>Exposure at 132 °C for 4 minutes, 20-minute | | | | | dry time | | | | | Gravity displacement – Exposure at 132 °C<br>for 15 minutes, 20-minute dry time | | | | | Neodent Instrument Kit Cases are intended<br>for sterilization of non-porous loads. | | | | | The combined weight of the GM Helix LG<br>Compact Kit Case and the instruments is | | | | | $297.3 g$ . The weight of the empty kit case is | | | | | $236 g$ . | | | | | Neodent Instrument Kit Cases are | | | | | recommended not to be stacked during<br>sterilization. | | | | | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | | | | K190665<br>Neodent Instrument Kit Cases<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | K171713<br>Neodent Instrument Kits<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | COMPARISON | | Intended Use | Neodent Instrument Kit Cases are intended<br>to be used to enclose other medical devices<br>that are to be sterilized by a health care<br>provider. Neodent Instrument Kit Cases are<br>intended to allow sterilization of the<br>enclosed medical devices. Neodent<br>Instrument Kit Cases require the use of FDA<br>cleared wrap to maintain the sterility of the<br>enclosed devices. | Neodent Instrument Kits are intended to<br>be used to enclose other medical devices<br>that are to be sterilized by a health care<br>provider. Neodent Instrument Kits are<br>intended to allow sterilization of the<br>enclosed medical devices. Neodent<br>Instrument Kits require the use of FDA<br>cleared wrap to maintain the sterility of the<br>enclosed devices. | Same | | Design | Rigid polysulfone polymer base and<br>removable inner tray with a<br>polyphenylsulfone lid.<br>Retention grommets of medical grade<br>silicone. | Rigid polysulfone polymer base and<br>removable inner tray with a<br>polyphenylsulfone lid.<br>Retention grommets of medical grade<br>silicone. | Same | | Perforated | Yes; allows moist heat (steam) penetration<br>to achieve sterilization | Yes; allows moist heat (steam) penetration<br>to achieve sterilization | Same | | Reusable | Yes | Yes | Same | | Overall<br>dimensions | GM Zygomatic Surgical Kit Case:<br>264 L x 163 W x 56 H, mm<br>GM Helix LG Compact Surgical Kit Case:<br>195 L x 90 W x 64 H, mm | 264 L x 163 W x 54 H, mm | Similar | | Vent to Volume<br>Ratio | GM Zygomatic Surgical Kit Case:<br>0.0093 cm² / cm³ (0.0236 in²/in³)<br>GM Helix LG Compact Surgical Kit Case:<br>0.0157 cm² / cm³ (0.0400 in² / in³) | 0.0102 cm² / cm³ (0.0259 in² / in³) | Similar | | Useful Life | Yes, reusable up to 100 cycles<br>Assembled/disassembled, cleaned, sterilized<br>Visual inspection<br>Component dimensional fit verification<br>Functional closure (lid-base latch)<br>verification | Yes, reusable up to 100 cycles<br>Assembled/disassembled, cleaned,<br>sterilized<br>Visual inspection<br>Component dimensional fit verification<br>Functional closure (lid-base latch)<br>verification | Same | | Biocompatibility | The kit cases are not intended to be in<br>contact with the patient. | The kit cases are not intended to be in<br>contact with the patient. | Same | | Sterilization<br>Method | Moist heat (steam) | Moist heat (steam) | Same | | Cycles | Gravity displacement (only for GM Helix LG<br>Compact Surgical Kit Case)<br>Fractionated vacuum (pre-vacuum) | Gravity displacement<br>Fractionated vacuum (pre-vacuum) | Same | | Parameters | Gravity (only for model number 110.300)<br>Sterilization temperature: 132 °C<br>Sterilization time: 15 minutes<br>Drying time: 20 minutes<br>Pre-Vacuum<br>Sterilization temperature: 132 °C<br>Sterilization time: 4 minutes;<br>Drying time: 30 minutes (model number<br>110.299) or 20 minutes (model number<br>110.300) | Gravity<br>Sterilization temperature: 132 °C<br>Sterilization time: 15 minutes;<br>Drying time: 20 minutes<br>Pre-Vacuum<br>Sterilization temperature: 132 °C<br>Sterilization time: 4 minutes;<br>Drying time: 20 minutes. | Similar<br>All validated cycles provide<br>similar sterilization<br>efficacy.<br>(minimum SAL of 10⁻⁶) | {8}------------------------------------------------ {9}------------------------------------------------ | SUBJECT DEVICE | | PRIMARY PREDICATE DEVICE | | COMPARISON | | |-----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|------------|------| | K190665<br>Neodent Instrument Kit Cases<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | | K171713<br>Neodent Instrument Kits<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | | | | | Sterile Barrier | Sterilization wrap, FDA-cleared for indicated<br>method and cycles | | Sterilization pouch, FDA-cleared for<br>indicated method and cycles | | Same | The subject devices and the primary predicate device per K171713 have the same intended use and have equivalent Indications for Use Statements. The subject devices (and the primary predicate device per K171713) are reusable rigid containers used to organize and protect dental surgical instruments that are sterilized by the healthcare provider. The subject device and the primary predicate device K171713 components are perforated to allow for penetration of the moist heat (steam) sterilant and require the use of an FDA-cleared wrap or pouch to maintain sterility. ### NON-CLINICAL PERFORMANCE DATA Manual cleaning instructions were validated using microbiological, protein, and hemoglobin assays. Sterilization validation, including sterilant penetration and drying time, was performed according to ANSI/AAMI/ISO 17665-1 and 17665-2. Life cycle (simulated usage) testing was performed, which included visual inspection, component dimensional fit verification, and functional closure (lid- bottom latch) verification. Biocompatibility testing was performed using methods described in ANSI/AAMI/ISO 10993-5 (cytotoxicity). No clinical data were included in this submission. | Standard or Test Method | Purpose of the Testing | Acceptance Criteria | Results | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Custom | Manual cleaning validation | Hemoglobin Test:<br>• <0.50 $µg/mL$<br>• <55 $µg/article$<br>• <0.0078 $µg/cm²$<br>Micro BCA Protein Test:<br>• <1.1 $µg/mL$<br>• <220 $µg/article$<br>• <0.018 $µg/cm²$ | Passed | | ANSI/AAMI/ISO 17665-1<br>ANSI/AAMI/ISO 17665-2 | Sterilization validation, including sterilant penetration and drying time | SAL of $10^{-6}$ | Passed | | Reprocessing Medical<br>Devices in Health Care<br>Settings: Validation<br>Methods and Labeling<br>Guidance for Industry<br>and Food and Drug<br>Administration Staff | Life cycle (simulate usage) testing | Visual and functional inspection following 100 cycles | Passed | | ANSI/AAMI/ISO 10993-5<br>(Cytotoxicity) | Cytotoxicity testing | <30% inhibition of proliferation of protein content | Passed | {10}------------------------------------------------ ## CONCLUSION The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device K17173.