Southern Implants Instrument Trays

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March 2, 2022 Southern Implants (Pty) Ltd Leith Cumming Official Correspondent 1 Albert Road Irene, Gauteng 0062 South Africa Re: K210923 Trade/Device Name: Southern Implants Instrument Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: Class II Product Code: KCT Dated: February 17, 2022 Received: February 18, 2022 ### Dear Leith Cumming: 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 {1}------------------------------------------------ 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, 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 Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K210923 Device Name Southern Implants Instrument Trays The Southern Implants Instrument Tray is designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared steam sterilizable wrap and sterilized in an FDA Cleared sterilizer for one of the following cycles: - · Pre-vacuum Steam At 132ºC for 4 minutes with a 20 minutes dry time. - · Pre-vacuum Steam At 135°C for 3 minutes with a 20 minutes dry time. The trays are not intended for sterilization of non-porous loads. The trays are recommended not to be stacked during sterilization. The Complete Surgical Trays represent the worst case validated load due to number of components (Large: 25 Medium: 90 and Small: 47 instruments) and the weight (Large: 752; Medium: 672 and Small 339 grams). Southern Implants (Pty.) Ltd. does not make any lumen claims for the Southern Implants Instrument Trays. | Size<br>(L x W x H) | Product Code | Number of<br>Instruments | Weight of<br>Tray (g) | Weight of<br>Full Tray (g) | Vent to Volume<br>Ratio (in²/in³) | For Use With | |--------------------------------|--------------|--------------------------|-----------------------|----------------------------|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Large | CH-I-ZYG | 19 | 485.5 | 752 | 0.01 | ZAGA Zygomatic Implants (K192651) | | 26.8 x 14.7 x 5.5 cm | I-ZYG-1 | 25 | 485 | 746 | 0.01 | Zygomatic Implants (K093562: K173343) | | Medium<br>18.7 x 13.5 x 5.5 cm | I-HEX-EG | 90 | 348 | 672 | 0.013 | External Hex Implants (K163634; K173706; K003620; K020617; K033171; K052490;<br>K070841), Provata Implants (K180465) | | | I-DC-EG | 53 | 386 | 540 | 0.013 | DC Implants (K163060) | | | I-INT-HEX-EG | 46 | 392 | 555 | 0.013 | Provata Implants (K180465) | | | I-IT-EG | 49 | 434 | 541 | 0.013 | IT Implants (K061169) | | | I-MAX-EG | 50 | 386 | 546 | 0.013 | MAX Implants (K071161; K191054) | | | I-TRI-NEX-EG | 60 | 390 | 547 | 0.013 | Tri-Nex Implants (K070905) | | Small<br>14.8 x 9.5 x 5.5 cm | I-PROS-EG | 25 | 180.5 | 280 | 0.014 | Abutments (K003620: K020617; K033171; K052490; K053478; K061169; K070841;<br>K070905; K071161; K082651; K093562; K163634; K172160; K173343; K173706;<br>K180465; K181850; K191054; K191250; K192651; K193084) | | | I-PROS-MINI | 7 | 122.5 | 147 | 0.056 | | | | I-IV-EG | 47 | 228 | 339 | 0.013 | Inverta Implants (K181850) | | 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. 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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 # Southern Implants Instrument Trays # 28/02/2022 ### ADMINISTRATIVE INFORMATION | Manufacturer Name | Southern Implants (Pty) Ltd<br>1 Albert Road<br>Irene, Gauteng, 0062 South Africa<br>Telephone: +27 12 667 1046<br>Fax: +27 12 667 1029 | |-------------------|-----------------------------------------------------------------------------------------------------------------------------------------| | Official Contact | Leith Cumming<br>Acting Head of Regulatory Affairs and Quality<br>Email: leith.c@southernimplants.com | ### DEVICE NAME AND CLASSIFICATION | Trade/Proprietary Name | Southern Implants Instrument Trays | |------------------------------------------|--------------------------------------------------------------------------| | Common Name | Instrument Trays | | Classification Name | Sterilization Wrap Containers, Trays, Cassettes and other<br>Accessories | | Classification Regulation | 21 CFR 880.6850, Class II | | Product Code | KCT | | Classification Panel<br>Reviewing Branch | General Hospital<br>General Hospital | ### PREDICATE DEVICE INFORMATION The primary predicate device is K142519 The reference device is K182865. {4}------------------------------------------------ ### INDICATIONS FOR USE STATEMENT The Southern Implants Instrument Tray is designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared steam sterilizable wrap and sterilized in an FDA Cleared sterilizer for one of the following cycles: - Pre-vacuum Steam At 132°C for 4 minutes with a 20 minutes dry time. ● - . Pre-vacuum Steam – At 135°C for 3 minutes with a 20 minutes dry time. The trays are not intended for sterilization of non-porous loads. The trays are recommended not to be stacked during sterilization. The Complete Surgical Trays represent the worst case validated load due to number of components (Large: 25 Medium: 90 and Small: 47 instruments) and the weight (Large: 752; Medium: 672 and Small 339 grams). Southern Implants (Pty.) Ltd. does not make any lumen claims for the Southern Implants Instrument Trays. | Size<br>(L x W x H) | Product<br>Code | Number of<br>Instruments | Weight of<br>Tray (g) | Weight of<br>Full Tray (g) | Vent to Volume<br>Ratio (in²/in³) | For Use With | |-----------------------------------|------------------|--------------------------|-----------------------|----------------------------|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------| | Large<br>26.8 x 14.7 x<br>5.5 cm | CH-I-ZYG | 19 | 485.5 | 752 | 0.01 | ZAGA Zygomatic Implants<br>(K192651) | | | I-ZYG-1 | 25 | 485 | 746 | 0.01 | Zygomatic Implants<br>(K093562; K173343) | | Medium<br>18.7 x 13.5 x<br>5.5 cm | I-HEX-EG | 90 | 348 | 672 | 0.013 | External Hex Implants<br>(K163634; K173706;<br>K003620; K020617;<br>K033171; K052490;<br>K070841)<br>Provata Implants<br>(K180465) | | | I-DC-EG | 53 | 386 | 540 | 0.013 | DC Implants (K163060) | | | I-INT-<br>HEX-EG | 46 | 392 | 555 | 0.013 | Provata Implants<br>(K180465) | | | I-IT-EG | 49 | 434 | 541 | 0.013 | IT Implants (K061169) | | | I-MAX-EG | 50 | 386 | 546 | 0.013 | MAX Implants (K071161;<br>K191054) | | | I-TRI-NEX-<br>EG | 60 | 390 | 547 | 0.013 | Tri-Nex Implants (K070905) | | Small<br>14.8 x 9.5 x<br>5.5 cm | I-PROS-EG | 25 | 180.5 | 280 | 0.014 | Abutments (K003620;<br>K020617; K033171;<br>K052490; K053478; | {5}------------------------------------------------ | I-PROS-<br>MINI | 7 | 122.5 | 147 | 0.056 | K061169; K070841;<br>K070905; K071161;<br>K082651; K093562;<br>K163634; K172160;<br>K173343; K173706;<br>K180465; K181850;<br>K191054; K191250;<br>K192651; K193084) | |-----------------|----|-------|-----|-------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | I-IV-EG | 47 | 228 | 339 | 0.013 | Inverta Implants (K181850) | #### SUBJECT DEVICE DESCRIPTION The device 'instrument trays' is a reusable rigid sterilization container or organizing tray intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit which contains and protects the interior Components during sterilization. Each tray consists of three components: a base tray, a lid and an internal individualized insert tray. All three the components are perforated for steam sterilization. The internal insert tray and base has the ability to hold individualized pieces and accessories which include dental tools, drills and ratchets /wrenches. The lid, base and insert are made of Radel R-5000. This material is a polymer resin. The instruments to be sterilized in the proposed tray are all non-porous devices and include dental surgical drills and tools. The rigid multi-piece tray holds dental device apparatus and accessories before, during and after the sterilization process. The tray set has a locking lid to contain the products. The trays are designed to fit any standard autoclave, which allows it to be effective for sterilization and be able to withstand the environment of repeated steam sterilization and be able to withstand the environment of repeated steam sterilization cycles in normal operating room. Since the trays are perforated, an FDA cleared sterilization wrap mush be used for sterilization purposes to maintain the sterility of the contents #### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS A comparison of the technological characteristics of the subject device and the primary predicate device K142519 is provided in the following table. {6}------------------------------------------------ | | Subject Device | Primary Predicate Device | Comparison | |----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | Comparison | Instrument Trays<br>Southern Implants (Pty) Ltd | K142519<br>InterActive Complete Surgical Tray<br>Implant Direct Sybron Manufacturing<br>LLC | | | Indications for Use<br>Statement | The Southern Implants Instrument Tray is<br>designed to hold various dental surgical drills<br>and tools in order to organize, steam<br>sterilize, and transport the instruments<br>between uses. The tray is to be enclosed in<br>an FDA cleared steam sterilizable wrap and<br>sterilized in an FDA Cleared sterilizer for<br>one of the following cycles: | The InterActive Complete Surgical Tray is<br>designed to hold various dental surgical drills<br>and tools in order to organize, steam sterilize,<br>and transport the instruments between uses.<br>The tray is to be enclosed in an FDA cleared<br>steam sterilizable wrap and sterilized in an<br>FDA Cleared sterilizer for one of the<br>following cycles: | Same | | Product Code | KCT | KCT | Same | | Intended Use | Perforated instrument cassette system to hold<br>dental instruments in place during transport,<br>steam sterilization, and storage. | Perforated instrument cassette system to hold<br>dental instruments in place during transport,<br>steam sterilization, and storage. | Same | | Material<br>Composition | Polymer Resin Radel-5000, biomedical<br>grade silicone, surgical grade stainless steel | Polymer Resin Radel-5000, biomedical grade<br>silicone | Same | | Design | Plastic tray with locking lid; silicone<br>containment brackets and stainless-steel<br>holder | Plastic tray with locking lid and silicone<br>containment brackets | Similar | | Sterilization by:<br>1. Gravity Steam<br>2. Pre-vacuum<br>Steam 132°C<br>Pre-vacuum<br>Steam 135°C | No<br>Yes<br>Yes | Yes<br>Yes<br>No | Similar for pre-<br>vacuum. | | Air Permeance | Yes | Yes | Same | | Locking system to<br>hold lid in place | Yes | Yes | Same | | Reusable | Yes | Yes | Same | | Material<br>compatibility with<br>sterilization process | Yes | Yes | Same | | Sterilant<br>Penetration Studies | Yes - Steam sterilization validation<br>conducted per ISO 17665; AAMI TIR 12 | Yes - Steam sterilization validation<br>conducted per AAMI / ANSO / ISO17665;<br>AAMI TIR 12 | Same | | Toxicological<br>Properties<br>(biocompatibility) | Yes - Cytoxicity tests conducted as per ISO<br>10993-5; ISO 10993-12 | Yes - Cytoxicity tests conducted as per ISO<br>10993-5; ISO 10993-12 | Same | | Transportation<br>Studies | Yes - Distribution studies conducted as per<br>ASTM D4169 | Yes - Distribution studies conducted as per<br>ASTM D4169 | Same | | Cleaning<br>Instructions for<br>Reusable devices | Cleaning validations conducted as per AAMI<br>TIR 30, AAMI TIR 12. | Cleaning validations conducted as per AAMI<br>TIR 30, AAMI TIR 12. | Same | | Material<br>Compatibility<br>(repeat validation) | Yes - Radel Technical Data Sheet | Yes - Radel Technical Data Sheet | Same | | Drying Time | Yes - Steam sterilization validation<br>conducted per AAMI 17665; AAMI TIR 12 | Yes - Steam sterilization validation<br>conducted per AAMI 17665; AAMI TIR 12 | Same | | Vent/Volume Ratio<br>in²/in³ | Large: 0.01<br>Medium: 0.013 - 0.014<br>Small: 0.014 - 0.056 | 0.184 | Different | | Maximum<br>Sterilization Load<br>density (g/cm³) | Large: 0.533<br>Medium: 0.532<br>Small: 0.397 | 0.375 | Different | | Dimensions (L x W<br>x H) (cm) | Large: 26.8 x 14.7 x 5.5<br>Medium: 18.7 x 13.5 x 5.5 | 19 x 14.2 x 6 | Different | | | Small: 14.8 x 9.5 x 5.5 | | | | Maximum weight<br>of tray with<br>instruments | Large: 752<br>Medium: 672<br>Small: 339 | 608.05 | Different | | Maximum number<br>of components | Large: 25<br>Medium: 90<br>Small: 47 | 45 | Different | # Table 1: Technological Characteristics Comparison {7}------------------------------------------------ The Indications for Use Statement for the subject device is similar to the primary predicate device K142519, with the difference being the name of the device The primary predicate device K142519 is for comparison to the subject device implant designs. The subject device Southern Implants Instrument Trays have a design that similar in design to trays in K142519. The subject device is also similar to the predicate device with regards to the intended use; the material composition; sterilization method; cleaning instruction validation and toxicological properties. ### PERFORMANCE DATA Provided below in Table 2 is the summary of the non-clinical testing that was performed per specification of the standard and test methodology listed below. The results of the performance testing demonstrated the subject device met the acceptance criteria of the standard and the test methodology. | Test Methodology | Purpose | Acceptance Criteria | Results | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|--------------------------------------------------------------------|-----------------------------------------------------------------------| | ISO 17665-1<br><i>Sterilization of health<br/>care products – moist</i> | To verify the ability of<br>the sterilization process<br>to adequately sterilize | 6 log reduction at half<br>cycle | The ability for<br>successful sterilization | | heat - part 1:<br>Requirements for the<br>development, validation<br>and routine control of a<br>sterilization process for<br>medical devices | the load at 132°C and<br>135°C | | at 132°C and 135°C<br>was confirmed | | ISO 17664 Processing<br>of health care products<br>– information to be<br>provided by the medical<br>device manufacturer<br>for the processing of<br>medical devices<br>AAMI TIR 12<br>Designing, testing, and<br>labelling reusable<br>medical devices for<br>reprocessing in health<br>care facilities: A guide<br>for medical device<br>manufacturers<br>AAMI TIR 30 A<br>compendium of<br>processes, materials,<br>test methods, and<br>acceptance criteria for<br>cleaning reusable<br>medical devices | To verify the<br>effectiveness of the<br>recommended cleaning<br>process. | Protein < 6 µg/ml<br>Hemoglobin < 100 mg<br>/ml | The recommended<br>cleaning process is<br>effective. | | ISO 10993-5 Biological<br>Evaluation of Medical<br>Device – part 5: Tests<br>for in-vitro cytotoxicity | To observe the<br>cytotoxicity potential of<br>the device | Morphological grade 2 | No cytotoxicity<br>potential was observed. | | ASTM D 4169 (2007)<br>Standard practice for<br>performance testing of<br>shipping containers<br>and systems | To verify the durability<br>of the device during<br>transportation. | No damage to the tray. | The instrument trays<br>survived transit and<br>transport conditions. | | Temperature<br>distribution control | To verify the<br>homogeneity of the<br>temperature distribution<br>inside the tray | There must be no areas<br>colder than the<br>specified temperature | Temperature was<br>homogenous. | #### Table 2: Summary of Non-Clinical Testing {8}------------------------------------------------ ### CONCLUSION The conclusions drawn from the nonclinical tests demonstrate that the Southern Implants Instrument Trays are as safe, as effective and performs as well as or better than the legally marketed device K142519 InterActive Complete Surgical tray.