Guided Surgery Kit

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. August 16, 2023 Implant Direct Sybron Manufacturing, LLC Reina Choi Regulatory Affairs Manager 3050 East Hillcrest Drive Thousand Oaks, California 91362 Re: K231087 Trade/Device Name: Guided Surgery Kit Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: DZI, KCT Dated: May 18, 2023 Received: May 19, 2023 Dear Reina Choi: 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 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. # Michael E. Adjodha -S Michael Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K231087 Device Name Guided Surgery Kit Indications for Use (Describe) The Guided Surgery Kit is designed to hold various dental surgical drills and instruments to organize, and transport between uses. The guided surgical drills are intended to cut into maxilla or mandible to create an osteotomy for endosseous dental implant placement. The kit is to be enclosed in a FDA cleared steam sterilizable wrap (maximum thickness KC300) and sterilized in a FDA cleared sterilizer for one of the following cycles: (1) Prevacuum Steam – At 132°C for 4 minutes with a 20 minute dry time. - (2) Gravity Steam At 132°C for 15 minutes with a 30 minute dry time. - · The kit is intended for sterilization of non-porous loads. - · Do not stack kits during sterilization. - · Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Sterilizable Guided kit. | Model Name | Model<br>Number | Max # of<br>Instruments | Mass (g) | Vent to Volume<br>Ratio (in-1) | |-------------------------------|-----------------|-------------------------|----------|--------------------------------| | Guided Surgical Kit - Legacy | GSK-L | 51 | 446.52 | 0.032 | | Guided Surgical Kit - Conical | GSK-C | 48 | 442.01 | 0.033 | | Guided Surgical Kit - Empty | GSK-E | N/A | 299.94 | 0.033 | | 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Implant Direct. The logo consists of a gray text that reads "IMPLANT DIRECT" with the trademark symbol next to the word "DIRECT". To the left of the text is a gray and orange graphic that resembles a screw. ## 510(k) Summary – K231087 ## i. Submitter Information | Submitter: | Implant Direct Sybron | |------------|-------------------------| | | Manufacturing, LLC | | | 3050 E. Hillcrest Drive | | | Thousand Oaks, CA | | | 91362, USA | | Contact Person: | Reina Choi, Sr. Regulatory Affairs Manage | |-------------------|-------------------------------------------| | E-Mail: | Reina.choi@envistaco.com | | Telephone Number: | (818) 307-3132 | | Prepared By: | Reina Choi, Sr. Regulatory Affairs Manage | | Date Prepared | August 15, 2023 | #### ii. Device Name | Proprietary name: | Guided Surgery Kit | |-------------------------|------------------------------------------| | Manufacturer: | Implant Direct Sybron Manufacturing, LLC | | Common Name: | Endosseous Dental Implant Drills | | Classification Name: | Bone cutting instrument and accessories | | Regulation Number: | 21 CFR 872.4120 | | Device Class: | II | | Primary Product Code: | DZI | | Secondary Product Code: | KCT | ## iii. Predicate Devices | Predicate Device | | |----------------------|------------------------------------------| | 510(k) #: | K200265 | | Propriety Name: | Surgical Drills | | Manufacturer: | Implant Direct Sybron Manufacturing, LLC | | Common Name: | Endosseous Dental Implant Drills | | Classification Name: | Bone cutting instrument and accessories | | Regulation Number: | 21 CFR 872.4120 | | Device Class: | Class II | | Product Code: | DZI | {4}------------------------------------------------ | Reference Device | | |----------------------|---------------------------------------------------------------------| | 510(k) #: | K202524 | | Propriety Name: | Standard Sterilizable Tray | | Manufacturer: | Implant Direct Sybron Manufacturing, LLC | | Common Name: | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | | Classification Name: | Sterilization Wrap | | Regulation Number: | 21 CFR 880.6850 | | Device Class: | Class II | | Product Code: | KCT | #### iv. Device Description The Guided Surgery Kit is offered in 2 complete kit variations for 3 implant systems: Legacy, Simply lconic, and InterActive as a reusable perforated tray for purposes of transport, steam sterilization and storage of dental instruments, similar to the reference device Standard Sterilizable Tray (K202524). The kit is sold non-sterile and contains site preparation instruments, dental driving tools, prosthetic driving tools and ratchet tool which can be used for implant placement. The proposed Guided Surgical Drills are reusable surgical instruments designed to prepare an osteotomy for a dental implant procedure. The features remain unchanged from the predicate Surgical Drills (K200265) except for the addition of a Guide Body and Shoulder Stop. The addition of a Guide Body allows the proposed drills to function with guide sleeves which can be integrated into an existing surgical quide template to assist in the drilling sequence and placement of dental implants. Note: The guide sleeves are not included in the scope of the clearance. #### v. Principle of Operation / Mechanism of Action The principal of operation is based on the placement of a Sleeve over an existing surgical guide template which allows all the instruments within the guided surgery kit to be quided for position, anqulation, and depth. The instruments found in the quided surqery kit share a common Guide Hub that has a Shoulder to act as a Stop. The Guided Drill is inserted into the Sleeve and the Guide Body portion of the Drill engages with the Sleeve prior to patient contact. Once the Guide Body is engaged with the Sleeve the Drill is now Guided to aid in drilling the osteotomy until the Shoulder contacts the Sleeve which prevents the drilling too deep. Once the osteotomy drilling is complete, the same Sleeve can be immediately used with the Guided Driver the implant into the planned site. #### vi. Compatible Devices and Accessories The Guided Surgery Kit is intended to be used with previously cleared or exempt accessories/devices from Implant Direct. {5}------------------------------------------------ ## vii. Patient Contacting Components Following the assessment set forth in ISO 10993-1:2018 Biological Evaluation of Medical Devices, Annex A, it was determined that the devices in scope of this submission do contain patient contacting components. The patient contacting components have direct patient contact for (≤ 24 hours and typically less than five (5) minutes in single clinical application to complete the surgical procedure). #### Table 0-2 - Patient Contacting Materials | Product Name | Material Description | Colorant | |---------------|----------------------------------------------------------------------|----------| | Dental Drills | Stainless Steel 455 per ASTM F899 with Diamond Like<br>Coating (DLC) | N/A | #### viii. Indications for Use The Guided Surgery Kit is designed to hold various dental surgical drills and instruments to organize, steam sterilize, and transport between uses. The quided surgical drills are intended to cut into maxilla or mandible to create an osteotomy for endosseous dental implant placement. The kit is to be enclosed in a FDA cleared steam sterilizable wrap (maximum thickness KC300) and sterilized in a FDA cleared sterilizer for one of the following cycles: - (1) Prevacuum Steam At 132°C for 4 minutes with a 20 minute dry time. - (2) Gravity Steam At 132°C for 15 minutes with a 30 minute dry time. - · The kit is intended for sterilization of non-porous loads. - · Do not stack kits during sterilization. - · Implant Direct Sybron Manufacturing, LLC does not make any lumen claims for the Sterilizable Guided kit. {6}------------------------------------------------ | Model Name | Model<br>Number | Max # of<br>Instruments | Mass (g) | Vent to Volume<br>Ratio (in-1) | |----------------------------------|-----------------|-------------------------|----------|--------------------------------| | Guided Surgical Kit -<br>Legacy | GSK-L | 51 | 446.52 | 0.032 | | Guided Surgical Kit -<br>Conical | GSK-C | 48 | 442.01 | 0.033 | | Guided Surgical Kit -<br>Empty | GSK-E | N/A | 299.94 | 0.033 | #### ix. Summary of Substantial Equivalence The similarities and differences between the Subject Device, Guided Surgery Kit and the Predicate Devices as described in Table 0-3 are as follows: The similarities between the Guided Surgery Kit (Subject Device), Predicate Device Surgical Drills (K200265) and Reference Device Standard Sterilizable Tray (K202524), listed in the table below are the Indications for Use, Mode of Action, material, and general design features. Exterior dimensions, surface finish, and mated surface of kit lid opens/closes via side hinges on the kit are the same. Also, Biocompatibility testing, Cleaning and Sterilization testing are the same. There are no major differences however there are minor differences between the Guided Surgery Kit (Subject Device) and Predicate Device Surgical Drills and Reference Device Standard Sterilizable Tray as follows: 1) subject device has additional integrated guided body and guide hub compared to predicate; 2) subject device has DLC coating covering the entire cutting flutes area, while predicate is only partially coated with DLC; 3) subject device has same outer tray dimensions and slight different inner tray layout from reference device; 4) subject device has larger maximum number of instruments, but smaller maximum sterilization load compared to reference device; 5) subject device has larger vent to volume ratio than reference device; 6) the total number of instruments surface area of the subject device is slightly larger by 3% than the reference device. #### Conclusion: Based on a comparison of intended use, indications for use, technological characteristics, principle of operation, features, and performance data, the Guided Surgery Kit is deemed to be substantially equivalent to the predicate devices as it satisfies all criteria of substantial equivalence and does not raise new concerns regarding substantial equivalence: (1) Indications for Use, (2) Technological Characteristics, and (3) Performance Data. The new device does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is substantial equivalent. {7}------------------------------------------------ #### Table 0-3: Guided Surgery Kit Comparison Table | Description | Subject Device<br>Guided Surgery Kit | Predicate<br>Surgical Drills<br>(K200265) | Reference Device<br>Standard Sterilizable Tray<br>(K202524) | Comparison | |------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Implant Direct | Implant Direct | Implant Direct | Same | | Pictorial<br>Representation | Image: Guided Surgery Kit | Image: Surgical Drills | Image: Standard Sterilizable Tray | N/A | | Regulatory Classification | | | | | | Regulation # | 21 CFR 872.4120<br>21 CFR 880.6850 | 21 CFR<br>872.4120 | 21 CFR 880.6850 | Same | | Regulation Title | Bone cutting instrument and<br>accessories;<br>Sterilization Wrap | Bone cutting<br>instrument and<br>accessories | Sterilization Wrap | Same | | Regulation<br>Class | II | II | II | Same | | Product Code | DZI, KCT | DZI | KCT | Same | | Indications for Use/Intended Use | | | | | | Indications for<br>Use /<br>Intended Use | The Guided Surgery Kit is designed to<br>hold various dental surgical drills and<br>instruments to organize, steam<br>sterilize, and transport between uses.<br>The guided surgical drills are intended<br>to cut into maxilla or mandible to<br>create an osteotomy for endosseous<br>dental implant placement.<br><br>The kit is to be enclosed in an FDA<br>cleared steam sterilizable wrap<br>(maximum thickness KC300) and<br>sterilized in an FDA cleared sterilizer<br>for one of the following cycles:<br>(1) Prevacuum Steam – At 132°C for 4<br>minutes with a 20 minute dry time.<br>(2) Gravity Steam – At 132°C for 15<br>minutes with a 30 minute dry time.<br>• The kit is intended for sterilization of<br>non-porous loads.<br>• Do not stack kits during sterilization.<br>• Implant Direct Sybron Manufacturing<br>LLC does not make any lumen claims<br>for the Guided Surgery Kit | The Surgical<br>Drills are<br>intended to cut<br>into maxilla or<br>mandible to<br>create an<br>osteotomy for<br>endosseous<br>dental implant<br>placement. | The Standard Sterilizable Tray is<br>designed to hold various dental<br>surgical and prosthetic instruments in<br>order to organize, steam sterilize, and<br>transport the instruments between<br>uses. The tray is to be enclosed in an<br>FDA cleared steam sterilizable wrap<br>(maximum thickness KC300) and<br>sterilized in an FDA cleared sterilizer<br>for one of the following cycles:<br>(1) Prevacuum Steam – At 132°C for<br>4 minutes with a 20 minutes dry time.<br>(2) Gravity Steam – At 132°C for 15<br>minutes with a 30 minutes dry time.<br>- The tray is intended for sterilization<br>of non-porous loads.<br>- Do not stack trays during<br>sterilization.<br>- The tested Tray represents the worst<br>case validated load of 667.52 grams.<br>- Implant Direct Sybron Manufacturing<br>LLC does not make any lumen claims<br>for the Standard Sterilizable Tray. | Same as<br>Predicate<br>and<br>Reference<br>Device,<br>except<br>subject<br>device has<br>larger # of<br>instruments,<br>smaller max<br>load, and<br>larger vent to<br>volume ratio. | | Description | Subject Device<br>Guided Surgery Kit | Predicate<br>Surgical Drills<br>(K200265) | Reference Device<br>Standard Sterilizable Tray<br>(K202524) | Comparison | | | Guided<br>Surgery<br>Kit -<br>Legacy | | | | | | GSK-L | | Standa<br>rd<br>Surgica<br>I Kit | | | | 51 | | CSSK | | | | 446.52 | | 46 | | | | 0.032 | | 667.52 | | | | | | 0.021 | | | | Guided<br>Surgery<br>Kit -<br>Conical | | Standa<br>rd<br>Surgica<br>I Kit | | | | GSK-C | | SSK | | | | 48 | | | | | | 442.01 | | 385.2 | | | | 0.033 | | 0.021 | | | | Guided<br>Surgery<br>Kit -<br>Empty | | Empty<br>InterAct<br>ive<br>Surgica<br>I Kit | | | | GSK-E | | CISK | | | | N/A | | 34 | | | | 299.94 | | 662.70 | | | | 0.033 | | 0.021 | | | | | | InterAct<br>ive<br>Surgica<br>I Kit<br>Empty | | | |…