Corin Optimized Positioning System (OPS) Plan

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November 26, 2018 Corin USA Martina Cecconi Regulatory and Clinical Affairs Team Leader Corin (Australia) 17 Bridge Street PYMBLE, NEW SOUTH WALES 2073 AUSTRALIA Re: K183038 Trade/Device Name: Corin Optimized Positioning System (OPS) Plan Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ, LZO, MEH Dated: October 30, 2018 Received: November 1, 2018 Dear Martina Cecconi: 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 mav, 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 avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 D. O'Hara Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### 2. INDICATION FOR USE DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K183038 Device Name Corin Optimized Positioning System (OPS™) Plan Indications for Use (Describe) The Corin Optimized Positioning System Plan (OPS™ Plan) is indicated for pre-operative planning for primary total hip arthroplasty. OPS™ Plan is intended to be used as a pre-operative tool to assist the Surgeon in the selection (for example, lateralised or standard stem), sizing and positioning of components of primary total hip arthroplasty. The Corin OPS™ Plan is intended to be used with the Corin TriFit TS (K121563, K153772), MetaFix (K082525, K121439, K131952, K153381), TaperFit (K142761, K153725), MiniHip (K083312, K11046, K131986) and TriFit CF (K173880) Femoral Hip Stems. | <b>Type of Use (Select one or both, as applicable)</b> | |--------------------------------------------------------| |--------------------------------------------------------| | <div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | |----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| 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](mailto: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."* FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {3}------------------------------------------------ | 1. | Applicant/Sponsor<br>Distributor: | Corin USA Limited<br>Distributor<br>12750 Citrus Park Lane<br>Suite 120<br>Tampa, Florida 33625<br>Establishment Registration No.: 1056629 | |----|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 2. | Manufacturer: | Optimized Ortho Pty Ltd<br>17 Bridge Street<br>Pymble NSW<br>2073 Australia<br>Establishment Registration No: 3012916784 | | 3. | Contact Person: | Martina Cecconi<br>Regulatory and Clinical Affairs Team Leader<br>Corin (Australia) Pty Limited<br>Martina.Cecconi@coringroup.com<br><br>Lucinda Gerber<br>Global Regulatory Affairs Manager<br>Corin USA Limited<br>1 (772) 321-2478<br>Lucinda.Gerber@coringroup.com | - 4. Date: Tuesday, 30 October 2018 - 5. Trade Name: Corin Optimized Positioning System (OPS™) Plan - 6. Common Name: Image Processing Software # 7. Classification Product Code(s): LLZ Additional Product Code(s): LZO, MEH # 8. Classification Name: 21 CFR 892.2050 – Picture archiving and communications system Additional Classification Names: 21 CFR 888.3353 – Hip joint metal/ceramic/polymer semi-constrained cemented or {4}------------------------------------------------ nonporous uncemented prosthesis. 21 CFR 888.3353 – Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis. # 9. Substantially Equivalent (predicate) device(s): - . Corin Optimized Positioning System (OPS™) Plan (K171847) ## 10. Device Description: The Corin Optimized Positioning System™ Plan (OPS™ Plan) is a pre-operative templating tool to assist the Surgeon in the planning of primary total hip arthroplasty using any Corin femoral stem. The Corin OPS™ Plan assists in selection (for example, lateralised or standard stem), sizing and placement of implant components (stem, head, cup) using anatomical landmarks of the femur and pelvis obtained from pre-operative CT scan and AP X-ray. The OPS™ Plan consists of the OPS™ Plan Report and the OPS™ Plan Appendix. The OPS™ Plan report is a static report which displays the selection (for example, lateralised or standard stem), sizing and placement of implant components. OPS™ Plan Appendix presents the steps taken by the Engineer on behalf of the Surgeon during the preoperative planning process, which include the identification of anatomical landmarks as well as sizing and positioning of the implants. The Corin OPS™ Plan process begins with booking the OPS case to final release of the OPS Plan Report. OPS™ case booking details and required CT and X-ray imaging in DICOM format are electronically transferred to the manufacturer via the online end-user interface, the OPS™ Portal. Image processing is completed by an Corin Simulation Engineer with results of the OPS™ analysis provided in the OPS™ Plan Report. The Surgeon does not actively interact with the image processing, implant positioning and/or report generation. Final acceptance of the OPS™ Plan by the Surgeon is confirmed following any modifications or clarifications of the reported results. The OPS™ Plan was originally cleared in K171847. The purpose of this submission is to include TriFit CF (K173880) to the Femoral Hip systems intended to be used with the OPS™ Plan. The design and all the other compatible components for use with the OPS™ Plan subject of this submission are identical to that of the predicate device K171847. {5}------------------------------------------------ ## 11. Indications for Use / Intended Purpose: The Corin Optimized Positioning System Plan (OPS™ Plan) is indicated for preoperative planning for primary total hip arthroplasty. OPS™ Plan is intended to be used as a pre-operative tool to assist the Surgeon in the selection (for example, lateralised or standard stem), sizing and positioning of components of primary total hip arthroplasty. The Corin OPS™ Plan is intended to be used with the Corin TriFit TS (K121563, K153772), MetaFix (K082525, K121439, K131952, K153381), TaperFit (K142761, K153725), MiniHip (K083312, K11046, K131986) and TriFit CF (K173880) Femoral Hip Stems. ## 12. Summary of Technologies/Substantial Equivalence: The Corin OPS™ Plan subject of this submission is identical to the predicate Corin OPS™ Plan (K171847) in design, technological characteristics, principles of operation and indication of use, with both the subject device and predicate device utilizing CT scans to generate 2D patient specific bone models and X-Ray imaging to identify bony landmarks. The end user and site of operation (hip) is identical for both the subject device and predicate device. Based on these similarities, Corin believes that the Corin OPS™ Plan is substantially equivalent to the predicate device. #### 13. Non-Clinical Testing: Non-clinical testing was performed to assess the safety and effectiveness of the device, to demonstrate the processing of patient imaging to produce accurate, repeatable and reproducible implant selection, sizing and placement of components, and the usability of the OPS™ Plan that is provided to the Surgeon. Testing verified that the accuracy and performance of the system is adequate to perform as intended. ### 14. Clinical Testing: Clinical testing was not necessary for this Traditional 510(k). #### 15. Conclusion: The subject device has similar intended uses and indications, technological characteristics, and principles of operation as its predicate device. The differences between the device and its predicate devices raise no new issues in terms of safety or effectiveness.