UNiD Spine Analyzer

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MEDICREA International, Inc. % Carrie Hetrick Director of Regulatory Sterling Medical Devices 250 Moonachie Road MOONACHIE NJ 07074 January 12, 2022 Re: K212005 Trade/Device Name: UNiD™ Spine Analyzer Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: December 9, 2021 Received: December 10, 2021 Dear Carrie Hetrick: 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. 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Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) Device Name UNiD™ Spine Analyzer Indications for Use (Describe) The UNID™ Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons and service providers to perform generic, as well as spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><span> <svg class="bi bi-check-square-fill" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2zm10.036 4.036a.75.75 0 0 1 .108.19l3.47 3.05a.75.75 0 0 1-.108 1.06L6.854 14.464a.75.75 0 0 1-1.06.108l-3.47-3.05a.75.75 0 0 1 .108-1.06L10.924 4.036a.75.75 0 0 1 1.06-.108z" fill-rule="evenodd"></path> </svg> </span>Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M0 2a2 2 0 0 1 2-2h12a2 2 0 0 1 2 2v12a2 2 0 0 1-2 2H2a2 2 0 0 1-2-2V2zm1.5 0a.5.5 0 0 0-.5.5v11a.5.5 0 0 0 .5.5h11a.5.5 0 0 0 .5-.5v-11a.5.5 0 0 0-.5-.5h-11z" fill-rule="evenodd"></path> </svg> </span>Over-The-Counter Use (21 CFR 801 Subpart C)</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 "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 ### UNiD Spine ## Analyzer K212005 #### 1. Submission Sponsor MEDICREA International, Inc. 5389 Route de Strasbourg - Vancia Rillieux La Pape 69140 France ### 2. Submission Correspondent Sterling Medical Devices 250 Moonachie Road, Suite 400 Moonachie, NJ 07074 Office Phone: (201) 227-7569 Contact: Carrie Hetrick, DDS, MScRSc Title: Director of Regulatory Affairs #### 3. Date Prepared June 25, 2021 #### 4. Device Identification | Trade/Proprietary Name: | UNiD Spine Analyzer | |-------------------------|------------------------------------------------| | Common/Usual Name: | Medical Image Management and Processing System | | Classification Name: | System, image processing, radiological | | Regulation Number: | 21 CFR §892.2050 | | Product Code: | LLZ | {4}------------------------------------------------ Device Class: Class II Classification Panel: Radiology #### 5. Legally Marketed Predicate Device K180091, MEDICREA International, Inc. UNiD Spine Analyzer v2.0 (primary predicate). This predicate has not been subject to a design-related recall¹ #### 6. Indication for Use Statement The UNiD™ Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons and service providers to perform generic, as well as spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software. ### 7. Device Description The MEDICREA UNiD Spine Analyzer was developed to perform preoperative and postoperative patient image measurements and simulate preoperative planning steps for spine surgery. This web-based, Software as a Medical Device (SaMD) application aims to simulate a surgical strategy, make measurements on a patient image, and draw patient-specific rods or choose from a pre-selection of standard implants and ordering the patient-specific rods. The UNiD Spine Analyzer allows the user to: - 1) Measure radiological images using generic tools and "specialty" tools - 2) Plan and simulate aspects of surgical procedures The purpose of this submission is to request clearance for the UNiD Spine Analyzer v4.0. The changes introduced are as follows: - . Addition of the Degenerative Predictive Model, which corresponds to a type of adult spinal fusion degenerative construct, trained with a retrospective longitudinal patient dataset. - . Update to the existing Adult Predictive Model consisting of three predictive model modules trained with retrospective longitudinal patient datasets, where one was included in Adult Deformity Model 1 (TKA-12) and two included in Adult Deformity Model 2 (PTA-12 and PTA-34). - Update to the existing Pediatric Predictive Model consisting of two predictive model modules trained with retrospective longitudinal patient datasets (PediaLL and PediaPT), ¹ On July 9, 2012, section 605 of FDASIA (Pub. L. 112-144) added section 518A to the FD&C Act, which directs FDA to establish a program to routinely and systematically assess information regarding device recalls, and to use that information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices. FDA believes that one way to carry out this directive is to provide greater transparency on recalled devices. Identifying whether a predicate was recalled is optional, but doing so would help the Agency achieve this FDASIA directive. {5}------------------------------------------------ - Addition of the display of a Predicted Value derived from a static machine-learning based model . when the user views simulated quantitative radiographic parameters of a planned surgery, generated when the Degenerative, Adult or Pediatric Predictive Models are used. - . The subject device update also includes the addition of implant templates among a preselected database of Medtronic standard implants cleared in in the following 510(k)s: K073291, K083026, K091813, K110543, K113528, K120368, K150135, K152277, K172199, K172328, and K201267. #### 8. Substantial Equivalence Discussion The following table compares the UNiD Spine Analyzer v4.0 to the UNiD Spine Analyzer v2.0 predicate device with respect to indications for use, features, and technological characteristics. | | Subject Device<br>MEDICREA UNID™ Spine Analyzer v4.0 | Predicate Device<br>MEDICREA UNID™ Spine Analyzer v2.0 | |---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | MEDICREA International, Inc. | MEDICREA International, Inc. | | 510(k) Number | To be determined | K180091 (Special) | | Device Class | II | II | | Product Code(s) | LLZ | LLZ | | Regulation<br>Description | Medical Image Management and<br>Processing System (MIMPS) | Picture Archiving and Communication<br>System (PACS) | | Regulation Number | 21 CFR §892.2050 | 21 CFR §892.2050 | | Indications for use: | The UNID Spine Analyzer is intended<br>for assisting healthcare professionals<br>in viewing and measuring images as<br>well as planning orthopedic surgeries.<br>The device allows surgeons and service<br>providers to perform generic, as well<br>as spine related measurements on<br>images, and to plan surgical<br>procedures. The device also includes<br>tools for measuring anatomical<br>components for placement of surgical<br>implants. Clinical judgment and<br>experience are required to properly<br>use the software. | The UNID Spine Analyzer is intended<br>for assisting healthcare professionals<br>in viewing and measuring images as<br>well as planning orthopedic surgeries.<br>The device allows surgeons and service<br>providers to perform generic, as well<br>as spine related measurements on<br>images, and to plan surgical<br>procedures. The device also includes<br>tools for measuring anatomical<br>components for placement of surgical<br>implants. Clinical judgment and<br>experience are required to properly<br>use the software. | | Computer | PC Compatible | PC Compatible | | Operating System | Windows + MAC | Windows + MAC | | Image Input | Local | Local | | | Subject Device | Predicate Device | | | MEDICREA UNID™ Spine Analyzer v4.0 | MEDICREA UNID™ Spine Analyzer v2.0 | | Runs on Server | Yes | Yes | | Osteotomy Module | Yes | Yes | | Generic<br>measurements | No additional changes | The measurement panel allows a user<br>to view the measured values of each<br>tool. The device allows surgeons and<br>service providers to perform generic,<br>as well as spine related measurements<br>on images, and to plan surgical<br>procedures. The device also includes<br>tools for measuring anatomical<br>components for placement of surgical<br>implants. Complementary to the pre-<br>op measure, this panel also displays<br>the simulated values and shows the<br>normative value. Quality for the<br>measurement is given coloring, the<br>simulated values depending on<br>reference values. | | Spine measurements | MEASURING TOOLS: Contains all<br>measurement tools (angle, LLordo,<br>line, circle, pelvic, T1SPi, SVA)<br>New features internally documented<br>and released include SA Analysis,<br>Sagittal wizard, Coronal wizard,<br>Transitional anatomy, Cervical, Lenke<br>classification, and Guide spline. | MEASURING TOOLS: Contains all<br>measurement tools (angle, LLordo,<br>line, circle, pelvic, T1SPi, SVA). | | Pre-operative<br>planning | SURGICAL TOOLS: Contains all surgery<br>tools (wedge, open, resect)<br>New features internally documented<br>and released include wedge auto,<br>open auto, and resect auto surgical<br>tools. | SURGICAL TOOLS: Contains all surgery<br>tools (wedge, open, resect). | | Custom implants | IMPLANTS: Contains all implants (UNID<br>Rod, cage, cage selection, screw, screw<br>selection).<br>New features internally documented<br>and released include UNID Rod Auto,<br>cage auto, screw wizard, and postop<br>screw. | IMPLANTS: Contains all implants (UNID<br>Rod, cage, cage selection, screw, screw<br>selection) | | Database | Yes (implants) | Yes (implants) | | | Subject Device | Predicate Device | | | MEDICREA UNID™ Spine Analyzer v4.0 | MEDICREA UNID™ Spine Analyzer v2.0 | | | The subject device update also<br>includes the addition of a selection of<br>implant templates among a<br>preselected database of Medtronic<br>standard implants cleared in in the<br>following 510(k)s: K073291, K083026,<br>K091813, K100175, K110543, K113528,<br>K120368, K150135, K152277, K172199,<br>K172328, and K201267. | | | Case sharing | Yes | Yes | | Human intervention<br>for interpretation and<br>manipulation of<br>images | Required | Required | | Web content | Yes | Yes | | Reference<br>information provided<br>to user during surgical<br>planning | Display of reference data to user<br>during surgery planning:<br>Normative data<br>Predictive model outputs from one of<br>three predictive models, depending on<br>procedure type (degenerative, adult<br>deformity, pediatric deformity) | Display of reference data to user<br>during surgery planning:<br>Normative data | #### Table 5A – Substantial Equivalence Comparison {6}------------------------------------------------ {7}------------------------------------------------ The new predictive models provide an additional tool to account for predicted spinal compensation when planning surgery; their use is similar to the display of reference and normative data, and does not raise new questions of safety and effectiveness when considered with existing methods of managing spinal compensation. Predictions are radiographic and do not include patient reported outcomes (e.g., ODI scores). {8}------------------------------------------------ #### 8. Non-Clinical Performance Data The device's software development, verification, and validation have been carried out in accordance with FDA guidelines. The software was tested against the established Software Design Specifications for each of the test plans to assure the device performs as intended. The device Hazard analysis was completed per ISO 14971, Application of Risk Management to Medical Devices and IEC 62304, Medical Device Software – Software Life-Cycle Processes, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria of each module and interaction of processes. The MEDICREA UNiD Spine Analyzer device passed all testing and supports the claims of substantial equivalence and safe operation. Validation activities included a usability study of the UNiD Spine Analyzer under actual use. The study demonstrated: - י Comprehension of the Health Care professional with the UNiD Spine Analyzer, - Appropriate human factors related to the UNiD Spine Analyzer, and - -Ease of use of the UNiD Spine Analyzer. ### 9. Clinical Performance Data There was no human clinical testing required to support the medical device as the indications for use is identical to the predicate device. These types of devices, including the predicate device, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device. #### 10. Conclusions By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device(s). The intended use and indications for use of the subject device is identical to the predicate device. The addition of the new features, consisting of measuring tool functionality and predictive models, to the device does not raise new issues of safety or effectiveness compared to the previously cleared versions of the device. Therefore, the UNiD Spine Analyzer v4.0 is determined to be substantially equivalent to the company's own legally marketed predicate device.