UNiD™ Spine Analyzer

{0} FDA U.S. FOOD & DRUG ADMINISTRATION Medicrea International S.A.S. (Medtronic) Cecile Humbert Sr Regulatory Affairs Specialist 5389 Route de Strasbourg - Vancia Rillieux-la-Pape, 69140 France August 7, 2025 Re: K251629 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: QIH, LLZ Dated: May 28, 2025 Received: May 28, 2025 Dear Cecile Humbert: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K251629 - Cecile Humbert Page 2 (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory- {2} K251629 - Cecile Humbert Page 3 assistance/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, Jessica Lamb, PhD Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} UNiD™ Spine Analyzer Page 9 of 32 | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K251629 | ? | | Please provide the device trade name(s). | | ? | | UNiD™ Spine Analyzer | | | | Please provide your Indications for Use below. | | ? | | 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. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} 510(k) Summary UNiD™ Spine Analyzer K251629 Date prepared: May 28, 2025 | I. Submitter information | | | | --- | --- | --- | | Submitter | MEDICREA INTERNATIONAL S.A.S. (MEDTRONIC) 5389 Route de Strasbourg – Vancia Rillieux-la-Pape, 69140 France Phone : 00 33 4 72 01 87 87 | | | Contact Person | Cécile HUMBERT Sr Regulatory Affairs Specialist MEDICREA INTERNATIONAL S.A.S. (MEDTRONIC) | | | II. Device identification | | | | Trade name | UNiD™ Spine Analyzer | | | Classification Regulation | Common Name | Automated radiological image processing software | | | Primary Product Code | QIH | | | Associated Product Code | LLZ | | | Regulation Number | 21 CFR 892.2050 | | | Regulation Name | Medical image management and processing system | | | Class | 2 | | III. Predicate and reference devices | | | | Primary predicate device | Device name | UNiD™ Spine Analyzer | | | 510(k) information | K212005, cleared on 01/12/2022 | | | Common Name | system, image processing, radiological | | | Product Code | LLZ | | | Regulation Number | 21 CFR 892.2050 | | | Regulation Name | Medical image management and processing system | | | Class | 2 | | IV. Subject device description | | | | The UNiD™ Spine Analyzer is a web-based application developed to perform preoperative and postoperative patient image measurements and simulate preoperative planning steps for spine surgery. It aims to make measurements on a patient image, simulate a surgical strategy, draw patient-specific rods or choose from a pre-selection of standard implants. 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 3. Estimate the compensatory effects of the simulated surgical procedure on the patient’s spine The planning of surgical procedures is done by Medtronic as part of the service of pre-operative planning. The surgical plan may then be used to assist in designing patient-specific implants. Surgeons will have to validate the surgical plan before Medtronic manufactures any implant. The UNiD™ Spine Analyzer interface is accessible in either standalone mode or connected mode. | | | {5} V. Intended use and indications for use Intended use / Indications for use 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. VI. Comparison of technological characteristics The subject device has similar fundamental scientific technology, overall design, features, computer configuration characteristics, intended use, and indications as the predicate device. The subject device and the predicate device are intended to assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The subject device and the predicate device are compared in the table below. | Feature/ Attribute | Subject Device UNiD™ Spine Analyzer 5.0.0 | Predicate UNiD™ Spine Analyzer 4.0.0 | | --- | --- | --- | | Product code(s) | QIH, LLZ | LLZ | | Regulation number | 892.2050 | 892.2050 | | Classification | 2 | 2 | | Intended use / Indications for use | 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. | 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. | | Fundamental scientific technology | Standalone software | Standalone software | | Computer | PC Compatible | PC Compatible | | Operating System | Windows + Mac | Windows + Mac | | Supply mean | Cloud-based | Cloud-based | | Health Data Host | AWS | AWS | | Frontend code | Angular 14 & Angular JS 1.7 | Angular JS 1.7 | | Backend code | .NET 8.0 | .NET 4.8 | | Databases server | SQL Server | MySQL | | Human intervention | Required for interpretation and manipulation of images | Required for interpretation and manipulation of images | | Supported image format | JPEG; PNG; GIF | JPEG; PNG; GIF | | Access mode | Standalone or connected mode | Standalone or connected mode | | Feature - Image setting | Contains all image setting tools (contrast; brightness; zoom in/out; flip, rotate, text overlay, calibration) Intermodal calibration has been removed as part of a bug fix. | Contains all image setting tools (contrast; brightness; zoom in/out; flip, rotate, text overlay, calibration; intermodal calibration) | {6} | Feature - Generic measurements tools | Contains all generic measurements tools (Line; circle; angle; measured, simulated, and normative values display; values color-coding) Color-coding thresholds are reworked but the operating mode is similar. | Contains all generic measurements tools (Line; circle; angle; measured, simulated, and normative values display; values color-coding) | | --- | --- | --- | | Feature - Spine measurements tools | Contains all spine-related measurements tools (Llordo; TKypho; pelvic; T1SPi; SVA; SA Analysis; Sagittal wizard; Coronal wizard; Transitional anatomy (as part of Sagittal wizard); Cervical; Lenke classification; Coronal correction factor) Sagittal Wizard, SA Analysis, Cervical tool and Lenke tool are reworked for improvement and adding new calculations, but the operating mode remains similar. The Guide Spline tool has been removed as part of a bug fix. | Contains all spine-related measurements tools (Llordo; TKypho; pelvic; T1SPi; SVA; SA Analysis; Sagittal wizard; Coronal wizard; Transitional anatomy (as part of Sagittal wizard); Cervical; Lenke classification; Guide spline; Coronal correction factor) | | Feature - Surgical tools | Contains surgical tools to simulate surgical gestures (wedge; open; resect; spondy; wedge auto; open auto; resect auto) | Contains surgical tools to simulate surgical gestures (wedge; open; resect; spondy, wedge auto; open auto; resect auto) | | Feature - Implants tools | Contains tools to place or draw rods, screws or cages (Free Rod; cage; screw; screw selection; Rod Auto; cage auto; screw wizard; postop screw). Some tools are reworked and relabeled. Tool functionalities have been improved, and bugs have been fixed, but there is no change in output data of the reworked tools. | Contains generic implants and tools to place and/or draw rods, screws or cages (UNiD Rod; cage; cage selection; screw; screw selection; UNiD Rod Auto; cage auto; screw wizard; postop screw). | | Feature - Implants database | Contains commercially available interbody devices. Some TLIF and ALIF implants have been removed from the database. | Contains commercially available interbody devices. | | Feature - AI algorithms | Degenerative; Adult Deformity; Pediatric Deformity The Degenerative model is updated. The functionality is similar. A new application is added (LIV=L5) | Degenerative; Adult Deformity; Pediatric Deformity | | Features - UNiD™ plan export | Contains several export options (as image, as ZIP file or to the Medtronic HUB). The export options to the Medtronic HUB are reworked (export default view with transitional anatomy; link a rod design to a rod order) | Contains several export options (as image, as ZIP file or to the Medtronic HUB). | Table 1: Substantial Equivalence Comparison {7} # VII. Performance data # Nonclinical tests The following non-clinical performance data were provided in support of substantial equivalence: # Software verification The software verification is a combination of software code review, software unit test, unit integration testing, and system level integration to ensure the software is developed correctly and adheres to its design specifications. Software verification was conducted on the UNiD™ Spine Analyzer in accordance with IEC 62304. # Software validation The software validation was performed through user acceptance testing to ensure the software satisfies the specified requirements and meets the user's needs. It was conducted on the UNiD™ Spine Analyzer in accordance with IEC 82304-1. # AI-enabled device software functions (AI-DSF) The software incorporates AI-DSF, which give indication to the user about compensatory mechanisms the patient could experience after the surgery according to the planned instrumentation. Depending on the type of surgery (Adult, Pediatric or Degenerative), a specific predictive model is available. Outputs of these models are intended to be used as inputs of the software system to simulate compensatory mechanisms after spinal fixation. The subject device incorporates a new version of the Degenerative Predictive model compared to the predicate device. This new version includes degenerative constructs with Lower Instrumented level on L5 and predicts Lower non instrumented lordosis in these situations. Preoperative and post operative images from 1050 patient surgery cases were collected from different clinical sites in the US only. After the images were collected, they were then provided to and measured by highly trained Medtronic measurement technicians, operating within a quality-controlled environment. The viability of images for use is vetted by these technicians before beginning surgical planning. Consequently, the manufacturer of imaging equipment does not have any impact on performance. Ground truth was derived from the measured images. Each patient case was assigned a unique identifier and included only in either the testing or the training dataset, in order to ensure the independence of both datasets. The demographic characteristics for the global dataset are presented in the table below. | Degen model | Training set (No. of subjects=776) | Testing set (No. of subjects=274) | Overall (No. of subjects=1050) | | --- | --- | --- | --- | | Mean age, years (sd) | 62.4 (11.5) | 61.0 (12.7) | 62.0 (11.8) | | Gender, N (%) | | | | | Female | 389 (50%) | 127 (46%) | 516 (49%) | | Male | 387 (50%) | 147 (54%) | 534 (51%) | Table 2: Degenerative Model Demographics global dataset Non-inferiority of the subject device vs the predicate device was evaluated: one-tailed paired T-tests for non-inferiority were performed between the MAEs obtained with the subject {8} | | device and the ones obtained with the predicate device. The acceptance criterion for these statistical tests were set to alpha of 0.025, and at least 90% power. The results from the degenerative predictive model performance testing met the defined acceptance criterion. The model showed non-inferiority compared to its predicate and is considered acceptable for use. **Cybersecurity testing** The cybersecurity testing was conducted on the UNiD™ Spine Analyzer in accordance with ANSI AAMI SW96 and IEC 81001-5-1 to ensure the software integrity, confidentiality and availability. Activities performed as part of cybersecurity testing included: security risk assessment and threat modeling, vulnerability assessment, and penetration testing. **Usability evaluation** Usability of the UNiD™ Spine Analyzer user interface was evaluated according to IEC 62366-1. The purpose was to assess the software ergonomics and ensure no usability issues could raise significant risks in terms of safety and effectiveness. | | --- | --- | | Clinical tests | No clinical testing was used in order to support this submission. | | **VIII. Conclusion** | | | Based on the information contained in this submission, the subject UNiD™ Spine Analyzer v5.0.0 device is substantially equivalent to the following predicate device: — Predicate 1 (Primary Predicate): UNiD™ Spine Analyzer v4.0.0 (K212005, S.E. 01/12/2022) | |