← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K120288 # ORTHOCAD SOFTWARE OPTION (K120288) _Esaote, S.p.A. · LLZ · Sep 19, 2012 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K120288 ## Device Facts - **Applicant:** Esaote, S.p.A. - **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md) - **Decision Date:** Sep 19, 2012 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use OrthoCAD is an option that provides the morphometry of the lumbo-sacral section of the spine, by means of semi-automatic segmentation of MR images, the generation of the relative 3D model and calculation of the significant geometrical properties of the vertebral bodies and spinal canal. When this data is interpreted by a trained physician, it can yield information that may assist diagnosis. ## Device Story OrthoCAD is a software option for the Esaote G-scan MR system. It processes sagittal FSE T2 MR images of the lumbosacral spine (L1-S1). Users perform manual or semi-automatic (wizard) segmentation of vertebral bodies and the spinal canal to construct 3D models. The system calculates clinical parameters including vertebral wedging, listhesis index, intervertebral translation/angles, vertebral collapse index, spinal curvature, spinal canal thickness/section, and foramen area. It supports endoscopic virtual navigation within the segmented canal and allows comparison of images acquired in clinostatic and orthostatic positions. Used by physicians in clinical settings to assist in diagnosis by providing quantitative geometric data. ## Clinical Evidence Bench testing only. Testing included comparison between manual and semi-automated segmentation of lumbar/sacral vertebrae and spinal canal; evaluation of variability, repeatability, and reproducibility of measurements; and validation of software correctness in measuring MRI images of the lumbar spine. ## Technological Characteristics Software-based image processing package. Operates on MR images acquired via G-scan (K111803). Features include semi-automatic segmentation, 3D model construction, and geometric measurement tools. Connectivity via database integration for patient management. No change to fundamental scientific technology of the host MR system. ## Regulatory Identification A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements. ## Special Controls *Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). ## Predicate Devices - G-scan ([K111803](/device/K111803.md)) - SpineAnalyzer ([K103475](/device/K103475.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K120288 SEP 1 1 9 2012 510(k) Summary OrthoCAD software option for G-scan Esaote, S.p.A. # 510(k) Summary The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a). # Submitter Information Donatella Ragghianti Esaote S.p.A. Via Siffredi 58 Genova 16153 Italy Contact Person: Allison Scott, RAC (317) 569-9500 x 106 Phone: Facsimile: (317) 569-9520 ascott@ansongroup.com | Date: | August 30, 2012 | |-------------------------|---------------------------------------------| | Trade Name: | OrthoCAD software option for G-scan | | Common Name: | System, Image Processing, Radiological | | Classification Name(s): | Picture archiving and communications system | | Classification Number: | LLZ | ## Predicate Device(s) | Trade name | Common name | Class | Product code | Manufacturer | K number | |---------------|--------------------------------------------------|-------|--------------|-----------------|----------| | G-scan | System, nuclear
magnetic resonance
imaging | II | LNH | Esaote S.p.A. | K111803 | | SpineAnalyzer | Spine Analysis
Software | II | LLZ | OPTASIA MEDICAL | K103475 | {1}------------------------------------------------ 510(k) Summarv OrthoCAD software option for G-scan Esaote, S.p.A. ## Device Description The OrthoCAD software option is a software package intended to be used with Esaote Gscan system cleared via K111803. OrthoCAD provides the morphometry of the lumbosacral section of the spine, by means of semi-automatic segmentation of MR images, the generation of the relative 3D model and calculation of the significant geometrical properties of the vertebral bodies and spinal canal. When this data is interpreted by a trained physician, it can yield information that may assist diagnosis. G-scan is a Magnetic Resonance (MR) system, which produces images of the internal structures of the patient's limbs and joints. The OrthoCAD system allows you to visualize, analyse and compare Magnetic Resonance images. The system is connected to a database that enables the physician to keep track of all the patients examined over time. The images are acquired by running FSE T2 Rel sequences on the G-scan of the lumbosacral tract of the vertebral spine, in the sagittal plane, and are transferred to the OrthoCAD database following acquisition. When the MR images are stored on the OrthoCAD database, the user can proceed with a manual or semi-automatic (wizard) segmentation of the vertebral bodies (from L1 up to S1) and of the spinal canal. During the segmentation of the anatomical elements, 3D models are constructed based on the segmented structures. When the segmentation procedure has been terminated, the user can proceed with the evaluation of the following significant clinical parameters: - . � Vertebral wedging - Listhesis index . - Intervertebral translation index . - Intervertebral angles . - Vertebral collapse index . - . Spinal curvature - . Spinal canal thickness - . Spinal canal section - Foramen area . . Following this process, the endoscopic virtual navigation within the segmented spinal canal is enabled. {2}------------------------------------------------ Finally, if the user has worked on MR images acquired both in the clinostatic and orthostatic mode, the measures calculated and the virtual navigation of the two the positions can be compared, and a report containing all the information is produced. OrthoCAD is made up of six environments: - . Patient Management: contains the functions required for the display and management of patients stored in the database associated with the system. - Home: keeps track of the procedures executed overtime for the selected patient . (analyses present, status of examinations associated with the various analyses, etc.). - . Segmentation: carries out the functions used for the segmentation and those related to the construction of 3D models of anatomic elements - Measurements: includes all tools required to measure the clinical parameters . used for the analysis of the currently selected exam. - Navigation: enables endoscopic virtual navigation within the segmented . anatomical structures by means of the definition of anatomic points, in order to construct one (or more) navigation routes. - . Comparison: enables the comparison of two different examinations within the same analysis or within different analyses provided they are the same type. This environment enables: - . The simultaneous display, or superimposed display when required, of anatomical elements which belong to the two volumes being compared. - 미 The simultaneous display of the different measurements, with an indication of the main differences between these values. ### Intended Use(s) OrthoCAD is an option that provides the morphometry of the lumbo-sacral section of the spine, by means of semi-automatic segmentation of MR images, the generation of the relative 3D model and calculation of the significant geometrical properties of the vertebral bodies and spinal canal. When this data is interpreted by a trained physician, it can yield information that may assist diagnosis. #### Technological Characteristics The addition of the OrthoCAD Software Option, reflected in this 510(k), does not alter the fundamental scientific technology of the G-scan system, cleared via K111803. #### Performance Data Non-clinical testing of the G-scan system with the addition of the OrthoCAD Software Option demonstrated that it met performance requirements and is as safe and effective as the predicate devices. {3}------------------------------------------------ Tests performed: - Comparison between the manual and semi-automated segmentation on lumbar ● and first sacral vertebrae - . Comparison between the manual and semi-automated segmentation on spinal canal - Comparison of the manual and semi-automated measurements and evaluation of . variability, repeatability and reproducibility 4 - Validation of new software OrthoCAD in its correctness in measuring MRI . images f the Lumbar spine {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The eagle is facing to the right. The logo is black and white. # DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 Esaote S.p.A. % Ms. Allison Scott RAC The Anson Group 9001 Wesleyan Road, Suite 200 INDIANAPOLIS IN 46268 Re: K120288 Trade/Device Name: OrthoCAD Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 30, 2012 Received: August 31, 2012 ### Dear Ms. Scott: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 910(t) presidentially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the chorosury to regars in medical Device Amendments, or to conninered print to May 20, 1978, in accordance with the provisions of the Federal Food, DNA devices mat have occh recassinou in asses approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, mercere, market the act include requirements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into class II (Special Controls), it may be subject to such If your device is classified (see above) into enass fr (or your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 costs of the at Please be advised that I DA 3 issumed on a second is with other requirements of the Act that FDA has made a determination that your device complies with other requirements of that IDA has made a determination and regulations administered by other Federal agencies. You must of any I edelal statutes and regularions and including, but not limited to: registration and listing (21 Comply with an the rece requirems, 801 and 809); medical device reporting (reporting of SEP 19 2012 {5}------------------------------------------------ ### Page 2 medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device felated du rerse evality systems (QS) regulation (21 CFR Part 820). This letter requirements as bet form in the quarny device as described in your Section 510(k) premarket with anow you to began maing of substantial equivalence of your device to a legally marketed nouticate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 11 you don't opening an receive of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket s 150. Theose not 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Tou may obtain other gefacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely Yours, Janine M. Morris Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # Indications for Use K120288 510(k) Number (if known): Device Name: OrthoCAD Indications for Use: OrthoCAD is an option that provides the morphometry of the lumbo-sacral section of the spine, by means of semi-automatic segmentation of MR images, the generation of the relative 3D model and calculation of the significant geometrical properties of the vertebral bodies and spinal canal. When this data is interpreted by a trained physician, it can yield information that may assist diagnosis. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Mundoff Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safe 510(k) --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K120288](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K120288) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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