(232 days)
Not Found
No
The description mentions "semi-automatic segmentation" and "wizard" functionality, which are typically rule-based or traditional image processing techniques, not explicitly AI/ML. There is no mention of AI, ML, or related terms like neural networks, deep learning, or training/test sets for model development.
No.
OrthoCAD is a software option that assists diagnosis by providing morphometry of the lumbosacral spine from MR images, but it does not treat or prevent any disease or condition.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device "can yield information that may assist diagnosis."
No
The device is described as a "software option" intended to be used with an existing MR system (Esaote Gscan, K111803). While OrthoCAD itself is software, its function is entirely dependent on and integrated with the hardware of the MR system for image acquisition. The 510(k) summary describes testing of the "G-scan system with the addition of the OrthoCAD Software Option," indicating it's not a standalone software device.
Based on the provided information, OrthoCAD is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- OrthoCAD's Function: OrthoCAD processes medical images (MR images of the spine) and performs measurements and analysis on those images. It does not interact with or analyze biological specimens taken from the patient.
- Intended Use: The intended use clearly states that OrthoCAD provides morphometry of the spine based on MR images and that this data, when interpreted by a physician, "may assist diagnosis." This aligns with the function of medical image analysis software, not IVDs.
Therefore, OrthoCAD falls under the category of medical image processing and analysis software, not In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes
LLZ
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.
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.
- The simultaneous display of the different measurements, with an indication of the main differences between these values.
Mentions image processing
System, Image Processing, Radiological
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
lumbosacral section of the spine, vertebral bodies, spinal canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
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
- Validation of new software OrthoCAD in its correctness in measuring MRI images of the Lumbar spine
Key Metrics
variability, repeatability and reproducibility
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
0
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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
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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)