STEREOS WORKSTATION

K101398 · Biospace Med · LLZ · Feb 4, 2011 · Radiology

Device Facts

• Record ID: K101398
• Device Name: STEREOS WORKSTATION
• Applicant: Biospace Med
• Product Code: LLZ · Radiology
• Decision Date: Feb 4, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device, Pediatric

Intended Use

The sterEOS Workstation is intended for use in the fields of musculoskeletal radiology and orthopedics in both pediatric and adult populations as a general PACS device for acceptance. transfer, display, storage, and digital processing of 2D X-ray images of the musculoskeletal system including interactive 2D measurement tools. When using 2D X-ray images obtained with the EOS Imaging EOS System (K071546). the sterEOS Workstation provides interactive 3D measurement tools: - to aid in the analysis of scoliosis and related disorders and deformities of the spine in adult patients as well as pediatric patients 7 years and older. The 3D measurement tools include interactive analysis based on a model of bone structures derived from an a priori image data set from 175 patients (91 normal patients, 47 patients with moderate idiopathic scoliosis and 37 patients with severe idiopathic scoliosis), and dry isolated vertebrae data. The model of bone structures is not intended for use in patients with a Cobb's angle > 50 degrees and is not intended for use to assess individual vertebral abnormalities. . . . . . - to aid in the analysis of lower limbs alignment and related disorders and deformities based on angle and length measurements. The 3D measurement tools include interactive analysis based either on identification of lower limb alignment landmarks or as for the spine, on a model of bone structures derived from an a priori image data set. The model of bone structures is not intended for use to assess individual bone abnormalities. The 3D package including model-based measurements and torsion angles is indicated only for patients 15 years or older. Only the 2D/3D ruler is indicated for measurements in patient younger than 15 years old.

Device Story

System for acceptance, transfer, display, storage, and digital processing of 2D X-ray images; provides interactive 2D/3D measurement tools. Inputs: 2D X-ray images from EOS Imaging EOS System. Operation: User identifies anatomical landmarks on frontal/lateral X-rays; system uses linear regression and a priori database (parametric models) to generate 3D bone structure models. Operator manually deforms 3D model to match X-ray contours using linear least squares estimation. Output: 3D skeletal models, angle/length measurements. Used in clinical settings by physicians/technologists to aid analysis of spine/lower limb deformities. Benefits: Enables 3D assessment of skeletal alignment from 2D images.

Clinical Evidence

Bench testing only. Accuracy and precision of automatic measurements computed from 3D lower limb models validated using clinical X-ray images. Results demonstrate equivalent performance to conventional measurement methods on native X-ray images.

Technological Characteristics

Supports DICOM 3.0. Runs on off-the-shelf hardware (Dell Precision) with Windows XP. 3D reconstruction uses parametric models of tibia/femur/spine derived from a priori databases of clinical descriptors and CT volumes. Deformation uses linear least squares estimation. Connectivity via DICOM query/retrieve.

Indications for Use

Indicated for musculoskeletal radiology and orthopedics in pediatric (spine: 7+ years; lower limb: 15+ years for 3D package) and adult populations. Used for PACS functions (acceptance, transfer, display, storage, processing) of 2D X-ray images. 3D tools aid analysis of scoliosis (Cobb's angle <= 50 degrees) and lower limb alignment/deformities. Contraindicated for individual vertebral/bone abnormality assessment and scoliosis patients with Cobb's angle > 50 degrees.

Regulatory Classification

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

• sterEOS Workstation (K080529)
• sterEOS Workstation (K090050)
• Agfa Orthopedic Software for Impax Workstations (K071972)

Reference Devices

• EOS Imaging EOS System (K071546)

Submission Summary (Full Text)

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K101398

# 510(k) SUMMARY

#### FEB - 4 20il EOS imaging's sterEOS Workstation

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

EOS imaging

10 rue Mercoeur

PARIS F-75011

FRANCE

Phone: [phone]

Facsimile: [phone]

| Contact Person: | Karine Chevrie |
|-----------------|----------------|
| Date Prepared: | Feb 01, 2011 |

| Trade Name: | sterEOS Workstation |
|-----------------------|---------------------|
| Common or Usual Name: | sterEOS Workstation |

Classification:

#### Classification:

21 CFR 892.2050; radiological image processing system

Product Code:

LLZ

# Predicate Devices:

sterEOS Workstation (K080529; K090050)

Agfa Orthopedic Software for Impax Workstations (K071972)

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## Device Description:

The sterEOS Workstation is a system for acceptance, transfer, display, storage, and digital processing of 2D X-ray images of the musculoskeletal system, including interactive 2D measurement tools.

When used with 2D X-ray images obtained with the EOS Imaging EOS System (K071546), the sterEOS Workstation provides interactive 3D measurement tools to aid in the analysis of skeletal deformities in spine and lower limbs.

The sterEOS workstation is intended to be used by trained medical personnel, physicians and technologists. ········

· : : : : Additional details about the device can be found in the table presented below in the substantial equivalence section.

#### Indications for Use:

The sterEOS Workstation is intended for use in the fields of musculoskeletal radiology and orthopedics in both pediatric and adult populations as a general PACS device for acceptance. transfer, display, storage, and digital processing of 2D X-ray images of the musculoskeletal system including interactive 2D measurement tools.

When using 2D X-ray images obtained with the EOS Imaging EOS System (K071546). the sterEOS Workstation provides interactive 3D measurement tools:

- to aid in the analysis of scoliosis and related disorders and deformities of the spine in adult patients as well as pediatric patients 7 years and older. The 3D measurement tools include interactive analysis based on a model of bone structures derived from an a priori image data set from 175 patients (91 normal patients, 47 patients with moderate idiopathic scoliosis and 37 patients with severe idiopathic scoliosis), and dry isolated vertebrae data. The model of bone structures is not intended for use in patients with a Cobb's angle > 50 degrees and is not intended for use to assess individual vertebral abnormalities. . . . . .
- to aid in the analysis of lower limbs alignment and related disorders and deformities based on angle and length measurements. The 3D measurement tools include interactive analysis based either on identification of lower limb alignment landmarks or as for the spine, on a model of bone structures derived from an a priori image data set. The model of bone structures is not intended for use to assess individual bone abnormalities. The 3D package including model-based measurements and torsion angles is indicated only for patients 15 years or older. Only the 2D/3D ruler is indicated for measurements in patient younger than 15 years old.

### Technological Characteristics:

The sterEOS Workstation supports DICOM 3.0 formatted images. The sterEOS Workstation is based on the Windows XP operating system and runs on off-the-shelf hardware. The sterEOS Workstation user interface follows typical clinical workflow patterns to process, review, and analyze digital images. and and the comments of the

A table setting forth the technological features of the sterEOS Workstation can be found in the substantial equivalence section below.

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#### Performance Data:

Accuracy and precision of the automatic measurements computed from the 3D model of the lower limbs have been confirmed with X-ray clinical images. Results validate the interactive 3D measurement tools for lower limb assessment and demonstrate the equivalent performance of the device with conventional measurement methods performed on native X-ray images.

#### Substantial Equivalence:

The sterEOS Workstation for the expanded indication for use in the lower extremities is as safe and effective as the company's cleared sterEOS device (K080529; K090050). The device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the device and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the device is as safe and effective as the company's cleared sterEOS device and thus, is substantially equivalent.

| | EOS Imaging Med | EOS Imaging Med | Agfa |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | sterEOS Workstation | sterEOS Workstation<br>K090050 | Orthopedic Software for<br>Impax workstation K071972 |
| Intended Use | Image processing system<br>accessory to X-ray imager | Image processing system<br>accessory to X-ray imager | Image processing system<br>accessory X-ray imager |
| Indications for<br>Use | The sterEOS Workstation is<br>intended for use in the fields<br>of musculoskeletal radiology<br>and orthopedics in both<br>pediatric and adult<br>populations as a general<br>PACS device for<br>acceptance, transfer,<br>display, storage, and digital<br>processing of 2D X-ray<br>images of the<br>musculoskeletal system<br>including interactive 2D<br>measurement tools.<br>When using 2D X-ray<br>images obtained with the<br>EOS Imaging EOS System<br>(K071546), the sterEOS<br>Workstation provides<br>interactive 3D measurement | The sterEOS Workstation is<br>intended for use in the fields<br>of musculoskeletal radiology<br>and orthopedics in both<br>pediatric and adult<br>populations as a general<br>PACS device for<br>acceptance, transfer,<br>display, storage, and digital<br>processing of 2D X-ray<br>images of the<br>musculoskeletal system<br>including interactive 2D<br>measurement tools.<br>When using 2D X-ray<br>images obtained with the<br>EOS Imaging EOS System<br>(K071546), the sterEOS<br>Workstation provides<br>interactive 3D measurement<br>tools | Workstations are intended for<br>use in the acquisition, display,<br>digital processing review,<br>transfer, storage, archiving and<br>printing of medical images and<br>patient demographic<br>information. They allow the<br>user to adjust image densities<br>(window/level), perform basic<br>length and angle<br>measurements and highlight<br>regions of interest. They have<br>the ability to use 2D, 3D and<br>time series (cine) images and<br>data. They are intended for<br>use by physicians to aid in<br>diagnosis, and by medical<br>professionals whenever they<br>require or desire access to<br>medical images and patient<br>demographic information. |
| | tools:<br>- to aid in the analysis of<br>scoliosis and related<br>disorders and<br>deformities of the spine<br>in adult patients as well<br>as pediatric patients 7<br>years and older. The<br>3D measurement tools<br>include interactive<br>analysis based on all<br>model of bone<br>structures derived from<br>an a priori image data<br>set from 175 patients<br>(91 normal patients, 47 | - to aid in the analysis<br>of scoliosis and<br>related disorders and<br>deformities of the<br>spine in adult patients<br>as well as pediatric<br>patients 7 years and<br>older. The 3D<br>measurement tools:<br>include interactive<br>analysis based on a<br>model of bone<br>structures derived<br>from an a priori image<br>data set from 175<br>patients (91 normal | The software application<br>allows orthopedic surgeons<br>and specialists to assess<br>images, plan surgical<br>procedures, monitor patient<br>progress and educate patients<br>in a digital environment.<br>It allows assessments to be<br>made of geometrical skeletal<br>parameters with comparisons<br>against normative references<br>for adults and children in order<br>to draw therapeutic<br>conclusions. It includes<br>modules for the hip, knee,<br>spine, leg, hand, wrist, elbow, |
| | patients with moderate<br>idiopathic scoliosis and<br>37 patients with severe<br>idiopathic scoliosis),<br>and dry isolated<br>vertebrae data. The<br>model of bone<br>structures is not<br>intended for use in<br>patients with a Cobb's<br>angle > 50 degrees<br>and is not intended for<br>use to assess<br>individual vertebral<br>abnormalities<br><br>- to aid in the analysis of<br>lower limb alignment<br>and related disorders<br>and deformities. The<br>3D measurement tools<br>include interactive<br>analysis based either<br>on identification of<br>lower limb alignment<br>landmarks or as for the<br>spine, on a model of,<br>bone structures derived<br>from an a priori image<br>data set. The model of<br>bone structures is not<br>intended for use in<br>pediatric patients and<br>is not intended for use<br>to assess individual<br>bone abnormalities. | patients, 47 patients<br>with moderate<br>idiopathic scoliosis<br>and 37 patients with<br>severe idiopathic<br>scoliosis), and dry<br>isolated vertebrae<br>data. The model of<br>bone structures is not<br>intended for use in<br>patients with a Cobb's<br>angle > 50 degrees<br>and is not intended for<br>use to assess<br>individual vertebral<br>abnormalities | shoulder, foot, ankle and<br>fractures (trauma planning).<br>Users can access a library of<br>manufacturers electronic<br>templates intended to assist in<br>the selection and positioning of<br>implants and the marking of<br>tissues prior to surgery |
| User<br>Population | Trained medical personnel,<br>physicians, and<br>technologists | Trained medical personnel,<br>physicians, and<br>technologists | Trained medical personnel,<br>physicians, and technologists |
| Platform | Off the shelf hardware | Off the shelf hardware | Impax workstation |
| Operating<br>system | Windows XP | Windows XP | |
| Imaging<br>modalities | Multimodality for 2D viewer<br>EOS radiological images for<br>3D visualization | Multimodality for 2D viewer<br>EOS radiological images for<br>3D visualization | Multimodality for 2D,3D<br>viewer. |
| DICOM<br>Conformance | DICOM 3.0 | DICOM 3.0 | DICOM 3.0 |
| Image type | Monoframe image | Monoframe image | |
| Hardware | Dell Precision hardware<br>●<br>Processor : Xeon Processor<br>RAM: 2x1 GB<br>Hard Disk: 250 Go<br>Graphic card: NVIDIA<br>Quadro (NVS 295)<br>16X DVD+/- RW Drive<br>At least 3 external USB port<br>connector<br>One mouse | Dell Precision 390<br>hardware<br>Processor : Intel Core 2 Duo<br>Processor<br>RAM: 2x1 GB<br>Hard Disk: 250 Go<br>Graphic card: NVIDIA<br>Quadro FX mid-range<br>(FX 3450)<br>16X DVD+/- RW Drive | |

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| | EIZO Radiforce LCD<br>screen size >21",<br>resolution >2 million<br>pixels, luminance > 200<br>cd/m², response time<br><100 ms. | At least 3 external USB port<br>connector<br>One mouse<br><br>EIZO Radiforce LCD<br>screen size >21",<br>resolution >2 million<br>pixels, luminance > 200<br>cd/m², response time<br><100 ms. | |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Image<br>manipulation<br>functions | Zoom<br>Magnifying glass<br>Pan<br>Grayscale inversion<br>Rotating flipping<br>Distance<br>Angle | Zoom<br>Magnifying glass<br>Pan<br>Grayscale inversion<br>Rotating flipping<br>Distance<br>Angle | Zoom<br>Magnifying glass<br>Pan<br>Grayscale inversion<br>Rotating flipping<br>Distance<br>Angle |
| Measurement<br>functions | | | |
| Workflow<br>features | DICOM query/retrieve from<br>archives | DICOM query/retrieve from<br>archives | DICOM query/retrieve from<br>archives |
| | Multiple series loading | Multiple series loading | Multiple series loading |
| | annotation | annotation | annotation |
| | DICOM print | DICOM print | DICOM print |
| 3D<br>reconstruction<br>method | Lower limb 3D<br>reconstruction process<br>is based on:<br>- Parametric models of<br>tibia and femur<br>- Statistical inference<br>defined from database<br>of clinical descriptors<br>measured in 45 lower<br>limbs of healthy adult<br>subjects.<br>- One morphorealist<br>model of lower limb<br>which is a meshed CT<br>volume of lower limb<br>regionalized as the<br>parametric models.<br><br>After identifying basic<br>anatomical landmarks,<br>corresponding to some<br>points of the parametric<br>models, on frontal and<br>lateral EOS X-ray images,<br>the others points of the<br>parametric models are<br>calculated by linear<br>regression with the<br>knowledge included in the a<br>priori data base. This<br>personalized parametric<br>model is used for adapting<br>the morpho-realistic<br>parametric meshed model<br>and provides a first 3D<br>model as close as possible<br>to the native X-ray contours.<br>This 3D model is deformed<br>manually by the operator<br>through control points up to | Spine 3D reconstruction<br>process is based on:<br>- parametric models of<br>spine and vertebrae<br>- Statistical inference<br>defined from database<br>of clinical descriptors<br>measured in 175<br>subjects with scoliosis<br>and 1628 cadaveric<br>vertebrae.<br>- One morphorealist<br>model of spine which is<br>a meshed CT volume of<br>spine regionalized as<br>the parametric models.<br><br>After identifying basic<br>anatomical landmarks,<br>corresponding to some<br>points of the parametric<br>models, on frontal and<br>lateral EOS X-ray images,<br>the others points of the<br>parametric models are<br>calculated by linear<br>regression with the<br>knowledge included in the a<br>priori data base. This<br>personalized parametric<br>model is used for adapting<br>the morpho-realistic<br>parametric meshed model<br>and provides a first 3D<br>model as close as possible<br>to the native X-ray contours.<br>This 3D model is deformed<br>manually by the operator<br>through control points up to<br>matching accurately the X- | |

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matching accurately the Xray contours. This deformation is performed by using common linear least squares estimation
algorithm.

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ray contours. This deformation is performed by using common linear least squares estimation algorithm.

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Image /page/6/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring. MD 20993-0002

Biospace Med % Mr. John J. Smith Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteenth Street, NW WASHINTON DC 20004

FEB - 4 201

Re: K101398

Trade/Device Name: sterEOS Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 14, 2011 Received: January 14, 2011

### Dear Mr. Smith:

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. 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting 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 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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/ReportalProblem/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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Postel

Mary Pastel. ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Image /page/8/Picture/0 description: The image shows a grainy, black and white picture of what appears to be a cluster of objects. The objects are small and irregularly shaped, and they are grouped together in the center of the image. The background is a uniform white color. Due to the image quality, it is difficult to determine the exact nature of the objects.

#### Indications for Use Statement

510(k) Number (if known): K101398

Device Name: sterEOS Workstation

The sterEOS Workstation is intended for use in the fields of musculoskeletal radiology and orthopedics in both pediatric and adult populations as a general PACS device for acceptance. transfer, display, storage, and digital processing of 2D X-ray images of the musculoskeletal system including interactive 2D measurement tools.

When using 2D X-ray images obtained with the EOS Imaging EOS System (K071546), the sterEOS Workstation provides interactive 3D measurement tools:

- to aid in the analysis of scoliosis and related disorders and deformities of the spine in adult patients as well as pediatric patients 7 years and older. The 3D measurement tools include interactive analysis based on a model of bone structures derived from an a priori image data set from 175 patients (91 normal patients, 47 patients with moderate idiopathic scoliosis and 37 patients with severe idiopathic scoliosis), and dry isolated vertebrae data. The model of bone structures is not intended for use in patients with a Cobb's angle > 50 degrees and is not intended for use to assess individual vertebral abnormalities.
- to aid in the analysis of lower limbs alignment and related disorders and deformities ﺍ based on angle and length measurements. The 3D measurement tools include interactive analysis based either on identification of lower limb alignment landmarks or as for the spine, on a model of bone structures derived from an a priori image data set. The model of bone structures is not intended for use to assess individual bone abnormalities. The 3D package including model-based measurements and torsion angles is indicated only for patients 15 years or older. Only the 2D/3D ruler is indicated for measurements in patient vounger than 15 years old.

| Prescription Use | _X_ |
|--------------------------------|-----|
| (Part 21 C.F.R. 801 Subpart D) | |

AND/OR

| Over-The-Counter Use | _ |
|---------------------------|---|
| (21 C.F.R. 807 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evarration (OD ///DC - 026967/000001 - 3203067 v1

510K. K101398