STEREOS WORKSTATION

K130395 · Eos Imaging, Inc. · LLZ · Mar 11, 2013 · Radiology

Device Facts

Record IDK130395
Device NameSTEREOS WORKSTATION
ApplicantEos Imaging, Inc.
Product CodeLLZ · Radiology
Decision DateMar 11, 2013
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 892.2050
Device ClassClass 2
AttributesAI/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 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, 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 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 patients younger than 15 years old.

Device Story

Workstation processes, displays, and stores 2D X-ray images of musculoskeletal system; provides interactive 2D/3D measurement tools. Inputs: 2D X-ray images from EOS Imaging EOS System. Operation: uses a priori bone structure model (derived from 175-patient dataset and dry vertebrae) to facilitate 3D analysis of spine and lower limbs; clinician identifies landmarks or applies model-based analysis. Output: 3D skeletal reconstructions, angle/length measurements. Used in clinical settings by radiologists/orthopedists to aid diagnosis of scoliosis and limb deformities. Clinical benefit: assists in quantifying skeletal disorders to inform treatment planning.

Clinical Evidence

Bench testing only. Software modifications verified at unit level; system-level V&V testing performed to ensure compliance with specifications, performance, and non-regression. No clinical data presented.

Technological Characteristics

Supports DICOM 3.0 images. Runs on off-the-shelf hardware with Windows 7 OS. Features interactive 2D/3D measurement tools and model-based bone structure analysis. Software-based image processing.

Indications for Use

Indicated for pediatric (7+ years for spine; 15+ years for 3D lower limb package) and adult patients requiring musculoskeletal radiology or orthopedic analysis. Used for scoliosis, spinal deformities, and lower limb alignment/deformity analysis. Contraindicated for assessing individual vertebral or bone abnormalities using the model-based tools.

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

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ K130395 Page 1 of 2 ## 510(k) SUMMARY # EOS imaging's sterEOS Workstation MAR 1 1 2013 Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared: | | EOS imaging<br>10 rue Mercoeur<br>PARIS F-75011<br>FRANCE | |-----------------------|------------------------------------------------------------------------| | Phone: | + 33 1 55 25 60 60 | | Facsimile: | + 33 1 55 25 60 61 | | Contact Person: | Karine Chevrie, Quality and Regulatory Affairs Officer | | Date Prepared: | February 14, 2013 | | Trade Name: | sterEOS Workstation | | Common or Usual Name: | sterEOS Workstation | | Classification: | 21 C.F.R. § 892.2050; image processing radiological system | | Product Code: | LLZ | | Predicate Devices: | EOS imaging's sterEOS Workstation (K113344, K101398, K090050, K080529) | ## Purpose of the Special 510(k) notice: The sterEOS workstation is a modification to the cleared sterEOS. ## Device Description The sterEOS Workstation is a general 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's EOS System (K120721 and K123740), the sterEOS Workstation provides interactive 3D measurement tools to aid in the analysis of skeletal deformities in spine and lower limbs. {1}------------------------------------------------ K130395 Page 2 of 2 ## 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 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, 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 o 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 to assess individual vertebral abnormalities. - To aid in the analysis of lower limbs alignment and related disorders and deformities based o 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 patients younger than 15 years old. ## Technological Characteristics The sterEOS Workstation supports DIGOM 3.0 formatted images. The sterEOS Workstation is based on the Windows 7 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. #### Performance Data Software modifications have been verified at the unit level. After integration, system software V&V testing was performed to ensure compliance with specifications, performance and non-regression. Additional performance and functional testing has confirmed the equivalent performance of the modified sterEOS compared to the predicate sterEOS workstation. ## Substantial Equivalence The device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor 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. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, with three wavy lines forming the body and a head-like shape at the top. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 # March 11. 2013 EOS Imaging, Inc. C/O John J. Smith, JD, MD Partner Hogan Lovells US, LLP 555 13th Street NW WASHINGTON DC 20004 Re: K130395 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: February 15, 2013 Received: February 15, 2013 Dear Dr. 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. 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. 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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportaProblem/dcfault.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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Sm.h.7) for Janine M: Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): K130395 Device Name: r sterEOS workstation 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 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, 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 0 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 scollosis and 37 patients with severe idiopathic scoliosis), and dry isolated vertebrae data. The model of bone structures 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 and length measurements. The 3D measurement tools indude 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 patients younger than 15 years old. 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 Diagnostics and Radiological Health (OIR) Smh.P). (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510 (k) : K130395 Page 1 of . 1
Innolitics
510(k) Summary
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