(137 days)
Yes
The device description mentions a "model of bone structures derived from an a priori image data set" used for interactive 3D measurement tools. While not explicitly using terms like "AI" or "ML," the use of a model derived from a training dataset for analysis strongly suggests the application of machine learning techniques for image analysis and measurement.
No
The device is described as a workstation that accepts, transfers, displays, stores, and digitally processes X-ray images, providing measurement tools to aid in the analysis of musculoskeletal deformities. It does not exert any direct therapeutic action on the patient.
Yes
The device is described as aiding in the "analysis of scoliosis and related disorders and deformities" and "lower limbs alignment and related disorders and deformities," which are diagnostic activities. It provides measurement tools for this analysis.
No
The device description explicitly states it is a "general system" for handling 2D X-ray images and provides interactive measurement tools. While it processes images, the description of "acceptance, transfer, display, storage, and digital processing" suggests it is a workstation that likely includes hardware components for these functions, even if the core functionality is software-based image analysis. Furthermore, it is used in conjunction with the EOS System, which is a hardware imaging device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The sterEOS Workstation processes and analyzes medical images (X-rays) of the musculoskeletal system. It does not perform tests on biological samples.
- Intended Use: The intended use clearly states its purpose is for processing and analyzing X-ray images to aid in the analysis of skeletal deformities.
Therefore, the sterEOS Workstation falls under the category of medical imaging software or a picture archiving and communication system (PACS) with advanced measurement tools, not an In Vitro Diagnostic device.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The provided text indicates "Not Found" for "Control Plan Authorized (PCCP) and relevant text."
Intended Use / 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 patients as well as pediatric patients. The 3D measurement tools include interactive analysis based either on identification of anatomical landmarks for postural assessment or 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 for spine modeling. The model of bone structures is not intended for use to assess individual vertebral abnormalities and is indicated only for patients 7 years and older. For postural assessment, a set of comparative tools is provided allowing the comparison of performed measurements to reference values for patients over 18 years old.
- 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.
Product codes
LLZ
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 (K123740), the sterEOS Workstation provides interactive 3D measurement tools to aid in the analysis of skeletal deformities in spine and lower limbs.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
2D X-ray images
Anatomical Site
musculoskeletal system, spine, lower limbs
Indicated Patient Age Range
Adult populations, pediatric patients. Specific age ranges:
Spine analysis: only for patients 7 years and older. For postural assessment, comparison to reference values for patients over 18 years old.
Lower limbs alignment: 3D package, model-based measurements and torsion angles indicated only for patients 15 years or older. Only the 2D/3D ruler is indicated for measurements in patients younger than 15 years old.
Intended User / Care Setting
musculoskeletal radiology and orthopedics
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
EOS imaging's sterEOS Workstation (K130395)
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).
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15, 2014
EOS Imaging % Mr. John J. Smith Regulatory Counsel Hogan Lovells US LLP Columbia Square 555 Thirteenth Street NW WASHINGTON DC 20004
Re: K141137
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: August 18, 2014 Received: August 18, 2014
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. 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/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 Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Smh.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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
510(k) Number (if known) K141137
Device Name sterEOS workstation
Indications for Use (Describe)
The sterEOS Workstation is intended for use in the fields of musculoskeletal radiology and orthopediations of 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 Inaging 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. O The 3D measurement tools include interactive analysis based either on identification of anatomical landmarks for postural assessment or on a model of bone structures derived from an a priori image data set from 175 patients, 47 patients with moderate idiopathic scoliosis with severe idiopathic scoliosis), and dry isolated vertebrae data for spine modeling. The model of bone structures is not intended for use to assess individual vertebral abnormalities and is indicated only for patients 7 years and older. For postural assessment, a set of comparative tools is provided allowing the comparison of performed measurements to reference values for patients over 18 years old.
- O 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.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
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510(k) SUMMARY
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: | + 33 1 55 25 60 60 |
|---|---|
| Facsimile: | + 33 1 55 25 60 61 |
| Contact Person: | Karine Chevrie, Quality and Regulatory Affairs Officer |
|---|---|
| Date Prepared: | August 15, 2014 |
| 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 (K130395) |
Purpose of the Traditional 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 (K123740), the sterEOS Workstation provides interactive 3D measurement tools to aid in the analysis of skeletal deformities in spine and lower limbs.
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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 o adult patients as well as pediatric patients. The 3D measurement tools include interactive analysis based either on identification of anatomical landmarks for postural assessment or 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 for spine modeling. The model of bone structures is not intended for use to assess individual vertebral abnormalities and is indicated only for patients 7 years and older. For postural assessment, a set of comparative tools is provided allowing the comparison of performed measurements to reference values for patients over 18 years old.
- To aid in the analysis of lower limbs alignment and related disorders and deformities o 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.
Technological Characteristics
The technological characteristics of the modified sterEOS Workstation are essentially identical to the cleared sterEOS Workstation (K130395). Like the cleared sterEOS Workstation, the instant device is based on the Windows 7 operating system, runs on off-the-shelf hardware, supports DICOM 3.0 formatted images and its user interface follows typical clinical workflow patterns to process, review, and analyze digital images. The main differences with the cleared sterEOS Workstation consist of the following minor software modifications:
- -Introduction of a new workflow dedicated to global postural assessment.
- Improvement of the lower limb 3D modeling using automatic adjustment. -
- -Addition of an export feature to allow for the transfer of sets of data for third-party applications.
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 nonregression. Additional performance and functional testing has confirmed the equivalent performance of the modified sterEOS compared to the predicate sterEOS workstation.
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Substantial Equivalence
The device has similar intended uses and 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.