(24 days)
Not Found
Yes
The device description mentions using a "model of bone structures derived from an a priori image data set" to aid in analysis. While not explicitly stating AI/ML, the use of a model derived from a dataset for analysis is a common characteristic of ML applications in medical imaging. The description of the dataset size and composition further supports this interpretation.
No.
The device is used for processing, analysis, and measurement of X-ray images, providing diagnostic information but not directly treating a disease or condition.
Yes
The device aids in the analysis of medical conditions (scoliosis and related disorders/deformities of the spine and lower limbs) by providing interactive 2D and 3D measurement tools based on X-ray images, which is characteristic of a diagnostic aid.
No
The device description explicitly states it is a "Workstation," which implies a hardware component (computer, display, etc.) in addition to the software. While the software is a key part of the device, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The sterEOS Workstation processes and analyzes images (2D X-ray images) of the musculoskeletal system. It does not analyze biological specimens.
- Intended Use: The intended use is for analyzing skeletal deformities and providing measurement tools based on imaging data, not on the analysis of biological samples.
Therefore, the sterEOS Workstation falls under the category of medical imaging software or a picture archiving and communication system (PACS) with advanced analysis capabilities, rather than an In Vitro Diagnostic device.
No
The letter does not mention that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
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 (K120721 and 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
pediatric and adult populations;
pediatric patients 7 years and older (for scoliosis analysis);
patients 15 years or older (for 3D package including model-based measurements and torsion angles for lower limbs);
patients younger than 15 years old (for 2D/3D ruler for measurements in lower limbs).
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
EOS imaging's sterEOS Workstation (K113344, K101398, K090050, K080529)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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
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: | 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
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