(103 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on image processing and user-driven planning tools, not AI/ML algorithms.
No
The device is described as software for preoperative planning of spine surgeries, assisting healthcare professionals in defining a patient-specific surgical strategy, rather than directly treating or diagnosing a medical condition.
No
The device is intended for preoperative planning of spine surgeries and does not diagnose disease or conditions.
Yes
The device description explicitly states that spineEOS is a software and its inputs are images and 3D datasets, not hardware components. The performance studies focus on software verification and validation, usability, and validation of clinical parameters within the software, without mentioning any hardware testing or integration.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for assisting healthcare professionals with preoperative planning of spine surgeries. This involves using images and measurements to define a surgical strategy. This is a clinical decision support tool, not a diagnostic test performed on biological samples.
- Device Description: The description reinforces the use of images and 3D datasets for surgical planning. It doesn't mention analyzing biological samples or providing diagnostic information about a patient's condition based on such analysis.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device operates on images and measurements, not biological samples.
Therefore, spineEOS software falls under the category of medical device software used for surgical planning and decision support, not as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
spineEOS software is indicated for assisting healthcare professionals with preoperative planning of spine surgeries. spineEOS provides access to EOS images with associated 3D datasets and measurements. spineEOS includes surgical planning tools that enable users to define a patient specific surgical strategy.
Product codes
LLZ
Device Description
spineEOS is a software indicated for assisting healthcare professionals with preoperative planning of spine surgeries. EOS images (generated from EOS imaging's acquisition system) and associated 3D datasets are used as inputs of the software. The product manages clinical measurements and allows user to access surgical planning tools to define a patient specific surgical strategy. The product is indicated for adolescent and adult patients.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
EOS images (generated from EOS imaging's acquisition system)
Anatomical Site
Spine
Indicated Patient Age Range
The product is indicated for adolescent and adult patients.
Patients 7 years or older who need spine surgery.
Intended User / Care Setting
healthcare professionals
Spine surgeons to define and validate the surgical plan.
EOS staff and implant distributors to define and save the optional pre-planning.
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)
Nonclinical performance testing performed on the subject device, spineEOS, supports substantial equivalence to the predicate device. The following V&V testing was performed:
A. Verifications activities cover the following:
- o Design input review
- Unit testing ●
- Software integration 0
- o System integration
B. Validation activities cover the following: - Validation of the multifunctional requirements in terms of design. ●
- Usability testing was performed to demonstrate that spineEOS can be used safely . by assessing and mitigating usability risks.
- Validation of the clinical parameters o
Determination of substantial equivalence is not based on an assessment of clinical performance data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
EOS imaging % Mathilde Masurel Design Quality and Regulatory Affairs Specialist 10 rue Mercoeur Paris, 75011 France
October 24, 2023
Re: K232086
Trade/Device Name: spineEOS Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: September 27, 2023 Received: September 27, 2023
Dear Mathilde Masurel:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232086
Device Name spineEOS
Indications for Use (Describe)
spineEOS software is indicated for assisting healthcare professionals with preoperative planning of spine surgeries. spineEOS provides access to EOS images with associated 3D datasets and measurements. spineEOS includes surgical planning tools that enable users to define a patient specific surgical strategy.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|
| -- | ----------------------------------------------------------------------------------------------------------------------------------------------------- |
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3
Image /page/3/Picture/0 description: The image shows the logo for EOS imaging, an "AN cotec COMPANY". The logo is in orange and features the letters "EOS" stacked on top of the word "imaging". The "O" in "EOS" is shaped like a diamond. The words "AN cotec COMPANY" are in a smaller font size and are located below the word "imaging".
1 SUBMITTER
EOS imaging 10 rue Mercoeur Paris, France 75011 Phone: +33 1 55 25 60 60 Fax: +33 1 55 25 60 61
| Contact Person: | Mathilde MASUREL |
|---|---|
| Design Quality and Regulatory Affairs Specialist | |
| EOS imaging | |
| Contact Phone: | +33 1 55 25 60 60 |
Date Summary Prepared: October 23, 2023
2 DEVICE
| Trade Name: | spineEOS |
|---|---|
| Common or Usual Name: | Cloud-based software |
| Classification Name: | System, image processing, radiological |
| (21 C.F.R. § 892.2050) | |
| Regulatory Class: | Class II |
| Product Code: | LLZ |
| Premarket Submission Number: | K232086 |
LEGALLY MARKETED PREDICATE DEVICES 3
| 510(k) | Product Name | Clearance Date |
|---|---|---|
| K160407 | spineEOS | August 2016 |
DEVICE DESCRIPTION 4
spineEOS is a software indicated for assisting healthcare professionals with preoperative planning of spine surgeries. EOS images (generated from EOS imaging's acquisition system) and associated 3D datasets are used as inputs of the software. The product manages clinical measurements and allows user to access surgical planning tools to define a patient specific surgical strategy. The product is indicated for adolescent and adult patients.
4
Image /page/4/Picture/0 description: The image shows the logo for EOS imaging, an orthopedic imaging company. The logo features the letters "EOS" in a stylized, sans-serif font, with the "O" shaped like a diamond. Below the letters "EOS" is the word "imaging" in a smaller, sans-serif font. Underneath "imaging" are the words "AN cctec COMPANY" in an even smaller font, indicating that EOS imaging is a subsidiary of cctec.
INDICATIONS FOR USE 5
spineEOS software is indicated for assisting healthcare professionals with preoperative planning of spine surgeries. spineEOS provides access to EOS images with associated 3D datasets and measurements. spineEOS includes surgical planning tools that enable users to define a patient specific surgical strategy.
TECHNOLOGICAL COMPARISON TO PREDICATES 6
The subject device was compared to the predicate device in intended use, indications for use, design, function and technology and it was demonstrated that they are substantially equivalent. Any technological differences within this 510(k), between the subject device and the predicate device, does not impact substantial equivalence, or safety and effectiveness.
5
| AN alec company |
|---|
| Characteristic | Cleared spineEOS (K160407) | Modified spineEOS | Substantially Equivalent? |
|---|---|---|---|
| Indications for Use | Using 3D data and models obtained from sterEOS workstation, spineEOS software is indicated for assisting healthcare professionals in viewing, measuring images as well as in preoperative planning of spine surgeries. The device includes tools for measuring spine anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software online. | spineEOS software is indicated for assisting healthcare professionals with preoperative planning of spine surgeries. spineEOS provides access to EOS images with associated 3D datasets and measurements. spineEOS includes surgical planning tools that enable users to define a patient specific surgical strategy. | Yes, the modified spineEOS has the same intended use as the cleared spineEOS. Specifically, both devices are indicated for assisting healthcare professionals with preoperative planning of spine surgeries. |
| The modified spineEOS has slightly modified indications for use. Specifically, the indications for use statement maintains the basic explanation of the device inputs and available tools. | |||
| In sum, the same information is provided to the end user; it is simply not organized in the same way. Thus, this change does not raise different questions of safety or effectiveness. | |||
| Regulatory Class/Code | Class II | ||
| LLZ | |||
| (21 CFR 892.2050) | Class II | ||
| LLZ | |||
| (21 CFR 892.2050) | Yes, same. | ||
| Device Classification Name | System, image processing, radiological | System, image processing, radiological | Yes, same. |
| User Population | spineEOS can only be used by a trained user including: | ||
| Spine surgeons to define and validate the surgical plan. | spineEOS can only be used by a trained user including: | ||
| Spine surgeons to define and validate the surgical plan.EOS staff and implant distributors to define and save the optional pre-planning. | Yes, similar. The modified spineEOS has EOS staff in addition to the users of cleared spineEOS. This minor change does not affect the safety and effectiveness of the product because EOS staff has the same account right as the implant distributors already considered in the predicate and needs to be properly trained in order to use the product. | ||
| Target Population | Patients 7 years or older who need spine surgery. spineEOS is | Patients 7 years or older who need spine surgery. spineEOS is | Yes, same. The modified spineEOS has the same target population as the cleared spineEOS. |
| Characteristic | Cleared spineEOS (K160407) | Modified spineEOS | Substantially Equivalent? |
| Hardware and | |||
| Software | |||
| Requirement | recommended in the preoperative | ||
| planning of spine surgeries for: | |||
| • Degenerative surgery | |||
| • Deformative adult spine | |||
| surgery | |||
| • Adolescent Idiopathic | |||
| Scoliosis (AIS) surgery. | recommended in the preoperative | ||
| planning for spine surgeries for: | |||
| • Degenerative Spine Surgery | |||
| • Deformative Spine Surgery | |||
| • Adolescent Idiopathic Scoliosis | |||
| (AIS) surgery. | Specifically, both devices are intended for patients 7 | ||
| years or older who need spine surgery. | |||
| Modified spineEOS has slightly modified target | |||
| population statement as compared to the predicate. | |||
| Specifically, the target population statement | |||
| maintains the description of degenerative and | |||
| deformative spine surgery for patients 7 years or | |||
| older as well as the description of AIS surgery but in | |||
| a more consistent way. | |||
| Web Browsers: | |||
| • Windows 7/8.1/10: Google | |||
| Chrome 47, Mozilla Firefox | |||
| 43, Opera 34; | |||
| • For Macintosh OS X | |||
| Yosemite 10.10 et El Capitan | |||
| 10.11: Google Chrome 47, | |||
| Mozilla Firefox 43, Opera 34 | |||
| et Safari 9. |
PC Configuration:
Stable internet connection - Dual
Core 2.4 GHz processor, 4 GB of
RAM and integrated graphics
board.
Screen Resolution:
The minimum screen resolution
ensuring full display of the | Web Browsers:
• Windows 10/11: Google
Chrome, Mozilla Firefox, Edge
• For macOS 12/13: Google
Chrome, Mozilla Firefox, Safari
PC Configuration:
Stable internet connection - Dual Core
2.4 GHz processor, 4 GB of RAM and
integrated graphics board.
Screen Resolution:
The minimum screen resolution
ensuring full display of the planning
page is 1920 x 1080 pixels.
At resolutions below 1600 x 900, the
application prompts the user to toggle | In sum, the same information is provided to the end
user; it is simply stated differently. Thus, this minor
change does not raise different questions of safety
or effectiveness.
Yes, similar. The differences between modified
spineEOS and the predicate take into account the
evolution of the web browsers. These minor
changes do not affect the safety and effectiveness
of the product. |
| Characteristic | Cleared spineEOS (K160407) | Modified spineEOS | Substantially Equivalent? |
| | planning page is 1920 x 1080 pixels.
At resolutions below 1600 x 900, the application prompts the user to toggle to full screen display to ensure correct visualization. | to full screen display to ensure correct visualization. | |
| Input Data | Patient's information X-rays images 3D model of the spine | Patient's information X-rays images 3D model of the spine | Yes, same. |
| Product
Workflow | Model Validation: allow users to validate or reject the 3D modeling.
Preoperative: allow user to consult the preoperative state of the patient
Planning: allow user to define patient specific surgical strategy
Rod: allow user to define the design of rods | Model Validation: allow users to validate or reject the 3D modeling.
Preoperative: allow user to consult the preoperative state of the patient
Planning: allow user to define patient specific surgical strategy
Rod: allow user to define the design of rods | Yes, same. |
| Tools Available
for Planning | Segmental Alignment Interbody Implant Osteotomy | Segmental Alignment Interbody Implant Osteotomy Spondylolisthesis Rod Curvature Management | Yes, similar. Modified spineEOS is an updated version of the cleared spineEOS. The fundamental tools of modified spineEOS are unchanged from the cleared spineEOS. Both devices have tools for segmental alignment, interbody implant, and osteotomy.
Modified spineEOS main difference from the cleared spineEOS is the introduction of the spondylolisthesis tool. This tool operates on the same principle than the existing segmental alignment tool, except that it allows movement of the vertebra on a different axis (translation for the spondylolisthesis tool vs. rotation for the segmental |
| Characteristic | Cleared spineEOS (K160407) | Modified spineEOS | Substantially Equivalent? |
| Software
Functionalities /
Modalities | Obtains an image and 3D model
transferred from other devices
Provides normative values used
to follow the impact of the
planning on the patient alignment
Provides color-coded clinical
parameters to display variance
from the defined normative values
Requires human intervention for
interpretation and manipulation of
images | Obtains an image and 3D model
transferred from other devices
Provides normative values used to
follow the impact of the planning on
the patient alignment
Provides color-coded clinical
parameters to display variance from
the defined normative values
Requires human intervention for
interpretation and manipulation of
images | alignment tool) and the possibility to manage the rod
curvature.
The introduction of this tool does not affect the
device safety and effectiveness.
Yes, same.
Yes, same.
Yes, same.
Yes, same. |
| Image
Manipulation
Functions | 2D images and 3D model display
and basic manipulation (zoom,
panning and angles
measurements) | 2D images and 3D model display and
basic manipulation (zoom, panning,
distance, and angles measurements) | Yes, same. In modified spineEOS, the possibility of
measuring distance directly in the image is based on
the same principle as the measurement of angles,
already available in the cleared spineEOS. It does
not affect the device safety and effectiveness.
Yes, same. |
| Measurement
Functions | Distances and Angles | Distances and Angles | Yes, same. |
| User Interface | Computer | Computer | Yes, same. |
| Software
Environment | Cloud-based software | Cloud-based software | Yes, same. |
Table 5-1: Comparison for Substantial Equivalence
6
Traditional 510(k) Premarket Notification
ಲ್ಲಿ ಪ್ರದ
7
Image /page/7/Picture/0 description: The image shows the logo for EOS imaging, an aztec company. The logo is vertically oriented, with the letters "EOS" stacked on top of each other in a sans-serif font. The word "imaging" is written to the right of the letters "EOS", and the phrase "an aztec company" is written below the word "imaging". The logo is orange in color.
8
Image /page/8/Picture/0 description: The image shows the logo for EOS imaging, an aztec company. The logo is vertically oriented, with the letters "EOS" stacked on top of each other in an orange, outlined font. To the right of the letters, the word "imaging" is written vertically in a smaller font. Below "imaging" is the phrase "AN aztec COMPANY" in an even smaller font.
9
Image /page/9/Picture/0 description: The image shows the logo for EOS imaging, an orthopedic imaging company. The logo is in orange and features the company name in a stylized font. Below the name, it says "AN cdetec COMPANY" in a smaller font. The logo is simple and modern, and the orange color is eye-catching.
PERFORMANCE DATA 7
Nonclinical performance testing performed on the subject device, spineEOS, supports substantial equivalence to the predicate device. The following V&V testing was performed:
A. Verifications activities cover the following:
- o Design input review
- Unit testing ●
- Software integration 0
- o System integration
- B. Validation activities cover the following:
- Validation of the multifunctional requirements in terms of design. ●
- Usability testing was performed to demonstrate that spineEOS can be used safely . by assessing and mitigating usability risks.
- Validation of the clinical parameters o
Determination of substantial equivalence is not based on an assessment of clinical performance data.
CONCLUSION 00
Based upon the information provided in this 510(k) submission, it has been determined that the subject device, spineEOS, is substantially equivalent to the legally marketed predicate device in regard to indications for use, intended use, design, technology, and performance.