(137 days)
Not Found
No
The summary describes image viewing, measurement, and surgical planning tools based on mathematical calculations and comparisons, with no mention of AI or ML algorithms. The "3D algorithm reconstruction on 2D Images" is verified against CT scans and manual calculations, suggesting a deterministic approach rather than a learned model.
No
The device is described as a software solution intended for viewing images, performing spine-related measurements, and planning surgical procedures, which are functions that assist healthcare professionals but do not directly treat a disease or condition.
No
The device is intended for viewing and measuring images, planning spine surgeries, and measuring anatomical components for surgical implant design and placement. It does not provide a diagnosis.
Yes
The device description explicitly states that the KEOPS Balance Analyzer 3D is a "software solution" and is "web-based software." The intended use and device description focus solely on the software's functionalities for viewing images, performing measurements, and planning surgical procedures. There is no mention of any accompanying hardware components that are part of the medical device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries." It focuses on image analysis and surgical planning, not on examining specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description reinforces the intended use, highlighting its function as software for viewing images, performing measurements, and planning surgical procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
The device falls under the category of medical image analysis and surgical planning software, which is distinct from IVD devices.
N/A
Intended Use / Indications for Use
The KEOPS Balance Analyzer 3D is intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries. The device allows surgeons and service providers to perform spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for design and placement of surgical implants. Clinical judgment and experience are required to properly use the software.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The KEOPS Balance Analyzer 3D (KBA3D) is a software solution developed for the medical community. It is intended to view images and perform spine related measurements and plan surgical procedures. The image formats supported include standards such as jpeg, tiff, png, and DICOM file types. Images can be stored in the KEOPS database and measurements made using generic measuring and surgical tools within overlays of the images. The KEOPS Balance Analyzer 3D offers the ability to plan spine surgical procedures such as ostectomies of the spine and templating implants (rods). Keops Balance Analyzer 3D is web-based software.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals / Not Found
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)
The performance characteristics of the Keops Balance Analyzer 3D were tested and analyzed per the FDA's guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained on Medical Devices" and the FDA guidance document entitled "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
The non-clinical tests performed with the subject included:
- Anatomical parameters measurements were verified via mathematical calculations.
- 3D algorithm reconstruction on 2D Images (Profile and Face) were verified by comparing vertebral body dimensions from the features 'Balance Analyzer 3D reconstruction' and '3D reconstruction CT-Scan'.
- Accuracy and precision testing were conducted to demonstrate the performance of the software.
- Surgical Simulation was verified by applying the post treatment radiographs with the simulation algorithm with comparison post operative images.
- A study was conducted with fifteen spine surgeons to validate the usability of the KBA3D software.
The results of the non-clinical performance testing showed:
- Comparison of original and "worst case variation" coordinates demonstrated acceptable variations of values and validated the accuracy of the software in measuring anatomical parameters.
- Data point acquisition was determined to be repeatable and reliable based on measurements showing location of the barycenter to be within the acceptance criteria of 3 pixels (or less).
- Calculation of spino-pelvic parameters showed no difference in results between the KBA3D software and manual calculations using MS Excel.
- The reliability of the KBA3D surgical planning and simulation algorithm was demonstrated by comparing the planned corrections by the software to the actual corrections obtained from postoperative radiographic images. The acceptance criteria were met.
- The reliability of KBA3D 2D3D reconstruction algorithm was validated by comparing 3D models from CT scans to 3D reconstructions from the KBA3D software from X-ray images; the results met the acceptance criteria of an allowable maximum deviation of 5mm (which is 10% of the average dimension of a vertebral body).
- The usability of the software was validated for the process of acquisition and intuitiveness of use by orthopaedic spine surgeons using the software for the first time. The results showed no measurable, clinically relevant differences between the user groups.
In addition, Software validation and performance testing of the KEOPS Balance Analyzer 3D consisted of verification and validation activities using the following guidelines and standards throughout the software development process:
- EN ISO 14971 Application of risk management to medical devices
- IEC 62304 Medical device software - Software life cycle processes
- ANSI/IEEE Standard 829-2008 IEEE Standard for Software and System Test Documentation
- FDA Guidance for Industry and FDA Staff Guidance for the content of premarket submissions for software contained in medical devices (May 11, 2005)
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.
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA) along with the Department of Health & Human Services. The FDA logo features a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below. To the left of the FDA logo is the symbol of the Department of Health & Human Services, which consists of a stylized human figure.
S.M.A.I.O % Robert A. Poggie, Ph.D. President BioVera, Inc. 65 Promenade Saint Louis Notre Dame de Llle Perrot, Quebec J7V7P2 CANADA
Re: K213975
May 6, 2022
Trade/Device Name: KEOPS Balance Analyzer 3D Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: April 1, 2022 Received: April 5, 2022
Dear Robert Poggie:
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. 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 located 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.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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).
Sincerely,
For
Thalia T. Mills, Ph.D. Director DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213975
Device Name KEOPS Balance Analyzer 3D
Indications for Use (Describe)
The KEOPS Balance Analyzer 3D is intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries. The device allows surgeons and service providers to perform spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for design and placement of surgical implants. Clinical judgment and experience are required to properly use the software.
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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510(k) SUMMARY for K213975
A. SUBMITTERS INFORMATION
| Submitter Name: | BioVera, Inc. | |||
|---|---|---|---|---|
| Submitter Address: | 65 Promenade Saint-Louis, NDIP, Québec, J7V 7P2, CANADA | |||
| Contact Person: | Robert A. Poggie, PhD | |||
| Phone & Fax Number: | 514-901-0796 | |||
| Date of Submission: | May 3, 2022 | |||
| B. DEVICE IDENTIFICATION & MANUFACTURER | ||||
| Manufacturer Name: | S.Μ.Α.Ι.Ο. | |||
| Manufacturer Address: | 2, Place Berthe Morisot - Parc Technologique | |||
| 69800 SAINT-PRIEST - France | ||||
| Registration Number: | 3015383864 | |||
| Contact Name: | Jean-Charles Roussouly | |||
| Title: | Operations Vice-President | |||
| Device Trade Name: | KEOPS Balance Analyzer 3D (KBA3D) | |||
| Device Common Name: | Image measurement and surgery planning software | |||
| Classification Name: | Picture archiving and communications system | |||
| Classification Code: | LLZ | |||
| Classification Panel: | Radiology Devices | |||
| Regulation Number: | 21 CFR sections 892.2050 |
| C1. PRIMARY PREDICATE DEVICE | |
|---|---|
| K141669 | SURGIMAP, NEMARIS INC |
| C2. PREDICATE DEVICE | |
| K180091 | UNID Spine Analyzer, Medicrea International |
D. DEVICE DESCRIPTION
The KEOPS Balance Analyzer 3D (KBA3D) is a software solution developed for the medical community. It is intended to view images and perform spine related measurements and plan surgical procedures. The image formats supported include standards such as jpeg, tiff, png, and DICOM file types. Images can be stored in the KEOPS database and measurements made using generic measuring and surgical tools within overlays of the images. The KEOPS Balance Analyzer 3D offers the ability to plan spine surgical procedures such as ostectomies of the spine and templating implants (rods). Keops Balance Analyzer 3D is web-based software.
4
E. INDICATIONS FOR USE
The KEOPS Balance Analyzer 3D is intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries. The device allows surgeons and service providers to perform spine related measurements on images and to plan surgical procedures. The device also includes tools for measuring anatomical components for design and placement of surgical implants. Clinical judgment and experience are required to properly use the software.
F. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
| Feature | Keops Balance
Analyzer 3D (KBA3D) | Nemaris Surgimap 2.0 | Medicrea
UNiD Spine Analyzer |
|------------------------------------------------------------------------|--------------------------------------|---------------------------|---------------------------------|
| | K # TBD | K141669 | K180091 |
| Computer | PC Compatible | PC Compatible | PC Compatible |
| Operating System | Windows + MAC | Windows + MAC | Windows + MAC |
| Image Input | Local | Local + PACS connectivity | Local |
| Runs on Server | Yes | No | Yes |
| Osteotomy Module | Yes | Yes | Yes |
| Spine measurements | Yes | Yes | Yes |
| Pre-operative planning | Yes | Yes | Yes |
| Database | No | Yes | No |
| Case sharing | No | Yes | No |
| Human Intervention for
interpretation and
manipulation of images | Yes | Yes | Yes |
| Web content | Yes | Yes | Yes |
The table below compares the technological characteristics of the KEOPS Balance Analyzer 3D subject device to the Nemaris and Medicrea predicate devices
The subject and predicate devices possess similar or the same technological, performance, and userinterface characteristics that are intended to aid health care professionals in the pre-operative planning of spine surgery. The minor differences in features present no new risks. The similarity of the technological features indicates the subject and predicate devices are substantially equivalent.
G. PERFORMANCE SUMMARY
The performance characteristics of the Keops Balance Analyzer 3D were tested and analyzed per the FDA's guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained on Medical Devices" and the FDA guidance document entitled "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
The non-clinical tests performed with the subject included:
- Anatomical parameters measurements were verified via mathematical calculations.
5
- . 3D algorithm reconstruction on 2D Images (Profile and Face) were verified by comparing vertebral body dimensions from the features 'Balance Analyzer 3D reconstruction' and '3D reconstruction CT-Scan'.
- Accuracy and precision testing were conducted to demonstrate the performance of the software.
- . Surgical Simulation was verified by applying the post treatment radiographs with the simulation algorithm with comparison post operative images.
- . A study was conducted with fifteen spine surgeons to validate the usability of the KBA3D software.
The results of the non-clinical performance testing showed:
- . Comparison of original and "worst case variation" coordinates demonstrated acceptable variations of values and validated the accuracy of the software in measuring anatomical parameters.
- . Data point acquisition was determined to be repeatable and reliable based on measurements showing location of the barycenter to be within the acceptance criteria of 3 pixels (or less).
- . Calculation of spino-pelvic parameters showed no difference in results between the KBA3D software and manual calculations using MS Excel.
- . The reliability of the KBA3D surgical planning and simulation algorithm was demonstrated by comparing the planned corrections by the software to the actual corrections obtained from postoperative radiographic images. The acceptance criteria were met.
- . The reliability of KBA3D 2D3D reconstruction algorithm was validated by comparing 3D models from CT scans to 3D reconstructions from the KBA3D software from X-ray images; the results met the acceptance criteria of an allowable maximum deviation of 5mm (which is 10% of the average dimension of a vertebral body).
- . The usability of the software was validated for the process of acquisition and intuitiveness of use by orthopaedic spine surgeons using the software for the first time. The results showed no measurable, clinically relevant differences between the user groups.
In addition, Software validation and performance testing of the KEOPS Balance Analyzer 3D consisted of verification and validation activities using the following guidelines and standards throughout the software development process:
| EN ISO 14971 | Application of risk management to medical devices |
|---|---|
| IEC 62304 | Medical device software - Software life cycle processes |
| ANSI/IEEE Standard 829-2008 | IEEE Standard for Software and System Test Documentation |
| FDA Guidance for Industry and | |
| FDA Staff | Guidance for the content of premarket submissions for software |
| contained in medical devices (May 11, 2005) |
The software for the KEOPS Balance Analyzer 3D is of moderate level of concern.
H. CONCLUSIONS
The KEOPS Balance Analyzer 3D is substantially equivalent to the identified predicate devices based on similarities in indications for use, design, technological characteristics, performance data, and user interface presented in this 510(k) notification.