(159 days)
No
The summary describes image processing, measurements, and surgical planning based on theoretical calculations and geometric representations. There is no mention of AI, ML, or related concepts like training data, test data, or performance metrics typically associated with AI/ML algorithms. The "Bendini" component is described as an algorithm for rod bending instructions, not an AI/ML system for image analysis or diagnosis.
No
The device is described as software intended for viewing images, performing measurements, and planning surgical procedures. It does not exert any direct therapeutic action on the patient.
No
The device is intended for viewing and measuring images, and for planning spine surgeries (e.g., osteotomies, implant templating). It provides 3D scaled representations, calculates parameters, and simulates surgical effects, but it explicitly states it does not "predict the results of surgery" and its calculations are "not correlated to the output of surgery." It assists in planning by visualizing implants and simulating alignments, but it does not perform diagnosis.
Yes
The device is described as a "SaaS software solution" and its function is to process images, perform measurements, and plan surgical procedures. While it interacts with other systems (like the Bendini service and KEOPS database), the core medical device functionality described is purely software-based.
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 derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The KBA3D v2.0.0 software analyzes medical images (X-rays) of the patient's spine and pelvis. It performs measurements, creates 3D representations, and assists in surgical planning. It does not analyze biological specimens.
- Intended Use: The intended use is to assist healthcare professionals in viewing and measuring images, and planning spine surgeries. This is a diagnostic imaging and surgical planning tool, not a test performed on a biological sample.
Therefore, the KBA3D v2.0.0 falls under the category of medical image processing and surgical planning software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The KBA3D v2.0.0 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.
The patient population targeted with the use of the KBA3D v2.0.0 software includes patients with mature skeletons requiring imaging measurements and planning of surgical procedures. The Bending algorithm is intended for patients older than 22 years old.
Product codes
LLZ
Device Description
The subject device KBA3D v2.0.0 is a SaaS software solution developed by S.M.A.I.O for the medical community; it is a second, independent version of the original KBA3D cleared by FDA in K213975. The current version of the KBA3D software is v.2.0.0. The user needs and requirements of the subject device were jointly defined by S.M.A.I.O and NuVasive. The software is intended to view images, perform spine related measurements, and plan surgical procedures such as osteotomies of the spine and templating of implants (screws, cages, rods).
KBA3D V2.0.0 software can be used by health professionals (orthopedic surgeons, radiologists, neurosurgeons) and service providers (imaging technicians, clinical study technicians) who are trained in spine imaging and pathologies. The KBA3D V2.0.0 software is intended for patients requiring measurements and planning of surgical procedures. KBA3D v2.0.0 aims to achieve three objectives:
-
- From two perpendicular patient's standing x-rays including patient's spine and pelvis from the femoral heads to the cervical levels, provide 3D scaled representation of the femoral heads, sacral plate, and vertebral bodies. Provide related shape and positioning parameters measurements (disc/vertebra/height/angulation), main curvatures description and global balance assessment.
-
- Simulate potential effects of a spine surgery on spinopelvic alignment and provide related shape and positioning parameters calculation.
-
- Visualize scaled representation of implant range (pedicle screws, interbody cages, union rods) relative to spinopelvic representation (pre-op versus realigned) to establish possible implant selection scenarios.
The software is not intended to predict the results of surgery as S.M.A.I.O does not provide tools to carry out planning. Therefore, regarding implant sizing, positioning, and correction impacts, accuracy levels provided by S.M.A.I.O are solely based on theoretical calculations that are not correlated to the output of surgery. KBA3D V2.0.0 provides scaled and simplified representations of the screws and cages relative to the patient's spine and pelvis.
Bendini service (part of NuVasive Pulse System, K210574, reference device):
- The first request from the software to the Bendini system enables the software to retrieve the most up-to-date benders/rods configuration file.
- A second request from the software to the Bendini system enables the software to obtain specific bending instructions for the rod.
Note: The Bendini Rod Bending algorithm is intended for patients older than 22 years old. The NuVasive Bendini Web App service is comprised of an API REST web service that facilities outside clients to utilize the NuVasive Bending algorithm. This algorithm is identical to the Bendini algorithm in K210574 for the NuVasive Pulse System and is hosted using the Microsoft Azure App Service. The KEOPS database manages connection to the software, patient data, and storage of data (X-rays and simulations).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-rays, CT-Scan
Anatomical Site
Spine, Pelvis, Femoral heads, Vertebral bodies
Indicated Patient Age Range
Patients with mature skeletons. The Bendini Rod Bending algorithm is intended for patients older than 22 years old.
Intended User / Care Setting
Health professionals (orthopedic surgeons, radiologists, neurosurgeons) and service providers (imaging technicians, clinical study technicians) who are trained in spine imaging and pathologies.
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
Summary of Performance Studies describes the testing done. No separate training or test sets are described.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance characteristics of the KBA3D V2.0.0 were tested and analyzed per the FDA's quidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained on Medical Devices" and the FDA quidance document entitled "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices". The pre-clinical tests and results for the subject device included:
- Anatomical parameters measurements were verified via mathematical calculations. The values were compared to the parameters calculated by the KBA3D V2.0.0 software. The results showed there was no difference in the calculations by Excel and KBA3D V2.0.0 software.
- 3D algorithm reconstruction on 2D Images were verified by comparison of Vertebral body dimensions from: (1) 3D reconstructions using the Balance Analyzer and 3D reconstructions from CT-Scan. The results showed that most of the deviations were less than 3mm and that the average was a maximum of 4.3mm (less than the maximum validation criterion of 5mm).
- Uncertainty testing studies comparing original coordinates and "worst case variation" coordinates demonstrated acceptable variations of values and validated the accuracy of the software. A deviation in distance of less than 2 pixels (px) and a deviation of not more than 2° were considered acceptable.
- Surgical Simulation was verified by applying the post treatment radiographs with the simulation algorithm in comparison with images (postop, 12 patients) by a spine surgeon. The highest value of the SSA error was 3.26% and the set of back types obtained by simulation was identical to the post-op version.
- Performance of the algorithm to position the screws was verified. A deviation
§ 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
S.M.A.I.O. % Robert Poggie, Ph.D. President BioVera, Inc. 65 Promenade Saint Louis Notre Dame de L'Ile Perrot, Quebec J7W3J6 CANADA
Re: K223841
May 30, 2023
Trade/Device Name: KBA3D v2.0.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: May 2, 2023 Received: May 2, 2023
Dear Dr. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device 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 (QS) 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,
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team 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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K223841
Device Name KBA3D v2.0.0
Indications for Use (Describe)
The KBA3D v2.0.0 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.
The patient population targeted with the use of the KBA3D v2.0.0 software includes patients with mature skeletons requiring imaging measurements and planning of surgical procedures. The Bending algorithm is intended for patients older than 22 years old.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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3
K223841
510(k) SUMMARY for K223841
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following is a summary of safety and effectiveness of S.M.A.I.O's KBA3D V2.0.0 software.
A. SUBMITTERS INFORMATION Submitter Name:
| Submitter Name: | BioVera, Inc. | ||
|---|---|---|---|
| Submitter Address: | 65 Promenade Saint-Louis, Notre-Dame-de- | ||
| L'Ile-Perrot, Québec, J7W 3J6, CANADA | |||
| Contact Person: | Robert A. Poggie, PhD | ||
| Phone & Fax Number: | 514-901-0796 | ||
| Date of Submission: | May 2, 2023 |
B. DEVICE IDENTIFICATION & MANUFACTURER
| Manufacturer Name: | S.M.A.I.O |
|---|---|
| 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: | KBA3D v2.0.0 |
| 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 | |
| K213975 | KEOPS Balance Analyzer 3D (KBA3D) |
| C2. PREDICATE DEVICES | |
| K180091 | UNiD Spine Analyzer, Medicrea International |
| K141669 | Nemaris Surgimap 2.0 |
| C3. REFERENCE DEVICE | |
| K210574 | NuVasive Pulse System |
4
D. DEVICE DESCRIPTION
The subject device KBA3D v2.0.0 is a SaaS software solution developed by S.M.A.I.O for the medical community; it is a second, independent version of the original KBA3D cleared by FDA in K213975. The current version of the KBA3D software is v.2.0.0. The user needs and requirements of the subject device were jointly defined by S.M.A.I.O and NuVasive. The software is intended to view images, perform spine related measurements, and plan surgical procedures such as osteotomies of the spine and templating of implants (screws, cages, rods).
KBA3D V2.0.0 software can be used by health professionals (orthopedic surgeons, radiologists, neurosurgeons) and service providers (imaging technicians, clinical study technicians) who are trained in spine imaging and pathologies. The KBA3D V2.0.0 software is intended for patients requiring measurements and planning of surgical procedures. KBA3D v2.0.0 aims to achieve three objectives:
-
- From two perpendicular patient's standing x-rays including patient's spine and pelvis from the femoral heads to the cervical levels, provide 3D scaled representation of the femoral heads, sacral plate, and vertebral bodies. Provide related shape and positioning parameters measurements (disc/vertebra/height/angulation), main curvatures description and global balance assessment.
-
- Simulate potential effects of a spine surgery on spinopelvic alignment and provide related shape and positioning parameters calculation.
-
- Visualize scaled representation of implant range (pedicle screws, interbody cages, union rods) relative to spinopelvic representation (pre-op versus realigned) to establish possible implant selection scenarios.
The software is not intended to predict the results of surgery as S.M.A.I.O does not provide tools to carry out planning. Therefore, regarding implant sizing, positioning, and correction impacts, accuracy levels provided by S.M.A.I.O are solely based on theoretical calculations that are not correlated to the output of surgery. KBA3D V2.0.0 provides scaled and simplified representations of the screws and cages relative to the patient's spine and pelvis.
Bendini service (part of NuVasive Pulse System, K210574, reference device):
- The first request from the software to the Bendini system enables the software to retrieve the most up-to-date benders/rods configuration file.
- A second request from the software to the Bendini system enables the software to obtain specific bending instructions for the rod.
Note: The Bendini Rod Bending algorithm is intended for patients older than 22 years old. The NuVasive Bendini Web App service is comprised of an API REST web service that facilities outside clients to utilize the NuVasive Bending algorithm. This algorithm is identical to the Bendini algorithm in K210574 for the NuVasive Pulse System and is hosted using the Microsoft Azure App Service. The KEOPS database manages connection to the software, patient data, and storage of data (X-rays and simulations).
5
E. INTENDED USE
The KBA3D v2.0.0 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.
The patient population targeted with the use of the KBA3D v2.0.0 software includes patients with mature skeletons requiring imaging measurements and planning of surgical procedures. The Bendini Rod Bending algorithm is intended for patients older than 22 years old.
F. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The table below compares the technological characteristics of the KBA3D V2.0.0 to the predicate and reference devices.
| | Subject Device | Predicate Device
(Primary) | Predicate
Device | Predicate
Device | Reference
Device |
|--------------------------------------------------------------|-------------------------|-----------------------------------------|------------------------------------|--------------------------------------|-------------------------------------|
| Feature | KBA3D V2.0.0
K223841 | KEOPS Balance
Analyzer 3D
K213975 | Nemaris
Surgimap 2.0
K141669 | Medicrea
UNiD Analyzer
K180091 | NuVasive Pulse
System
K210574 |
| Computer | PC Compatible | PC Compatible | PC Compatible | PC Compatible | PC Compatible |
| Operating System | Windows + MAC | Windows + MAC | Windows + MAC | Windows + MAC | Windows |
| Image Input | Local | Local | Local + PACS
connectivity | Local | Local |
| Runs on Server | Yes | Yes | No | Yes | No |
| Osteotomy Module | Yes | Yes | Yes | Yes | No |
| Spine measurements | Yes | Yes | Yes | Yes | Yes |
| Pre-op planning | Yes | Yes | Yes | Yes | No |
| Screws | Yes | No | No | Yes | Yes |
| Cages | Yes | No | Yes | No | No |
| Rods | Yes | Yes | Yes | Yes | Yes (Bendini) |
| Database | No | No | Yes | No | No |
| Case sharing | No | No | Yes | No | No |
| Human intervention for image interpretation and manipulation | Yes | Yes | Yes | Yes | Yes |
G. PERFORMANCE SUMMARY
The performance characteristics of the KBA3D V2.0.0 were tested and analyzed per the FDA's quidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained on Medical Devices" and the FDA quidance document entitled "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices". The pre-clinical tests and results for the subject device included:
- · Anatomical parameters measurements were verified via mathematical calculations. The values were compared to the parameters calculated by the KBA3D V2.0.0 software. The results showed
6
there was no difference in the calculations by Excel and KBA3D V2.0.0 software.
- · 3D algorithm reconstruction on 2D Images were verified by comparison of Vertebral body dimensions from: (1) 3D reconstructions using the Balance Analyzer and 3D reconstructions from CT-Scan. The results showed that most of the deviations were less than 3mm and that the average was a maximum of 4.3mm (less than the maximum validation criterion of 5mm).
- · Uncertainty testing studies comparing original coordinates and "worst case variation" coordinates demonstrated acceptable variations of values and validated the accuracy of the software. A deviation in distance of less than 2 pixels (px) and a deviation of not more than 2° were considered acceptable.
- Surgical Simulation was verified by applying the post treatment radiographs with the simulation algorithm in comparison with images (postop, 12 patients) by a spine surgeon. The highest value of the SSA error was 3.26% and the set of back types obtained by simulation was identical to the post-op version.
- · Performance of the algorithm to position the screws was verified. A deviation