(198 days)
Yes
The document explicitly states the addition of a "static machine-learning based model" and describes "Predictive Models" trained with "retrospective longitudinal patient datasets."
No
The device is intended for assisting healthcare professionals in viewing and measuring images and planning orthopedic surgeries, not for providing direct therapy.
Yes
The device is intended for "assisting healthcare professionals in viewing and measuring images" and includes predictive models trained on patient datasets to generate "Predicted Value" derived from a machine-learning model when viewing simulated radiographic parameters. These functionalities indicate its use in providing insights into a patient's condition, which aligns with diagnostic purposes.
Yes
The device description explicitly states it is a "web-based, Software as a Medical Device (SaMD) application" and the submission focuses on software updates and features. While it interacts with images and potentially implant templates (which are physical devices), the device itself is the software application.
Based on the provided text, the UNID™ Spine Analyzer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- UNID™ Spine Analyzer's Intended Use: The intended use clearly states that the device is for "assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries." It focuses on image analysis and surgical planning based on those images.
- Device Description: The description reinforces this by detailing its function as a "preoperative and postoperative patient image measurements and simulate preoperative planning steps for spine surgery." It's a software tool for analyzing existing images and planning procedures, not for analyzing biological specimens.
The device's function is centered around image processing and surgical planning, which falls outside the scope of IVD devices.
No
The clearance letter does not explicitly state 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 UNiD™ Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons and service providers to perform generic, as well as spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software.
Product codes
LLZ
Device Description
The MEDICREA UNiD Spine Analyzer was developed to perform preoperative and postoperative patient image measurements and simulate preoperative planning steps for spine surgery. This web-based, Software as a Medical Device (SaMD) application aims to simulate a surgical strategy, make measurements on a patient image, and draw patient-specific rods or choose from a pre-selection of standard implants and ordering the patient-specific rods. The UNiD Spine Analyzer allows the user to:
-
- Measure radiological images using generic tools and "specialty" tools
-
- Plan and simulate aspects of surgical procedures
The purpose of this submission is to request clearance for the UNiD Spine Analyzer v4.0. The changes introduced are as follows:
- . Addition of the Degenerative Predictive Model, which corresponds to a type of adult spinal fusion degenerative construct, trained with a retrospective longitudinal patient dataset.
- . Update to the existing Adult Predictive Model consisting of three predictive model modules trained with retrospective longitudinal patient datasets, where one was included in Adult Deformity Model 1 (TKA-12) and two included in Adult Deformity Model 2 (PTA-12 and PTA-34).
- Update to the existing Pediatric Predictive Model consisting of two predictive model modules trained with retrospective longitudinal patient datasets (PediaLL and PediaPT),
- Addition of the display of a Predicted Value derived from a static machine-learning based model . when the user views simulated quantitative radiographic parameters of a planned surgery, generated when the Degenerative, Adult or Pediatric Predictive Models are used.
- . The subject device update also includes the addition of implant templates among a preselected database of Medtronic standard implants cleared in in the following 510(k)s: K073291, K083026, K091813, K110543, K113528, K120368, K150135, K152277, K172199, K172328, and K201267.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes (machine-learning)
Input Imaging Modality
Not Found. (The document mentions "radiological images" but does not specify modalities like X-ray, CT, MRI, etc.)
Anatomical Site
Spine
Indicated Patient Age Range
Not Found. (The document mentions "adult spinal fusion degenerative construct," "Adult Predictive Model," and "Pediatric Predictive Model" implying use for adults and pediatric patients, but does not specify age ranges.)
Intended User / Care Setting
Healthcare professionals, surgeons and service providers
Description of the training set, sample size, data source, and annotation protocol
Retrospective longitudinal patient dataset
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)
Non-Clinical Performance Data: The device's software development, verification, and validation have been carried out in accordance with FDA guidelines. The software was tested against the established Software Design Specifications for each of the test plans to assure the device performs as intended. The device Hazard analysis was completed per ISO 14971, Application of Risk Management to Medical Devices and IEC 62304, Medical Device Software – Software Life-Cycle Processes, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria of each module and interaction of processes. The MEDICREA UNiD Spine Analyzer device passed all testing and supports the claims of substantial equivalence and safe operation.
Validation activities included a usability study of the UNiD Spine Analyzer under actual use. The study demonstrated:
- Comprehension of the Health Care professional with the UNiD Spine Analyzer,
- Appropriate human factors related to the UNiD Spine Analyzer, and
- -Ease of use of the UNiD Spine Analyzer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K073291, K083026, K091813, K100175, K110543, K113528, K120368, K150135, K152277, K172199, K172328, K201267
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 shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
MEDICREA International, Inc. % Carrie Hetrick Director of Regulatory Sterling Medical Devices 250 Moonachie Road MOONACHIE NJ 07074
January 12, 2022
Re: K212005
Trade/Device Name: UNiD™ Spine Analyzer Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: December 9, 2021 Received: December 10, 2021
Dear Carrie Hetrick:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name UNiD™ Spine Analyzer
Indications for Use (Describe)
The UNID™ Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons and service providers to perform generic, as well as spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for 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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3
510(k) Summary
UNiD Spine
Analyzer K212005
1. Submission Sponsor
MEDICREA International, Inc.
5389 Route de Strasbourg - Vancia
Rillieux La Pape
69140
France
2. Submission Correspondent
Sterling Medical Devices
250 Moonachie Road, Suite 400
Moonachie, NJ 07074
Office Phone: (201) 227-7569
Contact: Carrie Hetrick, DDS, MScRSc
Title: Director of Regulatory Affairs
3. Date Prepared
June 25, 2021
4. Device Identification
| Trade/Proprietary Name: | UNiD Spine Analyzer |
|---|---|
| Common/Usual Name: | Medical Image Management and Processing System |
| Classification Name: | System, image processing, radiological |
| Regulation Number: | 21 CFR §892.2050 |
| Product Code: | LLZ |
4
Device Class: Class II
Classification Panel: Radiology
5. Legally Marketed Predicate Device
K180091, MEDICREA International, Inc. UNiD Spine Analyzer v2.0 (primary predicate). This predicate has not been subject to a design-related recall¹
6. Indication for Use Statement
The UNiD™ Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons and service providers to perform generic, as well as spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software.
7. Device Description
The MEDICREA UNiD Spine Analyzer was developed to perform preoperative and postoperative patient image measurements and simulate preoperative planning steps for spine surgery. This web-based, Software as a Medical Device (SaMD) application aims to simulate a surgical strategy, make measurements on a patient image, and draw patient-specific rods or choose from a pre-selection of standard implants and ordering the patient-specific rods. The UNiD Spine Analyzer allows the user to:
-
- Measure radiological images using generic tools and "specialty" tools
-
- Plan and simulate aspects of surgical procedures
The purpose of this submission is to request clearance for the UNiD Spine Analyzer v4.0. The changes introduced are as follows:
- . Addition of the Degenerative Predictive Model, which corresponds to a type of adult spinal fusion degenerative construct, trained with a retrospective longitudinal patient dataset.
- . Update to the existing Adult Predictive Model consisting of three predictive model modules trained with retrospective longitudinal patient datasets, where one was included in Adult Deformity Model 1 (TKA-12) and two included in Adult Deformity Model 2 (PTA-12 and PTA-34).
- Update to the existing Pediatric Predictive Model consisting of two predictive model modules trained with retrospective longitudinal patient datasets (PediaLL and PediaPT),
1 On July 9, 2012, section 605 of FDASIA (Pub. L. 112-144) added section 518A to the FD&C Act, which directs FDA to establish a program to routinely and systematically assess information regarding device recalls, and to use that information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices. FDA believes that one way to carry out this directive is to provide greater transparency on recalled devices. Identifying whether a predicate was recalled is optional, but doing so would help the Agency achieve this FDASIA directive.
5
- Addition of the display of a Predicted Value derived from a static machine-learning based model . when the user views simulated quantitative radiographic parameters of a planned surgery, generated when the Degenerative, Adult or Pediatric Predictive Models are used.
- . The subject device update also includes the addition of implant templates among a preselected database of Medtronic standard implants cleared in in the following 510(k)s: K073291, K083026, K091813, K110543, K113528, K120368, K150135, K152277, K172199, K172328, and K201267.
8. Substantial Equivalence Discussion
The following table compares the UNiD Spine Analyzer v4.0 to the UNiD Spine Analyzer v2.0 predicate device with respect to indications for use, features, and technological characteristics.
| | Subject Device
MEDICREA UNID™ Spine Analyzer v4.0 | Predicate Device
MEDICREA UNID™ Spine Analyzer v2.0 |
|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | MEDICREA International, Inc. | MEDICREA International, Inc. |
| 510(k) Number | To be determined | K180091 (Special) |
| Device Class | II | II |
| Product Code(s) | LLZ | LLZ |
| Regulation
Description | Medical Image Management and
Processing System (MIMPS) | Picture Archiving and Communication
System (PACS) |
| Regulation Number | 21 CFR §892.2050 | 21 CFR §892.2050 |
| Indications for use: | The UNID Spine Analyzer is intended
for assisting healthcare professionals
in viewing and measuring images as
well as planning orthopedic surgeries.
The device allows surgeons and service
providers to perform generic, as well
as spine related measurements on
images, and to plan surgical
procedures. The device also includes
tools for measuring anatomical
components for placement of surgical
implants. Clinical judgment and
experience are required to properly
use the software. | The UNID Spine Analyzer is intended
for assisting healthcare professionals
in viewing and measuring images as
well as planning orthopedic surgeries.
The device allows surgeons and service
providers to perform generic, as well
as spine related measurements on
images, and to plan surgical
procedures. The device also includes
tools for measuring anatomical
components for placement of surgical
implants. Clinical judgment and
experience are required to properly
use the software. |
| Computer | PC Compatible | PC Compatible |
| Operating System | Windows + MAC | Windows + MAC |
| Image Input | Local | Local |
| | Subject Device | Predicate Device |
| | MEDICREA UNID™ Spine Analyzer v4.0 | MEDICREA UNID™ Spine Analyzer v2.0 |
| Runs on Server | Yes | Yes |
| Osteotomy Module | Yes | Yes |
| Generic
measurements | No additional changes | The measurement panel allows a user
to view the measured values of each
tool. The device allows surgeons and
service providers to perform generic,
as well as spine related measurements
on images, and to plan surgical
procedures. The device also includes
tools for measuring anatomical
components for placement of surgical
implants. Complementary to the pre-
op measure, this panel also displays
the simulated values and shows the
normative value. Quality for the
measurement is given coloring, the
simulated values depending on
reference values. |
| Spine measurements | MEASURING TOOLS: Contains all
measurement tools (angle, LLordo,
line, circle, pelvic, T1SPi, SVA)
New features internally documented
and released include SA Analysis,
Sagittal wizard, Coronal wizard,
Transitional anatomy, Cervical, Lenke
classification, and Guide spline. | MEASURING TOOLS: Contains all
measurement tools (angle, LLordo,
line, circle, pelvic, T1SPi, SVA). |
| Pre-operative
planning | SURGICAL TOOLS: Contains all surgery
tools (wedge, open, resect)
New features internally documented
and released include wedge auto,
open auto, and resect auto surgical
tools. | SURGICAL TOOLS: Contains all surgery
tools (wedge, open, resect). |
| Custom implants | IMPLANTS: Contains all implants (UNID
Rod, cage, cage selection, screw, screw
selection).
New features internally documented
and released include UNID Rod Auto,
cage auto, screw wizard, and postop
screw. | IMPLANTS: Contains all implants (UNID
Rod, cage, cage selection, screw, screw
selection) |
| Database | Yes (implants) | Yes (implants) |
| | Subject Device | Predicate Device |
| | MEDICREA UNID™ Spine Analyzer v4.0 | MEDICREA UNID™ Spine Analyzer v2.0 |
| | The subject device update also
includes the addition of a selection of
implant templates among a
preselected database of Medtronic
standard implants cleared in in the
following 510(k)s: K073291, K083026,
K091813, K100175, K110543, K113528,
K120368, K150135, K152277, K172199,
K172328, and K201267. | |
| Case sharing | Yes | Yes |
| Human intervention
for interpretation and
manipulation of
images | Required | Required |
| Web content | Yes | Yes |
| Reference
information provided
to user during surgical
planning | Display of reference data to user
during surgery planning:
Normative data
Predictive model outputs from one of
three predictive models, depending on
procedure type (degenerative, adult
deformity, pediatric deformity) | Display of reference data to user
during surgery planning:
Normative data |
Table 5A – Substantial Equivalence Comparison
6
7
The new predictive models provide an additional tool to account for predicted spinal compensation when planning surgery; their use is similar to the display of reference and normative data, and does not raise new questions of safety and effectiveness when considered with existing methods of managing spinal compensation. Predictions are radiographic and do not include patient reported outcomes (e.g., ODI scores).
8
8. Non-Clinical Performance Data
The device's software development, verification, and validation have been carried out in accordance with FDA guidelines. The software was tested against the established Software Design Specifications for each of the test plans to assure the device performs as intended. The device Hazard analysis was completed per ISO 14971, Application of Risk Management to Medical Devices and IEC 62304, Medical Device Software – Software Life-Cycle Processes, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria of each module and interaction of processes. The MEDICREA UNiD Spine Analyzer device passed all testing and supports the claims of substantial equivalence and safe operation.
Validation activities included a usability study of the UNiD Spine Analyzer under actual use. The study demonstrated:
- י Comprehension of the Health Care professional with the UNiD Spine Analyzer,
- Appropriate human factors related to the UNiD Spine Analyzer, and
- -Ease of use of the UNiD Spine Analyzer.
9. Clinical Performance Data
There was no human clinical testing required to support the medical device as the indications for use is identical to the predicate device. These types of devices, including the predicate device, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
10. Conclusions
By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device(s).
The intended use and indications for use of the subject device is identical to the predicate device. The addition of the new features, consisting of measuring tool functionality and predictive models, to the device does not raise new issues of safety or effectiveness compared to the previously cleared versions of the device. Therefore, the UNiD Spine Analyzer v4.0 is determined to be substantially equivalent to the company's own legally marketed predicate device.