(103 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard software functionalities like visualization, modification, and 3D model generation from CT data, without mentioning any learning or adaptive capabilities.
Yes
The device is a software interface that assists in visualization, modification, and validation of the planning of shoulder arthroplasty, which are steps in a surgical procedure aimed at treating a medical condition.
No
The "Intended Use / Indications for Use" explicitly states, "It is to be used for adult patients only and should not be used for diagnostic purposes."
Yes
The device description explicitly states that Customize "consists of a single software user interface" and its function is to visualize, modify, and manage surgical plans based on existing data (CT scans and implant libraries). There is no mention of any hardware component being part of the device itself. The performance studies focus on software verification and validation, segmentation validation, and 3D model generation accuracy, all of which are software-related functions.
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 a "software interface to assist in... planning of shoulder arthroplasty" and "should not be used for diagnostic purposes." IVDs are specifically intended for the diagnosis of diseases or other conditions.
- Device Description: The description focuses on visualizing and modifying surgical treatment options based on imaging data and implant libraries. This is a surgical planning tool, not a diagnostic test performed on biological samples.
- Lack of Biological Sample Analysis: IVDs typically involve the analysis of biological samples (blood, urine, tissue, etc.) to provide diagnostic information. This device uses imaging data (CT scans) for surgical planning.
While the device processes medical images, which is a component of some diagnostic workflows, its stated purpose and functionality are centered around surgical planning and visualization, not the diagnosis of a disease or condition.
N/A
Intended Use / Indications for Use
Customize for shoulder arthroplasty is intended to be used as a software interface to assist in:
- Visualization, modification, validation of the planning of shoulder arthroplasty
- Communication of treatment options
- Segmentation of CT-scan data
- 3D CAD models generation
- Managing timeline and cases
Customize is not intended to be used for
- Spine surgeries
- Implant and instrument design
Experience in usage and clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes.
Product codes
QIH
Device Description
Customize is intended to be used during the preparation of shoulder arthroplasties. It visualizes surgical treatment options that were previously created based on 3D CAD files generated from multi-slice DICOM data from a CT scanner. It consists of a single software user interface where the physician can review the CAD files in 3D and modify the position and orientation of the different 3D objects. Customize includes an implant library with 3D digital representations of various implant models so that the right implant positioning and sizing can be achieved based on the physician's input. After approval by the physician, the treatment plan is saved on the server and can be used as a reference during surgery.
Customize is prescription use only.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanner
Anatomical Site
shoulder
Indicated Patient Age Range
adult patients only
Intended User / Care Setting
Physician / 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)
Software verification and validation was performed, and documentation was provided following the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". This includes verification against defined requirements, and validation against user needs. In addition, performance testing included 1) segmentation validation of the Customize software, 2) Repeatability and Reproducibility study on the segmentation of shoulder anatomies and 3) accuracy study on 3D model generation for humerus and scapula.
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).
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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.
3D-Side SA % Mieke Janssen Regulatory Affairs Consultant OrthoGrow NV Davincilaan 1 Zaventem, Vlaams-Brabant 1930 BELGIUM
March 16, 2022
Re: K213779
Trade/Device Name: Customize Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH Dated: February 17, 2022 Received: February 18, 2022
Dear Mieke Janssen:
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); 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 (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,
Jessica Lamb Associate 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
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Indications for Use
510(k) Number (if known) K213779
Device Name Customize
Indications for Use (Describe)
Customize for shoulder arthroplasty is intended to be used as a software interface to assist in:
- Visualization, modification, validation of the planning of shoulder arthroplasty
- Communication of treatment options
- Segmentation of CT-scan data
- 3D CAD models generation
- Managing timeline and cases
Customize is not intended to be used for
- Spine surgeries
- Implant and instrument design
Experience in usage and clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes.
| 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)
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510(K) SUMMARY (21CFR807.92)
SUBMITTER
Company Name: Establishment registration number: Address:
| Phone number: | |
|---|---|
| Principal contact person: | |
| Principal contact e-mail address | |
| Additional contact person: | |
| Additional contact e-mail address | |
| Summary date: | March 14, 2022 |
DEVICE
Name & trade name: Classification name:
3D-Side 3013561205 Rue André Dumont 5 1435 Mont-Saint-Guibert, BE +32 (0) 10 81 35 48 Mieke Janssen mieke@ortho-grow.com Laurent Paul lp@3dside.eu
Customize Automated Radiological Image Processing Software QIH
Classification product code
PREDICATE AND REFERENCE DEVICES
The predicate device to which substantial equivalence is claimed:
| Trade or proprietary or model name | Preview Shoulder |
|---|---|
| 510(k) number | K210556 |
| Decision date | 21 April 2021 |
| Classification product code | QIH |
| Manufacturer | Genesis Software |
| Innovations |
DESCRIPTION AND FUNCTIONING OF THE DEVICE
Customize is intended to be used during the preparation of shoulder arthroplasties. It visualizes surgical treatment options that were previously created based on 3D CAD files generated from multi-slice DICOM data from a CT scanner. It consists of a single software user interface where the physician can review the CAD files in 3D and modify the position and orientation of the different 3D objects. Customize includes an implant library with 3D digital representations of various implant models so that the right implant positioning and sizing can be achieved based on the physician's input. After approval by the physician, the treatment plan is saved on the server and can be used as a reference during surgery.
Customize is prescription use only.
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INTENDED USE
Customize for shoulder arthroplasty is intended to be used as a software interface to assist in:
- Visualization, modification, validation of the planning of shoulder arthroplasty -
- Communication of treatment options -
- Segmentation of CT-scan data -
- 3D CAD models generation -
- -Managing timeline and cases
Customize is not intended to be used for
- Spine surgeries -
- Implant and instrument design -
Experience in usage and a clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes.
TECHNOLOGICAL CHARACTERISTICS
Comparison of technological characteristics with the predicate device (Preview Shoulder, K210556):
- . Following similarities exist between the subject device Customize and the predicate device:
- Intended use/indications for use: both the subject and the predicate device share a O similar intended use
- Patient population: both devices are applicable for adult population only о
- Device functionality: both devices enable visualization of medical images о (DICOM), include an implant library, and allow implant visualization in both the original scan images as well as the 3D model reconstruction. Both devices utilize image segmentation and allow 3D view manipulation.
- The following technological difference exists between the subject device and the predicate device:
- The subject device includes a distance map providing an approximate estimate of O the distance between two objects. This functionality is absent in the predicate device.
This difference in technological characteristics does not raise new questions of safety and effectiveness.
Performance Data
Non-clinical performance data was included in the 510(k)-submission demonstrating Customize has been validated for its intended use and substantial equivalence to the predicate device.
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Software verification and validation was performed, and documentation was provided following the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". This includes verification against defined requirements, and validation against user needs. In addition, performance testing included 1) segmentation validation of the Customize software, 2) Repeatability and Reproducibility study on the segmentation of shoulder anatomies and 3) accuracy study on 3D model generation for humerus and scapula.
SUMMARY
The characteristics that determine the functionality and performance of Customize, the subject device, are substantially equivalent to the predicate device cleared under K210556. The nonclinical testing indicates that the subject device is as safe, as effective, and performs as well as the predicate.