Axial3D Cloud Segmentation Service
Device Facts
| Record ID | K231607 |
|---|---|
| Device Name | Axial3D Cloud Segmentation Service |
| Applicant | Axial Medical Printing Limited |
| Product Code | LLZ · Radiology |
| Decision Date | Jan 24, 2024 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device, Pediatric |
Indications for Use
Axial3D Cloud Segmentation Service is intended for use as a cloud-based service and image segmentation Framework for the transfer of DICOM imaging information from a medical scanner to an output file, which can be used for the fabrication of physical replicas of the output file using additive manufacturing methods. The output file or physical replica can be used for treatment planning and/or diagnostic purposes in the field of orthopedic, maxillofacial, and cardiovascular applications in adults. The or physical replica may also be used for pediatrics between the ages of 12 and 21 years of age in cardiovascular applications. Axial3D Cloud Segmentation Service should be used with other diagnostic tools and expert clinical judgment.
Device Story
Cloud-based service and image segmentation framework; processes DICOM imaging (CT/CTA) from medical scanners. Transforms imaging data into output files for additive manufacturing of physical replicas. Used in hospitals by clinicians for treatment planning and diagnostic purposes in orthopedic, maxillofacial, and cardiovascular fields. Healthcare providers use the output (digital file or physical model) alongside other diagnostic tools and clinical judgment to assist in patient care. Benefits include enhanced visualization and planning for complex anatomical cases.
Clinical Evidence
Bench testing only. Software verification and validation performed per FDA guidance for Moderate Level of Concern software. Measurement accuracy validated to +/- 0.7mm. Printing of physical replicas validated for accuracy across compatible printers.
Technological Characteristics
Cloud-based software service; supports CT and CTA modalities. Features include automated segmentation tools with smart editing, volume rendering, and ROI quantification. Connectivity via internet browser (Internet Explorer 11 or equivalent).
Indications for Use
Indicated for adults requiring treatment planning or diagnostic support in orthopedic, maxillofacial, and cardiovascular applications, and for pediatric patients aged 12-21 years in cardiovascular applications. Uses DICOM imaging (CT/CTA) to generate output files for additive manufacturing of physical replicas.
Regulatory Classification
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.
Special Controls
*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).
Predicate Devices
- Axial3D (K221511)
Submission Summary (Full Text)
{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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Axial Medical Printing Limited % Sujith Shetty Executive Vice President Maxis Medical LLC 3031 Tisch Way, Suite 1010 San Jose, California 95128
January 24, 2024
Re: K231607
Trade/Device Name: Axial3D Cloud Segmentation Service Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: December 28, 2023 Received: January 2, 2024
Dear Sujith Shetty:
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 OS 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 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 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) K231607
Device Name Axial3D Cloud Segmentation Service
#### Indications for Use (Describe)
Axial3D Cloud Segmentation Service is intended for use as a cloud-based service and image segmentation Framework for the transfer of DICOM imaging information from a medical scanner to an output file, which can be used for the fabrication of physical replicas of the output file using additive manufacturing methods.
The output file or physical replica can be used for treatment planning and/or diagnostic purposes in the field of orthopedic, maxillofacial, and cardiovascular applications in adults. The or physical replica may also be used for pediatrics between the ages of 12 and 21 years of age in cardiovascular applications.
Axial3D Cloud Segmentation Service should be used with other diagnostic tools and expert clinical judgment.
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Axial3D. The word "axial" is in a bold, dark blue font, with a small teal diamond above the "i". To the right of "axial" is a superscript "3D". Below the logo is the tagline "Patient data made real" in a teal font.
## 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CRF 807.92.
## 510 (k) number: K231607
### Applicant Information
Axial Medical Printing Limited 17A Ormeau Avenue Belfast BT2 8HD United Kingdom Tel: +44 (0)28 90183590
### Contact Person
Joanne Flatley, QA/RA Lead
### Device Information
| Trade Name | Axial3D Cloud Segmentation Service |
|-----------------------|------------------------------------------------|
| Common Name | Medical image management and processing system |
| Classification number | 892.2050 |
| Regulatory Class | II |
| Product Code | LLZ |
### Predicate Device
Table 1 - Predicate Device
| Name | Manufacturer | 510(k)# |
|---------|-----------------------------------|---------|
| Axial3D | Axial Medical Printing<br>Limited | K221511 |
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image contains the logo for Axial3D. The logo consists of the word "axial" in a dark blue sans-serif font, with a teal diamond shape above the "i". To the right of "axial" is the number "3D" in a smaller, superscript font. Below the logo is the tagline "Patient data made real" in a teal sans-serif font.
This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
## Device Description
Axial3D Cloud Segmentation Service is a secure, highly available cloud-based image processing, segmentation, and 3D modelling framework for the transfer of imaging information either as a digital file or as a 3D printed physical model.
### Indications for Use
Axial3D Cloud Segmentation Service is intended for use as a cloud-based service and image segmentation framework for the transfer of DICOM imaging information from a medical scanner to an output file, which can be used for the fabrication of physical replicas of the output file using additive manufacturing methods.
The output file or physical replica can be used for treatment planning and/or diagnostic purposes in the field of orthopedic, maxillofacial, and cardiovascular applications in adults. The output file or physical replica may also be used for pediatrics between the ages of 12 and 21 years of age in cardiovascular applications.
Axial3D Cloud Segmentation Service should be used in conjunction with other diagnostic tools and expert clinical judgment.
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image is a logo for Axial3D. The logo consists of the word "axial" in a bold, dark blue font, with a small teal diamond shape above the "i". To the right of "axial" is the number "3D" in a smaller, lighter blue font. Below the word "axial" is the phrase "Patient data made real" in a teal color.
## Comparison of Intended Use to Predicate Devices
| | Table 2 - Predicate Device Comparison: Intended Use | |
|--|-----------------------------------------------------|--|
| Attribute | Axial3D Cloud<br>Segmentation Service<br>(Proposed Device) | Axial3D Cloud<br>Segmentation Service<br>(Predicate Device) | Comparison |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Manufacturer | Axial Medical Printing<br>Limited | Axial Medical Printing<br>Limited | Equivalent |
| Device Name | Axial3D Cloud<br>Segmentation Service | Axial3D Cloud<br>Segmentation Service | Equivalent |
| Device Trade or<br>Proprietary Name | Axial3D Cloud<br>Segmentation Service | Axial3D Cloud<br>Segmentation Service | Equivalent |
| 510(k) Number | K231607 | K221511 | N/A |
| Device<br>Regulation<br>Name: | Medical image<br>management and<br>processing system | Medical image<br>management and<br>processing system | Equivalent |
| Device<br>Regulation<br>Number: | 21 CFR 892.2050 | 21 CFR 892.2050 | Equivalent |
| Device Product<br>Code: | LLZ | LLZ | Equivalent |
| Device<br>Classification<br>FDA: | Class II | Class II | Equivalent |
| Indication for Use | Axial3D Cloud<br>Segmentation Service is<br>intended for use as a<br>cloud-based service and<br>image segmentation<br>framework for the transfer<br>of DICOM imaging<br>information from a<br>medical scanner to an<br>output file, which can be<br>used for the fabrication of<br>physical replicas of the<br>output file using additive<br>manufacturing methods.<br>The output file or physical<br>replica can be used for<br>treatment planning and/or<br>diagnostic purposes in the<br>field of orthopedic,<br>maxillofacial, and<br>cardiovascular<br>applications in adults. The<br>output file or physical<br>replica may also be used<br>for pediatrics between the | Axial3D Cloud<br>Segmentation Service is<br>intended for use as a<br>cloud-based service and<br>image segmentation<br>system for the transfer of<br>DICOM imaging<br>information from a<br>medical scanner to an<br>output file.<br>The Axial3D Cloud<br>Segmentation Service<br>output file can be used for<br>the fabrication of physical<br>replicas of the output file<br>using additive<br>manufacturing methods.<br>The output file or physical<br>replica can be used for<br>treatment planning.<br>The physical replica can<br>be used for diagnostic<br>purposes in the field of<br>orthopedic, maxillofacial | Similar. The proposed<br>device includes<br>specifications for ,<br>orthopedic,<br>maxillofacial, and<br>cardiovascular<br>applications for adults<br>and children greater<br>than 12 years old and<br>in cardiovascular<br>applications for children<br>greater than 2 months<br>of age population in<br>which 3D models can<br>be provided for based<br>on clinical imaging. |
| Attribute | Axial3D Cloud<br>Segmentation Service<br>(Proposed Device) | Axial3D Cloud<br>Segmentation Service<br>(Predicate Device) | Comparison |
| | ages of 12 and 21 years<br>of age in cardiovascular<br>applications.<br>Axial3D Cloud<br>Segmentation Service<br>should be used in<br>conjunction with other<br>diagnostic tools and<br>expert clinical judgment. | and cardiovascular<br>applications.<br>Axial3D Cloud<br>Segmentation Service<br>should be used in<br>conjunction with other<br>diagnostic tools and<br>expert clinical judgment. | |
| Intended Use | Axial3D Cloud<br>Segmentation Service<br>is intended for use as a<br>cloud-based service<br>and image<br>segmentation<br>framework for the<br>transfer of DICOM<br>imaging information<br>from a medical scanner<br>to an output file, which<br>can be used for the<br>fabrication of physical<br>replicas of the output<br>file using additive<br>manufacturing<br>methods.<br>The output file or<br>physical replica can be<br>used for treatment<br>planning and/or<br>diagnostic purposes in<br>the field of orthopedic,<br>maxillofacial, and<br>cardiovascular<br>applications in adults.<br>The output file or<br>physical replica may<br>also be used for<br>pediatrics between the<br>ages of 12 and 21<br>years of age in<br>cardiovascular<br>applications.<br>Axial3D Cloud<br>Segmentation Service<br>should be used in | Axial3D Cloud<br>Segmentation Service is<br>intended for use as a<br>cloud-based service and<br>image segmentation<br>system for the transfer of<br>DICOM imaging<br>information from a<br>medical scanner to an<br>output file.<br>The Axial3D Cloud<br>Segmentation Service<br>output file can be used for<br>the fabrication of physical<br>replicas of the output file<br>using additive<br>manufacturing methods.<br>The output file or physical<br>replica can be used for<br>treatment planning.<br>The physical replica can<br>be used for diagnostic<br>purposes in the field of<br>orthopedic, maxillofacial<br>and cardiovascular<br>applications.<br>Axial3D Cloud<br>Segmentation Service<br>should be used in<br>conjunction with other<br>diagnostic tools and<br>expert clinical judgment. | Similar. The proposed<br>device includes<br>specifications for ,<br>orthopedic,<br>maxillofacial, and<br>cardiovascular<br>applications for adults<br>and children greater<br>than 12 years old and<br>in cardiovascular<br>applications for children<br>greater than 2 months<br>of age population in<br>which 3D models can<br>be provided for based<br>on clinical imaging. |
| Attribute | Axial3D Cloud<br>Segmentation Service<br>(Proposed Device) | Axial3D Cloud<br>Segmentation Service<br>(Predicate Device) | Comparison |
| | conjunction with other<br>diagnostic tools and<br>expert clinical<br>judgment. | | |
| Target Populate | Adult for all indications<br>children 12 to 21 for<br>cardiovascular indication | Adult | Similar |
| Method of Use | Used in conjunction with<br>other diagnostic tools and<br>expert clinical judgement. | Used in conjunction with<br>other diagnostic tools and<br>expert clinical judgement. | Equivalent |
| Image Modality | Computed tomograghy<br>(CT),<br>CT Angiography (CTA) | Computed tomograghy<br>(CT),<br>CT Angiography (CTA) | Equivalent |
| Environment | Hospital | Hospital | Equivalent |
| OTC or<br>Prescription<br>Device | Prescription Use | Prescription Use | Equivalent |
| Level of Concern | Moderate | Moderate | Equivalent |
| V&V | Complies with FDA<br>Guidance Requirement | Complies with FDA<br>Guidance Requirement | Equivalent |
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for Axial3D. The logo consists of the word "axial" in a bold, dark blue font, with a small teal diamond shape above the "i". To the right of "axial" is the superscript "3D". Below the logo is the tagline "Patient data made real" in a teal font.
{7}------------------------------------------------
Image /page/7/Picture/1 description: The image shows the logo for Axial3D. The logo consists of the word "axial" in a dark blue sans-serif font, with a teal diamond shape above the "i". To the right of "axial" is the superscript "3D". Below the word "axial" is the tagline "Patient data made real" in a teal sans-serif font.
# Comparison of Technological Characteristics to the Predicate Device and Reference Device
| Attribute | Axial3D Cloud<br>Segmentation<br>Service<br>(Proposed Device) | Axial3D Cloud Segmentation<br>Service<br>(Predicate Device) | Comparison |
|-------------------------------------------|---------------------------------------------------------------|-------------------------------------------------------------|------------|
| Method of Use | software interface | software interface | Equivalent |
| Computer Platform and<br>Operating System | Internet Explorer 11<br>or equivalent | Internet Explorer 11 or<br>equivalent | Equivalent |
{8}------------------------------------------------
Image /page/8/Picture/1 description: The image shows the logo for Axial3D. The logo consists of the word "axial" in a dark blue sans-serif font, with a small teal diamond above the "i". To the right of "axial" is the number "3D" in a smaller, superscript font. Below the word "axial" is the tagline "Patient data made real" in a teal sans-serif font.
| Attribute | Axial3D Cloud<br>Segmentation<br>Service<br>(Proposed Device) | Axial3D Cloud Segmentation<br>Service<br>(Predicate Device) | Comparison |
|--------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------|------------|
| Supported Modalities | CT and CTA | CT and CTA | Equivalent |
| Image registration | Yes | Yes | Equivalent |
| Segmentation Features | A combination of<br>automated tools<br>with smart editing<br>tools | A combination of automated<br>tools with smart editing tools | Equivalent |
| View Manipulation and<br>Volume Rendering | Yes | Yes | Equivalent |
| Regions and Volumes of<br>Interest (ROI) | ● Orthopedic<br>● Maxillofacial<br>● Cardiovascular | ● Orthopedic<br>● Maxillofacial<br>● Cardiovascular | Equivalent |
| Region/volume of interest<br>measurements and size<br>measurements | Yes | Yes | Equivalent |
| Region/Volume<br>Quantification | Yes | Yes | Equivalent |
### Performance Data
#### Nonclinical testing
Axial3D performed software design verification and validation testing on all three software components of the device and the software documentation for a Moderate Level of Concern software in accordance with the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices May 11, 2015.
Axial3D has conducted software verification and validation, in accordance with the FDA quidance, General Principles of Software Validation; Final Guidance for Industry and FDA Staff, issued on January 11, 2002. All software requirements and risk analysis have been successfully verified and traced.
Axial3D Cloud Seqmentation Service device has been validated for its intended use to determine substantial equivalence to the predicate device. Measurement accuracy and comparisons were performed and confirmed to be within specification of +/- .7mm.
Validation of printing of physical replica models was performed and demonstrated to be accurate when using any of the compatible printers.
#### Conclusions:
The Axial3D Cloud Segmentation Service with its expanded indication for use to include, orthopedic, maxillofacial, and cardiovascular cases in adults and children
{9}------------------------------------------------
Image /page/9/Picture/1 description: The image contains the logo for Axial3D. The logo consists of the word "axial" in a bold, dark blue font, with a small teal diamond shape above the "i". To the right of "axial" is the superscript "3D", also in dark blue. Below the main logo is the tagline "Patient data made real" in a teal color.
greater than 12 years old is substantially equivalent to the predicate device cleared under K221511.
The technological aspects of the device have not changed from the original 510(k) approval. Validation of the printers and 3D model process has been performed and no safety or efficacy concerns are changed by the expanded indication for use.
