Who is the manufacturer of Axial3D Cloud Segmentation Service?

Axial Medical Printing Limited filed the 510(k) submission for Axial3D Cloud Segmentation Service (K221511).

What is the FDA product code for Axial3D Cloud Segmentation Service?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Axial3D Cloud Segmentation Service?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Axial3D Cloud Segmentation Service?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Axial3D Cloud Segmentation Service

K221511 · Axial Medical Printing Limited · LLZ · Jun 23, 2022 · Radiology

Device Facts

Record ID	K221511
Device Name	Axial3D Cloud Segmentation Service
Applicant	Axial Medical Printing Limited
Product Code	LLZ · Radiology
Decision Date	Jun 23, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device, 3rd-Party Reviewed

Intended 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. The Axial3D Cloud Segmentation Service output file 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. The physical replica can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications. Axial3D Cloud Segmentation Service should be used in conjunction with other diagnostic tools and expert clinical judgment.

Device Story

Cloud-based image segmentation service; transforms DICOM imaging data from medical scanners into digital output files (e.g., STL) for additive manufacturing. Used by clinicians for pre-surgical treatment planning and diagnostic support in orthopedic, maxillofacial, and cardiovascular fields. Operates as a cloud platform; processes medical images to generate 3D anatomical models. Healthcare providers use these physical replicas or digital files to visualize patient-specific anatomy, aiding in surgical planning and clinical decision-making. Benefits include improved anatomical understanding and surgical preparation.

Clinical Evidence

Bench testing only. Validation confirmed measurement accuracy and comparison of generated meshes against the predicate device. Printing validation demonstrated accuracy across compatible 3D printers. No clinical data presented.

Technological Characteristics

Cloud-based software platform; processes DICOM imaging data; generates digital output files for additive manufacturing. Employs image segmentation algorithms to produce 1:1 scale patient-specific anatomical models. Verification and validation performed per FDA guidance; minimal mesh smoothing applied to maintain accuracy to original DICOM data.

Indications for Use

Indicated for adult patients requiring medical image segmentation for treatment planning and diagnostic purposes in orthopedic, maxillofacial, and cardiovascular applications. Used in conjunction with other diagnostic tools and expert clinical judgment.

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

Mimics InPrint (K173619)

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Submission Summary (Full Text)

{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 logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION". Axial Medical Printing Limited % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114 June 23, 2022 Re: K221511 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: Mav 23, 2022 Received: May 24, 2022 Dear Prithul Bom: 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, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of 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 510(k) Number (if known) K221511 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 system for the transfer of DICOM imaging information from a medical scanner to an output file. The Axial3D Cloud Segmentation Service output file 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. The physical replica can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications. Axial3D Cloud Segmentation Service should be used in conjunction 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}------------------------------------------------ ### 510(k) Summary K221511 Image /page/3/Picture/3 description: The image shows the logo for Axial3D. The word "axial" is written in a dark blue color, with a teal diamond shape above the "i". To the right of "axial" is the number "3D" in a smaller font size. Below the logo is the tagline "Patient data made real" in teal. ### Submitters Contact Information Submitter's Name: Axial Medical Printing Limited 17A Ormeau Avenue Belfast BT2 8HD United Kingdom Tel: +44 (0)28 90183590 ### Name of Contact Person Jenna McGarry, QA/RA Manager #### Date of submission 25th February 2022 #### Subject Device Name Device Trade Name: Axial3D Cloud Segmentation Service Device Common Name: Axial3D Cloud Segmentation Service Classification Name: System, Image Processing, Radiological (21CFR 892.2050, Product Code LLZ) ### Identification of Legally Marketed Predicate Device The Axial Medical Printing Limited Axial3D Cloud Segmentation Service is substantially equivalent to the following: ### Predicate Device Manufacturer: Materialse NV Trade Name: Mimics InPrint Common Name: Mimics InPrint {4}------------------------------------------------ # Classification Name: System, Image Processing, Radiological (21CFR 892.2050, Product Code LLZ) 510(k) Number: K173619 ### Device Description Axial3D Cloud Segmentation Service is a secure, highly available cloud based image processing, segmentation and 3D modeling framework for the transfer of imaging information to either a digital file or as a 3D printed physical model. Axial3D Cloud Segmentation Service is made up of a number of component parts, which allow the production of patient-specific 1:1 scale replica models, either as a digital file or as a 3D printed physical model. ### Intended Use/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. The Axial3D Cloud Segmentation Service output file 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. The physical replica can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications. Axial3D Cloud Segmentation Service should be used in conjunction with other diagnostic tools and expert clinical judgment. ### Comparison between Proposed Device and Predicate Device | Product Details | New Device: | Proposed Predicate Device: | Comment: | |----------------------------------------|------------------------------------------|----------------------------------|----------| | Device Manufacturer | Axial Medical Printing Limited | Materialise N.V. | N/A | | Device Name | Axial3D Cloud Segmentation Service | Mimics inPrint | N/A | | Device Trade or Proprietary Name | Axial3D Cloud Segmentation Service | Mimics inPrint | N/A | | 510(k) Number | TBC | K173619 | N/A | {5}------------------------------------------------ # Axial Medical Printing Limited | Device Regulation Name: | Medical Image Management and Processing System | Picture archiving and communications system | The proposed device and predicate devices are identical | | |----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------| | Device Regulation Number: | 21 CFR 892.2050 | 21 CFR 892.2050 | The proposed device and predicate devices are identical | | | Device Product Code: | LLZ | LLZ | The proposed device and predicate devices are identical | | | Device Classification FDA: | Class II | Class II | The proposed device and predicate devices are identical | | | Intended Use /Indication 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. The Axial3D Cloud Segmentation Service output file 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. The physical replica can be used for diagnostic purposes in the field of orthopedic, maxillofacial and | Mimics inPrint is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. It is also used as pre-operative software for treatment planning. For this purpose, the Mimics inPrint output file can be used for the fabrication of physical replicas of the output file using traditional or additive manufacturing methods. The physical replica can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications. Mimics inPrint should be used in conjunction with other diagnostic tools | The proposed device and primary predicate have equivalent indications. | | | | | cardiovascular applications. Axial3D Cloud Segmentation Service should be used in conjunction with other diagnostic tools and expert clinical judgment. | and expert clinical judgment. | | | Target Population | | Adult | Adult | Same | | Method of Use | | Used in conjunction with other diagnostic tools and expert clinical judgment. | Used in conjunction with other diagnostic tools and expert clinical judgment. | The proposed device has an identical method of use to the predicate. | | Imaging Modality | | Computed tomograghy (CT), CT Angiography (CTA) | DICOM compliant types of imaging information | DICOM compliant types of imaging information | | Environment | | Hospital | Hospital | The proposed device and predicates have identical target environments | | OTC or Prescription Device | | Prescription Use | Prescription Use | The proposed device and predicate devices are identical | | | Level of Concer n | Moderate | Moderate | | | Software | Verifica tion & Validati on | Complies with FDA Guidance Requirement | Complies with FDA Guidance Requirement | The proposed device and predicate devices are identical | {6}------------------------------------------------ ### Comparison of Technological Characteristics Comparison shows the Axial3D Cloud Segmentation Service is substantially equivalent in intended use, design, functionality, operating principles and performance characteristics of the predicate device. Both the predicate and subject device are intended for use as a software interface and image segmentation process to facilitate the transfer of imaging information from a medical scanner to an output file. Both devices use the same segmentation functionality and generate the same output files. Both devices have functionalities to assist pre-surgical planning. Verification and validation of both the subject and predicate devices have been performed in the same way. It was found that minimal variances were visible between the Mesh generated from subject device and the predicate device, these variances are a result of mesh smoothing, Axial3D apply minimal smoothing to the STL file generated from the labeled images to retain a higher level of accuracy to {7}------------------------------------------------ the original DICOM images. The validation highlighted that the subject device performed to a higher standard, than the predicate device. The printer selection is also based on 3D printer manufacturers' guidance on the most commonly used printing technologies for the production of medical 3D printed anatomical models. The following technological differences exist between the subject and predicate device: - . The subject device is a cloud based software platform rather than a standalone software package like the predicate ### Performance Data Non-clinical Testing The Axial3D Cloud Segmentation 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. Validation of printing of physical replica models was performed and demonstrated to be accurate when using any of the compatible 3D printers. #### Conclusion The characteristics that determine functionality and performance of the subject device, Axial3D Cloud Segmentation Service are similar to the device cleared under K173619. The conclusions drawn from the nonclinical tests demonstrate that the proposed subject device is as safe, as effective, and performs as well as the legally marketed predicate device.