(30 days)
Not Found
No
The summary mentions image processing and segmentation but does not explicitly mention AI, ML, or related terms like deep learning or neural networks. The description of performance studies focuses on measurement accuracy and validation against a predicate device, without detailing any AI/ML model training or testing.
No
The device is used for image segmentation and creating physical replicas for treatment planning and diagnostic purposes, not for direct therapeutic intervention.
Yes
The 'Intended Use / Indications for Use' section explicitly states: "The physical replica can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications."
No
The device description explicitly states that the service allows for the production of "3D printed physical models," indicating a hardware component (the 3D printer) is part of the overall system or output, even if the core service is cloud-based software.
Based on the provided information, the Axial3D Cloud Segmentation Service is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Axial3D's Function: The Axial3D Cloud Segmentation Service processes medical imaging data (DICOM files) to create digital models or physical replicas. It does not analyze biological samples from the patient.
- Intended Use: The intended uses described are for treatment planning and diagnostic purposes using the output file or physical replica, which are derived from imaging data, not biological samples.
- Device Description: The description focuses on image processing, segmentation, and 3D modeling, not the analysis of biological specimens.
While the device is used in a medical context and for diagnostic purposes, its function falls under the category of medical image processing and modeling, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
LLZ
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.
Mentions image processing
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM imaging information
Computed tomograghy (CT), CT Angiography (CTA)
DICOM compliant types of imaging information
Anatomical Site
Not Found
Indicated Patient Age Range
Adult
Intended User / Care Setting
Used in conjunction with other diagnostic tools and expert clinical judgment.
Hospital
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)
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.
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).
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
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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)
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510(k) Summary
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
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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 |
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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 |
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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
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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.