(217 days)
No
The summary explicitly states the system uses "off-the-shelf modeling software" and relies on "expert clinical judgment" and "MirrorMe3D trained personnel" for processing and creating models, with no mention of AI or ML algorithms.
No
The device is used for image processing, visualization, measurement, and treatment planning, but it explicitly states that it is not for diagnostic use and is used in conjunction with expert clinical judgment, indicating it supports, rather than directly provides, therapy.
No
The "Intended Use / Indications for Use" section explicitly states, "The MirrorMe3D Modeling System should only be used in conjunction with expert clinical judgment and is not intended for diagnostic use." It also notes that the output physical anatomic model is "not for diagnostic use."
Yes
The device is described as "image processing software" and "Modeling System software". While it can be used to create physical models, the core device being cleared is the software itself for image processing, visualization, and treatment planning. The physical models are an output of the software, not the device itself.
Based on the provided information, the MirrorMe3D Modeling System is not an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly Stated Intended Use: The "Intended Use / Indications for Use" section clearly states: "The MirrorMe3D Modeling System should only be used in conjunction with expert clinical judgment and is not intended for diagnostic use." It also reiterates that the anatomic models are "not for diagnostic use."
- Focus on Visualization and Planning: The primary functions described are image processing for transfer, visualization for measuring and treatment planning, and creating virtual or physical anatomic models for surgical planning. These are all related to pre-operative assessment and planning, not diagnosing a disease or condition.
- No Mention of Diagnostic Purpose: There is no indication that the system is used to analyze biological samples, detect the presence of specific substances, or provide information for the diagnosis of a disease or condition, which are hallmarks of IVDs.
While the system processes medical images and is used in a clinical context, its stated purpose is for surgical planning and visualization, not for making a diagnosis.
N/A
Intended Use / Indications for Use
The MirrorMe3D Modeling System is intended for use as an image processing system for the transfer of 3D medical images. The MirrorMe3D Modeling System is also intended as a visualization system for measuring and treatment planning for aesthetic facial soft tissue. The input data is processed by the System using off-the-shelf modeling software and the result is an output data file that may then be provided as a digital model or used as input for the additive manufacturing of a physical anatomic model, which is not for diagnostic use. The MirrorMe3D Modeling System should only be used in conjunction with expert clinical judgment and is not intended for diagnostic use. MirrorMe3D trained personnel will use off-the-shelf software to assist users in creating the 3D virtual (or digital) model that depicts the surgeon's intended outcome. The anatomic models are not for diagnostic use.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The MirrorMe3D Modeling System is image processing software that enables the input and visualization of 3D medical imaging with output files that can be virtual or physical 3D anatomic models. The Modeling System software is used for visualization of preoperative treatment planning options, with measurement functionality, for surgery of the aesthetic facial soft tissue.
MirrorMe3D trained personnel will process the input data using off-the-shelf software and assist doctors in visualizing treatment plan options. The digital models created under the direction of doctors can then be additively manufactured or 3D printed to provide the surgeon with physical replicas of the digital models. The anatomic models are not for diagnostic use, do not have any contact with the patient and are not intended for use in a surgical environment. Patient-specific documentary reports will contain screenshots of the virtual models and depict dimensional differences.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
.OBJ, .MTL and other formats (such as TIFF, JPG, .PNG and raw images
Anatomical Site
aesthetic facial soft tissue, External maxillofacial soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons, Doctors; Not for diagnostic use, Not intended for use in a surgical environment
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)
MirrorMe3D's Modeling System consists of patient-specific output so to provide objective evidence that the system conforms to specifications and is fit for its intended use, MirrorMe3D intends to show that every product is tested to meet acceptance criteria and we periodically audit the processes. MirrorMe3D has tried to identify the risks associated with every step of the design and manufacture process and to mitigate all of those risks.
Testing For each device, MirrorMe3D checks the integrity of the input imaging data, validates the visualization of the patient specific treatment options through doctor and staff review, conducts testing and a verification of the model design files, and visually inspections all physical products using a quality protocol. The approval of the design of the anatomic model depicting the intended treatment outcome by the Doctor is required and indicates design acceptance. The model production process is tested on a monthly basis to confirm the additively manufactured outputs meet conformance standards and maintain geometric accuracy within an established tolerance range.
Biocompatibility and Sterilization: The models are not sterile and are not intended for any physical contact with the patient during the procedure.
Off-The-Shelf Software: MirrorMe3D uses only off-the-shelf software programs to design and manufacture its products. Software testing is periodically conducted to determine if the modeling maintains acceptable tolerances and is within reasonable measurement parameters and documentation was provided as recommended by the FDA Guidance for "Off-The-Shelf Software Use in Medical Devices" issued September 27, 2019. MirrorMe3D has analyzed the risks and determined that the severity of the harm that could result from a software failure is a minor level of hazard to patients.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
April 22, 2022
Image /page/0/Picture/1 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 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.
MirrorMe3D, LLC % Jordan Mills Chief Executive Officer 222 W 37th Street. Suite 1501 NEW YORK NY 10018
Re: K212981
Trade/Device Name: MirrorMe3D Modeling System Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: March 21, 2022 Received: March 22, 2022
Dear Jordan Mills:
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) K212981
Device Name MirrorMe3D Modeling System
Indications for Use (Describe)
The MirrorMe3D Modeling System is intended for use as an image processing system for the transfer of 3D medical images. The MirrorMe3D Modeling System is also intended as a visualization system for measuring and treatment planning for aesthetic facial soft tissue. The input data is processed by the System using off-the-shelf modeling software and the result is an output data file that may then be provided as a digital model or used as input for the additive manufacturing of a physical anatomic model, which is not for diagnostic use. The MirrorMe3D Modeling System should only be used in conjunction with expert clinical judgment and is not intended for diagnostic use. MirrorMe3D trained personnel will use off-the-shelf software to assist users in creating the 3D virtual (or digital) model that depicts the surgeon's intended outcome. The anatomic models are not for diagnostic use.
| 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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3
510(k) SUMMARY
Image /page/3/Picture/2 description: The image contains the logo for MirrorMe3D. The logo consists of a circular icon on the left and the text "MirrorMe3D" on the right. The icon features a stylized, geometric shape resembling a folded paper or origami design in light blue and white, set against a muted blue background.
212-376-4546 hello@mirrorme3d.com
222 W 37th Street Suite 1501 New York, NY 10018
A. SUBMITTER
| Submitter Name | MirrorMe3D, LLC |
|---|---|
| Submitter Address | 222 W 37th St., Suite 1501, New York, NY 10018 |
| Contact Person: | Jordan Mills (jordan@mirrorme3d.com) |
| Phone/Fax Numbers: | 212-376-4546 / 914-350-4697 |
| Date of Submission: | April 19, 2022 |
B. DEVICE IDENTIFICATION & MANUFACTURER
| Name of Device | MirrorMe3D Modeling System |
|---|---|
| Common Name | MirrorMe Modeling |
| Classification Name | 21 CFR 892.2050 Medical image management and |
| processing system | |
| Classification Code | LLZ |
| Regulatory Class | II |
C. PRIMARY, SECONDARY PREDICATE AND REFERENCE DEVICES
Primary Predicate Device: K183105, Materialise Mimics Medical Secondary Predicate: K161634, ISP CaseDesigner Reference Device: K192282, MedCAD AccuPlan® System The predicate, the secondary predicate and the reference devices have not been subject to a design-related recall.
D. DEVICE DESCRIPTION
The MirrorMe3D Modeling System is image processing software that enables the input and visualization of 3D medical imaging with output files that can be virtual or physical 3D anatomic models. The Modeling System software is used for visualization of preoperative treatment planning options, with measurement functionality, for surgery of the aesthetic facial soft tissue.
MirrorMe3D trained personnel will process the input data using off-the-shelf software and assist doctors in visualizing treatment plan options. The digital models created under the direction of doctors can then be additively manufactured or 3D printed to provide the surgeon with physical replicas of the digital models. The anatomic models
510(k) Summary Page 1
4
are not for diagnostic use, do not have any contact with the patient and are not intended for use in a surgical environment. Patient-specific documentary reports will contain screenshots of the virtual models and depict dimensional differences.
E. INDICATIONS FOR USE
The MirrorMe3D Modeling System is intended for use as an image processing system for the transfer of 3D medical images. The MirrorMe3D Modeling System is also intended as a visualization system for measuring and treatment planning for aesthetic facial soft tissue. The input data is processed by the System using off-the-shelf modeling software and the result is an output data file that may then be provided as a digital model or used as input for the additive manufacturing of a physical anatomic model, which is not for diagnostic use. The MirrorMe3D Modeling System should only be used in conjunction with expert clinical judgment and is not intended for diagnostic use. MirrorMe3D trained personnel will use off-the-shelf software to assist users in creating the 3D virtual (or digital) model that depicts the surgeon's intended outcome. The anatomic models are not for diagnostic use.
F. PREDICATE DEVICES
The intended use of the MirrorMe3D Modeling System and its predicate devices, the Materialise Mimics Medical (K183105) and ISP CaseDesigner (K161634) are substantially equivalent. The MedCAD AccuPlan® System (K192282) has been included as a reference device to address the minor differences in technological characteristics between the MirrorMe3D System and the primary and secondary predicates. The subject device, predicates and reference systems are intended for use in the transfer and processing of medical data and the visualization of treatment plan options, with 3D models as the output.
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| | MirrorMe3D Modeling
System | Primary Predicate Device:
Materialise Mimics Medical,
K183105 | Secondary Predicate
Device: ISP CaseDesigner
K161634 | Reference Device: MedCAD
AccuPlan®, K192282 | TREATMENT
PLANNING
/ APPROVAL | Surgeons virtually visualize
and plan treatment options.
Virtual models are created by
trained MirrorMe3D employees
and must be approved by the
surgeon before being
manufactured. | Users create the digital 3D
models and should be used in
conjunction with expert
clinical judgment | Surgeons (or clinicians)
virtually plan the surgery | Utilized by trained MedCAD
employees with the approval
of the surgeon before being
manufactured. |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| REGULATORY
CLASSIFICATION | II
892.2050
LLZ | II
892.2050
LLZ | II
892.2050
LLZ | II
892.2050 and 872.4120
DZJ, LLZ | OUTPUT | Additively manufactured
anatomic Models for visual use
only; documentary reports | Additively or traditionally
manufactured physical
replicas for diagnostic use | Patient specific 3D
Surgical models and
surgical splints | Rapid prototyping of
anatomical models, surgical
quides and dental splints;
case reports |
| INDICATIONS
FOR USE | The MirrorMe3D Modeling
System is intended for use as
an image processing system
for the transfer of 3D medical
images. The MirrorMe3D
Modeling System is also
intended as a visualization
system for measuring and
treatment planning for
aesthetic facial soft tissue.
The input data is processed
by the System using off-the-
shelf modeling software and
the result is an output data
file that may then be
provided as a digital model or
used as input for the additive
manufacturing of a physical
anatomic model, which is not
for diagnostic use. The
MirrorMe3D Modeling System
should only be used in
conjunction with expert
clinical judgment and is not | Mimics Medical is intended
for use as a software
interface and image
segmentation system for the
transfer of medical imaging
information to an output file.
Mimics Medical is also
intended for measuring and
treatment planning. The
Mimics Medical output 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 Medical should be
used in conjunction with
expert clinical judgement. | IPS CaseDesigner is
indicated for use as a
software and image
segmentation system for
the transfer of imaging
information from a
scanner such as a CT
scanner. It is also
indicated to support the
diagnostic and treatment
planning process of
craniomaxillofacial
procedures. IPS
CaseDesigner facilitates
the service offering of
individualized surgical
aids. | The MedCAD® AccuPlan®
System is intended for use as
a software system and image
segmentation system for the
transfer of imaging
information from a medical
scanner such as a CT based
system. The input data file is
processed by the MedCAD®
AccuPlan® System and the
result is an output data file
that may then be provided as
digital models or used as
input to a rapid prototyping
portion of the system that
produces physical outputs
including anatomical models,
surgical guides and dental
splints for use in
maxillofacial surgery. The
surgical guides and dental
splints are intended to be
used for the maxillofacial
bone in maxillofacial surgery.
The MedCAD® AccuPlan®
System is also intended as a
pre-operative software tool | SOFTWARE FOR
PLANNING | Commercial off-the shelf
software. | Image processing software | Image processing
software | Commercial off-the shelf
software |
| | intended for diagnostic use.
MirrorMe3D trained personnel
will use off-the-shelf software
to assist users in creating the
3D virtual (or digital) model
that depicts the surgeon's
intended outcome. The
anatomic models are not for
diagnostic use. | | | for evaluating surgical
treatment options. | Diagnostic Use | No | Yes | Yes | No |
| DEVICE TYPE,
USAGE | Patient specific,
Single Use | Patient specific,
Single Use | Patient specific,
Single Use | Patient specific,
Single Use | | | | | |
| SURGICAL
SITES | External maxillofacial soft
tissue | Orthopedic, maxillofacial, and
cardiovascular applications | Cranio-maxillofacial
including soft tissue | Maxillofacial surgery | | | | | |
| INPUT FILE
FORMATS | .OBJ, .MTL and other formats
(such as TIFF, JPG, .PNG and
raw images | DICOM and other formats
(such as BMP, TIFF, JPG, and
raw images) | DICOM from CT/CBCT, STL | CT based | | | | | |
| DEVICE
FUNCTION-
ALITY | Transferring and viewing
medical imaging;
Processing to output file;
Measuring and treatment
planning on 3D models | Transferring and viewing
medical imaging;
Image segmentation;
Processing to output file;
Measuring and treatment
planning on 3D models | Transferring and viewing
medical imaging;
Image segmentation;
Processing to output file;
Measuring and treatment
planning on 3D models | Transferring and viewing
medical imaging;
Image segmentation;
Processing to output file;
Measuring and Treatment
planning on 3D models | | | | | |
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Summary
-
- The subject device, predicate, secondary predicate, and reference systems are intended for use in the transfer and processing of medical data with 3D models as the output.
-
- The subject device, predicate, secondary predicate, and reference device are 3D visualization systems for measuring and treatment planning.
-
- The subject device, predicate, secondary predicate, and reference device start with medical imaging provided by a doctor then use software for manipulation in order to create virtual 3D models that reflect the doctor's intended treatment plan.
-
- The subject device, primary predicate, and reference systems produce an output file that is used for the additive manufacture of anatomic models, with the difference that the physical models by the subject device are not for diagnostic use.
-
- The outputs of all are prescriptive, patient-specific, and single use devices intended for use solely by Doctors, not Patients.
-
- The subject device and the reference systems include documentary or case reports as output.
-
- The MirrorMe3D System is more limited in its application to the facial soft tissue, as opposed to Mimics Medical (maxillofacial, orthopedic and cardiovascular applications), ISP CaseDesigner (craniomaxillofacial including soft tissue) and AccuPlan (maxillofacial).
-
- MirrorMe3D System starts with the input of 3D medical imaging of soft tissue, while the other devices start with files that must be segmented prior to 3D modeling.
MirrorMe3D believes its Modeling System is safe and effective and that it is substantially equivalent to legally marketed devices. The MirrorMe3D System has the same intended use as Mimics Medical, ISP CaseDesigner and the AccuPlan Systems. The differences in technical characteristics do not add any questions of safety or effectiveness to the subject device.
G. SUMMARY OF PERFORMANCE TESTING
MirrorMe3D's Modeling System consists of patient-specific output so to provide objective evidence that the system conforms to specifications and is fit for its intended use, MirrorMe3D intends to show that every product is tested to meet acceptance criteria and we periodically audit the processes. MirrorMe3D has tried to identify the risks associated with every step of the design and manufacture process and to mitigate all of those risks.
Testing For each device, MirrorMe3D checks the integrity of the input 1. imaging data, validates the visualization of the patient specific treatment options
510(k) Summary Page 6
9
through doctor and staff review, conducts testing and a verification of the model design files, and visually inspections all physical products using a quality protocol. The approval of the design of the anatomic model depicting the intended treatment outcome by the Doctor is required and indicates design acceptance. The model production process is tested on a monthly basis to confirm the additively manufactured outputs meet conformance standards and maintain geometric accuracy within an established tolerance range.
- Biocompatibility and Sterilization: The models are not sterile and are not intended for any physical contact with the patient during the procedure.
Off-The-Shelf Software: MirrorMe3D uses only off-the-shelf software 3. programs to design and manufacture its products. Software testing is periodically conducted to determine if the modeling maintains acceptable tolerances and is within reasonable measurement parameters and documentation was provided as recommended by the FDA Guidance for "Off-The-Shelf Software Use in Medical Devices" issued September 27, 2019. MirrorMe3D has analyzed the risks and determined that the severity of the harm that could result from a software failure is a minor level of hazard to patients.
Summary
The intention of these tests is to provide objective evidence that the system conforms to specifications, is fit for its intended use, and that its performance is substantially equivalent to the predicate device. All validations, verifications and testing demonstrate that MirrorMe3D has identified and evaluated the potential risks, and its design and production processes have been conformed to meet its quality standards.
The MirrorMe3D Modeling System is substantially equivalent to and has the same intended use as Mimics Medical but different tarqet areas, as well as slightly different technological characteristics that do not raise different questions of safety and effectiveness, and the information submitted herein demonstrates that the system is as safe as the legally marketed predicate device.