K Number
K190767
Device Name
AnatomicAligner
Date Cleared
2020-03-16

(357 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
AnatomicAligner is software for pre-operative simulation of orthognathic surgical treatment options, based on imaging information from a medical scanner such as CT or MRI, in patients who have reached sketal and dental maturity.
Device Description
AnatomicAligner is an image-processing software with a user-friendly interface for pre-operative simulation of orthognathic surgical treatment options based on imaging information from a medical scanner such as CT or MRI. The software planning results may be transferred to surgery.
More Information

Not Found

No
The summary describes image processing software for surgical planning but does not mention AI, ML, or related terms.

No.
The software is for pre-operative simulation and planning, not for active treatment or diagnosis.

No

Explanation: The device is described as software for "pre-operative simulation of orthognathic surgical treatment options." It uses imaging information to plan surgical procedures, but it does not diagnose a condition or disease.

Yes

The device description explicitly states "AnatomicAligner is an image-processing software" and does not mention any associated hardware components being part of the device itself. The input is imaging data from external medical scanners (CT or MRI), and the output is planning results, all consistent with a software-only function.

Based on the provided information, AnatomicAligner is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVDs are used to examine specimens derived from the human body. The intended use of AnatomicAligner is for pre-operative simulation based on imaging information (CT or MRI) from a medical scanner. This involves processing images of the patient's anatomy, not analyzing biological samples like blood, urine, or tissue.
  • The description focuses on image processing and surgical planning. The device description and intended use clearly indicate that the software is used for simulating surgical options based on imaging data. This is a different function than the diagnostic testing performed by IVDs.

Therefore, AnatomicAligner falls under the category of medical device software used for surgical planning and simulation, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

AnatomicAligner is software for pre-operative simulation of orthognathic surgical treatment options, based on imaging information from a medical scanner such as CT or MRI, in patients who have reached sketal and dental maturity.

Product codes (comma separated list FDA assigned to the subject device)

LLZ

Device Description

AnatomicAligner is an image-processing software with a user-friendly interface for pre-operative simulation of orthognathic surgical treatment options based on imaging information from a medical scanner such as CT or MRI. The software planning results may be transferred to surgery.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT or MRI

Anatomical Site

Not Found

Indicated Patient Age Range

patients who have reached skeletal and dental maturity.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

AnatomicAligner has successfully undergone extensive verification and validation testing to ensure that all requirements for the software have been met per FDA Guidance. These results provide objective evidence that the outputs of the software design activity meet all of the specified requirements for that activity. Therefore, the AnatomicAligner Software version 1.0 has been verified and validated as meeting all requirements.
Based on the criteria listed in FDA guidance documents, no clinical testing of AnatomicAligner was required or performed.

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.

K111641

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.

Not Found

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

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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

March 16, 2020

The Methodist Hospital Research Institute d/b/a Houston Methodist Research Institute Christina Talley Director, Regulatory Affairs and Translational Management Methodist Research Institute 6670 Bertner Avenue Houston, Texas 77030

Re: K190767

Trade/Device Name: AnatomicAligner Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: July 13, 2019 Received: July 17, 2019

Dear Christina Talley:

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

1

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 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 medical devices and radiation-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 Srinivas "Nandu" Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K190767

Device Name AnatomicAligner

Indications for Use (Describe)

AnatomicAligner is software for pre-operative simulation of orthognathic surgical treatment options, based on imaging information from a medical scanner such as CT or MRI, in patients who have reached sketal and dental maturity.

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: This image is a document with the title "AnatomicAligner Software" and the subtitle "510(k) Premarket Notification". The document number is AA-022, and the version is 3. The company is The Methodist Hospital Research Institute d/b/a Houston Methodist Research Institute, and the page number is 1 of 6.

1 510(K) SUMMARY K190767

In accordance with 21 CFR 807.92, the following summary of the information in the 510(k) submission is provided.

1.1 807.92(A)(1)

Summary Date:3/16/2020
Submitter:The Methodist Hospital Research Institute
d/b/a Houston Methodist Research Institute
6670 Bertner Ave.
Houston, Texas 77030
Contact:Christina Talley, MS, RAC, CCRP, CCRC.
Program Director
Direct: 713-363-9155
Email: ctalley@houstonmethodist.org

1.2 807.92(A)(2)

Trade Name:AnatomicAligner
Common Name:Radiology Image Processing Software
Device:System, Image Processing, Radiological
Regulation Number:21 CFR 892.2050
Regulation Description:Picture Archiving and Communication System
Review Panel:Radiology
Device Class:Class II
Product Code:LLZ
Indication For Use:AnatomicAligner is software for pre-operative
simulation of orthognathic surgical treatment
options, based on imaging information from a
medical scanner such as CT or MRI, in patients
who have reached skeletal and dental maturity.

4

| HOUSTON
Methodist

LEADING MEDICINETITLE:AnatomicAligner Software
SUBTITLE:510(k) Premarket Notification
NUMBER:AA-022VER:3
CONFIDENTIALCOMPANY:The Methodist Hospital Research Institute
d/b/a Houston Methodist Research InstitutePAGE:2 of 6

1.3 807.92(A)(3) — PRIMARY PREDICATE

Device Name:SurgiCase, SurgiCase CMF, ProPlan CMF
Manufacturer:Materialise N.V.
510(k) Number:K111641
Product Code:LLZ
Regulation Number:21 CFR 892.2050
Regulation
Description:Picture Archiving & Communication System

1.4 807.92(A)(4) — Device Description

| Device Description: | AnatomicAligner is an image-processing software
with a user-friendly interface for pre-operative
simulation of orthognathic surgical treatment options
based on imaging information from a medical scanner
such as CT or MRI. The software planning results
may be transferred to surgery. |

--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

5

TITLE:AnatomicAligner Software
SUBTITLE:510(k) Premarket Notification
NUMBER:AA-022VER:3
CONFIDENTIALCOMPANY:The Methodist Hospital Research Institute
d/b/a Houston Methodist Research InstitutePAGE:3 of 6

1.6 807.92(A)(6) — Technological Characteristics

1.6.1 Technological Similarities

The following table summarizes the similarities in the technological characteristics of AnatomicAligner and the predicate device ProPlan.

TechnologyAnatomicAlignerProPlan (Predicate)Comparison
ComputerThe AA software
interfaces with the
standard Windows
PC devices
including: Storage,
Mouse, Keyboard,
Display, and
Printer.Intel Core2Duo or
equivalent; 3GB
RAM; AMD Radeon or
NVIDIA GeForce
graphics card with
128MB RAM or
equivalent.Both products run on
general purpose
commercial
computers.
Operating
SystemThe AA software
interfaces with the
underlying Windows
operating system.Windows Vista SP2 x64
Windows 7 x64
Windows 8 x64Both products use a
general purpose
commercial operating
system.
Patient ImagesTo create a new
surgical simulation,
select New from the
AnatomicAligner
main screen. A
prompt to Select a
DICOM Document
will be presented.After scanning your
patient, you must
import the images to
the PROPLAN CMF
Software.Both products use
DICOM to import
patient images for
processing.
Segmentation
and 3D
reconstructionA 3D object is
created using the
selected mask and
applying the
selected options.The "Segmentation
Wizard" will guide you
step-by-step through
the process of
segmenting bone parts
and soft tissue. The
result will be a 3D
object that can be used
in planning wizards.Both products provide
the user software tools
to segment bone and
soft tissue to create
3D objects from the
patient images.

6

TITLE:AnatomicAligner Software
SUBTITLE:510(k) Premarket Notification
CONFIDENTIALNUMBER:AA-022VER:3
COMPANY:The Methodist Hospital Research Institute
d/b/a Houston Methodist Research InstitutePAGE:4 of 6
TechnologyAnatomicAlignerProPlan (Predicate)Comparison
Registration
And
ReorientationRegistration in
AnatomicAligner is
performed using
Transformation
and Auto-
Registration tools.The "Reposition
Wizard" can be used to
reposition 3D objects.
Selected 3D objects
can be translated. The
selected 3D object can
be rotated.Both products provide
the user software tools
to translate and rotate
3D objects.
Cephalometric
Analysis3D Cephalometry in
the AnatomicAligner
is achieved by
defining a
cephalometric
analysis scheme
and digitizing
landmarks for it.The "Cephalometry
Wizard" allows you to
indicate anatomical
landmarks on objects in
the 2D or 3D view to
perform a
cephalometric analysis.Both products provide
the user software tools
to perform a
cephalometric
analysis.
Virtual
OsteotomyVirtual osteotomy is
used to cut a 3D
bone model into
two bony segments.Different
osteotomy plane
types can be
selected.Both products provide
the user software tools
to perform an
osteotomy.
Surgical
SimulationCreate a Surgical
Plan or
orthognathic
surgery.The Orthognathics
module in PROPLAN
CMF Software allows
you to plan
Orthognathic
surgeries.Both products provide
the user software tools
to simulate
orthognathic surgery.

7

| HOUSTON
Methodist

LEADING MEDICINETITLE:AnatomicAligner Software
SUBTITLE:510(k) Premarket Notification
NUMBER:AA-022VER:3
CONFIDENTIALCOMPANY:The Methodist Hospital Research Institute
d/b/a Houston Methodist Research InstitutePAGE: 5 of 6

1.6.2 Technological Differences

The following table summarizes the differences in the technological characteristics of AnatomicAligner and the predicate device ProPlan.

TechnologyAnatomicAlignerProPlan (Predicate)Comparison
Graphical
User
Interface2D and 3D views2D and 3D
views.Both products provide
common 2D and 3D image
views and mouse controls.
Differences in graphic
appearance are cosmetic
and raise no new
questions.
Splint
designThe splint design is
transferred to an
STL file which can
be used by a 3rd
party lab to
manufacture the
splint.Export 3D objects as
.mdck files (this
proprietary file format
allows you to
exchange 3D objects
within relevant
Materialise software
solutions, for e.g.
opening your
PROPLAN CMF
Software planning file
in 3-maticSTL in order
to design your own
guides and splints.Both products provide a
mechanism to transfer a
splint design to a lab for
fabrication. As an
example, the STL file
created by AnatomicAligner
can be read and edited by
3-maticSTL. Thus,
differences in file formats
used to transfer the design
raise no new questions.

1.7 807.92(B)(1) - Non-Clinical Performance Data

AnatomicAligner has successfully undergone extensive verification and validation testing to ensure that all requirements for the software have been met per FDA Guidance. These results provide objective evidence that the outputs of the software design activity meet all of the specified requirements for that activity. Therefore, the AnatomicAligner Software version 1.0 has been verified and validated as meeting all requirements.

1.8 807.92(B)(2) - CLINICAL PERFORMANCE DATA

Based on the criteria listed in FDA guidance documents, no clinical testing of AnatomicAligner was required or performed.

8

Image: Houston Methodist LogoTITLE:AnatomicAligner Software
SUBTITLE:510(k) Premarket Notification
NUMBER:AA-022
CONFIDENTIALCOMPANY: The Methodist Hospital Research Institute d/b/a Houston Methodist Research InstituteVER: 3
PAGE: 6 of 6

1.9 807.92(B)(3) - Conclusion

The intended uses of AnatomicAligner and ProPlan are the same. The technological characteristics of the AnatomicAliqner and the predicate device ProPlan are very similar. Any differences are minor and do not affect a determination of substantial equivalence.

AnatomicAligner was developed under the Quality System Regulation using Design Controls 21 CFR 820.30. This included establishing and maintaining procedures to ensure design requirements are met. All elements of the process have been documented, including design and development plan, design input, design output, design review, design verification, design validation, design transfer, design changes, and design history file.

AnatomicAligner has successfully undergone extensive verification and validation testing to ensure that all requirements for the software have been met. These results provide objective evidence that the outputs of the software design activity meet all of the specified requirements for that activity. Therefore, the AnatomicAligner Software version 1.0 has been verified and validated as meeting all requirements.

No applicable mandatory performance standards or special controls exist for AnatomicAligner. The product design, development and manufacturing conform to Quality System Regulations. Results of testing and standards conformance demonstrate safety and effectiveness of AnatomicAligner. We conclude that AnatomicAligner and ProPlan are substantially equivalent.