Who is the manufacturer of AnatomicAligner?

The Methodist Hospital Research Institute D/B/A Houston filed the 510(k) submission for AnatomicAligner (K190767).

What is the FDA product code for AnatomicAligner?

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

What is the regulatory pathway for AnatomicAligner?

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

What are the predicate devices for AnatomicAligner?

SurgiCase, SurgiCase CMF, ProPlan CMF (K111641).

Who can help prepare an FDA 510(k) submission like AnatomicAligner?

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.

AnatomicAligner

K190767 · The Methodist Hospital Research Institute D/B/A Houston · LLZ · Mar 16, 2020 · Radiology

Device Facts

Record ID	K190767
Device Name	AnatomicAligner
Applicant	The Methodist Hospital Research Institute D/B/A Houston
Product Code	LLZ · Radiology
Decision Date	Mar 16, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

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 Story

AnatomicAligner is radiology image processing software for pre-operative orthognathic surgical planning. Input: DICOM images from CT or MRI scanners. Operation: software provides tools for 3D bone/soft tissue segmentation, cephalometric analysis, virtual osteotomy, and surgical simulation. Output: 3D surgical plan and splint design exported as STL files for third-party fabrication. Used in clinical settings by healthcare professionals. Benefits: enables precise pre-operative simulation and planning for orthognathic procedures, facilitating surgical execution.

Clinical Evidence

No clinical testing was performed. Evidence consists of bench-level verification and validation testing of software requirements per FDA guidance and 21 CFR 820.30 design controls.

Technological Characteristics

Software-based image processing system; runs on standard Windows PC hardware; utilizes DICOM standard for image input; provides 2D/3D visualization, segmentation, cephalometric analysis, and virtual osteotomy tools; exports STL files for splint fabrication; developed under 21 CFR 820.30 design controls.

Indications for Use

Indicated for pre-operative simulation of orthognathic surgical treatment options in patients who have reached skeletal and dental maturity, using CT or MRI imaging data.

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

SurgiCase, SurgiCase CMF, ProPlan CMF (K111641)

Related Devices

K200810 — IPS CaseDesigner · Nobel Biocare AB · Oct 8, 2020
K111641 — SURGICASE ORTHOGNATHIC SOFTWARE WIZARD · Materialise NV · Sep 26, 2011
K212570 — OsteoPlan System · Osteomed, LLC · Feb 11, 2022
K161634 — IPS CaseDesigner · Nobel Biocare AB · Nov 10, 2016
K221000 — ON3D · 3D Ons, Inc. · May 23, 2022

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 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 MEDICINE | TITLE: | AnatomicAligner Software | | | | |------------------------------------------|-----------|-----------------------------------------------------------------------------------------|---|-------|--------| | | SUBTITLE: | 510(k) Premarket Notification | | | | | NUMBER: | AA-022 | VER: | 3 | | | | CONFIDENTIAL | COMPANY: | The Methodist Hospital Research Institute d/b/a Houston Methodist Research Institute | | PAGE: | 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-022 | VER: | 3 | | | CONFIDENTIAL | COMPANY: | The Methodist Hospital Research Institute d/b/a Houston Methodist Research Institute | | PAGE: | 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. | Technology | AnatomicAligner | ProPlan (Predicate) | Comparison | |------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------| | Computer | The 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 System | The AA software interfaces with the underlying Windows operating system. | Windows Vista SP2 x64 Windows 7 x64 Windows 8 x64 | Both products use a general purpose commercial operating system. | | Patient Images | To 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 reconstruction | A 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 | | | | | CONFIDENTIAL | NUMBER: | AA-022 | VER: | 3 | | | | COMPANY: | The Methodist Hospital Research Institute d/b/a Houston Methodist Research Institute | | PAGE: | 4 of 6 | | Technology | AnatomicAligner | ProPlan (Predicate) | Comparison | |--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| | Registration And Reorientation | Registration 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 Analysis | 3D 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 Osteotomy | Virtual 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 Simulation | Create 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 MEDICINE | TITLE: | AnatomicAligner Software | | | |------------------------------------------|-----------|-----------------------------------------------------------------------------------------|------|--------------| | | SUBTITLE: | 510(k) Premarket Notification | | | | | NUMBER: | AA-022 | VER: | 3 | | CONFIDENTIAL | COMPANY: | The Methodist Hospital Research Institute d/b/a Houston Methodist Research Institute | | PAGE: 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. | Technology | AnatomicAligner | ProPlan (Predicate) | Comparison | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Graphical User Interface | 2D and 3D views | 2D 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 design | The 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 Logo | TITLE: | AnatomicAligner Software | |-------------------------------|-----------------------------------------------------------------------------------------------|-------------------------------| | | SUBTITLE: | 510(k) Premarket Notification | | | NUMBER: | AA-022 | | CONFIDENTIAL | COMPANY: The Methodist Hospital Research Institute d/b/a Houston Methodist Research Institute | VER: 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.