Planmeca Romexis

K200572 · Planmeca Oy · LLZ · Dec 2, 2020 · Radiology

Device Facts

• Record ID: K200572
• Device Name: Planmeca Romexis
• Applicant: Planmeca Oy
• Product Code: LLZ · Radiology
• Decision Date: Dec 2, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Indications for Use

Planmeca Romexis is a medical imaging software intented for use in dental and medical care as a tool for displaying and visualizing dental and medical 2D and 3D image files from imaging devices, such as projection radiography and CBCT. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, diagnose, review, store, print, and distribute images of both adult and pediatric patients. Planmeca Romexis is also a preoperative software used for dental implant planning. Based on the planned implant position a model of a surgical guide for a guided implant surgery can be designed. The designed objects can be exported to manufacture a separate physical product. Planmeca Romexis is also a preoperative software for simulating surgical treatment options. Planmeca Romexis is also intended to be used for monitoring, storing and displaying mandibular jaw positions and movements relative to the maxilla. Additionally, Planmeca Romexis includes monitoring features for Planmeca devices for maintenance purposes. The software is designed to work as a stand-alone or as an accessory to Planmeca imaging and Planmeca dental unit products in standard PC.

Device Story

Planmeca Romexis is modular dental/medical imaging software; operates on standard PCs; functions as standalone or accessory to Planmeca imaging/dental units. Inputs include 2D/3D image files (e.g., projection radiography, CBCT), optical impressions, and jaw motion data. Software processes, renders, and displays images; provides tools for enhancement, linear/angular/volumetric measurements, implant planning, surgical simulation, and mandibular movement monitoring. Includes maintenance monitoring for Planmeca hardware. Output consists of visualized diagnostic images, surgical guide designs for export/manufacturing, and treatment simulations. Used by radiologists, clinicians, and surgeons in clinical settings to assist in diagnosis and preoperative planning. Benefits include improved visualization, precise implant positioning, and surgical workflow efficiency.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation included risk analysis, requirements/design reviews, and performance/safety testing. Bench testing compared images rendered by Planmeca Romexis against predicate software versions, confirming equal effectiveness in essential functions and substantially equivalent clinical data output.

Technological Characteristics

Software-based imaging system; operates on standard PC hardware. Features multi-planar reconstruction (MPR), 3D volume rendering, and surface rendering. Supports DICOM format. Includes modules for implant planning, surgical simulation, and jaw motion tracking. Connectivity includes integration with Practice Management Systems and hospital PACS. No specific materials or energy sources as it is a software-only device.

Indications for Use

Indicated for adult and pediatric patients requiring dental and medical 2D/3D image visualization, dental implant planning, surgical treatment simulation, and monitoring of mandibular jaw positions relative to the maxilla. Intended for use by authorized healthcare professionals including radiologists, clinicians, and referring physicians. Implant planning requires training in implantology/surgical dentistry; surgical planning requires training in maxillofacial surgery.

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

• Anatomage InVivoDental (K123519)

Reference Devices

• Televere Systems TigerView (K061035)
• 3Shape Medical Implant Studio (K141570)
• SICAT Function (K133320)
• Patterson Dental Dolphin Imaging (K110430)

Submission Summary (Full Text)

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December 2, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health and Human Services logo. To the right of that is the FDA logo, which 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.

Planmeca Oy % Lars Moring Regulatory Affairs Manager Asentajankatu 6 Helsinki. 00880 FINLAND

Re: K200572

Trade/Device Name: Planmeca Romexis Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: October 19, 2020 Received: October 23, 2020

Dear Lars Moring:

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

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known) K200572

Device Name Planmeca Romexis

#### Indications for Use (Describe)

Planmeca Romexis is a medical imaging software intental and medical care as a tool for displaying and visualizing dental and medical 2D and 3D image files from imaging devices, such as projection radiography and CBCT. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, diagnose, review, store, print, and distribute images of both adult and pediatric patients.

Planmeca Romexis is also a preoperative software used for dental implant planning. Based on the plant position a model of a surgical guide for a guided implant surgery can be designed objects can be exported to manufacture a separate physical product.

Planmeca Romexis is also a preoperative software for simulating surgical treatment options.

Planmeca Romexis is also intended to be used for monitoring, storing and displaying mandibular jaw positions and movements relative to the maxilla.

Additionally, Planmeca Romexis includes monitoring features for Planmeca devices for maintenance purposes. The software is designed to work as a stand-alone or as an accessory to Planmeca dental unit products in standard PC.

The software is for use by authorized healthcare professionals. Use of the software for implant planning requires that the user has the necessary medical training in implantology and surgical dentistry. Use of the software for surgical treatment planning requires that the user has the necessary medical training in maxillofacial surgery.

Indications of the dental implants do not change with guided surgery compared to conventional surgery.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| <div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/4/Picture/0 description: The image shows the word "PLANMECA" in large, bold, blue letters. The letters are all capitalized and evenly spaced. The font appears to be sans-serif.

# 510(k) SUMMARY

K200572

# DATE

October 19, 2020

# PRODUCT, CLASSIFICATION NAME

| Device name: | Planmeca Romexis |
|----------------------|------------------------------------------------|
| Common name: | System, Image Processing, Radiological |
| Classification: | Class II |
| Classification name: | Imaging Processing System, LLZ, 21 CFR 892.205 |

## SUBMITTED BY

Planmeca Oy Asentajankatu 6 00880 Helsinki, Finland Phone: [phone] Contact person: Mr. Lars Moring

# U.S DESIGNATED AGENT

Planmeca USA Inc. 2600 Forbs Ave., Hoffman Estates, IL 60192 Phone: [phone] Contact person: Ed McDonough

# DEVICE DESCRIPTION

Planmeca Romexis is a modular imaging software for dental and medical use. It is divided into modules to provide user access to different workflow steps involving different diagnostic views of images. Patient management screen with search capabilities lets users to find patients and identify correct patient file before starting work with a patient. After creating or selecting patient, new images can be acquired using select Planmeca X-ray units.

Planmeca Romexis is capable of processing and displaying 2D images in different formats and 3D CBCT images in DICOM format. 3D CBCT images can be viewed in near real-time multi projection reconstruction (MPR) views. 2D and 3D image browsers are provided to allow user access to relevant images. Typical image enhancement filters and tools are available to assist the user in making diagnosis, but original exposure is always kept in the database for reference.

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Image /page/5/Picture/0 description: The image shows the word "PLANMECA" in large, bold, blue letters. The letters are evenly spaced and appear to be a sans-serif font. The word is the main focus of the image and takes up most of the space.

lmages can be exported to files or writable media, printed to paper or DICOM media or transferred securely to other users using Planmeca online services. Interfaces to select external software are provided to facilitate exchange of patient information and images or data between Software and 3rd party applications.

## INDICATIONS FOR USE

Planmeca Romexis is a medical imaging software intented for use in dental and medical care as a tool for displaying and visualizing dental and medical 2D and 3D image files from imaging devices, such as projection radiography and CBCT. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, diagnose, review, store, print, and distribute images of both adult and pediatric patients.

Planmeca Romexis is also a preoperative software used for dental implant planning. Based on the planned implant position a model of a surgical guide for a guided implant surgery can be designed. The designed objects can be exported to manufacture a separate physical product.

Planmeca Romexis is also a preoperative software for simulating surgical treatment options.

Planmeca Romexis is also intended to be used for monitoring, storing and displaying mandibular jaw positions and movements relative to the maxilla.

Additionally, Planmeca Romexis includes monitoring features for Planmeca devices for maintenance purposes. The software is designed to work as a stand-alone or as an accessory to Planmeca imaging and Planmeca dental unit products in standard PC.

The software is for use by authorized healthcare professionals. Use of the software for implant planning requires that the user has the necessary medical training in implantology and surgical dentistry. Use of the software for surgical treatment planning requires that the necessary medical training in maxillofacial surgery.

Indications of the dental implants do not change with quided surgery compared to conventional surgery.

## EQUIVALENT DEVICES

| | Primary predicate device: | |
|---------|---------------------------|--------------|
| K123519 | Anatomage | InVivoDental |

#### Reference devices:

Televere Systems K061035 K141570 3Shape Medical K133320 SICAT

TigerView Implant Studio SICAT Function

| Newly added reference device: | |
|-------------------------------|------------------|
| K110430 | Patterson Dental |

Dolphin Imaging

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Image /page/6/Picture/0 description: The image shows the word "PLANMECA" in large, bold, blue letters. The letters are all capitalized and evenly spaced. The font is sans-serif and the overall impression is one of strength and stability. The background is plain white.

# INDICATIONS FOR USE COMPARISON

The indications for use of Planmeca Romexis is substantially equivalent to that of the predicate devices, with few exceptions that do not raise any new or potential safety risks to the user or patient. The most evident is that Planmeca Romexis includes service managing features for Planmeca devices for maintenance purposes, which are not intended for clinical use.

# TECHNOLOGICAL CHARACTERISTICS

A comparison of key software characteristics, including operating environment, functionalities, image files, and other major features was performed. Some general comparison data:

## Primary predicate device:

| | Planmeca Romexis | InVivoDental (K123519) |
|-----------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Operating environment | standard PC hardware | standard PC hardware |
| Functionalities | Viewing, enhancing,<br>processing, archiving, printing<br>and sharing images | Retrieve, process, render,<br>review, store, print, assist in<br>diagnosis, and distribute<br>images |
| Image files | 2D, 3D | 3D |
| Major features | Multiplanar views | Section and Multislice View<br>Operations |
| | 3D volume rendering view | Volume Rendering of scan<br>data |
| | Linear, angular, area and<br>volumetric measurements | Linear, Angular,<br>Circumferential, Area and<br>Volumetric Measurements |
| | Implant Planning module | Implant, Abutment and<br>Restoration Treatment<br>Planning |
| | Airway volume measurement | Quick Airway Volume<br>Measurement and Evaluation |
| | TMJ module | TMJ Applications |
| | Virtual Cephalometric image | SuperCeph |
| | Virtual Panoramic image | SuperPano |
| | Software Viewer | InVivo Viewer |

## Reference devices:

| | Planmeca Romexis | TigerView Professional<br>(K061035) |
|-----------------------|------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Operating environment | standard PC hardware | standard PC hardware |
| Functionalities | Viewing, enhancing,<br>processing, archiving, printing<br>and sharing images | acquire, display, edit, review,<br>store, print, and distribute<br>images |
| Image files | 2D, 3D | 2D |

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| Integration with Practice<br>Management Systems | YES | YES |
|-------------------------------------------------|---------------------------------------------------------------|--------------------------------------------|
| Integration with hospital PACS<br>systems | YES | YES |
| Features | image processing, brightness &<br>contrast, crop, annotations | resize, adjust contrast, crop,<br>annotate |

| | Planmeca Romexis | Implant Studio<br>(K141570) |
|-----------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------|
| Operating environment | standard PC hardware | standard PC hardware |
| Functionalities | Viewing, 3D data fitting, implant<br>planning, implant guide<br>designing | prosthetic driven implant<br>planning, surgical guide<br>design |
| Image files | 2D, 3D | 3D |
| Major features | Implant guide designing,<br>implant and sleeve libraries | Implant guide designing,<br>implant and sleeve libraries |

| | Planmeca Romexis | SICAT Function<br>(K133320) |
|-----------------------|------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Operating environment | standard PC hardware | standard PC hardware |
| Functionalities | Viewing, enhancing,<br>processing, archiving, printing<br>and sharing images | Visualization and<br>segmentation of<br>imaging information |
| Visualized data types | 2D, 3D, optical impressions,<br>jaw motion data | 3D volume data, optical<br>impressions, jaw motion data |
| Major features | Visualization of 3D images<br>using multi-planar 2D views, 3D<br>volume rendering, 3D surface<br>rendering | Visualization of 3D images<br>using 2D slice views, 3D<br>volume rendering, 3D surface<br>rendering |
| | Fitting of optical impressions to<br>3D image | Registration of optical scans to<br>volume data |
| | Segmentation of the jaws | Segmentation of jaws using<br>wizard |
| | Visualization of jaw movement<br>data | Visualization of jaw movement<br>data |

Comparison table between the subject and newly added reference device:

| | Planmeca Romexis | Dolphin Imaging<br>(K110430) |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Operating environment | Standard PC hardware | Windows OS |
| Visualized data types | 2D, 3D, optical impressions, 3D<br>face photos | 2D, digital study models, 3D,<br>3D face camera photos |
| Major features | Visualization of 3D images<br>using multi-planar 2D views, 3D<br>volume rendering, 3D surface<br>rendering, airway rendering | Multi-planar visualization,<br>rendering of 3D volume, 3D<br>photo, digital impression,<br>airway |
| | Linear, angular, area and | 3D-2D measurements: |
| | volumetric measurements | distance, angle, area |
| | Segmentation of jaws | Segmentation of image data |

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| Definition of osteotomy planes | Definition of osteotomy planes |
|--------------------------------------------------|-------------------------------------------------------|
| Free movement and rotation of<br>bone fragments. | Treatment simulation by<br>moving skeletal structures |

Based on the presented technical comparison of the Planmeca Romexis and the predicate devices it was concluded that these devices are technically substantially equivalent.

The differences found are not significant as they do not raise any new or potential safety risks to the user or patient, or questions related to safety or effectiveness.

# NON-CLINICAL TEST RESULTS

The following quality assurance measures were applied to the development of the Software:

- Risk Analysis
- Requirements Reviews
- Design Reviews
- . Performance testing (Verification)
- . Safety testing (Verification)
- . Final acceptance testing (Validation)
- Bench testing to compare with predicate software ●

Testing confirmed that Planmeca Romexis is stable and operating as designed. Testing also confirmed that Planmeca Romexis has been evaluated for hazards and that the risk has been reduced to acceptable levels.

The non-clinical bench-testing of Planmeca Romexis with predicate software versions were performed by comparison of images rendered by Planmeca Romexis and the predicate software versions. The results confirm that the software applications are equally effective in performing the essential functions and provide substantially equivalent clinical data.

## SUMMARY

Based on the intended use, product, performance, and testing information provided in this notification, the subject device has been shown to be substantially equivalent in technology, functionality, and indicated use to the currently marketed predicate devices.