Otoplan

K203486 · Cascination AG · QQE · Aug 20, 2021 · Radiology

Device Facts

• Record ID: K203486
• Device Name: Otoplan
• Applicant: Cascination AG
• Product Code: QQE · Radiology
• Decision Date: Aug 20, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

OTOPLAN is intended to be used by otologists and neurotologists as a software interface allowing the display, segmentation, and transfer of medical image data from medical CT, MR, and XA imaging systems to investigate anatomy relevant for the preoperative planning and postoperative assessment of otological and neurotological procedures (e.g., cochlear implantation).

Device Story

OTOPLAN is a standalone software platform for otologists and neurotologists to assist in preoperative planning and postoperative assessment of otological procedures. It imports DICOM medical images (CT, MR, XA) for viewing and semi-automatic segmentation of ENT-relevant structures. Users perform manual 2D measurements using a virtual ruler and apply established formulae to estimate cochlear length and frequency. The device allows creation of virtual trajectories, identification of cochlear implant electrode array contacts, and visualization of audiogram data. It runs on a Windows 10 PC with touchscreen capability. The software is purely assistive; it does not alter data sets or control medical devices. By consolidating image viewing, measurement, and planning tools, it aids clinicians in surgical decision-making and assessing electrode positioning, potentially improving surgical outcomes.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including software verification and validation, human factors and usability validation (summative evaluation with 15 users per group), and internal performance testing using known dimensions to verify measurement accuracy.

Technological Characteristics

Standalone software for Windows 10. Functions: DICOM viewing, semi-automatic segmentation, 3D reconstruction, trajectory planning, and geometric measurement. No patient contact materials or energy sources. Software level of concern: moderate. Hardware requirements: 12.3in touchscreen, 8GB RAM, 2-core CPU, dedicated GPU with OpenGL 4.0.

Indications for Use

Indicated for otologists and neurotologists for preoperative planning and postoperative assessment of otological and neurotological procedures, such as cochlear implantation, using CT, MR, and XA medical image 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

• Surgical Planner (SRP) BrainStorm (K201465)

Reference Devices

• iPlan (iPlan Cranial, iPlan Stereotaxy, iPlan ENT, iPlan CMF, iPlan View, iPlan Spine) (K113732)

Submission Summary (Full Text)

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August 20, 2021

CAScination AG Jean-Francois Clemence Head of Quality and Regulatory Affairs Steigerhubelstrasse 3 Bern. CH-3008 Switzerland

Re: K203486

Trade/Device Name: Otoplan Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: QQE Dated: July 19, 2021 Received: July 23, 2021

Dear Jean-Francois Clemence:

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/cfpmr/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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Shuchen Peng -S

Shu-Chen Peng, Ph.D. Assistant Director DHT1C: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices 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) K203486

Device Name OTOPLAN

#### Indications for Use (Describe)

OTOPLAN is intended to be used by otologists and neurotologists as a software interface allowing the display, segmentation, and transfer of medical image data from medical CT, MR, and XA imaging systems to investigate anatomy relevant for the preoperative planning and postoperative assessment of otological procedures (e.g., cochlear implantation).

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span> <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> </div> |

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Image /page/3/Picture/0 description: The image shows the word "CAScination" in green font with a red and white Swiss flag at the end. The letters are all lowercase except for the first two letters, "CA", which are uppercase and larger than the rest of the letters. The Swiss flag is a white cross on a red background. The logo is likely for a company or organization based in Switzerland.

## 510(k) Summary

510(k) Number: K203486

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92.

## I. SUBMITTER

| Manufacturer: | CAScination AG<br>Steigerhubelstrasse 3<br>CH-3008 Bern<br>Switzerland<br>Tel: [phone]<br>Fax: [phone] |
|-----------------|-------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dr. Jean-François Clémence<br>Head of Regulatory and Clinical Affairs |
| Date Prepared: | August 20, 2021 (version 5) |

# II. SUBJECT DEVICE

| Device Name: | OTOPLAN |
|----------------------|------------------------------------------------|
| Classification Name: | Medical Image Management and Processing System |
| Regulation: | 892.2050 |
| Regulatory Class: | Class II |
| Product Code: | QQE |

## III. PREDICATE DEVICE

#### Primary Predicate Device

| Company: | Surgical Theater, Inc. |
|----------------|-----------------------------------|
| Device name: | Surgical Planner (SRP) BrainStorm |
| 510(k) number: | K201465 |

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Image /page/4/Picture/0 description: The image shows the word "CAScination" in green font with a red Swiss flag at the end. The letters are all capitalized except for the "c" in "Cascination". The font is sans-serif and the letters are evenly spaced. The Swiss flag is a square with a white cross in the center.

#### Reference Device

| Company: | Brainlab AG |
|----------------|----------------------------------------------------------------------------------------|
| Device name: | iPlan (iPlan Cranial, iPlan Stereotaxy, iPlan ENT, iPlan CMF, iPlan View, iPlan Spine) |
| 510(k) number: | K113732 |

## IV. DEVICE DESCRIPTION

OTOPLAN consolidates a DICOM viewer, ruler function, and calculator function into one software platform. The user can

- import DICOM-conform medical images and view these images.
- . navigate through the images and segment ENT-relevant structures (semi-automatic), which can be highlighted in the 2D images and 3D view.
- . use a virtual ruler to geometrically measure distances and a calculator to apply established formulae to estimate cochlear length and frequency.
- create a virtual trajectory, which can be displayed in the 2D images and 3D view.
- identify electrode array contacts of a cochlear implant to assess electrode insertion and position.
- input audiogram-related data that were generated during audiological testing with a standard . audiometer and visualize them in OTOPLAN.

OTOPLAN allows the visualization of third-party information, that is, a cochlear implant electrode array portfolio.

The information provided by OTOPLAN is solely assistive and for the user. All tasks performed with OTOPLAN require user interaction; OTOPLAN does not alter data sets but constitutes a software platform to perform tasks that are otherwise performed manually. Therefore, the user is required to have clinical experience and judgment.

OTOPLAN is designed to run on a PC and requires the 64 bit Microsoft Windows 10 operating system. A PDF Reader such as Adobe Acrobat is recommended to access the instructions for use.

For computation and usability purposes, the software is designed to be executed on a computer with touch screen capabilities. The minimum hardware requirements are:

- . 12.3in wide screen
- 8GB of RAM ●
- 2 core CPU (such as a 5th generation i5 or i7)
- dedicated GPU with OpenGL 4.0 capabilities ●
- . 250GB hard drive

## V. INDICATIONS FOR USE

OTOPLAN is intended to be used by otologists and neurotologists as a software interface allowing the display, segmentation, and transfer of medical image data from medical CT, MR, and XA

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Image /page/5/Picture/0 description: The image shows the word "CAScination" in green font. To the right of the word is a red square with a white plus sign in the center. The font is sans-serif and the letters are all capitalized. The image is likely a logo or branding for a company or organization.

imaging systems to investigate anatomy relevant for the preoperative planning and postoperative assessment of otological and neurotological procedures (e.g., cochlear implantation).

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VI. THE PREDICATE DEVICE

The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:

- Intended use Both the subject and predicate devices have the same intended use to . plan surgical procedures in the head and neck area by medical professionals.
- Design Features The predicate and subject device design features & modules are ● summarized in the Table 1.
- . Energy Source - Not applicable because both are software devices.
- . Materials - Not applicable, because both are software devices and do not have patient contact.
- . Performance Testing - Human Factors & Usability Validation, Software Design V&V and documentation, formal Internal Testing were done with both the predicate and subject devices

| Item | Subject Device<br>(OTOPLAN) | Predicate Device<br>SuRgical Planner (SRP)<br>BrainStorm K201465 | Reference Device (iPlan)<br>K113732 | Conclusion |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation<br>Number | Regulation Number: 21<br>CFR 892.2050<br>Product Code: ... | Regulation Number: 21<br>CFR 892.2050<br>Product Code: LLZ | Regulation Number: 21<br>CFR 892.1750<br>Product Code: JAK, LLZ | ⇒ Same<br>Both the<br>subject and<br>predicate<br>devices have<br>the same<br>regulation<br>number |
| Intended Use | | | | |
| Intended Use | Plan surgical procedures in<br>the head and neck area by<br>medical professionals | Plan surgical procedures<br>in the head and neck area<br>by medical professionals | Plan surgical procedures in<br>the head and neck area, and<br>other anatomy by medical<br>professionals | ⇒ Same<br>Both the<br>subject and<br>predicate<br>device have the |
| | | | | same intended use |
| Indications<br>for use<br>statement | OTOPLAN is intended to<br>be used by otologists and<br>neurotologists as a<br>software interface allowing<br>the display, segmentation,<br>and transfer of medical<br>image data from medical<br>CT, MR, and XA imaging<br>systems to investigate<br>anatomy relevant for the<br>preoperative planning and<br>postoperative assessment<br>of otological and<br>neurotological procedures<br>(e.g., cochlear<br>implantation). | The SuRgical Planner<br>(SRP) BrainStorm is<br>intended for use as a<br>software interface and<br>image segmentation<br>system for the transfer of<br>image information from a<br>CT, MR, or X-ray 3D<br>Angiography (XA) medical<br>scanner to an output file.<br>It can also be used for<br>pre-operative planning and<br>surgical training in a<br>virtual environment. | iPlan's indications for use are the<br>viewing, presentation and<br>documentation of medical<br>imaging, including different<br>modules for image processing,<br>image fusion, atlas assisted<br>visualization and segmentation,<br>intraoperative functional planning<br>where the output can be used<br>e.g. with stereotactic image<br>guided surgery or other devices<br>for further processing and<br>visualization. Example procedures<br>include but are not limited to:<br>- Planning and simulation of<br>cranial surgical procedures such<br>as tumor resection, shunt<br>placement, minimal-invasive<br>stereotactic interventions, biopsy,<br>planning and simulation of<br>trajectories for stimulation and<br>electrode recording<br>- ENT procedures such as sinus<br>surgery, tumor surgery<br>- Spine procedures such as<br>tumor surgery, pedicle screw<br>planning, vertebroplasty<br>planning<br>- Plan View is an application<br>which is intended to be used for<br>reviewing existing<br>treatment plans<br>-Planning and simulation of<br>cranlo-maxillofacial procedures<br>Typical users of iPlan are<br>medical professionals, including<br>but not limited to surgeons and<br>radiologists. | ⇒ Same<br>Both the<br>subject and<br>predicate<br>devices have<br>the same<br>intended use to<br>plan surgical<br>procedures in<br>the head and<br>neck area by<br>medical<br>professionals |
| User | Medical professionals | Medical professionals | Medical professionals | ⇒ Same |
| Technical Characteristics | | | | |
| Type | Standalone Software.<br>Does not<br>control the functions or<br>parameters of any<br>medical device | Standalone Software.<br>Does not<br>control the functions or<br>parameters of any<br>medical device | Standalone Software.<br>Does not<br>control the functions or<br>parameters of any medical<br>device | ⇒ Same |
| Operating<br>System | Windows 10 | Windows | Windows 7, 8, 10 | ⇒ Same |
| Functions | • Data Management<br>• Viewing<br>• 3D reconstruction<br>• Trajectory Planning | • Data Management<br>• Viewing<br>• 3D reconstruction<br>• Trajectory Planning | • Data Management<br>• Viewing<br>• 3D reconstruction<br>• Trajectory Planning | ⇒ Same |
| | • Patient/Image<br>Information (incl.<br>otological information) | • Patient/Image<br>Information (incl.<br>brainwave information) | • Patient/Image<br>Information | ⇒ Different<br>technological<br>characteristic:<br>⇒ No question of<br>safety and<br>effectiveness is<br>raised |
| Material | NA | NA | NA | ⇒ Same |
| Energy<br>Source | NA | NA | NA | ⇒ Same |
| Performance<br>Testing | Human Factors and<br>Usability Validation<br>Software design<br>verification and<br>validation and<br>documentation (the<br>software for this device<br>was considered a<br>"moderate" level of<br>concern.)<br>Formal Internal Testing<br>Standards | Human Factors and<br>Usability Validation<br>Software design<br>verification and<br>validation and<br>documentation (the<br>software for this device<br>was considered a<br>"moderate" level of<br>concern.)<br>Formal Internal Testing<br>Standards | Human Factors and<br>Usability Validation<br>Software design<br>verification and validation<br>and documentation<br>Formal Internal Testing<br>Standards | ⇒ Same |

#### Table 1 - Summary Substantial Equivalence Comparison to predicate devices:

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Image /page/6/Picture/0 description: The image shows the word "CAScination" in green font with a Swiss flag at the end. The letters are all lowercase except for the first two letters, which are uppercase. The Swiss flag is a red square with a white cross in the center. The word is written in a sans-serif font and is easy to read.

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Image /page/7/Picture/0 description: The image shows the word "CAScination" in green letters with a red square containing a white cross to the right of the word. The letters are all capitalized and in a sans-serif font. The red square with the white cross is a symbol of Switzerland.

Steigerhubelstrasse 3 CH-3008 Bern Switzerland

#### Technological Differences:

The subject, predicate and reference device all provide general patient/image information and specific patient information. The difference in the subject device is that it provides specific otological information such as the estimation of the cochlea length, a frequency map, display audiogram related data and catalogue information.

The estimation of the cochlear length and frequency map is based on a manual 2D measurement by the user and the application of published formulas. The same estimation is possible with the

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Image /page/8/Picture/0 description: The image shows the logo for CAScination. The logo is green and features the word "CAScination" in a sans-serif font. To the right of the word is a red square with a white plus sign in the center. The logo is simple and modern.

predicate and reference device by caring out the 2D measurement in the software and then using an external tool to apply the published formula. CASCINATION carried out a test of the 2D measurement according to internal standards with both the subject and reference device. Additionally, CASCINATION carried out specific software tests to confirm the correct calculation according to the published formula and display of the information.

The display of audiogram related data (manually input by the user) and catalogue information has been verified by specific software verification tests to confirm the correct display of the information.

All tests have been passed and demonstrate that no question on safety and effectiveness is raised by this technological difference.

Same as with the predicate and subject device human factors and usability validation, software design verification and validation and formal internal testing has been carried out with the subject device to demonstrate the safety and effectiveness of the overall device.

#### Conclusion - Comparison of the technological characteristics:

The subject device is equivalent to the predicate device with regard to intended use, safety and efficacy. This conclusion is based upon a comparison of intended use, technological characteristics and non-clinical performance testing.

## VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence de termination.

#### Biocompatibility Testing

Not Applicable to the subject device, because the device is stand-alone software.

#### Electrical safety and electromagnetic compatibility (EMC)

Not Applicable to the subject device, because the device is stand-alone software.

#### Mechanical and Acoustic Testing

Not Applicable to the subject device, because the device is stand-alone software.

#### Software Verification and Validation Testing

Software verification and validation testing were provided to demonstrate safety and efficacy of the subject device. Software validation and documentation was prepared according to the

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Image /page/9/Picture/0 description: The image shows the word "CAScination" in green font, with a red square containing a white cross to the right of the word. The font is sans-serif and the letters are all capitalized. The word is likely a company or organization name. The red square with the white cross is a symbol often associated with Switzerland.

"Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005).

This includes a hazard analysis, and the potential hazards have been classified as a moderate level of concern similar to the predicate device.

#### Human Factors and Usability Validation

Human Factors and Usability validation was carried out according to the FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices - Guidance for Industry and Food and Drug Administration Staff (2016-02)" and international standard "AAMI / ANSI / IEC 62366-1:2015, Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices". The Human Factors and Usability Validation includes a summative evaluation to be carried out in the US with15 users from each user group. OTOPLAN has been found to be safe and effective for the intended users, uses and use environments.

#### Internal Test Standards

Internal Test Protocols were executed and documented in test Reports to demonstrate performance characteristics of OTOPLAN. This included tests with known dimensions which were loaded into OTOPLAN and results compared to the know dimension. The results were in the expected range. The internal tests demonstrate that the subject device can fulfill the expected performance characteristics and no questions of safety or performance were raised.

#### Animal Study

Animal performance testing was not required to demonstrate safety and effectiveness of the device.

#### Clinical Studies

Clinical testing was not required to demonstrate the safety and effectiveness of OTOPLAN. This conclusion is based upon a comparison of intended use, technological characteristics, and nonclinical performance data (Software Verification and Validation Testing, Human Factors and Usability Validation, and Internal Test Standards).

### VIII. CONCLUSIONS

The subject device is substantially equivalent to the predicate device with regard to device performance. This conclusion is based upon a comparison of the intended use, technological characteristics, and benchtop testing.