Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description explicitly states that all tasks require user interaction and the software does not alter data sets, indicating a lack of autonomous decision-making or learning capabilities typically associated with AI/ML. The "semi-automatic" segmentation is likely based on traditional image processing algorithms rather than AI/ML.

Therapeutic

No.
OTOPLAN is a software interface used for displaying, segmenting, and transferring medical image data for the purpose of preoperative planning and postoperative assessment of otological procedures. It is an assistive tool for medical professionals and does not directly provide therapy or treatment.

Diagnostic

Yes

The device is intended for "preoperative planning and postoperative assessment" and allows for "segmentation" and "geometrically measure distances and a calculator to apply established formulae to estimate cochlear length and frequency", which are all diagnostic functions. It processes medical image data (CT, MR, XA) to "investigate anatomy relevant for the preoperative planning and postoperative assessment of otological procedures (e.g., cochlear implantation)". This strongly implies a diagnostic purpose, even if it is described as "solely assistive".

SaMD (Software as a Medical Device)

Yes

The device description explicitly states that OTOPLAN is a "software platform" and details its functions as a DICOM viewer, ruler, and calculator. While it requires specific hardware for execution (PC with Windows 10, minimum hardware requirements), the device itself is the software application, not the underlying computer hardware. The 510(k) summary focuses on the software's functionality, verification, and validation, not on the hardware components.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
OTOPLAN's Function: OTOPLAN's intended use and description clearly state that it is a software interface for displaying, segmenting, and transferring medical image data (CT, MR, XA) from imaging systems. It works with images of the patient's anatomy, not with biological specimens.
Activities Performed: The activities described (viewing images, navigating, segmenting structures, measuring distances, creating virtual trajectories, identifying electrode contacts, visualizing audiogram data) are all related to image processing, visualization, and planning based on anatomical imaging. None of these involve the analysis of biological samples.

Therefore, OTOPLAN falls under the category of medical imaging software or surgical planning software, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 procedures (e.g., cochlear implantation).

Product codes

QQE

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

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT, MR, and XA imaging systems

Anatomical Site

Otological and neurotological procedures (e.g., cochlear implantation)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Otologists and neurotologists / 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

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.

Key Metrics

Not Found

Predicate Device(s)

K201465

Reference Device(s)

K113732

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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Image /page/0/Picture/0 description: The image shows the logo for 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" in blue, with "ADMINISTRATION" written below in a smaller font.

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

1

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,

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

2

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)
X Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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
Steigerhubelstrasse 3
CH-3008 Bern
Switzerland
Tel: +41 31 632 0440
Fax: +41 31 552 04 41 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dr. Jean-François Clémence
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
(OTOPLAN) | Predicate Device
SuRgical Planner (SRP)
BrainStorm K201465 | Reference Device (iPlan)
K113732 | Conclusion |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation
Number | Regulation Number: 21
CFR 892.2050
Product Code: ... | Regulation Number: 21
CFR 892.2050
Product Code: LLZ | Regulation Number: 21
CFR 892.1750
Product Code: JAK, LLZ | ⇒ Same
Both the
subject and
predicate
devices have
the same
regulation
number |
| Intended Use | | | | |
| Intended Use | Plan surgical procedures in
the head and neck area by
medical professionals | Plan surgical procedures
in the head and neck area
by medical professionals | Plan surgical procedures in
the head and neck area, and
other anatomy by medical
professionals | ⇒ Same
Both the
subject and
predicate
device have the |
| | | | | same intended use |
| Indications
for use
statement | 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). | The SuRgical Planner
(SRP) BrainStorm is
intended for use as a
software interface and
image segmentation
system for the transfer of
image information from a
CT, MR, or X-ray 3D
Angiography (XA) medical
scanner to an output file.
It can also be used for
pre-operative planning and
surgical training in a
virtual environment. | iPlan's indications for use are the
viewing, presentation and
documentation of medical
imaging, including different
modules for image processing,
image fusion, atlas assisted
visualization and segmentation,
intraoperative functional planning
where the output can be used
e.g. with stereotactic image
guided surgery or other devices
for further processing and
visualization. Example procedures
include but are not limited to:

Planning and simulation of
cranial surgical procedures such
as tumor resection, shunt
placement, minimal-invasive
stereotactic interventions, biopsy,
planning and simulation of
trajectories for stimulation and
electrode recording
ENT procedures such as sinus
surgery, tumor surgery
Spine procedures such as
tumor surgery, pedicle screw
planning, vertebroplasty
planning
Plan View is an application
which is intended to be used for
reviewing existing
treatment plans
-Planning and simulation of
cranlo-maxillofacial procedures
Typical users of iPlan are
medical professionals, including
but not limited to surgeons and
radiologists. | ⇒ Same
Both the
subject and
predicate
devices have
the same
intended use to
plan surgical
procedures in
the head and
neck area by
medical
professionals |
| User | Medical professionals | Medical professionals | Medical professionals | ⇒ Same |
| Technical Characteristics | | | | |
| Type | Standalone Software.
Does not
control the functions or
parameters of any
medical device | Standalone Software.
Does not
control the functions or
parameters of any
medical device | Standalone Software.
Does not
control the functions or
parameters of any medical
device | ⇒ Same |
| Operating
System | Windows 10 | Windows | Windows 7, 8, 10 | ⇒ Same |
| Functions | • Data Management
• Viewing
• 3D reconstruction
• Trajectory Planning | • Data Management
• Viewing
• 3D reconstruction
• Trajectory Planning | • Data Management
• Viewing
• 3D reconstruction
• Trajectory Planning | ⇒ Same |
| | • Patient/Image
Information (incl.
otological information) | • Patient/Image
Information (incl.
brainwave information) | • Patient/Image
Information | ⇒ Different
technological
characteristic:
⇒ No question of
safety and
effectiveness is
raised |
| Material | NA | NA | NA | ⇒ Same |
| Energy
Source | NA | NA | NA | ⇒ Same |
| Performance
Testing | Human Factors and
Usability Validation
Software design
verification and
validation and
documentation (the
software for this device
was considered a
"moderate" level of
concern.)
Formal Internal Testing
Standards | Human Factors and
Usability Validation
Software design
verification and
validation and
documentation (the
software for this device
was considered a
"moderate" level of
concern.)
Formal Internal Testing
Standards | Human Factors and
Usability Validation
Software design
verification and validation
and documentation
Formal Internal Testing
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.