Predicate Devices

Reference Devices

Not Found

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 or learning-based functions characteristic of AI/ML. While it mentions "semi-automatic" segmentation, this is often achieved through traditional image processing techniques rather than AI/ML in this context. There is no mention of AI, ML, or related terms like deep learning or neural networks.

Therapeutic

No
The device is a software interface for displaying, segmenting, and transferring medical image data for planning and assessment of otological procedures. It is a tool for information processing and visualization, not a device that directly or indirectly provides therapy.

Diagnostic

Yes

The device assists in preoperative planning and postoperative assessment by processing medical images, segmenting structures, making measurements, and visualizing data, all of which contribute to understanding a patient's condition and guiding further medical action, thus fulfilling the role of a diagnostic device.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states that OTOPLAN is a "software platform" that runs on a PC with a specific operating system. It consolidates software functions (DICOM viewer, ruler, calculator, segmentation, etc.) and does not mention any accompanying hardware components that are part of the medical device itself. While it interacts with medical imaging systems and requires a computer for execution, the device being submitted for 510(k) is the software.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
OTOPLAN's Function: OTOPLAN is a software interface that processes medical image data (CT, MR, XA) to assist in the planning and assessment of otological procedures. It works with images of the patient's anatomy, not with samples taken from the body.
Intended Use: The intended use clearly states it's for displaying, segmenting, and transferring medical image data to investigate anatomy relevant for surgical procedures. This is not an in vitro diagnostic purpose.

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

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 arrav portfolio.

The information provided by OTOPLAN is solely assistive and for the benefit of 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) with a clock speed of 2.4 GHz .
. dedicated GPU with OpenGL 4.3 capabilities
. 250GB hard drive

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

medical CT, MR, and XA imaging systems

Anatomical Site

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

Indicated Patient Age Range

Not Found

Intended User / Care Setting

otologists and neurotologists

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

For the electrode contact identification function, the data sets consisted of human temporal bone cadaver specimens which were scanned with a Micro CT for ground truth and clinical CT for the test datasets.

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

Software Verification and Validation Testing:
Software validation and documentation was prepared according to the "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 with the predicate device 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 included a summative evaluation carried out in the US with 15 users from each user group. OTOPLAN has been found to be safe and effective for the intended users, uses, and use environments. New human factors testing was not required for the software update from the predicate device (version 1.3) to the subject device (version 2.0).

Internal Test Standards:
Internal Test Protocols were executed and documented in test Reports to demonstrate performance characteristics of OTOPLAN. This included tests with data sets with known dimensions which were loaded into OTOPLAN and results compared to the know dimension. For the electrode contact identification function, the data sets consisted of human temporal bone cadaver specimens which were scanned with a Micro CT for ground truth and clinical CT for the test datasets. All test 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 (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K203486

Reference Device(s)

Not Found

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 contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & 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.

June 24, 2022

Cascination AG Jean-Francois Clemence Head of Quality and Regulatory Affairs Steigerhubelstrasse 3 Bern, 3008 Switzerland

Re: K220300

Trade/Device Name: Otoplan Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QQE Dated: May 19, 2022 Received: May 23, 2022

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/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

1

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 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/cdrl-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,

Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220300

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)

☑ Prescription Use (Part 21 CER 801 Subpart D)
□ Over-The-Counter Use (21 CER 801 Subpart C)

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Document ID:	CASC18-610911768-2798
Document Version:	5.0
Page:	1 of 8

Document Title:	Part ID and Name:
510(k) Summary	5200 OTOPLAN

510(K) SUMMARY

510(k) Number: K220300

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 5520441 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dr. Jean-François Clémence
Head of Quality and Regulatory Affairs |
| Date Prepared: | June 22, 2022 |

II. SUBJECT DEVICE

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

The Subject Device (OTOPLAN version 2.0) is an updated version of the Predicate Device (OTOPLAN version 1.3).

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III. PREDICATE DEVICE

Primary Predicate Device

Company: CASCINATION AG, Steigerhubelstrasse 3, CH-3008 Bern, Switzerland Device name: OTOPLAN 510(k) number: K203486

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 arrav portfolio.

The information provided by OTOPLAN is solely assistive and for the benefit of 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) with a clock speed of 2.4 GHz .
. dedicated GPU with OpenGL 4.3 capabilities
. 250GB hard drive

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

VI. SUBSTANTIAL EQUIVALENCE

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 and 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 – Same for the subject and predicate device (new human factors testing was not required for the software update in the subject device).

Table 1

Summary of the Substantial Equivalence Comparison to Predicate Device

| Item | Subject Device
(OTOPLAN version 2.0) | Predicate Device
(OTOPLAN version 1.3) | Conclusion |
|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| 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 | ⇒ Same
Both the subject and
predicate devices
have the same
intended use |
| Item | Subject Device
(OTOPLAN version 2.0) | Predicate Device
(OTOPLAN version 1.3) | Conclusion |
| 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). | 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). | ⇒ Same
Both the subject and
predicate devices
have the same
indications for use
statement |
| User | Medical professionals such
as otologists,
neurotologists, and
audiologists | Medical professionals such
as otologists,
neurotologists, and
audiologists | ⇒ Same
Both the subject and
predicate devices
have the same user |
| 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 | ⇒ Same |
| Operating
System | Windows 10 | Windows 10 | ⇒ Same |
| Functions | • Cochlear Parametrization
(based on established
formula)
• Audiogram
• Electrode Visualization
• Virtual Trajectory Planning
• Postoperative Quality
Checks
• Export Report | • Cochlear Parametrization
(based on established
formula)
• Audiogram
• Electrode Visualization
• Virtual Trajectory Planning
• Postoperative Quality
Checks
• Export Report | ⇒ Same |
| 3D
Reconstruction
Functions
(same) | • 3D reconstruction
• Temporal bone
• Incus, Malleus
• Stapes
• Facial nerve
• Chorda tympani
External ear canal | • 3D reconstruction
• Temporal bone
• Incus, Malleus
• Stapes
• Facial nerve
• Chorda tympani
External ear canal | ⇒ Same |
| Item | Subject Device
(OTOPLAN version 2.0) | Predicate Device
(OTOPLAN version 1.3) | Conclusion |
| 3D
Reconstruction
Functions
(NEW with
SAME
technical.
Characteristic.) | • 3D reconstruction
• Cochlea
• Sigmoid sinus
• Cochlear bony overhang
• Cochlear round window | | ⇒ Same
technical characteristic
as functions
included in the
predicate device
(see discussion
below) |
| 3D
Reconstruction
Functions
(NEW with
DIFFERENT
technical.
Characteristic.) | • 3D reconstruction
• Electrode contacts | | ⇒ Different
technical characteristic
which does not
affect the safety and
effectiveness. (see
discussion below) |
| Performance
Testing | Software design verification
and validation and
documentation (the
software for this device
was considered a
"moderate" level of
concern.)
Formal Internal Testing
Standards | 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 Testing | ⇒ Same
(new Human Factors
and Usability
Testing was not
required for the
software update in
the subject device) |

6

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Substantial Equivalence Discussion

The Subject Device OTOPLAN (version 2.0) is an updated version of the Predicate Device OTOPLAN (version 1.3). Both the Subject Device OTOPLAN (version 2.0) and the Predicate Device OTOPLAN (version 1.3) have the same Intended Use.

The subject device introduces five new functions in the 3D reconstruction module.

From those five functions, four functions have the same technological characteristics as functions already included in the predicate device. They use the same process and numerical computation as functions in the predicate device. Those functions are same as the functions already included in the predicate device, for illustration purposes only.

Cochlea and Cochlear bony overhang functions: Use the same reconstruction method as the temporal bone function in the predicate device. The user selects the boundary box and intensity threshold for the segmentation and reviews the result. This results in an illustration of the Cochlea and Cochlear bony overhang.

8

Sigmoid sinus function: Uses the same reconstruction method as the facial nerve function in the predicate device. In both the user must set landmark points along the structure (facial nerve or sigmoid sinus). In a second step, the user must adjust the border points manually in a panoramic view along the structure. This results in an illustration of the Sigmoid sinus.

Cochlear round window function: Same as in the Stapes function of the predicate device, there is no numerical algorithm involved. The user manually defines four landmark points surrounding the round window. Based on these anatomical landmarks, an ellipse is fitted for illustrating the round window.

This safety and performance have been demonstrated through Software validation activities and documentation.

Discussion of Technological Differences:

The subject device and predicate device have one different technological characteristic in the 3D reconstruction module. The subject device allows the automatic detection of electrode contacts. Specific Non-Clinical Performance Testing and Software Validation has been carried out for this function. Human temporal bone cadaver specimens with cochlear implant electrodes arrays implanted were scanned with a Micro CT and electrode contacts marked for the ground truth dataset. The same specimens were scanned with clinical CTs for the test datasets. The electrode contact identification algorithm has been applied on the test dataset. The testing demonstrated that the algorithm can accurately identify the electrode contacts. The user reviews the result and can manually adjust the contacts points (same as in the predicate device). Through performance testing (see Section VII), it has been demonstrated that this technological difference does not adversely affect the safety and effectiveness of the subject device and is substantially equivalent to the predicate device.

Conclusion - Substantial Equivalence Discussion:

The subject device is substantially equivalent to the predicate device with regard to intended use, safety, and effectiveness. 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 determination.

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.

9

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 effectiveness of the subject device. Software validation and documentation was prepared according to the "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 with the predicate device 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 included a summative evaluation carried out in the US with 15 users from each user group. OTOPLAN has been found to be safe and effective for the intended users, uses, and use environments. New human factors testing was not required for the software update from the predicate device (version 1.3) to the subject device (version 2.0).

Internal Test Standards

Internal Test Protocols were executed and documented in test Reports to demonstrate performance characteristics of OTOPLAN. This included tests with data sets with known dimensions which were loaded into OTOPLAN and results compared to the know dimension. For the electrode contact identification function, the data sets consisted of human temporal bone cadaver specimens which were scanned with a Micro CT for ground truth and clinical CT for the test datasets. All test 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 non-clinical

10

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.