Geniant Cranial (Navigated Neurosurgical Positioning Robot)

K241333 · Koh Young Technology, Inc. · HAW · Jan 17, 2025 · Neurology

Device Facts

• Record ID: K241333
• Device Name: Geniant Cranial (Navigated Neurosurgical Positioning Robot)
• Applicant: Koh Young Technology, Inc.
• Product Code: HAW · Neurology
• Decision Date: Jan 17, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The device is intended to aid in locating anatomical structures and for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons for navigating and guiding compatible surgical instruments in open or percutaneous procedures. The device is indicated for any neurosurgical procedure in which stereotactic neurosurgery may be appropriate and where reference to a rigid anatomical structure, such as the skull, can be identified relative to anatomy images.

Device Story

Geniant Cranial is a navigated neurosurgical positioning robot used in operating rooms by neurosurgeons. It processes pre-operative CT/MR images to display axial, sagittal, and coronal views. Surgeons use the system to create/save surgical routes and 3D anatomical models. During surgery, the system tracks surgical tools relative to the patient's anatomy, continuously updating their position on images. The system guides the surgeon to follow planned trajectories by automatically adjusting the instrument guide position. The robot arm, equipped with relative encoders and an infrared camera, provides real-time navigation. The surgeon uses the output to verify the actual position/path against the pre-operative plan, aiding decision-making and surgical accuracy. Benefits include precise spatial positioning and orientation of surgical instruments during open or percutaneous procedures.

Clinical Evidence

Bench testing only. Performance evaluated using representative worst-case configurations. 3D positional accuracy mean error ≤1.5 mm; trajectory angle accuracy mean error ≤2.0 degrees. Testing included Paired Point Registration, Bone Fiducial Registration, and Tracing Registration methods, with results showing mean positional errors of 0.766 mm, 0.916 mm, and 0.872 mm respectively.

Technological Characteristics

Hardware platform includes console with infrared navigation camera, robot stand with robotic arm, patient positioning module, and head frame (O-frame kit). Connectivity via DICOM import/export (CD, DVD, USB). Software-based navigation and robotic guidance. Sterilization via moist heat, ethylene oxide, or low-temperature vaporized hydrogen peroxide for reusable components; disposable sterile drapes used for robot arm. Complies with IEC 60601-1, IEC 62304, and ISO 10993 standards.

Indications for Use

Indicated for neurosurgical procedures where stereotactic neurosurgery is appropriate and reference to rigid anatomical structures (e.g., skull) can be identified relative to anatomy images.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• ROSA ONE Brain Application (K200511)
• StealthStation S8 System Platforms and StealthStation Cranial Software (K162309)

Submission Summary (Full Text)

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January 17, 2025

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Koh Young Technology Inc. Sooji Shin RA Team Leader 1F, 66-27, Gwangdae 2-gil, Sejongdaewang-myeon, Yeoju-si, Gyeonggi-do, Republic of Korea

Re: K241333

Trade/Device Name: Geniant Cranial (Navigated Neurosurgical Positioning Robot) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: December 18, 2024 Received: December 18, 2024

Dear Sooji Shin:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Digitally signed by Yen-Yen-chih Lin Digitally sig Date: 2025.01.17 -2 16:36:20 -05'00'

For Adam Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine 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) K241333

Device Name

Geniant Cranial (Navigated Neurosurgical Positioning Robot)

Indications for Use (Describe)

The device is intended to aid in locating anatomical structures and for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons for navigating compatible surgical instruments in open or percutaneous procedures. The device is indicated for any neurosurgical procedure in which stereotactic neurosurgery may be appropriate and where reference to a rigid anatomical structure, such as the skull, can be identified relative to anatomy images.

Type of Use (Select one or both, as applicable)

| <div> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|---------------------------------------------------------------------------|
| <div> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(k) Summary

# Geniant Cranial

# 1. Submission Applicant

| a. Company: | KOH YOUNG TECHNOLOGY Inc.<br>1F, 66-27, Gwangdae 2-gil, Sejongdaewang-myeon,<br>Yeoju-si, Gyeonggi-do, Republic of Korea |
|-------------|--------------------------------------------------------------------------------------------------------------------------|
|-------------|--------------------------------------------------------------------------------------------------------------------------|

- b. Contact: Sooji Shin RA Team Leader Office Phone: [phone] Email: [e-mail]
# 2. Date Prepared

05/09/2024

# 3. Device Identification

Trade/Proprietary Name: Geniant Cranial (Navigated Neurosurgical Positioning Robot) Classification Name: Neurological stereotaxic instrument Regulation Number(s): 882.4560 Product Code(s): HAW Class: II Classification Panel: Neurology

# 4. Legally Marketed Predicate Device(s)

Primary Device name: ROSA ONE Brain Application 510(k) number: K200511 Manufacturer: Medtech S.A

Secondary Device name: StealthStation S8 System Platforms and StealthStation Cranial Software 510(k) number: K162309 Manufacturer: Medtronic Navigation, Inc.

#### 5. Device Description

Geniant Cranial is a hardware platform that supports real-time surgical navigation using medical patient images. The application software reprocesses the CT or MR images of the patient acquired before surgery.

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It displays the contents on the software screen in various fluoroscopy directions (axial, sagittal and coronal). Before surgery, the surgeon can create and save one or more surgical routes to simulate. The surgeon may create and manipulate one or more 3D models of human anatomy before the surgery. During surgery, the system tracks the position of special surgical tools in the patient's anatomy and continuously updates the positions of the surgical tools in these images.

The application software can also show you how the actual position and path during surgery relate to the pre-operative plan and guide the surgeon to follow the planned trajectory. The real-time location information obtained through Genial can help guide the surgeon's decision and the surgical route.

## 6. Indication for Use Statement

The device is intended to aid in locating anatomical structures and for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons for navigating and guiding compatible surgical instruments in open or percutaneous procedures. The device is indicated for any neurosurgical procedure in which stereotactic neurosurgery may be appropriate and where reference to a rigid anatomical structure, such as the skull, can be identified relative to anatomy images.

# 7. Substantial Equivalence Discussion

The following table compares the Geniant Cranial to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.

| Attributes | Subject Device | Primary Predicate<br>K200511 | Secondary Predicate<br>K162309 | Comparison |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>Number | New device | K200511 | K162309 | N/A |
| Manufacture<br>r | KOH YOUNG TECHNOLOGY<br>INC. | Medtech S.A | Medtronic Navigation, Inc. | N/A |
| Trade Name | Geniant Cranial | ROSA ONE Brain Application | StealthStation S8 System<br>Platforms and StealthStation<br>Cranial Software | N/A |
| Classification<br>Name | Neurological stereotaxic<br>instrument | Neurological stereotaxic<br>instrument | Neurological stereotaxic<br>instrument | Same |
| Product code | HAW | HAW | HAW | Same |
| Regulation<br>Number | 882.4560 | 882.4560 | 882.4560 | Same |
| Intended Use<br>/ Indications<br>for Use | The device is intended for use<br>as an aid for locating<br>anatomical structures and for<br>the spatial positioning and<br>orientation of instrument<br>holders or tool guides to be<br>used by neurosurgeons for<br>navigating and/or guiding | The device is intended for the<br>spatial positioning and<br>orientation of instruments<br>holders or tool guides to be<br>used by trained<br>neurosurgeons to guide<br>standard neurosurgical<br>instruments (biopsy needle, | The StealthStation™ System,<br>with StealthStation™ Cranial<br>Software, is intended as an<br>aid for locating anatomical<br>structures in either open or<br>percutaneous neurosurgical<br>procedures. Their use is | Different |
| | compatible surgical<br>instruments in open or<br>percutaneous procedures.<br>The device is indicated for any<br>neurosurgical procedure in<br>which the use of stereotactic<br>neurosurgery may be<br>appropriate, and where<br>reference to a rigid<br>anatomical structure, such as<br>the skull, can be identified<br>relative to images of the<br>anatomy. | stimulation or recording<br>electrode, endoscope). The<br>device is indicated for any<br>neurosurgical procedure in<br>which the use of stereotactic<br>neurosurgery may be<br>appropriate. | indicated for any medical<br>condition in<br>which the use of stereotactic<br>surgery may be appropriate,<br>and where reference to a<br>rigid anatomical structure,<br>such as the skull, can be<br>identified relative to images<br>of the anatomy.<br>This can include, but is not<br>limited to, the following<br>cranial procedures (including<br>stereotactic frame-based and<br>stereotactic frame<br>alternatives-based<br>procedures):<br>• Tumor resections<br>• General ventricular<br>catheter placement<br>• Pediatric ventricular<br>catheter placement<br>• Depth electrode, lead, and<br>probe placement<br>• Cranial biopsies | |
| Anatomical<br>site | Head | Head | Head | Same |
| Sites of use | Operating rooms | Operating rooms | Operating rooms | Same |
| Operator | Neurosurgeon / Staff inside<br>sterile field / Staff outside<br>sterile field | Neurosurgeon / Clinical<br>representative | Neurosurgeon / Clinical<br>representative / image<br>guidance staff | Different |
| System<br>Architecture | • Console with optical sensor<br>(Navigation HW platform)<br>• Robot stand with robotic<br>arm and Patient Positioning<br>Module<br>• Application SW<br>• Optical markers<br>• Probes<br>• Head frame (O-frame kit)<br>• Various tools mounted on<br>robot arm to hold the<br>surgical tools and make a<br>path according to planning<br>• Various optional parts and<br>accessories for ease of use | • Robot stand with robotic<br>arm and optical sensor<br>• Application SW<br>• Fiducial markers<br>• Probe<br>• Head frame (CRW Frame)<br>• Various tools mounted on<br>robot arm to hold the<br>surgical tools and make a<br>path according to planning<br>• Various optional parts and<br>accessories for ease of use | • StealthStation S8 with<br>optical sensor (Navigation<br>HW platform)<br>• Application SW<br>• Various optional parts and<br>accessories for ease of use | Different |
| Principle of<br>operation | • Intraoperative/preoperativ<br>e images<br>• Patient registration<br>• Surgical Planning<br>• Real-time tracking of<br>navigated instruments<br>• Guidance of instruments | • Intraoperative/preoperativ<br>e images<br>• Patient registration<br>• Surgical Planning<br>• Guidance of instruments | • Intraoperative/preoperativ<br>e images<br>• Patient registration<br>• Surgical planning<br>• Real-time tracking of<br>navigated instruments | Different |
| Input images | • 3D preoperative exam | • 3D preoperative exam | • 3D preoperative exam | Same |
| | • 2D intraoperative exam | • 2D intraoperative exam | • 2D intraoperative exam | |
| Integrated<br>Planning<br>Software | • KGuide V3.0 | • ROSANNA BRAIN | • StealthStation Cranial SW | Different |
| Localization<br>means | Infrared camera (Navigation<br>Camera, manufactured by<br>Koh Young Technology) and<br>Robot arm relative encoders | Robot arm absolute encoders | Infrared camera (Navigation<br>Camera, manufactured by<br>Northerm Digital Inc.) | Different |
| Scanner<br>Interface<br>Technology<br>(to imaging<br>devices) | CD, DVD, USB<br>DICOM Import/Export | CD, DVD, USB<br>DICOM Import/Export | Network connectivity<br>CD, DVD, USB<br>DICOM Import/Export | Different<br>The<br>differences<br>in scanner<br>interface<br>will not raise<br>any safety<br>and<br>performance<br>concerns. |
| Preoperative<br>images &<br>surgical<br>planning<br>features | • DICOM compliance<br>• Merge images<br>(multimodality image<br>fusion capability)<br>• Save/load planning<br>• Plan Entry and Target<br>Selection<br>• 3D Model Building<br>(Segmentation) | • DICOM compliance<br>• Merge images<br>(multimodality image<br>fusion capability)<br>• Save/load planning<br>• Define regions of interest<br>(ROI) | • Plan Entry and Target<br>Selection<br>• 3D Model Building<br>• Advanced Visualization<br>• Create Patient Based<br>Anatomical Coordinate<br>Space<br>• Stereotactic Frame Settings<br>• Brain Atlas: Schaltenbrand-<br>Wahren Atlas with<br>Talairach Grid<br>• STarFix™ Designer<br>Annotations | Different |
| Patient<br>registration<br>method | • Point-to-point registration<br>with anatomical markers or<br>skin/bone fiducials<br>• Stereotactic Localizer<br>Registration<br>• Optical trace merge<br>• Optical surface registration | • Point-to-point registration<br>with anatomical markers or<br>skin/bone fiducials<br>• Stereotactic Localizer<br>Registration<br>• Optical surface registration | • Point-to-point registration<br>with anatomical markers or<br>skin/bone fiducials<br>• Optical or electromagnetic<br>trace merge<br>• Intra-Op CT: Calibrated CT<br>gantry to camera merge<br>• Stereotactic Localizer<br>Registration | Different |
| Instruments<br>guidance<br>Features | • Image-guided<br>• Real-time display of the<br>instrument position<br>• Provide guidance for<br>surgical instruments<br>• Automatic instrument<br>guide position adjustment<br>• Surgeon carries out the<br>final gesture through the<br>instrument guide with the<br>traditional surgical<br>instrument | • Image-guided<br>• Real-time display of the<br>instrument position<br>• Provide guidance for<br>surgical instruments<br>• Automatic instrument<br>guide position adjustment<br>• Surgeon carries out the<br>final gesture through the<br>instrument guide with the<br>traditional surgical<br>instrument | N/A | Same |
| | | | | |
| Guidance<br>(robot arm)<br>controller | Axis controller for each joint<br>Kinematic transformation<br>between the Cartesian space<br>and joint space Supervisor<br>module | Axis controller for each joint<br>Kinematic transformation<br>between the Cartesian space<br>and joint space Supervisor<br>module | N/A | Same |
| Vigilance<br>system | • Foot pedal | • Foot pedal | N/A | Same |
| Performance | • 3D positional accuracy with<br>a mean error ≤ 1.5 mm<br>• Trajectory angle accuracy<br>with a mean error ≤ 2.0<br>degrees | • Robot arm positioning<br>accuracy <0.75 mm RMS<br>• Device applicative accuracy<br><2mm | • 3D positional accuracy with<br>a mean error ≤ 2.0 mm<br>• Trajectory angle accuracy<br>with a mean error ≤ 2.0<br>degrees | Different |
| Sterility | • Non-sterile instruments<br>• Disposable sterile drapes<br>and covers for the robot<br>arm | • Non-sterile and sterile<br>instruments<br>• Disposable sterile drapes<br>for the robot arm and<br>touchscreen | N/A | Different |
| Body Contact | Probes (skin, bone, brain<br>tissue)<br>Fixation pins for head fixation<br>to a head frame (skin, bone) | Fiducial markers (skin, bone)<br>Fixation pins and drill bits/drill<br>(for burr holes to access the<br>brain) | N/A | Different |
| Applicable<br>standards for<br>safety | AAMI/ANSI ES 60601-1<br>IEC 60601-1-2<br>ISO 10993-1<br>IEC 62304<br>ISO 17665-1 | IEC 60601-1<br>IEC 60601-1-2<br>ISO 10993-1<br>IEC 62304<br>ISO 17665-1 | AAMI/ANSI ES 60601-1<br>IEC 60601-1-2<br>IEC 62304 | Same with<br>Predicate<br>device #1. |

#### Table 1 - Comparison of Characteristics

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#### 8. Non-Clinical Performance Data

To demonstrate safety and effectiveness of Geniant Cranial and to show substantial equivalence to the predicate device, Koh Young completed all applicable non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The Geniant Cranial passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device:

#### Table 2 -Applied standards and regulations

| Standard / Regulation<br>No. | Title |
|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1:2020 | Medical electrical equipment - Part 1: General requirements for basic safety and essential<br>performance |
| IEC 60601-1-2:2020 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential<br>performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| IEC 60825-1:2014 | Safety of laser products - Part 1: Equipment classification and requirements |
| IEC 62471:2006 | Photobiological safety of lamps and lamp systems |
| IEC 60601-1-6:2020 | Amendment 2 - Medical electrical equipment - Part 1-6: General requirements for basic safety<br>and essential performance - Collateral standard: Usability |
| IEC 62366-1:2020 | Medical devices - Part 1: Application of usability engineering to medical devices |
| ANSI/AAMI<br>HE75:2009/(R)2018 | Human factors engineering – Design of medical devices |
| ASTM F2554-18 | Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems |
| ISO 9283:1998 | Manipulating industrial robots - Performance criteria and related test methods |
| AAMI TIR57:2016 | Principles for Medical Device Security - Risk Management |
| AAMI TIR97:2019 | Principles for medical device security - Postmarket risk management for device manufacturers |
| UL 2900-1 First Edition<br>2017 | Standard for Software Cybersecurity for Network-Connectable Products, Part 1: General<br>Requirements |
| UL 2900-2-1 First Edition<br>2017 | Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for<br>Network Connectable Components of Healthcare and Wellness Systems |
| IEC 62304:2015 | Medical device software - Software life cycle processes |
| ISO 10993-1:2018 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management<br>process |
| ISO 10993-3:2014 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and<br>reproductive toxicity |
| ISO 10993-4:2017 | Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood |
| ISO 10993-5:2009 | Biological evaluation of medical devices - Cytotoxicity |
| ISO 10993-10:2021 | Biological evaluation of medical devices - Skin Sensitization |
| SO 10993-11:2017 | Biological evaluation of medical devices - Systemic Toxicity |
| SO 10993-23:2021 | Biological evaluation of medical devices - Irritation |
| ASTM F2901-19 | Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices |
| USP <151> | United States Pharmacopeia - Pyrogen |
| ISO 17664-1:2021 | Processing of health care products - Information to be provided by the medical device<br>manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical<br>devices |
| ISO 17664-2:2021 | Processing of health care products - Information to be provided by the medical device<br>manufacturer for the processing of medical devices - Part 2: Non-critical medical devices. |
| AAMI TIR12:2010 | Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities:<br>A guide for medical device manufacturers |
| AAMI<br>TIR30:2011/(R)2016 | A compendium of processes, materials, test methods, and acceptance criteria for cleaning<br>reusable medical devices |
| ANSI/AAMI ST81:<br>2004/(R)2016 | Sterilization of medical devices - Information - Processing of Resterilizable Medical Devices |
| ISO 11737-1:2018/AMD<br>1:2021 | Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a<br>population of microorganisms on products |
| ISO 11737-2:2019 | Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility<br>performed in the definition, validation and maintenance of a sterilization process |
| ANSI AAMI ISO<br>14937:2009/(R)2013 | Sterilization of health care products - General requirements for characterization of a sterilizing<br>agent and the development, validation and routine control of a sterilization process for medical<br>devices |
| ISO 17665-1:2006 | Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development,<br>validation and routine control of a sterilization process for medical devices |
| ANSI/AAMI ST79:2017<br>with Amendments<br>A1:2020, A2:2020,<br>A3:2020, A4:2020 | Comprehensive guide to steam sterilization and sterility assurance in health care facilities |
| ISO 11135:2014 | Sterilization of health-care products - Ethylene oxide - Requirements for the development,<br>validation and routine control of a sterilization process for medical devices |
| ISO 10993-<br>7:2008_Amd1:2019 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including:<br>Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates<br>and infants (2019)] |
| ISO 22441:2022 | Sterilization of health care products — Low temperature vaporized hydrogen peroxide —<br>Requirements for the development, validation and routine control of a sterilization process for<br>medical devices |
| ISO 11607-1:2019 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile<br>barrier systems and packaging systems |
| ISO 11607-2:2019 | Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming,<br>sealing and assembly processes |
| ASTM F88-15 | Standard Test Method for Seal Strength of Flexible Barrier Materials |
| ASTM F1929-15 | Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration |
| ASTM F1980-16 | Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
| ASTM F1980-21 | Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
| ANSI AAMI<br>ST77:2013/(R)2018 | Containment devices for reusable medical device sterilization |
| ASTM F1608-21 | Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber<br>Method) |
| AATCC 42-2017 | Standard Test Method for Water Resistance: Impact Penetration |
| AATCC 127-2017(2018)e | Standard Test Method for Water Resistance: Hydrostatic Pressure |
| ISO 15223-1:2021 | Medical devices - Symbols to be used with medical device labels, labelling and information to be<br>supplied -- Part 1: General requirements |
| ISO 7000:2019 | Graphical symbols for use on equipment - Registered symbols |
| ISO 7010: 2019 | Graphical symbols - Safety colours and safety signs - Registered safety signs |
| ISO 20417:2021 | Medical devices - Information to be supplied by the manufacturer |
| IEC/TR 60878 Ed. 4.0<br>b:2022 | Graphical symbols for electrical equipment in medical practice |
| IEC 60417:2002 DB | Graphical symbols for use on equipment |
| ISTA 3E 2017 | Similar Packaged-Products in Unitized Loads of Truckload Shipment |
| FDA Guidance | Electromagnetic Compatibility (EMC) of Medical Devices (06/06/2022_Final) |
| FDA Guidance | Radio Frequency Wireless Technology in Medical Devices (08/14/2013_Final) |
| FDA Guidance | Applying Human Factors and Usability Engineering to Medical Devices (Feb, 2016) (Final) |
| FDA Guidance | Cybersecurity in Medical Devices: Quality System Considerations and<br>Content of Premarket Submissions |
| FDA Guidance | Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food<br>and Drug Administration Staff (12/28/2016_Final) |
| FDA Guidance | Content of Premarket Submissions for Device Software Functions (June 2023) |
| FDA Guidance | Off-The-Shelf Software Use in Medical Devices |
| FDA Guidance | Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1:<br>Evaluation and testing within a risk management process" (09/08/2023_Final) |
| FDA Guidance | Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling<br>(03/17/2015_Final) |
| FDA Guidance | Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No.<br>56) |

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# 9. Discussion of the Key Performance (Accuracy) Testing

To simulate the clinical procedure as closely as possible, Koh Young Technology considered all parameters that may influence the stereotactic procedure, which include the different devices, accessories, and components of Geniant Cranial, other influencing devices used in the procedure that are validated to be compatible with Genial, and other elements of the surgical environment.

Under the representative worst-case configuration considering an actual clinical procedure, the Geniant Cranial has demonstrated performance in 3D positional accuracy with a mean error ≤1.5 mm and trajectory angle accuracy with a mean error ≤2.0 degrees. Below are the test results.

#### Table 3 – Accuracy Testing Result

| | Positional Accuracy (mm) | | | Trajectory Angle Accuracy (degrees) | | |
|------------------------------------|--------------------------|-----------------------|---------------------------|-------------------------------------|-----------------------|---------------------------|
| Applied registration method…