(252 days)
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.
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. 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.
This document describes the acceptance criteria and the study proving the device meets them for the "Geniant Cranial (Navigated Neurosurgical Positioning Robot)".
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (from Predicate Device #2) | Reported Device Performance (Geniant Cranial) |
|---|---|---|
| 3D Positional Accuracy (mean error) | ≤ 2.0 mm | ≤ 1.5 mm |
| Trajectory Angle Accuracy (mean error) | ≤ 2.0 degrees | ≤ 2.0 degrees |
Detailed Performance Results for Geniant Cranial:
| Applied registration method | Positional Accuracy (mm) (Mean) | Positional Accuracy (mm) (99% CI Upper Bound) | Trajectory Angle Accuracy (degrees) (Mean) | Trajectory Angle Accuracy (degrees) (99% CI Upper Bound) |
|---|---|---|---|---|
| Paired Point Registration (PPR) | 0.766 | 1.616 | 0.264 | 0.678 |
| Bone Fiducial Registration | 0.916 | 1.907 | 0.292 | 0.750 |
| Tracing Registration | 0.872 | 1.849 | 0.334 | 0.860 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size for the test set used in the accuracy testing. It states that "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" and that the testing was performed "Under the representative worst-case configuration considering an actual clinical procedure".
The data provenance is not explicitly stated as retrospective or prospective, nor does it specify the country of origin. However, given that these are non-clinical performance and accuracy tests, the data likely originates from internal lab testing conducted by the manufacturer, Koh Young Technology Inc. (Republic of Korea).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing the ground truth for the non-clinical accuracy test set. As this is a non-clinical, performance-based test measuring instrument accuracy, the ground truth would likely be established through precise metrological measurements rather than human expert interpretation of medical images.
4. Adjudication Method for the Test Set
The document does not mention an adjudication method as it pertains to clinical interpretation or consensus. The described testing is a technical accuracy assessment, and thus, typical clinical adjudication methods (like 2+1, 3+1) are not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The provided document does not mention any multi-reader multi-case (MRMC) comparative effectiveness study evaluating human reader improvement with or without AI assistance. The device is a "Navigated Neurosurgical Positioning Robot," which falls under the category of surgical navigation systems and is not an AI-assisted diagnostic imaging interpretation tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance study was conducted. The accuracy testing detailed in "Table 3 – Accuracy Testing Result" presents the inherent accuracy of the Geniant Cranial device itself (robot and navigation system) in simulating spatial positioning and trajectory guidance. This testing measures the device's ability to achieve specific positional and angular accuracy independent of a human operator's varying performance, by comparing its output against a known, precise "ground truth" established during the test setup.
7. Type of Ground Truth Used
The ground truth used for the accuracy studies was established through precise physical measurements to determine the true 3D positional and trajectory angle targets. These are technical benchmarks for device performance, not clinical pathology or outcomes data. The study references "ASTM F2554-18 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems" and "ISO 9283:1998 Manipulating industrial robots - Performance criteria and related test methods," indicating that the ground truth was based on metrological standards for robotic and computer-assisted system accuracy.
8. Sample Size for the Training Set
The document does not specify a sample size for a training set. As this device is a surgical navigation robot and not a machine learning/AI diagnostic tool that requires image-based training, the concept of a "training set" in the context of data-driven algorithm development for image interpretation is not directly applicable here. The device's functionality is based on real-time tracking, image reprocessing, and robotic guidance, relying on established geometric and kinematic principles rather than statistical learning from a large training dataset.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, the document does not indicate the use of a "training set" in the context of machine learning. The device's operational principles rely on precise engineering and calibration rather than data-driven training. Therefore, the establishment of ground truth for a training set is not discussed or relevant to the reported performance evaluation.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Geniant Cranial
1. Submission Applicant
| a. Company: | KOH YOUNG TECHNOLOGY Inc.1F, 66-27, Gwangdae 2-gil, Sejongdaewang-myeon,Yeoju-si, Gyeonggi-do, Republic of Korea |
|---|---|
| ------------- | -------------------------------------------------------------------------------------------------------------------------- |
- b. Contact: Sooji Shin RA Team Leader Office Phone: +82 (31) 5181-8590 Email: sj.shin@kohyoung.com
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 PredicateK200511 | Secondary PredicateK162309 | Comparison |
|---|---|---|---|---|
| 510(k)Number | New device | K200511 | K162309 | N/A |
| Manufacturer | KOH YOUNG TECHNOLOGYINC. | Medtech S.A | Medtronic Navigation, Inc. | N/A |
| Trade Name | Geniant Cranial | ROSA ONE Brain Application | StealthStation S8 SystemPlatforms and StealthStationCranial Software | N/A |
| ClassificationName | Neurological stereotaxicinstrument | Neurological stereotaxicinstrument | Neurological stereotaxicinstrument | Same |
| Product code | HAW | HAW | HAW | Same |
| RegulationNumber | 882.4560 | 882.4560 | 882.4560 | Same |
| Intended Use/ Indicationsfor Use | The device is intended for useas an aid for locatinganatomical structures and forthe spatial positioning andorientation of instrumentholders or tool guides to beused by neurosurgeons fornavigating and/or guiding | The device is intended for thespatial positioning andorientation of instrumentsholders or tool guides to beused by trainedneurosurgeons to guidestandard neurosurgicalinstruments (biopsy needle, | The StealthStation™ System,with StealthStation™ CranialSoftware, is intended as anaid for locating anatomicalstructures in either open orpercutaneous neurosurgicalprocedures. Their use is | Different |
| compatible surgicalinstruments in open orpercutaneous procedures.The device is indicated for anyneurosurgical procedure inwhich the use of stereotacticneurosurgery may beappropriate, and wherereference to a rigidanatomical structure, such asthe skull, can be identifiedrelative to images of theanatomy. | stimulation or recordingelectrode, endoscope). Thedevice is indicated for anyneurosurgical procedure inwhich the use of stereotacticneurosurgery may beappropriate. | indicated for any medicalcondition inwhich the use of stereotacticsurgery may be appropriate,and where reference to arigid anatomical structure,such as the skull, can beidentified relative to imagesof the anatomy.This can include, but is notlimited to, the followingcranial procedures (includingstereotactic frame-based andstereotactic framealternatives-basedprocedures):• Tumor resections• General ventricularcatheter placement• Pediatric ventricularcatheter placement• Depth electrode, lead, andprobe placement• Cranial biopsies | ||
| Anatomicalsite | Head | Head | Head | Same |
| Sites of use | Operating rooms | Operating rooms | Operating rooms | Same |
| Operator | Neurosurgeon / Staff insidesterile field / Staff outsidesterile field | Neurosurgeon / Clinicalrepresentative | Neurosurgeon / Clinicalrepresentative / imageguidance staff | Different |
| SystemArchitecture | • Console with optical sensor(Navigation HW platform)• Robot stand with roboticarm and Patient PositioningModule• Application SW• Optical markers• Probes• Head frame (O-frame kit)• Various tools mounted onrobot arm to hold thesurgical tools and make apath according to planning• Various optional parts andaccessories for ease of use | • Robot stand with roboticarm and optical sensor• Application SW• Fiducial markers• Probe• Head frame (CRW Frame)• Various tools mounted onrobot arm to hold thesurgical tools and make apath according to planning• Various optional parts andaccessories for ease of use | • StealthStation S8 withoptical sensor (NavigationHW platform)• Application SW• Various optional parts andaccessories for ease of use | Different |
| Principle ofoperation | • Intraoperative/preoperative images• Patient registration• Surgical Planning• Real-time tracking ofnavigated instruments• Guidance of instruments | • Intraoperative/preoperative images• Patient registration• Surgical Planning• Guidance of instruments | • Intraoperative/preoperative images• Patient registration• Surgical planning• Real-time tracking ofnavigated instruments | Different |
| Input images | • 3D preoperative exam | • 3D preoperative exam | • 3D preoperative exam | Same |
| • 2D intraoperative exam | • 2D intraoperative exam | • 2D intraoperative exam | ||
| IntegratedPlanningSoftware | • KGuide V3.0 | • ROSANNA BRAIN | • StealthStation Cranial SW | Different |
| Localizationmeans | Infrared camera (NavigationCamera, manufactured byKoh Young Technology) andRobot arm relative encoders | Robot arm absolute encoders | Infrared camera (NavigationCamera, manufactured byNortherm Digital Inc.) | Different |
| ScannerInterfaceTechnology(to imagingdevices) | CD, DVD, USBDICOM Import/Export | CD, DVD, USBDICOM Import/Export | Network connectivityCD, DVD, USBDICOM Import/Export | DifferentThedifferencesin scannerinterfacewill not raiseany safetyandperformanceconcerns. |
| Preoperativeimages &surgicalplanningfeatures | • DICOM compliance• Merge images(multimodality imagefusion capability)• Save/load planning• Plan Entry and TargetSelection• 3D Model Building(Segmentation) | • DICOM compliance• Merge images(multimodality imagefusion capability)• Save/load planning• Define regions of interest(ROI) | • Plan Entry and TargetSelection• 3D Model Building• Advanced Visualization• Create Patient BasedAnatomical CoordinateSpace• Stereotactic Frame Settings• Brain Atlas: Schaltenbrand-Wahren Atlas withTalairach Grid• STarFix™ DesignerAnnotations | Different |
| Patientregistrationmethod | • Point-to-point registrationwith anatomical markers orskin/bone fiducials• Stereotactic LocalizerRegistration• Optical trace merge• Optical surface registration | • Point-to-point registrationwith anatomical markers orskin/bone fiducials• Stereotactic LocalizerRegistration• Optical surface registration | • Point-to-point registrationwith anatomical markers orskin/bone fiducials• Optical or electromagnetictrace merge• Intra-Op CT: Calibrated CTgantry to camera merge• Stereotactic LocalizerRegistration | Different |
| InstrumentsguidanceFeatures | • Image-guided• Real-time display of theinstrument position• Provide guidance forsurgical instruments• Automatic instrumentguide position adjustment• Surgeon carries out thefinal gesture through theinstrument guide with thetraditional surgicalinstrument | • Image-guided• Real-time display of theinstrument position• Provide guidance forsurgical instruments• Automatic instrumentguide position adjustment• Surgeon carries out thefinal gesture through theinstrument guide with thetraditional surgicalinstrument | N/A | Same |
| Guidance(robot arm)controller | Axis controller for each jointKinematic transformationbetween the Cartesian spaceand joint space Supervisormodule | Axis controller for each jointKinematic transformationbetween the Cartesian spaceand joint space Supervisormodule | N/A | Same |
| Vigilancesystem | • Foot pedal | • Foot pedal | N/A | Same |
| Performance | • 3D positional accuracy witha mean error ≤ 1.5 mm• Trajectory angle accuracywith a mean error ≤ 2.0degrees | • Robot arm positioningaccuracy <0.75 mm RMS• Device applicative accuracy<2mm | • 3D positional accuracy witha mean error ≤ 2.0 mm• Trajectory angle accuracywith a mean error ≤ 2.0degrees | Different |
| Sterility | • Non-sterile instruments• Disposable sterile drapesand covers for the robotarm | • Non-sterile and sterileinstruments• Disposable sterile drapesfor the robot arm andtouchscreen | N/A | Different |
| Body Contact | Probes (skin, bone, braintissue)Fixation pins for head fixationto a head frame (skin, bone) | Fiducial markers (skin, bone)Fixation pins and drill bits/drill(for burr holes to access thebrain) | N/A | Different |
| Applicablestandards forsafety | AAMI/ANSI ES 60601-1IEC 60601-1-2ISO 10993-1IEC 62304ISO 17665-1 | IEC 60601-1IEC 60601-1-2ISO 10993-1IEC 62304ISO 17665-1 | AAMI/ANSI ES 60601-1IEC 60601-1-2IEC 62304 | Same withPredicatedevice #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 / RegulationNo. | Title |
|---|---|
| IEC 60601-1:2020 | Medical electrical equipment - Part 1: General requirements for basic safety and essentialperformance |
| IEC 60601-1-2:2020 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essentialperformance - 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 safetyand essential performance - Collateral standard: Usability |
| IEC 62366-1:2020 | Medical devices - Part 1: Application of usability engineering to medical devices |
| ANSI/AAMIHE75:2009/(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 Edition2017 | Standard for Software Cybersecurity for Network-Connectable Products, Part 1: GeneralRequirements |
| UL 2900-2-1 First Edition2017 | Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements forNetwork 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 managementprocess |
| ISO 10993-3:2014 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity andreproductive 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 devicemanufacturer for the processing of medical devices - Part 1: Critical and semi-critical medicaldevices |
| ISO 17664-2:2021 | Processing of health care products - Information to be provided by the medical devicemanufacturer 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:A guide for medical device manufacturers |
| AAMITIR30:2011/(R)2016 | A compendium of processes, materials, test methods, and acceptance criteria for cleaningreusable medical devices |
| ANSI/AAMI ST81:2004/(R)2016 | Sterilization of medical devices - Information - Processing of Resterilizable Medical Devices |
| ISO 11737-1:2018/AMD1:2021 | Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of apopulation of microorganisms on products |
| ISO 11737-2:2019 | Sterilization of health care products — Microbiological methods — Part 2: Tests of sterilityperformed in the definition, validation and maintenance of a sterilization process |
| ANSI AAMI ISO14937:2009/(R)2013 | Sterilization of health care products - General requirements for characterization of a sterilizingagent and the development, validation and routine control of a sterilization process for medicaldevices |
| ISO 17665-1:2006 | Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development,validation and routine control of a sterilization process for medical devices |
| ANSI/AAMI ST79:2017with AmendmentsA1:2020, A2:2020,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,validation and routine control of a sterilization process for medical devices |
| ISO 10993-7:2008_Amd1:2019 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including:Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonatesand infants (2019)] |
| ISO 22441:2022 | Sterilization of health care products — Low temperature vaporized hydrogen peroxide —Requirements for the development, validation and routine control of a sterilization process formedical devices |
| ISO 11607-1:2019 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterilebarrier systems and packaging systems |
| ISO 11607-2:2019 | Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming,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 AAMIST77:2013/(R)2018 | Containment devices for reusable medical device sterilization |
| ASTM F1608-21 | Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure ChamberMethod) |
| 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 besupplied -- 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. 4.0b: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 andContent of Premarket Submissions |
| FDA Guidance | Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Foodand 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: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(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.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 | Mean | StandardDeviation | 99% CI*UpperBound | Mean | StandardDeviation | 99% CI*UpperBound |
| Paired Point Registration(PPR) | 0.766 | 0.330 | 1.616 | 0.264 | 0.161 | 0.678 |
| Bone Fiducial Registration | 0.916 | 0.385 | 1.907 | 0.292 | 0.178 | 0.750 |
| Tracing Registration | 0.872 | 0.379 | 1.849 | 0.334 | 0.204 | 0.860 |
*CI: Confidence Interval
10. Statement of Substantial Equivalence
Geniant Cranial has the same indications for use as the predicate devices. Any minor differences in the technological characteristics of the subject device when compared to the predicate device have been successfully evaluated through appropriate safety and performance testing which demonstrates that the subject device, when compared to the predicate device, does not raise any new questions of safety and effectiveness. Therefore, Genial has been determined to be substantially equivalent to the predicate devices.
§ 882.4560 Stereotaxic instrument.
(a)
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.(b)
Classification. Class II (performance standards).