(252 days)
Not Found
No
The description focuses on real-time tracking, image reprocessing, and pre-operative planning based on standard image processing and navigation techniques, without mentioning AI or ML algorithms for image analysis, planning, or tracking. The performance metrics are also standard for surgical navigation systems and do not suggest AI/ML-specific evaluation.
No.
The device is a surgical navigation system, which provides guidance and assists in locating anatomical structures and positioning instruments; it does not directly treat or cure medical conditions.
No
The device is intended for surgical navigation, guiding the surgeon in real-time during procedures, rather than diagnosing a medical condition.
No
The device description explicitly states "Geniant Cranial is a hardware platform that supports real-time surgical navigation". This indicates it includes hardware components, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for aiding in locating anatomical structures, spatial positioning and orientation of surgical instruments, and navigating compatible surgical instruments during neurosurgical procedures. This is a surgical navigation system, not a diagnostic test performed on biological samples.
- Device Description: The description details a hardware and software platform that uses pre-operative images (CT or MR) to track surgical tools in real-time and guide the surgeon. It processes images and provides spatial information, which is distinct from analyzing biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, tissue, etc.), chemical reactions, or diagnostic assays. The focus is entirely on image processing and spatial tracking for surgical guidance.
In summary, the device's function is to assist in surgical procedures by providing real-time spatial information based on medical images, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for 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 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.
Product codes
HAW
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. 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
• 3D preoperative exam
• 2D intraoperative exam
Anatomical Site
Head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Neurosurgeon / Staff inside sterile field / Staff outside sterile field
Operating rooms
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
§ 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).
0
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"
1
(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).
2
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
3
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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4
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.
5
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
K200511 | Secondary Predicate
K162309 | Comparison |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
Number | New device | K200511 | K162309 | N/A |
| Manufacture
r | KOH YOUNG TECHNOLOGY
INC. | Medtech S.A | Medtronic Navigation, Inc. | N/A |
| Trade Name | Geniant Cranial | ROSA ONE Brain Application | StealthStation S8 System
Platforms and StealthStation
Cranial Software | N/A |
| Classification
Name | Neurological stereotaxic
instrument | Neurological stereotaxic
instrument | Neurological stereotaxic
instrument | Same |
| Product code | HAW | HAW | HAW | Same |
| Regulation
Number | 882.4560 | 882.4560 | 882.4560 | Same |
| Intended Use
/ Indications
for Use | The device is intended for use
as an aid for locating
anatomical structures and for
the spatial positioning and
orientation of instrument
holders or tool guides to be
used by neurosurgeons for
navigating and/or guiding | The device is intended for the
spatial positioning and
orientation of instruments
holders or tool guides to be
used by trained
neurosurgeons to guide
standard neurosurgical
instruments (biopsy needle, | The StealthStation™ System,
with StealthStation™ Cranial
Software, is intended as an
aid for locating anatomical
structures in either open or
percutaneous neurosurgical
procedures. Their use is | Different |
| | compatible surgical
instruments in open or
percutaneous procedures.
The device is indicated for any
neurosurgical procedure in
which the use of stereotactic
neurosurgery may be
appropriate, and where
reference to a rigid
anatomical structure, such as
the skull, can be identified
relative to images of the
anatomy. | stimulation or recording
electrode, endoscope). The
device is indicated for any
neurosurgical procedure in
which the use of stereotactic
neurosurgery may be
appropriate. | indicated for any medical
condition in
which the use of stereotactic
surgery may be appropriate,
and where reference to a
rigid anatomical structure,
such as the skull, can be
identified relative to images
of the anatomy.
This can include, but is not
limited to, the following
cranial procedures (including
stereotactic frame-based and
stereotactic frame
alternatives-based
procedures):
• Tumor resections
• General ventricular
catheter placement
• Pediatric ventricular
catheter placement
• Depth electrode, lead, and
probe placement
• Cranial biopsies | |
| Anatomical
site | Head | Head | Head | Same |
| Sites of use | Operating rooms | Operating rooms | Operating rooms | Same |
| Operator | Neurosurgeon / Staff inside
sterile field / Staff outside
sterile field | Neurosurgeon / Clinical
representative | Neurosurgeon / Clinical
representative / image
guidance staff | Different |
| System
Architecture | • Console with optical sensor
(Navigation HW platform)
• Robot stand with robotic
arm and Patient Positioning
Module
• Application SW
• Optical markers
• Probes
• Head frame (O-frame kit)
• Various tools mounted on
robot arm to hold the
surgical tools and make a
path according to planning
• Various optional parts and
accessories for ease of use | • Robot stand with robotic
arm and optical sensor
• Application SW
• Fiducial markers
• Probe
• Head frame (CRW Frame)
• Various tools mounted on
robot arm to hold the
surgical tools and make a
path according to planning
• Various optional parts and
accessories for ease of use | • StealthStation S8 with
optical sensor (Navigation
HW platform)
• Application SW
• Various optional parts and
accessories for ease of use | Different |
| Principle of
operation | • Intraoperative/preoperativ
e images
• Patient registration
• Surgical Planning
• Real-time tracking of
navigated instruments
• Guidance of instruments | • Intraoperative/preoperativ
e images
• Patient registration
• Surgical Planning
• Guidance of instruments | • Intraoperative/preoperativ
e images
• Patient registration
• Surgical planning
• Real-time tracking of
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
Planning
Software | • KGuide V3.0 | • ROSANNA BRAIN | • StealthStation Cranial SW | Different |
| Localization
means | Infrared camera (Navigation
Camera, manufactured by
Koh Young Technology) and
Robot arm relative encoders | Robot arm absolute encoders | Infrared camera (Navigation
Camera, manufactured by
Northerm Digital Inc.) | Different |
| Scanner
Interface
Technology
(to imaging
devices) | CD, DVD, USB
DICOM Import/Export | CD, DVD, USB
DICOM Import/Export | Network connectivity
CD, DVD, USB
DICOM Import/Export | Different
The
differences
in scanner
interface
will not raise
any safety
and
performance
concerns. |
| Preoperative
images &
surgical
planning
features | • DICOM compliance
• Merge images
(multimodality image
fusion capability)
• Save/load planning
• Plan Entry and Target
Selection
• 3D Model Building
(Segmentation) | • DICOM compliance
• Merge images
(multimodality image
fusion capability)
• Save/load planning
• Define regions of interest
(ROI) | • Plan Entry and Target
Selection
• 3D Model Building
• Advanced Visualization
• Create Patient Based
Anatomical Coordinate
Space
• Stereotactic Frame Settings
• Brain Atlas: Schaltenbrand-
Wahren Atlas with
Talairach Grid
• STarFix™ Designer
Annotations | Different |
| Patient
registration
method | • Point-to-point registration
with anatomical markers or
skin/bone fiducials
• Stereotactic Localizer
Registration
• Optical trace merge
• Optical surface registration | • Point-to-point registration
with anatomical markers or
skin/bone fiducials
• Stereotactic Localizer
Registration
• Optical surface registration | • Point-to-point registration
with anatomical markers or
skin/bone fiducials
• Optical or electromagnetic
trace merge
• Intra-Op CT: Calibrated CT
gantry to camera merge
• Stereotactic Localizer
Registration | Different |
| Instruments
guidance
Features | • Image-guided
• Real-time display of the
instrument position
• Provide guidance for
surgical instruments
• Automatic instrument
guide position adjustment
• Surgeon carries out the
final gesture through the
instrument guide with the
traditional surgical
instrument | • Image-guided
• Real-time display of the
instrument position
• Provide guidance for
surgical instruments
• Automatic instrument
guide position adjustment
• Surgeon carries out the
final gesture through the
instrument guide with the
traditional surgical
instrument | N/A | Same |
| | | | | |
| Guidance
(robot arm)
controller | Axis controller for each joint
Kinematic transformation
between the Cartesian space
and joint space Supervisor
module | Axis controller for each joint
Kinematic transformation
between the Cartesian space
and joint space Supervisor
module | N/A | Same |
| Vigilance
system | • Foot pedal | • Foot pedal | N/A | Same |
| Performance | • 3D positional accuracy with
a mean error ≤ 1.5 mm
• Trajectory angle accuracy
with a mean error ≤ 2.0
degrees | • Robot arm positioning
accuracy | United States Pharmacopeia - Pyrogen |
| ISO 17664-1:2021 | Processing of health care products - Information to be provided by the medical device
manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical
devices |
| ISO 17664-2:2021 | Processing of health care products - Information to be provided by the medical device
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:
A guide for medical device manufacturers |
| AAMI
TIR30:2011/(R)2016 | A compendium of processes, materials, test methods, and acceptance criteria for cleaning
reusable medical devices |
| ANSI/AAMI ST81:
2004/(R)2016 | Sterilization of medical devices - Information - Processing of Resterilizable Medical Devices |
| ISO 11737-1:2018/AMD
1:2021 | Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a
population of microorganisms on products |
| ISO 11737-2:2019 | Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility
performed in the definition, validation and maintenance of a sterilization process |
| ANSI AAMI ISO
14937:2009/(R)2013 | Sterilization of health care products - General requirements for characterization of a sterilizing
agent and the development, validation and routine control of a sterilization process for medical
devices |
| 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 ST79:2017
with Amendments
A1:2020, 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 neonates
and 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 for
medical devices |
| ISO 11607-1:2019 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile
barrier 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 AAMI
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
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
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
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
Content of Premarket Submissions |
| FDA Guidance | Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food
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:
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) |
9
10
11
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 | Standard | ||||
| Deviation | 99% CI* | |||||
| Upper | ||||||
| Bound | Mean | Standard | ||||
| Deviation | 99% CI* | |||||
| Upper | ||||||
| Bound | ||||||
| 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.