(193 days)
"POINT" Kinguide Robotic-Assisted Surgical System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.
The device is indicated for medical condition in which the use of stereotactic spinal surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to images of the indications include medical procedures in which pedicle screws are implanted posteriorly into lumbar vertebrae (L1-L5) or sacral vertebrae (S1).
"POINT" Kinguide Robotic-Assisted Surgical System (Kinguide Surgical System) is an orthopedic stereotaxic medical device, which consists of a hand-held robot, a passive arm, a workstation, an infrared navigation camera, navigation software, C-arm ring calibrator and surgical navigation accessories. Among them, the workstation, as the main console for controlling the hand-held robot, is equipped with a computer and control modules, which performs all operations in the surgical procedure through the computer, and transmits its information to the control modules for controlling movements of the hand-held robot. The C-arm ring calibrator and the navigation probe are used to perform registration process. The infrared navigation camera receives the spatial positioning of the patients, the hand-held robot and the surgical accessories through Dynamic Reference Frames (DRFs), and in the meantime the camera sends the data back to the workstation for monitoring stereotactic surgical operation.
The Kinguide Surgical System can assist surgeons to find surgical trajectories quickly and precisely during surgical operations. Software application in the system provides the patient's image to match coordinates of the patient's anatomical structure, and establishes a surgical navigation map. The user can perform the operation according to the surgical navigation map with navigable tools.
Here's a breakdown of the acceptance criteria and study information for the "POINT" Kinguide Robotic-Assisted Surgical System based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Positional Accuracy: Mean Location Error | ≤ 2.0 mm (met criteria) |
| Positional Accuracy: Mean Trajectory Angle Error | ≤ 2° (met criteria) |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "cadaveric validation" was performed. However, it does not specify the sample size for the test set (i.e., the number of cadavers or specific test cases used). The data provenance is cadaveric. The document does not specify the country of origin or if the study was retrospective or prospective, although cadaveric studies are inherently prospective for device testing.
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 to establish the ground truth for the test set or their qualifications.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for establishing the ground truth of the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to evaluate how much human readers improve with AI vs. without AI assistance. The device described is a robotic-assisted surgical system, not an AI for image interpretation or diagnosis that would directly involve human readers in that capacity.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop)
The performance described (positional accuracy for location and trajectory) appears to be a standalone performance of the robotic system itself in achieving targets. The study evaluates the system's ability to guide to a precise location and trajectory, implying an algorithm-only (robotic system only) performance in meeting these physical accuracy metrics. The role of a human surgeon would be to operate the system, but the accuracy itself is attributed to the robotic assistance.
7. Type of Ground Truth Used
The ground truth for the non-clinical performance (accuracy) was established through verification and validation activities, including a "Cadaveric Validation Report," as stated. This suggests that precise physical measurements on cadaveric specimens were used to define the true position and trajectory, against which the robotic system's performance was compared.
8. Sample Size for the Training Set
The document does not provide information about a specific "training set" or its sample size. This type of robotic system involves engineering design and calibration rather than a machine learning model that would typically have a distinct training set for data-driven learning.
9. How the Ground Truth for the Training Set Was Established
As there is no explicit mention of a training set in the context of machine learning, the document does not describe how ground truth for a training set was established. The device's accuracy is likely established through engineering specifications, calibration procedures, and validation against known physical standards.
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August 9, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Point Robotics MedTech Inc. Wayne Kao, Director 7F., No.219, Sec.3, Beixin Rd., Xindian Dist. New Taipei City, 231 Taiwan
Re: K220241
Trade/Device Name: "POINT" Kinguide Robotic-Assisted Surgical System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: January 25, 2022 Received: d-
Dear Mr. Wayne Kao:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic 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) K220241
Device Name
"POINT" Kinguide Robotic-Assisted Surgical System
Indications for Use (Describe)
"POINT" Kinguide Robotic-Assisted System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.
The device is indicated for medical condition in which the use of stereotactic spinal surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to images of the indications include medical procedures in which pedicle screws are implanted posteriorly into lumbar vertebrae (L1-L5) or sacral vertebrae (S1).
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
January 13, 2022
1. Submitter's Information
Submission Submitter
| Company Name | Point Robotics MedTech Inc. |
|---|---|
| Address | 7F., No.219, Sec.3, Beixin Rd., Xindian Dist.,New Taipei City 231, Taiwan |
| Contact Person | Mr. Wayne Kao |
| Phone | 866-2-29130272#165 |
| wayne.kao@pointroboticsinc.com |
| Proprietary/Trade Name | “POINT” Kinguide Robotic-Assisted Surgical System |
|---|---|
| Regulation Name | Stereotaxic Instrument |
| Regulation Number | 882.4560 |
| Product Code | OLO |
| Device Classification | II |
| Review Panel | Orthopedic |
2. Subject Device Information
3. Device Description
"POINT" Kinguide Robotic-Assisted Surgical System (Kinguide Surgical System) is an orthopedic stereotaxic medical device, which consists of a hand-held robot, a passive arm, a workstation, an infrared navigation camera, navigation software, C-arm ring calibrator and surgical navigation accessories. Among them, the workstation, as the main console for controlling the hand-held robot, is equipped with a computer and control modules, which performs all operations in the surgical procedure through the computer, and transmits its information to the control modules for controlling movements of the hand-held robot. The C-arm ring calibrator and the navigation probe are used to perform registration process. The infrared navigation camera receives the spatial positioning of the patients, the hand-held robot and the surgical accessories through Dynamic Reference Frames (DRFs), and in the meantime the camera sends the data back to the workstation for monitoring stereotactic surgical operation.
The Kinguide Surgical System can assist surgeons to find surgical trajectories quickly and precisely during surgical operations. Software application in the system provides the
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patient's image to match coordinates of the patient's anatomical structure, and establishes a surgical navigation map. The user can perform the operation according to the surgical navigation map with navigable tools.
4. Indications for Use
"POINT" Kinguide Robotic-Assisted Surgical System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.
The device is indicated for any medical condition in which the use of stereotactic spinal surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to images of the anatomy. The indications include medical procedures in which pedicle screws are implanted posteriorly into lumbar vertebrae (L1-L5) or sacral vertebrae (S1).
5. Identification of Legally Marketing Devices
K201189 - StealthstationTM S8 Spine Software v1.3.0 K162309 - StealthstationTM S8 System Platforms and StealthStation Cranial Software K160713 - Stealth-Midas System
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6. Comparison to the Predicate Device
| Item | Subject Device | Software Predicate | Platform Predicate | Drill System Predicate |
|---|---|---|---|---|
| “POINT” KinguideRobotic-Assisted | Stealthstation™ S8 SpineSoftware v1.3.0 | StealthStation™ S8System | Stealth-Midas System | |
| Surgical System | ||||
| K number | N/A | K201189 | K162309 | K160713 |
| Product Code | OLO | OLO | HAW, OLO, PGW | OLO |
| Intended Use &Indications forUse | “POINT” KinguideRobotic-AssistedSurgical System isintended as an aid forprecisely locatinganatomical structures ineither open orpercutaneousneurosurgical andorthopedic procedures.The device is indicatedfor any medical conditionin which the use ofstereotactic spinalsurgery may beappropriate, and where | The StealthStation™System, withStealthStation SpineSoftware, is intended as anaid for precisely locatinganatomical structures ineither open orpercutaneousneurosurgical andorthopedic procedures.Their use is indicated forany medical condition inwhich the use ofstereotactic surgery maybe appropriate, and wherereference to a rigid | The StealthStation™System, withStealthStation Cranialsoftware, is intended as anaid for precisely locatinganatomical structures ineither open orpercutaneous surgicalprocedures. TheStealthStationTM Systemis indicated for anymedical condition in whichthe use of stereotacticsurgery may beappropriate, and wherereference to a rigid | The Stealth-Midas Systemis indicated for thedrilling, burring andremoval of hard tissue andbone in spinal surgicalprocedures. Computer-assisted surgery and itsassociated applications areintended as an aid forprecisely locatinganatomical structures ineither open orpercutaneous procedures.Their use is indicated forany medical condition inwhich the use of |
| Subject Device | Software Predicate | Platform Predicate | Drill System Predicate | |
| Item | "POINT" KinguideRobotic-AssistedSurgical System | Stealthstation™ S8 SpineSoftware v1.3.0 | StealthStation™ S8System | Stealth-Midas System |
| reference to a rigidanatomical structure canbe identified relative toimages of the anatomy.The indications includeall medical procedures inwhich pedicle screws areimplanted posteriorlyinto lumbar vertebrae(L1-L5) or sacralvertebrae (S1). | anatomical structure, suchas the spine or pelvis, canbe identified relative toimages of the anatomy.This can include, but isnot limited to, thefollowing procedures:• Pedicle Screw Placement• Iliosacral ScrewPlacement• Interbody DevicePlacement | anatomical structure, suchas the skull, can beidentified relative to a CTor MR based model,fluoroscopy images, ordigitized landmarks of theanatomy. | stereotactic surgery maybe appropriate, and wherereference to a rigidanatomical structure, suchas a long bone, orvertebra, can be identifiedrelative to a CT- or MR-based model, fluoroscopicimages, or digitizedlandmarks of the anatomy. | |
| SystemAccuracyRequirement | According to verificationand validation results,"POINT" KinguideRobotic-AssistedSurgical System hasdemonstratedperformance in 3D | Under representativeworst-case configuration,the StealthStation S8Spine software v1.3.0, hasdemonstrated performancein 3D positional accuracywith a mean positional | Under representativeworst-case configuration,the StealthStation S8System with StealthStationCranial v1.0.0 Software,has demonstratedperformance in 3D | |
| Subject Device | Software Predicate | Platform Predicate | Drill System Predicate | |
| Item | "POINT" KinguideRobotic-AssistedSurgical System | Stealthstation™ S8 SpineSoftware v1.3.0 | StealthStation™ S8System | Stealth-Midas System |
| positional accuracy witha mean positional error of$\leq$ 2.0 mm and meantrajectory error of $\leq$ 2degrees. | error of $\leq$ 2.0 mm andmean trajectory error of $\leq$2 degrees.Mean Accuracy Values(StealthAiR Spine):Positional Error – 1.01mmTrajectory Error – 0.37degreesMean Accuracy Values(Overlapping Slices):Positional Error - 0.51mmTrajectory Error -0.41degrees | positional accuracy with amean error $\leq$ 2.0 mm andin trajectory angleaccuracy with a mean error$\leq$ 2.0 degrees. | ||
| ImagingModalities | X-Ray based (CT) | X-Ray Based Imaging | X-Ray based, MR basedNuclear Medicine based | Identified relative to a CT-or MR-based model |
| Item | Subject Device | Software Predicate | Platform Predicate | Drill System Predicate |
| “POINT” KinguideRobotic-AssistedSurgical System | Stealthstation™ S8 SpineSoftware v1.3.0 | StealthStation™ S8System | Stealth-Midas System | |
| Surface MatchingRegistrationImage LandmarkRegistrationPrecise SurfaceRegistrationImage Registration | PointMerge RegistrationSurfaceMergeRegistrationFluoroMerge RegistrationAutomatic 2D ImageRegistrationAutomatic 3D ImageRegistrationStealthAiR SpineAutomatic Registration | PointMerge® registration(referred to as Landmarkregistrations)Tracer™ registrationTouch registration(previously Touch-N-Go™)StealthAiR® registration,O-arm® registration,Mechanical basedregistrations (StereotacticLocalizer Registration andStarFix™ Bone AnchorRegistration) | Stealth-Midas integratesseamlessly withStealthStation surgicalnavigation solutions. | |
| RegistrationFeatures | ||||
| PlanningFeatures | Plan Entry and TargetSelection3D Model Building | Plan Entry and TargetSelection3D Model BuildingDeformity Planning | Plan Entry and Targetselection3D Model BuildingAdvanced Visualization | Stealth-Midas integratesseamlessly withStealthStation surgicalnavigation solutions. |
| Item | Subject Device | Software Predicate | Platform Predicate | Drill System Predicate |
| Medical DeviceInterfaces | “POINT” KinguideRobotic-AssistedSurgical System | Stealthstation™ S8 SpineSoftware v1.3.0 | StealthStation™ S8System | Stealth-Midas System |
| Siemens Arcadis Varic C-ArmSiemens Arcadis OrbicC-Arm | O-arm Imaging SystemZiehm Vision FD Vario3D C-ArmISO-C 3D C-ArmZiehm Vision RFD 3D C-armStealth-Midas MR8Orbic 3D C-Arm | Microscope Navigation:Zeiss, LeicaUltrasound Navigation:Aloka and SonositeMedtronic O-arm®Stereotactic FrameSystems: Fischer ZD,Fischer RM, Integra CRWand Elekta LeksellNexframe® StereotacticSystemSTarFix™Platform System | Stealth-Midas integratesseamlessly withStealthStation surgicalnavigation solutions. | |
| View/DisplayFeatures | Look Sideways3D ViewAnatomic OrthogonalTrajectory 1 and 2Trajectory GuidanceProbe's EyeAP and Lateral | Look Sideways3DAnatomic OrthogonalTrajectory 1 and 2Trajectory GuidanceLook AheadProbe's Eye | Ultrasound Video In,Ultrasound Overlay,3D, 2D AnatomicOrthogonal,Trajectory 1 and 2, TargetGuidance, TrajectoryGuidance, Probes Eye, | |
| Item | Subject Device | Software Predicate | Platform Predicate | Drill System Predicate |
| “POINT” KinguideRobotic-AssistedSurgical System | Stealthstation™ S8 SpineSoftware v1.3.0 | StealthStation™ S8System | Stealth-Midas System | |
| Maximum IntensityProjection | AP and LateralSynthetic AP and LateralMaximum IntensityProjectionVideo Input | Look Ahead, MicroscopeInjection, Video Input,Endoscopic | ||
| SoftwareInterface (GUI) | User friendly interfacewith procedure taskoverview at home page.System tools for imageadjustment, surgicalplanning and instrumentmanagement arecontained in a left-sidebar. The systeminformation is shown onthe right-side bar. | Black and gray style withprocedure task overviewin left menu option andnext/back task flow atbottom of the screen.Software controls forimages, planning andinstrument managementare contained in a right-side bar. | Black and gray style withprocedure task overview inleft menu option andnext/back task flow atbottom of the screen.Software controls forimages, planning andinstrument managementare contained in a right-side bar. | Stealth-Midas integratesseamlessly withStealthStation surgicalnavigation solutions. |
| ProgrammingLanguage | C++ | C++ | C++ | Stealth-Midas integratesseamlessly withStealthStation surgical |
| Item | Subject Device | Software Predicate | Platform Predicate | Drill System Predicate |
| "POINT" KinguideRobotic-AssistedSurgical System | Stealthstation™ S8 SpineSoftware v1.3.0 | StealthStation™ S8System | ||
| navigation solutions. | ||||
| ScannerInterfaceTechnology(to imagingdevices) | CD, DVD, USBDICOM Import | Network ConnectivityCD, DVD, USBDICOM ImportDICOM Export | Network ConnectivityCD, DVD, USBDICOM ImportDICOM Export | Stealth-Midas integratesseamlessly withStealthStation surgicalnavigation solutions. |
| LocalizationTechnology | Optical (infra-red)Manufacturer: NorthernDigitalLocalizer: Vega | Optical (infra-red)Manufacturer: NorthernDigitalLocalizer: Vega | Optical (infra-red)Manufacturer: NorthernDigitalLocalizer: Vega | Optical (infra-red)Manufacturer: NorthernDigitalLocalizer: Vega |
| ComputerPlatform | Intel-based PC | Intel-based PC | Intel-based PC | Stealth-Midas integratesseamlessly withStealthStation surgicalnavigation solutions. |
| Item | Subject Device | Software Predicate | Platform Predicate | Drill System Predicate |
| “POINT” KinguideRobotic-AssistedSurgical System | Stealthstation™ S8 SpineSoftware v1.3.0 | StealthStation™ S8System | Stealth-Midas System | |
| Drill System | The Kinguide SurgicalSystem has a hand-heldrobot. The hand-heldrobot can be identified bythe infrared navigationcamera through theRobotic Base Frame(BF). It has high freedomof operation and high-precision positioningability. It is used toposition the surgicalinstrument connected tothe end-effector of therobot. | Not Applicable | Not Applicable | The Stealth-Midas™ is ahigh-speed drill with apermanently attachedtracker that allows forintraoperative navigationof spinal procedures usingthe StealthStation™surgical navigationsystem. |
| MechanicalSupport | A passive arm of thissystem is applied tosupport the hand-heldrobot during surgeries. It | Not Applicable | Not Applicable | A standard handpiece drillwith a permanentlyattached tracker. |
| Item | Subject Device | Software Predicate | Platform Predicate | Drill System Predicate |
| "POINT" KinguideRobotic-AssistedSurgical System | Stealthstation™ S8 SpineSoftware v1.3.0 | StealthStation™ S8System | Stealth-Midas System | |
| can assist surgeons tomove the hand-held robotstably and prevent fromunexpected drop. |
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Brief Substantial Equivalence Discussion -
"POINT" Kinguide Robotic-Assisted Surgical System and the predicates- StealthStation™ System (K201189, K162309 and K160713) are based on the following same technological elements:
- V Intended Use & Indications for Use
- V System Accuracy Requirement
- V Imaging Modalities
- V Registration Features
- V Planning Features
- V View/Display Features
- V Software Interface (GUI)
- V Programming Language
-
Scanner Interface Technology
-
Localization Technology
-
Computer Platform
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Point Robotics MedTech Inc. 510(k) Notification
The following technological differences exist between the subject and predicate devices:
- Drill System >
-
Mechanical Support
There are two minor differences between the subject and predicate devices; these differences are concerning the drilling system and its mechanical support.
"POINT" Kinguide Robotic-Assisted System can provide the high-precision postioning ability and assist surgeons to move the hand-held robot stably and prevent from unexpected drop. These minor differences are addressed and evaluated in our risk management, usability engineering and cadaveric validation.
As a result, we state that the differences haven't raised further issues of safety or effectiveness but mitigate potential risk.
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7. Performance Testing
The performance data, including required verification/validation, of the "POINT" Kinguide Robotic-Assisted Surgical System has been carried out thoroughly both at the top level and on underlying SW/HW modules according to international standards and following U.S. FDA guidance. The verification was done to demonstrate that the design specifications and the safety requirements are all met.
| Verification/Validation | Description |
|---|---|
| Human Factors &Usability Engineering | Usability of the system is validated in accordance withFDA guidance of applying Human Factors and UsabilityEngineering to Medical Devices and IEC 62366-1:2015. |
| Product Safety | Compliance with standards requirements, including:- ANSI/AAMI ES60601-1:2005/(R)2012 andA1:2012 & C1:2009/(R)2012 & A2:2010/(R)2012- IEC 60601-1:2005 +A1:2012 (Ed. 3.1)- IEC 60601-1-2:2014- IEC 60601-1-8:2006+AMD1:2012- IEC 80601-2-77:2019 |
| Positional Accuracy | Compliance with ASTM F2554-18 and ASTM F3107-14 |
| Biocompatibility | Biocompatibility of those accessories that having contactwith patients is evaluated in accordance with FDAguidance for the use of international standard ISO 10993-1. |
| Software | System software is validated in accordance with:- FDA guidance for the Content of PremarketSubmissions for Software contained in MedicalDevices, 2005- IEC 62304:2006 + A1:2015. |
| Reprocessing | Reusable accessories are validated in accordance with:- FDA guidance for the Reprocessing medicaldevices in health care settings: Validation methodsand labeling, 2015.- AAMI TIR30:2011/(R)2016- AAMI TIR12:2020 |
| Sterilization | Compliance with FDA guidance for Submission and |
| Verification/Validation | Description |
| Review of Sterility Information in Premarket Notification(510(k)) Submissions for Devices Labeled as Sterile,2016 | |
| Stability & Reliability | Stability & Reliability evaluation includes:- Standard Practice for Climatic Stressing ofPackaging Systems acc. ASTM F2825-18- Standard Practice for Performance Testing ofShipping Containers and Systems acc. ASTMD4169-16- Packaging for terminally sterilized medical devicesacc. ISO 11607-1:2019- Environmental testing (Vibration) acc. IEC 60068-2-6:2007- Environmental testing (Shock) acc. IEC 60068-2-27:2008- Degrees of protection provided by enclosures acc.IEC 60529:2013 |
| Non-clinical Performance(Accuracy) | The system has a mean accuracy of ≤2.0 mm forlocation error and ≤2° for trajectory angle error.The following verification and validation are performedin support of our performance study:- Performance and Accuracy Verification Report- Cadaveric Validation Report |
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8. Conclusion
The information provided above supports that the "POINT" Kinguide Robotic-Assisted Surgical System is substantially equivalent to the identified predicate devices. Substantial equivalence has been demonstrated through a comparison of intended use, design, and technological characteristics, as well as performance evaluations. The "POINT" Kinguide Robotic-Assisted Surgical System can be considered substantially equivalent to the identified 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).