Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on image-guided navigation using optical tracking and pre-operative/intra-operative imaging, without mentioning AI or ML algorithms for image analysis, planning, or guidance.

Therapeutic

No
The device is an image-guided navigation system intended as an aid for precisely locating anatomical structures during surgery, not for treating a disease or condition itself.

Diagnostic

No

This device is described as an "image-guided system" and "orthopedic stereotaxic instrument" that aids in precisely locating anatomical structures during surgery and planning surgical procedures. It provides real-time tracking of surgical instruments in relation to patient anatomy, which is a navigational function, not a diagnostic one. Diagnostic devices are typically used to identify or characterize diseases or conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of an infrared navigation camera, a system workstation (computer), navigation software, and surgical instruments, indicating it is a hardware and software system, not software-only.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is to aid in precisely locating anatomical structures during surgical procedures. This is a surgical navigation system, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
Device Description: The description clearly outlines a system for tracking surgical instruments in relation to patient anatomy using optical positioning and imaging. This is consistent with a surgical navigation system.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.

Therefore, the "POINT" Kinguide Agile Hybrid Navigation System falls under the category of a surgical navigation system, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

"POINT" Kinguide Agile Hybrid Navigation 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 pedicle screw entry point alignment and angular orientation when using a posterior approach into T12 and L1 vertebrae, and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images.

Product codes

OLO

Device Description

"POINT" Kinguide Agile Hybrid Navigation System (Kinguide Agile) is an imageguided system (IGS) that consists of an infrared navigation camera, a system workstation (computer), navigation software, and surgical instruments. This medical device system can also be referred to as an orthopedic stereotaxic instrument (OLO) according to the U.S. FDA Device Classification.

Kinguide Agile uses optical positioning technologies to track the position of surgical instruments in relation to patient anatomy by means of Dynamic Reference Frames (DRFs) and identify the patient anatomical structure on intraoperative images (obtained using the 3D C-arm or CT*). The user loads the software to plan the surgical procedure and then registers the patient anatomy during surgery to allow the software to track the patient's anatomy and the navigable surgical instruments in real-time.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-Ray Based Imaging

Anatomical Site

T12 and L1 vertebrae

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

The performance data, including required verification/validation, of Kinguide Agile 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. Verification has been conducted to demonstrate that the design specifications and the safety requirements are all met.
The system has a mean accuracy of $\leq$ 2.0 mm for location error and $\leq$ 2.0° for trajectory angle error.
The following verification and validation are performed in support of our performance study:

Performance and Accuracy Verification Report
Cadaveric Validation Report
Compatibility and Measuring Accuracy Verification Report

Key Metrics

Mean positional error of $\leq$ 2.0 mm and mean trajectory error of $\leq$ 2 degrees.

Predicate Device(s)

K220241, K201189, K162309

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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Image /page/0/Picture/0 description: The image contains 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 acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.

July 17, 2023

Point Robotics Medtech Inc. Wayne Kao Director, Quality Management Division 7F. No. 219, Sec. 3, Beixin Rd. Xindian Dist. New Taipei City, 231 Taiwan

Re: K230087

Trade/Device Name: "POINT" Kinguide Agile Hybrid Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: June 21, 2023 Received: June 21, 2023

Dear 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.

1

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 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.

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For 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) K230087

Device Name

"POINT" Kinguide Agile Hybrid Navigation System

Indications for Use (Describe)

"POINT" Kinguide Agile Hybrid Navigation 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 pedicle screw entry point alignment and angular orientation when using a posterior approach into T12 and L1 vertebrae, and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction 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

June 21, 2023

Company Name	Point Robotics MedTech Inc.
Address	7F., No.219, Sec.3, Beixin Rd., Xindian Dist.,
New Taipei City 231, Taiwan
Contact Person (Primary)	Mr. Wayne Kao
Phone	866-2-29130272#2610
Email	wayne.kao@pointroboticsinc.com

1. Submitter's Information

2. Subject Device Information

Proprietary/Trade Name	"POINT" Kinguide Agile Hybrid Navigation System
Regulation Name	Stereotaxic Instrument
Regulation Number	882.4560
Product Code	OLO
Device Classification	II
Review Panel	Orthopedic

3. Device Description

"POINT" Kinguide Agile Hybrid Navigation System (Kinguide Agile) is an imageguided system (IGS) that consists of an infrared navigation camera, a system workstation (computer), navigation software, and surgical instruments. This medical device system can also be referred to as an orthopedic stereotaxic instrument (OLO) according to the U.S. FDA Device Classification.

Kinguide Agile uses optical positioning technologies to track the position of surgical instruments in relation to patient anatomy by means of Dynamic Reference Frames (DRFs) and identify the patient anatomical structure on intraoperative images (obtained using the 3D C-arm or CT*). The user loads the software to plan the surgical procedure and then registers the patient anatomy during surgery to allow the software to track the patient's anatomy and the navigable surgical instruments in real-time.

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The software application primarily provides the stereotactic navigation function to match the coordinates of the patient anatomical structure and establishes a surgical navigation map. The user can perform the operation according to the surgical navigation map through the use of navigable surgical instruments. During surgery, the positions of navigable surgical instruments are continuously updated on the imaging system via optical tracking.

*CT image DICOM file reconstructed from the 3D C-arm or the same function equipment.

4. Indications for Use

"POINT" Kinguide Agile Hybrid Navigation 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 pedicle screw entry point alignment and angular orientation when using a posterior approach into T12 and L1 vertebrae, and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images.

5. Identification of Legally Marketing Devices

K220241 - "POINT" Kinguide Robotic-Assisted Surgical System K201189 - Stealthstation™ S8 Spine Software v1.3.0 K162309 - Stealthstation™ S8 System Platforms and StealthStation Cranial Software

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6. Comparison to the Predicate Device

Item	Subject Device	Primary Predicate	Software Predicate	Platform Predicate
	"POINT" Kinguide
Agile Hybrid
Navigation System	"POINT" Kinguide
Robotic-Assisted
Surgical System	Stealthstation™ S8
Spine Software v1.3.0	StealthStation™ S8
System
K number	N/A	K220241	K201189	K162309
Product Code	OLO	OLO	OLO	HAW, OLO, PGW
Intended Use
& Indications
for Use	"POINT" Kinguide Agile
Hybrid Navigation 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
pedicle screw entry point
alignment and angular
orientation when using a
posterior approach into
T12 and L1 vertebrae, and
where reference to the
rigid anatomical structure	"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	The StealthStation™
System, with
StealthStation Spine
Software, is intended as
an aid for precisely
locating anatomical
structures in either open
or percutaneous
neurosurgical and
orthopedic procedures.
Their use is indicated for
any medical condition in
which the use of
stereotactic surgery may
be appropriate, and where
reference to a rigid
anatomical structure,	The StealthStation™
System, with
StealthStation Cranial
software, is intended as
an aid for precisely
locating anatomical
structures in either open
or percutaneous surgical
procedures. The
StealthStation™ System
is indicated for any
medical condition in
which the use of
stereotactic surgery may
be appropriate, and where
reference to a rigid
anatomical structure,
	Subject Device	Primary Predicate	Software Predicate	Platform Predicate
Item	“POINT” Kinguide
Agile Hybrid
Navigation System	“POINT” Kinguide
Robotic-Assisted
Surgical System	Stealthstation™ S8
Spine Software v1.3.0	StealthStation™ S8
System
	can be identified by
intraoperative 3D
reconstruction images.	images of the anatomy.
The indications include
all medical procedures in
which pedicle screws are
implanted posteriorly into
lumbar vertebrae (L1-L5)
or sacral vertebrae (S1).	such as the spine, can be
identified relative to
images of the anatomy.
This can include, but is
not limited to, the
following procedures:
• Pedicle Screw
Placement
• Iliosacral Screw
Placement
• Interbody Device
Placement	such as the skull, can be
identified relative to a CT
or MR based model,
fluoroscopy images, or
digitized landmarks of
the anatomy.
	System
Accuracy
Requirement	According to verification
and validation results,
Kinguide Agile has
demonstrated
performance in 3D
positional accuracy with
a mean positional error of
$≤$ 2.0 mm and mean
trajectory error of $≤$ 2	According to verification
and validation results,
“POINT” Kinguide
Robotic-Assisted Surgical
System has demonstrated
performance in 3D
positional accuracy with
a mean positional error of
$≤$ 2.0 mm and mean	Under representative
worst-case configuration,
the StealthStation S8
Spine software v1.3.0,
has demonstrated
performance in 3D
positional accuracy with
a mean positional error of
$≤$ 2.0 mm and mean
Item	Subject Device	Primary Predicate	Software Predicate	Platform Predicate
	"POINT" Kinguide
Agile Hybrid
Navigation System	"POINT" Kinguide
Robotic-Assisted
Surgical System	Stealthstation™ S8
Spine Software v1.3.0	StealthStation™ S8
System
	degrees.	trajectory error of ≤ 2
degrees.	trajectory error of ≤ 2
degrees.
Mean Accuracy Values
(StealthAiR Spine):
Positional Error – 1.01 mm
Trajectory Error – 0.37 degrees
Mean Accuracy Values
(Overlapping Slices):
Positional Error – 0.51 mm
Trajectory Error -0.41 degrees	a mean error ≤ 2.0 mm
and in trajectory angle
accuracy with a mean
error ≤ 2.0 degrees.
Imaging
Modalities	X-Ray Based Imaging	X-Ray Based Imaging	X-Ray Based Imaging	X-Ray based, MR based
Nuclear Medicine based
Rigid
Anatomical
Positioning
Methods	Fiducial Frame Lock is a
set of optical markers
mounted on a
dynamic reference frame	Fiducial Frame Lock is a
set of optical markers
mounted on a
dynamic reference frame	N/A	Patient reference frame is
a set of optical markers
mounted on a
metal frame which allows
	Subject Device	Primary Predicate	Software Predicate	Platform Predicate
Item	"POINT" Kinguide
Agile Hybrid
Navigation System	"POINT" Kinguide
Robotic-Assisted
Surgical System	Stealthstation™ S8
Spine Software v1.3.0	StealthStation™ S8
System
	which allows user to
register and track the
anatomy. The Schanz
Screw (reference pin) is
dock on the iliac crest
and combines with the
Fiducial Frame Lock.	which allows user to
register and track the
anatomy. The Schanz
Screw (reference pin) is
dock on the iliac crest
and combines with the
Fiducial Frame Lock.		user to register and track
the anatomy. The
reference pin docks on
the bone and combines
with reference frame.
	Skin Marker Registration
(Referred to as Automatic
Image Registration (AIR)
of predicate devices)	Surface Matching
Registration
Image Landmark
Registration
Precise Surface
Registration
Image Registration	PointMerge Registration
SurfaceMerge
Registration
FluoroMerge Registration
Automatic 2D Image
Registration
Automatic 3D Image
Registration
StealthAiR Spine
Automatic
Registration	PointMerge® registration
(referred to as Landmark
registrations)
Tracer™ registration
Touch registration
(previously Touch-N-
Go™)
StealthAiR® registration,
O-arm® registration,
Mechanical based
registrations (Stereotactic
Localizer Registration
and StarFix™ Bone
Anchor Registration)
Registration
Features
Item	Subject Device	Primary Predicate	Software Predicate	Platform Predicate
	"POINT" Kinguide
Agile Hybrid
Navigation System	"POINT" Kinguide
Robotic-Assisted
Surgical System	Stealthstation™ S8
Spine Software v1.3.0	StealthStation™ S8
System
	Planning
Features	Plan Entry and Target
Selection
3D Model Building	Plan Entry and Target
Selection
3D Model Building	Plan Entry and Target
Selection
3D Model Building
Deformity Planning
	Medical
Device
Interfaces	Philips XperCT
Siemens Artis Pheno
Siemens Artis Zeego
Siemens SOMATOM
Definition AS
Siemens Arcadis Orbic
3D
GE Discovery IGS 730
GE Discovery IGS 7 OR	Siemens Arcadis Varic C-
Arm
Siemens Arcadis Orbic
C-Arm	O-arm Imaging System
Ziehm Vision FD Vario
3D C-Arm
ISO-C 3D C-Arm
Ziehm Vision RFD 3D C-
arm
Stealth-Midas MR8
Orbic 3D C-Arm
		View/Display
Features	Look Sideways
3D View
Anatomic Orthogonal
Trajectory 1 and 2	Look Sideways
3D View
Anatomic Orthogonal
Trajectory 1 and 2
	Subject Device	Primary Predicate	Software Predicate	Platform Predicate
Item	“POINT” Kinguide
Agile Hybrid
Navigation System	“POINT” Kinguide
Robotic-Assisted
Surgical System	Stealthstation™ S8
Spine Software v1.3.0	StealthStation™ S8
System
	Trajectory Guidance
Probe's Eye
AP and Lateral
Maximum Intensity
Projection	Trajectory Guidance
Probe's Eye
AP and Lateral
Maximum Intensity
Projection	Trajectory Guidance
Look Ahead
Probe's Eye
AP and Lateral
Synthetic AP and Lateral
Maximum Intensity
Projection
Video Input	Trajectory 1 and 2, Target
Guidance, Trajectory
Guidance, Probes Eye,
Look Ahead, Microscope
Injection, Video Input,
Endoscopic
Software
Interface
(GUI)	User friendly interface
with procedure task
overview at home page.
System tools for image
adjustment, surgical
planning and instrument
management are
contained in a left-side
bar. The system
information is shown on
the right-side bar.	User friendly interface
with procedure task
overview at home page.
System tools for image
adjustment, surgical
planning and instrument
management are
contained in a left-side
bar. The system
information is shown on
the right-side bar.	Black and gray style with
procedure task overview
in left menu option and
next/back task flow at
bottom of the screen.
Software controls for
images, planning and
instrument management
are contained in a right-side bar.	Black and gray style with
procedure task overview
in left menu option and
next/back task flow at
bottom of the screen.
Software controls for
images, planning and
instrument management
are contained in a right-side bar.
Item	Subject Device	Primary Predicate	Software Predicate	Platform Predicate
	"POINT" Kinguide
Agile Hybrid
Navigation System	"POINT" Kinguide
Robotic-Assisted
Surgical System	Stealthstation™ S8
Spine Software v1.3.0	StealthStation™ S8
System
	Using the algorithm of
transformation matrices
for real-time visualization
& navigation of
instruments relative to
patient image sets	Using the algorithm of
transformation matrices
for real-time visualization
& navigation of
instruments relative to
patient image sets	Not applicable	Not applicable
Navigation
Algorithm
Programming
Language	C++	C++	C++	C++
Scanner
Interface
Technology
(to imaging
devices)	CD, DVD, USB
DICOM Import	CD, DVD, USB
DICOM Import	Network Connectivity
CD, DVD, USB
DICOM Import
DICOM Export	Network Connectivity
CD, DVD, USB
DICOM Import
DICOM Export

Localization
Technology	Optical (infra-red)
Manufacturer: Northern
Digital
Localizer: Vega	Optical (infra-red)
Manufacturer: Northern
Digital
Localizer: Vega	Optical (infra-red)
Manufacturer: Northern
Digital
Localizer: Vega	Optical (infra-red)
Manufacturer: Northern
Digital
Localizer: Vega

Computer
Platform	Intel-based PC	Intel-based PC	Intel-based PC	Intel-based PC

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6.1. Brief Substantial Equivalence Discussion

Kinguide Agile and the predicates "POINT" Kinguide Robotic-Assisted System (K20241) and StealthStation™ System (K201189 and K162309) are based on the following same technological elements:

Intended Use & Indications for Use
System Accuracy Requirement
Imaging Modalities
Rigid Anatomical Positioning Methods
Registration Features
Planning Features
Medical Device Interfaces
View/Display Features
Software Interface (GUI)
Navigation Algorithm
V Programming Language
Scanner Interface Technology
Localization Technology
Computer Platform >

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7. Performance Testing

The performance data, including required verification/validation, of Kinguide Agile 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. Verification has been conducted to demonstrate that the design specifications and the safety requirements are all met.

Verification/Validation	Description
General Design
Requirements	The design control process follows 21 CFR 820.
Risk Management	Compliance with ISO 14971:2019
Human Factors &
Usability Engineering	Usability of the system is validated in accordance
with FDA guidance of applying Human Factors and
Usability Engineering to Medical Devices and IEC
62366-1:2015.
Product Safety	Compliance with standards requirements, including:

IEC 60601-1:2005/CORR.1(2006)+
CORR.2(2007)+AM1(2012)
IEC 60601-1: 2012
IEC 60601-1-2:2014
IEC 60601-1-8:2006+AMD1:2012 |
| Positional Accuracy | Compliance with ASTM F2554-18 and ASTM
F3107-14 |
| Biocompatibility | Biocompatibility of those accessories that having
contact with patients is evaluated in accordance with
FDA guidance for the use of international standard
ISO 10993-1. |
| Software | System software is validated in accordance with:
FDA guidance for the Content of Premarket
Submissions for Software contained in
Medical Devices, 2005
IEC 62304:2006 + A1:2015. |
| Reprocessing | Reusable accessories are validated in accordance |
| Verification/Validation | Description |
| | with: |
| | - FDA guidance for the Reprocessing medical
devices in health care settings: Validation
methods and labeling, 2015. |
| | - AAMI TIR30:2011/(R)2016 |
| | - AAMI TIR12:2020 |
| Sterilization | Compliance with FDA guidance for Submission and
Review of Sterility Information in Premarket
Notification (510(k)) Submissions for Devices
Labeled as Sterile, 2016 |
| | Stability & Reliability evaluation includes: |
| | - Standard Practice for Climatic Stressing of
Packaging Systems acc. ASTM F2825-18 |
| | - Standard Practice for Performance Testing of
Shipping Containers and Systems acc. ASTM
D4169-16 |
| Stability & Reliability | - Standard Guide for Accelerated Aging of
Sterile Barrier Systems for Medical Devices
acc. ASTM F1980-16 |
| | The system has a mean accuracy of $\leq$ 2.0 mm for
location error and $\leq$ 2.0° for trajectory angle error. |
| | The following verification and validation are
performed in support of our performance study: |
| Non-clinical
Performance (Accuracy) | - Performance and Accuracy Verification
Report |
| | - Cadaveric Validation Report |
| | - Compatibility and Measuring Accuracy
Verification Report |

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8. Conclusion

Based on the supporting evidence provided in this premarket notification, Point Robotics believes that the subject device, "POINT" Kinguide Agile Hybrid Navigation System, is substantially equivalent to the predicate devices.