(267 days)
Not Found
No
The summary describes a standard image-guided surgical navigation system that tracks instrument position relative to pre-acquired CT scans. There is no mention of AI, ML, or any related techniques for image analysis, decision support, or other functions. The image processing mentioned is likely for tracking, not AI/ML analysis.
No.
The device is a surgical navigation system that guides the surgeon by providing real-time visualization of instrument tips relative to patient anatomy, assisting in performing surgery rather than directly performing a therapeutic function itself.
No.
The device is a surgical navigation system intended to guide surgical procedures by presenting the location of a surgical instrument relative to existing CT scans. It assists in surgery, not in diagnosing conditions.
No
The device description explicitly lists four main hardware components: NaviENT Cart, Tracking System, Laptop Computer, and NaviENT Instruments. This indicates it is a hardware-based system with integrated software, not a software-only device.
Based on the provided information, the NaviENT device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The NaviENT system's intended use is to guide surgical procedures on the patient's body using pre-acquired CT scans. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The description focuses on surgical guidance and visualization. The core function is to track the position of surgical instruments relative to the patient's anatomy based on imaging data. This is a surgical navigation system, not a diagnostic test performed on a specimen.
Therefore, NaviENT falls under the category of a surgical navigation system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
NaviENT is a computerized surgical navigation system intended to guide sinus and trans-nasal skull base endoscopic surgery by dynamically presenting the location of the tip of a surgical instrument mapped to a corresponding location in a pre-acquired CT scan of the patient's head. The device is intended for use by a qualified ENT surgeon (otolaryngologist).
NaviENT is 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. Surgery procedures include but are not limited to the following: transphenoidal procedures, maxillary antrostomnies, ethmoidectomies, sphenoidectomies, sphenoid explorations, turbinate resections, frontal sinusotomnies, intranasal procedures, intranasal tumor resections, and ENT related skull base surgery.
Product codes
PGW
Device Description
NaviENT is a cart-based, computerized, image-guided navigational system, operating as a combined package for performing guided ENT surgery.
Using pre-acquired CT scan of the sinus, NaviENT provides the surgeon (usually otolaryngologists) with easy-to-use real-time guidance during sinus surgery. The key function performed by NaviENT during navigation is visualization of the instrument tip relative to the surrounding anatomy. This visualization assists the surgeon in performing the surgery.
NaviENT consists of four main components:
-
- NaviENT Cart: Its main purpose is to hold the laptop computer and the tracking camera. The cart is light weight and the arm height can be adjusted. This allows the user to easily position the system in the operating room.
-
- Tracking System: It contains a stereoscopic camera and an IR LED light source, both operating in the near infrared (NIR) light spectrum. The tacking system identifies and pin-points checkered marker patterns affixed on the NaviENT instruments.
-
- Laptop Computer: The NaviENT software runs on a 15.4" Apple Mac Book Pro laptop. Windows 10 operating system is installed on the laptop. The tracking camera's live video stream is received by the laptop via a thunderbolt port and is processed by the NaviENT application.
-
- NaviENT Instruments: The instruments are marked with Black & White patterns which make them trackable by the NaviENT Tracking system. It includes 950-NE-PT Patient Tracker, 950-NE-RP Registration Pointer, 950-NE-FS Frontal Seeker, 950-NE-MS Maxillary Seeker, 950-NE-BP Bayonet Probe, 950-NE-TC Tip Calibrator and 950-NE-UT Universal Tag.
Mentions image processing
The tracking camera's live video stream is received by the laptop via a thunderbolt port and is processed by the NaviENT application.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Sinus, trans-nasal skull base
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified ENT surgeon (otolaryngologist) / Operating Room
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
Bench Testing: Accuracy testing was conducted using 3 different human head models in an OR simulated environment with typical navigation instruments. The NaviENT system demonstrated 3D positional accuracy with an average error of less than 2mm.
Key Metrics
Average Error less than 2.0 (for 3D positional accuracy)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 1, 2017
Claronav Inc. Ahmad Kolahi CEO 1140 Sheppard Avenue West - Unit 10 Toronto, M3K 2A2 CA
Re: K163439
Trade/Device Name: Navient Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: August 2, 2017 Received: August 3, 2017
Dear Ahmad Kolahi:
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. 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.
1
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
NaviENT
Indications for Use (Describe)
NaviENT is a computerized surgical navigation system intended to guide sinus and trans-nasal skull base endoscopic surgery by dynamically presenting the location of the tip of a surgical instrument mapped to a corresponding location in a pre-acquired CT scan of the patient's head. The device is intended for use by a qualified ENT surgeon (otolaryngologist).
NaviENT is 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 identified relative to images of the anatomy. Surgery procedures include but are not limited to the following: transphenoidal procedures, maxillary antrostomnies, ethmoidectomies, sphenoidectomies, sphenoid explorations, frontal sinusotomnies, intranasal procedures, intranasal tumor resections, and ENT related skull base surgery.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image contains a logo with two distinct parts. On the left, there is a circular graphic with alternating black and white quadrants, each containing radiating lines. To the right of the graphic, the text "ClaroNav" is displayed above a black rectangle containing the word "Kolahi" in white font.
510(k) SUMMARY
SUBMITTER INFORMATION
| Company Name: | ClaroNav Kolahi Inc. |
|---|---|
| Company Address: | 1140 Sheppard Avenue West - Unit 10 |
| Toronto, Ontario | |
| Canada - M3K 2A2 | |
| Company Phone: | (647) 951-1525 |
| Company Fax: | (647) 951-1524 |
| Contact Person: | Ahmad Kolahi, CEO |
| Date Summary Prepare: | August 2nd 2017 |
DEVICE IDENTIFICATION
| Trade/Proprietary Name: | NaviENT |
|---|---|
| Classification: | II |
| Generic Device Name: | Surgical Navigation System |
| Product Code: | PGW |
| Classification Names: | Stereotaxic Instrument |
| Classification Regulation #: | 21 CFR 882.4560 |
| Classification Panel: | ENT |
| Predicate Device: | Karl Storz Navigation Panel Unit (NPU) System (K122096) |
DEVICE DESCRIPTION
NaviENT is a cart-based, computerized, image-guided navigational system, operating as a combined package for performing guided ENT surgery.
Using pre-acquired CT scan of the sinus, NaviENT provides the surgeon (usually otolaryngologists) with easy-to-use real-time guidance during sinus surgery. The key function performed by NaviENT during navigation is visualization of the instrument tip relative to the surrounding anatomy. This visualization assists the surgeon in performing the surgery.
NaviENT consists of four main components:
4
Image /page/4/Picture/0 description: The image contains the logo for ClaroNav Kolahi. On the left side of the logo is a black and white circular design. To the right of the design is the text "ClaroNav" in black, and below that is the text "Kolahi" in white on a black background.
-
- NaviENT Cart: Its main purpose is to hold the laptop computer and the tracking camera. The cart is light weight and the arm height can be adjusted. This allows the user to easily position the system in the operating room.
-
- Tracking System: It contains a stereoscopic camera and an IR LED light source, both operating in the near infrared (NIR) light spectrum. The tacking system identifies and pin-points checkered marker patterns affixed on the NaviENT instruments.
-
- Laptop Computer: The NaviENT software runs on a 15.4" Apple Mac Book Pro laptop. Windows 10 operating system is installed on the laptop. The tracking camera's live video stream is received by the laptop via a thunderbolt port and is processed by the NaviENT application.
-
- NaviENT Instruments: The instruments are marked with Black & White patterns which make them trackable by the NaviENT Tracking system. It includes 950-NE-PT Patient Tracker, 950-NE-RP Registration Pointer, 950-NE-FS Frontal Seeker, 950-NE-MS Maxillary Seeker, 950-NE-BP Bayonet Probe, 950-NE-TC Tip Calibrator and 950-NE-UT Universal Tag.
NaviENT Clinical Workflow:
NaviENT Software workflow provides step by step instructions on how to set up and use the system in the Operating room. The software has been pre-installed on the NaviENT laptop. The shortcut for the NaviENT application is placed on the desktop. When started it opens the data browser window, allowing the user to load, import and delete patient image data. Once data is loaded, NaviENT operation proceeds sequentially through 5 stages as follows:
-
- Verify: This stage displays the 3D data as well as 2D axial, coronal and sagittal reformatted slice views and allows the user to rotate, zoom and explore the data.
-
- Mark Landmarks: This stage walks the user through selecting a few anatomical landmarks on the 3D scan. The names of each landmark and an illustration of its approximate locations are displayed for convenience.
-
- Set Up: This stage provides step by step instructions to place the patient tracker and position the tracking device. The live video stream displayed on the side panel makes it very intuitive to position the camera.
-
- Registration: NaviENT uses landmark based registration followed by trace based registration. This stage provides step by step instructions to perform registration process.
-
- Navigation: Presents real-time location of the instrument tip super imposed on the 2D images of sagittal, axial and coronal views of the patient scan.
5
Image /page/5/Picture/0 description: The image contains the logos for ClaroNav and Kolahi. The ClaroNav logo is on the top line, and the Kolahi logo is on the second line. Below the logos, the text "INDICATIONS FOR USE" is written.
NaviENT has the following Indications for Use:
NaviENT is a computerized surgical navigation system intended to guide sinus and trans-nasal skull base endoscopic surgery by dynamically presenting the location of the tip of a surgical instrument mapped to a corresponding location in a pre-acquired CT scan of the patient's head. The device is intended for use by a qualified ENT surgeon (otolaryngologist).
NaviENT is 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. Surgery procedures include but are not limited to the following: transphenoidal procedures, maxillary antrostomnies, ethmoidectomies, sphenoidectomies, sphenoid explorations, turbinate resections, frontal sinusotomnies, intranasal procedures, intranasal tumor resections, and ENT related skull base surgery.
SUBSTANTIAL EQUIVALENCE
NaviENT shares technological, performance and clinical features and has an identical intended use as the Karl Storz Navigation Panel Unit (NPU) System:
| Predicate
Company | Predicate
Trade Name | 510(k) # | Predicate Intended Use |
|----------------------|--------------------------------------------------------|----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Karl Storz | Karl Storz
Navigation
Panel Unit
(NPU) System | K122096 | The Navigation Panel Unit System (NPU) is an
intraoperative image guided localization system that
links a freehand probe tracked by a passive marker
sensor system to a virtual computer image space on a
patient's preoperative diagnostic image data set. The
system is intended to be used as a positioning aid for
navigation in ENT surgery, including but not limited to
endoscopic surgery. The NPU is indicated for any
medical condition in which the use of stereotactic
surgery may be appropriate and where a reference to
a rigid anatomical structure can be identified relative
to the radiological imaging-based model of the
anatomy. Surgery procedures include but are not
limited to the following: transphenoidal procedures,
maxillary antrostomnies, ethmoidectomies,
sphenoidectomies, sphenoid explorations, turbinate
resections, frontal sinusotomnies, intranasal
procedures, intranasal tumor resections, otologic
surgery, and ENT skull base surgery. |
6
Image /page/6/Picture/0 description: The image contains a logo with a black and white design. On the left side, there is a circular pattern with alternating black and white sections and radiating lines. To the right of the pattern, the text "ClaroNav" is displayed in a bold, sans-serif font above a black rectangle. Within the black rectangle, the word "Kolahi" is written in a similar bold, sans-serif font.
Comparison of Technological Characteristics
NaviENT shares many clinical, technological and performance characteristics with a predicate device, the Karl Storz Navigation Panel Unit (NPU) System. These characteristics are outlined in the following table:
| Feature/
Characteristic | Karl Storz NPU (predicate) | NaviENT | Rationale for any
differences |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Class/Product
Code/Classification
Name | Class II/ HAW/ 882.4560 (
Stereotaxic Instrument) | Class II/ PGW/ 882.4560 (
Stereotaxic Instrument) | Same |
| Indications for Use | The Navigation Panel Unit System
(NPU) is an intraoperative image
guided localization system that links
a freehand probe tracked by a
passive marker sensor system to a
virtual computer image space on a
patient's preoperative diagnostic
image data set. The system is
intended to be used as a positioning
aid for navigation in ENT surgery,
including but not limited to
endoscopic surgery. The NPU is
indicated for any medical condition
in which the use of stereotactic
surgery may be appropriate and
where a reference to a rigid
anatomical structure can be
identified relative to the
radiological imaging-based model of
the anatomy. Surgery procedures
include but are not limited to the
following: transphenoidal
procedures, maxillary
antrostomnies, ethmoidectomies,
sphenoidectomies, sphenoid
explorations, turbinate resections,
frontal sinusotomnies, intranasal
procedures, intranasal tumor
resections, otologic surgery, and
ENT skull base surgery. | NaviENT is a computerized
surgical navigation system
intended to guide sinus and
trans-nasal skull base endoscopic
surgery by dynamically
presenting the location of the tip
of a surgical instrument mapped
to a corresponding location in a
pre-acquired CT scan of the
patient's head. The device is
intended for use by a qualified
ENT surgeon (otolaryngologist).
NaviENT is 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. Surgery
procedures include but are not
limited to the following:
transphenoidal procedures,
maxillary antrostomnies,
ethmoidectomies,
sphenoidectomies, sphenoid
explorations, turbinate
resections, frontal
sinusotomnies, intranasal
procedures, intranasal tumor
resections, and ENT related skull
base surgery. | Same indications,
phrased differently. |
| Feature/
Characteristic | Karl Storz NPU (predicate) | NaviENT | Rationale for any
differences |
| Main functions | Locating anatomical locations inside
patient. | Locating anatomical locations
inside patient | Same. |
| Use Environment | Operating Room | Operating Room | Same. |
| Target Population | Patients who has to go under
endoscopic sinus surgery or ENT
skull base surgery. | Patients who has to go under
endoscopic sinus surgery or ENT
skull base surgery. | Same. |
| Users | ENT Surgeons(Otolaryngologist) | ENT Surgeons(Otolaryngologist) | Same. |
| Technological
Characteristics | | | |
| Input imaging modality | CT and MRI | CT | Navient supports a
subset of the predicate's
inputs, therefore any
input suitable for
NaviENT is suitable for
the predicate device as
well. |
| Dynamic object pose
measurement
technology | Stereoscopic Optical Tracking
system | Stereoscopic Optical Tracking
system | Same. |
| Illumination of
tracking targets | Infra-red light | Infra-red light | Same. |
| Patient to CT image
registration | Landmark based registration
followed by surface matching | Landmark based registration
followed by surface matching | Same. |
| Standard Navigation
Instruments | 1. Patient Tracker
2. Navigation Probe
3. Frontal Sinus Probe
4. DrillCut-X Shaver
Handpiece
5. Microscope Probe
6. Optical Instrument
Tracker | 1. Patient Tracker
2. Bayonet pointer
3. Frontal Ostium Seeker
4. Universal Tag
5. Registration Pointer
6. Maxillary Ostium
Seeker
7. Calibrator | Similar.
NaviENT provides extra
instruments of
Registration Pointer,
Maxillary Ostium Seeker
and Calibrator. This is
intended to improve
usability.
NaviENT does not require
the use of a Microscope
Probe and Optical
Instrument Tracker. |
| Mount for camera and
display | Both Camera and display mounted
on the cart | Both camera and the display
mounted on the cart. | Similar.
NaviENT cart has foldable
arm where as NPU cart is
pull up/down bar. |
| Instruments Tip
Calibration | By touching Patient Tracker | By touching Calibrator
instrument. | Similar.
NaviENT has provided a
designated instrument to
calibrate instrument tips
where as NPU is using
patient tracker. |
| Presentation of
navigation guidance | 3D graphics presentation of
instrument position, angle relative
to patient image. | 3D graphics presentation of
instrument position, angle
relative to patient image. | Same. |
| Software Equivalence | | | |
| Clinical Software
Features | DICOM image visualization in 3D
and 2D views (axial, coronal,
sagittal), Patient to image
registration features | DICOM image visualization in 3D
and 2D views (axial, coronal,
sagittal), Patient to image
registration features | Similar. Minor
differences, mainly in
user interface to the
same underlying
functions. |
| Performance
Characteristics | | | |
| System Accuracy | N/A | Average Error less than 2.0 | Similar. A direct
published accuracy data
for the predicate is not
available however the
predicate to NPU system
(i.e. K964229) claims
accuracy of 2.56mm. |
| Materials
Equivalence | | | |
| Patient Mucosal
membrane contacting
parts | Navigation Probe
Frontal Sinus Probe | Bayonet pointer
Frontal Ostium Seeker
Maxillary Ostium Seeker | Similar.
NPU Navigation probe is
equivalent to NaviENT
Bayonet probe.
NaviENT provides both
Frontal and Maxillary
Ostium seekers. This
improves usability. |
| Patient contacting
Instruments Material | Medical grade Stainless Steel | Medical grade Stainless Steel | Same. |
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Image /page/7/Picture/0 description: The image contains the logo for ClaroNav Kolahi. On the left side of the logo is a black and white circular design with lines radiating from the center. To the right of the design, the word "ClaroNav" is written in black, and below that, the word "Kolahi" is written in white on a black background.
8
Image /page/8/Picture/0 description: The image contains the logo for ClaroNav Kolahi. The logo is split into two sections, with the left side containing a black and white circular design with radiating lines. The right side of the logo contains the text "ClaroNav" in white above a black rectangle with the text "Kolahi" in white.
9
Image /page/9/Picture/0 description: The image contains a logo with a geometric design on the left and text on the right. The geometric design features a circle divided into quadrants with alternating black and white sections, surrounded by radiating lines. To the right of the design, the text "ClaroNav" is displayed above a black rectangle containing the word "Kolahi" in white. The text is in a sans-serif font and appears to be the name of a company or product.
Determination of Substantial Equivalence
NaviENT is identical to the predicate device in indications for use, intended target populations, the target users, the principles of operation and the indications for use.
NaviENT has very similar technological characteristics to the predicate device. The supported Tracking device, image modality, registration techniques and software are very similar. Minor technological differences between NaviENT and predicate device include:
- . Markers: Both NaviENT and the predicate device are using Optical Tracking system with very similar principle of operation. The only minor difference is that, NPU is using spherical shape marker where as NaviENT is using multi-facet flat markers. This difference does not impact the safety and effectiveness of either device in performing its intended use.
- Instruments: NaviENT provides dedicated instruments to perform the Registration process, while the predicate device uses its Navigation Probe to perform registration process as well. NaviENT provides a dedicated instrument to perform Calibration process, while the predicate device uses its Patient Tracker not only to track the patient but also to perform the Calibration process. NaviENT also provides additional dedicated instrument of Maxillary Ostium Seeker, while the predicate does not provide such an instrument. The dedicated instruments improves the usability. NaviENT does not provide Microscope Probe and Optical Instrument Tracker.
10
Image /page/10/Picture/0 description: The image contains a logo with two distinct parts. On the left, there is a circular graphic with alternating black and white sections, resembling a stylized target or compass. To the right of the graphic, the text "ClaroNav" is displayed above the word "Kolahi", with the latter set against a solid black background.
- While the predicate device permits using MRI data and NaviENT does not, equivalence is maintained for all cases where CT data input is used.
The above design differences relate solely to the usability aspects of the devices, not to the core functions they perform, which are substantially identical. These differences do not impact the safety and effectiveness of either device in performing its intended use.
In conclusion, the systems are substantially equivalent.
COMPLIANCE TO STANDARDS AND REGULATIONS
The following FDA approved standards are met by the Navident system as demonstrated through performance testing:
ISO 14971 Second edition 2007-03-01, medical devices - application of risk management to medical devices
AAMI/ANSI/IEC 62304:2006 Medical Device Software - Software Life Cycle Processes.
ISO 15223-1 Second Edition 2012-07-01, medical devices - symbols to be used with medical device labels, labelling, and information to be supplied - part 1: general requirements.
AAMI/ANSI/ISO 10993-1:2009/(R) 2013, Biological Evaluation of Medical Devices - part 1: evaluation and testing within a risk management process.
AAMI / ANSI / ISO 10993-5:2009/(R) 2014, biological evaluation of medical devices -- part 5: tests for in vitro cytotoxicity.
AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (IEC 60601-1:2005, mod)
AAMI / ANSI / IEC 60601-1-2:2007/(R)2012, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests (Edition 3)
IEC 62471 First edition 2006-07, photobiological safety of lamps and lamp systems. (Radiology)
SUMMARY OF PERFORMANCE TESTING
Safety and performance testing of the NaviENT system was conducted in accordance with all above referenced standards and regulations. All system requirements, including accuracy requirements, were validated thoroughly, and found to be comparable to those specified by the FDA cleared predicate devices.
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Image /page/11/Picture/0 description: The image contains a logo with a geometric design on the left and text on the right. The geometric design features a circle divided into quadrants with alternating black and white sections, and radiating lines extending from the center. To the right of the design, the text "ClaroNav" is displayed above the text "Kolahi", with the latter set against a black background.
The following safety and performance testing was conducted:
-
- Software Validation: Successful testing verifying the software requirements are met and software performs as intended.
-
- Cleaning and Sterilization: A representative sample of the re-usable NaviENT components were tested to validate that the components can withstand the recommended cleaning, disinfection and sterilization processes and that a sterility assurance level (SAL) of 10-6 can be achieved using the recommended sterilization protocols. The sterilization validation testing was conducted according to ISO 17665-1:2006 and it validated that the re-usable NaviENT components can be sterilized to reach an SAL of 10-6.
-
- Bench Testing: All planned performance tests were executed as planned, and all of them succeeded in meeting their acceptance criteria. Accuracy testing was conducted to ensure that the NaviENT system met the prescribed requirement for accuracy. The NaviENT system demonstrates performance in 3D positional accuracy with average error of less than 2mm. this performance was determined using 3 different human head models in an OR simulated environment with all of the typical navigation instruments.
-
- Electrical and EMC Testing: The NaviENT system was tested for electrical safety and essential performance according to the requirements IEC 60601-1:2005 In addition, NaviENT passed all the relevant requirements of the IEC 60601-1-2:2007 and IEC 62471:2006 standards demonstrating that the device meets the applicable electromagnetic compatibility requirements as well as and that the lights used in the NaviENT system are safe to be used as intended.
-
- Biocompatibility Testing: The patient contacting NaviENT components were tested according to the requirements of ISO 10993-1 and were deemed to be biocompatible.
-
- Human Factors: NaviENT human factors report and validation testing provided sufficient data to support their conclusion of substantial equivalence with regards to differences in system user interface and use scenarios from the predicate.
CONCLUSION
NaviENT is identical to the predicate device in indications for use, intended target populations, the target users, the principles of operation and the indications for use.
NaviENT has very similar technological characteristics to the predicate device. The supported Tracking device, image modality, registration techniques and software are very similar. The only differences relate to minor differences in the markers used by the tracking devices; the instruments provided and the type of image data input. These differences do not impact the safety and effectiveness of either device in performing its intended use.
In conclusion, NaviENT and its identified predicate systems are substantially equivalent.