(111 days)
Not Found
No
The description focuses on image-guided navigation using pre-acquired CT scans and optical tracking, without mentioning any AI or ML components for image analysis, planning, or guidance.
No.
The device assists in surgical planning and guidance, aiming to improve the accuracy of a surgical procedure rather than directly treating a disease or condition itself.
No
Explanation: The device is described as a surgical navigational system that assists in planning and guiding drilling during implantation surgery. Its function is to help in the execution of a medical procedure, not to diagnose a condition.
No
The device description explicitly lists four main components, including hardware components like a notebook computer, handpiece attachment, patient jaw attachment, and an optical position sensor. While software runs on the computer, the system relies on these physical components for its functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Navident's Function: Navident is a surgical navigation system. It uses pre-acquired CT scans of the patient's jaw to assist in planning and guiding drilling during dental implant surgery. It directly interacts with the patient's anatomy during a surgical procedure.
- Lack of Specimen Analysis: The device does not analyze any biological specimens from the patient. Its function is entirely focused on image-guided surgical assistance.
Therefore, Navident falls under the category of a surgical guidance system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Navident is a computerized dental navigational system intended to assist preoperative planning and to guide drilling in a patient jaw during implantation surgery, using pre-acquired CT scan of the jaw. The device is intended for use by a qualified dental surgeon in the treatment of partial edentulism.
Product codes
PLV
Device Description
Navident is a cart-based, computerized, image-guided dental navigational system, operating as a combined package for performing both pre-operative planning and guided implant insertion. Using preacquired CT scan of the jaw, Navident provides the dentist (usually a GP dentist, prosthodontist, periodontist or dental surgeon) with implantation planning and real-time guidance during dental implants insertion.
The guidance function of Navident is primarily provided using a visualization of the drill pose (tip location and shaft axis direction) relative to the desired pose of the implant, as planned on a preacquired CT image of the jaw. This visualization assists the dentist in implementing their implantation plan.
Navident consists of four main components:
-
- A notebook computer positioned above the patient's chest. The Navident software running on the computer provides both planning and navigation functionalities.
-
- A handpiece attachment. The attachment consists of a universal removable metal adapter, and a specially marked plastic part, named DrillTag, which latches on the adapter.
-
- A customizable patient jaw attachment consisting of a moldable stent part, named NaviStent, and a matching specially marked plastic tag, named JawTag. NaviStent can be formed, customized and tested for fit directly on the patient's jaw or on a plaster model. The patient wears the NaviStent during the CT scan and again during the surgery. Navident is able to continuously register NaviStent's position during surgery with its appearance in the CT scan automatically.
-
- An optical position sensor which detects high contrast patterns printed on the DrillTag and JawTag and constantly reports their relative positions to the Navident software.
To allow Navident to provide accurate guidance, the dentist fits the NaviStent retainer to the patient's jaw in a chair-side process. The fit can be evaluated to ensure predictable results.
A special CT-Marker is connected to the NaviStent, and the patient is CT-scanned with the NaviStent in place, as with any CT-guide stent. The CT data is loaded into Navident and an implant plan is prepared by the surgeon.
Prior to start of drilling for implants, NaviStent is placed in the patient's mouth, the DrillTag is latched on the tag adapter, and the drill axis location is calibrated in a single motion. When a new drill is inserted, its length and exact tip position are calibrated by touching a dimpled point on the JawTag prior to inserting it into the mouth.
During surgery, Navident automatically tracks the handpiece's motions. When the drill approaches a pre-planned implant location, Navident provides a cross-hairs dynamic visualization of the drill pose relative to the planned pose of the implant. This visualization guides the hand motions of the surgeon towards locating the planned entry point, adjusting the drill axis to the planned angle, and drilling to the planned depth. When not near a marked implantation path, Navident provides real-time visual feedback showing the bone densities in the region in front of the drill's tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Jaw
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Qualified dental surgeon in a dental clinic.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing of the Navident system was conducted in accordance with all the above referenced standards and regulations. All system requirements, including accuracy requirements, were validated thoroughly, and found to be comparable to those of the predicate device.
Navident's performance testing included:
-
- Sterilization Validation: A representative sample of the re-usable Navident components were tested to validate that the components can withstand the steam sterilization process and that acceptable sterility is achieved using the recommended sterilization protocols. The sterilization validation testing was conducted according to ISO 17665-1:2006 and it validated that the reusable Navident components can be sterilized to reach an acceptable sterility assurance level.
-
- Biocompatibility Testing: The patient-contacting Navident components were tested according to the ISO 10993-1 series as follows:
- . Navident components were tested using the MEM Elution test method to assess cytotoxic effects. as per ISO 10993-5 biological evaluation of medical devices -- part 5: tests for in vitro cytotoxicity. All test method acceptance criteria were met, supporting the conclusion that the Navident component is biocompatible and appropriate for its intended use.
- . Navident components were tested for hypersensitivity reactions following the Maximization Sensitization Test Method which meets the criteria of ISO 10993-10:2010 Biological Evaluation of medical devices Part 10: Tests for Irritation and Skin Sensitization. No evidence of reaction or sensitization of the Navident test article on the test subjects was observed and all acceptance criteria were met.
- . Irritation testing of Navident components was completed following the Oral Mucosal Irritation Study which meets the criteria of SO 10993-10:2010 Biological Evaluation of medical devices Part 10: Tests for Irritation and Skin Sensitization. No evidence of irritation to the test subject's oral mucous membranes was observed and all acceptance criteria were met.
-
- Full system bench testing was conducted on the Navigation system. The bench tests evaluated the following operational aspects:
- a. Overall accuracy of the system in mapping the drill tip to the CT image;
- Repeatability of the handpiece calibration process;
- C. Effect of different image voxel sizes on the mapping accuracy;
- d. Effect of distance between the tracking camera and the JawTag on mapping accuracy;
- e. Effect of the number of available fiducial corners on mapping accuracy;
- f. Effect of different ambient lighting conditions on mapping accuracy;
- Effect of camera warmup time on mapping accuracy; g.
- Effectiveness of the NaviStent fabrication process with a number of random jaw models; h.
- i. Evaluating possibility of getting the NaviStent locked onto the teeth;
- j. Repeatability of interlocking of CT Marker with Retainer during CT scan;
- Impact of autoclaving cycles on Silicon tape strength; k.
- l. Tag adapter sterilization tolerance;
- m. Effect of ambient temperature on accuracy;
- n. Effect of strong light shining on one of the tags (HDR mode);
The bench tests were executed as planned, and all of them succeeded in meeting their acceptance criteria. Additionally, the system passed all tests of immunity to electromagnetic interference according to IEC 60601-1-2 while providing accurate drilling guidance.
-
- Human factors/usability summative evaluation was conducted on the Navident system under controlled simulated setting. 15 representative users (i.e., oral surgeons, general dental practitioners) were observed performing representative and high-risk tasks with the Navident system while test administrators monitored the proceedings for any use errors, close calls, operational difficulties that may be indicative of use-safety or usability problems. The assessment of the test results demonstrated that the Navident system satisfies user specifications for use by qualified dentists for its intended use. .
-
- ClaroNav has collected and compiled clinical, usability and accuracy data related to the application of Navident in clinical practice by a diverse international group of surgeons. The clinical case data collected consisted of 21 cases with 36 guided implantations. In all cases, Navident fully performed its intended function without complications. Accuracy assessment demonstrated that, with Navident's guidance, an experienced user is able to achieve an implant placement accuracy averaging 1.0mm deviation from plan at both entry and apex. The clinical evaluation further consisted of collecting systematic feedback on usage history and professional impressions from 7 surgeons who treated a total 150 patients guided by Navident. No significant patient adverse events or complications were reported by any participating surgeon.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy at the drill tip: ≤1.0mm
Presentation update rate: Real time
Accuracy assessment demonstrated that, with Navident's guidance, an experienced user is able to achieve an implant placement accuracy averaging 1.0mm deviation from plan at both entry and apex.
Predicate Device(s)
X-Guide Surgical Navigation System (K150222)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that forms the shape of a serpent. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 8, 2016
ClaroNav Inc. Doron Dekel CEO 1140 Sheppard Avenue West, Unit 10 Toronto, Ontario M3K 2A2 Canada
Re: K161406
Trade/Device Name: Navident Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: PLV Dated: August 9, 2016 Received: August 15, 2016
Dear Doron Dekel:
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. 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
1
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 yours,
Michael J. Ryan -S
for Tina Kiang, Ph.D.
Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161406
Device Name
Navident
Indications for Use (Describe)
Navident is a computerized dental navigational system intended to assist preoperative planning and to guide drilling in a patient jaw during implantation surgery, using pre-acquired CT scan of the jaw. The device is intended for use by a qualified dental surgeon in the treatment of partial edentulism.
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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Image /page/3/Picture/0 description: The image contains the logo for ClaroNav. The logo features a black and white circular design on the left side, resembling a stylized target or radar. To the right of the circular design, the text "ClaroNav" is displayed in a bold, sans-serif font. The text is positioned above a solid black rectangle, creating a contrasting visual element.
510(k) SUMMARY
SUBMITTER INFORMATION
| Company Name: | ClaroNav 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: | Doron Dekel, CEO |
| Date Summary Prepared: | September 2 , 2016 |
DEVICE IDENTIFICATION
| Trade/Proprietary Name: | Navident |
|---|---|
| Classification: | II |
| Generic Device Name: | Surgical Navigation System |
| Product Code: | PLV |
| Classification Names: | Bone Cutting Instrument and Accessories |
| Classification Regulation #: | CFR 872.4120 |
| Classification Panel: | Dental |
| Predicate Devices: | X-Guide Surgical Navigation System (K150222) |
DEVICE DESCRIPTION
Navident is a cart-based, computerized, image-guided dental navigational system, operating as a combined package for performing both pre-operative planning and guided implant insertion. Using preacquired CT scan of the jaw, Navident provides the dentist (usually a GP dentist, prosthodontist, periodontist or dental surgeon) with implantation planning and real-time guidance during dental implants insertion.
The guidance function of Navident is primarily provided using a visualization of the drill pose (tip location and shaft axis direction) relative to the desired pose of the implant, as planned on a preacquired CT image of the jaw. This visualization assists the dentist in implementing their implantation plan.
4
Image /page/4/Picture/0 description: The image contains the logo for ClaroNav. The logo consists of a black and white circular design on the left, with the text "ClaroNav" in black on a white background to the right of the design. A black bar is located underneath the text.
Navident consists of four main components:
-
- A notebook computer positioned above the patient's chest. The Navident software running on the computer provides both planning and navigation functionalities.
-
- A handpiece attachment. The attachment consists of a universal removable metal adapter, and a specially marked plastic part, named DrillTag, which latches on the adapter.
-
- A customizable patient jaw attachment consisting of a moldable stent part, named NaviStent, and a matching specially marked plastic tag, named JawTag. NaviStent can be formed, customized and tested for fit directly on the patient's jaw or on a plaster model. The patient wears the NaviStent during the CT scan and again during the surgery. Navident is able to continuously register NaviStent's position during surgery with its appearance in the CT scan automatically.
-
- An optical position sensor which detects high contrast patterns printed on the DrillTag and JawTag and constantly reports their relative positions to the Navident software.
To allow Navident to provide accurate guidance, the dentist fits the NaviStent retainer to the patient's jaw in a chair-side process. The fit can be evaluated to ensure predictable results.
A special CT-Marker is connected to the NaviStent, and the patient is CT-scanned with the NaviStent in place, as with any CT-guide stent. The CT data is loaded into Navident and an implant plan is prepared by the surgeon.
Prior to start of drilling for implants, NaviStent is placed in the patient's mouth, the DrillTag is latched on the tag adapter, and the drill axis location is calibrated in a single motion. When a new drill is inserted, its length and exact tip position are calibrated by touching a dimpled point on the JawTag prior to inserting it into the mouth.
During surgery, Navident automatically tracks the handpiece's motions. When the drill approaches a pre-planned implant location, Navident provides a cross-hairs dynamic visualization of the drill pose relative to the planned pose of the implant. This visualization guides the hand motions of the surgeon towards locating the planned entry point, adjusting the drill axis to the planned angle, and drilling to the planned depth. When not near a marked implantation path, Navident provides real-time visual feedback showing the bone densities in the region in front of the drill's tip.
5
Image /page/5/Picture/0 description: The image contains the logo for ClaroNav. The logo features a stylized circular design on the left, composed of black and white sections. To the right of the circular design, the text "ClaroNav" is displayed in a bold, sans-serif font. A horizontal black bar runs beneath the text, creating a contrasting visual element.
INDICATIONS FOR USE
Navident has the following Intended Use:
Navident is a computerized dental navigational system intended to assist preoperative planning and to guide drilling in a patient jaw during implantation surgery, using pre-acquired CT scan of the jaw. The device is intended for use by a qualified dental surgeon in the treatment of partial edentulism.
SUBSTANTIAL EQUIVALENCE
Navident shares technological, performance and clinical features and has substantially equivalent intended use as the X-Guide Surgical Navigation System:
| Predicate
Company | Predicate
Trade Name | 510(k) # | Predicate Indications for Use |
|-----------------------|---------------------------------------------|----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| X-NAV
Technologies | X-Guide
Surgical
Navigation
System | K150222 | The X-Guide ® Surgical Navigation System is a
computerized navigational system intended to provide
assistance in both preoperative planning phase and
intra-operative surgical phase of dental implantation
procedures. The system provides software to
preoperatively plan dental implantation procedures
and provides navigational guidance of the surgical
instruments. The device is intended for use for
partially edentulous and edentulous adult and geriatric
patients who require dental implants as part of their
treatment plan. |
Comparison of Technological Characteristics
Navident shares many clinical, technological and performance characteristics with a predicate device, the X-Guide Surgical Navigation System. These characteristics are outlined in the following table:
| Feature/
| Characteristic | X-Guide (predicate) | Navident | Rationale for any differences |
|---|---|---|---|
| Intended Use | |||
| Class/Product | |||
| Code/Classification | |||
| Name | Class II/ PLV/ 21 CFR | ||
| 872.4120 ( (Bone Cutting | |||
| Instrument and Accessories) | Class II/ PLV/ 21 CFR | ||
| 872.4120 ( (Bone Cutting | |||
| Instrument and Accessories) | Same | ||
| The X-Guide® Surgical | Navident is a computerized | Since Navident's indications are | |
| Indications for Use | The X-Guide® Surgical | ||
| Navigation System is a | |||
| computerized navigational | |||
| system intended to provide | |||
| assistance in both the | |||
| preoperative planning phase | |||
| and the intra-operative surgical | |||
| phase of dental implantation | |||
| procedures. The system | |||
| provides software to | |||
| preoperatively plan dental | |||
| implantation procedures and | |||
| provides navigational guidance | |||
| of the surgical instruments. The | |||
| device is intended for use for | |||
| partially edentulous and | |||
| edentulous adult and geriatric | |||
| patients who need dental | |||
| implants as part of their | |||
| treatment plan. | Navident is a computerized | ||
| dental navigational system | |||
| intended to assist preoperative | |||
| planning and to guide drilling in | |||
| a patient jaw during | |||
| implantation surgery, using pre- | |||
| acquired CT scan of the jaw. The | |||
| device is intended for use by a | |||
| qualified dental surgeon in the | |||
| treatment of partial edentulism. | a subset of the predicate's, each | ||
| case in which Navident is used is | |||
| indicated for the predicate as | |||
| well. | |||
| Main functions | CT-based implant placement | ||
| planning. Presentation of | |||
| position, angle and depth | |||
| indicators when drilling in the | |||
| jaw. | CT-based implant placement | ||
| planning. Presentation of | |||
| position, angle and depth | |||
| indicators when drilling in the | |||
| jaw. | Same | ||
| Use Environment | Dental clinic | Dental clinic | Same |
| Target Population | Adult and geriatric patients | Adult patients | Same |
| Users | Dental surgeon | Dental surgeon | Same |
| Technological | |||
| Characteristics | |||
| Input imaging modality | CT | CT | Same |
| Dynamic object pose | |||
| measurement | |||
| technology | Stereoscopic triangulation of | ||
| illuminated checker-board | |||
| patterns (X-Corners). | Stereoscopic triangulation of | ||
| illuminated checker-board | |||
| patterns (X-Points). | Similar technology with some | ||
| differences in implementation | |||
| details. | |||
| Handpiece tracking | |||
| attachment | An optically marked tube-like | ||
| attachment to the back of the | |||
| handpiece. | Universal adapter for any | ||
| handpiece with a visually | |||
| marked lightweight disposable | |||
| plastic tag. | Both systems provide a rigid | ||
| handpiece attachment | |||
| mechanism with some | |||
| differences in implementation | |||
| details. | |||
| Jaw tracking | |||
| attachment | U-shaped "X-clip" with a | ||
| molded thermoplastic insert, | |||
| mounted on the available | |||
| dentition. During surgery, a | |||
| metallic arm holding an | |||
| optically marked metal | |||
| cylinder is connected to it. | "NaviStent" molded | ||
| thermoplastic sheet with an | |||
| integrated arm holding an | |||
| optically marked plastic tag. | In both systems, a thermoplastic | ||
| part is molded to the surface of | |||
| the jaw to provide a coupling to | |||
| the teeth. In both systems, the | |||
| optically tracked object is rigidly | |||
| connected to the molded part. | |||
| Differences relate to | |||
| implementation details. | |||
| Patient to CT image | |||
| registration | Manual, using small fiducial | ||
| spheres embedded in the X- | |||
| clip and a jaw tracker | |||
| calibration process. | Automatic, using a removable | ||
| CT Marker part containing a | |||
| CT-visible fiducial body. | In both systems, fiducial objects | ||
| of known shapes are used to | |||
| obtain a registration mapping | |||
| between the patient jaw and the | |||
| CT image. Navident uses an | |||
| automated process. | |||
| Jaw attachment | |||
| calibration | Needed prior to each | ||
| operation. Different | |||
| procedures depending on the | |||
| type of attachment. | Not needed. | Navident's automated | |
| registration process eliminates | |||
| the need for this step. | |||
| Drill tip calibration | Initial handpiece calibration | ||
| using a special optically | |||
| marked tool, plus tip | |||
| calibration by touching a point | |||
| after each drill change. | Initial drill axis calibration, plus | ||
| tip calibration by touching a | |||
| point in a dimple after each | |||
| drill change. Only the jaw tag | |||
| is used. | The calibration steps are similar. | ||
| However, the jaw tag is used in | |||
| Navident to also perform these | |||
| calibration steps, eliminating the | |||
| need for a separate tool. | |||
| Mount for camera and | |||
| display | Mobile cart weighing 130lb | ||
| with a large arm holding | |||
| camera above patient's head. | |||
| Screen is attached to cart | |||
| pole. | Mobile cart weighing 55lb | ||
| with a folding arm holding | |||
| camera and screen above | |||
| patient's chest. | Similar. | ||
| Presentation of | |||
| navigation guidance | 3D graphics presentation of | ||
| drill position, angle and depth | |||
| relative to planned placement. | 3D graphics presentation of | ||
| drill position, angle and depth | |||
| relative to planned placement. | Same | ||
| Illumination of tracking | |||
| targets | Visible light emitted by LED | ||
| panel | Visible light emitted by LED | ||
| panel (optional) | Same | ||
| Performance | |||
| Characteristics | |||
| Accuracy at the drill tip | ≤1.0mm | ≤1.0mm | Same |
| Presentation update | |||
| rate | Real time | Real time | Same |
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Image /page/6/Picture/0 description: The image contains the logo for ClaroNav. The logo consists of a circular design on the left, which is divided into four quadrants with alternating black and white colors. To the right of the circular design, the text "ClaroNav" is displayed in a clear, sans-serif font. The text is positioned horizontally and appears to be aligned with the center of the circular design.
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Image /page/7/Picture/0 description: The image is a close-up of a black and white pattern. The pattern consists of a square in the upper left corner that is divided into black and white quadrants. To the right of the square is a circular pattern of concentric circles that are also divided into black and white sections. The overall effect is a high-contrast, geometric design.
8
Image /page/8/Picture/0 description: The image contains the logo for ClaroNav. The logo consists of a black and white circular design on the left, with the text "ClaroNav" to the right of the design. The text is in a sans-serif font, with the first letter capitalized and the rest in lowercase. The background behind the text is divided horizontally, with the top half being white and the bottom half being black.
Navident's intended use for planning and guidance of drilling for dental implementations is identical to the intended use of the predicate device. Each clinical case indicated for Navident is indicated for the predicate as well. The components, performance and operational characteristics of Navident are very similar to those of the predicate device. Noticeable differences between the designs of Navident and the predicate device include:
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Image /page/9/Picture/0 description: The image contains the logo for ClaroNav. The logo consists of a black and white circular design on the left, resembling a stylized target or compass. To the right of the design is the text "ClaroNav" in a bold, sans-serif font. Below the text is a solid black bar, creating a contrasting visual element.
- . In the predicate, calibration of the drilling axis requires a separate procedure using a special tool, while Navident provides an automatically triggered process using a pin on the JawTag. Both provide the same mathematical result and use it in the same manner during guidance.
- In the predicate, the user needs to manually calibrate the registration mapping between the patient jaw and its CT image by touching with a pointer small fiducial spheres placed near the jaw both during the CT scan and the surgery. Navident performs registration using fiducial objects placed near the jaw during the CT scan, and automates the process of computing the registration mapping. Both registration procedures produce the same mathematical result and use it in the same manner during guidance.
- . Navident is mounted on a cart with an arm enabling the positioning of the optical tracker and screen above the patient's chest.
The above design differences relate solely to the usability aspects of the devices, not to the core functions they perform, which 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
IEC 62366-1 Edition 1.0 2015-02, Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices
IEC 62304 First edition 2006-05, 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.
ISO 10993-1 Fourth edition 2009-10-15, biological evaluation of medical devices - part 1: evaluation and testing within a risk management process. (Biocompatibility)
AAMI / ANSI / ISO 10993-5:2009/(R) 2014, biological evaluation of medical devices -- part 5: tests for in vitro cytotoxicity.
ISO 10993-10 Third Edition 2010-08-01, biological evaluation of medical devices - part 10: tests for irritation and skin sensitization
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
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essential performance (IEC 60601-1:2005, mod)
IEC 60601-1-2 Edition 3: 2007-03, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility requirements and tests.
IEC 62471 First edition 2006-07, photobiological safety of lamps and lamp systems. (Radiology)
FDA Guidance Document Applying Human Factors and Usability Engineering to Optimize Medical Device Design, June 22, 2011
SUMMARY OF PERFORMANCE TESTING
Performance testing of the Navident system was conducted in accordance with all the above referenced standards and regulations. All system requirements, including accuracy requirements, were validated thoroughly, and found to be comparable to those of the predicate device.
Navident's performance testing included:
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- Sterilization Validation: A representative sample of the re-usable Navident components were tested to validate that the components can withstand the steam sterilization process and that acceptable sterility is achieved using the recommended sterilization protocols. The sterilization validation testing was conducted according to ISO 17665-1:2006 and it validated that the reusable Navident components can be sterilized to reach an acceptable sterility assurance level.
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- Biocompatibility Testing: The patient-contacting Navident components were tested according to the ISO 10993-1 series as follows:
- . Navident components were tested using the MEM Elution test method to assess cytotoxic effects. as per ISO 10993-5 biological evaluation of medical devices -- part 5: tests for in vitro cytotoxicity. All test method acceptance criteria were met, supporting the conclusion that the Navident component is biocompatible and appropriate for its intended use.
- . Navident components were tested for hypersensitivity reactions following the Maximization Sensitization Test Method which meets the criteria of ISO 10993-10:2010 Biological Evaluation of medical devices Part 10: Tests for Irritation and Skin Sensitization. No evidence of reaction or sensitization of the Navident test article on the test subjects was observed and all acceptance criteria were met.
- . Irritation testing of Navident components was completed following the Oral Mucosal Irritation Study which meets the criteria of SO 10993-10:2010 Biological Evaluation of medical devices Part 10: Tests for Irritation and Skin Sensitization. No evidence of irritation to the test subject's oral mucous membranes was observed and all acceptance criteria were met.
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- Full system bench testing was conducted on the Navigation system. The bench tests evaluated the following operational aspects:
- a. Overall accuracy of the system in mapping the drill tip to the CT image;
- Repeatability of the handpiece calibration process; ﻗ
- C. Effect of different image voxel sizes on the mapping accuracy;
- d. Effect of distance between the tracking camera and the JawTag on mapping accuracy;
- e. Effect of the number of available fiducial corners on mapping accuracy;
- f. Effect of different ambient lighting conditions on mapping accuracy;
- Effect of camera warmup time on mapping accuracy; g.
- Effectiveness of the NaviStent fabrication process with a number of random jaw models; h.
- i. Evaluating possibility of getting the NaviStent locked onto the teeth;
- j. Repeatability of interlocking of CT Marker with Retainer during CT scan;
- Impact of autoclaving cycles on Silicon tape strength; k.
- l. Tag adapter sterilization tolerance;
- m. Effect of ambient temperature on accuracy;
- n. Effect of strong light shining on one of the tags (HDR mode);
The bench tests were executed as planned, and all of them succeeded in meeting their acceptance criteria. Additionally, the system passed all tests of immunity to electromagnetic interference according to IEC 60601-1-2 while providing accurate drilling guidance.
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- Human factors/usability summative evaluation was conducted on the Navident system under controlled simulated setting. 15 representative users (i.e., oral surgeons, general dental practitioners) were observed performing representative and high-risk tasks with the Navident system while test administrators monitored the proceedings for any use errors, close calls, operational difficulties that may be indicative of use-safety or usability problems. The assessment of the test results demonstrated that the Navident system satisfies user specifications for use by qualified dentists for its intended use. .
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- ClaroNav has collected and compiled clinical, usability and accuracy data related to the application of Navident in clinical practice by a diverse international group of surgeons. The clinical case data collected consisted of 21 cases with 36 guided implantations. In all cases, Navident fully performed its intended function without complications. Accuracy assessment demonstrated that, with Navident's guidance, an experienced user is able to achieve an implant placement accuracy averaging 1.0mm deviation from plan at both entry and apex. The clinical evaluation further consisted of collecting systematic feedback on usage history and professional impressions from 7 surgeons who treated a total 150 patients guided by Navident. No significant patient adverse events or complications were reported by any participating surgeon.
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CONCLUSION
Navident is substantially equivalent to its predicate in its indications for use, principles of operation, technical characteristics, performance and usability as demonstrated using a comprehensive comparison of all relevant characteristics, and by thoroughly testing all key aspects of Navident's performance.