Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a traditional image-guided navigation system based on pre-acquired CT scans and real-time tracking, without mentioning any AI or ML components for image processing, planning, or guidance.

Therapeutic

No.
The device is described as a surgical navigation system that assists with planning and guiding drilling during implantation surgery, rather than directly treating a disease or condition.

Diagnostic

No

The device is described as a surgical navigation system that assists with pre-operative planning and guides drilling during implantation surgery. It provides real-time feedback on the position of drilling tools relative to the patient's anatomy and a planned path. It does not diagnose diseases or conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states that Navident is comprised of hardware components including a cart, a stereoscopic video camera, a laptop, and various tracking and registration accessories, in addition to the proprietary software.

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 clearly states that the device is a "computerized dental navigational system intended to assist preoperative planning and to guide drilling in a patient jaw during implantation surgery". This describes a device used in vivo (within the living body) to guide a surgical procedure.
Device Description: The description details a system that tracks the position of a dental handpiece relative to a patient's anatomy using a camera and CT images. This is a surgical guidance system, not a device that analyzes samples taken from the body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are typically used to diagnose diseases, monitor conditions, or screen for specific markers by examining samples outside the body.

Therefore, this device falls under the category of a surgical guidance system, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 partially or fully edentulous jaws.

Product codes

PLV

Device Description

Navident is an image-guided dental navigational system intended to assist with preoperative planning and real-time positioning of drilling tools during implantation surgery. In particular, Navident provides visual, real-time feedback on the location of the working tip of a dental handpiece. It shows the location and direction of the tip relative to a volumetric CT image of the patient's jaw registered to that anatomy, and, when available, relative to a path planned on that image.

Navident is comprised of the following parts:

The main system is comprised of a cart that carries a stereoscopic video camera and a laptop with pre-installed proprietary software.
The Navident system also includes several types of accessories:
- Jaw motion Tracking Accessories: Accessories that are rigidly attached to the patient's jaw and are used to maintain the registration between the jaw and its CT image throughout the procedure via real-time tracking of the jaw. They comprise a tag with optical markings trackable by the stereoscopic video camera and a mechanism for rigid attachment of the tag to the patient's Jaw (for tracking the upper jaw only).
- Dental Handpiece Tracking Accessories: Accessories that are rigidly attached to a dental handpiece to be navigated during the dental procedure. They comprise a tag with optical markings trackable by the stereoscopic video camera and a mechanism for rigid attachment of the tag to the handpiece.
- Registration accessories: Accessories that are used in the registration of the patients' anatomy with the patients' CT scan.
- Calibrator: A tool used for calibrating the working tip of the handpiece to determine the geometric relationship between the optical marking on the handpiece-attached tag and the working tip of the surgical instrument.
Navident's four core functions are:
- Model: Using data imported from CT and intraoral surface scanners, a digital model of the jaw anatomy is compiled and presented to the user.
- Plan: The user, using functions provided by the Navident application software, prepares a digital treatment plan for drilling in bone.
- Register: At the start of the actual treatment, the digital model is aligned with the real anatomy it models. The plan, which was created in geometrical reference to the model can now be referenced, or mapped, to the real anatomy.
- Guide: The tooltip (the working end) of the treatment tool, usually a handpiece with an exchangeable tip, is dynamically shown to the user relative to the (registered) model and the treatment plan.

The user uses the on-screen guidance to align the tooltip with the planned tooltip path to ensure correct and accurate execution of the plan. During surgery, Navident automatically tracks the handpiece's motions. When the handpiece 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 quides the hand motions of the surgeon towards precisely locating the planned entry point, adjusting the drill axis to the planned angle, and drilling to the planned depth. When the tip is away from a marked implantation path, Navident provides real-time visual feedback showing the CT image intensities in the region surrounding the drill's tip.
The Navident is intended for the drilling of osteotomies for dental implant placement with high-speed and low-speed dental handpieces This submission focuses on modification of the Navident predicate device (K161406) to include additional components including the wireless connection, use of bone screws for edentulous patients, additional patient tracker designs, and a tracing method for registration.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT

Anatomical Site

Patient 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)

Reprocessing validation: Manual and automated cleaning validation was performed on representative devices to confirm that the cleaning processes of Navident's accessories can reduce the organic soil load, per AAMI TIR 30: 2011(R) 2016, to:
- Proteins :

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

ClaroNav Inc. Carly Desmond Director of Regulatory Affairs 1140 Sheppard Avenue West Unit 10 Toronto, Ontario M3K 2A2 CANADA

Re: K210947

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: June 2, 2022 Received: June 2, 2022

Dear Carly Desmond:

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.

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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.

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210947

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 partially or fully edentulous jaws.

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 K210947 ClaroNav's Navident

| Sponsor: | ClaroNav Inc.
1140 Sheppard Avenue West, Unit 10
Toronto, Ontario, M3K 2A2
Canada |
|------------------------------------|--------------------------------------------------------------------------------------------|
| Contact Person | Doron Dekel |
| Phone
e-mail | +1 647 868 6813
doron@claronav.com |
| Submission Date | June 24, 2022 |
| Device Proprietary Name | Navident |
| Common Name | Surgical Navigation System |
| Classification | PLV |
| Class | II |
| Regulation
Classification Panel | 21 CFR 872.4120; Bone Cutting Instrument and Accessories
Dental |

Predicate Devices

Primary predicate: ClaroNav's Navident (K161406)

Reference device: X-Nav's X-Guide (K200662)

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 partially or fully edentulous jaws.

Technological Characteristics

Navident is an image-guided dental navigational system intended to assist with preoperative planning and real-time positioning of drilling tools during implantation surgery. In particular, Navident provides visual, real-time feedback on the location of the working tip of a dental handpiece. It shows

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the location and direction of the tip relative to a volumetric CT image of the patient's jaw registered to that anatomy, and, when available, relative to a path planned on that image.

Navident is comprised of the following parts:

The main system is comprised of a cart that carries a stereoscopic video camera and a laptop . with pre-installed proprietary software.
. The Navident system also includes several types of accessories:
- Jaw motion Tracking Accessories: Accessories that are rigidly attached to the O patient's jaw and are used to maintain the registration between the jaw and its CT image throughout the procedure via real-time tracking of the jaw. They comprise a tag with optical markings trackable by the stereoscopic video camera and a mechanism for rigid attachment of the tag to the patient's Jaw (for tracking the upper jaw only).
- Dental Handpiece Tracking Accessories: Accessories that are rigidly attached to a O dental handpiece to be navigated during the dental procedure. They comprise a tag with optical markings trackable by the stereoscopic video camera and a mechanism for rigid attachment of the tag to the handpiece.
- Registration accessories: Accessories that are used in the registration of the patients' O anatomy with the patients' CT scan.
- Calibrator: A tool used for calibrating the working tip of the handpiece to determine O the geometric relationship between the optical marking on the handpiece-attached tag and the working tip of the surgical instrument.
Navident's four core functions are: ●
- Model: Using data imported from CT and intraoral surface scanners, a digital model of O the jaw anatomy is compiled and presented to the user.
- Plan: The user, using functions provided by the Navident application software, O prepares a digital treatment plan for drilling in bone.
- Register: At the start of the actual treatment, the digital model is aligned with the real O anatomy it models. The plan, which was created in geometrical reference to the model can now be referenced, or mapped, to the real anatomy.
- Guide: The tooltip (the working end) of the treatment tool, usually a handpiece with O an exchangeable tip, is dynamically shown to the user relative to the (registered) model and the treatment plan.

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The user uses the on-screen quidance to align the tooltip with the planned tooltip path to ensure correct and accurate execution of the plan. During surgery, Navident automatically tracks the handpiece's motions. When the handpiece 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 quides the hand motions of the surgeon towards precisely locating the planned entry point, adjusting the drill axis to the planned angle, and drilling to the planned depth. When the tip is away from a marked implantation path, Navident provides real-time visual feedback showing the CT image intensities in the region surrounding the drill's tip.

The Navident is intended for the drilling of osteotomies for dental implant placement with high-speed and low-speed dental handpieces This submission focuses on modification of the Navident predicate device (K161406) to include additional components including the wireless connection, use of bone screws for edentulous patients, additional patient tracker designs, and a tracing method for registration.

Performance Data

Navident's performance testing included:

Reprocessing validation: .
- . Manual and automated cleaning validation: manual and automated cleaning validation was performed on representative devices to confirm that the cleaning processes of Navident's accessories can reduce the organic soil load, per AAMI TIR 30: 2011(R) 2016, to:
  - o Proteins : "NaviStent" : molded thermoplastic sheet with an integrated arm holding an optically marked plastic tag. OR: "Jaw Tracker" : optically marked flat tag attached to a hand-configurable stainless steel wire attached to the jaw at its other end. The JawTracker C and S version attaches to a tooth, crown or abutment using approved dental composite resin and bonding agent. The JawTracker U version attaches to several adjacent teeth using a U-shaped clamp filled with bite registration material. | "NaviStent" molded thermoplastic sheet with an integrated arm holding an optically marked plastic tag. No support for edentulous jaws. | X-Clip®, is attached to patient teeth using an impression material (low temperature thermoplastic). The Patient Tracker which includes the tracking patterns that is visualized by the tracking camara is firmly attached to the X-Clip. This device remains on the patient teeth for the duration of surgery. | Navident offers an identical solution for Jaw tracking (the NaviStent) as the cleared Navident device. In addition, two alternative jaw attachment solutions are offered (JawTracker C and JawTracker U). While the materials used for the attachment (thermoplastic, PVS, composite) and their hardening methods (cooling, chemical or light curing) vary, they are all moldable dental materials in common usage, with well-known properties. |
    | Jaw Tracking
    Attachment
    (Edentulous Patient) | JawTracker B: optically marked
    flat tag attached to a hand-
    configurable stainless steel wire
    attached to the jaw bone using 3
    small bone screws. | None | Edentulous Clip® - fixated into
    position on the patient's jaw
    using bone screws. The patient
    tracker, which includes the
    tracking patterns that is
    visualized by the tracking
    camera is firmly attached to the
    Edentulous Clip. This device
    remains on the patient teeth for
    the duration of surgery. | Navident's Jaw Tracker B solution is very
    similar to the Edentulous clip of the reference
    X-Guide device, and is based on an optically
    marked tag that is attached to the patients Jaw
    using a small plate that is fixated into position
    on the patient's jaw using bone screws. |
    | Patient to CT image
    registration | NaviStent: includes a
    removable CT Marker part
    containing a CT-visible
    fiducial body. Trace Registration:
    registration based on
    Anatomical Landmarks on
    the jaw's surface.. Bone screws: placed in the
    patient's Jaw prior to CT
    scan to create fiducials. NaviBite: plastic appliance
    containing several screws
    with their heads exposed.
    Used with impression
    material to form a bite
    registration plate that can
    be repeatably coupled to
    both jaws. | NaviStent: includes a removable
    CT Marker part containing a CT-
    visible fiducial body. | X-Clip: contains embedded
    radiodense spheres used as
    fiducial. Bone hole Fiducials: For
    edentulous patients, the
    surgeon drills several narrow
    holes in the bone to serve as
    fiducials for the CT scan. X-Mark: registration based
    on Anatomical Landmarks. Bone screws: placed in the
    patient's Jaw prior to CT
    scan to create artificial
    landmarks. | Navident's registration solutions are identical
    or very similar to the ones offered in the
    predicate and the reference devices: The Navistent is a fiducial based
    registration, identical to Navident's cleared
    registration solution (K161406). The "Trace Registration" is very similar to
    X-Guide X-mark registration solution. Both
    are based on existing anatomical
    landmarks as fiducials. These landmarks
    are manually marked in the Software and
    are traced by touching them with the tip
    of an optically trackable tracer tool. Bone Screw: same as offered by X-Guide
    reference device, the bone screws are
    placed in the patient's Jaw prior to CT scan
    to create artificial landmarks. NaviBite: The screw heads, anchored to
    the NaviBite plastic shell, function very
    similarly to the spheres embedded in the
    X-Clip solution of X-Guide. In the
    registration process, both are touched by
    a special pointer to provide their location |
    | | | | | |
    | Drill tip calibration | Initial drill axis calibration on a tracked pin, plus tip calibration by placing the tip in a dimple in a special optically marked tool (Calibrator) after each drill change. Support for both low speed and high-speed handpieces | Initial drill axis calibration on a tracked pin, plus tip calibration by placing the tip in a dimple in the Jaw Tag after each drill change. | Initial handpiece calibration using a special optically marked tool, plus tip calibration by touching a point after each drill change. | relative to the optical markings on the tag coupled to the jaw.
    The calibration steps are similar. In the cleared Navident device, the jaw tag was used to also perform these calibration steps, eliminating the need for a separate tool. The Navident, offers a dedicated calibration tool, same as the reference device (X-Guide). |
    | Mount for camera and display | Mobile cart weighing 55lb with a folding arm holding camera and screen above patient's chest. | Mobile cart weighing 55lb with a folding arm holding camera and screen above patient's chest. | Mobile cart with a large arm holding camera above patient's head. Screen is attached to cart pole. | Identical to the cleared Navident device |
    | 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. | 3D graphics presentation of drill position, angle and depth relative to planned placement. | Identical to the cleared Navident device |
    | Illumination of tracking targets | Visible light emitted by LED panel (optional) | Visible light emitted by LED panel (optional) | Visible light emitted by LED panel (optional) | Identical to the cleared Navident device |
    | Performance Characteristics | | | | |
    | Accuracy at the drill tip | ≤1.0mm | ≤1.0mm | | Identical to the cleared Navident device |
    | Presentation update rate | Real time | Real time | | Identical to the cleared Navident device |

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ClaroNav's Navident

SECTION 5 510(k) Summary

Doc #: 985-09011 Page: 5- 7 of 9

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SECTION 5 510(k) Summary

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ClaroNav's Navident

SECTION 5 510(k) Summary

Doc #: 985-09011 Page: 5- 9 of 9

Conclusions

The Navident has been shown through technical comparison to be substantially equivalent to the identified predicate and referenced devices when used as intended.