Yomi Robotic System

K231018 · Neocis, Inc. · PLV · Aug 14, 2023 · Dental

Device Facts

• Record ID: K231018
• Device Name: Yomi Robotic System
• Applicant: Neocis, Inc.
• Product Code: PLV · Dental
• Decision Date: Aug 14, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4120
• Device Class: Class 2

Intended Use

Yomi Robotic System is a computerized robotic navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides robotional guidance of the surgical instruments. The system can also be used for planning and performing guided bone reduction (also known as alveoplasty) of the mandible and/or maxilla. Yomi Robotic System is intended for use in partially edentulous adult patients who qualify for dental implants. When YomiPlan software is used for preplanning on third party PCs, it is intended to perform the planning (pre-operative) phase of dental implantation surgery. YomiPlan provides pre-operative planning for dental implantation procedures using the Yomi Robotic System. The output of YomiPlan is to be used with the Yomi Robotic System.

Device Story

Yomi Robotic System is a dental stereotaxic instrument providing robotic navigational guidance for dental implantation and alveoplasty. Input data includes patient CBCT scans used in YomiPlan software to create 3D anatomical models for virtual surgical planning. During surgery, the system uses a robotic arm to hold and guide third-party powered bone cutting instruments. The system provides physical, visual, and audible haptic feedback to the surgeon, restricting instrument movement to the predefined surgical volume. Patient tracking is maintained via physical linkages (Patient Tracker, Kinematic Mount, Tracker End Effector) connected to the patient via YomiLink splints or bone-anchored devices. The subject submission introduces YomiLink Arch (YLA) and a Probing Bit, allowing CBCT acquisition prior to YomiLink Bone placement and enabling guided placement. The surgeon operates the system in a clinical setting, using the robotic guidance to improve precision during implant site preparation.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including total system accuracy verification, guided splint placement verification, probing and registration accuracy, deflection/repeatability testing, proximity warning verification, and software end-user validation. Biocompatibility and reprocessing were validated per ISO 10993-1, ISO 17665-1, and ISO 17665-2.

Technological Characteristics

Dental stereotaxic instrument; 6-degree-of-freedom robotic arm; haptic feedback. Materials: Avaspire AV-651 CF30 (main body), Silicon Nitride (fiducial beads), EA M-31CL epoxy, 17-4 PH Stainless Steel (probing bit). Connectivity: Standalone/networked planning software. Sterilization: Moist heat (end-user).

Indications for Use

Indicated for partially and fully edentulous adult patients qualifying for dental implants, requiring assistance in pre-operative planning and intra-operative robotic navigational guidance for dental implantation or guided bone reduction (alveoplasty).

Regulatory Classification

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.

Predicate Devices

• Yomi Robotic System (K222750)

Reference Devices

• Yomi Robotic System (K211129)

Submission Summary (Full Text)

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Neocis Inc. Joshua Davis Regulatory Affairs Manager 2800 Biscayne Blvd, Suite 600 Miami, Florida 33137

Re: K231018

Trade/Device Name: Yomi Robotic System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: PLV, QRY Dated: July 13, 2023 Received: July 14, 2023

Dear Joshua Davis:

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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Andrew I. Steen -S

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) K231018

Device Name Yomi Robotic System

#### Indications for Use (Describe)

Yomi Robotic System is a computerized robotic navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides robotional guidance of the surgical instruments. The system can also be used for planning and performing guided bone reduction (also known as alveoplasty) of the mandible and/or maxilla. Yomi Robotic System is intended for use in partially edentulous adult patients who qualify for dental implants.

When YomiPlan software is used for preplanning on third party PCs, it is intended to perform the planning (pre-operative) phase of dental implantation surgery. YomiPlan provides pre-operative planning for dental implantation procedures using the Yomi Robotic System. The output of YomiPlan is to be used with the Yomi Robotic System.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K231018

#### I. Submitter

Neocis Inc. 2800 Biscayne Blvd. Suite 600 Miami, FL 33137 Tel: 1-855-9NEOCIS

Contact Person: Joshua Davis, Regulatory Affairs Manager Date Prepared: August 14, 2023

## II. Device

Trade Name: Yomi Robotic System Common Name: Dental Stereotaxic Instrument Classification Name: Bone cutting instrument and accessories (21 CFR 872.4120) Classification: Class II QRY, PLV Product Code:

## III. Predicate and Reference Devices

Primary Predicate: Yomi Robotic System (K222750) Reference Device: Yomi Robotic System (K211129)

## IV. Indications for Use

Yomi Robotic System is a computerized robotic navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides robotic navigational guidance of the surgical instruments. The system can also be used for planning and performing guided bone reduction (also known as alveoplasty) of the mandible and/or maxilla. Yomi Robotic System is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

When YomiPlan software is used for preplanning on third party PCs, it is intended to perform the planning (pre-operative) phase of dental implantation surgery. YomiPlan provides pre-operative planning for dental implantation procedures using the Yomi Robotic System. The output of YomiPlan is to be used with the Yomi Robotic System.

## V. Device Description

Yomi Robotic System is a dental stereotaxic instrument and a powered surgical device for bone cutting. Yomi Robotic System is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. The Yomi Robotic System is intended

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for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

The Yomi Robotic System allows the user to plan the surgery virtually in YomiPlan, cleared for use alone on third-party PCs for preplanning. The operative plan is based on a cone beam computed tomography (CBCT) scan of the patient, which is used to create a 3-D model of the patient anatomy in the planning software. The plan is used for the system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation. The Yomi robotic arm holds and guides a standard FDA-cleared third party powered bone cutting instrument.

The patient tracking portion of Yomi is comprised of linkages from the patient to Yomi, which include the Patient Splint (YomiLink Teeth or YomiLink Bone), Tracker End Effector (TEE), and the Patient Tracker (PT). In cases where YomiLink Teeth is utilized, it is attached to the contralateral side of the patient's mouth over stable teeth using on-label dental materials prior to the presurgical CBCT scan. In cases where YomiLink Bone is utilized, it is placed using bone screws prior to the presurgical CBCT scan (appropriate local anesthesia is required), or after the scan when using the subject YomiLink Arch device.

The subject of this submission is to introduce new accessories, the YomiLink Arch and Probing Bit. The YomiLink Arch allows for CBCT scan acquisition prior to YomiLink Bone placement and enables guided YomiLink Bone placement. This submission also introduces an update to the system planning software to enable use of the YomiLink Arch (YLA).

Following attachment of YomiLink Bone (YLB) to the patient, probing of the YLA is performed utilizing the YLA Probing Bit to transfer registration in the software from YLA to YLB and allow for tracking of the YLB throughout the remaining surgical procedure. The YLA Probing Bit is available in straight and contra-angle configurations corresponding to the handpiece to which they are attached.

All other aspects of the Yomi Robotic System remain unchanged from prior clearances.

## VI. Comparison of Technological Characteristics

The following Table 1 provides a summary of the subject Yomi Robotic System features compared to the predicate device, Yomi Robotic System (K222750), and reference device, Yomi Robotic System (K211129).

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Image /page/5/Picture/0 description: The image shows the logo for Neocis. The logo consists of the word "neocis" in a sans-serif font, with the letters in a golden color. Above the word is a gray line that extends horizontally, and a gray vertical line intersects the horizontal line at the center of the word. There is a small circle at the intersection of the two lines.

Table 1: Comparison of technological characteristics to the predicate and reference devices.

| Technological<br>Characteristics | Subject Device: Yomi<br>Robotic System with<br>YomiLink Arch | Primary Predicate: Yomi<br>Robotic System with<br>Intraoral Fiducial Array<br>(K222750) & Reference<br>Device: Yomi Robotic<br>System (K211129) | Comparison |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for<br>Use (IFU) | Yomi Robotic System is a<br>computerized robotic<br>navigational system intended to<br>provide assistance in both the<br>planning (pre-operative) and the<br>surgical (intra-operative) phases<br>of dental implantation surgery.<br>The system provides software<br>to preoperatively plan dental<br>implantation procedures and<br>provides robotic navigational<br>guidance of the surgical<br>instruments. The system can<br>also be used for planning and<br>performing guided bone<br>reduction (also known as<br>alveoplasty) of the mandible<br>and/or maxilla. Yomi Robotic<br>System is intended for use in<br>partially edentulous and fully<br>edentulous adult patients who<br>qualify for dental implants.<br>When YomiPlan software is<br>used for preplanning on third<br>party PCs, it is intended to<br>perform the planning (pre-<br>operative) phase of dental<br>implantation surgery. YomiPlan<br>provides pre-operative planning<br>for dental implantation<br>procedures using the Yomi<br>Robotic System. The output of<br>YomiPlan is to be used with the<br>Yomi Robotic System. | Yomi Robotic System is a<br>computerized robotic<br>navigational system intended<br>to provide assistance in both<br>the planning (pre-operative)<br>and the surgical (intra-<br>operative) phases of dental<br>implantation surgery. The<br>system provides software to<br>preoperatively plan dental<br>implantation procedures and<br>provides robotic navigational<br>guidance of the surgical<br>instruments. The system can<br>also be used for planning and<br>performing guided bone<br>reduction (also known as<br>alveoplasty) of the mandible<br>and/or maxilla. Yomi is<br>intended for use in partially<br>edentulous and fully<br>edentulous adult patients who<br>qualify for dental implants.<br>When YomiPlan software is<br>used for preplanning on third<br>party PCs, it is intended to<br>perform the planning (pre-<br>operative) phase of dental<br>implantation surgery. YomiPlan<br>provides pre-operative<br>planning for dental<br>implantation procedures using<br>the Yomi Robotic System. The<br>output of YomiPlan is to be<br>used with the Yomi Robotic<br>System. | Equivalent |
| Technological<br>Characteristics | Subject Device: Yomi<br>Robotic System with<br>YomiLink Arch | Primary Predicate: Yomi<br>Robotic System with<br>Intraoral Fiducial Array<br>(K22750) & Reference<br>Device: Yomi Robotic<br>System (K211129) | Comparison |
| Principles of<br>Operation | YomiLink Arch contains<br>fiducial markers that allow for<br>registration in CBCT scans<br>prior to surgery. The Tracker<br>End Effector is attached to<br>YomiLink Arch to provide a<br>connection between the patient<br>and the Patient Tracker arm of<br>the system. YomiLink Arch<br>contains divots that can then be<br>probed with the robot to match<br>to known locations in the CBCT<br>scan image space based on the<br>fiducial markers | The Intraoral Fiducial Array<br>contains fiducial markers that<br>allow for registration in CBCT<br>scans prior to surgery. The<br>Intraoral Fiducial Array<br>mounts to the YomiLink Teeth<br>patient splint | Equivalent |
| Robotic Guide<br>Arm | Guided robotic arm | Guided robotic arm | Equivalent |
| Movement<br>Direction | Guided Robotic Arm holds a<br>surgical instrument and<br>provides haptic feedback on<br>position with respect to the plan<br>restricting movement outside of<br>volume predefined during<br>planning.<br>6 degrees of freedom | Guided Robotic Arm holds a<br>surgical instrument and<br>provides haptic feedback on<br>position with respect to the<br>plan restricting movement<br>outside of volume predefined<br>during planning.<br>6 degrees of freedom | Equivalent |
| Patient affixed<br>tracking parts | YomiLink Arch<br>Splints | Splints with arrays | Equivalent |
| Patient Tracking<br>Mechanism | Physical linkage to patient via<br>Patient Tracker (PT), Kinematic<br>Mount (KM), and Tracker End<br>Effector (TEE) | Physical linkage to patient via<br>Patient Tracker (PT),<br>Kinematic Mount (KM), and<br>Tracker End Effector (TEE) | Equivalent |
| Fiducials for CT<br>scan | YomiLink Arch contains<br>fiducial beads and is placed<br>directly on patient arch during<br>the CT scan to provide a<br>reference in the image | Intraoral Fiducial Array<br>contains fiducial beads and is<br>attached to patient splint<br>during the CT scan to provide<br>a reference in the image | Equivalent |
| Technological<br>Characteristics | Subject Device: Yomi<br>Robotic System with<br>YomiLink Arch | Primary Predicate: Yomi<br>Robotic System with<br>Intraoral Fiducial Array<br>(K222750) & Reference<br>Device: Yomi Robotic<br>System (K211129) | Comparison |
| Probing Bit | YLB is registered by probing<br>the YLA divots | N/A. YLB is registered via<br>CT scan | Equivalent |
| Patient Contact | Surface device<br>Limited duration | Surface device<br>Limited duration | Equivalent |
| Biocompatibility | Mucosal membrane, tissue, bone,<br>dentin contact | Mucosal membrane, tissue,<br>bone, dentin contact | Equivalent |
| Reprocessing<br>Classification | N/A. Single use only | Non-critical reusable | Equivalent |
| Reprocessing<br>Method | N/A. Single use only.<br>Sterilized by the end user prior to<br>use | Cleaning & Sterilization | Equivalent |
| Sterilization<br>Method | Provided unsterile, end user<br>moist heat sterilized | Provided unsterile, end user<br>moist heat sterilized | Equivalent |
| Mating<br>Component<br>Design | Kinematic Mount | Kinematic Mount | Equivalent |
| Materials | Main body: Avaspire AV-651<br>CF30<br>Fiducial Beads: Silicon Nitride<br>Epoxy: EA M-31CL epoxy<br>Probing Bit: 17-4 Stainless Steel,<br>Precipitation Hardened (PH) | Main body: Avaspire AV-651<br>CF30<br>Fiducial Beads: Silicon Nitride<br>Epoxy: EA M-31CL epoxy | Equivalent |
| Performance<br>Testing | Total System Accuracy<br>• Verification<br>Probing and Registration<br>• Verification<br>Deflection and<br>• Repeatability Verification<br>Guided Splint Placement<br>• Verification<br>Proximity Warnings<br>• Verification<br>Typical Run Through<br>• Verification<br>Human Factors<br>• Validation<br>Software End User<br>• Validation | Total System Accuracy<br>• Verification<br>Registration Verification<br>• Deflection and<br>• Repeatability Verification<br>Human Factors<br>• Validation | Equivalent |

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Image /page/7/Picture/0 description: The image shows the logo for Neocis. The logo consists of the word "neocis" in a sans-serif font, with the letters in a light orange color. Above the word is a thin gray line that extends horizontally. To the right of the word is a gray crosshair symbol with a small circle at the intersection.

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## VII. Performance Testing

The following testing has been fully executed to ensure that the subject device functions as intended:

- . Total System Accuracy Verification: to verify the accuracy of the full system with the additional YLA workflow
- Guided Splint Placement Verification: to verify the accuracy of guided splint placement as part of the YLA workflow
- Probing and Registration Verification: to verify the accuracy of probing the YLA ●
- Deflection and Repeatability Verification: to assess the stability and repeatability of attachment of the YLA
- Proximity Warnings Verification: to assess the proximity warnings generated in the user application throughout the YLA workflow
- Typical Run Through Verification: to assess the typical steps in the user application ● throughout the YLA workflow
- Human Factors Validation: to validate the human factors and design of the YLA ●
- Software End User Validation: to validate that the YLA user application meets the user ● requirements

Non-clinical data referenced or relied upon for the subject YomiLink Arch and Probing Bit from the predicate, K222750, to demonstrate substantial equivalence include: Biocompatibility testing per the FDA Guidance Document for Use of Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process," and validated cleaning & sterilization instructions per FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" and ISO 17665-1 and ISO 17665-2.

## VIII. Conclusion

The subject of this submission is to introduce new accessories, the YomiLink Arch and Probing Bit. which allow for CBCT scan acquisition prior to YomiLink Bone placement and enables guided YomiLink Bone placement. This submission also introduces an update to the system planning software to enable use of the YomiLink Arch. There are no changes to the intended use compared to the predicate device. There are no fundamental changes to the technology. The performance testing demonstrates substantially equivalent performance of the subject device as compared to the predicate.