Yomi Robotic System

K222049 · Neocis, Inc. · QRY · Nov 4, 2022 · Dental

Device Facts

• Record ID: K222049
• Device Name: Yomi Robotic System
• Applicant: Neocis, Inc.
• Product Code: QRY · Dental
• Decision Date: Nov 4, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4120
• Device Class: Class 2
• Attributes: Therapeutic

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 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 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. Yomi Plan provides pre-operative planning for dental implantation procedures using the Yomi Robotic System. The output of Yomi Plan is to be used with the Yomi Robotic System.

Device Story

Yomi Robotic System is a computerized robotic navigational system for dental implantation and alveoplasty. Input: CBCT scan of patient anatomy. Process: YomiPlan software creates 3D model for virtual surgical planning; robotic arm provides physical, visual, and audible feedback during surgery. Output: Robotic navigational guidance for surgical instruments. Used in dental clinics by surgeons. The robotic arm constrains movement of a third-party powered bone-cutting instrument to planned locations, boundaries, and depth. Real-time GUI visualization shows bone reduction progress. Benefits: Enhanced precision and control during implant site preparation and bone reduction.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including unit-level testing, integration and regression testing, verification of bone reduction planning/visualization/accuracy, and full-system cadaver validation.

Technological Characteristics

Computerized robotic navigational system with 6-DOF guided robotic arm. Patient tracking via splints (CPS/EPS), kinematic mounts, and end effectors. Windows-based software for planning and guidance. Compatible with third-party powered bone-cutting instruments (burs/drills). Connectivity: Standalone/PC-based. Standards: ANSI AAMI ISO 14971:2019, ANSI AAMI IEC 62304:2006/A1:2016.

Indications for Use

Indicated for partially edentulous and fully edentulous adult patients who qualify for dental implants, requiring dental implantation surgery or guided bone reduction (alveoplasty) of the mandible or maxilla.

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

• Neocis Guidance System (NGS) with Yomi Plan v2.0.1 (K210711)

Reference Devices

• Mako Partial Knee Application (K142530)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 4, 2022

Neocis Inc. Olga Lewis Regulatory Affairs Director 2800 Biscayne Blvd Suite 600 Miami, Florida 33137

Re: K222049

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: QRY, PLV Dated: October 13, 2022 Received: October 17, 2022

Dear Olga Lewis:

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.

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

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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 (OS) 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,

# Bobak Shirmohammadi -S

For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K222049

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 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 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. Yomi Plan provides pre-operative planning for dental implantation procedures using the Yomi Robotic System. The output of Yomi Plan 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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Image /page/3/Picture/0 description: The image shows the logo for Neocis. The logo features the word "neocis" in a sans-serif font, with the letters in a golden color. Above the word is a horizontal gray line, and to the right of the word is a gray crosshair symbol. The crosshair is positioned such that the horizontal line aligns with the top of the word, and the vertical line extends above and below the horizontal line.

### 510(k) Summary

#### K222049

#### l. Submitter

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

| Contact Person: | Olga Lewis, Director of Regulatory Affairs |
|-----------------|--------------------------------------------|
| Date Prepared: | November 3, 2022 |

#### II. Device

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

#### III. Predicate Devices

Primary Predicate: Neocis Guidance System (NGS) with Yomi Plan v2.0.1 K210711 Reference Device: Mako Partial Knee Application K142530

#### 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 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. Yomi Plan provides pre-operative planning for dental implantation procedures using the Yomi Robotic System. The output of Yomi Plan is to be used with the Yomi Robotic System.

#### V. Device Description

In terms of FDA regulations, the Yomi Robotic System is a dental stereotaxic instrument (Product Code PLV) and a powered surgical device for bone cutting (21 CFR 872.4120). In terms of previously FDAcleared indications for use (K210711), the 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 for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

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Image /page/4/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 horizontal gray line that extends from the left of the "n" to the right of the "s". A vertical gray line intersects the horizontal line above the "o", forming a cross shape with a small circle at the intersection.

The Yomi System allows the user to plan the surgery virtually in Yomi Plan, 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 our 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 FDAcleared third party powered bone cutting instrument.

The patient tracking portion of Yomi is comprised of linkages from the patient to Yomi, which include the Chairside Patient Splint (CPS) or Edentulous Patient Splint (EPS), the End Effector (EE) and the Patient Tracker (PT). The Patient Splint is attached to the contralateral side of the patient's mouth over stable teeth. The CPS is placed on the patient using on-label dental materials prior to the presurgical CBCT scan. The EPS is placed using bone screws prior to the presurgical CBCT scan (appropriate local anesthesia is required).

The subject of this submission is introducing a feature to allow the system to be used for planning and performing guided bone reduction (also known as alveoplasty). The bone reduction feature is intended for use during dental implant procedures to flatten the surface of the bone intended for dental implant placement. The device is used with compatible bone cutting tool secured to the guidance arm for the bone reduction. The bone reduction feature is intended to be performed on full arch or partially edentulous patients. During preoperative planning, the surgeon identifies the area of the bone to be reduced. Real-time visualization of the bone reduction is visualized on the graphic user interface. The guidance arm constrains the movement of the cutting tool to the planned location, boundaries, and depth. After the bone reduction, the implant procedure continues with the Yomi Robotic System.

### VI. Comparison of Technological Characteristics

The following Table 1 provides a summary of the subject Yomi System features compared to the predicate device, Neocis Guidance System (NGS) with Yomi Plan v2.0.1 (K210711), and a reference device, Mako Partial Knee Application (K142530). The MAKO device was chosen as the reference device since the visualization method during bone removal with the MAKO system for PKA is essentially the same as the subject device. Although the indications for use are different, the implementation of the visualization of the bone removal process is equivalent with both, the reference device as well as the predicate device.

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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 light orange color. Above the word is a gray line that extends horizontally, and a gray line that extends vertically, intersecting at a small circle.

#### Table 1: Comparison of technological characteristics to the predicates

| Technological<br>Characteristics | Subject Device: Yomi Robotic<br>System with Yomi Robotic<br>Guided Bone Reduction | Primary Predicate: Neocis<br>Guidance System (NGS) with<br>Yomi Plan v2.0.1 K210711 | Reference Device: Mako<br>Partial Knee Application<br>K142530 | Comparison |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>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 to<br>preoperatively plan dental<br>implantation procedures and<br>provides robotic navigational<br>guidance of the surgical<br>instruments. The system can also<br>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 intended<br>for use in partially edentulous and<br>for fully edentulous adult patients<br>who qualify for dental implants.<br>When YomiPlan software is used<br>for preplanning on third party PCs,<br>it is intended to perform the<br>planning (pre-operative) phase of<br>dental implantation surgery. Yomi<br>Plan provides pre-operative<br>planning for dental implantation<br>procedures using the Yomi<br>Robotic System. The output of<br>Yomi Plan is to be used with the<br>Yomi Robotic System. | Neocis Guidance System (NGS) is<br>a 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 to<br>preoperatively plan dental<br>implantation procedures and<br>provides robotic navigational<br>guidance of the surgical<br>instruments. The NGS is intended<br>for use in partially edentulous<br>and fully edentulous adult<br>patients who qualify for dental<br>implants.<br>When YomiPlan software is used<br>for preplanning on third party<br>PCs, it is intended to perform the<br>planning (pre-operative) phase of<br>dental implantation surgery.<br>YomiPlan provides pre-operative<br>planning for dental implantation<br>procedures using the NGS. The<br>output of Yomi Plan is to be used<br>with the NGS. | The Partial Knee Application (PKA),<br>for use with the Robotic Arm<br>Interactive Orthopedic System<br>(RIO), is intended to assist the<br>surgeon in providing software<br>defined spatial boundaries for<br>orientation and reference<br>information to anatomical<br>structures during orthopedic<br>procedures.<br>The Partial Knee Application<br>(PKA), for use with the Robotic<br>Arm Interactive Orthopedic<br>System (RIO), is indicated for use<br>in surgical knee procedures in<br>which the use of stereotactic<br>surgery may be appropriate, and<br>where reference to rigid<br>anatomical bony structures can be<br>identified relative to a CT based<br>model of the anatomy. These<br>procedures include unicondylar<br>knee replacement and/or<br>patellofemoral knee replacement.<br>The Implant systems with which<br>the system is compatible:<br>-Restoris Multicompartmental<br>Knee System<br>-Restoris Porous Partial Knee<br>System | When compared to<br>the primary predicate<br>device, K210711,<br>added text specific to<br>bone reduction.<br>Reference device has<br>different indications<br>but overall is<br>equivalent since it<br>offers power tools<br>and software<br>modifications for<br>bone cutting. |
| Technological<br>Characteristics | Subject Device: Yomi Robotic<br>System with Yomi Robotic<br>Guided Bone Reduction | Primary Predicate: Neocis<br>Guidance System (NGS) with<br>Yomi Plan v2.0.1 K210711 | Reference Device:<br>Partial Knee Application<br>K142530 | Comparison |
| Robotic<br>Guide<br>Arm | Guided robotic 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<br>plan restricting movement<br>outside of volume predefined<br>during 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 | 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<br>affixed<br>tracking parts | Splints with arrays | Splints with arrays | Femoral and tibial tracking<br>arrays affixed to bones during<br>surgery | Equivalent |
| Patient Tracking<br>Mechanism | Physical linkage to patient via<br>Patient Tracker (PT), Kinematic<br>Mount (KM), and End Effector<br>(EE) connected to splints | Physical linkage to patient via<br>Patient Tracker (PT),<br>Kinematic Mount (KM), and<br>End Effector (EE) connected to<br>splints | Optical IR camera used for<br>tracking femoral and tibial<br>arrays | Equivalent |
| Fiducials for CT<br>scan | Fiducial Array (FA) attached to<br>splint | Fiducial Array (FA) attached to<br>splint | Fiducials | Equivalent |
| Powered<br>Handpiece | Handpiece and drills | Handpiece and drills | Anspach Black Max bone<br>cutting system | Equivalent |
| Cutting tools | Burs and drills | Drills and burs | Burs | Equivalent |
| Planning<br>and<br>Guidance<br>Software | Updated Yomi Plan and NeoK<br>software to support bone<br>reduction feature (Windows-<br>based) | Yomi Plan software used for<br>planning and osteotomy<br>(Windows-based) | Linux-based software<br>application used for planning<br>and bone preparation | Equivalent |
| Workflow | Surgeon plans bone reduction<br>and implant placement and<br>executes according to the plan<br>following steps displayed on | Surgeon plans implant<br>placement and executes<br>according to the plan<br>following steps displayed on | Surgeon plans surgical<br>procedure, including bone<br>cutting and implant placement,<br>and executes according to the | Equivalent |
| Technological<br>Characteristics | Subject Device: Yomi Robotic<br>System with Yomi Robotic<br>Guided Bone Reduction | Primary Predicate: Neocis<br>Guidance System (NGS) with<br>Yomi Plan v2.0.1 K210711 | Reference Device: Mako<br>Partial Knee Application<br>K142530 | Comparison |
| | the GUI | the GUI | plan following steps displayed<br>on the GUI | |
| Visualization of<br>Bone Removal | Bone to be removed is colored<br>and during removal, the color<br>of the bone on the screen is<br>updated (in real time) to<br>another color to reflect bone<br>removal. | N/A | Bone to be removed is colored<br>and during removal, the color<br>of the bone on the screen is<br>updated (in real time) to<br>another color to reflect bone<br>removal. | Equivalent |
| Performance<br>Testing | Unit Level Testing<br>Integration and regression<br>testing<br>Verification testing of the new<br>handpiece and bur<br>Verification of bone reduction<br>planning, visualization, and<br>performance<br>Bone reduction accuracy<br>verification<br>Full system cadaver validation | Unit Level Testing<br>Integration and regression<br>testing<br>Verification testing of<br>compatible instrumentation<br>Verification of osteotomy<br>planning, visualization, and<br>performance<br>Osteotomy accuracy<br>verification<br>Full system cadaver validation | Sub-system level software<br>functional testing of Setup and<br>Bone Preparation<br>Implant visuals, boundaries and<br>stereotactic verification<br>Resection accuracy verification<br>Full system mock procedure<br>run-through verification<br>Full system cadaver validation | Equivalent |

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Image /page/6/Picture/0 description: The image shows the logo for Neocis. The word "neocis" is written in a sans-serif font, with the letters in gold. Above the word is a gray horizontal line, and to the right of the word is a gray crosshair symbol with a circle in the center.

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Image /page/7/Picture/0 description: The image shows the logo for Neocis. The word "neocis" is written in a sans-serif font in a golden color. Above the word is a gray horizontal line that extends beyond the word on both sides. There is a small circle above the "i" with a vertical line extending above it, creating a crosshair-like design.

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Image /page/8/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. A thin gray line runs above the word. To the right of the word, there is a gray symbol that looks like a plus sign with a small circle in the center.

#### VII. Performance Testing

Software verification testing has been fully executed to ensure that the software user interface functions as intended according to the following:

- ANSI AAMI ISO 14971: 2019 Medical devices - Applications of risk management to medical devices
- . ANSI AAMI IEC 62304:2006/A1:2016 Medical device software - Software life cycle processes [Including Amendment 1 (2016)]
- Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions ● for Software Contained in Medical Devices Document issued on: May 11, 2005
- Guidance for Industry and FDA Staff General Principles of Software Validation Document ● issued on: January 11, 2002

Additionally, verification testing for new instruments used in bone reduction procedures has been performed with the Yomi System along with validation testing, including cadaveric Human Factors Validation for Bone Reduction and Software End User Validation of Bone Reduction.

#### VIII. Conclusion

This submission introduces a bone reduction feature to the Yomi Robotic System. 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.