Yomi Robotic System

K222750 · Neocis, Inc. · QRY · Dec 8, 2022 · Dental

Device Facts

• Record ID: K222750
• Device Name: Yomi Robotic System
• Applicant: Neocis, Inc.
• Product Code: QRY · Dental
• Decision Date: Dec 8, 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 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.

Device Story

Yomi Robotic System is a dental stereotaxic instrument providing robotic navigational guidance for dental implantation and alveoplasty. Input data consists of patient CBCT scans processed via YomiPlan software to create 3-D 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 tracks patient position via physical linkages (Patient Tracker, Kinematic Mount, Tracker End Effector) attached to splints secured to the patient's mouth. The system provides physical, visual, and audible haptic feedback to the surgeon, restricting instrument movement to the pre-defined surgical volume. Used in dental clinics by clinicians; the system enhances surgical precision by ensuring instrument placement aligns with the pre-operative plan, potentially improving implant outcomes.

Clinical Evidence

Bench testing only. Performance validation included total system accuracy, kinematic mount repeatability, and drill jig accuracy. High-level disinfection validation was performed per AAMI TIR12 and FDA reprocessing guidance. Usability validation testing was conducted with dental clinicians to evaluate critical tasks related to the modified disinfection instructions.

Technological Characteristics

Dental stereotaxic instrument; 6-degree-of-freedom robotic arm; haptic feedback. Materials: TEE main body (Aluminum 7075), TEE thumb screws (Stainless Steel 316). Patient tracking via physical linkages (Patient Tracker, Kinematic Mount, Tracker End Effector) to splints. Reprocessing: High-level disinfection. Connectivity: YomiPlan software for pre-operative planning on third-party PCs.

Indications for Use

Indicated for partially edentulous and fully edentulous adult patients who qualify 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 (K222049)

Reference Devices

• Neocis Guidance System (K191605)
• Neocis Guidance System (K161399)
• Resert XL HD High-Level Disinfectant (K091022)

Submission Summary (Full Text)

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

Re: K222750

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: September 29, 2022 Received: September 30, 2022

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K222750

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 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.

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 K22750

#### 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: December 7, 2022

## 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 |
| Product Code: | QRY, PLV |

## III. Predicate Devices

Primary Predicate: Yomi Robotic System (K222049) Reference Device: Neocis Guidance System (K191605) Reference Device: Neocis Guidance System (K161399) Reference Device: Resert XL HD High-Level Disinfectant (K091022)

#### 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. 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

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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 light orange color. Above the word is a thin gray line that extends horizontally. To the right of the word, there is a gray crosshair symbol with a small circle in the center.

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.

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 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 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 Clamped Chairside Patient Splint (C-CPS) or YomiLink Bone (YLB), the Tracker End Effector (TEE) 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 to modify the design and reprocessing method for the Tracker End Effector (TEE) of the Yomi Robotic System. 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 (K222049).

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| Technological<br>Characteristics | Subject Device: Yomi Robotic<br>System | Primary Predicate: Yomi<br>Robotic System (K222049) | Comparison |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use (IFU) | Yomi Robotic System is a<br>computerized robotic navigational<br>system intended to provide<br>assistance in both the planning<br>(pre-operative) and the surgical<br>(intra-operative) phases of dental<br>implantation surgery. The system<br>provides software to preoperatively<br>plan dental implantation<br>procedures and provides robotic<br>navigational guidance of the<br>surgical instruments. The system<br>can also be used for planning and<br>performing guided bone reduction<br>(also known as alveoplasty) of the<br>mandible and/or maxilla. Yomi is<br>intended for use in partially<br>edentulous and fully edentulous<br>adult patients who qualify for<br>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.<br>YomiPlan provides pre-operative<br>planning for dental implantation<br>procedures using the Yomi Robotic<br>System. The output of YomiPlan is<br>to be used with the Yomi Robotic<br>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. Yomi<br>Plan provides pre-operative<br>planning for dental<br>implantation procedures using<br>the Yomi Robotic System.<br>The output of Yomi Plan is to<br>be used with the Yomi<br>Robotic System. | Equivalent |
| Principles of<br>Operation | The Tracker End Effector<br>physically attaches to, and provides<br>linkage between, the Patient<br>Tracker of the Yomi Robotic<br>System and the Patient Splint. The<br>Tracker End Effector is connected<br>to the Patient Tracker via a screw at<br>the Patient Tracker Flange. The | The Tracker End Effector<br>physically attaches to, and<br>provides linkage between, the<br>Patient Tracker of the Yomi<br>Robotic System and the Patient<br>Splint. The Tracker End<br>Effector is connected to the<br>Patient Tracker via a screw at | Equivalent |
| Technological<br>Characteristics | Subject Device: Yomi Robotic<br>System | Primary Predicate: Yomi<br>Robotic System (K222049) | Comparison |
| | Tracker End Effector is then also<br>connected via screw to the Patient<br>Splint. | the Patient Tracker<br>Flange. The Tracker End<br>Effector is then also connected<br>via screw to the Patient Splint. | |
| Robotic Guide<br>Arm | Guided robotic arm | Guided robotic arm | Equivalent |
| Movement<br>Direction | Guided Robotic Arm holds a surgical<br>instrument and provides haptic<br>feedback on position with respect to<br>the plan restricting movement outside<br>of 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 | Splints with arrays | Splints with arrays | Equivalent |
| Patient Tracking<br>Mechanism | Physical linkage to patient via Patient<br>Tracker (PT), Kinematic Mount<br>(KM), and Tracker End Effector<br>(TEE) connected to splints | Physical linkage to patient via<br>Patient Tracker (PT),<br>Kinematic Mount (KM), and<br>Tracker End Effector (TEE)<br>connected to splints | Equivalent |
| Fiducials for CT<br>scan | Fiducial Array (FA) attached to splint | Fiducial Array (FA) attached<br>to splint | Equivalent |
| Patient Contact | No contact | No contact | Equivalent |
| Reprocessing<br>Classification | Non-critical | Non-critical | Equivalent |
| Reprocessing<br>Method for<br>Tracker End<br>Effector | High level disinfection | Sterilization | Equivalent<br>Disinfection<br>validation testing<br>has demonstrated<br>disinfection of the<br>subject device<br>provides adequate<br>microbicidal<br>reprocessing |
| Mating<br>Component<br>Design | V-coupled design | Fiducial pins and spheres | Equivalent<br>Verification testing<br>has demonstrated the<br>modified design has<br>no impact on |
| Technological<br>Characteristics | Subject Device: Yomi Robotic<br>System | Primary Predicate: Yomi<br>Robotic System (K222049) | Comparison |
| | | | substantial<br>equivalence<br>Equivalent |
| Materials | TEE main body: Aluminum 7075<br>TEE thumb screws: Stainless Steel<br>316 | TEE main body: Aluminum<br>6061<br>TEE thumb screws: Stainless<br>Steel 316 | Verification<br>testing has<br>demonstrated the<br>modified material<br>has no<br>impact on substantial<br>equivalence |
| Performance<br>Testing | Total System Accuracy<br>Kinematic Mount<br>Repeatability<br>Drill Jig Accuracy<br>Disinfection Validation<br>Reprocessing Instruction<br>Validation | Total System Accuracy<br>Kinematic Mount<br>Repeatability<br>Drill Jig Accuracy | Equivalent |

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

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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 in gold color. A thin gray line is above the word, and a thin gray line intersects the word at the "i", forming a crosshair-like symbol. A small gray circle is at the intersection of the lines.

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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 horizontal line that extends to the left of the "n" and to the right of the "s". A thin gray vertical line intersects the horizontal line above the "i", forming a cross shape with a small circle at the intersection.

#### VII. Performance Testing

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

- Total System Accuracy Verification
- Kinematic Repeatability Verification
- Drill Jig Accuracy Verification ●
- High-Level Disinfection Validation was performed in accordance with recommended evaluations as listed in AAMI TIR12 and Guidance for Industry and FDA Staff -Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling

Usability validation testing for the modified reprocessing instructions has been performed. Usability testing included dental clinician users who were evaluated on critical tasks for the disinfection steps per the disinfection instructions for use and provided responses to open-ended questions.

#### VIII. Conclusion

This subject of this submission is to modify the design and reprocessing method for the Tracker End Effector (TEE) of 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.