(399 days)
No
The description focuses on robotic guidance based on surgeon input and direct visualization, not on automated analysis or decision-making using AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
Explanation: The device is a computerized robotic navigational system designed to assist in dental implantation surgery, not to treat or cure a disease or condition itself. It provides guidance for surgical instruments, which is a tool for a procedure, not a therapeutic action.
No
The device is a computerized robotic navigational system intended to assist in the planning and surgical phases of dental implantation. It provides robotic guidance for surgical instruments and allows surgeons to select the point, axis, and trajectory for an osteotomy. It does not perform any diagnostic function; its role is in surgical execution and planning, not in identifying diseases or conditions.
No
The device description explicitly states that Yomi is a "computerized robotic navigational system" and provides "robotic navigational guidance of the surgical instruments." This indicates the presence of hardware components beyond just software.
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 Yomi is a computerized robotic navigational system intended to provide assistance in the planning and surgical phases of dental implantation surgery. It guides surgical instruments.
- Device Description: The description focuses on the robotic system, software for planning, and the mechanism for guiding the surgeon's actions during the procedure.
- Lack of In Vitro Activity: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on biological samples. It is a surgical guidance system.
- Focus on Surgical Procedure: The entire description revolves around assisting a surgical procedure performed directly on the patient's anatomy.
Therefore, Yomi falls under the category of a surgical guidance or robotic surgical system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Yomi 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. 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.
Product codes
PLV
Device Description
The subject of this submission is YomiPlan Go, a feature of the Yomi Robotic System which enables the use of the system without the uploading of a preoperative CT scan. The dynamic planning feature in K202264 requires a pre-operative CT scan for use. This submission includes a new workflow called YomiPlan Go and provides instructions on how to use this feature without the need of uploading a CT scan to the Yomi system. This planning involves placing the robotic arm drill tip to the point where an osteotomy is to be performed i.e., the surgeon performs planning with their direct visualization of the anatomy and with the use of the robotic arm to select where the osteotomy is to be performed. YomiPlan Go gives surgeons the ability to perform an osteotomy under robotic guidance at the point that the surgeon selects on the patient's anatomy. The selected point, axis, and trajectory are maintained by the robotic arm while the surgeon performs the osteotomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
Surgeons (general dentists, oral surgeons) in a clinical setting.
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
A clinical study (G210363) was performed. The investigation was a prospective, multi-center, single-arm study, in which partially or fully edentulous patients had as part of their treatment single or multiple implant placement in the maxilla or the mandible. A total of 44 of implants were placed in fifteen (15) patient arches with Yomi Active. Each of the (5) sites had (3) partial and (2) full arch dental restorations performed by each investigator. The study was performed by general dentists. A 3rd party oral surgeon performed an independent clinical assessment of all cases. Each investigator provided subjective data through completion of quantitative and open-ended subjective questionnaires.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Testing (G210363):
- Study Type: Prospective, multi-center, single-arm clinical study.
- Sample Size: 15 patient arches, 44 implants placed.
- Key Results:
- Primary objective: Evaluate human factors related issues with YomiPlan Go during the preoperative and intraoperative use. Investigators determined that the YomiPlan Go met its design and performance requirements. No serious adverse events. One adverse event where implant transported into sinus (user error).
- Secondary objective: Evaluate accuracy of YomiPlan Go by comparing pre-operative CBCT scans (implants planned in ideal locations) with postoperative CBCT scans (actual implant placement). Included third-party oral surgeon's assessment for safety, parallelism, and restorability.
- Precision, depth, and lateral error of YomiPlan Go are equivalent to the predicate.
- Angular deviations were higher with YomiPlan Go (12.91 +/- 7.56 degrees) than with the predicate device (3.3 degrees). These results were found to be within a similar range to freehand accuracy data (average angular deviation of 7.03 degrees, range 0.7-21.3 degrees from Varga, et al study).
- Accuracy is not a specification or advantage of YomiPlan Go; precision is.
- Independent 3rd party clinical review of all 15 cases from the IDE found no vital anatomical structure concerns after completion of each procedure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
| Comparison Metric | Raw Data of Implant Placements Grouped by Patient, Absolute Values, reported in Mean/StdDev | ||
|---|---|---|---|
| Depth Error (mm) | Lateral Error (mm) | Angular Error (degs) | |
| Investigator Plan on PreOp CT vs Investigator PostOp CT of Final Implant Placement | 1.38 +/- 0.71 | 2.04 +/- 1.59 | 12.91 +/- 7.56 |
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.
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Neocis Inc. William Tapia VP RA/QA 2800 Biscayne Blvd Suite 600 Miami, Florida 33137
Re: K211466
Trade/Device Name: Yomi Robotic System with YomiPlan Go Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: PLV Dated: May 20, 2022 Received: May 20, 2022
Dear William Tapia:
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.
1
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
2
Indications for Use
510(k) Number (if known) K211466
Device Name Yomi Robotic System with YomiPlan Go
Indications for Use (Describe)
Yomi 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. 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 word "neocis" is written in a sans-serif font, with the letters in gold. Above the word is a gray horizontal line that extends to the left and right of the word. To the right of the word is a gray vertical line that intersects the horizontal line, forming a cross shape.
510(k) Summary K211466
l. Submitter
Neocis Inc.
2800 Biscayne Blvd.
Suite 600
Miami, FL 33137
Tel: 1-855-9NEOCIS
Contact Person: William Tapia, VP RA/QA
Date Prepared: June 14, 2022
II. Device
Trade Name: Yomi Robotic System with YomiPlan Go
Common Name: Dental Stereotaxic Instrument
Classification Name: Bone cutting instrument and accessories (21 CFR 872.4120)
Classification: Class II
Product Code: PLV
lll. Predicate Device
Neocis Guidance System (NGS) with YomiPlan v2.0 (K202264)
IV. Reference Device
Orthosoft Navitrack System-Optical TKR CT-Less System (K021760)
V. Indications for Use
Yomi 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. 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.
VI. Device Description
The subject of this submission is YomiPlan Go, a feature of the Yomi Robotic System which enables the use of the system without the uploading of a preoperative CT scan. The dynamic planning feature in K202264 requires a pre-operative CT scan for use. This submission includes a new workflow called YomiPlan Go and provides instructions on how to use this feature without the need of uploading a CT scan to the Yomi system. This planning involves placing the robotic arm drill tip to the point where an osteotomy is to be performed i.e., the surgeon performs
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planning with their direct visualization of the anatomy and with the use of the robotic arm to select where the osteotomy is to be performed. YomiPlan Go gives surgeons the ability to perform an osteotomy under robotic guidance at the point that the surgeon selects on the patient's anatomy. The selected point, axis, and trajectory are maintained by the robotic arm while the surgeon performs the osteotomy.
Principal of Operation
YomiPlan Go gives surgeons the ability to place implants on the trajectory defined by the axis and location of the robotic arm drill tip for any selected implant, without the use of a preoperative CT scan uploaded to the Yomi System. This feature allows surgeons to place implants with precision without a preloaded CT scan. With YomiPlan Go, the surgeon selects the implant and then creates the desired path for the planned osteotomy by positioning the robotic arm drill tip at the site of where the osteotomy is to be performed.
Intended Patient Population
Based on a clinical study performed with YomiPlan Go (G210363), the intended population for YomiPlan Go was determined to be:
- . Healthy adults 18 years of age or older with sufficient bone height and width appropriate for dental implant surgery
- Partially or fully edentulous patients ●
Preplanning with YomiPlan Go
Preplanning with YomiPlan Go is similar to that of traditional freehand technique as no CT image is actively referenced within YomiPlan. It is important to note that this does not preclude the surgeon from taking a pre-operative image and using it mentally as consideration for the freehand planning. The surgeon uses the system to indicate the plan on the patient by observing the patient's specific anatomy that is plainly visible.
The clinical study performed via G210363 demonstrated that YomiPlan Go could be used to successfully capture the trajectory of the osteotomy based mainly on the drill bit tip established by the surgeon and was adequate to provide placement of the implant at the position determined by the surgeon. In the study, YomiPlan Go was able to provide guidance which used a single point with a trajectory and resulting in placement of the implant at the position established by the surgeon.
Labeling for YomiPlan Go
Labeling (i.e., instructions for use, training) is an important part of YomiPlan Go. The following are key points from these materials:
- . We recommend preoperative CT as standard of care for consultation and diagnosis. No imaging is required by Yomi Go software for preoperative planning or intraoperative guidance.
- . Accuracy is not a specification or an advantage of YomiPlan Go, however precision is an important specification which has been validated through performance testing.
- . The surgeon must use clinical judgment in determining the best plan (position, angle, and depth) based on any anatomy that is plainly visible as well as any pre-operative X-rays or CT they may have taken of the patient.
- Use of YomiPlan Go vields less position accuracy relative to a CBCT than the guided technique for osteotomy placement in which CBCT scanning and digital intraoral impressions are used
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to generate a virtual representation of the patient's jaw and oral anatomy, and the exact position of the implant is determined in advance of treatment.
Use of Anatomical Cues to Define Trajectory
The implant position and angle are defined by the surgeon by using the drill tip as a pointer. This enables the surgeon to indicate to the system the desired position and angle based on any anatomical cues they believe are relevant, e.g., neighboring teeth, bone ridge, extraction socket, etc. It is up to the surgeon to plan the implant appropriately based on the patient's clinical condition and rely on their medical training and ability to visualize the relevant anatomy of the patient.
VII. Substantial Equivalence Discussion
The table below summarizes a comparison of YomiPlan Go with the predicate NGS with Yomi Plan 2.0 (K202264).
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Feature | Yomi Robotic System with YomiPlan Go | NGS with Yomi Plan v2.0 | SE Analysis |
| K211466 | K202264 | ||
| Indications for use | Yomi 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. | |||
| Yomi is intended for use in partially edentulous and | |||
| fully edentulous adult patients who qualify for dental | |||
| implants. | The Neocis Guidance System (NGS) 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 NGS is intended for use in | |||
| partially edentulous and fully edentulous adult | |||
| patients who qualify for dental implants. | Equivalent - Updated to | ||
| include reference to | |||
| robotic arm. | |||
| When Yomi Plan 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. | When Yomi Plan 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. The output of Yomi | |||
| Plan is to be used with the Neocis Guidance | |||
| System (NGS). | |||
| Contraindications | Most surgical dental implant placement involves | ||
| three-dimensional placement into a non-visible | |||
| space. Two-dimensional radiographs may provide | |||
| important information, but they often lack the oral- | |||
| facial dimension that completes the picture. more- | |||
| detailed information from 3D x-ray imaging is | |||
| needed, most frequently, CBCT imaging. | |||
| Complications in implant dentistry are common and | |||
| can range from minor to severe. One of the most | |||
| common complications in implant dentistry is | |||
| implant malposition. This can result in a host of | |||
| complications: fenestrations, dehiscences and | |||
| recession, difficult restoration, poor biomechanics, | |||
| loss of interproximal structure, damage to adjacent | None | Different - difference | |
| validated as acceptable | |||
| with successful | |||
| completion of G210363 | |||
| Subject Device | Predicate Device | ||
| Feature | Yomi Robotic System with YomiPlan Go | NGS with Yomi Plan v2.0 | SE Analysis |
| K211466 | K202264 | ||
| anatomy, and many others. | |||
| Use of the YomiPlan Go is contraindicated when the | |||
| intended implant location has concerns related to | |||
| bone volume, architecture, and proximity to critical | |||
| anatomic structures, such as nerves, maxillary sinus | |||
| or nasal floor or neurovasculature. | |||
| OS | Windows 10 | Windows 10 | Identical |
| PC Requirements | PC with 64-bit Windows 10 OS or newer with a | ||
| minimum of 4 GB of RAM and a 2 GHz dual core | |||
| processor. Local memory (hard drive) should be a | |||
| minimum of 100 GB with 7200 RPM or SSD. | |||
| Connectivity requirements include ethernet, Wi-Fi, | |||
| USB, or CD drive. | PC with 64-bit Windows 10 OS or newer with | ||
| a minimum of 4 GB of RAM and a 2 GHz dual | |||
| core processor. Local memory (hard drive) | |||
| should be a minimum of 100 GB with 7200 | |||
| RPM or SSD. Connectivity requirements | |||
| include ethernet, Wi-Fi, USB, or CD drive. | Identical | ||
| Preplanning Steps | Preplanning is performed by the surgeon | ||
| by direct visualization of the patient's | |||
| anatomy and placing the drill tip at the | |||
| desired location and angle. The dimension | |||
| of the implant is identified in YomiPlan Go | |||
| and the trajectory established by the | |||
| surgeon is captured. | The predicate device uses a | ||
| preoperative CBCT scan which is | |||
| uploaded to YomiPlan to support | |||
| a surgeon's planning of the desired | |||
| implant placement. | Equivalent | ||
| Level of Concern | Moderate | Moderate | Identical |
| Installation | Windows Installer .msi file | Windows Installer .msi file | Identical |
| Origin | Proprietary | Proprietary | Identical |
| OTS Software | TeamViewer | TeamViewer | Identical |
| Hardware | No changes (activate/use pre-existing network | ||
| features) | No changes (activate/use pre-existing | ||
| network features) | Identical | ||
| Wireless data | |||
| transmission over | |||
| LAN | Yes, via integrated hardware, tested according to: | ||
| AAMI TIR69: 2017 Technical Information | |||
| Report Risk management of radio- | |||
| frequency wireless coexistence for | |||
| medical devices and systems. IEEE ANSI C63.27-2017 American National | |||
| Standard for Evaluation of Wireless | |||
| Coexistence | Yes, via integrated hardware, tested | ||
| according to: AAMI TIR69: 2017 Technical | |||
| Information Report Risk | |||
| management of radio-frequency | |||
| wireless coexistence for medical | |||
| devices and systems. IEEE ANSI C63.27-2017 American | |||
| National Standard for Evaluation of | |||
| Wireless Coexistence | Identical | ||
| Interface | Windows based GUI | Windows based GUI | Identical |
| System Accuracy / | |||
| Precision | |||
| Specifications | Accuracy: N/A for YomiPlan Go |
Precision: Upper 95% Probability with 95% Model
Fit