(87 days)
No
The summary describes a robotic navigational system for dental surgery that uses pre-operative planning based on CBCT scans and provides guidance during the procedure. There is no mention of AI or ML in the device description, intended use, or performance studies. The modifications are related to the Tracker End Effector and its reprocessing.
No.
The device is a surgical guide system that assists in planning and performing dental implantation surgery, not a device that directly treats a disease or condition.
No
This device is described as a "computerized robotic navigational system" that provides assistance in the planning and surgical phases of dental implantation. Its primary function is to guide surgical instruments, not to diagnose a condition or disease.
No
The device is described as a "computerized robotic navigational system" and a "dental stereotaxic instrument and a powered surgical device for bone cutting." It includes a robotic arm, patient tracking components (splints, tracker end effector, patient tracker), and guides a standard bone cutting instrument. While it has a software component (YomiPlan), it is clearly a system with significant hardware components for physical guidance and manipulation.
Based on the provided information, the Yomi Robotic System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, such as diagnosing a disease or monitoring a condition.
- Yomi's Function: The Yomi Robotic System is a surgical guidance system used during dental implantation surgery. It assists in planning and performing the procedure based on imaging data (CBCT scans) of the patient's anatomy. It does not analyze biological specimens to provide diagnostic information.
- Intended Use: The intended use clearly states its purpose is for "assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery." This is a surgical aid, not a diagnostic tool.
Therefore, the Yomi Robotic System falls under the category of a surgical device or a robotic surgical system, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
QRY, PLV
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
cone beam computed tomography (CBCT)
Anatomical Site
mandible and/or maxilla
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (6/20)
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
3
Image /page/3/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 horizontal line that extends to the right, where it intersects with a vertical line. At the intersection of the two lines, there is a small circle.
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
4
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).
5
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 horizontal line that extends to the left and right of the word. A gray circle is above the "i" in "neocis", and a vertical gray line extends upwards from the circle.
| Technological
Characteristics | Subject Device: Yomi Robotic
System | Primary Predicate: Yomi
Robotic System (K222049) | Comparison |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use (IFU) | 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. | 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. | Equivalent |
| Principles of
Operation | The Tracker End Effector
physically attaches to, and provides
linkage between, the Patient
Tracker of the Yomi Robotic
System and the Patient Splint. The
Tracker End Effector is connected
to the Patient Tracker via a screw at
the Patient Tracker Flange. The | The Tracker End Effector
physically attaches to, and
provides linkage between, the
Patient Tracker of the Yomi
Robotic System and the Patient
Splint. The Tracker End
Effector is connected to the
Patient Tracker via a screw at | Equivalent |
| Technological
Characteristics | Subject Device: Yomi Robotic
System | Primary Predicate: Yomi
Robotic System (K222049) | Comparison |
| | Tracker End Effector is then also
connected via screw to the Patient
Splint. | the Patient Tracker
Flange. The Tracker End
Effector is then also connected
via screw to the Patient Splint. | |
| Robotic Guide
Arm | Guided robotic arm | Guided robotic arm | Equivalent |
| Movement
Direction | Guided Robotic Arm holds a surgical
instrument and provides haptic
feedback on position with respect to
the plan restricting movement outside
of volume predefined during
planning.
6 degrees of freedom | Guided Robotic Arm holds a
surgical instrument and
provides haptic feedback on
position with respect to the
plan restricting movement
outside of volume predefined
during planning.
6 degrees of freedom | Equivalent |
| Patient affixed
tracking parts | Splints with arrays | Splints with arrays | Equivalent |
| Patient Tracking
Mechanism | Physical linkage to patient via Patient
Tracker (PT), Kinematic Mount
(KM), and Tracker End Effector
(TEE) connected to splints | Physical linkage to patient via
Patient Tracker (PT),
Kinematic Mount (KM), and
Tracker End Effector (TEE)
connected to splints | Equivalent |
| Fiducials for CT
scan | Fiducial Array (FA) attached to splint | Fiducial Array (FA) attached
to splint | Equivalent |
| Patient Contact | No contact | No contact | Equivalent |
| Reprocessing
Classification | Non-critical | Non-critical | Equivalent |
| Reprocessing
Method for
Tracker End
Effector | High level disinfection | Sterilization | Equivalent
Disinfection
validation testing
has demonstrated
disinfection of the
subject device
provides adequate
microbicidal
reprocessing |
| Mating
Component
Design | V-coupled design | Fiducial pins and spheres | Equivalent
Verification testing
has demonstrated the
modified design has
no impact on |
| Technological
Characteristics | Subject Device: Yomi Robotic
System | Primary Predicate: Yomi
Robotic System (K222049) | Comparison |
| | | | substantial
equivalence
Equivalent |
| Materials | TEE main body: Aluminum 7075
TEE thumb screws: Stainless Steel
316 | TEE main body: Aluminum
6061
TEE thumb screws: Stainless
Steel 316 | Verification
testing has
demonstrated the
modified material
has no
impact on substantial
equivalence |
| Performance
Testing | Total System Accuracy
Kinematic Mount
Repeatability
Drill Jig Accuracy
Disinfection Validation
Reprocessing Instruction
Validation | Total System Accuracy
Kinematic Mount
Repeatability
Drill Jig Accuracy | Equivalent |
Table 1: Comparison of technological characteristics to the predicate
6
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.
7
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.