(114 days)
No
The description focuses on mechanical guidance, real-time tracking based on fiducial markers, and software for pre-operative planning and visualization. There is no mention of AI or ML algorithms for image analysis, decision support, or adaptive control beyond simple positional adjustments based on tracking data. The performance studies and key metrics are also typical for a mechanical guidance system, not AI/ML performance metrics.
No.
This device is a surgical navigation system that assists dental surgeons during implant procedures by providing guidance and feedback, rather than directly treating a condition or disease.
No
The device is a navigational and guidance system for dental implant surgery, assisting in planning and intra-operative guidance rather than diagnosing a condition.
No
The device description explicitly details physical components like the Guidance Arm, Patient Splint/Chairside Splint, Patient Tracker, Calibration Drill Bit, and Depth Gauge, which are integral to the system's function and guidance.
Based on the provided information, the Neocis Guidance System (NGS) is not an IVD (In Vitro Diagnostic) 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 for diagnosis, monitoring, or screening.
- NGS Function: The NGS is a surgical guidance system. It uses a CT scan of the patient's anatomy to plan and guide the surgeon during dental implant surgery. It does not analyze biological specimens from the patient.
- Intended Use: The intended use clearly states assistance in the planning and surgical phases of dental implantation surgery, not diagnostic testing of biological samples.
- Device Description: The description focuses on physical and visual guidance during surgery, patient tracking, and calibration of surgical instruments. It does not mention any analysis of biological materials.
Therefore, the NeocGS is a surgical navigation and guidance system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
PLV
Device Description
The Neocis Guidance System (NGS) is a stereotaxic medical device that guides surgeons during dental implant surgery. The system allows the user to plan the surgery virtually in software using a CT scan of the patient, and the plan is used by a guidance system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation.
The implant process occurs in two phases. First, the dental surgeon plans the surgical procedure with the planning software. A virtual implant is placed at the desired location in the CT scan, allowing the dental surgeon to avoid interfering with critical anatomical structures during implant surgery. Second, when the implant plan is optimally positioned, the NGS provides accurate guidance of the dental surgical instruments according to the pre-operative plan.
Physical guidance is provided via the Guidance Arm. The Guidance Arm grips a standard dental drill from the back end, allowing the surgeon to grip the drill as normal. The Guidance Arm does not move unless the surgeon applies a manual force to the drill. The Guidance Arm will constrain the surgeon to drill according to the prescribed surgical plan, preventing deviation. The surgeon is constantly in control of the drilling.
Visual guidance is provided by 3D graphics and 2D cross sections that indicate the position and orientation of the drill in relation to the pre-operative plan and scan. The visual feedback is updated in real-time so any relative motion between the dental handpiece and the patient properly update the visualization.
The patient tracking portion of the NGS is comprised of the Patient Splint and the Patient Tracker. The Patient Splint is attached to the contralateral side of the patient's mouth. The Patient Splint is placed on the patient prior to the CT scan. A fiducial array with fiducial markers is placed on the Patient Splint prior to the CT scan so the virtual plan can be related to the physical space of the system. The Patient Tracker is a mechanical feedback system that is connected to the Patient Splint on the patient, which relays information to the control software in order to track patient movement. If patient movement occurs during the surgical procedure, the system will respond by altering the prescribed surgical cutting angle and position to accommodate the patient movement, which will maintain the accuracy of the drill placement.
Several steps are required for calibration and measurement during the procedure. The drill is calibrated using the Calibration Drill Bit inserted into a precise position on the Patient Tracker. During the surgery, each drill bit must be measured with the Depth Gauge to determine the proper length of the bit. These measurements complete the loop so the entire NGS is accurate to the tip of the drill.
The NGS is a supporting device, providing additional information and guidance to the decision-making process during the surgical procedure. It is not intended to replace the surgeon's judgment. The final clinical decisions are the sole responsibility of the surgeon. The surgeon can at any time during the surgical procedure modify the planned implant positions. Under no circumstances does the device relieve the surgeon of his or her ultimate clinical responsibility.
The subject device is the same as the NGS cleared under K161399 (the predicate device), except for a change to the splint. The Patient Splint of the predicate device has been modified to allow for a chairside workflow. This modified splint is referred to as the Chairside Splint.
The splint is a key component for patient tracking for the NGS. The patient tracking portion of the NGS is comprised of the Chairside Splint and the Patient Tracker. The Chairside Splint is attached to the contralateral side of the patient's mouth. The Chairside Splint is affixed to the patient's teeth using Lang Jet Tooth Shade Dental Acrylic (K083195). The Chairside Splint is placed on the patient prior to the CT scan. A fiducial array with fiducial markers is placed on the Chairside Splint prior to the CT scan so the virtual plan can be related to the physical space of the system. The Patient Tracker is a mechanical feedback system that is connected to the Patient Chairside on the patient, which relays information to the control software in order to track patient movement. If patient movement occurs during the surgical procedure, the system will respond by altering the prescribed surgical cutting angle and position to accommodate the patient movement, which will maintain the accuracy of the drill placement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons (dental surgeons), clinical environment.
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)
Non-clinical Testing:
Type: Simulated Use (End User Validation)
Description: Run through of typical splint affixation cases using typodonts, performed by Surgeons.
Type: Total System Accuracy
Description: The Total System was evaluated for accuracy via simulated use with a typodont as simulation of a patient with three osteotomies per typodont in four locations (Upper Right / Upper Left / Lower Right / Lower Left).
Type: Patient Tracker and Splint Mounting Verifications
Description: Evaluating the effect of 2x Patient Tracker weight as total downward force on a standard splint mounted on a typodont per the IFU. In addition, evaluation of kinematic mount repeatability and patient anatomy accommodation analysis.
Non-clinical testing performed on the predicate NGS relied upon for clearance of the modified splint:
Biocompatibility Testing: Conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. Testing included cytotoxicity (ISO 10993-5), sensitization and irritation (ISO 10993-10). Components considered tissue contacting for less than 24 hours.
Cleaning and Sterilization Validation: Tested reusable NGS components to validate steam sterilization process and acceptable sterility. Conducted according to ISO 17665-1:2006.
Electrical Safety and Electromagnetic Compatibility (EMC): Comprehensive performance testing by a recognized third-party organization according to IEC 60601-1:2005 and IEC 60601-1-2:2007.
Software and System Verification and Validation: Conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered "moderate" level of concern. Software Development and Testing performed per IEC 62304: 2006, FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) and FDA General Principles of Software Validation (January 11, 2002). Risk analysis conducted in compliance with ISO 14971: 2012 including FMEA analysis (Use FMEA, Design FMEA, 60601 FMEA, Software FMEA).
Software and System Verification and Validation detailed:
Simulated Use: Run through of Typical Use Case.
Boundary Condition: Testing of all potential boundary parameters in the Application Software.
Registration: Testing of registration process.
Case File Contents: Simulated use testing of features associated with saving / loading Cases.
Error Case Injection: Simulating all error messages and pop-ups.
CT Scan Verification: Verification of the resolution and validity of CT Scans.
Control SW Boundary Condition Testing: Testing the mechanical boundaries of the Control Software and Guidance Arm.
Control Software Gravity Calibration Verification: Verifying that the Gravity Calibration is effective over multiple start-up / shut down cycles.
Work Volume and Floor Grid Verification: Verifying the design and functionality of the Work Volume and Floor Grid features in the application software.
Accuracy Verification: Patient Tracker: The Patient Tracker was evaluated for accuracy per ASTM F2554.
Guidance Arm Accuracy / Repeatability: The positional accuracy of the Guidance Arm was evaluated by collecting 27 data points in spaces within two work volumes (54 total points) against a calibrated CMM.
Communication Rate Verification: Force-Torque (F/T) Sensor to Control Software, Patient Tracker to Control Software, Guidance Arm to Control Software and communication between Application Software and Control Software rates were evaluated for appropriate speed.
End User Calibration Verification: Dimensional analysis and verification of Calibration Materials (Calibration Drill Bit and Calibration End Effector Divot).
F/T Sensor Verification: Guidance Arm speed limit testing and drift / idle F/T Sensor verification, intended to evaluate safety mitigations for Guidance Arm motion.
Start-Up / Shutdown Process Verification: Qualitative evaluation of all start-up / shutdown steps performed in a simulated clinical environment.
Start-Up Joint Position Identification: Verification to ensure system integrity of Guidance Arm in case any joint motion that may have occurred while system was not powered.
User Emergency Safety Verification: Evaluation of time required for a Guidance Arm emergency shutdown, and emergency disconnection of the patient.
Guidance Arm Adjustment to Patient Motion: Simulation of Patient Tracker motion while system is in Drill Mode, and drill bit is in simulated bone block.
Work Volume Verification: Assessment of physical design and cable management throughout available work volumes.
Speed Trap Verification: Evaluation of the Guidance Arm and Patient Tracker speed trap safety mitigations.
End User Validation of User Requirements: Validation of User Requirements as they pertain to NGS Design and Development, and Software Lifecycle Design and Development, performed by End User in simulated environment.
End User Validation of User Requirements for Splint Application and Removal: An addendum to the NGS End User Validation to repeat validation steps associated with changes made to the design and instructions for the use of the NGS Splint.
End User Validation of User Requirements for Changes made to Patient Tracker End Effector: An addendum to the NGS End User Validation to repeat validation steps associated with changes made to the design, and procedural steps associated with the Patient Tracker End Effector.
Nonclinical validation testing was conducted in a simulated clinical environment and included full use of the system through the complete workflow. Testing demonstrated that the device is substantially equivalent to the predicate device.
Clinical Testing:
Study Type: To assess the application and removal of the Chairside Splint, with a primary focus on human factors issues.
Sample Size: 15 dentists at two different sites over a total of 75 subjects.
Key results: The investor population included a variety of experience levels and the subject population included both upper and lower jaw testing.
Primary study endpoint: Evaluation of human factors regarding Chairside Splint application and removal.
Evaluated using:
- Duration of Chairside Splint application and removal
- Photos and intra-oral scans of the site before and after Chairside Splint placement
- Occurrence of adverse events related to acrylic fixation
- Occurrence of adverse events during removal due to drilling the Chairside Splint
- Occurrence of adverse events due to debris or other swallowing or aspiration potential hazards
- Subjective evaluation by Investigators
Study results support the substantial equivalence of the NGS Chairside Splint to the cleared Patient Splint. No significant adverse events or complications have been reported. In comparison to the predicate device, no significant new issues or risks have been identified.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
0
February 22, 2018
Image /page/0/Picture/1 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Neocis Inc. Alon Mozes, Ph.D. CEO and Co-Founder 2800 Biscayne Blvd Suite 600 Miami, Florida 33137
Re: K173402
Trade/Device Name: Neocis Guidance System (NGS) with Chairside Splint Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: PLV Dated: January 22, 2018 Received: January 25, 2018
Dear Alon Mozes:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Mary S. Runner -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173402
Device Name
Neocis Guidance System (NGS) with Chairside Splint
Indications for Use (Describe)
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.
| 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/1 description: The image shows the logo for Neocis. The word "neocis" is written in a sans-serif font, with the "neo" portion in yellow and the "cis" portion in gray. Above the word is a gray line, and to the right of the word is a gray circle with lines extending from it in four directions.
Section 7. 510(k) Summary
| Submitter Name: | Neocis Inc.
2800 Biscayne Blvd.
Suite 600
Miami, FL 33137
Tel: 1-855-9NEOCIS |
|----------------------|-------------------------------------------------------------------------------------------------|
| Contact Person: | Alon Mozes, Ph.D.
2800 Biscayne Blvd.
Suite 600
Miami, FL 33137
Tel: (305) 409-2819 |
| Date Prepared: | January 22, 2018 |
| Trade Name: | Neocis Guidance System (NGS) with Chairside Splint |
| Common Name: | Dental Stereotaxic Instrument |
| Classification Name: | Bone cutting instrument and accessories (21 CFR 872.4120) |
| Classification: | Class II |
| Product Code: | PLV |
| Predicate Device: | Neocis Guidance System (K161399) |
Indications for Use:
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.
Device Description:
The Neocis Guidance System (NGS) is a stereotaxic medical device that guides surgeons during dental implant surgery. The system allows the user to plan the surgery virtually in software using a CT scan of the patient, and the plan is used by a quidance system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation.
The implant process occurs in two phases. First, the dental surgeon plans the surgical procedure with the planning software. A virtual implant is placed at the desired location in the CT scan, allowing the dental surgeon to avoid interfering with critical anatomical structures during implant surgery. Second, when the implant plan is optimally positioned, the NGS provides accurate guidance of the dental surgical instruments according to the pre-operative plan.
Physical guidance is provided via the Guidance Arm. The Guidance Arm grips a standard dental drill from the back end, allowing the surgeon to grip the drill as normal. The Guidance Arm does
4
Image /page/4/Picture/0 description: The image shows the logo for Neocis. The word "neocis" is written in a sans-serif font and is colored in yellow. Above the word is a gray line, and to the right of the word is a gray symbol that looks like a plus sign with a circle in the middle.
not move unless the surgeon applies a manual force to the drill. The Guidance Arm will constrain the surgeon to drill according to the prescribed surgical plan, preventing deviation. The surgeon is constantly in control of the drilling.
Visual guidance is provided by 3D graphics and 2D cross sections that indicate the position and orientation of the drill in relation to the pre-operative plan and scan. The visual feedback is updated in real-time so any relative motion between the dental handpiece and the patient properly update the visualization.
The patient tracking portion of the NGS is comprised of the Patient Splint and the Patient Tracker. The Patient Splint is attached to the contralateral side of the patient's mouth. The Patient Splint is placed on the patient prior to the CT scan. A fiducial array with fiducial markers is placed on the Patient Splint prior to the CT scan so the virtual plan can be related to the physical space of the system. The Patient Tracker is a mechanical feedback system that is connected to the Patient Splint on the patient, which relays information to the control software in order to track patient movement. If patient movement occurs during the surgical procedure, the system will respond by altering the prescribed surgical cutting angle and position to accommodate the patient movement, which will maintain the accuracy of the drill placement.
Several steps are required for calibration and measurement during the procedure. The drill is calibrated using the Calibration Drill Bit inserted into a precise position on the Patient Tracker. During the surgery, each drill bit must be measured with the Depth Gauge to determine the proper length of the bit. These measurements complete the loop so the entire NGS is accurate to the tip of the drill.
The NGS is a supporting device, providing additional information and quidance to the decisionmaking process during the surgical procedure. It is not intended to replace the surgeon's iudgment. The final clinical decisions are the sole responsibility of the surgeon. The surgeon can at any time during the surgical procedure modify the planned implant positions. Under no circumstances does the device relieve the surgeon of his or her ultimate clinical responsibility.
The subject device is the same as the NGS cleared under K161399 (the predicate device), except for a change to the splint. The Patient Splint of the predicate device has been modified to allow for a chairside workflow. This modified splint is referred to as the Chairside Splint.
The splint is a key component for patient tracking for the NGS. The patient tracking portion of the NGS is comprised of the Chairside Splint and the Patient Tracker. The Chairside Splint is attached to the contralateral side of the patient's mouth. The Chairside Splint is affixed to the patient's teeth using Lang Jet Tooth Shade Dental Acrylic (K083195). The Chairside Splint is placed on the patient prior to the CT scan. A fiducial array with fiducial markers is placed on the Chairside Splint prior to the CT scan so the virtual plan can be related to the physical space of the system. The Patient Tracker is a mechanical feedback system that is connected to the Patient Chairside on the patient, which relays information to the control software in order to track patient movement. If patient movement occurs during the surgical procedure, the system will respond by altering the prescribed surgical cutting angle and position to accommodate the patient movement, which will maintain the accuracy of the drill placement.
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Image /page/5/Picture/0 description: The image shows the logo for Neocis. The logo consists of the word "neocis" in a sans-serif font, with the letters in a golden color. Above the word is a gray horizontal line that extends to the left and right of the word. A gray vertical line intersects the horizontal line at a point above the "i" in "neocis", forming a crosshair-like symbol.
Comparison of Technological Characteristics:
This submission involves only a modification to the Patient Splint for the NGS. The new version will be referred to as the Chairside Splint, to be differentiated from the previous Patient Splint. Otherwise, all performance characteristics of the NGS are the same. The Chairside Splint involves a modification that allows for a chairside creation of the Patient Splint rather than requiring a patient impression and model and fabrication through a dental lab. The differences introduced by this modification are detailed in Table 1.
| Technological
| Characteristics | NGS with Chairside Splint | NGS with Patient Splint | Comments |
|---|---|---|---|
| Subject Device | Predicate Device (K161399) | ||
| Indications for Use | |||
| Indications for | |||
| Use | 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 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. | No difference | ||
| Materials | |||
| Materials | lxef®-HC-1022 | lxef®-HC-1022 | No difference |
| Technology / Performance Characteristics | |||
| Supply Voltage | 120 V | 120 V | No difference |
| Phases | 1 | 1 | No difference |
| Type of Current | AC | AC | No difference |
| Rated Frequency | |||
| (Hz) | 60 Hz | 60 Hz | No difference |
| Rated Power | |||
| Input (VA) | 600 VA | 600 VA | No difference |
| Types and | |||
| Ratings of | |||
| external | |||
| accessible fuses | 5.0 A for 240 V | 5.0 A for 240 V | No difference |
| Type of Protection | |||
| against Electric | |||
| Shock | Class I Equipment | Class I Equipment | No difference |
| Degree of | |||
| Protection against | |||
| Electric Shock | Type BF | Type BF | No difference |
| Technological | NGS with Chairside Splint | NGS with Patient Splint | Comments |
| Characteristics | Subject Device | Predicate Device (K161399) | |
| Equipment | |||
| Suitable for use in | |||
| the presence of | |||
| Flammable | |||
| Mixtures? | No | No | No difference |
| Mode of | |||
| Operation | Continuous Operation | Continuous Operation | No difference |
| System Lateral | |||
| Accuracy | RMS |