(216 days)
No
The summary describes a stereotaxic navigation system that uses pre-operative planning and real-time tracking to guide a surgeon. It relies on physical constraints, visual feedback, and mechanical tracking, but there is no mention of AI or ML being used for image analysis, planning, or guidance. The system responds to patient movement by altering the guidance based on the pre-operative plan, not through learning or adaptive algorithms.
No.
This device is a surgical guidance system that assists in planning and performing dental implantation surgery. It does not directly treat a disease or condition but rather aids in a surgical procedure.
No
Explanation: The device is a surgical navigation system that provides guidance during dental implantation surgery based on pre-operative planning and intra-operative tracking. Its primary function is to assist in performing a procedure, not to diagnose a condition. While it uses CT scans for planning, it does not interpret or analyze them to identify diseases or conditions.
No
The device description explicitly mentions physical components like the "Guidance Arm," "Patient Splint," and "Patient Tracker," which are hardware components used for physical guidance and patient tracking during the surgical procedure.
Based on the provided text, the Neocis Guidance System (NGS) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- NGS Function: The NGS is a surgical navigation system used during a surgical procedure (dental implantation). It uses pre-operative imaging (CT scans) and real-time tracking to guide surgical instruments. It does not analyze biological specimens.
The NGS is a surgical guidance system, not a diagnostic tool that analyzes samples outside the body.
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 quides surgeons during dental implant surgery (see Table 1 below for significant physical and performance characteristics details). 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 quidance 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 decisionmaking 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT Scan
Anatomical Site
Dental (jaw)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended User: Dental surgeon
Care Setting: Clinical Setting, Doctors Office
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
Test was conducted in a simulated clinical environment and included full use of the system through the complete workflow.
Clinical testing was conducted with primary focus on human factors issues and involved 3 surgeons at 3 different surgical sites, for a total of 17 implants placed in 15 patients.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing:
- Biocompatibility Testing: Evaluation of NGS components in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. Components are tissue contacting for less than 24 hours. Testing included cytotoxicity (ISO 10993-5), sensitization, and irritation (ISO 10993-10).
- Cleaning and Sterilization Validation: Tested representative reusable NGS components for steam sterilization process per ISO 17665-1:2006 to achieve acceptable sterility assurance level.
- Electrical Safety and Electromagnetic Compatibility (EMC): Tested per IEC 60601-1:2005 + Corr. 1 (2006) + Corr. 2 (2007), ANSI/AAMI ES60601-1:2005(R)2012 and C1:2009/(R) 2012 and A2:2010/(R) 2012 (Consolidated Text) for product safety, and IEC 60601-1-2:2007 for EMC.
- Software and System Verification and Validation: Conducted per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software level of concern is "moderate." 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; Final Guidance for Industry and FDA Staff (January 11, 2002). Risk analysis per ISO 14971: 2012, including Use FMEA, Design FMEA, 60601 FMEA, and Software FMEA.
- Verification / Validation Types: Simulated Use, Boundary Condition, Registration, Case File Contents, Error Case Injection, CT Scan Verification, Control SW Boundary Condition Testing, Control Software Gravity Calibration Verification, Work Volume and Floor Grid Verification, Accuracy Verification (Patient Tracker - ASTM F2554, Total System Accuracty - simulated use with typodont, Guidance Arm Accuracy / Repeatability), Communication Rate Verification, End User Calibration Verification, F/T Sensor Verification, Patient Tracker and Splint Mounting Verifications, Start-Up / Shutdown Process Verification, Start-Up Joint Position Identification, User Emergency Safety Verification, Guidance Arm Adjustment to Patient Motion, Work Volume Verification, Speed Trap Verification, End User Validation of User Requirements for NGS Design and Development, Software Lifecycle Design and Development, Splint Application and Removal, and Patient Tracker End Effector.
- Non-clinical Comparisons to Predicate Device: Hardware and software verification and validation included accuracy testing (Patient Tracker, Guidance Arm, full system), communication rate verification, calibration testing, and emergency use. Internal validation testing in simulated clinical environment demonstrated substantial equivalence to predicate device.
Clinical Testing:
- Study Type: Clinical study to assess accuracy, usability, and performance, with focus on human factors.
- Sample Size: 3 surgeons, 3 surgical sites, 17 implants placed in 15 patients.
- Patient Population: Male and female patients with upper and lower jaw implant requirements.
- Primary Endpoint: Feasibility of NGS use with regard to human factors issues, evaluated by:
- Subjective evaluation in a survey using the Likert scale
- Duration for set-up
- Duration for osteotomy preparation
- Splint stability evaluation during surgery
- System deactivation due to patient motion
- Secondary Endpoint: Feasibility and accuracy of osteotomy preparation using the NGS, evaluated by:
- Quality of the osteotomy
- Accuracy of the osteotomy relative to the pre-operative plan as measured in pre- and post-operative CT scans
- Key Results: Clinical test results show that use of the NGS is feasible and accurate. The results demonstrated that the NGS enables surgeons to achieve implant accuracy with RMS error
§ 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 22, 2016
Neocis Inc. Alon Mozes, Ph.D. CEO and Co-Founder 2800 Biscayne Blvd Suite 600 Miami. Florida 33137
Re: K161399
Trade/Device Name: Neocis Guidance System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: PLV Dated: November 30, 2016 Received: December 1, 2016
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Ryan -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) K161399
Device Name Neocis Guidance System
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/0 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. A gray line extends horizontally above the word, and a vertical line intersects it at the right end of the word, forming a crosshair-like symbol. A small circle is present at the intersection of the lines.
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: | December 20, 2016 |
| Trade Name: | Neocis Guidance System (NGS) |
| Common Name: | Dental Stereotaxic Instrument |
| Classification Name: | Bone cutting instrument and accessories (21 CFR 872.4120) |
| Classification: | Class II |
| Product Code: | PLV |
Predicate Device: X-Guide® Surgical Navigation System (K150222) as primary predicate, IGI System (K023424) as reference device
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 quides surgeons during dental implant surgery (see Table 1 below for significant physical and performance characteristics details). 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.
4
Image /page/4/Picture/0 description: The image shows the logo for Neocis. The word "neocis" is written in lowercase letters, with the "neo" part in a yellow-gold color and the "cis" part in a light gray color. Above the word is a horizontal gray line that extends over the "neo" part of the word. The "cis" part of the word has a gray circle above it, with a vertical gray line extending upwards and horizontal gray lines extending to the left and right.
Physical quidance 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 decisionmaking 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.
| Technological Characteristic | Neocis Guidance System |
|---|---|
| Supply Voltage | 120 V |
| Phases | 1 |
| Type of Current | AC |
| Rated Frequency (Hz) | 60 Hz |
| Rated Power Input (VA) | 600 VA |
| Types and Ratings of external | |
| accessible fuses | 5.0 A for 240 V |
| Type of Protection against Electric | |
| Shock | Class I Equipment |
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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 yellow-gold color. Above the word is a gray horizontal line that extends over the "neo" portion of the word. A gray vertical line intersects the horizontal line above the "c" in "neocis", forming a plus sign with a small circle in the center.
| Degree of Protection against Electric
| Shock | Type BF |
|---|---|
| Equipment Suitable for use in the | |
| presence of Flammable Mixtures? | No |
| Mode of Operation | Continuous Operation |
| System Lateral Accuracy | RMS |