(81 days)
No
The summary describes a stereotaxic navigation system using pre-operative planning from CT scans and providing physical, visual, and audible guidance. It explicitly states "Mentions AI, DNN, or ML: Not Found" and focuses on mechanical and software-based guidance, not AI/ML algorithms for image analysis, planning, or guidance. The testing described is also focused on system accuracy and mechanical properties, not AI/ML model performance.
No.
Explanation: This device is a computerized navigational system designed to assist dental surgeons during implantation surgery. It provides planning software and guidance for surgical instruments but does not directly treat or prevent a disease, nor does it restore, modify, or correct body function or structure. It is a support tool for the surgeon rather than a therapeutic intervention itself.
No
The device 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. It provides navigational guidance and feedback but does not diagnose conditions.
No
The device description explicitly mentions physical components like the Guidance Arm, Patient Splint, Patient Tracker, Calibration Drill Bit, and Depth Gauge, indicating it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
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. This testing is done outside of the body (in vitro).
- Device Function: The Neocis Guidance System (NGS) is a surgical guidance system used during dental implantation surgery. It assists the surgeon in planning and executing the procedure on the patient's body.
- Intended Use: The intended use clearly states it's for "assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery." This is an in-vivo (within the body) application.
- Device Description: The description details a system that provides physical, visual, and audible feedback to the surgeon during the procedure, involving components attached to the patient.
- Input: While it uses a CT scan for planning, the device's primary function is to guide the surgical instruments on the patient.
The NGS is a surgical navigation system, not a device that analyzes biological samples.
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 (comma separated list FDA assigned to the subject device)
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 K173402 (the predicate device), except for a change to the dental materials used to affix the 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 dental materials specified in this submission. 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
dental surgeon, surgical procedure
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:
Chairside Splint verification and validation testing from K173402:
- Simulated Use (End User Validation): Run through of typical splint affixation cases using typodonts, performed by Surgeons.
- Total System Accuracy: 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).
- Patient Tracker and Splint Mounting Verifications: 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 previously performed on the NGS (K161399) that were relied upon for clearance of the modified splint:
- Biocompatibility Testing: Evaluation for NGS components 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: Representative sample of re-usable NGS components tested to validate they can withstand steam sterilization process and acceptable sterility is achieved. Testing conducted according to ISO 17665-1:2006.
Electrical Safety and Electromagnetic Compatibility (EMC):
- Comprehensive performance testing conducted on the NGS in accordance with IEC 60601-1:2005 + Corr. 1 (2006) + Corr. 2 (2007) ANSI/AAMI ES60601-1:2005@2012 and C1:2009/® 2012 and A2:2010/® 2012 (Consolidated Text) for product safety, and IEC 60601-1-2:2007 for EMC.
Software and System Verification and Validation:
- Conducted and documented 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; Final Guidance for Industry and FDA Staff (January 11, 2002).
- Risk analysis conducted in compliance with ISO 14971: 2012, including Use FMEA, Design FMEA, 60601 FMEA, and Software FMEA.
- Software and system testing included: 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 (per ASTM F2554), Guidance Arm Accuracy / Repeatability (27 data points in two work volumes (54 total points) against a calibrated CMM), Communication Rate Verification, End User Calibration Verification, F/T Sensor Verification, 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, End User Validation of User Requirements for Splint Application and Removal, End User Validation of User Requirements for Changes made to Patient Tracker End Effector.
Nonclinical Comparisons to Predicate Device in this Submission (for chairside patient splint affixation using additional dental materials):
- Material polymerization temperature measurements: Splints affixed to typodonts in a heat box set to 37°C. Curing temperature measured with thermocouple. Maximum temperatures reported.
- Rigidly mounted splint deflection measurement: Splints mounted to typodonts with dental materials. Load 2-times Patient tracker weight placed on splints. Deflection measured at various points using FARO arm. Mean deflection with standard deviation reported.
- Comparison of materials' material safety data sheets (MSDS): MSDS sheets compared for material compositions and safety hazards.
- Simulated clinical use validation: Surgeons affixed and removed chairside patient splints from typodonts using the dental materials. Qualitative validation and usability endpoints recorded.
Conclusion: Performance testing demonstrates substantially equivalent chairside patient splint performance when used with the specified additional dental materials. Nonclinical testing demonstrated the modified splint is substantially equivalent to the predicate device splint when used as intended.
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.
Not Found
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 21, 2018
Neocis Inc. Thomas Claiborne, Ph.D. Regulatory Affairs Manager 555 NW 29th Street Miami, Florida 33127
Re: K182776
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: December 3, 2018 Received: December 4, 2018
Dear Thomas Claiborne:
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/cdrl/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.
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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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,
Digitally signed by Mary S. Mary S. Runner -S3 Runner -S3 Date: 2018.12.21
2018-05-09 09:51:12 -05'00'
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
| 510(k) Number (if known) | K182776 |
|---|---|
| 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/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. A gray horizontal line extends from the left of the word to above the "neo" portion. A gray vertical line extends from above the "cis" portion, intersecting with the horizontal line at a small circle.
510(k) Summary
| Submitter Name: | Neocis Inc.
2800 Biscayne Blvd.
Suite 600
Miami, FL 33137
Tel: 1-855-9NEOCIS |
|----------------------|------------------------------------------------------------------------------------------------------|
| Contact Person: | Thomas Claiborne, Ph.D.
2800 Biscayne Blvd.
Suite 600
Miami, FL 33137
Tel: 1-855-9NEOCIS |
| Date Prepared: | December 20, 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 (NGS) with Chairside Splint (K173402) |
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 quidance 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 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 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
4
Image /page/4/Picture/1 description: The image shows the logo for Neocis. The word "neocis" is written in a sans-serif font, with the letters in gold. A gray line is above the word, and a gray crosshair is to the right of the word. The crosshair has a small circle in the center.
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 quidance 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.
The subject device is the same as the NGS cleared under K173402 (the predicate device). except for a change to the dental materials used to affix the 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 dental materials specified in this submission. 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/1 description: The image shows the logo for Neocis. The logo consists of the word "neocis" in a sans-serif font, with the letters in gold. Above the word is a gray line that extends horizontally, and a gray line that extends vertically. The two lines intersect at a small gray circle above the "c" in "neocis."
Comparison of Technological Characteristics:
This submission involves only a modification to the dental materials for use with the chairside patient splint. Otherwise, all performance characteristics of the NGS are the same. The differences introduced by this modification are detailed in Table 1.
| Technological | NGS with Chairside Splint | NGS with Chairside Splint | Comments |
|---|---|---|---|
| Characteristics | Subject Device | Predicate Device (K173402) | |
| 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 | Ixef®-HC-1022 | Ixef®-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 | |||
| Characteristics | NGS with Chairside Splint | NGS with Chairside Splint | |
| Subject Device | Predicate Device (K173402) | Comments | |
| 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 |