Who is the manufacturer of Neocis Guidance System?

Neocis, Inc. filed the 510(k) submission for Neocis Guidance System (K182776).

What is the FDA product code for Neocis Guidance System?

PLV. It is classified under 21 CFR 872.4120 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Neocis Guidance System?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like Neocis Guidance System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Neocis Guidance System

K182776 · Neocis, Inc. · PLV · Dec 21, 2018 · Dental

Device Facts

Record ID	K182776
Device Name	Neocis Guidance System
Applicant	Neocis, Inc.
Product Code	PLV · Dental
Decision Date	Dec 21, 2018
Decision	SESE
Submission Type	Special
Regulation	21 CFR 872.4120
Device Class	Class 2

Intended 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 Story

Neocis Guidance System (NGS) is a stereotaxic dental surgical navigation system. Input: CT scan data for pre-operative planning; real-time tracking of patient and surgical instrument position. Operation: Surgeon plans implant placement on CT scan; system uses a patient-affixed splint with fiducial markers and a mechanical Patient Tracker to monitor patient movement. A robotic Guidance Arm grips the dental drill, providing physical, visual, and audible feedback to constrain the drill to the pre-planned trajectory. If the patient moves, the system dynamically adjusts the guidance parameters to maintain accuracy. Used in dental clinics by surgeons. Output: Real-time 3D/2D visual guidance on a display and physical haptic constraint via the Guidance Arm. Benefits: Improved accuracy in implant site preparation and avoidance of critical anatomical structures.

Clinical Evidence

No clinical data. Bench testing only. Verification included simulated use cases with typodonts, total system accuracy evaluation, patient tracker/splint mounting verification, material polymerization temperature, and splint deflection measurements. System accuracy metrics: RMS < 1 mm (lateral and depth), RMS < 6.0° (angular).

Technological Characteristics

Stereotaxic dental navigation system. Materials: Ixef HC-1022 (splint), various dental acrylics/resins (Alike, Cool Temp, ProTemp, Visalys, EZ Pickup, Ufi Gel, Triad). Sensing: Mechanical Patient Tracker, F/T sensor (+/- 30 N force, +/- 2 Nm torque). Guidance: Robotic arm with 1.25 m/s translation speed limit. Connectivity: Standalone system. Sterilization: Steam. Software: Moderate level of concern, IEC 62304 compliant.

Indications for Use

Indicated for dental implantation surgery planning and intra-operative navigational guidance of surgical instruments.

Regulatory Classification

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.

Predicate Devices

Neocis Guidance System (NGS) with Chairside Splint (K173402)

Related Devices

K161399 — Neocis Guidance System · Neocis, Inc. · Dec 22, 2016
K203401 — Neocis Guidance System (NGS) with Patient Splints (EPS) · Neocis, Inc. · Dec 15, 2020
K173402 — Neocis Guidance System (NGS) with Chairside Splint · Neocis, Inc. · Feb 22, 2018
K191605 — Neocis Guidance System (NGS) · Neocis, Inc. · Sep 11, 2019
K200348 — Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) · Neocis, Inc. · May 8, 2020

Submission Summary (Full Text)

{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) #### 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." {3}------------------------------------------------ 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. {5}------------------------------------------------ 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 < 1 mm | RMS < 1 mm | No difference | | System Depth Accuracy | RMS < 1 mm | RMS < 1 mm | No difference | | System Angular Accuracy | RMS < 6.0° | RMS < 6.0° | No difference | | CT Scan Quality Requirements | 0.3 mm Voxel, 0.3 mm Slice Thickness, Matrix 512x512, Full 13cm 21 sec, Multi 2 DICOM format. | 0.3 mm Voxel, 0.3 mm Slice Thickness, Matrix 512x512, Full 13cm 21 sec, Multi 2 DICOM format. | No difference | | F/T Sensor Force Measurement Range | +/- 30 N | +/- 30 N | No difference | | F/T Sensor Torque Measurement Ra nge | +/- 2 Nm | +/- 2 Nm | No difference | | F/T Sensor Single Axis Force Overload Limit | 200 N | 200 N | No difference | | F/T Sensor Sinale Axis Torque Overload Limit | 20 Nm | 20 Nm | No difference | | Upper limit specification for Guidance Arm Translation Speed | 1.25 m/s | 1.25 m/s | No difference | | Storage Requirements | Store powered at Room Temperature (68°F to 76°F or 20°C to 24.4°C) and standard ambient humidity (5% to 95%) in a dust free, clean environment. | Store powered at Room Temperature (68°F to 76°F or 20°C to 24.4°C) and standard ambient humidity (5% to 95%) in a dust free, clean environment. | No difference | | Splint Attachment | Chairside Splint can be attached chairside with use of acrylic or developed with acrylic on a patient model in a dental lab. | Chairside Splint can be attached chairside with use of acrylic or developed with acrylic on a patient model in a dental lab. | No difference | | Dental materials (acrylics or resins) | · Alike (K942670-GC Pattern Resin) · Cool Temp Natural (K041098) · 3M ESPE ProTemp Plus (K033022-Protemp 3 Garant) · Visalys Core (UV light curable) (K143104) · EZ Pickup (UV light curable) (K984341-SternVantage Varnish LC Model 221001) · Ufi Gel hard C (K030916) · Triad C&B Material (UV light curable) (K850911) | Lang Jet Tooth Shade (K083195) | Additional dental materials meet performance specifications for the chairside splint. | | Splint Removal | Chairside Splint may be removed either by cutting bridges along a seam of the splint or manually pulling off. | Chairside Splint may be removed either by cutting bridges along a seam of the splint or manually pulling off. | No difference | | Fiducial Array | The Fiducial Array attaches to the | The Fiducial Array attaches to the | No difference | | Attachment to | splint during the CT scan to | splint during the CT scan to | No difference | {6}------------------------------------------------ Image /page/6/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 a golden color and the "cis" portion in a lighter golden color. Above the word is a gray horizontal line that extends over the "neo" portion. Above the "i" in "cis" is a gray circle with a vertical line extending upwards and horizontal lines extending to the left and right. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for Neocis. The word "neocis" is written in a sans-serif font, with the letters in a golden color. Above the word is a gray line that extends horizontally, and a gray line that extends vertically, intersecting at a small circle above the "c" in "neocis". {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for Neocis. The logo features the word "neocis" in a sans-serif font, with the "neo" portion in gold and the "cis" portion in gray. Above the word is a gray horizontal line that extends over the "neo" portion and connects to a circle above the "c" in "cis". A vertical line extends upward from the circle, creating a cross-like shape. | Technological | NGS with Chairside Splint | NGS with Chairside Splint | Comments | |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------| | Characteristics | Subject Device | Predicate Device (K173402) | | | Splint | provide a reference in the image. | provide a reference in the image. | | | Kinematic Mount Attachment to Splint | The Kinematic Mount attaches to the splint to provide a mounting point for the Fiducial Array and Patient Tracker. | The Kinematic Mount attaches to the splint to provide a mounting point for the Fiducial Array and Patient Tracker. | No difference | | Splint Shape and Kinematic Mount Location | The shape of the splint and the location of the Kinematic Mount attachment point are designed to allow for proper ergonomic approach of the Patient Tracker and Guidance Arm. | The shape of the splint and the location of the Kinematic Mount attachment point are designed to allow for proper ergonomic approach of the Patient Tracker and Guidance Arm. | No difference | | Safety Features | | | | | Biocompatibility | Yes (ISO 10993-1, -5, -10, -11, - 12) | Yes (ISO 10993-1, -5, -10, -11, - 12) | No difference | | Sterilization | Steam | Steam | No difference | | Components | | | | | Patient Tracking Device | Patient Tracker | Patient Tracker | No difference | | Patient Tracking Attachment System | Chairside Splint | Chairside Splint | No difference | # Table 1: Summary of Technological Characteristics Comparison # Performance Testing: # Non-clinical Testing Chairside Splint verification and validation testing from K173402 is described below in Table 2. | Verification / Validation Type | Description | |------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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. | {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the logo for "neocis". The word "neocis" is written in a sans-serif font, with the letters in a golden color. Above the word is a gray horizontal line that extends over the word. There is a gray circle with a vertical line extending above and below the circle, intersecting the horizontal line above the word. # Table 2: Summary of component and system verification and validation. The subject of this 510(k) was only a modification to the dental materials used to affix the chairside patient splint. As such, non-clinical testing performed in support of clearance of the predicate NGS itself did not need to be repeated. Below is a list of the non-clinical testing previously performed on the NGS (K161399) that were relied upon for clearance of the modified splint. ### Biocompatibility Testing The biocompatibility evaluation for NGS components was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included cytotoxicity (ISO 10993-5), sensitization and irritation (ISO 10993-10). The components of the NGS are considered tissue contacting for a duration of less than 24 hours. ### Cleaning and Sterilization Validation A representative sample of the re-usable NGS components were tested to validate that the components can withstand the steam sterilization process and that acceptable sterility is achieved using the recommended sterilization protocols. The sterilization validation testing was conducted according to ISO 17665-1:2006 and it validated that the reusable NGS components can be sterilized to reach an acceptable sterility assurance level. # Electrical Safety and Electromagnetic Compatibility (EMC) Comprehensive performance testing has been conducted on the NGS in accordance with various recognized industry standards, by a recognized third party organization. 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) Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance was used for product safety and IEC 60601-1-2:2007 was used for EMC. #### Software and System Verification and Validation Software and system verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could directly result in result in minor injury to the patient or operator. Software Development and Testing was performed per IEC 62304: 2006 Medical Device Software - Software Lifecycle Processes, 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 was conducted in compliance with ISO 14971: 2012 and includes FMEA analysis to review the following: - · risks associated with the use, usability and performance of the device (Use FMEA) - · the risks associated with and specific to the design aspects of the device (Design FMEA) {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows the logo for Neocis. The logo features the word "neocis" in a sans-serif font, with the "neo" portion in a golden color and the "cis" portion in a lighter golden color. Above the word is a horizontal gray line that extends over the entire word. A gray vertical line intersects the horizontal line at the letter "o" in "neocis", forming a cross shape. - the risks associated with the electrical safety of the device design as it applies to IEC 60601-1 (60601 FMEA) - the risks associated with software functionality and software interaction with the user (Software FMEA) The combined software and system testing and analysis of results (details in Table 3 below) provide assurance that the device performs as intended. | Verification / Validation Type | Description | |----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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. | | Verification / Validation Type | Description | | 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 ldentification | 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 | {11}------------------------------------------------ Image /page/11/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 yellow. Above the word is a gray horizontal line that extends beyond the letters on both sides. A gray vertical line intersects the horizontal line at the center of the logo, forming a crosshair-like shape. Table 3: Summary of all software and system verification and validation. Nonclinical Comparisons to Predicate Device in this Submission {12}------------------------------------------------ Image /page/12/Picture/1 description: The image shows the logo for Neocis. The logo features 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 over the word. There is a circle with vertical and horizontal lines extending from it, creating a cross-like shape. We performed the following tests to establish substantial equivalence for chairside patient splint affixation using additional dental materials: - . Material polymerization temperature measurements Splints were affixed to typodonts using the dental materials specified in this submission in a heat box set to 37°C. Curing temperature of the dental material was measured using a thermocouple. Maximum temperatures were reported. - . Rigidly mounted splint deflection measurement Splints were mounted to typodonts using the dental materials specified in this submission then a load 2-times the weight of the Patient tracker was placed on the chairside patient splints. Deflection was measured at various points using a FARO arm. Mean defelction with standard deviation were reported. - Comparison of materials' material safety data sheets (MSDS) . We compared the MSDS sheets to not material compositions and safety hazards. Each dental material was similar. - . Simulated clinical use validation (simulated clinical affixation and removal by surgeons) Surgeons affixed and removed chairside patient splints from typodonts using the dental materials specified in this submission. Qualitative validation and usability endpoints were recorded. # Conclusion: There are no technological changes to the NGS or chairside patient splint in this submission. There are no changes to the indications for use of the subject device in this submission. Our performance testing demonstrates substantially equivalent chairside patient splint performance when it is used with the specified additional dental materials. The nonclinical testing demonstrated that the modified splint is substantially equivalent to the predicate device splint when used as intended.