← Product Code [PLV](/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV) · K161399 # Neocis Guidance System (K161399) _Neocis, Inc. · PLV · Dec 22, 2016 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV/K161399 ## Device Facts - **Applicant:** Neocis, Inc. - **Product Code:** [PLV](/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV.md) - **Decision Date:** Dec 22, 2016 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.4120 - **Device Class:** Class 2 - **Review Panel:** Dental ## 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: patient CT scan. Process: surgeon uses planning software to place virtual implants; system uses mechanical tracking via a Patient Splint and Patient Tracker to monitor patient movement in real-time. Output: physical, visual, and audible guidance provided to the surgeon during implant site preparation. The Guidance Arm grips the dental drill, providing physical constraints to prevent deviation from the pre-operative plan while allowing the surgeon to maintain manual control. Used in clinical settings/doctor's offices by dental surgeons. The system automatically adjusts the surgical cutting angle and position if patient movement is detected. Benefits include increased accuracy of implant placement and reduced risk of damaging critical anatomical structures. The device is a supporting tool and does not replace surgeon judgment. ## Clinical Evidence Clinical study conducted with 3 surgeons at 3 sites, involving 17 implants in 15 patients (male and female). Evaluated feasibility, human factors, and accuracy. Primary endpoints: Likert scale surveys, set-up/preparation duration, splint stability, and system response to patient motion. Secondary endpoint: osteotomy quality and accuracy relative to pre-operative plan via CT scans. Results: NGS enables implant accuracy with RMS error < 1mm. No adverse events reported. ## Technological Characteristics Stereotaxic mechanical navigation system. Components: Patient Splint, Patient Tracker, Guidance Arm. Materials: Biocompatible (ISO 10993-1, -5, -10, -11, -12). Power: 120V AC, 60Hz, 600VA. Connectivity: Ethernet. Accuracy: RMS < 1mm (lateral/depth), < 6.0° (angular). Sterilization: Steam for reusable components. Software: Moderate level of concern, IEC 62304 compliant. Safety: Class I equipment, Type BF applied part, IEC 60601-1 and 60601-1-2 compliant. ## Regulatory 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 - X-Guide® Surgical Navigation System ([K150222](/device/K150222.md)) ## Reference Devices - IGI System ([K023424](/device/K023424.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, forming a single, flowing shape. 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) | # 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/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 | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Neocis. The logo consists of the word "neocis" in a sans-serif font, with the letters in a 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 < 1 mm | | System Depth Accuracy | RMS < 1 mm | | System Angular Accuracy | RMS < 6.0° | | CT Scan Quality Requirements | 0.3 mm Voxel, 0.3 mm Slice Thickness, Matrix 512x512, Full
13cm 21 sec, Multi 2 DICOM format. | | F/T Sensor Force Measurement Range | +/- 30 N | | F/T Sensor Torque
Measurement Range | +/- 2 Nm | | F/T Sensor Single Axis Force Overload
Limit | 200 N | | F/T Sensor Single Axis Torque
Overload Limit | 20 Nm | | Upper limit specification for Guidance
Arm Translation Speed | 1.25 m/s | | 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. | #### Table 1: Significant physical and performance characteristics of the NGS # Comparison of Technological Characteristics: Both the subject and predicate systems provide accurate guidance of surgical tools and implantable devices through the use of computer-aided navigation. This guidance is achieved through the tracking of the surgical tools. Neither device is intended to replace human assessment, but to provide objective information relating to the positioning and alignment of the surgical tools in reference to the patient's anatomy. Additionally, Neocis Guidance System and the predicate device share several other significant features: - Both devices have the same Intended Use. . - Both devices provide animated indicators to show the real time location of the surgical . tool relative to the patient anatomy, showing the tool in the patient CT in real time. - Both devices share identical specified environments of use. . - Both devices provide planning software allowing for placement of implant, target surgical . site, and guidance to the implant site. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Neocis. The word "neocis" is written in a sans-serif font in yellow. Above the word is a gray line, and to the right of the word is a gray crosshair symbol. - Both devices provide sub-millimeter guidance accuracy. ● - . Both devices use CT Scans for registration of the patient tracking attachment, for use in planning the desired implant location, and as a reference to determine the exact positioning of the surgical tools during the surgical procedure. There are many similarities between the Neocis Guidance System and X-Guide, however there are also some differences (see Table 2 below for detailed comparison). The two systems use different tracking methods. X-Guide utilizes LED camera tracking, whereas the Neocis Guidance System uses mechanical tracking. The mechanical tracker eliminates the risk of line-of-sight failures in optical tracking when stereoscopic cameras fail to see the markers on the patient or the surgical tool. In addition to visual feedback, the Neocis Guidance System also provides physical guidance via the Guidance Arm, which grips the drill and provides constraints to limit the surgeon's motion to match the pre-operative plan. X-Guide only provides visual feedback, which does not physically prevent the surgeon from deviating from the plan. | Technological
Characteristics | NGS (K161399)
Subject Device | X-Guide (K150222)
Predicate Device | IGI-System (K023424)
Reference Device | Justification of
Differences | |-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Use Specifications | | | | | | 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 surgical
procedures and
provides
navigational
guidance of the
surgical
instruments. | The X-Guide® Surgical
Navigation System is a
computerized
navigational system
intended to provide
assistance in both the
preoperative planning
phase and the intra-
operative surgical
phase of dental
implantation
procedures. The
system provides
software to
preoperatively plan
dental surgical
procedures and
provides navigational
guidance of the
surgical instruments.
The device is intended
for use for partially
edentulous and
edentulous adult and
geriatric patients who
need dental implants | The Image-Guided
Implantation (IGI)
System is a
computerized
navigational system
intended to provide
assistance in both the
planning (pre-
operative) and the
surgical (intra-
operative) phases of
dental implantation
procedure. The system
provides accurate
navigational guidance
of surgical instruments,
with regard to the
preoperative planning
in dental implantation
procedure. The device
is intended for use for
partially or fully
endentulous patients
who need dental
implants as part of
their treatment plan. | No significant
difference | | Technological
Characteristics | NGS (K161399) | X-Guide (K150222) | IGI-System (K023424) | Justification of
Differences | | | Subject Device | Predicate Device | Reference Device | | | | | as part of their
treatment plan | | | | Technology / Performance Characteristics | | | | | | Use Environment | Clinical Setting,
Doctors Office | Clinical Setting,
Doctor's Office | Clinical Setting,
Doctor's Office | No difference | | Operating
Temperature | 10 - 35 deg C | 10 - 35 deg C | Not Specified | Both systems are
intended for use in
similar clinical
environments. | | Operating
Relative Humidity | 5-95% | 30% - 90% non-
condensing | Not Specified | Both systems are
intended for use in
similar clinical
environments. | | Altitude | 500 hPa-1060hPa | 500 hPa-1060hPa | 500 hPa-1060hPa | No difference | | Transport
Temperature | 0°C to 46°C | -20 - +60 deg C | 0 - 40 deg C | No significant
difference | | Transport
Humidity | 5-95% | 10% - 95% non-
condensing | 10% - 80% non-
condensing | No significant
difference | | Optical Radiation | N/A | LED, Risk Group 1
(minimal risk) per IEC
62471-1 | Laser, Class II (<1mW)
per IEC 60825-1, 620-
690 nm | NGS has no risk
related to optical
radiation | | Tracking
Technology | Mechanical
Tracking | Stereo Cameras /
LEDs / Pattern | Stereo Cameras /
Infrared LEDs | Mechanical tracking
provides an
alternative tracking
method that avoids
line-of-sight
challenges caused
by optical tracking. | | Calibration
Frequency | Prior to each
surgery | Prior to each surgery | Factory Calibrated and
authorized service
personnel | No difference | | Overall System
Accuracy (RMS) | <1mm | <1mm | <1mm | No difference | | Alarms | Audible, Visual | Audible, Visual | Audible, Visual | No difference | | Monitor | LCD-TFT | LCD-TFT | LCD-TFT | No difference | | Technological
Characteristics | NGS (K161399)
Subject Device | X-Guide (K150222)
Predicate Device | IGI-System (K023424)
Reference Device | Justification of
Differences | | Communications
Interface | Ethernet | Ethernet | Ethernet | No difference | | Software | Navigational
Guidance and
Implant Planning | Navigational Guidance
and Implant Planning | Navigational Guidance
and Implant Planning | No difference | | Dimensions | Height: 73 in
(1854.2 mm)
Width: 64 in
(1625.6 mm)
Depth: 34 in (863
mm) | Height: 64.653 in
(1642.19 mm) Width:
21.011 in (533.67mm) | Unavailable | Both systems are
intended for use in
similar clinical
environments and
are classified as
mobile per IEC / EN
60601-1definition. | | Mounting
Configuration | Mobile Cart | Mobile Cart | Mobile Cart | No difference | | Weight | 427lbs. (194 kg) | 130lbs. (58.97 kg) | Unavailable | Both systems are
classified as Mobile,
per IEC / EN 60601-
1 definition.
Differences in weight
that may exist do not
affect either device's
efficacy or intended
use. | | Safety Features | | | | | | Electrical Safety | Compliance with
the following: 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 | IEC 60601-1:2005 3rd
Edition AAMI
ES60601-1:2005
+A1:2009 +A2:2010
EN 60601-1:2006
ISO15223-1:2012
BS EN ISO
14971:2012 | Compliance with the
following: EN60601-
1:1990 +A1:1992
+A2: 1995; +A13
IEC 601-1:1998
+A1:1991
+A2:1995
+Corrigendum
EN60601-1-1:1993
+A1:1995
IEC60601-1-4:1996 | Both systems have
been tested to
equivalent
standards. | | Technological
Characteristics | NGS (K161399)
Subject Device | X-Guide (K150222)
Predicate Device | IGI-System (K023424)
Reference Device | Justification of
Differences | | | Essential
Performance. | | EN980:1996 +A1:1999 | | | | ISO15223-1:2012 | | EN1441:1997 |… --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV/K161399](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV/K161399) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com