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 NGS is intended for use in partially edentulous adult patients who qualify for dental implants.

When Yomi Plan software is used for preplanning on third party PCs, it is intended to perform the planning (pre-operative) phase of dental implantation surgery. Yomi Plan provides pre-operative planning for dental implantation procedures. The output of Yomi Plan is to be used with the Neocis Guidance System (NGS).

Device Description

In terms of FDA regulations, the Neocis Guidance System (NGS) is a dental stereotaxic instrument (Product Code PLV) and a powered surgical device for bone cutting (21 CFR 872.4120).

In terms of previously FDA-cleared indications for use (K200805), 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 NGS is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

The system allows the user to plan the surgery virtually in Yomi Plan (K191363-cleared for use alone on third party PCs for preplanning). The operative plan is based on a cone beam computed tomography (CBCT) scan of the patient, which is used to create a 3-D model of the patient anatomy in our planning software. The plan is used by a guidance system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation. The NGS robotic arm holds and guides a standard FDA-cleared third party powered bone cutting instrument (K191605).

The patient tracking portion of the NGS is comprised of linkages from the patient to the NGS, which include the Chairside Patient Splint (CPS) (K173402) or Edentulous Patient Splint (EPS) (K200805), the End Effector (EE) and the Patient Tracker (PT). The Patient Splint is attached to the contralateral side of the patient's mouth over stable teeth. The CPS is placed on the patient using on-label dental materials (K182776) prior to the presurgical CBCT scan. The EPS is placed using bone screws prior to the presurgical CBCT scan (appropriate local anesthesia is required). A Fiducial Array (FA) with radio-opaque fiducial markers is placed on the CPS prior to the CBCT scan so the virtual plan can be related to the physical space of the system using the markers. The PT is an electromechanical feedback system that is connected to the CPS on the patient, which relays information to the NGS 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, position, and depth to accommodate the patient movement, which will maintain the accuracy of the osteotomy.

The implant process occurs in two phases: (1) The dental surgeon plans the surgical procedure with the planning software, on the day of surgery or sometime prior if a pre-operative CT scan was taken at an earlier visit. A virtual dental implant, selected from the dental implant library or using a generic model, both contained within our planning software, is placed at the desired location in the patient model. The software highlights critical anatomical structures to avoid, such as the inferior alveolar nerve. (2) When the dental implant plan is optimized, the NGS provides precise and accurate guidance of the dental surgical instruments according to the preoperative plan. The NGS robotic arm, which holds the surgical instrument, provides haptic feedback to the surgeon by constraining the motion of the bone cutting instrument to the plan. This allows the surgeon to feel resistance to attempts at motions that may deviate from the plan. The surgeon may modify the plan intraoperatively, if needed, has direct visualization of the patient anatomy, and is always in control of the surgical instrument.

Key safety features include:

Emergency stop
Safety pause
Audio and visual queues
Drill torque limits
Full surgeon control and direct visualization of the surgical field

The Neocis Guidance System (NGS) with Yomi Plan v2.0 is a "catch-up" focused on the planning software and presenting changes made from v1.2 (K161399) to the current release v2.0 (wireless network capabilities, interface updates, etc.). The Neocis Guidance System (NGS) contains two software packages: (1) planning and (2) control. Each resides on a separate PC on the device: (1) planning station laptop PC and (2) control PC in the cart base. There are no changes to the control software or the NGS hardware in this submission. The use of TeamViewer has been implemented to access NGS systems that connected to external networks to examine system performance for postmarket.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Neocis Guidance System (NGS) with Yomi Plan v2.0". This submission primarily focuses on updates to the planning software (Yomi Plan v2.0) and the addition of wireless network capabilities. It does not include detailed acceptance criteria or a study proving device performance against those criteria in the way a clinical trial or algorithm validation study typically would. Instead, it relies on demonstrating substantial equivalence to previously cleared predicate devices through comparisons of technological characteristics, software verification and validation, and wireless coexistence testing.

Therefore, many of the requested details cannot be extracted from the provided document as they are not present.

Here's what can be inferred or stated based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly list "acceptance criteria" and "reported device performance" in a table format for a specific clinical or performance outcome. Instead, it focuses on demonstrating that the updated software (Yomi Plan v2.0) and new wireless features do not negatively impact the system's intended use and maintain substantial equivalence to predicate devices.

The "Performance Testing" section (Page 8) mentions that "Software V&V has been fully executed" and "Wireless Coexistence was testing according to the following". This implies that the acceptance criteria for these aspects would be compliance with the listed standards and successful execution of the validation activities.

Acceptance Criteria Category	Reported Device Performance (Summary)
Software Verification & Validation (V&V)	Fully executed according to ANSI AAMI ISO 14971:2019, ANSI AAMI IEC 62304:2006/A1:2016, and FDA guidance documents for software in medical devices and cybersecurity.
Wireless Coexistence	Tested according to AAMI TIR69:2017 and IEEE ANSI C63.27-2017.
End User Validation	Performed in a simulated use environment representative of a surgical environment to ensure the system (design, manufacture, labeling, processes) meets user needs.
Substantial Equivalence	Demonstrated for updated planning software and added networking capabilities compared to predicate devices. No fundamental changes to technology; no changes to NGS hardware or intended use.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated for performance testing (e.g., how many cases or patients were used in end-user validation).
Data Provenance: Not specified. The end-user validation was performed in a "simulated use environment." This suggests it was not a real-world patient study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study is mentioned. The device provides "navigational guidance" but is not primarily an AI-driven diagnostic or interpretative tool evaluated by human readers in this context. The focus is on the safety and effectiveness of the updated planning software and wireless functionality.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The document implies that the "planning software" (Yomi Plan) is part of a "computerized navigational system" that provides "navigational guidance of the surgical instruments" to a surgeon. The system provides "haptic feedback to the surgeon" and emphasizes "Full surgeon control and direct visualization of the surgical field." This indicates a human-in-the-loop system. Standalone algorithm performance without human interaction is not the primary focus or explicitly described for the system's core function. The "planning" component could be considered "standalone" in its ability to create a plan, but its output is used by the guidance system in a human-controlled surgical procedure.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the software V&V, the "ground truth" would be adherence to software requirements, standards, and risk management principles. For wireless coexistence, it would be compliance with communication standards. For "End User Validation," it's ensuring the system "meet[s] the needs of the user," which implies functional correctness and usability in a simulated surgical context. Specific clinical ground truth based on patient outcomes or expert pathological review is not detailed in this submission as it's not a diagnostic AI device.

8. The sample size for the training set:

The document describes a software update for a guidance system and does not mention machine learning or AI training sets. Therefore, this information is not applicable and not provided.

9. How the ground truth for the training set was established:

Not applicable, as no training set for machine learning/AI is mentioned.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The text reads "U.S. FOOD & DRUG ADMINISTRATION".

December 4, 2020

Neocis Inc. Thomas E. Claiborne, Ph.D. Regulatory Affairs Manager 2800 Biscayne Blvd Suite 600 Miami, Florida 33137

Re: K202264

Trade/Device Name: Neocis Guidance System (NGS) with Yomi Plan v2.0 Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: PLV Dated: September 4, 2020 Received: September 10, 2020

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/cdrh/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

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202264

Device Name Neocis Guidance System (NGS) with Yomi Plan v2.0

Indications for Use (Describe)

When Yomi Plan software is used for preplanning on third party PCs, it is intended to perform the planning (preoperative) phase of dental implantation surgery. Yomi Plan provides pre-operative planning for dental implantation procedures. The output of Yomi Plan is to be used with the Neocis Guidance System (NGS).

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 logo consists of the word "neocis" in a sans-serif font, with the letters in a light orange color. Above the word is a gray horizontal line that extends over the "neo" portion of the word. To the right of the word is a gray crosshair symbol, with a small circle at the intersection of the lines.

510(k) Summarv

K202264

-Submitter

Neocis Inc. 2800 Biscayne Blvd. Suite 600 Miami, FL 33137 Tel: 1-855-9NEOCIS

Contact Person: Thomas Claiborne, Ph.D., Regulatory Affairs Manager Date Prepared: December 3, 2020

II. Device

Trade Name:	Neocis Guidance System (NGS) with Yomi Plan v2.0
Common Name:	Dental Stereotaxic Instrument
Classification Name:	Bone cutting instrument and accessories (21 CFR 872.4120)
Classification:	Class II
Product Code:	PLV

III. Predicate Devices

Primary Predicate: ●
- o Neocis Guidance System (NGS) (K161399)
Reference Devices ●
- Neocis Planning Software Application for 3rd Party PCs (K191363) O
- Neocis Guidance System (NGS) with Edentulous Patient Splint (EPS) O (K200805)

IV. Indications for Use

When Yomi Plan software is used for preplanning on third party PCs, it is intended to perform the planning (pre-operative) phase of dental implantation surgery. Yomi Plan provides preoperative planning for dental implantation procedures. The output of Yomi Plan is to be used with the Neocis Guidance System (NGS).

V. Device Description

In terms of FDA regulations, the Neocis Guidance System (NGS) is a dental stereotaxic instrument (Product Code PLV) and a powered surgical device for bone cutting (21 CFR 872.4120).

In terms of previously FDA-cleared indications for use (K200805), the Neocis Guidance System

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Image /page/4/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 a golden color. Above the word is a gray horizontal line that extends to the left and right of the word. A gray vertical line intersects the horizontal line at the center of the word, forming a crosshair-like symbol.

(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. The NGS is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

The system allows the user to plan the surgery virtually in Yomi Plan (K191363-cleared for use alone on third party PCs for preplanning). The operative plan is based on a cone beam computed tomography (CBCT) scan of the patient, which is used to create a 3-D model of the patient anatomy in our planning software. The plan is used by a guidance system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation. The NGS robotic arm holds and quides a standard FDA-cleared third party powered bone cutting instrument (K191605).

The implant process occurs in two phases: (1) The dental surgeon plans the surgical procedure with the planning software, on the day of surgery or sometime prior if a pre-operative CT scan was taken at an earlier visit. A virtual dental implant, selected from the dental implant library or using a generic model, both contained within our planning software, is placed at the desired location in the patient model. The software highlights critical anatomical structures to avoid, such as the inferior alveolar nerve. (2) When the dental implant plan is optimized, the NGS provides precise and accurate quidance of the dental surgical instruments according to the preoperative plan. The NGS robotic arm, which holds the surgical instrument, provides haptic feedback to the surgeon by constraining the motion of the bone cutting instrument to the plan. This allows the surgeon to feel resistance to attempts at motions that may deviate from the plan. The surgeon may modify the plan intraoperatively, if needed, has direct visualization of the patient anatomy, and is always in control of the surgical instrument.

Key safety features include:

Emergency stop
Safety pause
Audio and visual queues
Drill torque limits
. Full surgeon control and direct visualization of the surgical field

The Neocis Guidance System (NGS) with Yomi Plan v2.0 is a "catch-up" focused on the planning software and presenting changes made from v1.2 (K161399) to the current release

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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 a light orange color. Above the word is a thin gray horizontal line that extends beyond the letters on both sides. There is a small gray circle above the "c" with a vertical line extending above and below the circle.

v2.0 (wireless network capabilities, interface updates, etc.). The Neocis Guidance System (NGS) contains two software packages: (1) planning and (2) control. Each resides on a separate PC on the device: (1) planning station laptop PC and (2) control PC in the cart base. There are no changes to the control software or the NGS hardware in this submission. The use of TeamViewer has been implemented to access NGS systems that connected to external networks to examine system performance for postmarket.

VI. Comparison of Technological Characteristics

This submission is focused on an update to our planning software, Yomi Plan v2.0, and adds wireless network capabilities to the system primarily for CBCT file transfer during the planning phase of the procedure. During the osteotomy (guidance) phase of the system disables the wireless network connection. Once the osteotomy portion of the procedure is completed and exited in the software application, the wireless network connection is reenabled.

Feature	Subject Device:NGS with Yomi Planv2.0	Predicate 1: NGSK161399	Predicate 2: NeocisPlanning andGuidance Softwarefor 3rd Party PCsK191363	Predicate 3: NGSwith EdentulousPatient SplintK200805	SEAnalysis
Indications foruse	The Neocis GuidanceSystem (NGS) is acomputerizednavigational systemintended to provideassistance in both theplanning (pre-operative) and thesurgical (intra-operative) phases ofdental implantationsurgery. The systemprovides software topreoperatively plandental implantationprocedures andprovides navigationalguidance of thesurgical instruments.The NGS is intendedfor use in partiallyedentulous and fullyedentulous adultpatients who qualifyfor dental implants.When Yomi Plansoftware is used forpreplanning on thirdparty PCs, it isintended to performthe planning (pre-operative) phase ofdental implantationsurgery. Yomi Planprovides pre-operative planning fordental implantationprocedures. Theoutput of Yomi Plan isto be used with theNeocis GuidanceSystem (NGS).	The NeocisGuidance System(NGS) is acomputerizednavigational systemintended to provideassistance in boththe planning (pre-operative) and thesurgical (intra-operative) phases ofdental implantationsurgery. The systemprovides software topreoperatively plandental implantationprocedures andprovides navigationalguidance of thesurgical instruments.	The Neocis PlanningSoftware Application(NPSA) for 3rd PartyPCs is intended toperform the planning(pre-operative)phase of dentalimplantationsurgery. The NPSAprovides pre-operative planningfor dentalimplantationprocedures. Theoutput of the NPSAis to be used withthe NeocisGuidance System.	The Neocis GuidanceSystem (NGS) is acomputerizednavigational systemintended to provideassistance in both theplanning (pre-operative) and thesurgical (intra-operative) phases ofdental implantationsurgery. The systemprovides software topreoperatively plandental implantationprocedures andprovides navigationalguidance of thesurgical instruments.The NGS is intendedfor use in partiallyedentulous and fullyedentulous adultpatients who qualifyfor dental implants.	Subjectdevicecombinesindicationsfrom thepredicates.Rebrand as"Yomi Plan."
Feature	Subject Device:NGS with Yomi Planv2.0	Predicate 1: NGSK161399	Predicate 2: NeocisPlanning andGuidance Softwarefor 3rd Party PCsK191363	Predicate 3: NGSwith EdentulousPatient SplintK200805	SEAnalysis
Yomi PlanSoftwareVersion	v2.0	v1.2	v1.8.1	v1.10 (not a subjectof the submission)	UpdatedGIU,networkconnectivity,remoteaccessadded
OS	Windows 10	Windows 7	Windows 7	Windows 10	RemainsWindowsbased
PCRequirements	PC with 64-bitWindows 10 OS ornewer with aminimum of 4 GB ofRAM and a 2 GHzdual core processor.Local memory (harddrive) should be aminimum of 100 GBwith 7200 RPM orSSD. Connectivityrequirements includeethernet, Wi-Fi, USB,or CD drive.	PC with 64-bitWindows 7 OS ornewer with aminimum of 4 GB ofRAM and a 2 GHzdual core processor.Local memory (harddrive) should be aminimum of 100 GBwith 7200 RPM orSSD. USB or CDdrive.	PC with 64-bitWindows 7 OS ornewer with aminimum of 4 GB ofRAM and a 2 GHzdual core processor.Local memory (harddrive) should be aminimum of 100 GBwith 7200 RPM orSSD. USB or CDdrive.	PC with 64-bitWindows 7 OS ornewer with aminimum of 4 GB ofRAM and a 2 GHzdual core processor.Local memory (harddrive) should be aminimum of 100 GBwith 7200 RPM orSSD. USB or CDdrive.	Addednetworkconnectivityvia ethernetor Wi-Fi
Yomi PlanFunctions	Load CT● Scanned Image● Optimize Image● Plan Procedure(place implant)● Save SurgicalPlanConnect to● ControlsoftwareProvide● Feedback toSurgeonregardingphysicallocation of Drilland DrillcomponentsSelect Surgical● PhaseSet areas for● mechanicalrestrictionduring surgicaloperationVisualize CT● Scanned Imagewith 2D SlicesGenerate● Panoramicreconstructionalong archVisualize● Panoramicreconstructionwith crosssections alongpanoramic archMap Splint● coordinate	Load CT● Scanned Image● Optimize Image● Plan Procedure● (place implant)Save Surgical● PlanConnect to● ControlsoftwareProvide● Feedback toSurgeonregardingphysicallocation of Drilland DrillcomponentsSelect SurgicalPhaseSet areas for● mechanicalrestrictionduring surgicaloperationVisualize CT● Scanned Imagewith 2D SlicesGenerate● Panoramicreconstructionalong archVisualizePanoramicreconstructionwith crosssections alongpanoramic archMap Splint● coordinate	Load CT● ScannedImage● OptimizeImage● PlanProcedure(place implant)● Save SurgicalPlanVisualize CTScannedImage with 2DSlicesGenerate● Panoramicreconstructionalong archVisualizePanoramicreconstructionwith crosssections alongpanoramicarchDefine● anatomicalplanesClip CT● ScannedImagesDefine Arch for● generatingpanoramicreconstructionProvide the● user with ameans todefine a nerve	Load CT● Scanned Image● Optimize Image● Plan Procedure● (place implant)Save Surgical● PlanConnect to● ControlsoftwareProvide● Feedback toSurgeonregardingphysicallocation of Drilland DrillcomponentsSelect Surgical● PhaseSet areas formechanicalrestrictionduring surgicaloperationVisualize CT● Scanned Imagewith 2D SlicesGenerate● Panoramicreconstructionalong archVisualize● Panoramicreconstructionwith crosssections alongpanoramic archMap Splint● coordinate	No Changes
Feature	Subject Device:NGS with Yomi Planv2.0	Predicate 1: NGSK161399	Predicate 2: NeocisPlanning andGuidance Softwarefor 3rd Party PCsK191363	Predicate 3: NGSwith EdentulousPatient SplintK200805	SEAnalysis
	system tostructures in CTScan• Defineanatomicalplanes• Clip CTScannedImages• Define Arch forgeneratingpanoramicreconstruction• Provide theuser with ameans to definea nerve• Allow the userto plan multipleimplants• Measuredistances andangles in theplan	system tostructures inCT Scan• Defineanatomicalplanes• Clip CTScannedImages• Define Arch forgeneratingpanoramicreconstruction• Provide theuser with ameans todefine a nerve• Allow the userto plan multipleimplants• Measuredistances andangles in theplan	• Allow the userto planmultipleimplants• Measuredistances andangles in theplan	system tostructures in CTScan• Defineanatomicalplanes• Clip CTScannedImages• Define Arch forgeneratingpanoramicreconstruction• Provide theuser with ameans to definea nerve• Allow the userto plan multipleimplants• Measuredistances andangles in theplan
Level ofConcern	Moderate	Moderate	Moderate	Moderate	Identical
Installation	Windows Installer.msi file	Executable file .exe	Windows Installer.msi file	Windows Installer.msi file	Upgrade touseWindowsInstaller
OTS Software	TeamViewer	N/A	N/A	N/A	AddTeamViewerIdentical
NGSHardware	No changes(activate/use pre-existing networkfeatures)	See predicate 510(k)Summary	See predicate510(k) Summary	See predicate 510(k)Summary	Identical
Wireless datatransmissionover LAN	Yes, via integratedhardware, testedaccording to:• AAMI TIR69:2017 TechnicalInformationReport Riskmanagement ofradio-frequencywirelesscoexistence formedical devicesand systems.• IEEE ANSIC63.27-2017AmericanNational Standardfor Evaluation ofWirelessCoexistence	N/A	N/A	N/A	Add wirelesstransmissionof files overLAN
Interface	Windows based GUI	Windows based GUI	Windows based GUI	Windows based GUI	Updatedlook andorganization

Table 1: Comparison of technological characteristics to the predicates

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K202264

Image /page/6/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 a golden color. Above the word is a horizontal gray line, and to the right of the word is a gray line with a circle in the middle. The logo is simple and modern, and the colors are eye-catching.

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Image /page/7/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 a light orange color. Above the word is a horizontal gray line that extends over the "neo" portion of the word. To the right of the "cis" portion of the word is a vertical gray line with a circle at the top, intersecting the horizontal line.

VII. Performance Testing

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Image /page/8/Picture/1 description: The image shows the logo for Neocis. The word "neocis" is written in a sans-serif font in yellow color. A thin gray line is above the word, and a gray circle with a plus sign through it is above the "i" in "neocis". The logo is simple and modern.

This submission only includes the planning software and wireless transmission coexistence.

Software V&V has been fully executed according to the following:

• ANSI AAMI ISO 14971: 2019 Medical devices - Applications of risk management to medical devices

· ANSI AAMI IEC 62304:2006/A1:2016 Medical device software - Software life cycle processes [Including Amendment 1 (2016)]

· Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005

· Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document Issued on: October 2. 2014

Wireless Coexistence was testing according to the following:

· AAMI TIR69: 2017 Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems.

· IEEE ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence

· End User Validation testing was performed in a simulated use environment that is representative of the Surgical Environment and represents use with a patient to ensure that the system in its entirety, inclusive of design, manufacture, labeling, and processes developed for use meet the needs of the user, a validation activity will be performed.

VIII. Conclusion

This submission includes an update to our planning software and adds networking capabilities to the system. There are no technological changes to the hardware (NGS) in this submission. There are no changes to the intended use in this submission. There are no fundamental changes to the technology. Our performance testing demonstrates substantially equivalent performance of the subject device as compared to the predicate.

Regulation Number and Section

§ 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.