(115 days)
No
The summary describes a computerized navigational system for dental surgery that uses pre-operative planning based on CBCT scans and provides intra-operative guidance through a robotic arm and haptic feedback. It mentions software for planning and control, but there is no mention of AI or ML algorithms being used for image analysis, planning optimization, or guidance adjustments. The system's response to patient movement is described as an electromechanical feedback system, not an AI/ML-driven adaptation.
No
The device is a computerized navigational system for dental implant surgery, providing planning and guidance. It does not directly provide therapy; rather, it assists the surgeon in performing the procedure.
No
The Neocis Guidance System (NGS) is a computerized navigational system intended for pre-operative planning and intra-operative guidance of surgical instruments for dental implantation surgery. It assists in precise placement and guidance during a surgical procedure, rather than providing diagnosis.
No
The device description explicitly states that the Neocis Guidance System (NGS) includes hardware components such as a robotic arm, patient tracking linkages (Chairside Patient Splint, Edentulous Patient Splint, End Effector, Patient Tracker), and PCs. While it includes software for planning and control, it is not solely software.
Based on the provided text, the Neocis Guidance System (NGS) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- NGS Function: The NGS is a surgical guidance system. Its purpose is to assist the dental surgeon in planning and performing dental implant surgery by providing navigation and guidance for surgical instruments based on a CBCT scan of the patient's anatomy. It does not analyze biological specimens.
- Intended Use: The intended use clearly states assistance in the planning and surgical phases of dental implantation surgery.
- Device Description: The description details the system's components and how it guides surgical instruments based on anatomical data from a CBCT scan.
- Regulatory Classification: The device is classified as a dental stereotaxic instrument and a powered surgical device for bone cutting, not an IVD.
Therefore, the Neocis Guidance System (NGS) is a surgical guidance system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. 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 (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).
Product codes
PLV
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 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 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 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
cone beam computed tomography (CBCT) scan
Anatomical Site
Dental
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Dental surgeon
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image 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
1
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
2
Indications for Use
510(k) Number (if known) K202264
Device Name Neocis Guidance System (NGS) with Yomi Plan v2.0
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. 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 (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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3
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
-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 ●
IV. 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 NGS is intended for use in partially edentulous and fully 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 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
4
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 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 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
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 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 Plan
v2.0 | Predicate 1: NGS
K161399 | Predicate 2: Neocis
Planning and
Guidance Software
for 3rd Party PCs
K191363 | Predicate 3: NGS
with Edentulous
Patient Splint
K200805 | SE
Analysis |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| 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 NGS is intended
for use in partially
edentulous and fully
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). | 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 Planning
Software Application
(NPSA) for 3rd Party
PCs is intended to
perform the planning
(pre-operative)
phase of dental
implantation
surgery. The NPSA
provides pre-
operative planning
for dental
implantation
procedures. The
output of the NPSA
is to be used with
the Neocis
Guidance System. | 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. | Subject
device
combines
indications
from the
predicates.
Rebrand as
"Yomi Plan." |
| Feature | Subject Device:
NGS with Yomi Plan
v2.0 | Predicate 1: NGS
K161399 | Predicate 2: Neocis
Planning and
Guidance Software
for 3rd Party PCs
K191363 | Predicate 3: NGS
with Edentulous
Patient Splint
K200805 | SE
Analysis |
| Yomi Plan
Software
Version | v2.0 | v1.2 | v1.8.1 | v1.10 (not a subject
of the submission) | Updated
GIU,
network
connectivity,
remote
access
added |
| OS | Windows 10 | Windows 7 | Windows 7 | Windows 10 | Remains
Windows
based |
| PC
Requirements | PC with 64-bit
Windows 10 OS or
newer with a
minimum of 4 GB of
RAM and a 2 GHz
dual core processor.
Local memory (hard
drive) should be a
minimum of 100 GB
with 7200 RPM or
SSD. Connectivity
requirements include
ethernet, Wi-Fi, USB,
or CD drive. | PC with 64-bit
Windows 7 OS or
newer with a
minimum of 4 GB of
RAM and a 2 GHz
dual core processor.
Local memory (hard
drive) should be a
minimum of 100 GB
with 7200 RPM or
SSD. USB or CD
drive. | PC with 64-bit
Windows 7 OS or
newer with a
minimum of 4 GB of
RAM and a 2 GHz
dual core processor.
Local memory (hard
drive) should be a
minimum of 100 GB
with 7200 RPM or
SSD. USB or CD
drive. | PC with 64-bit
Windows 7 OS or
newer with a
minimum of 4 GB of
RAM and a 2 GHz
dual core processor.
Local memory (hard
drive) should be a
minimum of 100 GB
with 7200 RPM or
SSD. USB or CD
drive. | Added
network
connectivity
via ethernet
or Wi-Fi |
| Yomi Plan
Functions | Load CT
● Scanned Image
● Optimize Image
● Plan Procedure
(place implant)
● Save Surgical
Plan
Connect to
● Control
software
Provide
● Feedback to
Surgeon
regarding
physical
location of Drill
and Drill
components
Select Surgical
● Phase
Set areas for
● mechanical
restriction
during surgical
operation
Visualize CT
● Scanned Image
with 2D Slices
Generate
● Panoramic
reconstruction
along arch
Visualize
● Panoramic
reconstruction
with cross
sections along
panoramic arch
Map Splint
● coordinate | Load CT
● Scanned Image
● Optimize Image
● Plan Procedure
● (place implant)
Save Surgical
● Plan
Connect to
● Control
software
Provide
● Feedback to
Surgeon
regarding
physical
location of Drill
and Drill
components
Select Surgical
Phase
Set areas for
● mechanical
restriction
during surgical
operation
Visualize CT
● Scanned Image
with 2D Slices
Generate
● Panoramic
reconstruction
along arch
Visualize
Panoramic
reconstruction
with cross
sections along
panoramic arch
Map Splint
● coordinate | Load CT
● Scanned
Image
● Optimize
Image
● Plan
Procedure
(place implant)
● Save Surgical
Plan
Visualize CT
Scanned
Image with 2D
Slices
Generate
● Panoramic
reconstruction
along arch
Visualize
Panoramic
reconstruction
with cross
sections along
panoramic
arch
Define
● anatomical
planes
Clip CT
● Scanned
Images
Define Arch for
● generating
panoramic
reconstruction
Provide the
● user with a
means to
define a nerve | Load CT
● Scanned Image
● Optimize Image
● Plan Procedure
● (place implant)
Save Surgical
● Plan
Connect to
● Control
software
Provide
● Feedback to
Surgeon
regarding
physical
location of Drill
and Drill
components
Select Surgical
● Phase
Set areas for
mechanical
restriction
during surgical
operation
Visualize CT
● Scanned Image
with 2D Slices
Generate
● Panoramic
reconstruction
along arch
Visualize
● Panoramic
reconstruction
with cross
sections along
panoramic arch
Map Splint
● coordinate | No Changes |
| Feature | Subject Device:
NGS with Yomi Plan
v2.0 | Predicate 1: NGS
K161399 | Predicate 2: Neocis
Planning and
Guidance Software
for 3rd Party PCs
K191363 | Predicate 3: NGS
with Edentulous
Patient Splint
K200805 | SE
Analysis |
| | system to
structures in CT
Scan
• Define
anatomical
planes
• Clip CT
Scanned
Images
• Define Arch for
generating
panoramic
reconstruction
• Provide the
user with a
means to define
a nerve
• Allow the user
to plan multiple
implants
• Measure
distances and
angles in the
plan | system to
structures in
CT Scan
• Define
anatomical
planes
• Clip CT
Scanned
Images
• Define Arch for
generating
panoramic
reconstruction
• Provide the
user with a
means to
define a nerve
• Allow the user
to plan multiple
implants
• Measure
distances and
angles in the
plan | • Allow the user
to plan
multiple
implants
• Measure
distances and
angles in the
plan | system to
structures in CT
Scan
• Define
anatomical
planes
• Clip CT
Scanned
Images
• Define Arch for
generating
panoramic
reconstruction
• Provide the
user with a
means to define
a nerve
• Allow the user
to plan multiple
implants
• Measure
distances and
angles in the
plan | |
| Level of
Concern | Moderate | Moderate | Moderate | Moderate | Identical |
| Installation | Windows Installer
.msi file | Executable file .exe | Windows Installer
.msi file | Windows Installer
.msi file | Upgrade to
use
Windows
Installer |
| OTS Software | TeamViewer | N/A | N/A | N/A | Add
TeamViewer
Identical |
| NGS
Hardware | No changes
(activate/use pre-
existing network
features) | See predicate 510(k)
Summary | See predicate
510(k) Summary | See predicate 510(k)
Summary | Identical |
| Wireless data
transmission
over LAN | Yes, via integrated
hardware, tested
according to:
• 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 | N/A | N/A | N/A | Add wireless
transmission
of files over
LAN |
| Interface | Windows based GUI | Windows based GUI | Windows based GUI | Windows based GUI | Updated
look and
organization |
Table 1: Comparison of technological characteristics to the predicates
6
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.
7
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
8
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.