(287 days)
No
The document describes a computerized navigational system for dental implantation surgery, focusing on pre-operative planning and intra-operative guidance based on CBCT scans. It mentions software for planning and a robotic arm for guidance. There is no mention of AI, ML, or related concepts like training sets, test sets, or specific performance metrics typically associated with AI/ML algorithms. The modification described is specifically related to Wi-Fi functionality.
No.
The device is a computerized navigational system intended to provide assistance in the planning and surgical phases of dental implantation, and is classified as a dental stereotaxic instrument and a powered surgical device for bone cutting, which are not therapeutic devices in themselves.
No
The device is a computerized navigational system for planning and guiding dental implantation surgery, not a diagnostic device that identifies or characterizes a disease or condition. Its purpose is to assist in surgical procedures.
No
The device description explicitly lists multiple hardware components including a Monitor, Planning Station Laptop PC, Lift Column, Base Cart, Robotic Guide Arm, and Patient Tracker, in addition to the 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 is a medical device used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Intended Use: The intended use of the NGS is to provide assistance in the planning and surgical phases of dental implantation surgery. It uses imaging data (CBCT scans) and provides navigational guidance for surgical instruments. It does not perform tests on biological samples.
- Device Description: The description details a system with components like a monitor, robotic arm, and patient tracker, all focused on surgical guidance. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD-related information: The text does not mention any assays, reagents, or procedures typically associated with IVD testing.
Therefore, the Neocis Guidance System falls under the category of 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 (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).
Product codes (comma separated list FDA assigned to the subject device)
PLV
Device Description
The purpose of subject device is for modification of the Neocis Guidance System (K202264) to allow for Wi-Fi to be continuously active in the Yomi Plan v2.0.1 while it is powered on. All other software and hardware features/functions remain identical to the predicate. 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) (Figure 1).
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 FDAcleared 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 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. For partially edentulous patients, surgeons now have the option to use our new Clamped Chairside Patient Splint (CCPS) (K202100).
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 (Yomi Plan), is placed at the desired location in the virtual patient model within our planning software. The software highlights critical anatomical structures to avoid, such as the inferior alveolar nerve or maxillary sinuses. (2) When the dental implant plan is optimized, the NGS provides precise and accurate guidance of the dental surgical instruments according to the pre-operative plan. The NGS robotic arm, which holds the powered bone cutting tool, 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 bone cutting tool's foot pedal control is not connect to the NGS guide arm. Once the guide arm places the bone cutting tool into position according to the operative plan, the surgeon must activate the tool using the provided foot pedal associated with the bone cutting tool control box. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
cone beam computed tomography (CBCT)
Anatomical Site
Not Found
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 verification testing 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
- . Postmarket Management of Cybersecurity in Medical Devices Document issued on December 28, 2016.
- Cybersecurity for Networked Medical Devices Containing Off the-Shelf (OTS) Software
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
EMC testing was conducted according to the following:
- IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K200805, K191363, K191605, K173402, K182776, K202100
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
12/22/21
Neocis Inc. William Tapia VP, RA-QA 2800 Biscayne Blvd. Suite 600 Miami. Florida 33137
Re: K210711
Trade/Device Name: Neocis Guidance System (NGS) with Yomi Plan v2.0.1 Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: PLV Dated: November 24, 2021 Received: November 26, 2021
Dear William Tapia:
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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.
for Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT 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) K210711
Device Name
Neocis Guidance System (NGS) with Yomi Plan v2.0.1
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).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for Neocis. The 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 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.
510(k) Summary
[K210711](https://510k.innolitics.com/search/K210711)
l. Submitter
Neocis Inc. 2800 Biscayne Blvd. Suite 600 Miami, FL 33137 Tel: 1-855-9NEOCIS
| Contact Person: | William Tapia, VP, RA-QA |
|---|---|
| Date Prepared: | December 21, 2021 |
II. Device
| Trade Name: | Neocis Guidance System (NGS) with Yomi Plan v2.0.1 |
|---|---|
| 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:
- Neocis Guidance System (NGS) with YomiPlan v2.0 (K202264) O
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 pre-operative planning for dental implantation procedures. The output of Yomi Plan is to be used with the Neocis Guidance System (NGS).
V. Device Description
[There is no device-specific guidance document, special controls document, and/or requirements in a device-specific regulation regarding device description that is applicable to the subject device. The NGS is not an In Vitro Diagnostic device.]
The purpose of subject device is for modification of the Neocis Guidance System (K202264) to allow for Wi-Fi to be continuously active in the Yomi Plan v2.0.1 while it is powered on. All other software and hardware features/functions remain identical to the predicate. 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) (Figure 1).
In terms of previously FDA-cleared indications for use (K200805), the Neocis Guidance System (NGS) is a
4
Image /page/4/Picture/1 description: The image shows the logo for Neocis. The word "neocis" is written in a sans-serif font, with the letters in gold. Above the word is a gray line, and to the right of the word is a gray crosshair symbol with a circle in the middle. The logo is simple and modern.
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.
Image /page/4/Picture/3 description: The image shows a Yomi robotic surgery system. The system includes a monitor (1), a planning station PC (2), a lift column (3), a base cart (4), a robotic guide arm (5), and a patient tracker (6). The monitor and planning station PC display the Yomi logo. The robotic guide arm is positioned above the base cart.
Figure 1. Overview of the Neocis Guidance System (NGS). Major components list below.
-
- Monitor: Provides visibility of Yomi Plan for the user and operative team during a procedure. Displays the same information as the Planning station laptop PC
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 golden color. Above the word is a gray horizontal line that extends over the word. There is a gray circle with a vertical line extending above and below the circle, intersecting the horizontal line above the word.
-
- Planning Station Laptop PC: Used to execute Yomi Plan for planning and surgery. This PC is used during the procedure as well to execute commands for the Guide Arm. There is not separate keyboard. (Not intended for removal and use by itself for planning. Remote preplanning shall be executed on a different third party PC that is not connected to the NGS or provided by Neocis.)
-
- Lift Column: Supports the Robotic Guide Arm and Patient Tracker assembly and is used to adjust the height of the assembly.
- Base Cart: Supports the NGS, provides mobility with four swivel casters and locks in position 4. with the foot brake lever. Contains control PC and UPS.
- Robotic Guide Arm: Used to assist the surgeon in performing the surgery. Holds dental drill and 5. provides haptic feedback on position with respect to the plan.
-
- Patient Tracker: Attached to Patient Splint via the End Effector to monitor and relay any changes in patient position.
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 FDAcleared 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 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. For partially edentulous patients, surgeons now have the option to use our new Clamped Chairside Patient Splint (CCPS) (K202100).
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 (Yomi Plan), is placed at the desired location in the virtual patient model within our planning software. The software highlights critical anatomical structures to avoid, such as the inferior alveolar nerve or maxillary sinuses. (2) When the dental implant plan is optimized, the NGS provides precise and accurate guidance of the dental surgical instruments according to the pre-operative plan. The NGS robotic arm, which holds the powered bone cutting tool, 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 bone cutting tool's foot pedal control is not connect to the NGS guide arm. Once the guide arm places the bone cutting tool into position according to the operative plan, the surgeon must activate the tool using the provided foot pedal associated with the bone cutting tool control box. 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.
6
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 gold. Above the word is a gray horizontal line that extends to the left of the word. To the right of the word is a gray crosshair symbol with a circle in the center.
Key safety features include:
- Emergency stop
- Automatic software-controlled safety pause triggered by joint or force limits
- Audio and visual queues
- Drill torque limits provided by the drill control console
- . Full surgeon control and direct visualization of the surgical field
[There is no device-specific guidance document, special controls document, and/or requirements in a device-specific regulation regarding the device description that is applicable to the subject device. The NGS is not an In Vitro Diagnostic device.]
VI. Comparison of Technological Characteristics
This submission is focused on an update to our planning software, Yomi Plan v2.0.1, which allows Wi-Fi to be continuously active while the system is powered on.
Table 1: Comparison of technological characteristics to the predicates
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Feature | NGS with Yomi Plan v2.1 | ||
| K210711 | NGS with Yomi Plan v2.0 | ||
| K202264 | 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 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). | Identical |
| Yomi Plan
Software Version | v2.0.1 | v2.0 | Version
change |
| OS | Windows 10 | Windows 10 | Identical |
| 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 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. | Identical |
| 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 | 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 | Identical |
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Image /page/7/Picture/1 description: The image shows the logo for Neocis. The word "neocis" is written in a sans-serif font, with the letters in gold. There is a gray line above the word, and a gray line extending vertically from the "i" in "neocis". There is a small gray circle at the intersection of the two lines.
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Feature | NGS with Yomi Plan v2.1 | NGS with Yomi Plan v2.0 | SE Analysis |
| K210711 | K202264 | ||
| Visualize CT Scanned Image with 2D Slices Generate Panoramic reconstruction along arch Visualize Panoramic reconstruction with cross sections along panoramic arch Map Splint coordinate 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 | Visualize CT Scanned Image with 2D Slices Generate Panoramic reconstruction along arch Visualize Panoramic reconstruction with cross sections along panoramic arch Map Splint coordinate 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 | Identical |
| Installation | Windows Installer.msi file | Windows Installer.msi file | Identical |
| Origin | Proprietary | Proprietary | Identical |
| OTS Software | TeamViewer | TeamViewer | Identical |
| NGS Hardware | No changes (activate/use pre-existing network features) | No changes (activate/use pre-existing network features) | 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 | 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 | Identical | ||
| Interface | Windows based GIU | Windows based GIU | Identical |
| Wi-Fi | Always active | Disabled during osteotomy | Disabled |
| Wi-Fi no | |||
| longer a | |||
| safety | |||
| mitigation |
VII. Performance Testing
This submission only includes the planning software and wireless transmission coexistence.
Software verification testing 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
- . Postmarket Management of Cybersecurity in Medical Devices Document issued on December 28, 2016.
- Cybersecurity for Networked Medical Devices Containing Off the-Shelf (OTS) Software
8
Image /page/8/Picture/1 description: The image shows the logo for Neocis. The logo features the word "neocis" in a sans-serif font, with the letters in a golden color. Above the word is a thin gray horizontal line that extends to the left and right of the word. At the end of the horizontal line on the right, there is a small gray circle with a vertical line extending upwards and downwards from it, forming a cross-like shape.
Document issued on: January 14, 2005.
-
AAMI TIR57: 2016 Principles For Medical Device Security - Risk Management Wireless
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.
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. IEEE ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence
EMC testing was conducted according to the following:
- IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
VIII. Conclusion
This submission includes an update to our planning software that enables Wi-Fi to be active continuously while the system is powered on. There are no technological changes to the hardware (NGS) or software in this submission. There are no changes to the intended use or the indications for 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.