(26 days)
No
The description focuses on computerized navigation, planning software, and electromechanical feedback for tracking and guidance, without mentioning AI or ML.
No.
This device is a surgical guidance system that provides assistance in planning and performing dental implant surgery, but it does not directly treat or cure a disease or condition.
No
The device is described as a "computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery." Its function is to guide surgical instruments and provide feedback during the procedure, not to diagnose a condition.
No
The device description explicitly mentions physical components like linkages, splints (Chairside Patient Splint, Clamped Chairside Patient Splint, Edentulous Patient Splint), a Patient Tracker (described as an electromechanical feedback system), and the system's ability to hold and guide a standard FDA-cleared powered bone cutting instrument. It also describes haptic feedback, which implies physical interaction. While software is a critical part of the system for planning and guidance, the device is clearly a system that includes significant hardware components.
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, such as blood, urine, or tissue, to provide information for the diagnosis, treatment, or prevention of disease.
- 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 navigational guidance for surgical instruments based on a CBCT scan of the patient. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for assistance in the planning and surgical phases of dental implantation surgery.
- Device Description: The description details a computerized navigational system, robotic components, and surgical instrument guidance. There is no mention of analyzing biological samples.
Therefore, the Neocis Guidance System falls under the category of a surgical guidance system or a dental stereotaxic instrument, 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.
Product codes
PLV
Device Description
The Neocis Guidance System (NGS) (K161399) is a dental stereotaxic instrument (Product Code PLV) and a powered surgical device for bone cutting (21 CFR 872.4120). 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 precise and accurate navigational guidance of surgical instruments, with regard to planning in dental implantation procedures. The system allows the user to plan the surgery virtually in software using a cone beam computed tomography (CBCT) scan of the patient, and the plan is used by a guidance system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation. The holds and guides a standard FDA-cleared powered bone cutting instrument.
The implant process occurs in two phases. First, the dental surgeon plans the surgical procedure with the planning software. A virtual implant is placed at the desired location in the CT scan, allowing the dental surgeon to avoid interfering with critical anatomical structures during implant surgery. Second, when the implant plan is optimally positioned, the NGS provides accurate guidance of the dental surgical instruments according to the pre-operative plan. The NGS 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 patient tracking portion of the NGS is comprised of linkages from the NGS, which for partially edentulous patients include the Chairside Patient Splint (CPS) (K173402) or the Clamped Chairside Patient Splint (CCPS) (K202100), the End Effector (EE) and the Patient Tracker (PT). The CPS or CCPS 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. A Fiducial Array (FA) with radio-opaque fiducial markers is placed on the splint 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 splint on the patient, which relays information to the control software in order to track patient movement. If patient movement occurs during the surgical procedure, the system will respond by altering the prescribed surgical cutting angle, position, and depth to accommodate the patient movement, which will maintain the accuracy of the osteotomy.
The subject of this submission is a design change to the sleeves in our Edentulous Patient Splint (EPS) (K200805). The EPS enables use of the NGS in fully edentulous patients. It is affixed to the anterior mandible or maxilla using standard bone screws. Like the CPS and CCPS, the EPS serves as rigid connection to the patient for robotic tracking of the patient during the procedure. The EPS is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.
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)
EPS Weighted Deflection Test with Optical Tracking in Sawbones®
Total System Accuracy
ANSI AAMI ISO 14971:2019 Medical devices Applications of risk management to medical devices
ANSI AAMI ISO 17665-1:2006/(R)2013 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical device
ANSI AAMI ISO 10993-1:2009/(R)2013 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ANSI AAMI ISO 10993-5:2009/(R)2014 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ANSI AAMI ISO 10993-10:2010/(R)2014 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ANSI AAMI ISO 10993-12: 2012 Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials
Key results: The design changes to the EPS sleeves have been verified using well established methods. The new design is functionally the same as the predicate device. The subject device different questions of safety and effectiveness. Therefore, the subject device is substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K161399, K173402, K202100, K182776, K190059, K014263
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
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December 15, 2020
Neocis Inc. Thomas E. Claiborne, Ph.D. Regulatory Affairs Manager 2800 Biscayne Blvd Suite 600 Miami, Florida 33317
Re: K203401
Trade/Device Name: Neocis Guidance System (NGS) with Patient Splints (EPS) Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: PLV Dated: November 18, 2020 Received: November 19, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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,
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) K203401
Device Name Neocis Guidance System (NGS) with Edentulous Patient Splint (EPS)
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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ☑ | ☐ |
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 word "neocis" is written in a sans-serif font, with the letters in gold. Above the word is a gray horizontal line. To the right of the word is a gray vertical line with a circle in the middle. The vertical line intersects the horizontal line.
510(k) Summary
I. Submitter
Neocis Inc. 2800 Biscayne Blvd. Suite 600 Miami, FL 33137 Tel: 1-855-9NEOCIS
Contact Person: Thomas E. Claiborne, Ph.D., Regulatory Affairs Manager Date Prepared: November 18, 2020
II. Device
| Trade Name: | Neocis Guidance System (NGS) with Edentulous Patient Splint (EPS) |
|---|---|
| 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
- Neocis Guidance System (NGS) with Patient Splints (K200805) ●
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.
V. Device Description
The Neocis Guidance System (NGS) (K161399) is a dental stereotaxic instrument (Product Code PLV) and a powered surgical device for bone cutting (21 CFR 872.4120). 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 precise and accurate navigational guidance of surgical instruments, with regard to planning in dental implantation procedures. The system allows the user to plan the surgery virtually in software using a cone beam computed tomography (CBCT) scan of the patient, and the plan is used by a guidance system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation. The holds and guides a standard FDA-cleared powered bone cutting instrument.
The implant process occurs in two phases. First, the dental surgeon plans the surgical procedure with the planning software. A virtual implant is placed at the desired location in the CT scan, allowing the dental surgeon to avoid interfering with critical anatomical structures during implant surgery. Second, when the implant plan is optimally positioned, the NGS provides accurate guidance of the dental surgical instruments according to the pre-operative plan. The NGS 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 patient tracking portion of the NGS is comprised of linkages from the NGS, which for partially edentulous patients include the Chairside Patient Splint (CPS) (K173402) or the Clamped Chairside Patient Splint (CCPS) (K202100), the End Effector (EE) and the Patient Tracker (PT). The CPS or CCPS 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. A Fiducial Array (FA) with radio-opaque fiducial markers is placed on the splint 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 splint on the
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 "neo" portion in a golden color and the "cis" portion in a gray color. Above the word is a gray horizontal line that extends over the "neo" portion and connects to a vertical line that extends down to the "cis" portion. There is a small circle at the intersection of the horizontal and vertical lines.
patient, which relays information to the control software in order to track patient movement. If patient movement occurs during the surgical procedure, the system will respond by altering the prescribed surgical cutting angle, position, and depth to accommodate the patient movement, which will maintain the accuracy of the osteotomy.
The subject of this submission is a design change to the sleeves in our Edentulous Patient Splint (EPS) (K200805). The EPS enables use of the NGS in fully edentulous patients. It is affixed to the anterior mandible or maxilla using standard bone screws. Like the CPS and CCPS, the EPS serves as rigid connection to the patient for robotic tracking of the patient during the procedure. The EPS is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.
VI. Comparison of Technological Characteristics
This submission includes a design change to the sleeves in the EPS. There are no changes to the indications for use. There are no changes to the NGS hardware or software in this submission. The differences introduced by this modification are detailed in Table 1.
| Technological
| Characteristics | Subject Device | Predicate K200805 | SE Analysis |
|---|---|---|---|
| Indications for | |||
| Use (IFU) | 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 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. | Identical | ||
| NGS Technology | |||
| (non-splint | |||
| hardware and | |||
| software) | No changes | No Changes | Identical |
| Patient Splint | EPS | EPS | Identical |
| Splint Sleeves | Neocis design titanium | Third party stainless steel | |
| (K190059) | Material & | ||
| manufacturing | |||
| change | |||
| Patient | |||
| Contacting | |||
| Materials | ● Ixef®-HC-1022 | ||
| ● Titanium Alloy | ● Ixef®-HC-1022 | ||
| ● Stainless Steel | |||
| ● Titanium Alloy | Removed | ||
| stainless steel | |||
| Patient Tracking | Physical linkage to patient via | ||
| Patient Tracker, Kinematic Mount, | |||
| and End Effector connected to: | |||
| ● EPS | Physical linkage to patient via | ||
| Patient Tracker, Kinematic | |||
| Mount, and End Effector | |||
| connected to: | |||
| ● EPS | Identical |
Table 1: Comparison of technological characteristics to the predicates
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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 horizontal gray 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.
| Technological
| Characteristics | Subject Device | Predicate K200805 | SE Analysis |
|---|---|---|---|
| Affixation of | |||
| tracking | |||
| technology to | |||
| patient | Stryker Mandibular Fracture | ||
| and Reconstruction Fixation | |||
| System, Bone Fixation Screws | |||
| 2.0, 2.3 mm Diam, 10 – 20 mm | |||
| length (K014263) | Stryker Mandibular Fracture and | ||
| Reconstruction Fixation System, | |||
| Bone Fixation Screws 2.0, 2.3 mm | |||
| Diam, 10–20 mm length | |||
| (K014263) | Identical | ||
| Patient | |||
| attachment | |||
| removal | EPS is removed by unscrewing the | ||
| bone screws | EPS is removed by unscrewing the | ||
| bone screws | Identical | ||
| Fiducials | Fiducial Array (FA) attached to | ||
| splint | Fiducial Array (FA) attached to | ||
| splint | Identical | ||
| Kinematic mount | Integrated into the splint | Integrated into the splint | Identical |
VII. Performance Testing
The subject of this 510(k) was a design change to the sleeves in the EPS. There are no other system or labeling changes in this submission.
- EPS Weighted Deflection Test with Optical Tracking in Sawbones®
- Total System Accuracy
- ANSI AAMI ISO 14971:2019 Medical devices Applications of risk management to medical devices ●
- . ANSI AAMI ISO 17665-1:2006/(R)2013 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical device
- ANSI AAMI ISO 10993-1:2009/(R)2013 Biological evaluation of medical devices Part 1: Evaluation and ● testing within a risk management process
- ANSI AAMI ISO 10993-5:2009/(R)2014 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- . ANSI AAMI ISO 10993-10:2010/(R)2014 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- . ANSI AAMI ISO 10993-12: 2012 Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials
VIII. Conclusion
The design changes to the EPS sleeves have been verified using well established methods. The new design is functionally the same as the predicate device. The subject device different questions of safety and effectiveness. Therefore, the subject device is substantially equivalent to the predicate.