(86 days)
No
The description focuses on a computerized navigational system using pre-operative planning and intra-operative guidance based on a CT scan and physical tracking. There is no mention of AI or ML in the device description, intended use, or performance studies. The system appears to be based on traditional image processing, registration, and electromechanical feedback.
No.
The device is a computerized navigational system intended to assist in planning and performing dental implantation surgery, providing guidance to surgical instruments rather than directly treating a disease or condition.
No
The device is a surgical guidance system that uses pre-operative data (CBCT scan) to assist with surgical planning and intra-operative guidance for dental implantation, rather than diagnosing a condition.
No
The device description explicitly mentions hardware components like the Patient Tracker (PT), Chairside Patient Splint (CPS), End Effector (EE), and the Fiducial Array Splint (FAS), which are physical components used in the system's operation and guidance. It also holds and guides a standard FDA-cleared powered bone cutting instrument.
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 intended for use in vitro for the examination of specimens, including blood, tissues, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Intended Use of NGS: The NGS is intended to provide assistance in the planning and surgical phases of dental implantation surgery. It uses a CBCT scan of the patient to plan the surgery and then provides navigational guidance during the procedure.
- Device Description: The description clearly states that the NGS is a "dental stereotaxic instrument" and a "powered surgical device for bone cutting." It guides surgical instruments and provides haptic feedback during the actual surgical procedure.
- Lack of Specimen Examination: The NGS does not examine any specimens from the human body. It uses imaging data (CBCT) and provides guidance for a surgical procedure performed directly on the patient.
Therefore, the Neocis Guidance System falls under the category of a surgical guidance system or a dental surgical device, 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.
Product codes (comma separated list FDA assigned to the subject device)
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 accurate navigational guidance of surgical instruments, with regard to pre-operative 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 patient to the NGS, which include the Chairside Patient Splint (CPS) (K173402), 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. 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 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 device is a design variation of the predicate CPS (K173402). The portion of the splint that attaches to the patient now contains the fiducial markers. We are calling the subject device, the Fiducial Array Splint (FAS). This provides an alternative workflow in which the FA is not needed. These are the only changes in this submission. The NGS is otherwise the same as the cleared device (K161399). The indications for use and contraindications for the subject and predicate devices are the same.
Since the fiducial markers are on the portion of the splint that is affixed using dental material, we do have to limit the use of cleared dental materials (K182776) to those that are not radioopaque:
- 3M ESPE ProTemp Plus
- Alike
- Traid C&B Material (UV light curable)
The other dental materials cleared for use with the CPS cannot be used with the FAS.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
cone beam computed tomography (CBCT) scan
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
Performance Testing Submitted with this Submission:
- Bite force testing on fiducial markers
- Cut removal
- Loaded splint deflection testing using 2x PT weight
- Simulated clinical use: end user validation on a typodont
- Fiducial marker registration
- Fiducial marker single use autoclave test
- Total system accuracy testing
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.
Neocis Guidance System (NGS) with Chairside Splint (K173402)
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.
Neocis Guidance System (K191605), Neocis Guidance System (K182776)
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 logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized symbol. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
May 8, 2020
Neocis Inc. Thomas Claiborne Regulatory Affairs Manager 2800 Biscayne Blvd Suite 600 Miami, Florida 33137
Re: K200348
Trade/Device Name: Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: PLV Dated: February 11, 2020 Received: February 12, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 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.
for Srinivas "Nandu" Nandkumar, Ph.D. 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) K200348
Device Name
Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)
Indications for Use (Describe)
The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CER 801 Subnart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Submitter Name:
Neocis Inc. 2800 Biscayne Blvd. Suite 600 Miami, FL 33137 Tel: 1-855-9NEOCIS
Contact Person:
Thomas Claiborne, Ph.D. 2800 Biscayne Blvd. Suite 600 Miami, FL 33137 Tel: 1-855-9NEOCIS
Date Prepared: May 7, 2020
Trade Name: Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)
Common Name: Dental Stereotaxic Instrument
Classification Name: Bone cutting instrument and accessories (21 CFR 872.4120)
Classification: Class II
Product Code: PLV
Primary Predicate Device: Neocis Guidance System (NGS) with Chairside Splint (K173402)
Reference Devices: Neocis Guidance System (K191605) & Neocis Guidance System (K182776)
Indications for Use:
The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments.
Device Description:
The Neocis Guidance System (NGS) (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 accurate navigational guidance of surgical instruments, with
4
regard to pre-operative 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 patient to the NGS, which include the Chairside Patient Splint (CPS) (K173402), 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. 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 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 device is a design variation of the predicate CPS (K173402). The portion of the splint that attaches to the patient now contains the fiducial markers. We are calling the subject device, the Fiducial Array Splint (FAS). This provides an alternative workflow in which the FA is not needed. These are the only changes in this submission. The NGS is otherwise the same as the cleared device (K161399). The indications for use and contraindications for the subject and predicate devices are the same.
Since the fiducial markers are on the portion of the splint that is affixed using dental material, we do have to limit the use of cleared dental materials (K182776) to those that are not radioopaque:
- 3M ESPE ProTemp Plus
- Alike
- Traid C&B Material (UV light curable)
The other dental materials cleared for use with the CPS cannot be used with the FAS.
5
Since the FAS does need the FA, we can use the FAS in CBCT scanners with smaller scan volumes and standard chin rests.
Comparison of Technological Characteristics:
This submission involves only a modification to the CPS, referred to as the FAS, to be differentiated from the other Neocis splints. Otherwise, all performance characteristics of the NGS are the same. The differences introduced by this modification are detailed in Table 1.
| Technological
| Characteristics | Subject Device | Predicate K173402 | 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 accurate navigational | |||
| guidance of surgical instruments, | |||
| with regard to pre-operative | |||
| planning in dental implantation | |||
| procedures. | 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 accurate | |||
| navigational guidance of surgical | |||
| instruments, regarding pre- | |||
| operative planning in dental | |||
| implantation procedures. | Identical | ||
| Technology / Performance Characteristics | |||
| Power supply | 120VAC/60Hz | 120VAC/60Hz | Identical |
| Splint | |||
| Attachment | |||
| Using Dental | |||
| Materials | 3M ESPE ProTemp Plus | ||
| (K033022) Alike (K942670) Traid C&B Material (UV | |||
| light curable) (K850911) *Radio-opaque dental materials | |||
| not recommended | Lang Jet Tooth Shade (K083195) | Additional radio- | |
| transparent | |||
| dental materials | |||
| from reference | |||
| device K182776 | |||
| Splint Removal | FAS may be removed either by | ||
| cutting bridges along a seam of the | |||
| splint or manually pulling off. | CPS may be removed either by | ||
| cutting bridges along a seam of | |||
| the splint or manually pulling | |||
| off. | Identical | ||
| Fiducial Array | |||
| (FA) | Not required | The Fiducial Array attaches to | |
| the splint during the CT scan to | |||
| provide a reference in the | |||
| image. | Fiducial beads | ||
| relocated to the | |||
| FAS | |||
| Kinematic Mount | |||
| (KM) | KM integrated into the FAS | KM screwed to CPS and FA | Simpler interface, |
| less parts |
Table 1: SE Summary
6
| Technological
| Characteristics | Subject Device | Predicate K173402 | SE Analysis |
|---|---|---|---|
| Splint Materials | IXEF-HC-1022 Aluminum 2017 Epoxy (EPO-TEK 353ND) | IXEF-HC-1022 | Addition of |
| fiducial marker | |||
| and adhesive | |||
| materials | |||
| Safety Features | |||
| Biocompatibility | Tissue, bone, dentin contact |