(123 days)
No
The summary describes a computerized navigational system providing guidance based on a pre-operative plan and patient tracking, but does not mention AI or ML in its description, function, or testing.
No
The device provides computerized navigational assistance and guidance for surgical instruments during dental implantation, but it does not directly treat a disease or condition itself.
No
The device is a computerized navigational system intended to provide assistance in the planning and surgical phases of dental implantation surgery by guiding surgical instruments. It does not diagnose conditions.
No
The device description explicitly details hardware components such as the Patient Tracker (an electromechanical feedback system), the Guidance Arm, the Chairside Patient Splint (CPS), the End Effector (EE), the Patient Tracker (PT), and the Edentulous Patient Splint (EPS). It also mentions the system holding and guiding a standard FDA-cleared powered bone cutting instrument. The performance studies include testing of these physical components (e.g., Guidance Arm Accuracy, Patient Tracker and Splint Mounting Verifications, EPS Bench Testing, EPS Cadaver Testing). Therefore, it is not a software-only medical device.
Based on the provided information, 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 taken 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 navigation system used during dental implant surgery. It uses pre-operative imaging (CBCT scans) and provides guidance for surgical instruments in vivo (within the patient's body).
- Lack of Specimen Analysis: The NGS does not analyze any specimens taken from the patient's body. Its function is to assist the surgeon in physically performing the surgical procedure based on pre-operative planning and real-time tracking.
The device description clearly states its purpose is to provide assistance in the planning and surgical phases of dental implantation surgery and to provide navigational guidance of surgical instruments. This aligns with the definition of a surgical guidance system, not an IVD.
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 and fully edentulous adult patients who qualify for dental implants.
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 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 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 can be used for flapless dental implant procedures, which is a type of minimally invasive surgical approach. The NGS provides haptic feedback to the surgeon by constraining 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 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 of this submission is our Edentulous Patient Splint (EPS). The EPS is affixed to the anterior mandible or maxilla using standard bone screws. Like the CPS, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
cone beam computed tomography (CBCT) scan
Anatomical Site
Dental, mandible, maxilla
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Not Found
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)
Bench Testing:
- EPS Bench Testing:
- Rigidly mounted EPS deflection measurement: Internal protocol to measure the deflection error introduced by the weight of our patient tracker.
- Kinematic Mount Repeatability measurement: Internal protocol to measure the repeatability of connection to the kinematic features of the device.
- Total System Accuracy: The full system is used to perform a simulated clinical procedure on a typodont to measure the system accuracy.
PRE-CLINICAL VALIDATION:
- EPS Cadaver Testing:
- Human cadaver heads (n=2) were used to test EPS affixation and removal. One surgeon experienced with the NGS performed the procedures. Two splints (1 upper, 1 lower) were tested per surgeon. The Surgeon used bone screws to secure the splints. They attached the Patient Tracker to the EPS and moved the head around. Rigidity of splint affixation was checked qualitatively. Surgeons were asked qualitative performance questions about the device.
CLINICAL VALIDATION:
- IDE Study G190282:
- A prospective two-center (private practice) IDE study that was not randomized or controlled.
- Sample size: 10 adult patients (5 per site) and 67 dental implants placed.
- Endpoints included usability, safety, and effectiveness.
- Key results: No adverse events observed or reported. No usability concerns identified. Implant location accuracy was examined using a before and after analysis of CT data showing the location of the implant in the preop plan versus postop CT. All implants met system specifications for accuracy. Patient risks have been mitigated by design. No new clinical risks were identified in comparison to the predicate and our preop risk assessment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- System Lateral Accuracy: RMS
§ 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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July 28, 2020
Neocis Inc. Thomas E. Claiborne, Ph.D. Regulatory Affairs Manager 2800 Biscayne Blvd. Suite 600 Miami, Florida 33137
Re: K200805
Trade/Device Name: Neocis Guidance System (NGS) with Patient Splints Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: PLV Dated: April 28, 2020 Received: April 29, 2020
Dear Thomas E. 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 probibitions 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 (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-devices/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 (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) K200805
Device Name
Neocis Guidance System (NGS) with Patient Splints
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) |
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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 golden color. Above the word is a horizontal gray line that extends over the "neo" part of the word. A vertical gray line intersects the horizontal line above the "c" in "neocis", forming a plus sign with a small circle at the intersection.
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: July 27, 2020
II. Device
| Trade Name: | Neocis Guidance System (NGS) with Patient Splints |
|---|---|
| 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
- X-Guide Surgical Navigation System (K150222) ●
IV. Reference Devices
- Neocis Chairside Splint (K173402)
- . Dentsply Sirona Cerec Guides (K190059)
- . Stryker Mandibular Fracture and Reconstruction Fixation System, Bone Fixation Screws (K014263)
V. 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.
VI. 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 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 can be used for flapless dental implant procedures, which is a type of minimally invasive surgical approach. The NGS provides haptic feedback to the surgeon by constraining the bone cutting instrument to the plan. This allows the surgeon to feel resistance to attempts at motions that may deviate from the plan.
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 light orange color. Above the word is a thin gray horizontal line that extends beyond the letters on both sides. A thin gray vertical line intersects the horizontal line at a small gray circle above the "i" in "neocis".
The patient tracking portion of the NGS is comprised of linkages from 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 of this submission is our Edentulous Patient Splint (EPS). The EPS is affixed to the anterior mandible or maxilla using standard bone screws. Like the CPS, 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.
VII. Comparison of Technological Characteristics
This submission includes changes to the indications for use and a new patient splint for use in partially edentulous and fully edentulous patients. There are no changes to the NGS hardware or software in this submission. Since the NGS (K161399) was previously found to be substantially equivalent to K150222, we refer to our prior clearance for a full technological comparison. We have selected K150222 again as a predicate device because we now have technology that allows us to match its performance requirements for fully edentulous patients, which is the focus of this submission. The differences introduced by this modification are detailed in Table 1: Comparison of technological characteristics to the predicates below.
5
Image /page/5/Picture/6 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 gray horizontal line, and to the right of the word is a gray vertical line with a circle at the top.
| Technologic
al
Characterist
ics | NGS with
Patient
Splints
Subject
Device | X-Guide Surgical
Navigation System
Predicate Device
(K150222) | Reference
Device-CPS
K173402 | Reference
Device-
Sleeves
K190059 | Reference
Device-
Screws
K014263 | 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 X-Guide(R)
Surgical Navigation
System is a
computerized
navigational system
intended to provide
assistance in both the
preoperative planning
phase and intra-
operative surgical
phase of dental
implantation
procedures. The
system provides
software to
preoperatively plan
dental implantation
procedures and
provides navigational
guidance of the
surgical instruments.
The device is intended
for use for partially
edentulous and
edentulous adult and
geriatric patients who
require dental
implants as part of
their treatment plan. | The Neocis
Guidance
System
(NGS) is a
computerize
d
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
preoperative
ly plan
dental
implantation
procedures
and
provides
navigational
guidance of
the surgical
instruments. | N/A | N/A | Added condition
and patient
population from
predicate. |
| Technologic
al
Characterist
ics | NGS with
Patient
Splints
Subject
Device | X-Guide Surgical
Navigation System
Predicate Device
(K150222) | Reference
Device-CPS
K173402 | Reference
Device-
Sleeves
K190059 | Reference
Device-
Screws
K014263 | SE Analysis |
| Contraindication
s | The Neocis
Guidance
System is not
intended for
use with
patients that
have
insufficient
bone to retain
a Neocis
Edentulous
Patient Splint
(EPS) rigidly
throughout a
surgical
procedure.
The EPS
should not be
affixed to
patients that
exhibit:
•Patients
with
insufficient
bone quality
•Patients
with a
history of
jaw or TMJ
pain | Medical conditions
which contraindicate
the use of X-Guide
and its associated
applications include
any medical
conditions which may
contraindicate the
medical procedure
itself.
Only for those where
dental implants are
appropriate & patient
is healthy.
• Not for use with
patients less than
21 years of age.
• Not for use with
photosensitive
epileptic patients.
Patient sensitivity
may be caused
from the LEDs. | The
Neocis
Guidance
System is
not
intended
for use
with
patients
that have
insufficien
t bone to
retain a
Neocis
Edentulou
s Patient
Splint
(EPS)
rigidly
throughout
a surgical
procedure.
The EPS
should not
be affixed
to patients
that
exhibit:
Patients
with
insufficien
t bone
quality
Patients
with a
history of
jaw or TMJ
pain
Patients
with
allergies to
acrylates | N/A | N/A | Adjusted for
EPS.
Acrylic-like
dental materials
are not used with
the EPS.
Similar to X-
Guide. |
| Patient
Contacting
Materials | • Ixef®-
HC-1022
• Stainless
Steel
• Titanium
Alloy | • Stainless
Steel
• Titanium
Alloy | IXEF | Stainless
Steel | Titanium | Addition of
predicate
materials |
| NGS Power
Supply | 120VAC/60 Hz | 120VAC/60Hz | Same as the
subject
device | N/A | N/A | Same |
| Type of
Protection
against Electric
Shock | Class I
Equipment | Class I Equipment | Same as the
subject
device | N/A | N/A | Same |
| Technologic
al
Characterist
ics | NGS with
Patient
Splints
Subject
Device | X-Guide Surgical
Navigation System
Predicate Device
(K150222) | Reference
Device-CPS
K173402 | Reference
Device-
Sleeves
K190059 | Reference
Device-
Screws
K014263 | SE Analysis |
| Equipment
Suitable for
use in the
presence of
Flammable
Mixtures? | No | No | N Same as
the subject
device /A | N/A | N/A | Same |
| Electrical
Safety | ANSI AAMI
ES60601-
1:2005/(R)2012
and A1:2012,
C1:2009/(R)20
12 and
A2:2010/(R)20
12
(Consolidated
Text) Medical
electrical
equipment -
Part 1: General
requirements
for basic safety
and essential
performance
(IEC 60601-
1:2005, MOD) | ANSI AAMI
ES60601-
1:2005/(R)2012 and
A1:2012,C1:2009/(R)
2012 and
A2:2010/(R)2012
(Consolidated Text)
Medical electrical
equipment - Part 1:
General requirements
for basic safety and
essential performance
(IEC 60601-1:2005,
MOD) | Same as the
subject
device | N/A | N/A | Same |
| Electromagneti
c Disturbances | IEC 60601-1-2
Edition 4.0
2014-02
Medical
electrical
equipment -
Part 1-2:
General
requirements
for basic safety
and essential
performance -
Collateral
Standard:
Electromagneti
c disturbances .
Requirements
and tests | IEC 60601-1-2
Edition 4.0 2014-02
Medical electrical
equipment - Part 1-2:
General requirements
for basic safety and
essential performance
- Collateral Standard:
Electromagnetic
disturbances -
Requirements and
tests | Same as the
subject
device | N/A | N/A | Same |
| Ingres
S
Protec
tion | IPX0 | IPX2 | Same as the
subject
device | N/A | N/A | The X-Guide has
a higher IPX
rating. NGS is 0
because of our
draping. |
| Mode
of
Opera
tion | Continuous
Operation | Continuous Operation | Same as the
subject
device | N/A | N/A | Same |
| System
Lateral
Accuracy | RMS