(103 days)
No
The description focuses on computerized navigation, 3D modeling from CBCT scans, and electromechanical feedback for tracking and guidance, without mentioning AI or ML algorithms for image analysis, planning, or control.
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 condition.
No
Explanation: 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." It provides "navigational guidance of the surgical instruments" and a "robotic arm holds and guides a standard FDA-cleared third party powered bone cutting instrument." This indicates it is a surgical guidance and assistance system, not a device used to diagnose a medical condition.
No
The device description explicitly mentions hardware components such as a robotic arm, patient tracking linkages (Chairside Patient Splint, Edentulous Patient Splint, End Effector, Patient Tracker), and a Fiducial Array. While it includes software for planning and guidance, it is not solely software.
Based on the provided information, the Neocis Guidance System (NGS) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for providing assistance in the planning and surgical phases of dental implantation surgery. This is a surgical guidance system, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease or impairment.
- Device Description: The description details a computerized navigational system that uses imaging data (CBCT) to guide surgical instruments during a procedure. It involves physical components like a robotic arm, patient tracking systems, and splints. This aligns with a surgical guidance system, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on laboratory tests.
The device is classified as a dental stereotaxic instrument and a powered surgical device for bone cutting, which are classifications for surgical devices, not IVDs.
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
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 FDA-cleared third party powered bone cutting instrument (K191605).
The patient tracking portion of the NGS is comprised of linkages from the patient to the NGS, which include the Chairside Patient Splint (CPS) (K173402) or Edentulous Patient Splint (EPS) (K200805), the End Effector (EE) and the Patient Tracker (PT). The Patient Splint is attached to the contralateral side of the patient's mouth over stable teeth. The CPS is placed on the patient using on-label dental materials (K182776) prior to the presurgical CBCT scan. The EPS is placed using bone screws prior to the presurgical CBCT scan (appropriate local anesthesia is required).
A Fiducial Array (FA) with radio-opaque fiducial markers is placed on the CPS prior to the CBCT scan so the virtual plan can be related to the physical space of the system using the markers. The PT is an electromechanical feedback system that is connected to the CPS on the patient, which relays information to the NGS in order to track patient movement. If patient movement occurs during the surgical procedure, the system will respond by altering the prescribed surgical cutting angle, position, and depth to accommodate the patient movement, which will maintain the accuracy of the osteotomy.
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.
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
The subject of this submission is adding Intraoral Fiducial Array (IOFA) as a new device accessory based on a previously cleared design.
The IOFA is intended for use in clinical sites with reduced scan volumes. The IOFA is designed to reside with all the fiducial beads within the patient's mouth. The IOFA can only be used with the C-CPS.
The Intraoral Fiducial Array corresponds directly to the type of C-CPS being used. There are four basic types of C-CPS.
- Lower Left/ Upper Right (LLUR) Posterior- sits on teeth 11-15 for the maxilla or teeth 27-31 for the mandible.
- Lower Right/ Upper Left (LRUL) Posterior- sits on teeth 2-6 for the maxilla or teeth 18-22 for the mandible.
- Lower Left/ Upper Right (LLUR) Anterior- sits on teeth 6-11 for the maxilla or teeth 22-27 for the mandible.
- Lower Right/Upper Left (LRUL) Anterior- sits on teeth 6-11 for the maxilla or teeth 22-27 for the mandible.
A LLUR C-CPS requires an LLUR Intraoral Fiducial Array, and an LRUL C-CPS requires an LRUL Intraoral Fiducial Array. See Figure 2 for LLUR and LRUL Fiducial Arrays.
The IOFA uses kinematic features to attach to the C-CPS and therefore has only one correct orientation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Cone beam computed tomography (CBCT)
Anatomical Site
Dental/Oral
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Dental surgeon in a clinical site.
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)
- Studies Performed: Verification and Validation
- Verification: Registration Testing, Autoclave Cycle Testing, Kinematic Mount Repeatability, Scan Artifact Testing, Fit Clearance Simulation, Total System Accuracy, IOFA Deflection Test
- Validation: IOFA End User Validation (nonclinical surrogate simulating applying, evaluating rigidity, and removing an Intraoral Fiducial Array by a surgeon/end user)
- Clinical Testing: Not conducted
- Conclusion: The IOFA is substantially equivalent to the predicate. There are no changes to the intended use or to the fundamental technology, and there are no new risks to patients or users.
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Neocis Inc. William Tapia Vice President Regulatory Affairs/Quality Assurance 2800 Biscayne Blvd Suite 600 Miami, Florida 33137
Re: K211129
Trade/Device Name: Neocis Guidance System (NGS) with Intraoral Fiducial Array Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: PLV Dated: July 1, 2021 Received: July 2, 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.
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211129
Device Name
Neocis Guidance System (NGS) with Intraoral Fiducial Array
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary - K211129
l. Submitter
Neocis Inc. 2800 Biscayne Blvd. Suite 600 Miami, FL 33137 Tel: 1-855-9NEOCIS
Contact Person: William Tapia, Vice President Regulatory Affairs/Quality Assurance Date Prepared: July 27, 2021
II. Device
Trade Name: Neocis Guidance System (NGS) with Intraoral Fiducial Array 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) (K161399) .
- Reference Devices: ●
IV. Indications for Use
The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments.
V. Device Description
In terms of FDA regulations, the Neocis Guidance System (NGS) is a dental stereotaxic instrument (Product Code PLV) and a powered surgical device for bone cutting (21 CFR 872.4120) (Figure 1).
4
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.
Image /page/4/Picture/4 description: The image shows a Yomi robotic surgery system. The system includes a monitor, planning station PC, lift column, base cart, robotic guide arm, and patient tracker. The monitor and planning station PC display the Yomi logo. The robotic guide arm is positioned above the lift column and base cart.
Figure 1. Overview of the Neocis Guidance System (NGS). Major components list below.
5
-
- Monitor: Provides visibility of Yomi Plan for the user and operative teamduring a procedure. Displays the same information as the Planning station laptop PC
-
- 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 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 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 FDA-cleared third party powered bone cutting instrument (K191605).
The patient tracking portion of the NGS is comprised of linkages from the patient to the NGS, which include the Chairside Patient Splint (CPS) (K173402) or Edentulous Patient Splint (EPS) (K200805), the End Effector (EE) and the Patient Tracker (PT). The Patient Splint is attached to the contralateral side of the patient's mouth over stable teeth. The CPS is placed on the patient using on-label dental materials (K182776) prior to the presurgical CBCT scan. The EPS is placed using bone screws prior to the presurgical CBCT scan (appropriate local anesthesia is required).
A Fiducial Array (FA) with radio-opaque fiducial markers is placed on the CPS prior to the CBCT scan so the virtual plan can be related to the physical space of the system using the markers. The PT is an electromechanical feedback system that is connected to the CPS on the patient, which relays information to the NGS in order to track patient movement. If patient movement occurs during the surgical procedure, the system will respond by altering the prescribed surgical cutting angle, position, and depth to accommodate the patient movement, which will maintain the accuracy of the osteotomy.
For partially edentulous patients, surgeons now have the option to use our new Clamped
6
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.
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
The subject of this submission is adding Intraoral Fiducial Array (IOFA) as a new device accessory based on a previously cleared design.
Image /page/6/Picture/11 description: The image shows two views of a black plastic tool. The tool has a flat, wide blade at the bottom and a handle with a hole at the top. There are several small, raised bumps on the handle. Text is visible on the blade of the tool.
Figure 2. LLUR and LRUL Intraoral Fiducial Arrays.
7
The IOFA is intended for use in clinical sites with reduced scan volumes. The IOFA is designed to reside with all the fiducial beads within the patient's mouth. The IOFA can only be used with the C-CPS.
The Intraoral Fiducial Array corresponds directly to the type of C-CPS being used. There are four basic types of C-CPS.
- . Lower Left/ Upper Right (LLUR) Posterior- sits on teeth 11-15 for the maxilla or teeth 27-31 for the mandible.
- . Lower Right/ Upper Left (LRUL) Posterior- sits on teeth 2-6 for the maxilla or teeth 18-22 for the mandible.
- . Lower Left/ Upper Right (LLUR) Anterior- sits on teeth 6-11 for the maxilla or teeth 22-27 for the mandible.
- . Lower Right/Upper Left (LRUL) Anterior- sits on teeth 6-11 for the maxilla or teeth 22-27 for the mandible.
A LLUR C-CPS requires an LLUR Intraoral Fiducial Array, and an LRUL C-CPS requires an LRUL Intraoral Fiducial Array. See Figure 2 for LLUR and LRUL Fiducial Arrays.
The IOFA uses kinematic features to attach to the C-CPS and therefore has only one correct orientation.
8
VI. Substantial Equivalence (SE) Discussion
The indications for use (IFU) and contraindications of the subject device have remained the same as the predicate and reference devices. Acrylates allergy contraindication was removed since it is no longer applicable. Contraindications remain the same as the previously cleared reference device K202100. The subject device represents a design change to the predicate device. They are functionally equivalent.
a. Comparison of the Indications for Use and Contraindications
The indications for use (IFU) and contraindications of the subject device have remained the same as the predicate and reference devices. Acrylates allergy contraindication was removed since it is no longer applicable. Contraindications remain the same as the previously cleared reference device K202100. The subject device represents a design change to the predicate device. They are functionally equivalent.
9
| Technological
Characteristics | K211129
IOFA
Subject Device | K161399
Predicate | K200348
FAS
Reference Device | K202100
C-CPS
Reference Device | Substantial
Equivalence
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 Neocis Guidance
System (NGS) is a
computerized
navigational system
intended to provide
assistance in both
the planning (pre-
operative) and the
surgical (intra-
operative) phases of
dental implantation
surgery. The system
provides software to
preoperatively plan
dental implantation
procedures and
provides
navigational
guidance of the
surgical instruments. | The Neocis
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 | 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 | No difference. |
| Technological
Characteristics | K21xxxx
IOFA
Subject Device | K161399
Predicate | K200348
FAS
Reference Device | K202100
C-CPS
Reference Device | Substantial
Equivalence
Analysis |
| Contraindicati
ons | The Neocis Guidance
System is not intended
for use with patients
that have insufficient
bone or teeth to retain a
Neocis Clamped
Chairside Patient Splint
(C-CPS) rigidly
throughout a surgical
procedure.
The Neocis Chairside
Patient Splint (C-CPS) | The Neocis Guidance
System is not intended
for use with patients
that have insufficient
bone or teeth to
retain a Splint rigidly
throughout a surgical
procedure.
Patients with allergies
to methyl
methacrylates. | The Neocis
Guidance System is
not intended for use
with patients that
have insufficient
bone or teeth to
retain a FAS rigidly
throughout a
surgical procedure. | The Neocis Guidance
System is not
intended for use
with patients that
have insufficient
bone or teeth to
retain a Neocis
Clamped Chairside
Patient Splint (C-
CPS) rigidly
throughout a
surgical procedure. | Acrylates allergy
contraindication
not needed.
Contraindications
remain the same as
the previously
cleared reference
device K202100. |
| Technological
Characteristics | K21xxxx
IOFA
Subject Device | K161399
Predicate | K200348
FAS
Reference Device | K202100
C-CPS
Reference Device | Substantial
Equivalence
Analysis |
| | should not be affixed to
patients that exhibit:
• Periodontal disease
to include loose
teeth and inflamed
tissue
• Fixed orthodontic
appliances, bridges,
or dental implants
• Patients with a
history of jaw or TMJ
pain | | The FAS should not
be affixed to
patients that exhibit:
• Periodontal
disease to include
loose teeth and
inflamed tissue
| The Neocis Clamped
Chairside Patient
Splint (C-CPS) should
not be affixed to
patients that exhibit:
• Periodontal
disease to
include loose
teeth and
inflamed tissue
• Fixed
orthodontic
appliances,
bridges, or
dental implants
• Patients with a
history of jaw or
TMJ pain | |
Table 1. Comparison of the Indications for Use and Contraindications
10
11
12
b. Comparison of Technology to Predicate Devices
There are no changes to the non-splint NGS hardware or software in this submission.
c. Head-to-Head Comparison
| VII. | Table 2. Head-to-Head Comparison | |
|---|---|---|
| Technological
Characteristics | NGS with IOFA
Subject Device | K161399
Predicate | K200348
FAS
Reference Device | K202100
C-CPS
Reference Device | SE Analysis |
|-------------------------------------------------------------------------------|------------------------------------------|-------------------------------|------------------------------------|--------------------------------------|-------------|
| Patient Contacting
Materials | Ixef®-HC-1022
Avaspire AV-651
CF30 | Same as the
subject device | Same as the
subject device. | Same as the subject
device. | Same |
| NGS Power Supply | 120VAC/60 Hz | Same as the
subject device | Same as the
subject device. | Same as the subject
device. | Same |
| Type of
Protection
against Electric
Shock | Class I Equipment | Same as the
subject device | Same as the
subject device. | Same as the subject
device. | Same |
| Equipment
Suitable for use
in the presence
of Flammable
Mixtures? | No | Same as the
subject device | Same as the
subject device. | Same as the subject
device. | Same |
13
| Technological
Characteristics | NGS with IOFA
Subject Device | K161399
Predicate | K200348
FAS
Reference Device | K202100
C-CPS
Reference Device | SE Analysis |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|---------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Electrical Safety | 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 | Same as the
subject device. | Same as the subject
device. | Same |
| Technological
Characteristics | NGS with IOFA
Subject Device | K161399
Predicate | K200348
FAS
Reference Device | K202100
C-CPS
Reference Device | SE Analysis |
| Electromagnetic
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:
Electromagnetic
disturbances -
Requirements
and tests | Same as the
subject device | Same as the
subject device. | Same as the subject
device. | Same |
| Ingress
Protection | IPXO | Same as the
subject device | Same as the
subject device. | Same as the subject
device. | Same |
| Mode of
Operation | Continuous
Operation | Same as the
subject device | Same as the
subject device. | Same as the subject
device. | Same |
| System Lateral
Accuracy | RMS