Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)
Device Facts
| Record ID | K202100 |
|---|---|
| Device Name | Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) |
| Applicant | Neocis, Inc. |
| Product Code | PLV · Dental |
| Decision Date | Oct 19, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.4120 |
| Device Class | Class 2 |
Intended 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 Story
The Neocis Guidance System (NGS) is a dental stereotaxic instrument providing navigational guidance for dental implant surgery. The system uses a CBCT scan to create a 3D patient model for virtual surgical planning. Intra-operatively, a robotic arm holds and guides a powered bone-cutting instrument. The system tracks patient movement via a Patient Tracker (PT) connected to a Chairside Patient Splint (CPS) or the new Clamped Chairside Patient Splint (C-CPS) affixed to stable teeth. The system provides haptic feedback by constraining instrument motion to the pre-operative plan and adjusts for patient movement in real-time. The surgeon maintains control, with visual/audible feedback and safety features like emergency stops and torque limits. The C-CPS uses a clamping mechanism with dental impression material for fixation, replacing traditional acrylic-based methods. The device is used in a clinical setting by dental surgeons.
Clinical Evidence
Bench testing only. No clinical or animal data were conducted. Verification included splint deflection, pressure assessment, kinematic mount repeatability, removal force, screw failure, and total system accuracy. Validation included simulated clinical testing to evaluate user requirements for application, rigidity, and removal.
Technological Characteristics
Dental stereotaxic instrument; robotic arm guidance; haptic feedback. Materials: Ixef HC-1022, 6061 aluminum, 316 stainless steel. Connectivity: Networked planning station. Sterilization: Steam (ISO 17665-1). Electrical safety: IEC 60601-1, IEC 60601-1-2. Accuracy: RMS < 1 mm (lateral/depth), < 6.0° (angular). Software: Moderate level of concern.
Indications for Use
Indicated for dental implantation surgery planning and intra-operative navigational guidance. Contraindicated for patients with insufficient bone/teeth to retain the splint, periodontal disease (loose teeth/inflamed tissue), fixed orthodontic appliances, bridges, dental implants, or history of jaw/TMJ pain.
Regulatory Classification
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.
Predicate Devices
- Neocis Guidance System (NGS) with Chairside Splint (K173402)
Reference Devices
- Neocis Guidance System (NGS) (K161399)
- 3rd party PC (K191363)
- Aseptico Drill Motor (K030163)
- Anthogyr Mont Blanc handpiece (K070084)
- DMG O-Bite (K013236)
- Lang Jet Tooth Shade (K083195)
- Dental materials (K182776)
Related Devices
- K203401 — Neocis Guidance System (NGS) with Patient Splints (EPS) · Neocis, Inc. · Dec 15, 2020
- K211129 — Neocis Guidance System (NGS) with Intraoral Fiducial Array · Neocis, Inc. · Jul 28, 2021
- K182776 — Neocis Guidance System · Neocis, Inc. · Dec 21, 2018
- K202264 — Neocis Guidance System (NGS) with Yomi Plan v2.0 · Neocis, Inc. · Dec 4, 2020
- K161399 — Neocis Guidance System · Neocis, Inc. · Dec 22, 2016
Submission Summary (Full Text)
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October 19, 2020
Neocis Inc. Thomas Claiborne Regulatory Affairs Manager 2800 Biscayne Blvd Suite 600 Miami. Florida 33137
Re: K202100
Trade/Device Name: Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: PLV Dated: July 24, 2020 Received: July 29, 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
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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 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
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# Indications for Use
510(k) Number (if known) K202100
Device Name
Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)
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): | |
|------------------------------------------------------------------------------------------------|--|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | |
| <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | |
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# 510(k) Summary - K202100
l. Submitter
Neocis Inc. 2800 Biscayne Blvd. Suite 600 Miami, FL 33137 Tel: 1-855-9NEOCIS
Contact Person: Thomas Claiborne, Ph.D., Regulatory Affairs Manager Date Prepared: October 19, 2020
#### II. Device
Trade Name: Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) Common Name: Dental Stereotaxic Instrument Classification Name: Bone cutting instrument and accessories (21 CFR 872.4120) Classification: Class II Product Code: PLV
#### lll. Predicate Devices
- Neocis Guidance System (NGS) with Chairside Splint (K173402)
#### 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).
In terms of previously FDA-cleared indications for use, the Neocis Guidance System (NGS) (K161399) 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 system allows the user to plan the surgery virtually in our Neocis Planning Software
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Application installed on the NGS planning station or on a 3rd party PC (K191363). 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 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), 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 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.
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, is placed at the desired location in the patient model. The software highlights critical anatomical structures to avoid, such as the inferior alveolar nerve. (2) When the dental implant plan is optimized, the NGS provides precise and accurate guidance of the dental surgical instruments according to the preoperative plan. The NGS robotic arm, which holds the surgical instrument, 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 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
- Safety pause
- Audio and visual queues
- Drill torque limits
- Surgeon control
The subject device in this submission is the new Clamped Chairside Patient Splint (C-CPS). The C-CPS offers our users an alternative to acrylic-type dental material affixation. The subject device replaces the acrylic-type dental material locking mechanism of affixation with a clamplike mechanism of affixation using softer dental impression (registration) material, alignment slots, and an approximation screw. The clamping screw is not a bone screw, and it does not
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interact directly with the patient. The screw is positioned above the teeth inside the splint. The subject device is essentially a CPS (K173402) that has been bisected lengthwise with screw holes and alignment slots in each half to approximate the two halves around the patient's stable teeth. The dental impression material is placed inside the splint to form a tight conformational gripping surface between the splint and the teeth. The dental impression material conforms the shape of the patient's teeth to form a large gripping surface area. The C-CPS initial placement is like a dental impression tray. A torque-brake screwdriver with hex bit is used to tighten and loosen the screw. The proper C-CPS model (left/right or anterior/posterior) should be selected based upon the accommodation of the patient's anatomy and the intended surgical location.
#### VI. Comparison of Technological Characteristics:
The indications for use (IFU) of the subject device have remained unchanged from the predicate device Acrylates allergy contraindication is not applicable to the C-CPS. There are no changes to the non-splint NGS hardware or software in this submission.
| Technological<br>Characteristics | NGS with C-CPS<br>Subject Device | NGS with CPS K173402<br>Predicate Device | SE Analysis |
|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Patient Contacting<br>Materials | lxef®-HC-1022 | Same as the subject<br>device | Identical |
| NGS Power Supply | 120VAC/60 Hz | Same as the subject<br>device | Identical |
| Type of Protection<br>against Electric Shock | Class I Equipment | Same as the subject<br>device | Identical |
| Equipment Suitable<br>for use in the<br>presence of<br>Flammable<br>Mixtures? | No | Same as the subject<br>device | Identical |
| Electrical Safety | ANSI AAMI ES60601-<br>1:2005/(R)2012 and<br>A1:2012, C1:2009/(R)2012<br>and A2:2010/(R)2012<br>(Consolidated Text) Medical<br>electrical equipment - Part<br>1: General requirements for<br>basic safety and essential<br>performance (IEC 60601-<br>1:2005, MOD) | Same as the subject<br>device | Identical |
| Technological<br>Characteristics | NGS with C-CPS | NGS with CPS K173402 | SE Analysis |
| | Subject Device | Predicate Device | |
| Electromagnetic<br>Disturbances | IEC 60601-1-2 Edition 4.0<br>2014-02<br>Medical electrical<br>equipment - Part 1-2:<br>General requirements for<br>basic safety and essential<br>performance - Collateral<br>Standard: Electromagnetic<br>disturbances -<br>Requirements and tests | Same as the subject<br>device | Identical |
| Ingress<br>Protection | IPXO | Same as the subject<br>device | Identical |
| Mode of<br>Operation | Continuous Operation | Same as the subject<br>device | Identical |
| System Lateral<br>Accuracy | RMS < 1 mm | Same as the subject<br>device | Identical |
| System Depth<br>Accuracy | RMS < 1 mm | Same as the subject<br>device | Identical |
| System Angular<br>Accuracy | RMS < 6.0° | Same as the subject<br>device | Identical |
| CT Scan Quality<br>Requirements | 0.3 mm Voxel, 0.3 mm<br>Slice Thickness, Matrix<br>512 x 512, Full 13 cm 21<br>sec, Multi 2 DICOM<br>format. | Same as the subject<br>device | Identical |
| F/T Sensor Force<br>Measurement Range | +/- 30 N | Same as the subject<br>device | Identical |
| F/T Sensor Torque<br>Measurement Ra<br>nge | +/- 2 Nm | Same as the subject<br>device | Identical |
| F/T Sensor Single<br>Axis Force Overload<br>Limit | 200 N | Same as the subject<br>device | Identical |
| F/T Sensor Single<br>Axis Torque<br>Overload Limit | 20 Nm | Same as the subject<br>device | Identical |
| Upper limit<br>specification for<br>Guidance Arm<br>Translation Speed | 1.25 m/s | Same as the subject<br>device | Identical |
| | | | |
| Technological<br>Characteristics | NGS with C-CPS<br>Subject Device | NGS with CPS K173402<br>Predicate Device | SE Analysis |
| Storage<br>Requirements | Store powered at Room<br>Temperature (68°F to 76°F<br>or 20°C to 24.4°C) and<br>standard ambient<br>humidity (5% to 95%) in a<br>dust free, clean<br>environment. | Same as the subject<br>device | Identical |
| Splint Purpose | Physical linkage to patient<br>via Patient Tracker and<br>Kinematic Mount<br>connected to:<br>• C-CPS, or<br>• CPS (K173402) | Same as the subject<br>device | Addition of C-CPS to NGS<br>workflow. |
| Splint Models | -Posterior (left &<br>right)<br>-Anterior (left &<br>right);<br>Each with one<br>aluminum screw | -Posterior (left &<br>right)<br>-Anterior (left &<br>right) | Addition of screw |
| Splint Volume | Approximately 16k<br>mm3 | Approximately 13k<br>mm3 | Subject device<br>approximately 20%<br>larger than predicate |
| Splint Surface Area | Anterior Model:<br>-Mucosa: 206 mm²<br>-Teeth: 1062 mm²<br>Posterior Model:<br>-Mucosa: 155 mm²<br>-Teeth 898 mm² | Anterior Model:<br>-Mucosa: 200 mm²<br>-Teeth: 725 mm²<br>Posterior Model:<br>-Mucosa: 65 mm²<br>-Teeth 583 mm² | C-CPS is % Larger<br>than CPS:<br>Anterior Model:<br>-Mucosa: 3%<br>-Teeth: 46%<br>Posterior Model:<br>-Mucosa: 140%<br>-Teeth: 54% |
| Patient Contacting<br>Materials | -IXEF<br>-#8-32 UNC 6061<br>aluminum screw<br>-316 Stainless steel<br>hex bit | -IXEF | Addition of screw and<br>screwdriver bit<br>materials |
| Splint Application<br>Tools | -Torque-brake<br>screwdriver set to<br>1.8Nm with 9/64-inch<br>hex bit;<br>-Dental material<br>applicator | Dental material<br>applicator | Added screwdriver |
| Dental Materials<br>Used with the Splints | Dental impression<br>material DMG O-Bite<br>(Luxabite K013236) | Lang Jet Tooth<br>Shade<br>(K083195)<br>(Additional<br>materials cleared in<br>K182776) | Use of softer<br>impression materials<br>instead of hard<br>acrylic-like materials,<br>both FDA-cleared for<br>dental use |
| Technological<br>Characteristics | NGS with C-CPS<br><i>Subject Device</i> | NGS with CPS K173402<br><i>Predicate Device</i> | SE Analysis |
| Splint Affixation | Clamping and gripping<br>teeth with compressive<br>force and dental<br>impression material<br>grip (friction force) | Hardening and<br>locking of dental<br>materials to teeth<br>(with mild<br>compression due to<br>material shrinkage) | Reliance on increased<br>compression force for<br>fixation |
| Splint removal | Backing out clamping<br>screw and manually<br>separating the two halves | CPS can be removed<br>manually or by powered<br>cutting tool | Splint cutting not needed |
| Dental Material<br>Removal | Standard dental<br>techniques | Same as subject device | Identical |
| Fiducials | Fiducial Array (FA)<br>attached to splint | Same as the Subject<br>Device | NGS Fiducial is not patient<br>contacting |
| Kinematic mount | Integrated into the splint | KM as separate part | Similar implementation |
| Biocompatibility | Yes<br>(ISO 10993-1, -5, -10, -12)<br>Provided nonsterile | Same as the Subject<br>Device | Identical |
| Sterilization | User sterilized by Steam<br>(ISO 17665-1) | Same as the Subject<br>Device | Identical |
| Use | Splint single use only<br>Tools reusable | Splint single use only | Addition of tools for<br>subject device |
| Dental Drill Motor<br>and Hand Piece | Held by NGS guidance arm Aseptico Drill Motor (Model No. AEU-7000LNE-70V) (K030163) Anthogyr Mont Blanc handpiece (Aseptico Model No. AHP-85MBFO-CX) (K070084) | Same as the Subject<br>Device | Aseptico cleared for use<br>with NGS under K191605,<br>NGS guidance arm cleared<br>under K161399 |
| Planning Software | Neocis Planning Software Application v1.2 (K161399), or Neocis Planning Software Application for 3rd Party PCs v1.8.1 (K191363) | Same as the Subject<br>Device | Identical |
| Technological | NGS with C-CPS | NGS with CPS K173402 | SE Analysis |
| Characteristics | Subject Device | Predicate Device | |
| Software Level of<br>Concern | Moderate | Same as the Subject<br>Device | Identical |
## Table 1. Comparison of Technologies Characteristics
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T
## Comparison of the Indications for Use and Contraindications
The indications for use (IFU) of the subject device are identical to the predicate device. Acrylates allergy contraindication was removed since it is no longer applicable.
| Technological | NGS with C-CPS | CPS K173402 | SE Analysis |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Characteristics | Subject Device | Predicate Device | |
| Indications for<br>Use (IFU) | The Neocis Guidance<br>System (NGS) is a<br>computerized<br>navigational system<br>intended to provide<br>assistance in both the<br>planning (pre-operative)<br>and the surgical (intra-<br>operative) phases of<br>dental implantation<br>surgery. The system<br>provides software to<br>preoperatively plan<br>dental implantation<br>procedures and provides<br>navigational guidance of<br>the surgical instruments | The Neocis Guidance System<br>(NGS) is a computerized<br>navigational system<br>intended to provide<br>assistance in both the<br>planning (pre-operative) and<br>the surgical (intra-operative)<br>phases of dental<br>implantation surgery. The<br>system provides software to<br>preoperatively plan dental<br>implantation procedures and<br>provides navigational<br>guidance of the surgical<br>instruments | Identical |
| Technological | NGS with C-CPS | CPS K173402 | SE Analysis |
| Characteristics | Subject Device | Predicate Device | |
| Contraindications | The Neocis Guidance<br>System is not intended for<br>use with patients that<br>have insufficient bone or<br>teeth to retain a Neocis<br>Chairside Patient Splint<br>(CPS) rigidly throughout a<br>surgical procedure.<br><br>The Neocis Chairside<br>Patient Splint (CPS) should<br>not be affixed to patients<br>that exhibit:<br>• Periodontal<br>disease to include<br>loose teeth and<br>inflamed tissue<br>• Fixed orthodontic<br>appliances, bridges,<br>or dental implants<br>• Patients with a<br>history of jaw or<br>TMJ pain | The Neocis Guidance System<br>is not intended for use with<br>patients that have<br>insufficient bone or teeth to<br>retain a Neocis Chairside<br>Patient Splint (CPS) rigidly<br>throughout a surgical<br>procedure.<br><br>The Neocis Chairside Patient<br>Splint (CPS) should not be<br>affixed to patients that<br>exhibit:<br>• Periodontal disease<br>to include loose teeth<br>and inflamed tissue<br>• Fixed orthodontic<br>appliances, bridges,<br>or dental implants<br>• Patients with a<br>history of jaw or TMJ<br>pain<br>• Patients with allergies<br>to methyl<br>methacrylates | Acrylates allergy<br>contraindication<br>not needed |
### Table 2. Comparison of the Indications for Use and Contraindications
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#### VII. Performance Testing
Use of FDA-Recognized Consensus Standards
A risk analysis, sterilization, and biocompatibility testing were conducted on the final finished device per the following standards:
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- . ANSI AAMI ISO 14971:2007/(R)2010 (Corrected 4 October 2007) 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 devices
- . 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
- . ANSI AAMI ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
# Verification
- Clamped Chairside Patient Splint (C-CPS) Splint Deflection Test with Optical Tracking
- Clamped Chairside Patient Splint (C-CPS) Pressure Assessment (Teeth)
- Clamped Chairside Patient Splint (C-CPS) Kinematic Mount Repeatability ●
- Clamped Chairside Patient Splint (C-CPS) Pressure Assessment (Soft Tissue)
- Clamped Chairside Patient Splint (C-CPS) Removal Force Test
- Clamped Chairside Patient Splint (C-CPS) DOE for Parameter Evaluation
- Clamped Chairside Patient Splint (C-CPS) Screw Failure Test
- Clamped Chairside Patient Splint (C-CPS) Lingual-Buccal Assembly Failure Torque
- Dimension Analysis (Clamped Chairside Patient Splint (C-CPS) vs. Chairside Patient Splint (СРУ))
- Total System Accuracy
# Validation
- . C-CPS Technique Validation: Simulated Clinical Testing
- O To validate the user requirements of the C-CPS, as performed by a surgeon (enduser). This validation activity is a nonclinical surrogate that simulates the process of applying, qualitatively evaluating rigidity, and removing a C-CPS directly to a patient.
Animal or clinical testing was not conducted for the subject device.
# Conclusion:
The C-CPS is substantially equivalent to the predicate. There are no changes to the intended use or to the fundamental technology.
