(82 days)
No
The summary describes a computerized navigational system for dental surgery with planning software and robotic guidance. It mentions tracking patient movement and adjusting the surgical path, but this appears to be based on electromechanical feedback and pre-programmed responses, not adaptive learning or pattern recognition characteristic of AI/ML. There is no mention of AI, ML, or related terms in the text.
No.
The device's description and intended use outline its function as a computerized navigational system for dental implantation surgery, providing planning assistance and guidance for surgical instruments, rather than directly treating a disease or condition.
No
The device is described as a computerized navigational system for dental implantation surgery, providing assistance in planning and surgical guidance, not for diagnosing conditions.
No
The device description explicitly mentions hardware components like a robotic arm, patient tracking system with linkages, and a physical splint (C-CPS) that interacts with the patient's anatomy. While software is a crucial part of the system for planning and guidance, it is not the sole component.
Based on the provided information, the Neocis Guidance System (NGS) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- NGS Function: The NGS is a surgical guidance system. It uses imaging data (CBCT scans) to plan and guide surgical instruments during a dental implantation procedure. It does not analyze biological specimens.
- Intended Use: The intended use clearly states assistance in the "planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery." This is a surgical application, not a diagnostic one based on in vitro analysis.
- Device Description: The description details a system for surgical navigation, including a robotic arm, patient tracking, and guidance of surgical instruments. This aligns with a surgical device, not an IVD.
- FDA Classification: The device is classified as a dental stereotaxic instrument and a powered surgical device for bone cutting, further supporting its classification as a surgical device.
Therefore, the Neocis Guidance System is a surgical guidance system, 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
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).
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 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 clamp-like 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
cone beam computed tomography (CBCT)
Anatomical Site
dental, mouth
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)
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 (CPS))
- Total System Accuracy
Validation:
- C-CPS Technique Validation: Simulated Clinical Testing
To validate the user requirements of the C-CPS, as performed by a surgeon (end-user). 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.
Key results: The C-CPS is substantially equivalent to the predicate. There are no changes to the intended use or to the fundamental technology.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K161399, K191363, K191605, K182776, K013236, K083195, K030163, K070084
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 shows 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 box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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) 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): | |
|---|---|
| X 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 - 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
4
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
5
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
Characteristics | NGS with C-CPS
Subject Device | NGS with CPS K173402
Predicate Device | SE Analysis |
|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Patient Contacting
Materials | lxef®-HC-1022 | Same as the subject
device | Identical |
| NGS Power Supply | 120VAC/60 Hz | Same as the subject
device | Identical |
| Type of Protection
against Electric Shock | Class I Equipment | Same as the subject
device | Identical |
| Equipment Suitable
for use in the
presence of
Flammable
Mixtures? | No | Same as the subject
device | Identical |
| 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 | Identical |
| Technological
Characteristics | NGS with C-CPS | NGS with CPS K173402 | SE Analysis |
| | Subject Device | Predicate Device | |
| 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 | Identical |
| Ingress
Protection | IPXO | Same as the subject
device | Identical |
| Mode of
Operation | Continuous Operation | Same as the subject
device | Identical |
| System Lateral
Accuracy | RMS Subject Device | NGS with CPS K173402
Predicate Device | SE Analysis |
| Splint Affixation | Clamping and gripping
teeth with compressive
force and dental
impression material
grip (friction force) | Hardening and
locking of dental
materials to teeth
(with mild
compression due to
material shrinkage) | Reliance on increased
compression force for
fixation |
| Splint removal | Backing out clamping
screw and manually
separating the two halves | CPS can be removed
manually or by powered
cutting tool | Splint cutting not needed |
| Dental Material
Removal | Standard dental
techniques | Same as subject device | Identical |
| Fiducials | Fiducial Array (FA)
attached to splint | Same as the Subject
Device | NGS Fiducial is not patient
contacting |
| Kinematic mount | Integrated into the splint | KM as separate part | Similar implementation |
| Biocompatibility | Yes
(ISO 10993-1, -5, -10, -12)
Provided nonsterile | Same as the Subject
Device | Identical |
| Sterilization | User sterilized by Steam
(ISO 17665-1) | Same as the Subject
Device | Identical |
| Use | Splint single use only
Tools reusable | Splint single use only | Addition of tools for
subject device |
| Dental Drill Motor
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
Device | Aseptico cleared for use
with NGS under K191605,
NGS guidance arm cleared
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
Device | Identical |
| Technological | NGS with C-CPS | NGS with CPS K173402 | SE Analysis |
| Characteristics | Subject Device | Predicate Device | |
| Software Level of
Concern | Moderate | Same as the Subject
Device | Identical |
Table 1. Comparison of Technologies Characteristics
6
7
8
9
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 | |||
| 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 | Identical | ||
| Technological | NGS with C-CPS | CPS K173402 | SE Analysis |
| Characteristics | Subject Device | Predicate Device | |
| Contraindications | The Neocis Guidance | ||
| System is not intended for | |||
| use with patients that | |||
| have insufficient bone or | |||
| teeth to retain a Neocis | |||
| Chairside Patient Splint | |||
| (CPS) rigidly throughout a | |||
| surgical procedure. |
The Neocis Chairside
Patient Splint (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 | The Neocis Guidance System
is not intended for use with
patients that have
insufficient bone or teeth to
retain a Neocis Chairside
Patient Splint (CPS) rigidly
throughout a surgical
procedure.
The Neocis Chairside Patient
Splint (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
• Patients with allergies
to methyl
methacrylates | Acrylates allergy
contraindication
not needed |
Table 2. Comparison of the Indications for Use and Contraindications
10
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:
11
- . 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.