Who is the manufacturer of SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM?

Materialise Dental NV filed the 510(k) submission for SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM (K112679).

What is the FDA product code for SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM?

SimPlant® 2011 (K110300); Nobel Biocare Guided Surgery Concept (K050393).

Who can help prepare an FDA 510(k) submission like SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM

K112679 · Materialise Dental NV · LLZ · Feb 22, 2012 · Radiology

Device Facts

Record ID	K112679
Device Name	SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM
Applicant	Materialise Dental NV
Product Code	LLZ · Radiology
Decision Date	Feb 22, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2

Intended Use

SimPlant Navigator Personalized Dental Care System is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance scanner. It is also intended as pre-planning software for dental implant placement and surgical treatment. SurgiGuide® guides and the BIOMET 3i Navigator Surgical Kit, which are used intra-operatively to prepare the osteotomy for placement of BIOMET 3i implants pre-operatively determined in the software.

Device Story

SimPlant Navigator is a software-based system for dental implant pre-operative planning. It imports CT or MRI scan data to create 3D anatomical models of the jaw. Clinicians use the software to perform image segmentation, visualize anatomical structures, and plan dental implant positions and orientations. The system includes a library of dental implants and instruments. Output includes a surgical plan and the design for patient-specific SurgiGuide® templates. These guides, along with the BIOMET 3i Navigator Surgical Kit, are used by surgeons intra-operatively to transfer the virtual plan to the patient by guiding drill locations and osteotomy preparation. The device assists in the placement of implants to support temporary or final prostheses. It is intended for use by qualified surgeons in a clinical setting.

Clinical Evidence

No clinical data provided. Performance was established through software validation and bench-top testing to ensure compatibility of system components, including biocompatibility, sterilization, and dimensional stability testing.

Technological Characteristics

Software-based image processing and planning system. Hardware components include polyamide patient-specific guides and stainless steel surgical instruments. Connectivity via DICOM standards. Software developed in C++ for Windows. Complies with ISO 14971 (risk management), ISO 13485 (quality management), and ISO 10993 (biocompatibility).

Indications for Use

Indicated for use as a software interface and image segmentation system for transferring medical imaging (CT/MRI) and as pre-planning software for dental implant placement and surgical treatment. Used with SurgiGuide® and BIOMET 3i Navigator Surgical Kit for intra-operative osteotomy preparation.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

SimPlant® 2011 (K110300)
Nobel Biocare Guided Surgery Concept (K050393)

Related Devices

K093090 — GALILEOS IMPLANT, VERSION 1.7 · Sicat GmbH & Co. KG · Dec 17, 2009
K040224 — CADIMPLANT · Praxim, Inc. · Apr 6, 2004
K152078 — Implant Studio 2015 · 3Shape Medical A/S · Dec 4, 2015
K172239 — SIMPLANT 18 · Dentsply Sirona · Apr 4, 2018
K113739 — SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM · Materialise Dental NV · May 30, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ ## 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 892.2050. | Submitter: | Materialise Dental NV Technologielaan 15 Leuven Belgium | |-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Establishment Reg. Number: | 3006638827 | | Contact: | Carl Van Lierde QA/RA Manager Materialise Dental NV Technologielaan 15 Leuven Belgium Tel. +32 16 39 67 14 Fax. +32 16 39 66 22 Email: carl.vanlierde@materialise.be | | Date Prepared: | September 12, 2011 | | Trade/ Proprietary Name: | SimPlant Navigator Personalized Dental Care System | | Common/Usual Name: | System, Image processing. The product uses images acquired from Computerized Tomography (CT) scanners | | Classification Name/ FDA Reviewing Branch: | Radiology branch | | Device Classification/ Code: | Class II - 21 CFR §892.2050 LLZ | {1}------------------------------------------------ K112679 ge 2 of 7. K\\2679 | K\12679 | K\12679 Special 510(k) Premarket Notification | Rape 2 of 2 of 2 of 2 | 2 of 21 | Plant Care System T | Predicate Device Manufacturer: | SimPlant® 2011; (K110300) Nobel Biocare Guided Surgery Concept; (K050393) | |---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Purpose of the SPECIAL 510(k) notice: | The reason for this Special 510k submission is to request clearance for a modificatio to a device that has been cleared under the 510(k) process referred to herein a SimPlant Navigator Personalized Dental Care System (Image processing system referenced under 21 CFR §892.2050 and are considered Class II devices. | | Device Description: | SimPlant Navigator Personalized Dental Care System provides a method o importing medical imaging information from radiological imaging systems such as Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) to a computer fi that is usable in conjunction with other diagnostic tools and expert clinical judgmen Visual representations of the imaged anatomical structures (e.g. the jaw) are derive allowing for a three-dimensional assessment of the patient without patient contac Dental implant positions including orientations are planned pre-operatively. Compute visualization of the 3D anatomical jaw models, planned implants, planned tooth setu and numerical measurements assist the surgeon in the creation and approval of a pre surgical plan. SurgiGuide® guides and the BIOMET 3i Navigator Surgical Kit are use intra-operatively to prepare the osteotomy for placement of BIOMET 3i implants pre operatively determined in the software. | | Indications for Use: | SimPlant Navigator Personalized Dental Care System is intended for use as a softwar interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance scanner. It is als intended as pre-planning software for dental implant placement and surgical treatment. SurgiGuide® guides and the BIOMET 3i Navigator Surgical Kit, which are used intra operatively to prepare the osteotomy for placement of BIOMET 3i implants pre operatively determined in the software. | | Technological Characteristics: | The predicate devices, SimPlant® 2011 and Nobel Biocare Guided Surgery Conce have a number of very similar and equivalent design /technological characteristics: which are very similar and equivalent with the SimPlant Navigator Personalized Dent Care System (see Substantial Equivalence comparison table in Section 14). | | Performance Data: | Software Validation in addition to bench top performance testing was conducted t ensure the compatibility of all system components. | | Clinical Data: | N/A | {2}------------------------------------------------ | Performance Standards: | a. DICOM NEMA PS3.1-3.18: Digital imaging and communication in medicine: 2009 b. ISO14971: Applications of risk management to medical devices: 2007 c. ISO13485: Medical Devices Quality Management System: 2003 d. ISO9001: Quality Management System: 2008 e. ISO10993: Biological evaluations of medical devices: 1992 | | Intended Use | | | | | | | | | | | | | | | | | | | |-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|---------------------------------------------------------|--|--| | Substantial Equivalence: | Materialise Dental NV's SimPlant Navigator Personalized Dental Care System included in this submission have the same intended use, fundamental scientific technology, similar indications, and principles of operation as the previously cleare SimPlant® 2011; (K110300). Refer to the following substantial equivalence data table: | | The SimPlant Navigator Navigator Personalized Dental Care System is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance scanner. It is also intended as pre-planning software for dental implant placement and surgical treatment. The SimPlant Navigator Personalized Dental Care System can be used with the following Biomet 3i instrument kits and their respective components: implant mounts, cortical perforator, tissue punches, drill positioning handles, twist drills, countersink drills, shaping drills, bone taps, bone profilers, drivers, and ratchets. | Materialise Dental's SimPlant® 2011 software is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance scanner. It is also intended as pre-planning software for dental implant placement and surgical treatment. | The Guided Surgery Concept and Teeth-in- an-Hour are indicated for the treatment of single, partially and totally edentulous jaws for placement of implant fixtures with immediate function to restore patient esthetics and chewing function. The following prerequisites must be fulfilled: - Adequate amount of jaw bone - The quality of jaw bone must be judged as adequate | | | | | | | | | | | | | | | | | | | Device for premarket notification K110300 K050393 Trade name SimPlant® Navigator Personalized Dental Care System SimPlant® 2011 Nobel Biocare The Guided Surgery Concept Common name SimPlant® Software Classification Product Code: LLZ 21 CFR. § 892.2050 Classification Panel: Radiology Device Class: II Product code: LLZ 21 CFR. § 892.2050 Classification Panel: Radiology Device Class: II Product code: DZE 21 CFR. § 872.3640 Classification Panel: Dental Device Class: II | | | | | | | | | | | | | | | | | | SurgiGuide® guides are intended for single use only. | | | | | | | | | | | | | | | | | | | | | | | | | | | | Software – magnetic media | Software – Magnetic media | Software – Magnetic media | | | | | | | | | | | | | | | | | | | | Material | Hardware – polyamide guides – biocompatible material stainless steel tubes/sleeves medical grade | | Hardware Polyamide guides biocompatible material | | | | | | | | | | | | | | | | | | | ﻟﻢ {3}------------------------------------------------ Special 510(k) Premarket Notification -The SimPlant® Navigator Personalized Dental Care System K112679 Page র্য . {4}------------------------------------------------ K\267-9. Page 5 of 7 Special S10(k) Premarket Notification – Page 5 – F Special S10(k) Premarket Notification – The SimPlant® Navigator Personalized Dental Care System | | | Software for use in pre- operative planning. | Software for use in pre- operative planning. | Software for use in pre- operative planning. | |-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Design | The SimPlant Navigator Personalized Dental Care System includes SimPlant® software, which provides a means for the clinician for image segmentation and advanced pre-operative planning. This enables the clinician to view three- dimensional CT-scan data as well as to plan the case in a virtual three-dimensional environment. | SimPlant® software provides a means for image segmentation and advanced pre-operative planning. Surgical templates may be fabricated based on the output of the pre-operative planning. | The Guided Surgery Concept includes a 3D- Planning Software that enables the clinician to view three-dimensional CT-scan data as well as to plan the case in a virtual three- dimensional environment. | | | | The case planning can be used to produce a Surgical Template, thus transferring the virtual case planning into physical tools enabling the surgical installation according to the virtual case planning. | | This case planning can be used to produce a Surgical Template, thus transferring the virtual case planning into physical tools enabling the surgical installation according to the virtual case planning. | | | | The SimPlant Navigator Personalized Dental Care System is based upon knowledge of the location and orientation of the implant(s) prior to the surgery. This knowledge enables the production of a SurgiGuide. | | The Guided Surgery Concept is based upon knowledge of the location and orientation of the implant(s) prior to the surgery. This knowledge enables the production of a Surgical Template. | | | | Aided by the SurgiGuide, the sites can be prepared and the implants placed in the predetermined locations enabling the immediate attachment of the prefabricated temporary or final prosthesis. | | Aided by the Surgical Template, the sites can be prepared and the implants placed in the predetermined locations enabling the immediate attachment of the prefabricated temporary or final prosthesis. | | | | | | | | | The SimPlant® software component is used to incorporate the images from either an MRI or CT scan of the affected joint into the specialized planning software. | SimPlant® software is used to incorporate the images from either an MRI or CT scan of the affected joint into the specialized planning software. | | | | | The SimPlant® software is used by a qualified surgeon to plan, inspect, fine-tune and approve the pre-surgical plan. The software is used pre-operatively. | The SimPlant® software is used by a qualified surgeon to plan, inspect, fine-tune and approve the pre-surgical plan. The software is used pre- operatively. | | | | Function | SimPlant® software contains a library of dental implants, and additional instruments for the placement of implants. | SimPlant® software contains a library of dental implants, and additional instruments for the placement of implants. | | | | | A SurgiGuide® guide may be designed and fabricated based on the output of the pre-operative planning. | A SurgiGuide® guide may be designed and fabricated based on the output of the pre-operative planning. | | | | | SurgiGuide® guides are patient specific templates that are intended to transfer the pre-operatively determined positioning of the dental implants to the patient intra-operatively, assisting the surgeon in placing dental implants by guiding and marking drill locations. | | | | | Programming language | C++ | C++ | | | | Operating system | Windows | Windows | | | | | | | | | {5}------------------------------------------------ Special 510(k) Premarket Notification --The SimPlant® Navigator Personalized Dental Care System Page X112679 87 {6}------------------------------------------------ | Testing | Hardware testing: • Biocompatibility testing of patient contacting components • Sterilization testing • Sterilization dimensional stability test | | |-------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Software testing: • Unit testing • Integration testing • IR testing • Smoke testing • Formal testing • Acceptance testing • Alpha testing • Beta testing | Software testing: • Unit testing • Integration testing • IR testing • Smoke testing • Formal testing • Acceptance testing • Alpha testing • Beta testing | | Conclusion: | SimPlant Navigator Personalized Dental Care System and its predicate device: SimPlant® 2011 (K110300) and the Nobel Biocare Guided Surgery Concep (K050393), have the same intended use, indications for use, similar technologica characteristics, and principles of operation. SurgiGuide® guides and the BIOMET 3i Navigator® Surgical Kit, which are used intra operatively to prepare the osteotomy for placement of BIOMET 3i implants pre operatively determined in the software. By modifying the SimPlant® 2011 to include the SurgiGuide® and Navigation Surgica Kit does not raise any new questions of safety or effectiveness. | | | | The differences noted above do not present new issues of safety or effectiveness for th SimPlant® Navigator Personalized Dental Care System. | | K112679 , 7 of 7 {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 Mr. Carl Van Lierde QA/RA Manager Materialise Dental NV Technologielaan 15 3001 LEUVEN BELGIUM FEB 2 2 2012 Re: K112679 Trade/Device Name: SimPlant® Personalized Dental Care System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, NOF, NDP, and DZA Dated: January 10, 2012 Received: February 16, 2012 ### Dear Mr. Van Lierde: 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. The r ou may, merelove, manel of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into class II (Special Controls), it may be subject to such 11 your device is elassified to regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 r reads of ac now has a determination that your device complies with other requirements of the Act that I Dr has intact a and regulations administered by other Federal agencies. You must or uny 1 eather the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of {8}------------------------------------------------ medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical do rece forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirences as set form in the quarty, adevice as described in your Section 510(k) premarket win anow you to begin marial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 11 You don't openite and the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely Yours, Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ Special 510(k) Premarket Notification --The SimPlant® Navigator Personalized Dental Care System # Indications for Use 510(k) Number (if known): K // Ze 79 Device Name: SimPlant® Personalized Dental Care System Indications for Use: SimPlant Navigator Personalized Dental Care System is intended for use as a software Simirralit Navigator Tersonation system for the transfer of imaging information from a medical meriate and mage segmentation by Magnetic Resonance scanner. It is also intended as prebearing software for dental implant placement and surgical treatment. SurgiGuide® guides and the BIOMET 3i Navigator Surgical Kit, which are used intra-Surgioure guides and the Droming of BIOMET 31 implants pre-operatively determined in the software. Prescription Use Over-The-Counter Use (Part 21 CFR 801 Subpart D) AND/OR (Part 21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety | 510K. | K112679 | |-------|---------| |-------|---------|