Who is the manufacturer of SICAT Implant V2.0?

Sicat GmbH & Co. KG filed the 510(k) submission for SICAT Implant V2.0 (K192348).

What is the FDA product code for SICAT Implant V2.0?

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

What is the regulatory pathway for SICAT Implant V2.0?

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

Who can help prepare an FDA 510(k) submission like SICAT Implant V2.0?

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.

SICAT Implant V2.0

K192348 · Sicat GmbH & Co. KG · LLZ · Dec 4, 2019 · Radiology

Device Facts

Record ID	K192348
Device Name	SICAT Implant V2.0
Applicant	Sicat GmbH & Co. KG
Product Code	LLZ · Radiology
Decision Date	Dec 4, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

SICAT Implant is a software application of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. SICAT Implant is intended for use as planning software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments. The dental professionals' planning data can be exported from SICAT Implanning data includes in particular the positions and types of implants and drill sleeves to be used in the surgical procedures. This data may be used as input to design and manufacture surgical guides for dental implants.

Device Story

SICAT Implant V2.0 is a software application for dental professionals (implantologists) to visualize oral-maxillofacial 3D volume data (CT/CBCT) and optical impressions. Users manipulate 3D volumes, name/position/rotate/resize dental implants, and define nerve canals. The software enables precise planning of implant positions, orientations, and types. Output includes planning data (implant/drill sleeve specifications) exported for surgical guide design and manufacture. Used in dental clinics; operated by dental professionals. The software aids clinical decision-making by providing a 3D environment for pre-surgical planning, potentially improving implant placement accuracy and patient outcomes.

Clinical Evidence

Bench testing only. Verification and validation activities included requirements reviews, design validation, risk management (ISO 14971:2007), and software testing (unit, integration, system, and usability) per IEC 62304 and IEC 62366 standards. No clinical data was required.

Technological Characteristics

Pure software device. Operates on Windows 7/8.1/10 64-bit platforms. Connectivity via DICOM import and proprietary SSI/SIXD container formats. Implements 3D volume rendering, orthogonal/panoramic slicing, and polygonal mesh manipulation. Software developed using C# and C++. Adheres to ISO 13485, IEC 62304, and IEC 62366.

Indications for Use

Indicated for qualified dental professionals to visualize oral-maxillofacial imaging data (CT/CBCT) and plan dental implant placement and surgical treatments, including defining positions and types of implants and drill sleeves for surgical guide manufacturing.

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

SICAT Implant V1.2 (K103723)

Related Devices

K090119 — SICAT IMPLANT · Sicat GmbH & Co. KG · Feb 5, 2009
K103723 — SICAT IMPLANT V1.2 · Sicat GmbH & Co. KG · May 20, 2011
K230012 — Atomica Planner · Atomica Technology, Inc. · Feb 2, 2023
K061472 — GALILEOS IMPLANT, V 1.0 · Sicat GmbH & Co. KG · Jun 9, 2006
K202256 — 3Shape Implant Studio · 3Shape Medical A/S · Sep 9, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/10 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo features a stylized caduceus symbol on the left, followed by a blue square. To the right of the blue square, the text "U.S. Food & Drug ADMINISTRATION" is displayed in a clear, sans-serif font. The text is arranged in three lines, with "U.S." and "Drug" on the top line, "Food" on the second line, and "ADMINISTRATION" on the third line. December 4, 2019 SICAT GmbH & Co. KG % Manfred Breuer Head of Quality Management and Regulatory Affairs Brunnenallee 6 53177 Bonn. NRW GERMANY Re: K192348 Trade/Device Name: SICAT Implant V2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: October 2, 2019 Received: October 7, 2019 Dear Manfred Breuer: 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ 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 Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K192348 Device Name SICAT Implant V2.0 #### Indications for Use (Describe) SICAT Implant is a software application of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. SICAT Implant is intended for use as planning software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments. The dental professionals' planning data can be exported from SICAT Implanning data includes in particular the positions and types of implants and drill sleeves to be used in the surgical procedures. This data may be used as input to design and manufacture surgical guides for dental implants. Type of Use (Select one or both, as applicable) × Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ # 510(k) Summary for Implant V2.0 #### Content and format as required by section 21 CFR 807.92 ( http://www.fda.gov/ MedicalDevices/ DeviceRegulationandGuidance/ HowtoMarket YourDevice/PremarketSubmissions/PremarketNotification510k/ucm142651.htm) #### 1. SUBMITTER/510(K) HOLDER SICAT GmbH & Co. KG Brunnenallee 6 53177 Bonn Germany | Establishment Registration Number: | 3006098230 | |---------------------------------------|-----------------------| | Telephone: | +49 (228) 854697-82 | | Facsimile: | +49 (228) 854697-99 | | Primary Contact: | Mr. Dr. Manfred Breue | | Secondary Contact: | Mr. Markus Gratzfeld | | Date Prepared: | December 4th, 2019 | #### 2. DEVICE NAME AND DEVICE CLASSIFICATION | Proprietary Name: | SICAT Implant V2.0 | |-------------------------|----------------------------------------------------------------------------------| | Common/Usual Name: | Radiological Visualization Software for Diagnosis and Dental Implant Planning | | Classification Name: | System, Image Processing, Radiological | | Regulation Description: | Picture archiving and communications system | | Product Code: | LLZ | | Classification Panel: | Radiology | | Regulation Number: | 21 CFR 892.2050 | | Device Class: | Class II | #### 3. PREDICATE DEVICE | Proprietary Name: | SICAT Implant V1.2 | |-------------------|---------------------| | Manufacturer: | SICAT GmbH & Co. KG | | 510(k) number: | K103723 | #### 4. DEVICE DESCRIPTION SICAT Implant V2.0 is a pure software device. {4}------------------------------------------------ SICAT Implant V2.0 is a software application for the visualization of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. SICAT Implant V2.0 is intended for use as planning software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments. SICAT Implant V2.0 allows to name, position, move, rotate, resize and visualize dental implants and other planning objects (i.e. nerves) within the visualized 3D volume. Thus, dental professionals like implantologists are enabled to precisely plan the positions, orientations, types and sizes of implants to be placed in the patient's mandible/maxilla together with the related surgical procedures. The dental professionals' planning data can be exported from SICAT Implant. This planning data includes in particular the positions, orientations and types of implants and drill sleeves to be used in the surgical procedures. This data may be used as input to design and manufacture surgical quides for dental implants. The modifications to SICAT Implant V1.2 (K103723) include the following: - Complete reengineering including significant software re-write - - -Added planning functionality - -Updated user interface #### 5. Indications for Use Indications for use of SICAT Implant V2.0 are: SICAT Implant is a software application for the visualization of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. SICAT Implant is intended for use as planning software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments. The dental professionals' planning data can be exported from SICAT Implant. This planning data includes in particular the positions, orientations and types of implants and drill sleeves to be used in the surgical procedures. This data may be used as input to design and manufacture surgical guides for dental implants. #### 6. Device Comparison Table The modified device SICAT Implant V2.0 has the same intended use and fundamental scientific technology. A comparison of the proposed device SICAT Implant V2.0 to the currently marketed predicate device SICAT Implant V1.2 including intended use. technological characteristics, design and function is provided in the following table. | | SICAT Implant V2.0 | SICAT Implant V1.2, SICAT (marketed in EU / USA cleared under 510(k) number K103723) | | |--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Common/Usual Name | | | | | | Radiological Visualization Software for Diagnosis and Dental Implant Planning | Radiological Visualization Software for Diagnosis and Dental Implant Planning | | | | SICAT Implant V2.0 | SICAT Implant V1.2, SICAT (marketed in EU / USA cleared under 510(k) number K103723) | | | | Device Description | | | | General Description | SICAT Implant V2.0 is a pure software device. SICAT Implant V2.0 is a software application for the visualization of imaging information of the oral- maxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. SICAT Implant V2.0 is intended for use as planning software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments. SICAT Implant V2.0 allows to name, position, move, rotate, resize and visualize dental implants and other planning objects (i.e. nerves) within the visualized 3D volume. Thus, dental professionals like implantologists are enabled to precisely plan the positions, orientations, types and sizes of implants to be placed in the patient's mandible/maxilla together with the related surgical procedures. The dental professionals' planning data can be exported from SICAT Implant. This planning data includes in particular the positions, orientations and types of implants and drill sleeves to be used in the surgical procedures. This data may be used as input to design and manufacture | SICAT Implant V1.2 is a pure software device. SICAT Implant V1.2 is a software application for the visualization of imaging information of the oral- maxillo-facial region. The imaging data originates from medical scanners such as CT or DVT scanners. SICAT Implant V1.2 is intended for use as planning and simulation software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments. SICAT Implant V1.2 allows to name, position, move, rotate, resize and visualize dental implants and other planning objects (i.e. nerve canals) within the visualized 3D volume. Thus, dental professionals like implantologists are enabled to precisely plan the positions, orientations, types and sizes of implants to be placed in the patient's mandible/maxilla together with the related surgical procedures. The dental professionals' planning data may be exported from SICAT Implant V1.2 and used as input data for CAD or Rapid Prototyping Systems. | | | | SICAT Implant V2.0 surgical guides for dental implants. | SICAT Implant V1.2, SICAT (marketed in EU / USA cleared under 510(k) number K103723) | | | Indications for Use/ Intended use | SICAT Implant is a software application for the visualization of imaging information of the oral- maxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. SICAT Implant is intended for use as planning software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments. The dental professionals' planning data can be exported from SICAT Implant. This planning data includes in particular the positions, orientations and types of implants and drill sleeves to be used in the surgical procedures. This data may be used as input to design and manufacture surgical guides for dental implants. | SICAT Implant is a software application for the visualization of imaging information of the oral- maxillofacial region. The imaging data originates from medical scanners such as CT or DVT scanners. SICAT Implant is intended for use as planning and simulation software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments. The dental professionals' planning data may be exported from SICAT Implant and used as input data for CAD or Rapid Prototyping Systems. | | | Contraindications | None | None | | | Medical data viewing | | | | | Data types visualized | 3D volume data, 3D surface data (optical impressions, restorations, implant objects) | 3D volume data, 3D surface data (optical impressions, implant objects) | | | Imaging data visualization region | Oral-maxillofacial region | Oral-maxillofacial region | | | Viewing modes | | | | | *Orthogonal slices | Axial, coronal, sagittal | Axial, coronal, sagittal | | | | SICAT Implant V2.0 | SICAT Implant V1.2, SICAT (marketed in EU / USA cleared under 510(k) number K103723) | | | *Panoramic view | Panoramic view (ray sum) based on a panoramic curve. Panoramic curve can be manually adjusted. | Panoramic view (ray sum) based on a panoramic curve. Panoramic curve can be manually adjusted. | | | *Panoramic slice | Movable small or not movable maximized "Panoramic Slicing Window" embedded in panoramic view | Movable "Panoramic Slicing Window" embedded in panoramic view | | | *TSA and LSA | Transversal slice (TSA) and longitudinal slice (LSA), both with respect to panoramic curve panoramic view | Transversal slice (TSA) and longitudinal slice (LSA), both with respect to panoramic curve | | | * 3D volume rendering | Yes | Yes | | | * 3D surface rendering of volume data | Yes | Yes | | | | Volume Data Navigation and Manipulation | | | | *View manipulating tools | Zoom, Pan, Change of orientation | Zoom, Pan, Change of orientation | | | *Color manipulating tools | Brightness, Contrast | Brightness, Contrast | | | *Scrolling through slices | Yes | Yes | | | Volume orientation | Yes | Yes | | | | Measurements | | | | *Length measurement | Yes | Yes…