3D Anatomic Models

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION". Ricoh USA, Inc. % Mr. Scott Brewer Sr. Manager, Regulatory Compliance, Additive Manufacturing 5575 Venture Drive Unit A PARMA OH 44130 ### Re: K220205 June 3, 2022 Trade/Device Name: Ricoh 3D Anatomic Models Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: May 2, 2022 Received: May 3, 2022 Dear Mr. Brewer: 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR {1}------------------------------------------------ 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 Thalia T. Mills, Ph.D. Director DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K220205 Device Name Ricoh 3D Anatomical Models ### Indications for Use (Describe) Ricoh 3D Anatomic Models are intended as physical replicas of patient anatomy to be used for diagnostic purposes in the fields of craniomaxillofacial and orthopedic applications. The Anatomic Models are based on DICOM imaging information from a medical scanner and output files from FDA cleared software intended for the creation and output of digital files suitable for the fabrication of physical replicas. The models should be used in conjunction with other diagnostic tools and expert clinical judgement. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ### 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." {3}------------------------------------------------ # 510(k) SUMMARY This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92: #### -SUBMITTER Ricoh USA, Inc. 5575 Venture Drive Unit A Parma, Ohio | USA | 44130 Tel: +1.954.648.5680 Email: Gary.Turner@RicohUSA.com | Contact Person: | Scott Brewer | |-----------------|--------------| | Date Prepared: | May 31, 2022 | #### DEVICE . Name of Device: Ricoh 3D Anatomic Models Classification Name: Radiological Image Processing System Regulation: 21 CFR §892.2050 Requlatory Class: Class II Product Classification Code: LLZ #### = PREDICATE & REFERENCE DEVICES | Predicate Manufacturer: | Materialise NV | |-------------------------|----------------| | Predicate Trade Name: | Mimics inPrint | | Predicate 510(k): | K173619 | #### DEVICE DESCRIPTION IV. The subject device, each "Ricoh 3D Anatomic Model," is a patient-specific physical replica of an anatomic structure or site, produced via additive manufacturing from a user generated 3D print file. The input 3D print file is created from medical images in DICOM format that have been seqmented to a specific reqion of interest within an FDA cleared application, IBM iConnect Access (K203104). The input 3D print file is then transferred to Ricoh for production and delivery of the physical replica. #### V. INDICATIONS FOR USE Ricoh 3D Anatomic Models are intended as physical replicas of patient anatomy to be used for diagnostic purposes in the fields of craniomaxillofacial and orthopedic applications. The Anatomic Models are based on DICOM imaging information from a medical scanner and output files from FDA cleared software intended for the creation and output of digital files suitable for the fabrication of physical replicas. The models should be used in conjunction with other diagnostic tools and expert clinical judgement. {4}------------------------------------------------ ## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVCE The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence: | | Anatomic Models | Mimics inPrint K173619 | Comments on SE | |-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | Anatomic Models, Ricoh<br>3D | Mimics inPrint, Materialise | - | | Common Name | Image processing system | Image processing system | Same | | Classification Name | System, Image<br>processing, Radiological | System, Image<br>processing, Radiological | Same | | Classification | LLZ | LLZ | Same | | Product Code | 892.2050 | 892.2050 | Same | | Indications for Use | Ricoh 3D Anatomic<br>Models are intended as<br>physical replicas of patient<br>anatomy to be used for<br>diagnostic purposes in the<br>fields of craniomaxillofacial<br>and orthopedic<br>applications. The<br>Anatomic Models are<br>based on DICOM imaging<br>information from a medical<br>scanner and output files<br>from FDA cleared software<br>intended for the creation<br>and output of digital files<br>suitable for the fabrication<br>of physical replicas. The<br>models should be used in<br>conjunction with other<br>diagnostic tools and expert<br>clinical judgement. | Mimics inPrint is intended<br>for use as a software<br>interface and image<br>segmentation system for<br>the transfer of DICOM<br>imaging information from a<br>medical scanner to an<br>output file. It is also used as<br>pre-operative software for<br>treatment planning. For this<br>purpose, the Mimics inPrint<br>output file can be used for<br>the fabrication of physical<br>replicas of the output file<br>using traditional or additive<br>manufacturing methods.<br>The physical replica can be<br>used for diagnostic<br>purposes in the field of<br>orthopedic, maxillofacial<br>and cardiovascular<br>applications. Mimics inPrint<br>should be used in<br>conjunction with other<br>diagnostic tools and expert<br>clinical judgement. | The indications for<br>use of the subject<br>device are a subset<br>of the predicate<br>device.<br>The subject device<br>does not provide<br>diagnostic image<br>segmentation or the<br>transfer of medical<br>imaging information<br>to an output file.<br>Instead, the device<br>utilizes output files<br>from a cleared Class<br>II medical device.<br>The subject device<br>includes a subset of<br>anatomical regions,<br>including only<br>craniomaxillofacial<br>and orthopedic<br>applications. | | Design (key<br>components/features) | The Ricoh 3D Anatomical<br>Models are produced from<br>a 3D print file. The 3D print<br>file is imported from a<br>Class II medical device,<br>IBM iConnect Access,<br>which allows for advanced<br>image segmentation and<br>editing tools for the<br>purpose of creating digital<br>3D anatomical models.<br>Once the 3D print file is<br>imported, the surgical<br>team, radiological team | Mimics inPrint is image<br>processing software that<br>allows the user to import,<br>visualize and segment<br>medical images, check and<br>correct the segmentations,<br>and create digital 3D<br>models. The models can be<br>used in Mimics inPrint for<br>measuring, treatment<br>planning and producing an<br>output file to be used for<br>additive manufacturing (3D<br>printing). Mimics inPrint is | The subject device<br>design is a subset of<br>the predicate device.<br>The subject device<br>utilizes an imported<br>3D print file for<br>design and<br>fabrication of the<br>physical replica. | | | Anatomic Models | Mimics inPrint K173619 | Comments on SE | | | (segmentation team) and<br>Ricoh production team<br>can:<br>• Communicate about<br>project needs/scope,<br>establish/track project<br>timelines,<br>• Approve final STL file for<br>fabrication<br>Under the direction of the<br>clinical user, the Ricoh<br>Biomedical Engineering<br>team will generate a<br>printable anatomic model.<br>Once final approval of the<br>model is achieved from the<br>clinical user, the<br>anatomical model will be<br>printed, post-processed,<br>and undergo a quality<br>validation process. After<br>inspection and approval,<br>the anatomical model is<br>labeled and distributed to<br>the customer. | structured as a modular<br>package. This includes the<br>following functionality:<br>• Importing medical<br>images in DICOM format<br>and other formats (such<br>as BMP, TIFF, JPG and<br>raw images)<br>• Viewing images and<br>DICOM data<br>• Selecting a region of<br>interest using generic<br>segmentation tools<br>• Segmenting specific<br>anatomy using dedicated<br>semi-automatic tools or<br>fully automatic<br>algorithms<br>• Verifying and editing a<br>region of interest<br>• Calculating a digital 3D<br>model and editing the<br>model<br>• Planning treatments<br>(surgical cuts etc.) on the<br>3D models<br>The output digital 3D model<br>is suitable for production of<br>a physical model using<br>compatible 3D printers and<br>materials. | | | Performance Testing | • Geometric accuracy of<br>the physical replicas | • Software measurement<br>accuracy and calculate<br>3D study<br>• Geometric Accuracy of<br>physical replicas. | The subject device<br>includes a subset of<br>the testing of the<br>predicate device, and<br>only includes<br>geometric accuracy<br>testing of physical<br>replicas. | {5}------------------------------------------------ ## VII. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. ## Validation Testing Validation testing included assessment of the workflow from input digital 3D file to output physical replica. Similar to the predicate device, the geometric accuracy of printed orthopedic and craniomaxillofacial physical models was assessed via bench testing. Testing showed that the physical models can be printed accurately at less than 1mm mean deviation when compared against the input digital 3D file, and all clinically relevant acceptance criteria was met. {6}------------------------------------------------ ### Shipping Validation Simulated distribution and handling testing was performed to assess the packaging for Ricoh 3D Anatomic Models. Testing showed that the packaging adequately protects the product from damage throughout the distribution process. ## VIII. CONCLUSIONS A comparison of intended use and technological characteristics combined with performance data demonstrates that Ricoh 3D Anatomical Model is substantially equivalent to the predicate device.