PRE-SURE

{0}------------------------------------------------ July 8, 2021 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Lazarus, 3D, Inc. % Elisa Maldonado-Holmertz RA/QA Consultant Obelix Consulting 12416 Fairfax Ridge Place AUSTIN TX 78738 Re: K201835 Trade/Device Name: PRE-SURE Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: May 29, 2021 Received: June 2, 2021 Dear Elisa Maldonado-Holmertz: 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K201835 Device Name PRE-SURE Indications for Use (Describe) The PRE-SURE software system is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. It is also intended as pre-operative software for surgical planning. For this purpose, the output file may be used to produce a physical replical replica is intended for adjunctive use along with other diagnostic tools and expert clinical judgement for diagnosis, patient management, and/or treatment selection of genitourinary applications. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------|------------------------------------------------------------------------------| | <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Lazarus 3D. The logo consists of a blue and orange diamond shape on the left, followed by the words "Lazarus 3D" in black font. Below the company name is the phrase "Operate with confidence" in a smaller, black font. # Section 005 - 510(k) Summary # 1. INTRODUCTION This document contains the 510(k) summary for the PRE-SURE device. The content of this summary is based on the requirements of 21 CFR 807.92. ## 2. SUBMISSION SPONSOR | Name: | Lazarus 3D, Inc. | |-----------------------------------|-----------------------------------------------| | Address: | 3513 NW Mink Pl<br>Corvallis, OR 97330 | | Phone: | (541) 760 1805 | | Contact Name: | Dr. Smriti Zaneveld | | Contact Email: | Smriti@laz3D.com | | Additional Contact: | Dr. Jacques Zaneveld | | Additional Email: | Zaneveld@laz3D.com | | Submission Correspondent<br>Name: | Obelix Consulting, LLC | | Address: | 12416 Fairfax Ridge Place<br>Austin, TX 78738 | | Phone: | (512) 431 6069 | | Contact Name: | Elisa Maldonado-Holmertz | | Contact Email: | elisamh@obelixconsult.com | Date Prepared: 7 July 2021 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Lazarus 3D. The logo consists of a blue and orange diamond shape on the left, followed by the text "LAZARUS 3D" in black. Below the company name is the text "Operate with confidence" in a smaller font size. ## Device Identification Type of 510(k) Submission: Traditional Trade Name: PRE-SURE Common Name: System, Image Processing, Radiological Regulation Description: Medical Image Management and Processing System Regulation Number: 21 CFR 892.2050 Product Code: LLZ Class of Device: II Review Panel: Radiology Reason for Submission: New device Prior Related Submissions: None Multiple Devices: None ## 3. LEGALLY MARKETED PREDICATE DEVICE The PREoperateive SUrgical REhearsal (PRE-SURE) device is claimed to be substantially equivalent to the following legally marketed device: - . D2P, 3D Systems, Inc. (K183489). No reference devices were used in this submission. ## 4. DEVICE DESCRIPTION End Users of the PRE-SURE device receive digital and/or physical patient anatomical models from Lazarus 3D. The physical models are intended for adjunctive use along with other diagnostic tools and expert clinical judgement for diagnosis, patient management, and/or treatment selection of genitourinary applications. Digital models may be viewed by End Users using any program cleared for their intended use. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image is a logo for Lazarus 3D. The logo consists of a blue and orange diamond shape on the left, followed by the text "LAZARUS 3D" in black. Below the text is the phrase "Operate with confidence" in a smaller font, also in black. The PRE-SURE patient modeling system is a method for the creation of patient models. This system will be used exclusively by Lazarus 3D, with some physician input and feedback, to produce models for End Users. Importantly, and unlike other 3D modeling systems, in the PRE-SURE process the design and production of patient models is performed by Lazarus 3D and not by the End User or a third party. The internal process within Lazarus 3D used for creating PRE-SURE patient models includes use of an FDA cleared stand-alone software package. As a part of the PRE-SURE production process, this software is intended for internal use within Lazarus 3D to create digital anatomical models from patient radiological data that can be used by End Users for a variety of uses such as training, education, and pre-operative surgical planning. The patient specific digital anatomical models may be further used as an input to a 3D printing-based production process performed by Lazarus 3D to create physical patient models. Each individual patient's model can be created rapidly from the patient's radiological data using Lazarus 3D's patented rapid prototyping technology. The resulting physical models of patient anatomy are primarily composed of silicone materials that can be cut, can be sutured, and in some cases can even bleed. ## 5. INDICATIONS FOR USE The PRE-SURE software system is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. It is also intended as pre-operative software for surgical planning. For this purpose, the output file may be used to produce a physical replica. The physical replica is intended for adjunctive use along with other diagnostic tools and expert clinical judgement for diagnosis, patient management, and/or treatment selection of genitourinary applications. ## 6. SUBSTANTIAL EQUIVALENCE DISCUSSION PRE-SURE employs similar fundamental technologies as the identified predicate device, including: - . Viewing of medical imaging data in the axial, coronal, and sagittal views - Ability to process, review and analyze medical imaging data - lmage transfer and manipulation via software used for the creation of a 3D object. - Use of the 3D object for diagnosis, patient management and/or treatment selection. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for Lazarus 3D. The logo consists of a blue and orange diamond shape on the left, followed by the text "LAZARUS 3D" in a bold, sans-serif font. Below the company name is the tagline "Operate with confidence" in a smaller, regular font. However, in the PRE-SURE process the analysis of patient data and production of patient models is performed by Lazarus 3D and is provided as a service to End Users. By contrast, the predicate device is sold as a software and hardware package that allows End Users or third parties to produce their own patient models. Additionally, while the predicate patient models are produced in relatively hard materials (e.g., plastics), PRE-SURE physical models can be created in soft silicone materials that can be cut, sutured, and in some cases even bleed. Both devices can be used to create a physical rendering of radiological data for visualization and analysis. However, the additional capabilities of PRE-SURE models may provide new opportunities for pre-surgical planning and rehearsal. #### Comparison to Legally Marketed Device: | Manufacturer | Subject Device | Predicate Device | Significant Differences | |---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Lazarus 3d, Inc. | 3D Systems, Inc. | | | Trade Name | PRE-SURE | D2P | None | | 510(k) Number | K201835 | K183489 | | | Product Code | LLZ | LLZ | None | | Regulation Number | 892.2050 | 892.2050 | None | | Regulation Name | Medical Image Management<br>and Processing System | Medical Image Management<br>and Processing System | None | | Common Name | System, Image Processing,<br>Radiological | System, Image Processing,<br>Radiological | None | | Indications for Use | The PRE-SURE software is<br>intended for use as a<br>software interface and image<br>segmentation system for the<br>transfer of DICOM imaging<br>information from a medical<br>scanner to an output file. It is<br>also intended as pre-<br>operative software for<br>surgical planning. For this<br>purpose, the output file may<br>be used to produce a<br>physical replica. The physical<br>replica is intended for<br>adjunctive use along with | The D2P software is intended<br>for use as a software<br>interface and image<br>segmentation system for the<br>transfer of DICOM imaging<br>information from a medical<br>scanner to an output file. It is<br>also intended as pre-<br>operative software for<br>surgical planning. For this<br>purpose, the output file may<br>be used to produce a<br>physical replica. The physical<br>replica is intended for<br>adjunctive use along with | Nearly identical, except the<br>subject device is only<br>intended for use in<br>genitourinary applications,<br>while the predicate device is<br>intended for use in<br>cardiovascular, craniofacial,<br>gastrointestinal,<br>genitourinary, neurological,<br>and/or musculoskeletal<br>applications. | #### Table 12A – Device Comparison Chart: Similarities and Differences {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Lazarus 3D. The logo consists of a blue and orange diamond shape on the left, followed by the text "LAZARUS 3D" in black. Below the company name is the tagline "Operate with confidence" also in black. | Manufacturer | Subject Device<br>Lazarus 3d, Inc. | Predicate Device<br>3D Systems, Inc. | Significant Differences | |--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | Trade Name | PRE-SURE | D2P | None | | | other diagnostic tools and<br>expert clinical judgement for<br>diagnosis, patient<br>management, and/or<br>treatment selection of<br>genitourinary applications. | other diagnostic tools and<br>expert clinical judgement for<br>diagnosis, patient<br>management, and/or<br>treatment selection of<br>cardiovascular, craniofacial,<br>gastrointestinal,<br>genitourinary, neurological,<br>and/or musculoskeletal<br>applications. | | | Material | Non-hazardous silicones,<br>resins, and food products | Plastics | All components of PRE-SURE<br>models are certified non-<br>hazardous by OSHA 29 CFR<br>1910.1200. | | Sterile | No | No | None | # 7. NON-CLINICAL PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination: ## Production Process Accuracy Study The purpose of this accuracy study was to evaluate the accuracy of PRE-SURE patient model production processes. Models of various dimensions were created using PRE-SURE from computer models with dimensions pre-defined in silico. Comparisons were made between the physical models created using PRE-SURE and the in-silico input data, revealing that measurements fell within pre-defined acceptance criteria. # Digital and Physical Model Accuracy Study The purpose of this accuracy study was to compare results from the entire PRE-SURE workflow to those of the predicate device. MRI and CT scan input data from actual cases were analyzed using the predicate and subject devices to create 3D computer models and {8}------------------------------------------------ Image /page/8/Picture/0 description: The image is a logo for Lazarus 3D. The logo consists of a blue and orange diamond shape on the left, followed by the words "LAZARUS 3D" in black, bold font. Below the company name is the tagline "Operate with confidence" in a smaller, regular font. physical models of the patient anatomy. These models were then compared, revealing that measurements fell within pre-defined acceptance criteria. # Build Envelope Testing - Accuracy Validation The purpose of this study is to define where on the 3D printer, and in what orientation, models can be produced in sufficient accuracy for the intended use. Models of genitourinary conditions were built using 3D prints from different locations the 3D printer build plate, and in different orientations. Results show that sufficient accuracy can be achieved for models built in any orientation or position. ## Materials Testing - Accuracy Validation The purpose of this study is to test the accuracy and bonding of the range of materials included in the build envelope for PRE-SURE physical patient models. Multi-material genitourinary models were produced using combinations of the most difficult to use materials within the PRE-SURE build envelope. Testing shows that all materials and material combinations produce models of sufficient accuracy for the intended use. Additionally, all tested materials bond well with all other tested materials and thus can be used together to form multi-material patient models. # Testing on Especially Challenging Genitourinary Cases The purpose of this study is to test was to test the accuracy of the subject production process when creating complex genitourinary models. Models of three conditions that are difficult to produce for a variety of reasons were manufactured. These physical models were analyzed using a CT scanner and volumetrically compared against the digital design. Results indicate that the subject 3D manufacturing process can reproduce complex genitourinary conditions with sufficient accuracy for the intended use. ## Summary All performance testing which was conducted as a result of risk analyses and design impact assessments showed conformity to pre-established specifications and acceptance criteria. The acceptance criteria were established in order to demonstrate the device performance and substantial equivalence to the predicate device. ## 8. STATEMENT OF SUBSTANTIAL EQUIVALENCE Based on a comparison of the intended use and technological characteristics, the PRE-SURE device is substantially equivalent to the identified predicate device. Minor {9}------------------------------------------------ Image /page/9/Picture/0 description: The image is a logo for Lazarus 3D. The logo consists of a blue and orange diamond shape on the left, followed by the words "Lazarus 3D" in black, bold font. Below the company name is the tagline "Operate with confidence" in a smaller, regular font. differences in technological characteristics did not raise new or different questions of safety and effectiveness. Additionally, the validation data supports that the system performs in accordance with its intended use and is substantially equivalent to the predicate device.