decimal3D

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and 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 square, followed by the words "U.S. Food & Drug Administration" in blue text. December 13, 2019 .decimal, LLC % Kevin Erhart, Ph.D. President/Chief Technology Officer 121 Central Park Place SANFORD FL 32771 Re: K192554 Trade/Device Name: decimal3D Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ Dated: October 14, 2019 Received: October 15, 2019 Dear Dr. Erhart: 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, 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) K192554 Device Name decimal3D #### Indications for Use (Describe) The primary purpose and intended use of this device is to improve the efficiency of designing patient specific radiation therapy beam-shaping block devices through the use of optical scanning technology. This device will serve as a direct replacement to the current processes for designing such radiotherapy devices in cases where a "clinical patient set up" is used (i.e. cases where the treatment field is determined by direct physician examination, not by internal imaging technology). This product is not intended to replace CT imaging or other internal imaging modalities and should be used only in cases where a qualified radiation oncologist has made appropriate determination of the acceptability of a "clinical patient set up" approach, independent of any information provided by this application. In other words, the role of this product is to simply ensure efficient and accurate ordering of a patient-specific beam-shaping block device from our company, in cases where a licensed radiation oncologist has predetermined that such a device and treatment approach is appropriate for the patient at hand. Thus this device's indications for use include patients with a variety of cancer and disease conditions, which will be treated under the direct supervision and guidance of a radiation oncologist that has prescribed a desired dose of radiation to be delivered to the patient. Type of Use (Select one or both, as applicable) | <div><span style="font-family: Arial;"> </span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | |------------------------------------------------------------------------------------------------------------------------------------------------------| | <div><span style="font-family: Arial;"> </span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C)</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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for ".decimal" in blue and gray. Below the logo is the text "The benchmark for custom radiation therapy" in a smaller font. The logo is simple and modern, and the text is clear and concise. Section 5 510(k) Summary Section 807.87 (h) A 510(k) Summary as described in Section 807.92 # Premarket Notification [510(k)] Summary as required by 21 CFR 807.92 # Date summary was prepared: November 21, 2019 ## Submitter's Name: .decimal, LLC. 121 Central Park PL Sanford, Florida 32771 ## Contact Person: Kevin Erhart, PhD President/Chief Technology Officer Phone: 407-330-3300 Fax: 407-322-7546 Email:kerhart@dotdecimal.com #### Device Name: decimal3D (K192554) # Classification Name: MUJ 21 CFR 892.5050 Medical charged-particle radiation therapy systems Class II {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Decimal. The logo is in blue and gray, with the word "decimal" in a sans-serif font. Below the logo is the tagline "The benchmark for custom radiation therapy" in a smaller font. The logo is simple and modern, and the tagline is clear and concise. # Device Description: This device is a software product with the primary purpose to improve the efficiency of designing patient specific radiotherapy treatment devices. It uses proven off-the-shelf optical scanning technology to replace portions of the current clinical treatment device design workflow to achieve this goal. Specifically, this device uses an off-the-shelf depth sensing scanner to accurately capture and construct a full color, 3D model of a patient's treatment area. This scanner captures dimensionally accurate depth information in realtime using a combination of a structured light field infrared projector and infrared camera, and is coupled with a color camera to provide precise, full color, 3D models of patients without exposing them to any harmful radiation. Our decimal3D software is an iPad application that guides users through the process of capturing a scan of a patient. It then provides tools that allow users to digitize the treatment area, which is pre-drawn on the patient's skin by the radiation oncologist, on the 3D model. Users also specify other device parameters, such as their treatment machine type, applicator size, and treatment direction, which allows the decimal3D software to complete the design of their treatment device. Finally, our software allows them to view and order the device for fabrication by our company. This process is directly analogous to the current digitization process in the existing clinical workflow except the predicate software device requires the user to use a clear plastic template placed in the head of the actual treatment delivery machine to project the device shape to the patient's skin surface using a light field. This acrylic template is then scanned using a flatbed document scanner and the shape is digitized in 2D using the predicate software. #### Predicate Device(s): .decimal p.d K151369 #### Intended Use: The primary purpose and intended use of this device is to improve the efficiency of designing patient specific radiotherapy devices. This device will serve as a direct replacement to the current processes for designing such patient-specific radiotherapy devices. One such common current process is for electron therapy clinical setups, which involves hand drawing of the patient-specific aperture shape onto a semi-transparent "template" block, using the treatment light field to verify accuracy against the treatment area that has been outlined directly on a patient by the treating physician. This now flattened and projected aperture shape can then be scanned and digitized allowing for computer controlled fabrication. This decimal3D device will replace this process by providing a means to accurately scan and digitize the treatment area. This device also provides a means for designing and ordering the required devices. #### Indications for Use: The primary purpose and intended use of this device is to improve the efficiency of designing patient specific radiation therapy beam-shaping block devices through the use of optical scanning technology. This device will serve as a direct replacement to the current processes for designing such radiotherapy devices in cases where a "clinical patient set up" is used (i.e. cases where the treatment field is determined by direct physician examination, not by internal imaging technology). {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for "decimal". The logo is in two colors, with the ".d" in blue and the rest of the word in gray. Below the logo is the tagline "The benchmark for custom radiation therapy". This product is not intended to replace CT imaging or other internal imaging modalities and should be used only in cases where a qualified radiation oncologist has made appropriate determination of the acceptability of a "clinical patient set up" approach, independent of any information provided by this application. In other words, the role of this product is to simply ensure efficient and accurate ordering of a patient-specific beamshaping block device from our company, in cases where a licensed radiation oncologist has predetermined that such a device and treatment approach is appropriate for the patient at hand. Thus this device's indications for use include patients with a variety of cancer and disease conditions, which will be treated under the direct supervision and guidance of a radiation oncologist that has prescribed a desired dose of radiation to be delivered to the patient. ## Summary of Technological Characteristics: decimal3D technology is substantially equivalent to the listed predicate device p.d (K151369). decimal3D and p.d both provide tools to digitize physician outlined treatment fields into patient-specific devices to be used in radiotherapy treatment delivery. Both p.d and decimal3D include displays for visualizing the physician drawn shape and tools for digitizing this image into a two dimensional contour. Unlike p.d, decimal3D provides a mechanism to directly capture the physician drawn treatment area rather than importing this image from a separate system. However, this does not detract from the point that the features included in both software for creating the patient device are substantially equivalent in terms of technology, intended uses, and end user profiles. ## Summary of Non-Clinical Testing: Clinical testing was not performed as part of the development of this product. Clinical testing is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk. Clinically oriented validation test cases were written and executed by .decimal personnel and hospital-based testing partners where this device was deemed safe and effective for clinical use. The tests show that this device performed as well as the predicate device and demonstrated that the quality of the resulting surface scans is sufficient to provide the accuracy needed to design patient specific beam shaping devices.