3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Adaptiiv Medical Technologies Inc. % Anastasiia Mereshchuk Regulatory Affairs Manager 1344 Summer Street, Suite 406 Halifax, NS B3H 0A8 Canada # Re: K213438 Trade/Device Name: 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: MUJ Dated: October 19, 2021 Received: October 22, 2021 ## Dear Anastasiia Mereshchuk: 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 Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. Submission Number (if known) ## K213438 Device Name 3D Bolus Software Application; 3D Brachy Software Application; Patient-Matched 3D Printed Radiation Therapy Accessory Indications for Use (Describe) 3D Bolus and 3D Brachy applications are indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during external beam (photon or electron) radiation therapy, and surface brachytherapy. Users may choose to send the Stereolithography (STL) files to Adaptiiv Medical Technologies Inc. to 3D print the external beam radiation therapy accessories to the specification of the prescribing radiation therapy professional or 3D print either external beam or surface brachytherapy accessories in-house. If 3D printing is performed by Adaptiiv Medical Technologies Inc., 3D printed accessories will be sent to the requesting care center for the final quality control and acceptance by the trained radiation therapy personnel. The use of 3D Bolus and 3D Brachy applications as well as the 3D printed radiation therapy accessories is by prescription only. 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." {3}------------------------------------------------ K213438 Image /page/3/Picture/1 description: The image shows the logo for Adaptiiv. The logo consists of a blue abstract shape resembling a stylized letter 'A' or a series of waves, followed by the word "ADAPTIIV" in bold, black sans-serif font. The logo is clean and modern, suggesting innovation and adaptability. | Manufacturer | Adaptiiv Medical Technologies Inc. (Adaptiiv)<br>1344 Summer Street, Suite 406<br>Halifax, NS, B3H 0A8<br>Canada | |-----------------------------|------------------------------------------------------------------------------------------------------------------------------------| | Primary Contact | Anastasiia Mereshchuk<br>Regulatory Affairs Manager<br>1344 Summer Street, Suite 406<br>Halifax, NS, B3H 0A8<br>Canada | | Date Summary Prepared | January 19, 2022 | | Trade Name | 1. 3D Bolus Software Application<br>2. 3D Brachy Software Application<br>3. Patient-Matched 3D Printed Radiation Therapy Accessory | | Product Code | MUJ | | Device | System, Planning, Radiation Therapy Treatment | | Regulation Description | Medical charged-particle radiation therapy system | | Regulation number | 892.5050 | | Device Class | Class II | | Predicate Device | 3D Bolus Software, Adaptiiv Medical Technologies Inc., K18028- | | Establishment registration: | 3014873236 | #### Device Description Adaptiv Medical Technologies Inc. solution is software as a medical device that consist of two (2) separate desktop applications: - 3D Bolus Software Application, which includes the Simple Bolus and Modulated Electron Bolus modules; a. - 3D Brachy Software Application, which includes the Surface Brachytherapy module. b. The 3D Bolus and 3D Brachy software applications enable trained radiation therapy personnel to use DICOM and DICOM RT files from the radiation therapy treatment planning system (TPS) as inputs to produce Stereolithography (STL) files are compatible with the third-party 3D printing of the customized, patient-matched accessories for external beam radiation therapy, and or surface brachytherapy applicators in-house or through Adaptiv's OnDemand function. Accessories generated by the Adaptiv's software must be verified by the trained radiation therapy professionals on their TPS for correctness prior to print initiation or accessory order through Adaptiiv OnDemand. Adaptiv's 3D printed patient-matched radiation therapy accessory that expands the application of external-beam radiation therapy, allowing to overcome the skin-sparing effects inherent to high energy photons and electrons. If 3D printing is to be performed by Adaptiv Medical Technologies Inc., desired external beam radiation therapy accessories will be {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "ADAPTIIV" in all capital letters next to a blue icon. The icon is a stylized letter A, with three horizontal lines of varying lengths stacked on top of each other. The text is in a bold, sans-serif font and is black. The overall impression is of a modern and professional logo. 3D printed using the HP Jet Fusion 5200 Series 3D Printing Solution. Adaptiiv Medical Technologies Inc. has validated the Ultrasint® Thermoplastic polyurethane (TPU01) powder for use in 3D printing of radiation therapy accessories. #### Indications for Use 3D Bolus and 3D Brachy applications are intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during external beam (photon or electron) radiation therapy, and surface brachytherapy. Users may choose to send the Steredithography (STL) files to Adaptiv Medical Technologies Inc. to 3D print the external beam radiation therapy accessories to the prescribing radiation therapy professional or 3D print either external beam or surface brachytherapy accessories in -house. If 3D printing is performed by Adaptiiv Medical Technologies Inc., 3D printed accessories will be sent to the final quality control and acceptance by the trained radiation therapy personnel. The use of 3D Bolus and 3D Brachy applications as well as the 3D printed radiation therapy accessories is by prescription only. | ATTRIBUTE | PREDICATE DEVICE | DEVICE | |----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | 3D Bolus Software | 3D Bolus and 3D Brachy Software Applications | | Indications for Use | 3D Bolus Software is indicated for, and intended for use as, an accessory to a radiation therapy treatment planning system (TPS) to design patient-specific 3D printable objects intended for use during external beam photon or electron radiation therapy, or brachytherapy. | 3D Bolus and 3D Brachy applications are indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during external beam (photon or electron) radiation therapy, and surface brachytherapy. Users may choose to send the Stereolithography (STL) files to Adaptiiv Medical Technologies Inc. to 3D print the external beam radiation therapy accessories to the specification of the prescribing radiation therapy professional or 3D print either external beam or surface brachytherapy accessories in-house. If 3D printing is performed by Adaptiiv Medical Technologies Inc., 3D printed accessories will be sent to the requesting care center for the final quality control and acceptance by the trained radiation therapy personnel. The use of 3D Bolus and 3D Brachy applications as well as the 3D printed radiation therapy accessories is by prescription only. | | Target Population | Any patient prescribed radiation therapy requiring an applicable accessory device. | Any patient who is prescribed radiation therapy and requires an accessory device. | | Anatomical Site(s) | Various | Various | | Use Environment | Radiation oncology clinical setting | Radiation oncology clinical setting | | Product Material | 1. Polylactic Acid (PLA) filament<br>2. Thermoplastic Polyurethane (TPU) filaments | Accessories designed using 3D Bolus application are printed using:<br>a. Polylactic Acid (PLA) filament<br>b. Thermoplastic Polyurethane (TPU) filament<br>c. Ultrasint® Thermoplastic polyurethane (TPU01) powder | | ATTRIBUTE | PREDICATE DEVICE<br>3D Bolus Software | DEVICE<br>3D Bolus and 3D Brachy Software Applications | | Printer Compatibility | The following printers have been validated to be compatible with the 3D Bolus Software:<br>• Axiom 20 from Airwolf 3D | The following printers have been validated to be compatible with the 3D Bolus software application:<br>1. Axiom 20 from Airwolf 3D<br>2. HP Jet Fusion 5200 Series<br><br>The following printers have been validated to be compatible with the 3D Brachy software application:<br>• Axiom 20 from Airwolf 3D | | Bolus Product | 3D printed variable thickness bolus. | 3D printed variable thickness bolus. | | Brachytherapy Product | 3D printed surface brachytherapy applicator with source trajectory tunnels. | 3D printed surface brachytherapy applicator with source trajectory tunnels. | | Patient Product Plan | From treatment planning system. 3D Bolus software modifies plan for 3D printing within the treatment facility. | From treatment planning system. 3D Bolus and 3D Brachy applications modify the plan for 3D printing either by Adaptiiv Medical Technologies Inc. or within the treatment facility. | | Communication with Treatment Planning System | DICOM and DICOM RT | DICOM and DICOM RT | | Quality Assurance | Product designed by 3D Bolus Software is checked for accuracy on the treatment planning system before printing by in-house 3D printer or external 3D printing manufacturer utilizing verified and validated printing settings | 1. 3D structures, designed in 3D Bolus and 3D Brachy applications, are verified for accuracy in the TPS before printing by the in-house 3D printer or external 3D printing manufacturer utilizing verified and validated printing settings.<br><br>2. If 3D printing is performed by Adaptiiv Medical Technologies Inc., dimensional fidelity and material uniformity will be evaluated as a condition for final product release to ensure product specifications are within the established acceptance criteria. Final product acceptance is performed by the trained radiation therapy professional at the care center. | | Biocompatibility | It is recommended to place food-safe plastic wrap between the patient's skin and the accessory for cleanliness. | It is recommended to place food-safe plastic wrap between the patient's skin and the accessory for cleanliness. | #### Summary of technological characteristics {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Adaptiiv. The logo consists of a blue icon on the left and the word "ADAPTIIV" in black letters on the right. The icon is a stylized letter A, with three curved lines stacked on top of each other. #### Non-clinical Testing Verification and Validation studies were performed to show substantial equivalence to the following evaluations were carried out to ensure that 3D Bolus and 3D Brachy software applications meet the established product specifications and can be used safely and effectively. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for Adaptiiv. The logo consists of a blue icon on the left and the word "ADAPTIIV" in black letters on the right. The icon is a stylized letter "A" made up of three curved lines in different shades of blue. - a. Unit Testing - to assess the 3D Bolus and 3D Brachy applications against the Functional Specifications. The se tests are automated and are intended to verify the system at the code-level. Such testing ensures that at the functional level of the system, each software function performs as expected. - Integration Testing to assess the 3D Bolus and 3D Brachy applications against the User Experience. The tests are b. designed to assess the functional units of the software end to-end against the respective functional requirements. - System Testing to assess user requirements at the system's external interfaces. Such testing addresses functional C. requirements of the software as they relate to the intended use. System testing evaluates software functionality at the intended operating environment. Furthermore, the performance and compatibility of the printer and material set used to 3D print patient-matched radiation therapy accessories was assessed to demonstrate safety and efficacy of the 3D printed accessories. Spatial fidelity, dimensional consistency, and 3D printed material unifornity were assessed to ensure compliance with the required product specifications. #### Argument for Substantial Equivalence to the Predicate Device A subset of features of the subject device are different from the predicate device. These differences do not adversely impat performance of the device for its intended use. The nonclinical testing performed includes essential performance testing, fun ctional performance characteristics testing, as well as software and radiation therapy accessory validation testing. All tests confirmed that 3D Bolus software application, 3D Brachy software application, and patient-matched 3D printed radiation therapy accessories perform as intended, can be used safely and effectively, and are substantially equivalent to the predicate device.