SIR-Spheres Microspheres Activity Calculator (SMAC)

{0}------------------------------------------------ October 23, 2020 Image /page/0/Picture/1 description: The image contains 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 logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. Sirtex Medical US Holdings, Inc. Sirtex Medical Pty Ltd. % Mr. Michael P. Hanley Senior Regulatory Affairs Specialist 300 Unicorn Park, 2nd Floor WOBURN MA 01801 Re: K202392 Trade/Device Name: SIR-Spheres Microspheres Activity Calculator (SMAC) Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS Dated: August 19, 2020 Received: August 21, 2020 Dear Mr. Hanley: 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) K202392 Device Name SIR-Spheres Microspheres Activity Calculator (SMAC) Indications for Use (Describe) The SIR-Spheres® Microspheres Activity Calculator (SMAC) is intended as a tool to assist with developing personalized dose activity calculations , based on relevant data, for patients undergoing selective internal radiation therapy (SIRT) with SIR-Spheres Y-90 resin microspheres . Using the BSA formula, the SMAC automatically performs calculations that are typically done manually by a physicist and/ or licensed healthcare practitioner. The algorithms used have been established and documented in scientific literature. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------| | <div><span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div><span style="font-size:16px">☐</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}------------------------------------------------ #### SECTION 5 K202392 510 (k) Summary ### 510(k) Summary – SIR-Spheres Microspheres Activity Calculator (SMAC) This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content contained in this 510 (k) summary has been provided in conformance with 21 CFR 807.92(c). Date Prepared: August 19, 2020 ### A. Sponsor Sirtex Medical Pty Ltd Shop 6, 207 Pacific Hwy St Leonards NSW 2065, Australia ### B. Contact Michael Hanley Senior Regulatory Affairs Specialist 781-721-3842 Email: Michael.Hanley@sirtex.com ### C. Device Name Trade Name: | Trade Name: | SIR-Spheres Microspheres Activity Calculator (SMAC) | |-----------------------|-----------------------------------------------------------------| | Common/Usual Name: | System, Imaging Processing, Radiological | | Classification Panel: | Radiology | | Pro Code: | KPS/Class II | | Regulation Number | 21 CFR 892.1200 | ### D. Legally Marketed Device (Predicate Device) The following legally marketed device has been used for comparison. | Proprietary/Trade Name | | |------------------------|-------------------------------------| | Trade Name: | HERMES Hybrid3D v3.0 SIRT (K181468) | ### E. Description of the device that is subject of this premarket notification: The SIR-Spheres Microspheres Activity Calculator (SMAC) is a software modelling program that is designed to assist physicians and licensed healthcare practitioners when prescribing Selective Internal Radiation Therapy (SIRT) with SIR-Spheres Y-90 resin microspheres. It allows physicians 510(k) Premarket Notification Sirtex Medical Pty Ltd. {4}------------------------------------------------ and licensed healthcare practitioners to determine an individualized dose activity calculation based upon specific patient characteristics. The program computes the prescribed activity calculation using the Body Surface Area (BSA) formula that has been published in peer reviewed journals of medicine and models treatment parameters. This is a tool only and does not replace the need for the physician or licensed healthcare practitioner to make an independent determination of the therapy best suited for the patient. The SIR-Spheres Microspheres Activity Calculator (SMAC) tool employs a simple algorithm to calculate Y90 dose activity based on the Body Surface Area (BSA) model and patient specific user inputs. The SMAC tool does not incorporate imaging capabilities. The HERMES Hybrid3D SIRT (K181468) is an acceptable predicate device because both devices perform dosimetry calculations based on the BSA formula Calculated Activity (GBq) BSA (m2) = 0.20247 × height (m)0.725 x weight(kg)0 # Figure 1: Prescribed activity calculation of SIR-Spheres resin microspheres ### F. Indications for Use/Intended Use The proposed SMAC Calculator application has the following Indications for Use: The SIR-Spheres® Microspheres Activity Calculator (SMAC) is intended as a tool to assist with developing personalized dose activity calculations, based on relevant patient data, for patients underqoing selective internal radiation therapy (SIRT) with SIR-Spheres Y-90 resin microspheres. Using the BSA formula, the SMAC automatically performs calculations that are typically done manually by a physician or licensed healthcare practitioner. The algorithms used have been established and documented in scientific literature. ### The proposed SMAC Calculator application has the following Intended Use: The SIR-Spheres Microspheres Activity Calculator (SMAC) is intended as a tool to assist with developing personalized dose activity calculations, based on relevant patient data, for patients undergoing selective internal radiation therapy (SIRT) with SIR-Spheres Y-90 resin microspheres. {5}------------------------------------------------ ## G. Summary of Similarities and Differences in Technological Characteristics and Performance The proposed SMAC software is equivalent when compared to the marketed predicate in comparison to software design, function, and operation as the identified predicate. The table below provides the comparison of the devices. | Characteristic | Proposed Device:<br>Sirtex<br>SIR-Spheres Microspheres<br>Activity Calculator (SMAC) | Predicate: Hermes<br>Medical Solutions<br>Hybrid 3D<br>K181468 | Comparison | |------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications<br>for Use | The SIR-Spheres®<br>Microspheres Activity<br>Calculator (SMAC) is<br>intended as a tool to assist<br>with developing<br>personalized dose activity<br>calculations, based on<br>relevant patient data, for<br>patients undergoing<br>selective internal radiation<br>therapy (SIRT) with SIR-<br>Spheres Y-90 resin<br>microspheres. Using the<br>BSA formula, the SMAC<br>automatically performs<br>calculations that are<br>typically done manually by<br>a physician or licensed<br>healthcare practitioner.<br>The algorithms used have<br>been established and<br>documented in scientific<br>literature. | Hybrid3D is a software<br>application that can be<br>used to process, display,<br>analyze and manage<br>nuclear medicine and<br>other medical imaging<br>data transferred from<br>other workstations or<br>acquisition stations | Similar<br><br>Both software<br>programs<br>calculate dose<br>based on the<br>exact same<br>SIRTEX BSA<br>formula as seen<br>in the<br>instructions for<br>use.<br><br>Hybrid 3D<br>includes more<br>features than<br>dose calculation,<br>whereas the<br>SMAC only<br>provides the<br>software<br>automation of<br>the formula. | | Intended<br>Users | Physicians and licensed<br>healthcare practitioners | The user may be an<br>experienced physician,<br>medical physicist,<br>technologist nurse or<br>other operator who has<br>been trained by an<br>authorized distributor or | Very Similar | | Characteristic | Proposed Device:<br>Sirtex<br>SIR-Spheres Microspheres<br>Activity Calculator (SMAC) | Predicate: Hermes<br>Medical Solutions<br>Hybrid 3D<br>K181468 | Comparison | | | | by Hermes Medical<br>Solutions. | | | Device<br>Environment | Hospital, Clinic<br>Office Based Interventional<br>Suite (OBIS) | Hospital<br>Clinic | Similar:<br>Both the<br>proposed and<br>predicate devices<br>are intended to<br>be used in<br>licensed<br>healthcare<br>facilities | | Operating<br>Platform | The SMAC system is<br>designed to be supported<br>by the last two versions of<br>the web browsers:<br>Chrome, Firefox, Safari,<br>Opera, Mobile Safari, and<br>Internet Explorer (IE)<br>mobile as well as Internet<br>Explorer 9+ and android<br>browser 2.3. | Microsoft Windows 7 & 10<br>(64 bit only) / Windows<br>Server | Similar<br>Proposed<br>device's<br>operating<br>platform has<br>been evaluated<br>for browser<br>compatibility. | | Algorithms to<br>Perform<br>Calculations | Algorithm performs Y90<br>dose calculations based<br>upon the Body Surface<br>Area (BSA) model using<br>patient specific<br>characteristics. | Algorithm performs Y90<br>dose calculations based<br>upon the Body Surface<br>Area (BSA) model using<br>patient specific<br>characteristics. | Identical<br>The proposed<br>and predicate<br>devices utilize the<br>BSA Method to<br>perform dose<br>calculations. | {6}------------------------------------------------ ### H. Performance Data The performance evaluation of the proposed SMAC Calculator included testing conducted in accordance to the following FDA Guidance Documents, domestic and international standards: 510(k) Premarket Notification Sirtex Medical Pty Ltd. {7}------------------------------------------------ Results of this testing demonstrate safety and effectiveness of the proposed device and substantial equivalence. ### I. Substantially Equivalent / Conclusion The Proposed device is determined to be substantially equivalent to the predicate device based on: - The Intended Use and Indications for Use - Operating principles/technology - . Results of safety and performance testing - Responses to questions posed in FDA 510 (k) "Substantial Equivalence" Decision Making . Flowchart