Affinity

{0}------------------------------------------------ February 14, 2020 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo 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. Hermes Medical Solutions AB % Joakim Arwidson VP Quality and Regulatory Strandbergsgatan 16 Stockholm, 11251 SWEDEN Re: K193152 Trade/Device Name: Affinity Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: Class II Product Code: KPS Dated: February 7, 2020 Received: February 12, 2020 Dear Joakim Arwidson: 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) K193152 Device Name Affinity #### Indications for Use (Describe) AFFINITY is a software application used to process, display, and manage nuclear medicine and other medical imaging data transferred from other workstations, PACS or acquisition stations. The information acquired from viewing the images is used, in conjunction with other patient related data, for diagnosis and monitoring of disease. Type of Use (Select one or both, as applicable) | <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | |--------------------------------------------------------------------------------------| | <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> | #### 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}------------------------------------------------ # 5.0 510 (k) SUMMARY #### A. Submitted by: - Submitters name and address: Hermes Medical Solutions AB Strandbergsgatan 16 112 51 Stockholm Sweden #### . Submitters telephone number Phone: +46 8 19 03 25 E-mail: joakim.arwidson@hermesmedical.com #### ● Contact person Joakim Arwidson VP Quality and Requlatory Hermes Medical Solutions AB Strandbergsgatan 16 112 51 Stockholm Sweden - Registration number 9710645 B. Preparation date: 2019-10-28 #### C. Proprietary/Trade name, Common name, Classification name: - Proprietary/Trade name ● Affinity - . Common name Image processing systems - . Classification name Emission Computer Tomography System, Class II, 21CFR892.1200 #### D. Legally marketed device (predicate device): The following legally marketed devices have been used for comparison. - Hybrid3D (K181468) primary ● - Hermes Medical Imaging Suite (K171681) reference . #### E. Description of the device that is subject of this premarket notification: The Affinity v1.0 is a Viewer that will be the first Hermes application released on the new development platform Affinity. The application provides 2D and 3D visualization and processing of medical images in Digital Imaging and Communications in Medicine (DICOM) format from different modalities, such {4}------------------------------------------------ as PET/CT, MR and tomographic reconstructed SPECT from SPECT/CT. Affinity supports coregistration, with the exception of 2D images, and fusion of multiple time points with studies in the same frame of reference, different tracers, and modalities. Affinity is developed with Microsoft Visual Studio on the .NET framework environment and designed for high throughput clinical scenarios with fast image loading and configurable workflows and layouts. In the design, emphasis has been placed on ease of use, where the user can easily access tools for 3D ROI and uptake analysis. The application supports pre-selection and automatic detection of all uptake areas within the body above a certain threshold level, by using threshold region tool. Where the user can define a threshold for any modality and unit within that modality to include all pixels of the study in a region or islands of regions. Based on selected regions, quantification of the following parameters can be done SUV, SUVR, SUVbsa, SUVlbm, SUVbw, SUV Peak, SUV Mean, TLG and MTV. Reference: RECIST to Percist: Evolving Considerations for PRT Response Criteria in Solid Tumors, Wahl R.L et al, Journal of Nuc Med:2009:Vol 50:122S-150S. #### F. Intended use AFFINITY is a software application used to process, display, analyse and manage nuclear medicine and other medical imaging data transferred from other workstations, PACS or acquisition stations. The information acquired from viewing the images is used, in conjunction with other patient related data, for diagnosis and monitoring of disease. {5}------------------------------------------------ #### G. Technological characteristics Comparison of the proposed device Affinity and the primary predicate device Hybrid3D (K181468) and reference device I Imaging Suite (K171681). | Trade Name | Affinity | Hybrid3D | Hermes Medical Imaging<br>Suite | Comparison | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510k # | This application | K181468 | K171681 | N/A | | Operating System | Microsoft® Windows 10,<br>64 bit | Microsoft® Windows 7<br>and 10, 64 bit | Microsoft® Windows 7<br>and10, 64 bit | Affinity supports Windows 10 OS | | Indications for<br>use | AFFINITY is a software<br>application used to<br>process, display, analyse<br>and manage nuclear<br>medicine and other<br>medical imaging data<br>transferred from other<br>workstations, PACS or<br>acquisition stations. The<br>information acquired from<br>viewing the images is<br>used, in conjunction with<br>other patient related data,<br>for diagnosis and<br>monitoring of disease. | 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. | HERMES Medical Imaging<br>suite provides software<br>applications used to<br>process, display, analyze<br>and manage nuclear<br>medicine and other<br>medical imaging data<br>transferred from other<br>workstation or acquisition<br>stations. | Equivalent Intended Use. Affinity<br>also includes the specification<br>that "The information acquired<br>from viewing the images is used,<br>in conjunction with other patient<br>related data, for diagnosis and<br>monitoring of disease." | | Patient population | All patients undergoing<br>molecular imaging<br>investigations. | All patients undergoing<br>molecular imaging<br>investigations. | All patients undergoing<br>molecular imaging<br>investigations. | Equivalent patient population | | Software Input /<br>Modalities<br>PET/CT | Yes | Yes | Yes | Equivalent to Hybrid3D / Hermes<br>medical Imaging Suite | | Trade Name | Affinity | Hybrid3D | Hermes Medical Imaging<br>Suite | Comparison | | SPECT/CT | Yes (tomographic<br>reconstructed) | Yes (tomographic<br>reconstructed) | Yes | Equivalent to Hybrid3D / Hermes<br>medical Imaging Suite | | MR | Yes | Yes | No | Equivalent to Hybrid3D | | Anatomical sites | Whole body or constrained<br>field of view (e.g.<br>abdomen, brain) | Whole body or<br>constrained field of view<br>(e.g. abdomen, brain) | Whole body or constrained<br>field of view (e.g.<br>abdomen, brain) | Equivalent anatomical sites | | Software Output<br>Parameters | Methods used for<br>quantification | Methods used for<br>quantification | Methods used for<br>quantification | Affinity uses equivalent algorithms<br>for quantification. | | SUV | Yes | Yes | Yes | Equivalent to Hybrid3D / Hermes<br>medical Imaging Suite | | SUVR | Yes | Yes (in percist criteria) | No | Equivalent to Hybrid3D | | SUVbsa | Yes | Yes | Yes | Equivalent to Hybrid3D / Hermes<br>medical Imaging Suite | | SUVIbm | Yes | Yes | Yes | Equivalent to Hybrid3D / Hermes<br>medical Imaging Suite | | SUVbw | Yes | Yes | Yes | Equivalent to Hybrid3D / Hermes<br>medical Imaging Suite | | SUV Peak | Yes | Yes | Yes | See Note 1. | | SUV Mean | Yes | Yes | Yes | Equivalent to Hybrid3D / Hermes<br>medical Imaging Suite | | TLG | Yes | Yes | Yes | Equivalent to Hybrid3D / Hermes<br>medical Imaging Suite | | MTV | Yes | Yes | Yes | Equivalent to Hybrid3D / Hermes<br>medical Imaging Suite | | Trade Name | Affinity | Hybrid3D | Hermes Medical Imaging<br>Suite | Comparison | | Clinical modules | | | | | | Viewing 2D | Yes | Yes | Yes | Equivalent to Hybrid3D / Hermes<br>medical Imaging Suite | | Viewing 3D | Yes | Yes | Yes | Equivalent to Hybrid3D | | SIRT (Selective<br>Internal Radiation<br>Therapy) - post<br>treatment | No | Yes | No | No support of SIRT in Affinity | | Lung Lobar<br>Quantification | No | Yes | No | No support of Lung Lobar<br>Quantification in Affinity | | NM Processing | No | No | Yes | No support of NM Processing<br>modules in Affinity | | Renogram, Gastric<br>Emptying, DMSA,<br>Gall Bladder EF,<br>Lung<br>Quantification,<br>Sacro Illiac Joint,<br>First Pass Shunt,<br>Functional Gated<br>Analysis, Brain<br>Analysis, Thyroid<br>Analysis, Colonic<br>Transit,<br>Parathyroid,<br>Dosimetry,<br>Oesophageal<br>Transit, Salivary<br>Gland, HIDA,<br>Bone3Phase<br>Analysis | No | No | Yes | No support of NM Processing<br>modules in Affinity | | Trade Name | Affinity | Hybrid3D | Hermes Medical Imaging<br>Suite | Comparison | | SPECT Recon-<br>struction | No | No | Yes | Affinity can load and present<br>tomographic reconstructed<br>SPECT data, but not do the<br>reconstruction itself. | | Communication | | | | | | DICOM | Yes | Yes | Yes | Equivalent to Hybrid3D / Hermes<br>medical Imaging Suite | | IF (Interfile) | No | No | Yes | No support of IF (Interfile) in<br>Affinity. | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ Note 1) The method for calculating SUVpeak for Affinity is exactly as described in the paper 'RECIST to Percist: Evolving Considerations for PRT Response Criteria in Solid Turnors, Wahl R.L et al, Journal of Nuc Med:2009: Vol 50:122S-150S . Consequently, an SUV peak will not be calculated for a volume which a sphere of at least 1 cubic centimeter (1 cc). The primary predicate device Hybrid3D, on the other hand, uses a spherical volume for calculating SUVpeak which is as close as possible to 1 cc, so it may present an SUVpeak value even if the volume cannot contain a 1cc sphere. {9}------------------------------------------------ ### H. Testing The tests for verification and validation followed Hermes Medical Solutions AB design-controlled procedures. The Risk analysis was completed, and risk control implemented to mitigate identified hazards. The test results confirm that all the software specifications have met the acceptance criteria. ### I. Substantially Equivalent/Conclusions The clinical features supported by Affinity are equivalent in comparison to the primary predicate device Hybrid3D (K181468) and the reference device Hermes Medical Imaging Suite(K171681) as presented in 'G Technological characteristics. When validating Affinity, comparisons were made of the parameters SUV, SUVR, SUVPeak, SUVbsa, SUVIbm, SUVMean, TLG, HU, MTV and linear measurements with the primary predicate device Hybrid3D (K181468) and the reference device Hermes Medical Imaging Suite (K171681, Hybrid Viewer). Comparison of the parameters was done with different NEMA phantom based on studies from cameras by GE, SIEMENS and Philips. | Linear Measurements on a GE CT phantom study (mm) | | | | |---------------------------------------------------|-----------|----------|----------| | # | Hybrid 3D | Affinity | Diff (%) | | 1 | 37.81 | 38.7 | -2.4 | | 2 | 29.04 | 28.9 | 0.5 | | 3 | 22.37 | 23.9 | -6.8 | | 4 | 17.88 | 18.0 | -0.7 | | 5 | 14.16 | 14.5 | -2.4 | | Linear Measurements on a Siemens CT phantom (mm) | | | | |--------------------------------------------------|-----------|----------|----------| | # | Hybrid 3D | Affinity | Diff (%) | | 1 | 26.87 | 26.7 | 0.6 | | 2 | 27.17 | 27.3 | -0.5 | | 3 | 17.81 | 17.5 | 1.7 | | 4 | 76.16 | 77.1 | -1.2 | | 5 | 188.69 | 188.2 | 0.3 | | Hounsfield Unit Numbers on a GE CT Phantom | | | | |--------------------------------------------|-----------|----------|----------| | Parameter | Hybrid 3D | Affinity | Diff (%) | | VOI1, Vol ml | 2.41 | 2.4 | 0.4 | | VOI1, Max HU | 37 | 41 | -10.8 | | VOI1, Mean HU | 5.52 | 6 | -8.7 | | VOI2, Vol ml | 1.03 | 1.0 | 2.9 | | VOI2, Max HU | 1140 | 1140 | 0 | | VOI2, Mean HU | 222 | 239 | -7.7 | | SUV Threshold VOIs of Phillips PET study | | | | |------------------------------------------|-----------|----------|----------| | Parameter | Hybrid 3D | Affinity | Diff (%) | | Vol ml | 7.55 | 7.6 | -0.7 | | SUV peak | 15.99 | 16.36 | -2.3 | | SUV max | 19.3 | 19.3 | 0 | | SUV mean | 10.5 | 10.5 | 0 | | TLG | 79.28 | 79.3 | 0 | {10}------------------------------------------------ | SUV Threshold VOIs of GE PET study | | | | |------------------------------------|-----------|--------------------------|-----------------------------------------------------------------------------| | Parameter | Hybrid 3D | Affinity | Diff (%) | | Vol ml | 1.35 | 1.3 | 3.7 | | SUV peak | 5.08 | NA<br>(volume too small) | Not applicable<br>See Note 1) in section 'G.<br>Technology Characteristics' | | SUV max | 7.42 | 7.42 | 0 | | SUV mean | 5.04 | 5.11 | -1.4 | | TLG | 6.8 | 6.5 | 4.4 | | SUV Threshold VOIs of Siemens PET | | | | |-----------------------------------|-----------|----------|----------| | Parameter | Hybrid 3D | Affinity | Diff (%) | | Vol ml | 81.07 | 82.4 | -1.6 | | SUV peak | 18.07 | 18.28 | -1.2 | | SUV max | 24.73 | 24.73 | 0 | | SUV mean | 12.45 | 12.39 | 0.5 | | TLG | 1009.21 | 1021 | -1.2 | | SUV values for different modes using VOI on Siemens PET study (Hybrid3D / Affinity) | | | | |-------------------------------------------------------------------------------------|-----------|----------|----------| | Parameter | Hybrid 3D | Affinity | Diff (%) | | SUVBW | | | | | Vol ml | 81.07 | 81.1 | 0 | | SUV peak | 18.07 | 18.28 | -1.2 | | SUV max | 24.73 | 24.45 | 1.1 | | SUV mean | 12.45 | 12.39 | 0.5 | | TLG | 1009.21 | 1009 | 0 | | SUVBSA | | | | | Vol ml | 81.07 | 81.1 | 0 | | SUV peak | 5.16 | 5.22 | -1.2 | | SUV max | 7.06 | 7.06 | 0 | | SUV mean | 3.55 | 3.55 | 0 | | SUV min | 1.71 | 1.71 | 0 | | TLG | 288.07 | 288 | 0 | | SUV values for different modes using VOI on Siemens PET study (Hybrid Viewer / Affinity) | | | | |------------------------------------------------------------------------------------------|---------------|----------|----------| | Parameter | Hybrid Viewer | Affinity | Diff (%) | | SUVLBM (120) | | | | | Vol ml | 81.21 | 81.1 | 0.1 | | SUV peak | 17.67 | 15.73 | 11 | | SUV max | 21.29 | 21.29 | 0 | | SUV mean | 10.69 | 10.72 | -0.3 | | TLG | 868.43 | 869 | -0.1 | | SUVLBM (128) | | | | | Vol ml | 81.21 | 81.1 | 0.1 | | SUV peak | 17.34 | 15.44 | 11 | | SUV max | 20.9 | 20.9 | 0 | | SUV mean | 10.49 | 10.52 | -0.3 | | TLG | 852.34 | 853 | -0.1 | {11}------------------------------------------------ The quantitative assessment obtained from Affinity is in good agreement with the predicate devices Hybrid3D (K181468) and HybridViewer (Hermes Medical Imaging Suite, K171681). The biggest difference was in SUV peak compared to HybridViewer, where a difference of up to 11% was observed. The difference in SUV peak is due to that the region is manually positioned and a slight difference in the applications algorithm, where Affinity is strictly in accordance with the definition in the paper 'RECIST to Percist: Evolving Considerations for PRT Response Criteria in Solid Tumors, Wahl R.L et al, Journal of Nuc Med:2009:Vol 50:122S-150S'. In summary, the Affinity v1.0 described in this submission is in our opinion substantially equivalent to the predicate devices.