Affirm Contrast Biopsy

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Hologic, Inc % Ms. Kate Brown Sr. Specialist, Regulatory Affairs 36 Apple Ridge Road DANBURY CT 06810 Re: K202294 Trade/Device Name: Affirm® Contrast Biopsy Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: Class II Product Code: IZH Dated: September 21, 2020 Received: September 22, 2020 Dear Ms. Brown: 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). 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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) K202294 Device Name Affirm® Contrast Biopsy #### Indications for Use (Describe) Affirm® Contrast Biopsy is indicated as an optional accessory for the Selenia Dimensions 2D Full Field Digital Mammography System and 3Dimensions system. It is designed to allow the accurate location of lesions in the breast in three dimensions, using information extracted from stereotactic pairs of two-dimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices). Contrast Enhanced Digital Mammography (CEDM) is an extension of the existing indication for diagnostic mammography with the Selenia Dimensions system. Biopsy targeting can be done on captured contrast enhanced images (scout and stereo pair). The CEDM application shall enable contrast imaging using a dual energy technique. This imaging technique can be used as an adjunct following mammography and/or ultrasound exams to localize a known or suspected lesion. Affirm® Contrast Biopsy is intended for patients recommended for biopsy who have had a suspicious finding on previous contrast enhanced imaging or have lesions that may be occult under other modalities. 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. 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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {3}------------------------------------------------ # Section 006 – 510(k) Summary K202294 Please see the next page for the 510(k) Summary. {4}------------------------------------------------ # Special 510(k) Summary # This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807.92 | Date Prepared: | October 1, 2020 | |----------------------------------------------------------|--------------------------------------------------------------------| | Manufacturer: | Hologic, Inc.<br>36 Apple Ridge Road<br>Danbury, CT 06810 USA | | Establishment Registration #: | 1220984 | | Contact Person: | Kate Brown<br>Sr. Regulatory Affairs Specialist<br>P: 203.702.7819 | | Identification of the Device: | | | Proprietary/Trade Name: | Affirm® Contrast Biopsy | | Classification Name: | Mammographic X-ray System | | Regulatory Number: | 21 CFR 892.1710 | | Product Code: | IZH | | Device Class: | Class II | | Review Panel: | Radiology | | Identification of the Legally Marketed Predicate Device: | | | Trade Name: | Affirm® Breast Biopsy Guidance System | | Classification Name: | Mammographic X-ray System | | Regulatory Number: | 21 CFR 892.1710 | | Product Code: | IZH | | Device Class: | Class II | | Review Panel: | Radiology | | Submitter/510(k) Holder: | Hologic, Inc. | | Clearance: | K103512 (cleared January 07, 2011) | | Identification of the Legally Marketed Reference Device: | | | Trade Name: | Contrast Enhanced Digital Mammograp | | Classification Name: | Full Field Digital, System, X-Ray, Mamm | | | | Regulatory Number: Product Code: Device Class: Review Panel: Submitter/510(k) Holder: Clearance: graphy ammographic 21 CFR 892.1715 MUE Class II Radiology Hologic, Inc. K123873 (cleared January 29, 2013) {5}------------------------------------------------ ## Device Description The proposed Affirm® Contrast Biopsy is a licensable software for the Selenia Dimensions and 3Dimensions system platforms (P010025 and P08003, respectively). The proposed software option will be used with the Affirm® Breast Biopsy Guidance System (K103512). The proposed software is a stereotactic lesion localization system option for the Dimensions systems. It allows clinicians to perform biopsy targeting on captured contrast enhanced images. Affirm® Contrast Biopsy uses the same workflow as stereotactic biopsy, substituting standard scout and stereo pair views with contrast enhanced views captured at the associated angles. The proposed device is compatible with the standard vertical biopsy approach as well as the right or left lateral approach. Affirm® Contrast Biopsy introduces new software and labeling. There are no changes to the Dimensions platform and Affirm® Breast Biopsy Guidance System hardware, platform software architecture, or stereotactic function as a result of the proposed software. ### Indications for Use The Affirm® Contrast Biopsy is indicated as an optional accessory for the Selenia Dimensions 2D Full Field Digital Mammography System and 3Dimensions system. It is designed to allow the accurate location of lesions in the breast in three dimensions, using information extracted from stereotactic pairs of two-dimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices). Contrast Enhanced Digital Mammography (CEDM) is an extension of the existing indication for diagnostic mammography with the Selenia Dimensions system and 3Dimensions system. Biopsy targeting can be done on captured contrast enhanced images (scout and stereo pair). The CEDM application shall enable contrast enhanced breast imaging using a dual energy technique. This imaging technique can be used as an adjunct following mammography and/or ultrasound exams to localize a known or suspected lesion. Affirm® Contrast Biopsy is intended for patients recommended for biopsy who have had a suspicious finding on previous contrast enhanced imaging or have lesions that may be occult under other modalities. ### Technological Characteristics The Affirm® Contrast Biopsy uses the same technological principles as that of the cleared Affirm® Breast Biopsy Guidance System; however, Contrast Enhanced Digital Mammography (K123873) images are utilized instead of standard scout and standard stereo pair images. In the proposed device the lesion will be localized by 2D stereotactic image acquisition of the lesion enhancement after an IV injection of an iodinated contrast agent. Stereo pair images are captured at plus and minus 15-degree angles using Dual Energy Contrast Enhanced Digital Mammography (CEDM). Low energy, and subtracted images can be displayed on the Acquisition Workstation monitor and are used for targeting purposes. The user then positions on-screen cursors to identify the position of the target lesion in the projected image pairs. Utilizing the target lesion information from these acquired images, the software uses trigonometric calculations to determine the Cartesian coordinates (X, Y, and Z) of the targeted lesion within the breast. The calculated coordinates of the targeted lesion are sent to the Affirm biopsy control module mounted on the Selenia Dimensions Gantry C-Arm, which positions the biopsy device under user guidance in preparation of the biopsy procedure. {6}------------------------------------------------ # Comparison with Predicate Devices The Affirm® Contrast Biopsy and its predicate device, Affirm® Breast Biopsy Guidance System (K103512) and reference device, Contrast Enhanced Digital Mammography (K123873), have the same or similar intended use, technological characteristics, and operational use. # Summary of Substantial Equivalence {7}------------------------------------------------ | | Affirm® Breast<br>Biopsy Guidance<br>System | I-View™/ Contrast<br>Enhanced Digital<br>Mammography<br>(CEDM) | Affirm® Contrast<br>Biopsy | Comparison | |---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Features and<br>Characteristics | Primary Predicate<br>(K103512) | Reference Device<br>(K123873) | Proposed | | | Indications for<br>Use | The Affirm®<br>Breast Biopsy<br>Guidance System<br>is an optional<br>accessory for the<br>Selenia<br>Dimensions 2D<br>Full Field Digital<br>Mammography<br>System. It is<br>designed to allow<br>the accurate<br>location of lesions<br>in the breast in<br>three dimensions,<br>using information<br>extracted from<br>stereotactic pairs<br>of two-<br>dimensional<br>images. It is<br>intended to<br>provide guidance<br>for interventional<br>purposes (such as<br>biopsy, pre-<br>surgical<br>localization or<br>treatment<br>devices). | Contrast Enhanced<br>Digital<br>Mammography<br>(CEDM) is an<br>extension of the<br>existing indication<br>for diagnostic<br>mammography<br>with the Selenia<br>Dimensions<br>system. The CEDM<br>application shall<br>enable contrast<br>enhanced breast<br>imaging using a<br>dual energy<br>technique. This<br>imaging technique<br>can be used as an<br>adjunct following<br>mammography<br>and/or ultrasound<br>exams to localize a<br>known or<br>suspected lesion. | Affirm® Contrast<br>Biopsy is indicated<br>as an optional<br>accessory for the<br>Selenia Dimensions<br>2D Full Field Digital<br>Mammography<br>System and<br>3Dimensions<br>system. It is<br>designed to allow<br>the accurate<br>location of lesions<br>in the breast in<br>three dimensions,<br>using information<br>extracted from<br>stereotactic pairs<br>of two-dimensional<br>images. It is<br>intended to<br>provide guidance<br>for interventional<br>purposes (such as<br>biopsy, pre-surgical<br>localization or<br>treatment devices).<br>Contrast Enhanced<br>Digital<br>Mammography<br>(CEDM) is an<br>extension of the<br>existing indication<br>for diagnostic<br>mammography<br>with the Selenia<br>Dimensions system<br>and 3Dimensions<br>system. Biopsy<br>targeting can be<br>done on captured | Similar. The<br>proposed device's<br>indications for use<br>will be a<br>combination of the<br>primary predicate<br>and reference<br>device's indications<br>for use statement.<br>The addition of<br>"3Dimensions<br>system" was added<br>to the proposed<br>indications for use<br>statement. The<br>3Dimensions<br>system does not<br>differ<br>technologically<br>from that of the<br>Selenia Dimensions<br>system. | | | | | contrast enhanced<br>images (scout and<br>stereo pair). The<br>CEDM application<br>shall enable<br>contrast enhanced<br>breast imaging<br>using a dual energy<br>technique. This<br>imaging technique<br>can be used as an<br>adjunct following<br>mammography<br>and/or ultrasound<br>exams to localize a<br>known or<br>suspected lesion.<br>Affirm® Contrast<br>Biopsy is intended<br>for patients<br>recommended for<br>biopsy who have<br>had a suspicious<br>finding on previous<br>contrast enhanced<br>imaging or have<br>lesions that may be<br>occult under other | | | X-Ray Image<br>Device | Selenia<br>Dimensions 2D<br>FFDM | Selenia Dimensions<br>2D FFDM | modalities.<br>Selenia Dimensions<br>and 3Dimensions | Similar. Selenia<br>Dimensions and<br>3Dimensions are<br>both capable of 2D<br>FFDM which is<br>utilized for the<br>proposed device's<br>lesion localization. | | Coordinate<br>Determination | Cartesian<br>Coordinates<br>determined from<br>Dimensions<br>Stereotactic<br>software | Not applicable to<br>CEDM | Cartesian<br>Coordinates<br>determined from<br>Dimensions<br>Stereotactic<br>software | Same as primary<br>predicate, Affirm®<br>Breast Biopsy<br>Guidance System | | Movement<br>Method | X: Motorized<br>Y: Motorized<br>Z: Manual | Not applicable to<br>CEDM | X: Motorized<br>Y: Motorized<br>Z: Manual | Same as primary<br>predicate, Affirm®<br>Breast Biopsy<br>Guidance System | | | | | | | | Stereotactic<br>Angle | +/- 15° | Not applicable to<br>CEDM | +/- 15° | Same as primary<br>predicate, Affirm®<br>Breast Biopsy<br>Guidance System | | Method of<br>Use | Lesion localization<br>is obtained from<br>2D stereotactic<br>image acquisition. | Lesion localization<br>is obtained from<br>contrast enhanced<br>2D breast imaging<br>using a dual energy<br>technique. | Lesion localization<br>is obtained from<br>2D contrast<br>enhanced image<br>acquisition from<br>low energy and<br>subtracted image<br>pairs. | Similar. Lesion<br>localization is<br>obtained utilizing<br>the primary<br>predicate and<br>reference device's<br>method of use. | | Mechanism of<br>Action | Guidance for<br>breast biopsy:<br>-Standard<br>(vertical)<br>approach | Not applicable to<br>CEDM | Guidance for<br>breast biopsy:<br>-Standard (vertical)<br>approach<br>-Right or left lateral<br>approach | Similar. The<br>addition of the<br>lateral approach<br>was cleared via<br>K161575 and is<br>compatible with<br>the proposed<br>device. | | Workflow | Stereotactic<br>biopsy workflow | Dual energy<br>imaging technique<br>workflow | Stereotactic biopsy<br>workflow | Similar. The<br>proposed device's<br>workflow is similar<br>to the primary<br>predicate device's<br>workflow. The only<br>difference are the<br>additional steps on<br>the AWS GUI which<br>allow the user to<br>choose Contrast<br>Enhanced Digital<br>Mammography<br>images instead of<br>2D images before<br>performing the<br>stereotactic biopsy.<br>The proposed<br>device Affirm®<br>Contrast Biopsy<br>workflow differs<br>from the reference<br>device CEDM<br>workflow as it is<br>specific to biopsy. | {8}------------------------------------------------ {9}------------------------------------------------ Summary of Testing {10}------------------------------------------------ Non-clinical bench testing demonstrates the Affirm® Contrast Biopsy is substantially equivalent to the predicate and reference device with regards to the indication for use, software, technology, and performance. Design verification testing demonstrates the proposed device complies with design specifications. The proposed device was developed under Hologic's Quality Management System which adheres to 21 CFR Part 820 and ISO 13485:2016. Risk management activities, in accordance with ISO 14971:2019, demonstrate that the risks associated with the use of the Affirm® Contrast Biopsy software are mitigated as far as possible. Analyses of these activities indicate the benefits associated with the use of the Affirm® Contrast Biopsy outweigh the residual risks. The software, and performance showed that the overall system demonstrated equivalent performance and equivalent safety and effectiveness as the predicate Affirm® Breast Biopsy Guidance System (K103512) and reference Contrast Enhanced Digital Mammography (K123873). ## Benefit-Risk Analysis The benefit of the device is to allow visualization and biopsy of suspicious lesions that may otherwise be occult or difficult to confidently target using other modalities. The main risks are the additional radiation dose and exposure to contrast agents. The radiation dose is approximately 25% greater than performing FFDM stereotactic biopsy, and per exposure would be about the same as the reference device operating in 2D contrast enhanced imaging mode. The exposure of the patient to the iodinated contrast agent presents another risk. Although the probability of occurrence is remote, the most significant additional risk to a patient during a contrast enhanced biopsy procedure relative to a stereotactic biopsy is an allergic reaction to the injected contrast agent which could potentially result in a life threatening aphylactic reaction. Recent estimates suggest that the rate of acute adverse events for low-osmolar contrast agents is approximately 0.2%-0.7%, with a severe acute reactions being approximately 0.04%. This risk is mitigated via procedural guidelines set up in hospitals which cover training, pre-screening of patients' kidney function (i.e.; glomerular filtration rate or GFR), and appropriate acute care readiness (e.g., "crash carts"), as may be expected to be in place for the reference device as well. Furthermore, if the patient has had previous exposure to iodinated contrast agents safely with no adverse reaction, such as a contrast-enhanced digital mammography exam, then this risk will be additionally reduced. These additional radiation and contrast agent risks are therefore likely outweighed by the benefits of the device for patients recommended for biopsy who have had a suspicious finding on previous contrast enhanced imaging or have lesions that may be occult under other modalities. ### Conclusion The Affirm® Contrast Biopsy is substantially equivalent to the legally marketed predicate device, Affirm Breast Biopsy Guidance System cleared on January 08, 2011 via K103512, and the legally marketed reference device, Contrast Enhanced Digital Mammography, cleared on January 29, 2013 via K123873. The indications for use and fundamental scientific technology of the proposed device are the same or similar to that of the Affirm® Breast Biopsy Guidance System and Contrast Enhanced Digital Mammography.