(53 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on stereotactic localization using existing imaging techniques and workflows, with no mention of AI/ML algorithms for image analysis or decision support.
No.
The device is described as a software accessory for a mammography system, designed for accurate localization of breast lesions for interventional procedures like biopsy or pre-surgical localization. Its purpose is guidance for diagnosis and intervention, not direct therapy.
No.
The device is described as a software for lesion localization and guidance for interventional procedures, such as biopsy, not for diagnostic purposes. It is explicitly stated that Contrast Enhanced Digital Mammography (CEDM) is an extension of the existing indication for diagnostic mammography, but this device uses captured contrast-enhanced images for biopsy targeting and guidance rather than generating a primary diagnosis. Its use is as an adjunct following mammography and/or ultrasound exams to localize a known or suspected lesion, implying the diagnostic step has already occurred.
Yes
The device description explicitly states that the proposed Affirm® Contrast Biopsy is a "licensable software" and that there are "no changes to the Dimensions platform and Affirm® Breast Biopsy Guidance System hardware". It functions as an option for existing hardware systems.
Based on the provided information, the Affirm® Contrast Biopsy is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens taken from the human body. The intended use and device description clearly state that the Affirm® Contrast Biopsy is a software accessory for a mammography system used to locate lesions within the breast for guidance during interventional procedures like biopsy. It works with imaging data, not biological samples.
- The device's function is image-based guidance. It uses contrast-enhanced digital mammography images to help clinicians accurately target lesions for biopsy or other interventions. This is a form of medical imaging and guidance, not laboratory testing of biological samples.
Therefore, the Affirm® Contrast Biopsy falls under the category of a medical device used for imaging and interventional guidance, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
IZH
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Contrast Enhanced Digital Mammography (CEDM)
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
October 5, 2020
Image /page/0/Picture/1 description: The image shows 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 is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
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). 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 and Part 809); 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
1
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 medical devices and radiation-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) 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)
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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. |
| 36 Apple Ridge Road | |
| Danbury, CT 06810 USA | |
| Establishment Registration #: | 1220984 |
| Contact Person: | Kate Brown |
| Sr. Regulatory Affairs Specialist | |
| 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
Biopsy Guidance
System | I-View™/ Contrast
Enhanced Digital
Mammography
(CEDM) | Affirm® Contrast
Biopsy | Comparison |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Features and
Characteristics | Primary Predicate
(K103512) | Reference Device
(K123873) | Proposed | |
| Indications for
Use | The Affirm®
Breast Biopsy
Guidance System
is an optional
accessory for the
Selenia
Dimensions 2D
Full Field Digital
Mammography
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. 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 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 | Similar. The
proposed device's
indications for use
will be a
combination of the
primary predicate
and reference
device's indications
for use statement.
The addition of
"3Dimensions
system" was added
to the proposed
indications for use
statement. The
3Dimensions
system does not
differ
technologically
from that of the
Selenia Dimensions
system. |
| | | | 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 | |
| X-Ray Image
Device | Selenia
Dimensions 2D
FFDM | Selenia Dimensions
2D FFDM | modalities.
Selenia Dimensions
and 3Dimensions | Similar. Selenia
Dimensions and
3Dimensions are
both capable of 2D
FFDM which is
utilized for the
proposed device's
lesion localization. |
| Coordinate
Determination | Cartesian
Coordinates
determined from
Dimensions
Stereotactic
software | Not applicable to
CEDM | Cartesian
Coordinates
determined from
Dimensions
Stereotactic
software | Same as primary
predicate, Affirm®
Breast Biopsy
Guidance System |
| Movement
Method | X: Motorized
Y: Motorized
Z: Manual | Not applicable to
CEDM | X: Motorized
Y: Motorized
Z: Manual | Same as primary
predicate, Affirm®
Breast Biopsy
Guidance System |
| | | | | |
| Stereotactic
Angle | +/- 15° | Not applicable to
CEDM | +/- 15° | Same as primary
predicate, Affirm®
Breast Biopsy
Guidance System |
| Method of
Use | Lesion localization
is obtained from
2D stereotactic
image acquisition. | Lesion localization
is obtained from
contrast enhanced
2D breast imaging
using a dual energy
technique. | Lesion localization
is obtained from
2D contrast
enhanced image
acquisition from
low energy and
subtracted image
pairs. | Similar. Lesion
localization is
obtained utilizing
the primary
predicate and
reference device's
method of use. |
| Mechanism of
Action | Guidance for
breast biopsy:
-Standard
(vertical)
approach | Not applicable to
CEDM | Guidance for
breast biopsy:
-Standard (vertical)
approach
-Right or left lateral
approach | Similar. The
addition of the
lateral approach
was cleared via
K161575 and is
compatible with
the proposed
device. |
| Workflow | Stereotactic
biopsy workflow | Dual energy
imaging technique
workflow | Stereotactic biopsy
workflow | Similar. The
proposed device's
workflow is similar
to the primary
predicate device's
workflow. The only
difference are the
additional steps on
the AWS GUI which
allow the user to
choose Contrast
Enhanced Digital
Mammography
images instead of
2D images before
performing the
stereotactic biopsy.
The proposed
device Affirm®
Contrast Biopsy
workflow differs
from the reference
device CEDM
workflow as it is
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.