(64 days)
No
The summary describes a mechanical accessory for a biopsy guidance system and does not mention any software features related to AI or ML. The performance studies focus on mechanical accuracy and safety standards.
No
The device is described as a guidance system for interventional procedures like biopsy and pre-surgical localization. It does not directly provide a therapy but rather aids in pinpointing lesions for potential treatment.
No
This device is designed to guide interventional procedures like biopsies, not to diagnose conditions. It localizes lesions for a biopsy, which is a procedure to obtain tissue for diagnosis, rather than making the diagnosis itself.
No
The device description explicitly mentions new hardware components such as a lateral biopsy paddle, lateral arm stand, case, and QC phantom, and the performance studies include testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is designed for "guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices)." This describes a device used during a medical procedure to guide instruments within the body.
- Device Description: The description details a physical accessory that attaches to a mammography system to facilitate needle placement. It describes mechanical components and their function in guiding a biopsy needle.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any analysis of biological samples. It is a tool for guiding a procedure.
The device is a medical device used for image-guided intervention, specifically breast biopsy.
N/A
Intended Use / Indications for Use
The Affirm Breast Biopsy Guidance System is an optional accessory for the Selenia Dimensions Mammography System. It is designed to allow the accurate localization of lesions in three dimensions. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).
Product codes (comma separated list FDA assigned to the subject device)
IZH
Device Description
This submission introduces the optional Affirm Lateral Arm Upright Biopsy Accessory which attaches to the Affirm Breast Biopsy Guidance System used with the Selenia Dimensions 2D/3D Mammography System, software version 1.8.4 and higher.
The optional Affirm Lateral Arm Upright Biopsy Accessory attaches to the Affirm Biopsy Guidance Module (BGM) to enable lateral needle approach procedures. The Lateral Arm can only be used when the Selenia Dimensions C-arm is positioned at 0 degrees. When using the Lateral Arm, the X- Y- and Z-axis movement is the same as for the Affirm standard (upright) needle approach. For the lateral approach, the biopsy needle is manually advanced into the breast along its own X-axis, referred to as "Lat X".
When performing lateral approach biopsies, the biopsy device is installed onto the lateral arm in the same manner as when performing standard (upright biopsies).
New components used with the Affirm Lateral Arm Upright Biopsy Accessory include: lateral biopsy paddle, lateral arm stand, case, and QC phantom specifically to be used for Lateral approach biopsies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
The (optional) Affirm Lateral Arm Upright Biopsy Accessfully performed system design control verification and validation tests, which are summarized in accordance with FDA's Guidance for the Content of premarket Submissions for Software Contained in Medical Devices (issued on May 11, 2005) based on a moderate level of concern.
In addition, the following test reports are included:
- Lateral Arm Targeting Accuracy Test ●
- Default Needle Parameter Validation Test Report .
The Affirm CB test report was updated to include the optional Lateral Arm Accessory and the new lateral biopsy paddle. Third party testing was conducted on the tests listed below which were considered necessary to evaluate the noted changes:
- Tensile Safety Factor (IEC 60601-1, Clause 9.8.2)
- Strength of Compression Plates (IEC 60601-2-45, Subclause 203.8.5.4.102.5)
- Biopsy Needle Positioning Accuracy of Mammographic Stereotactic Devices *IEC ● 60601-2-45, Subclause 201.9.2.1013 a,b,c)
No clinical studies were performed. Substantial equivalence has been demonstrated by nonclinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 10, 2016
Hologic, Inc. % Ms. Debbie Peacock Senior Manager, Regulatory Affairs 36 Apple Ridge Road DANBURY CT 06810
Re: K161575
Trade/Device Name: Affirm Lateral Arm Upright Biopsy Accessory Regulation Number: 21 CFR 892.1710 Regulation Name: Mammography x-ray system Regulatory Class: II Product Code: IZH Dated: June 8, 2016 Received: June 9, 2016
Dear Ms. Peacock:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Affirm Lateral Arm Upright Biopsy Accessory
Indications for Use (Describe)
The Affirm Breast Biopsy Guidance System is an optional accessory for the Selenia Dimensions Mammography System. It is designed to allow the accurate localization of lesions in three dimensions. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).
| 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."
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
3
Traditional 510(k) Summary
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807.92
| Date Prepared: | June 6, 2016 |
|---|---|
| Manufacturer: | Hologic, Inc. |
| 36 Apple Ridge Road | |
| Danbury, CT 06810 USA | |
| Est. Registration #: | 1220984 |
| Manufacturer: | Hologic, Inc. |
| 37 Apple Ridge Road | |
| Danbury, CT 06810 USA | |
| Est. Registration #: | 1225717 |
| Contact Person: | Debbie Peacock |
| Sr. Manager, Regulatory Affairs | |
| Phone: (203) 702-7794 | |
| Identification of the Device: |
Identification of the Device:
| Proprietary/Trade Name | Affirm™ Lateral Arm Upright Biopsy Accessory |
|---|---|
| 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 General name: Mammographic X-ray system Submitter / 510(k) Holder: HOLOGIC, Inc. 510(k) #'s: K122836, cleared on 01/11/13 Product Code: IZH Regulation Number: 892.1710
Identification of the Legally Marketed Reference Device:
Trade name: GE Senographe General name: Mammographic X-ray system Submitter / 510(k) Holder: General Electric, Inc. 510(k) #'s: K040125, cleared on 04/19/04 Product Code: IZH Regulation Number: 892.1710
4
Device Description:
This submission introduces the optional Affirm Lateral Arm Upright Biopsy Accessory which attaches to the Affirm Breast Biopsy Guidance System used with the Selenia Dimensions 2D/3D Mammography System, software version 1.8.4 and higher.
The optional Affirm Lateral Arm Upright Biopsy Accessory attaches to the Affirm Biopsy Guidance Module (BGM) to enable lateral needle approach procedures. The Lateral Arm can only be used when the Selenia Dimensions C-arm is positioned at 0 degrees. When using the Lateral Arm, the X- Y- and Z-axis movement is the same as for the Affirm standard (upright) needle approach. For the lateral approach, the biopsy needle is manually advanced into the breast along its own X-axis, referred to as "Lat X".
When performing lateral approach biopsies, the biopsy device is installed onto the lateral arm in the same manner as when performing standard (upright biopsies).
New components used with the Affirm Lateral Arm Upright Biopsy Accessory include: lateral biopsy paddle, lateral arm stand, case, and QC phantom specifically to be used for Lateral approach biopsies.
The Indications for Use is unchanged from the predicate Affirm Breast Biopsy Guidance System as shown below.
Indications for Use:
The Affirm Breast Biopsy Guidance System is an optional accessory for the Selenia Dimensions Mammography System. It is designed to allow the accurate localization of lesions in the breast in three dimensions. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).
Substantial Equivalence:
The (optional) Affirm Lateral Arm Upright Biopsy Accessory is substantially equivalent to the predicate Affirm Breast Biopsy Guidance System (K122836) and to the lateral arm attachment used as a reference device, cleared in GE's Senographe Stereo System, (K040125). Substantial equivalence is based on design, technology, Indications for Use, labeling, operation, basic constructions and materials used. The addition of the optional Lateral Arm Accessory to the cleared Affirm Biopsy Guidance System poses no additional hazards and is substantially equivalent to our predicate and reference devices listed below.
| | Affirm Lateral Arm
Upright Biopsy
Accessory
(Proposed) | Predicate Device
Affirm Breast Biopsy
Guidance System
(K122836) | Reference Device
GE Senographe
Stereo (K040125);
(lateral arm) |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The Affirm Breast Biopsy
Guidance System is an
optional accessory for the
Selenia Dimensions
Mammography System. It | The Affirm Breast Biopsy
Guidance System is an
optional accessory for the
Selenia Dimensions
Mammography System. It is | Senographe Stereo is
an optional accessory
for the Senographe DS
full field digital system.
It is designed to allow |
| | | | |
| X-ray Image
Device | is designed to allow the
accurate localization of
lesions in the breast in
two/and or three
dimensions. It is intended
to provide guidance for
interventional purposes
(such as biopsy, pre-
surgical localization or
treatment devices).
Hologic Selenia
Dimensions 2D/3D
Mammography System | designed to allow the
accurate localization of
lesions in the breast in three
dimensions. It is intended
to provide guidance for
interventional purposes
(such as biopsy, pre-surgical
localization or treatment
devices).
Same | 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).
GE Senographe DS 2D |
| Software | Selenia Dimensions V1.8.4
and higher) | Selenia Dimension V1.8.3
(current version) | Same description;
version unknown. |
| Method of Use | Breast lesion localization
and biopsy
core biopsy vacuum assisted
biopsy fine needle
aspiration hook wire
localization
exams. | Breast lesion localization
and biopsy
core biopsy vacuum assisted
biopsy fine needle
aspiration hook wire
localization exams. | Breast lesion
localization and biopsy,
such as:
core biopsy vacuum
assisted biopsy fine needle
aspiration hook wire
localization
exams. |
| Dedicated
Breast Biopsy
Positioner | Yes | Yes | Yes |
| Mechanism of
Action | Guidance for breast biopsy
-Standard (vertical)
approach, and
-Right or left lateral
approach. | Guidance for breast biopsy
-Standard (vertical) approach | Guidance for breast
biopsy
-Standard (vertical),
and right or left lateral
approach. |
| Technology | | | |
| Coordinate
Determination | Yes | Yes | Yes |
| Needle
Positioning | Biopsy Positioning
Module gets X, Y, Z
coordinates of target area
from AWS | Biopsy Positioning Module
gets X, Y, Z coordinates of
target area from AWS | Biopsy Positioning
Module gets X, Y, Z
coordinates of target
area from AWS |
5
6
| Stereotactic/
Tomographic
Angle | Stereo:
+/- 15 °
Tomo:
15 degrees total (+/- 7.5
degrees) | Stereo:
Same
Tomo:
Same | Stereo:
+/- 15 °
Tomo:
N/A |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Stated
Accuracy | +/- 1 mm in X, Y and Z
Axis
[overall targeting
accuracy is equal to
combined targeting
accuracy of the Biopsy
arm controller and the
biopsy device (maximum
deviation from target
coordinate will not be
more than 2 mm from
either side)]. | Same | +/- 1 mm in X, Y and Z
Axis |
| Compression
Method | Manual, automatic
compression release is
disabled automatically
when the BGM is
installed. | Same | Manual, compression
range is 10-100 mm,
with compression
controlled manually. |
| Compression
Paddle | Vertical approach
w/window,
Lateral approach, no
window | Vertical approach w/window | Vertical approach
w/window,
Lateral approach, no
window: |
| Safety
Features | Same
Plus:
When the system is in
lateral approach biopsy
mode, the system shall
only allow exposures at C-
arm position of 0 degrees. | Automatic detection of
mounting, latching and
connection of biopsy module
C-arm motion disabled if
biopsy module is not locked
in place.
Automatic compression
release disabled when biopsy
module installed
C-Arm Motion disabled
when breast is under
compression
Motorized movement of
biopsy device only under
user control.
Audible alert when biopsy
device motion may result in | Unknown |
| | | mechanical interference. | |
| Materials (Short-term Skin Contracting) | | | |
| Breast
Platform
Material | Carbon Fiber | Same | Same |
| Biopsy Paddle
Material | Polycarbonate plastics | Same | Same |
7
Summary of Testing:
The (optional) Affirm Lateral Arm Upright Biopsy Accessfully performed system design control verification and validation tests, which are summarized in accordance with FDA's Guidance for the Content of premarket Submissions for Software Contained in Medical Devices (issued on May 11, 2005) based on a moderate level of concern.
In addition, the following test reports are included:
- Lateral Arm Targeting Accuracy Test ●
- Default Needle Parameter Validation Test Report .
The Affirm CB test report was updated to include the optional Lateral Arm Accessory and the new lateral biopsy paddle. Third party testing was conducted on the tests listed below which were considered necessary to evaluate the noted changes:
- Tensile Safety Factor (IEC 60601-1, Clause 9.8.2)
- Strength of Compression Plates (IEC 60601-2-45, Subclause 203.8.5.4.102.5)
- Biopsy Needle Positioning Accuracy of Mammographic Stereotactic Devices *IEC ● 60601-2-45, Subclause 201.9.2.1013 a,b,c)
No clinical studies were performed. Substantial equivalence has been demonstrated by nonclinical testing.
Conclusion:
The Affirm Lateral Arm Upright Biopsy Accessory is a modification to the predicate Affirm Breast Biopsy Guidance System (K122836) and is also substantially equivalent to the lateral arm component used in the reference GE Senographe Stereo System. (K040125). The design, operation, basic construction and materials used are substantially equivalent to the above predicate devices. Selenia Dimensions software V1.8.4 and higher enables use of either 2D or tomosynthesis-guided biopsy in a standard (vertical) or lateral approach. The addition of the (optional) Affirm Lateral Arm Upright Biopsy Accessory to the cleared Affirm Biopsy Guidance System is substantially equivalent to our predicate and reference devices listed above.