Who is the manufacturer of Affirm Lateral Arm Upright Biopsy Accessory?

Hologic filed the 510(k) submission for Affirm Lateral Arm Upright Biopsy Accessory (K161575).

What is the FDA product code for Affirm Lateral Arm Upright Biopsy Accessory?

IZH. It is classified under 21 CFR 892.1710 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Affirm Lateral Arm Upright Biopsy Accessory?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Affirm Lateral Arm Upright Biopsy Accessory?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Affirm Lateral Arm Upright Biopsy Accessory

Q: What are the predicate devices for Affirm Lateral Arm Upright Biopsy Accessory?

Affirm Breast Biopsy Guidance System (K122836).

K161575 · Hologic · IZH · Aug 10, 2016 · Radiology

Device Facts

Record ID	K161575
Device Name	Affirm Lateral Arm Upright Biopsy Accessory
Applicant	Hologic
Product Code	IZH · Radiology
Decision Date	Aug 10, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1710
Device Class	Class 2

Intended 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).

Device Story

Affirm Lateral Arm Upright Biopsy Accessory is an optional attachment for the Hologic Selenia Dimensions Mammography System; enables lateral needle approach for breast biopsies. Device consists of lateral biopsy paddle, lateral arm stand, case, and QC phantom. Operates only when C-arm is at 0 degrees. Biopsy needle manually advanced along X-axis (Lat X). System uses X, Y, Z coordinates from the Biopsy Positioning Module to guide needle placement. Used in clinical settings by trained healthcare professionals. Provides visual guidance for interventional procedures; assists in accurate lesion targeting. Benefits include expanded surgical access options for breast biopsies.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical bench testing, including targeting accuracy tests, needle parameter validation, tensile safety factor testing (IEC 60601-1), compression plate strength testing (IEC 60601-2-45), and biopsy needle positioning accuracy testing.

Technological Characteristics

Accessory for Selenia Dimensions Mammography System. Materials: Carbon fiber (breast platform), polycarbonate (biopsy paddle). Sensing/Actuation: Manual needle advancement with coordinate-based positioning via Biopsy Positioning Module. Connectivity: Integrated with Selenia Dimensions system (software V1.8.4+). Safety: C-arm position interlock (0 degrees only). Sterilization: Not specified. Software: Moderate level of concern.

Indications for Use

Indicated for patients requiring breast lesion localization and interventional procedures, including core biopsy, vacuum-assisted biopsy, fine needle aspiration, and hook wire localization.

Regulatory Classification

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.

Predicate Devices

Affirm Breast Biopsy Guidance System (K122836)

Reference Devices

GE Senographe Stereo System (K040125)

Related Devices

K153486 — Affirm Prone Biopsy System · Hologic, Inc. · Apr 1, 2016
K103512 — AFFIRM BREAST BIOPSY GUIDANCE SYSTEM · Hologic, Inc. · Jan 7, 2011
K191495 — Biopsy Positioner · Fujifilm Corporation · Jul 3, 2019
K122836 — AFFIRM BREAST BIOPSY GUIDANCE SYSTEM · Lorad, A Hologic Co. · Jan 11, 2013
K023864 — PERFORMA STEREO · Instrumentarium Corp. Imaging Division · Jan 9, 2003

Submission Summary (Full Text)

{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) K161575 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) | | |---------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." 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.