(38 days)
Not Found
No
The description focuses on stereotactic imaging and Cartesian coordinate calculations for lesion localization, with no mention of AI or ML techniques.
No.
The device is for guiding biopsy and localization, not for treating a disease or condition itself.
No
The device is a guidance system for interventional procedures like biopsy, not one that directly diagnoses a condition.
No
The device description explicitly states it is an "optional accessory" for a mammography system and includes safety features related to the physical mounting, latching, and connection of a "biopsy module," as well as motorized movement of a "biopsy device." These are hardware components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device function: The Affirm breast biopsy guidance system is a guidance system used during a medical procedure (biopsy). It helps the physician accurately locate a lesion within the breast using imaging data. It does not analyze a sample taken from the body to provide diagnostic information.
- Intended Use: The intended use clearly states it is for "guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices)." This is a procedural aid, not a diagnostic test performed on a sample.
- Device Description: The description reinforces its role in localizing lesions and guiding the biopsy procedure. It doesn't mention any analysis of biological samples.
Therefore, the Affirm breast biopsy guidance system falls under the category of a medical device used for image-guided intervention, not an in vitro diagnostic device.
N/A
Intended Use / 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).
Product codes
IZH
Device Description
The Affirm Breast Biopsy Guidance System used with the Selenia Dimensions 2D Full Field Digital Mammography System (FFDM), is a stereotactic lesion localization system that has the application of localizing, and then giving a physician the capability of performing fine needle aspiration or core biopsy of lesions determined to be suspicious through prior mammographic examination.
Stereotactic images on the host mammography system are acquired at +/-15°. The stereo images are calculated with Cartesian coordinates to target lesions. Stereo images are displayed on the mammography system display for the targeting procedure. Images are then sent to PACS for archiving via DICOM protocol.
Safety Features include:
- 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
- Motorized movement of biopsy device only under user control
- Audible alert if biopsy device motion could result in mechanical interference
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Mammographic X-Ray System (Selenia Dimensions 2D Full Field Digital Mammography System)
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician (for breast biopsy or pre-surgical localization)
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 Hologic Affirm Breast Biopsy Guidance System was successfully tested by UL to IEC 60601-1 Medical Electrical Equipment Standards. Stereotactic images captured, saved and/or transmitted by the Selenia Dimensions 2D FFDM conform with ACR/NEMA Digital Imaging Communications in Medicine version 3.0.
Hologic successfully performed design control verification and validation tests in accordance with 21 CFR Part 820.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Hologic, Inc.
Affirm Breast Biopsy Guidance System Special 510(k) Premarket Notification
KI03212
510(k) Summarv
JAN 7 - 2011
This 510(k) summary is submitted in accordance with the requirements of 21 CFR Part 807.87 (b)
Product Name: Affirm Breast Biopsy Guidance System
Product Classification Name: Mammographic X-Ray System
Product Classification Code: 90 IZH CFR Section: 892.1710
Classification Panel: Radiology
Class
Manufacturer:
Hologic, Inc. 36-37 Apple Ridge Road Danbury, CT 06810 USA
| Contact Person: | Gail Yaeker-Daunis |
|---|---|
| Telephone Number: | (203) 731-8337 |
| Fax Number: | (203) 731-8440 |
November 28, 2010 Date Prepared:
Predicate Device: K071542, Hologic Digital StereoLoc II
Device Description:
The Affirm Breast Biopsy Guidance System used with the Selenia Dimensions 2D Full Field Digital Mammography System (FFDM), is a stereotactic lesion localization system that has the application of localizing, and then giving a physician the capability of performing fine needle aspiration or core biopsy of lesions determined to be suspicious through prior mammographic examination.
Stereotactic images on the host mammography system are acquired at +/-15°. The stereo images are calculated with Cartesian coordinates to target lesions. Stereo images are displayed on the mammography system display for the targeting procedure. Images are then sent to PACS for archiving via DICOM protocol.
Safety Features include:
Automatic detection of mounting, latching, and connection of biopsy module
1
- C-arm motion disabled if biopsy module is not locked in place
- Automatic compression release disabled when biopsy module installed
- Motorized movement of biopsy device only under user control
- Audible alert if biopsy device motion could result in mechanical interference
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).
Comparison with Predicate Devices:
The Hologic Affirm Breast Biopsy Guidance System is substantially equivalent to K071542 Hologic Digital StereoLoc II, which is used with the Selenia Full Field Digital Mammography X-ray system to provide location of areas of concern and pre-surgical localization for performance of breast biopsies on an upright mammography system.
Summary of Testing
The Hologic Affirm Breast Biopsy Guidance System was successfully tested by UL to IEC 60601-1 Medical Electrical Equipment Standards. Stereotactic images captured, saved and/or transmitted by the Selenia Dimensions 2D FFDM conform with ACR/NEMA Digital Imaging Communications in Medicine version 3.0.
Hologic successfully performed design control verification and validation tests in accordance with 21 CFR Part 820.
Conclusion
The Affirm Breast Biopsy Guidance System design, operation, construction and materials are similar to existing marketed device with no additional risks or hazards.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
JAN 7 2011
Ms. Gail Yaeker-Daunis Senior Regulatory Specialist Hologic, Inc. 36-37 Apple Ridge Road DANBURY CT 06810
Re: K103512
Trade/Device Name: Affirm Breast Biopsy Guidance System Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: II Product Code: IZH Dated: November 29, 2010 Received: November 30, 2010
Dear Ms. Yaeker-Daunis:
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 10 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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Signature
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Hologic, Inc.
Affirm Breast Biopsy Guidance System Special 510(k) Premarket Notification
Indications for Use
Premarket Notification: Affirm Breast Biopsy Guidance System
KID3512 510(k) No.
Device Name: Affirm Breast Biopsy Guidance System
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).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription Use : AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K103512
015
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