(116 days)
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).
The Affirm Breast Biopsy Guidance System is used with Selenia Dimensions 2D or with Selenia Dimensions 3D tomosynthesis. Lesion location can be obtained from either 2D stereotactic or 3D tomosynthesis image acquisition. Both stereotactic and 3D localization calculate a three dimensional location for percutaneous placement for biopsy, pre-surgical localization or treatment devices. Safety Features include: Automatic detection of mounting, latching, and connection of biopsy guidance module; C-arm motion disabled if biopsy guidance module is not locked in place; Automatic compression release disabled when biopsy guidance module installed; Motorized movement of biopsy device only under user control; Audible alert if biopsy device motion could result in mechanical interference.
The provided text describes a Special 510(k) Premarket Notification for the "Modified Affirm Breast Biopsy Guidance System." However, it does not contain the detailed acceptance criteria or the specifics of a study proving the device meets those criteria in the format requested.
The document states that the device "meets IEC 60601-2-45 Medical Electrical Equipment - Safety of Mammographic X-ray Equipment and Mammographic Stereotactic Devices" and that "Hologic successfully performed design control verification and validation tests in accordance with 21 CFR Part 820." It also mentions that "Accuracy can be verified during the biopsy process."
The core of this 510(k) submission is to demonstrate substantial equivalence to a predicate device (K103512), specifically regarding a software change that enables the use of 3D tomosynthesis calculations for lesion localization, in addition to the existing 2D stereotactic capabilities. The manufacturer asserts that the "3D tomosynthesis lesion location is substantially equivalent to and as safe and effective as the cleared Affirm Breast Biopsy Guidance System and poses no additional risks or hazards."
Without explicit reported device performance metrics or a detailed study description in the provided text, I cannot populate most of the requested table.
Here's a breakdown of what can and cannot be answered based on the input:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated/Implied) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-2-45 (Safety of Mammographic X-ray Equipment and Mammographic Stereotactic Devices) | "The Affirm Breast Biopsy Guidance System meets IEC 60601-2-45" |
| Compliance with 21 CFR Part 820 (Design Control Verification and Validation) | "Hologic successfully performed design control verification and validation tests in accordance with 21 CFR Part 820." |
| Substantial Equivalence in Accuracy for 3D Tomosynthesis Lesion Localization compared to 2D Stereotactic Localization of the predicate device | "Accuracy can be verified during the biopsy process. The 3D tomosynthesis lesion location is substantially equivalent to and as safe and effective as the cleared Affirm Breast Biopsy Guidance System and poses no additional risks or hazards." |
| No additional risks or hazards compared to the predicate device | "poses no additional risks or hazards." |
| Specific Accuracy Metrics (e.g., in mm) | Not reported in the provided text. |
| Sensitivity/Specificity/AUC | Not reported in the provided text. |
2. Sample size used for the test set and the data provenance:
- Not specified in the provided text. The document refers to "design control verification and validation tests," but does not detail the specific test set size or data provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified in the provided text.
4. Adjudication method for the test set:
- Not specified in the provided text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study is mentioned. The device is a guidance system for biopsy, not an AI-assisted diagnostic tool for human readers in the classical sense of an MRMC study. The "AI" component would be the 3D tomosynthesis calculations for localization, but the text focuses on its equivalence rather than reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies that the "3D tomosynthesis lesion location" calculation itself was evaluated for "accuracy" and "substantial equivalence." This suggests an evaluation of the algorithm's output (lesion coordinates) as a standalone function, separate from a human interpreting images. However, specific details of such a standalone study (e.g., methodology, metrics, and number of cases) are not provided.
7. The type of ground truth used:
- The document states "Accuracy can be verified during the biopsy process." This strongly suggests that the ground truth for localization accuracy would be based on biopsy results or confirmation during the interventional procedure. However, it is not explicitly stated how this ground truth was used in specific verification or validation tests mentioned.
8. The sample size for the training set:
- Not specified in the provided text. This document is for a modified version of an already cleared device, primarily focusing on a software change. Details of the original device's training are not provided, nor are details of any specific training done for the 3D tomosynthesis algorithm.
9. How the ground truth for the training set was established:
- Not specified in the provided text.
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Hologic, Inc.
Modified Affirm Breast Biopsy Guidance System Special 510(k) Premarket Notification
510(k) Summary
JAN 1 1 2013
This 510(k) summary is submitted in accordance with the requirements of 21 CFR Part 807.92
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 II
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 |
Date Prepared: August 14, 2012
Predicate Device: Affirm Breast Biopsy Guidance System, K103512
Device Description:
The Affirm Breast Biopsy Guidance System is used with Selenia Dimensions 2D or with Selenia Dimensions 3D tomosynthesis. Lesion location can be obtained from either 2D stereotactic or 3D tomosynthesis image acquisition.
Both stereotactic and 3D localization calculate a three dimensional location for percutaneous placement for biopsy, pre-surgical localization or treatment devices.
Safety Features include:
- Automatic detection of mounting, latching, and connection of biopsy guidance . module
- C-arm motion disabled if biopsy guidance module is not locked in place ●
- Automatic compression release disabled when biopsy guidance 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:
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Hologic, Inc.
Modified Affirm Breast Biopsy Guidance System Special 510(k) Premarket Notification
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).
Comparison with Predicate Devices:
The modified Affirm Breast Biopsy Guidance System is substantially equivalent to Affirm Breast Biopsy Guidance System which was cleared as K103512 for use with the Selenia Dimensions 2D Mammography system to provide localization of areas of concern for performance of breast biopsies. The intended use is the same using either stereotactic or 3D tomosynthesis lesion localization for biopsy with Selenia Dimensions Mammography System.
Summary of Testing:
The Affirm Breast Biopsy Guidance System meets IEC 60601-2-45 Medical Electrical Equipment - Safety of Mammographic X-ray Equipment and Mammographic Stereotactic Devices. Hologic successfully performed design control verification and validation tests in accordance with 21 CFR Part 820.
Conclusion:
The Affirm Breast Biopsy Guidance System's design, operation, construction and materials are unchanged from the cleared Affirm Breast Biopsy Guidance System. A software change enables use of either stereotactic or 3D tomosynthesis calculations for lesion localization for biopsy when the Affirm is used with a Selenia Dimensions 3D system . There is no change to the device when used with the Selenia Dimensions 2D system. Accuracy can be verified during the biopsy process. The 3D tomosynthesis lesion location is substantially equivalent to and as safe and effective as the cleared Affirm Breast Biopsy Guidance System and poses no additional risks or hazards.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the left side of the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 11, 2013
Ms. Gail Yaeker-Daunis Senior Regulatory Specialist Hologic, Inc. 36 Apple Ridge Road DANBURY CT 06810
Re: K122836
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: December 14, 2012 Received: December 17, 2012
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 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2-Ms. Yaeker-Daunis
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 1-800- 638-2041 or 301-796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sean M. Boyd -S for
Janine M. Morris Director. Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure .
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Indications for Use
510(k) Number (if known): K122836
Device Name:
Affirm Breast Biopsy Guidance System
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).
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Sean M. Boyd -S
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k) K122836
Page 1 of 1
§ 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.