(119 days)
The Affirm Prone Biopsy System combines the function of a standard x-ray mammography unit with that of a lesion localization system to produce a device that has specific application in first accurately localizing lesions in the breast in two and/or three dimensions, and then providing guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices) for lesions determined to be suspicious through prior mammographic examination.
It is intended for lesion location for biopsy while the patient is in the prone position to provide guidance for interventional purposes (such as biopsy, presurgical localization or treatment devices).
The Affirm Prone Biopsy Table is a mammographic x-ray system intended for lesion location while the patient is in the prone position. The subject device will be capable of both 2D and 3D imaging methods to calculate the target location. The system localizes suspicious lesions, as determined through prior mammographic examinations, using either stereotactic or tomosynthesis techniques. The system then affords a physician the capacity of performing vacuum assisted or needle core biopsy, or wire localization of the lesion.
Localization can be accomplished either via conventional 2D stereotactic imaging, or by use of a 3D data set. With the 3D data set, the image plane or "slice" most fully containing the suspected lesion is chosen by the physician from the data set to compute the lesion depth within the breast.
Here's an analysis of the provided text to extract information about acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided document, specific quantitative acceptance criteria or a direct performance table are not explicitly stated or presented. The document focuses on regulatory compliance and substantial equivalence to predicate devices.
However, the "Performance Testing" section (Page 4, Section 7) indirectly points to an acceptance criterion:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-2-45 (Safety of Mammographic X-ray Equipment and Mammographic Stereotactic Devices) | "The Affirm Prone Biopsy System meets IEC 60601-2-45 Medical Electrical Equipment - Safety of Mammographic X-ray Equipment and Mammographic Stereotactic Devices." |
| Compliance with 21 CFR Part 820 (Quality System Regulation - Design Control Verification and Validation) | "Hologic successfully performed design control verification and validation tests in accordance with 21 CFR Part 820." |
| Functional Performance (Equivalence to Predicates) | "The Affirm Prone Biopsy Table has been shown to be equivalent in technology, method of operation, functional performance and intended use to the predicates..." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a sample size for a test set in the context of clinical performance or diagnostic accuracy. The testing mentioned appears to be primarily engineering verification and validation against safety and quality standards.
The data provenance (e.g., country of origin, retrospective/prospective) related to any clinical test set is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The type of testing described (compliance with IEC standards, design control) does not typically involve expert-established ground truth in the same way a clinical performance study would.
4. Adjudication Method for the Test Set:
An adjudication method (e.g., 2+1, 3+1) for a clinical test set is not mentioned because a clinical test set for diagnostic performance is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not mentioned in this document. The device is a "Biopsy System" for guidance, not a diagnostic AI interpretation tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The document describes the "Affirm Prone Biopsy System" as a physical mammographic x-ray system that provides guidance for interventional procedures. While it utilizes "2D and 3D imaging methods to calculate the target location" (Page 4, Section 4), it is fundamentally a system that aids a physician. Therefore, a standalone (algorithm only) performance, separate from human operation or decision-making, is not described or implied. The device's function is to guide a human operator.
7. The Type of Ground Truth Used:
The document focuses on engineering and regulatory ground truth:
- Compliance with IEC 60601-2-45 standards: This implies meeting established technical specifications and safety requirements.
- Compliance with 21 CFR Part 820 (Design Controls): This refers to documented evidence that the device design meets user needs and intended uses.
- Equivalence to Predicate Devices: The "ground truth" for its performance is its demonstrated similarity in technology, operation, and functional performance to previously cleared devices.
There is no mention of clinical ground truth such as pathology, expert consensus on lesions, or outcomes data for a diagnostic or interventional accuracy claim. The device's purpose is localization and guidance, not diagnostic interpretation.
8. The Sample Size for the Training Set:
The document does not mention a training set size. This is consistent with the nature of the device being an imaging and guidance system, rather than a machine learning or AI algorithm requiring a training set for feature learning. The image processing for 2D/3D localization would be based on established algorithms, not necessarily a trained machine learning model.
9. How the Ground Truth for the Training Set Was Established:
Since a training set is not mentioned, the method for establishing its ground truth is also not applicable/provided.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 1, 2016
Hologic, Inc. % Ms. Sarah Fairfield Principal Regulatory Affairs Specialist 36 Apple Ridge Road DANBURY CT 06810
Re: K153486
Trade/Device Name: Affirm Prone Biopsy System Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: II Product Code: IZH Dated: March 9, 2016 Received: March 10, 2016
Dear Ms. Fairfield:
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.'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}------------------------------------------------
Indications for Use
510(k) Number (if known)
K153486
Device Name Affirm Prone Biopsy System
Indications for Use (Describe)
The Affirm Prone Biopsy System combines the function of a standard x-ray mammography unit with that of a lesion localization system to produce a device that has specific application in first accurately localizing lesions in the breast in two and/or three dimensions, and then providing guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices) for lesions determined to be suspicious through prior mammographic examination.
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."
{3}------------------------------------------------
7. 510(k) SUMMARY
1. Submitter:
Hologic, Inc. 36 Apple Ridge Rd. Danbury, CT 06810 USA Telephone: 508.263.8857
Contact: Sarah Fairfield, Principal Regulatory Affairs Specialist Date Prepared: December, 4 2015
2. Device:
Trade Name: Affirm Prone Biopsy System Common Name: Mammographic x-ray system Classification Name: Mammographic x-ray system Regulation number: 21 CFR 892.1710 Product Code: IZH Class: II
3. Predicate Device:
Multicare Platinum Prone Breast Biopsy Table (K030666) Affirm Breast Biopsy Guidance System (K122836)
4. Device Description:
The Affirm Prone Biopsy Table is a mammographic x-ray system intended for lesion location while the patient is in the prone position. The subject device will be capable of both 2D and 3D imaging methods to calculate the target location. The system localizes suspicious lesions, as determined through prior mammographic examinations, using either stereotactic or tomosynthesis techniques. The system then affords a physician the capacity of performing vacuum assisted or needle core biopsy, or wire localization of the lesion.
Localization can be accomplished either via conventional 2D stereotactic imaging, or by use of a 3D data set. With the 3D data set, the image plane or "slice" most fully containing the suspected lesion is chosen by the physician from the data set to compute the lesion depth within the breast.
Safety features include:
- Automatic Detection of mounting, latching and connection of biopsy ● guidance module.
- C-arm motion is disabled if biopsy module is not locked in place
- Automatic compression release is disabled when biopsy guidance ● module is installed
{4}------------------------------------------------
- Motorized movement of biopsy device only occurs under user control
- . Audible alert if biopsy motion could result in mechanical interference.
5. Intended Use:
It is intended for lesion location for biopsy while the patient is in the prone position to provide guidance for interventional purposes (such as biopsy, presurgical localization or treatment devices).
The Affirm Prone Biopsy System combines the function of a standard x-ray mammography unit with that of a lesion localization system to produce a device that has specific application in first accurately localizing lesions in the breast in two and/or three dimensions, and then providing guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices) for lesions determined to be suspicious through prior mammographic examination.
6. Comparison of Characteristics:
The Affirm Prone Breast Biopsy System's design, operation, basic construction and materials used are substantially equivalent to the cleared Multicare Platinum System. The software enables use of either lesion localization in two and/or three dimensions for biopsy and is substantially equivalent to the cleared Affirm Breast Biopsy System (K122836). The Affirm Prone Biopsy System is substantially equivalent to and as safe and effective as the cleared the Multicare Platinum System (K030666) and the Affirm Breast Biopsy Guidance System (K122836), and poses no additional risks or hazards.
7. Performance Testing:
The Affirm Prone Biopsy 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.
8. Conclusion:
Based on the intended use, descriptive information and performance testing provided in this submission, the Affirm Prone Biopsy Table has been shown to be equivalent in technology, method of operation, functional performance and intended use to the predicates, Multicare Platinum Prone Breast Biopsy Table (K030666) and Affirm Breast Biopsy Guidance System (K122836).
§ 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.