(302 days)
Not Found
Unknown
The summary describes image analysis and pattern recognition but does not explicitly mention AI or ML, nor does it provide details about the underlying algorithms or training data that would confirm the use of these technologies.
No
The device aids radiologists in assessing breast tissue composition by categorizing breast density, but it is explicitly stated that "The Quantra software produces adjunctive information; it is not a diagnostic aid." and it does not treat or alleviate a medical condition.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The Quantra software produces adjunctive information; it is not a diagnostic aid."
Yes
The device description explicitly states "Quantra is a software application" and the intended use describes it as a "software application". There is no mention of accompanying hardware components being part of the device itself.
Based on the provided information, the Quantra™ software application is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use explicitly states that the software is "intended for use with mammographic images acquired using digital breast x-ray systems." This involves analyzing medical images, not biological samples or specimens.
- Nature of Analysis: The software analyzes the distribution and texture of tissue patterns within the mammographic images to estimate breast composition. This is image analysis, not laboratory testing of biological materials.
- "Adjunctive Information" and "Not a Diagnostic Aid": The intended use clearly states that the software produces "adjunctive information" and is "not a diagnostic aid." IVDs are typically used to provide diagnostic information or aid in diagnosis.
- Device Description: The device description focuses on the software's function in analyzing image characteristics (fat and fibroglandular tissue) within the mammogram.
- Input: The input is "mammographic images," not biological samples.
In Vitro Diagnostics (IVDs) are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This is typically done by examining specimens derived from the human body, such as blood, urine, or tissue.
The Quantra software analyzes images, which falls under the category of medical image analysis software, not IVDs.
N/A
Intended Use / Indications for Use
The Quantra™ software application is intended for use with mammographic images acquired using digital breast x-ray systems. The Quantra software segregates breast density into categories, which may be useful in the reporting of consistent BI-RADS® breast composition categories as mandated by certain state regulations. The Quantra software reports a result for each subject, which is intended to aid radiologists in the assessment of breast tissue composition. The Quantra software produces adjunctive information; it is not a diagnostic aid.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Quantra is a software application used to produce assessments of breast composition and categorize them. A breast consists of fat and fibroglandular tissue. Fibroglandular tissue, also referred to as dense tissue, contains a mixture of fibrous connective tissue (stroma) and glandular tissue (epithelial cells), and usually appears brighter than surrounding tissue on a digital mammographic image. Abnormal lesions also appear bright on a mammogram and can be obscured or masked by fibroglandular tissue.
The Quantra software is designed to estimate breast composition categories by analyzing distribution and texture of parenchymal tissue patterns which can be responsible for the masking effect during mammographic reading.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
mammographic images acquired using digital breast x-ray systems.
Anatomical Site
breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists
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
Non-clinical (Bench) testing has been performed using retrospectively collected images of 4view screening negative cases. The proposed Quantra software (Version 2.2) was tested against an independent data set of 230 studies, for which the 5 radiologists' consensus assessment of BIRADS 5th Edition categories are known.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical (Bench) testing has been performed using retrospectively collected images of 4view screening negative cases. The proposed Quantra software (Version 2.2) was tested against an independent data set of 230 studies, for which the 5 radiologists' consensus assessment of BIRADS 5th Edition categories are known.
Quantra 2.2 2D Fatty vs. Dense (Fatty (a+b) Accuracy: 92.9%, Dense (c+d) Accuracy: 99.1%)
Quantra 2.2 Tomo Fatty vs. Dense (Fatty (a+b) Accuracy: 92.0%, Dense (c+d) Accuracy: 94.0%)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Quantra 2.2 2D Fatty vs. Dense:
Fatty (a+b) Accuracy: 92.9%
Dense (c+d) Accuracy: 99.1%
Quantra 2.2 Tomo Fatty vs. Dense:
Fatty (a+b) Accuracy: 92.0%
Dense (c+d) Accuracy: 94.0%
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.
Not Found
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 20, 2017
Hologic, Inc. Neil Kelly Principal Regulatory Affairs Specialist 36 Apple Ridge Road DANBURY, CT 06810
Re: K163623
Trade/Device Name: Quantra™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: December 20, 2016 Received: December 22, 2016
Dear Neil Kelly:
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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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.
Robert Ocks
Robert Ochs, Ph.D. 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) K163623
Device Name Quantra™M
Indications for Use (Describe)
The Quantra™ software application is intended for use with mammographic images acquired using digital breast x-ray systems. The Quantra software segregates breast density into categories, which may be useful in the reporting of consistent BI-RADS® breast composition categories as mandated by certain state regulations. The Quantra software reports a result for each subject, which is intended to aid radiologists in the assessment of breast tissue composition. The Quantra software produces adjunctive information; it is not a diagnostic aid.
| 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) |
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Traditional 510(k) Summary
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807.92
| Date Prepared: | October 05, 2017 |
|---|---|
| Manufacturer: | Hologic, Inc. |
| 36 Apple Ridge Road | |
| Danbury, CT 06810 USA | |
| Est. Registration #: | 1220984 |
| Contact Person: | Neil Kelly |
| Manager, Regulatory Affairs | |
| Phone: (508) 263-8634 |
Identification of the Device:
| Proprietary/Trade Name: | Quantra™ |
|---|---|
| Software Version: | 2.2 |
| Classification Name: | System, Image Processing, Radiology |
| Regulatory Number: | 21 CFR 892.2050 |
| Product Code: | LLZ |
| Device Class: | Class II |
| Review Panel: | Radiology |
Identification of the Legally Marketed Predicate Device:
| Trade name: | Quantra™ |
|---|---|
| Software Version: | 2.1 |
| Classification Name: | System, Image Processing, Radiology |
| Regulatory Number: | 21 CFR 892.2050 |
| Product Code: | LLZ |
| Device Class: | Class II |
| Review Panel: | Radiology |
| Submitter/510(k) Holder: | Hologic, Inc. |
| Clearance: | K142037 (cleared October 10, 2014) |
Device Description:
Quantra is a software application used to produce assessments of breast composition and categorize them. A breast consists of fat and fibroglandular tissue. Fibroglandular tissue, also referred to as dense tissue, contains a mixture of fibrous connective tissue (stroma) and glandular tissue (epithelial cells), and usually appears brighter than surrounding tissue on a digital
4
mammographic image. Abnormal lesions also appear bright on a mammogram and can be obscured or masked by fibroglandular tissue.
The Quantra software is designed to estimate breast composition categories by analyzing distribution and texture of parenchymal tissue patterns which can be responsible for the masking effect during mammographic reading.
Indications for Use:
The Quantra™ software application is intended for use with mammographic images acquired using digital breast x-ray systems. The Quantra software segregates breast density into categories, which may be useful in the reporting of consistent BI-RADS® breast composition categories as mandated by certain state regulations. The Quantra software reports a result for each subject, which is intended to aid radiologists in the assessment of breast tissue composition. The Quantra software produces adjunctive information; it is not a diagnostic aid.
Standards:
IEC 62304:2006 - Medical Device Software - Software Life Cycle Process ISO 14971:2012 – Medical Devices – Application of Risk Management to Medical Devices
Comparison with Predicate Device:
The focus of this submission is to introduce improvements in the proposed Quantra software algorithm to align with ACR BI-RADS® Atlas (Fifth Edition, 2013), and to enhance the accuracy of breast composition estimation. To the end user the proposed Ouantra software is still used in the exact same way as the predicate Quantra software (K142037). The differences are inherent to the algorithm and reported calculations.
Substantial Equivalence:
| | Quantra
SW Version 2.1
Predicate (K142037) | Quantra
SW Version 2.2
(Proposed) | Comparison |
|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | Quantra™ is a software
application intended for use with
images acquired using digital
breast x-ray systems. Quantra
calculates volumetric breast
density as a ratio of
fibroglandular tissue and total
breast volume estimates.
Quantra also provides area
breast density as a ratio of | The Quantra™ software
application is intended for use
with mammographic images
acquired using digital breast x-
ray systems. The Quantra
software segregates breast
density into categories, which
may be useful in the reporting of
consistent BI-RADS® breast
composition categories as | Similar |
| | fibroglandular tissue area and
total breast area estimates.
Quantra segregates breast
density into categories, which
may be useful in the reporting of
consistent BI-RADS® breast
composition categories as
mandated by certain state
regulations. The Quantra results
for each image, breast, and
subject, are intended to aid
radiologists in the assessment of
breast tissue composition.
Quantra produces adjunctive
information; it is not an
interpretive or diagnostic aid. | mandated by certain state
regulations. The Quantra
software reports a result for each
subject, which is intended to aid
radiologists in the assessment of
breast tissue composition. The
Quantra software produces
adjunctive information; it is not
a diagnostic aid. | |
| Level of
Concern | Moderate | Moderate | Same |
| Input
Modality | Digital x-ray breast images | Digital x-ray breast images | Same |
| Software
Product | Yes | Yes | Same |
| Reportable
Information | Fibroglandular (dense) Tissue Volume Total Breast Volume Volumetric Breast Density Area Breast Density Volume of Fibroglandular Tissue Score Volumetric Breast Density Score Estimate of Breast Density (integer) Estimate of Breast Density (fractional) | Quantra Generated Breast Density Category | Similar. Uses
distribution of
glandular
tissue rather
than density of
glandular
tissue when
assessing
breast
composition. |
| Statistical
comparison
to a
reference
population | Yes | Yes | Same, with the
proposed
device also
being
compared
against a |
| | | | dataset scored to BI-RADS 5th edition. |
| BI-RADS® Atlas | Yes, 4th Edition 2003 | Yes, 5th Edition 2013 | Similar, with enhancements |
| Brest Composition Estimates | Yes, displayed as 1, 2, 3 and 4 | Yes, displayed as a, b, c, d | Similar, with enhanced accuracy |
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Summary of Testing:
Non-clinical (Bench) testing has been performed using retrospectively collected images of 4view screening negative cases. The proposed Quantra software (Version 2.2) was tested against an independent data set of 230 studies, for which the 5 radiologists' consensus assessment of BIRADS 5th Edition categories are known.
Quantra 2.2 2D Fatty vs. Dense
| Quantra 2.2- QDC 2D | |||||
|---|---|---|---|---|---|
| Fatty | |||||
| (a+b) | Dense | ||||
| (c+d) | Per category | ||||
| total | Accuracy | ||||
| BI-RADS- 5th | |||||
| Ed. | Fatty | ||||
| (a+b) | 105 | 8 | 113 | 92.9% | |
| Dense | |||||
| (c+d) | 1 | 116 | 117 | 99.1% | |
| Total | 230 |
Quantra 2.2 Tomo Fatty vs. Dense
| Quantra2.2 – QDC Tomo (3D Center Projection) | |||||
|---|---|---|---|---|---|
| Fatty | |||||
| (a+b) | Dense | ||||
| (c+d) | Per category | ||||
| total | Accuracy | ||||
| BI-RADS- 5th | |||||
| Ed. | Fatty | ||||
| (a+b) | 104 | 9 | 113 | 92.0% | |
| Dense | |||||
| (c+d) | 7 | 110 | 117 | 94.0% | |
| Total | 230 |
No animal studies or clinical studies were performed.
Conclusion:
Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics and performance testing, the proposed Quantra software (version 2.2) is substantially equivalent to the predicate Quantra software (version 2.1).