(273 days)
No
The description focuses on spectral imaging and calculations based on X-ray attenuation properties of different tissues, not on learning from data or using AI/ML algorithms for image analysis or density assessment. The performance studies evaluate the correlation of the device's measurements with existing methods and expected biological trends, not the performance of an AI/ML model.
No
The device is indicated for generating mammographic images for screening and diagnosis of breast cancer, and for measuring breast density. It does not provide any form of therapy.
Yes
The device is indicated for generating mammographic images for screening and diagnosis of breast cancer and measures breast density, which are diagnostic purposes.
No
The device description explicitly states that this application is an addition of functionality to a previously cleared hardware device, the MicroDose SI, Model L50. It describes modifications to the detector electronics and the use of spectral imaging technology, which are hardware-based functionalities.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The MicroDose SI (model L50) is a medical imaging device that generates mammographic images and performs breast density measurements based on the spectral properties of X-rays passing through the breast tissue. It analyzes the physical properties of the breast in vivo (within the living body) using imaging technology.
- Lack of Specimen Analysis: The device does not analyze biological specimens (like blood, tissue samples, etc.) collected from the patient.
Therefore, based on the provided information, the MicroDose SI (model L50) is a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The MicroDose SI (model L50) is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The MicroDose SI (model L50) is intended to be used in the same clinical applications as traditional film/screen systems.
Product codes
MUE, LLZ
Device Description
This application is to add functionality to the previously cleared MicroDose SI, Model L50, (K123995) that allows for breast density measurements.
The L50 submission described that the detector electronics have been modified to do spectral imaging through the functionality to discriminate between high and low energy photons based on an energy threshold. The first application of this technology is Spectral Breast Density Measurement where breast glandularity and thickness is measured simultaneously by the spectral difference in X-ray attenuation between adipose and fibroglandular tissue. The MicroDose’Sl can thereby measure volumetric glandularity and breast thickness for each pixel in the image. Total breast volume is calculated by integrating the breast thickness over the breast region. taking pixel size and beam geometry into account. Fibroglandular thickness is calculated as the product of breast thickness and volumetric glandularity for each pixel. Total fibroglandular volume is then calculated by integrating the fibroglandular thickness over the breast region. The total breast volumetric glandularity is then given as the ratio of fibroglandular to breast volume. The correlation between the MicroDose Density Score and the radiologist's BI-RADS score has The following Information is sent as part of the content of a DICOM Structured Report, SR, to selected destinations (for example a PACS). Breast analysis information is also included as private attributes in the DICOM header of the acquired images.
- Volumetric glandularity (%)
- Glandular volume (cm3)
- Breast volume (cm³)
- Breast density score (I, III, III, IV). The density score correlates to the BI-RADS categories.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital Mammography
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 MicroDose SI L50 Breast Density Measurement application has been developed in accordance with Philips Digital Mammography Sweden AB's product development process. It has been verified and validated in accordance with the company's design control process. The design control process is divided into several levels of verification, unit, integration and system level. The results from the performance testing have been included in the application.
The bench testing and clinical validation of the MicroDose SI included:
- Comparisons of MicroDose Breast Density Measurement parameters to industry standard . breast tissue equivalent phantoms;
- Validation that the Breast Density Measurement application can be easily incorporated into the clinical workflow of the radiologists;
- Based on a substantial clinical screening population dataset:
- The agreement between the MicroDose Density score and the BI-RADS breast composition score given by MQSA qualified radiologists was evaluated for a screening population;
- Evaluation of the correlation between MicroDose Breast Density Measurements in CC and MLO views and left and right laterality to confirm consistent results;
- Evaluation of the correlation between volumetric glandularity and age to confirm the expected decrease with age;
- Evaluation of the correlation between volumetric glandularity and breast volume to confirm the expected decrease with volume;
- Evaluation of the correlation between volumetric glandularity and BI-RADS breast composition score to confirm the expected increase with BI-RADS score.
The verification and validation activities confirm that the established acceptance criteria were met.
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
§ 892.1715 Full-field digital mammography system.
(a)
Identification. A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”See § 892.1(e) for the availability of this guidance document.
0
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DEC 1 3 2013
K130704
Page 1 of 4
510(k) Summary (21 CFR 807.92)
A. SUBMITTER INFORMATION
| Submitter's name | Philips Digital Mammography Sweden AB |
|---|---|
| Address | Smidesvägen 5 |
| SE-171 41 Solna | |
| Sweden | |
| Establishment registration number | 3009307584 |
| Contact person | Mr. Gustav Lins |
| Telephone | +46-8-623 52 00 |
| FAX | +46-8-623 52 01 |
| Title | Manager Regulatory Affairs |
| Date of the summary preparation | 2013-10-09 |
B. DEVICE IDENTIFICATION
| Device trade name | MicroDose SI (model L50) |
|---|---|
| Device common name | Full-Field Digital Mammography X-ray System |
| Classification name | Full-Field Digital Mammography X-ray System |
| Classification product code | MUE, LLZ (secondary) |
| Device class | II |
| Regulation code | 21 CFR 892.1715, 21 CFR 892.2050 (secondary) |
C. DEVICE DESCRIPTION
This application is to add functionality to the previously cleared MicroDose SI, Model L50, (K123995) that allows for breast density measurements.
The L50 submission described that the detector electronics have been modified to do spectral imaging through the functionality to discriminate between high and low energy photons based on an energy threshold. The first application of this technology is Spectral Breast Density Measurement where breast glandularity and thickness is measured simultaneously by the spectral difference in X-ray attenuation between adipose and fibroglandular tissue. The MicroDose'Sl can thereby measure volumetric glandularity and breast thickness for each pixel in the image. Total breast volume is calculated by integrating the breast thickness over the breast region. taking pixel size and beam geometry into account. Fibroglandular thickness is calculated as the product of breast thickness and volumetric glandularity for each pixel. Total fibroglandular volume is then calculated by integrating the fibroglandular thickness over the breast region. The total breast volumetric glandularity is then given as the ratio of fibroglandular to breast volume. The correlation between the MicroDose Density Score and the radiologist's BI-RADS score has The following Information is sent as part of the content of a DICOM Structured Report, SR, to selected destinations (for example a PACS). Breast analysis information is also included as private attributes in the DICOM header of the acquired images.
- Volumetric glandularity (%) �
- Glandular volume (cm3) ●
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- Breast volume (cm³) .
- Breast density score (I, III, III, IV). The density score correlates to the BI-RADS categories. .
D. indications for use
The MicroDose SI (model L50) is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The MicroDose SI (model L50) is intended to be used in the same clinical applications as traditional film/screen systems.
E. SUBSTANTIAL EQUIVALANCE
The subject device is identical to the MicroDose SI (model L50) in regards to FFDM characteristics. Furthermore, with regards to the applications described in this submission, it is substantially equivalent to the software predicates Volpara and Quantra.
| | MicroDose SI (model
L50) | MicroDose SI (model
L50) | Volpara
K102556 | Quantra
K120472 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject device | K123995
Predicate | Predicate | Predicate |
| Manufacturer | Philips Digital
Mammography
Sweden AB | Philips Digital
Mammography
Sweden AB | Matakina Technology Limited | Hologic, Inc. |
| Indication For
Use | The MicroDose SI
(model L50) is
indicated for
generating
mammographic
images that can be
used for screening
and diagnosis of
breast cancer. | The MicroDose SI
(model L50) is
indicated for
generating
mammographic
images that can be
used for screening
and diagnosis of
breast cancer. | Volpara is a software application
intended for use with digital
mammography systems. Volpara
calculates volumentric breast
density as a ratio of
fibroglandular tissue and total
breast volume estimates.
Volpara provides these numerical
values for each image to aid
radiologists in the assessment of
breast tissue composition.
Volpara produces adjunctive
information. It is not an
interpretive or diagnostic aid.
Volpara is a software application
which runs on Windows or Linux-
based computers. | QuantraTM 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 area and
total breast area estimates. It
segregates breast density into BI-
RADS-like breast composition
categories, which may be useful
in the reporting of consistent
breast composition values for
each image, breast and subject,
to aid radiologists in the
assessment of breast tissue
composition. Quantra produces
adjunctive information, it is not
an interpretive or diagnostic aid.
Quantra runs on a Windows
platform. |
| Device
Classification
Name | Full field digital,
System, X-ray,
Mammographic | Full field digital,
System, X-ray,
Mammographic | System, Image Processing,
Radiological | System, Image Processing,
Radiological |
| Device Class | II | II | II | II |
| Detector
technology | Photon counting
Crystalline silicon
strip detectors
Rejection of
electronic noise
24 x 26 cm imaging
area | Photon counting
Crystalline silicon
strip detectors
Rejection of
electronic noise
24 x 26 cm imaging
area | N/A | N/A |
| Image
Evaluation
Source | Digital
Mammography
Images | Digital Mammography Images | Digital Mammography Images | Digital Mammography Images |
| Anatomical
Assessment
Area | Breast | Breast | Breast | Breast |
2
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| | MicroDose Si (model L50)
Subject device | MicroDose Si (model L50)
K123995
Predicate | Volpara
K102556
Predicate | Quantra
K120472
Predicate |
|-------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------|---------------------------------|-----------------------------------------|
| Assessment
output | Glandular volume (cm³)
(volume of fibroglandular tissue) | N/A | Volume of fibroglandular tissue | Volume of fibroglandular tissue; |
| | Volumetric glandularity (%)
(volumetric breast density) | | Volumetric breast density | Volumetric breast density |
| | Breast volume (cm³) | | Breast volume | Area breast density measure |
| | Breast density score (I, II, III, IV). The density score correlates to the Bi-RADS categories. | | | BI-RADS like breast composition measure |
| Image storage
and report
generation | DICOM Structured report to send to PACS | | Output to console | DICOM Structured report to send to PACS |
E. PERFORMANCE/BENCH TESTING
The MicroDose SI L50 Breast Density Measurement application has been developed in accordance with Philips Digital Mammography Sweden AB's product development process. It has been verified and validated in accordance with the company's design control process. The design control process is divided into several levels of verification, unit, integration and system level. The results from the performance testing have been included in the application.
The bench testing and clinical validation of the MicroDose SI included:
-
Comparisons of MicroDose Breast Density Measurement parameters to industry standard . breast tissue equivalent phantoms;
-
. Validation that the Breast Density Measurement application can be easily incorporated into the clinical workflow of the radiologists;
-
. Based on a substantial clinical screening population dataset:
- The agreement between the MicroDose Density score and the BI-RADS breast 0 composition score given by MQSA qualified radiologists was evaluated for a screening population;
- Evaluation of the correlation between MicroDose Breast Density Measurements in o CC and MLO views and left and right laterality to confirm consistent results;
- Evaluation of the correlation between volumetric glandularity and age to confirm o the expected decrease with age;
- o Evaluation of the correlation between volumetric glandularity and breast volume to confirm the expected decrease with volume;
- Evaluation of the correlation between volumetric glandularity and BI-RADS breast O composition score to confirm the expected increase with BI-RADS score.
3
K130704
page 4 of 4
The verification and validation activities confirm that the established acceptance criteria were met.
G. CONCLUSION
The breast density measurement functionality that is the subject of this application relies on the technology of a FFDM device which has already been cleared by the FDA (MicroDose SI, K123995). Breast density assessments have previously been introduced by Quantra (K120472) and Volpara (K102556). These devices provide information that is very similar to that generated by the MicroDose SI (Model L50), and are intended for the same purpose, i.e. to generate adjunctive information regarding breast density. Like the breast density functionality of the predicate devices Volpara and Quantra, the MicroDose Breast Density Measurement aids the clinician in the assessment of breast tissue composition. The Breast Density Measurement functionality is well characterized by the design control process and the physical laboratory tests show results that are comparative to the predicate devices.
4
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
December 13, 2013
PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB GUSTAV LINS MANAGER REGULATORY AFFAIRS SMIDESVAGEN 5, SOLNA, SW SE-171 41 SWEDEN
Re: K130704
Trade/Device Name: MicroDose SI Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: II Product Code: MUE, LLZ Dated: October 29, 2013 Received: October 31, 2013
Dear Mr. Lins:
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.
5
Page 2-Mr. Lins
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resources/or You/Industry/default.htm. 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/McdicalDevices/Safety/ReportaProblem/dcfault.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.ida.gov/MedicalDevices/Resources/orYou/Industry/default.htm.
Sincerely yours,
Michael D. O'Hara
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
for
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K130704
Device Name
MicroDose SI (Model L50)
Indications for Use (Describe)
The MicroDose SI (model L50) is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer.
The MicroDose SI (model L50) is intended to be used in the same clinical applications as traditional film/screen systems.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
| FOR FDA USE ONLY |
|---|
| ------------------ |
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | Michael D. O'Hara |
|---|---|
| ------------------------------------------------------------------------------ | ------------------- |
| FORM FDA 3881 (9/13) | Page 1 of 2 |
|---|---|
| ---------------------- | ------------- |
ORM FUA 3681 (8/13)
178 Publisher Ser sam 1 100 : 441-4741 141-4741 EF
7
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