ScreenPoint Medical B.V.
℅ Umar Waqas, Ph.D.
Head of Regulatory and Quality Affairs
Mercator II, 7th floor, Toernooiveld 300
6525EC Nijmegen, Gelderland
THE NETHERLANDSMarch 5, 2020

Re: K193229
Trade/Device Name: Transpara™ 1.6.0
Regulation Number: 21 CFR 892.2090
Regulation Name: Radiological computer assisted detection and diagnosis software
Regulatory Class: Class II
Product Code: QDQ
Dated: January 28, 2020
Received: February 3, 2020
Dear Dr. Waqas:
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 theenclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, theenactment date of the Medical Device Amendments, or to devices that have been reclassified in accordancewith the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of apremarket approval application (PMA). You may, therefore, market the device, subject to the generalcontrols provisions of the Act. Although this letter refers to your product as a device, please be aware thatsome cleared products may instead be combination products. The 510(k) Premarket Notification Databaselocated at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration. 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 besubject to additional controls. Existing major regulations affecting your device can be found in the Code ofFederal 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 Part801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID# 04017.04.13

K193229 - Umar Waqas, Ph.D.

Page 2

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (seehttps://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531542 of the Act); 21 CFR 1000-1050.
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 Part803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact theDivision of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,For
Thalia T. Mills, Ph.D.
Director
Division of Radiological Health
OHT7: Office of In Vitro Diagnostics
and Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
EnclosureDEPARTMENT OF HEAL TH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: 0MB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.

510(k) Number (if known)
Kl93229
Device NameTranspara™ 1.6.0

Indications for Use (Describe)

Transpara™ software is intended for use as a concurrent reading aid for physicians interpreting screening full-field digital
mammography exams and digital breast tomosynthesis exams from compatible FFDM and DBT systems, to identify
regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes locations ofcalcifications groups and soft-tissue regions, with scores indicating the likelihood that cancer is present, and an exam scoreindicating the likelihood that cancer is present in the exam. Patient management decisions should not be made solely on
the basis of analysis by Transpara™.

Type of Use (Select one or both, as applicable)[El Prescription Use (Part 21 CFR 801 Subpart D)

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 thetime 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 aspectof 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'�n 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 0MB number."
FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301) 443-6740

EFK193229

510(k) Summary Transpara™
This 510(k) summary of safety and effectiveness information is prepared in accordancewith the requirements of 21 CFR § 807.92.

1. Submitter
Manufacturer:
ScreenPoint Medical B.V.
Mercator II, 7th floor
Toernooiveld 300
6525 EC Nijmegen
Netherlands
www.screenpoint-medical.com

Contact person:
Umar Waqas
Office: +31 24 3030045 | +31 24 2020020
Mobile: +31 6 44077104
Mercator II, 7th floor, Toernooiveld 300, 6525 EC Nijmegen, Netherlands
Date:
January 28, 2020

TransparaTM 510(k) Submission

K193229

2. DeviceDevice trade name
DeviceClassification regulation
Panel
Device class
Product code
Submission typeTranspara™ 1.6.0
Radiological Computer Assisted Detection andDiagnosis Software
21 CFR 892.2090
Radiology
II
QDQ
Traditional 510(k)3. Legally marketed predicate device
Device trade name
Legal Manufacturer
DeviceClassification regulation
Panel
Device class
Product code

Transpara™ 1.3.0 (K181704)
ScreenPoint Medical B.V.
Radiological Computer Assisted Detection andDiagnosis Software
21 CFR 892.2090
Radiology
II
QDQ

4. Device description
TransparaTM is a software only application designed to be used by physicians to improve
interpretation of digital mammography and digital breast tomosynthesis. The system isintended to be used as a concurrent reading aid to help readers with detection andcharacterization of potential abnormalities suspicious for breast cancer and to improve
workflow. ‘Deep learning’ algorithms are applied to FFDM images and DBT slices forrecognition of suspicious calcifications and soft tissue lesions (including densities,
masses, architectural distortions, and asymmetries). Algorithms are trained with a large
database of biopsy-proven examples of breast cancer, benign abnormalities, andexamples of normal tissue.
Transpara™ offers the following functions which may be used at any time during reading(concurrent use):a) Computer aided detection (CAD) marks to highlight locations where the device
detected suspicious calcifications or soft tissue lesions.

TransparaTM 510(k) Submission

K193229b) Decision support is provided by region scores on a scale ranging from 0-100, withhigher scores indicating a higher level of suspicion.
c) Links between corresponding regions in different views of the breast, which may
be utilized to enhance user interfaces and workflow.
d) An exam score which categorizes exams on a scale of 1-10 with increasing
likelihood of cancer. The score is calibrated in such a way that approximately 10
percent of mammograms in a population of mammograms without cancer falls ineach category.
Results of TransparaTM are computed in processing server which accepts mammogramsor DBT exams in DICOM format as input, processes them, and sends the processing
output to a destination using the DICOM protocol in a standardized mammography CAD
DICOM format. Use of the device is supported for images from the following modality
manufacturers: FFDM (Hologic, Siemens, General Electric, Philips, Fujifilm) and DBT(Hologic, Siemens). Common destinations are medical workstations, PACS and RIS.
TransparaTM is offered as a virtual machine and runs on pre-selected standard PC
hardware as well as a dedicated virtual machine cluster. The system can be configured
using a service interface. Implementation of a user interface for end users in a medical
workstation is to be provided by third parties.

5. Indications for use
Transpara™ is a software medical device for use in a healthcare facility or hospital withthe following indications for use:
Transpara™ software is intended for use as a concurrent reading aid for physicians
interpreting screening full-field digital mammography exams and digital breast
tomosynthesis exams from compatible FFDM and DBT systems, to identify regions
suspicious for breast cancer and assess their likelihood of malignancy. Output of thedevice includes locations of calcifications groups and soft-tissue regions, with scoresindicating the likelihood that cancer is present, and an exam score indicating the likelihoodthat cancer is present in the exam. Patient management decisions should not be madesolely on the basis of analysis by Transpara™.
Intended user population
Intended users of Transpara™ are physicians qualified to read screening mammography
exams and digital breast tomosynthesis exams.
Intended patient population
The device is intended to be used in the population of women undergoing screening
mammography and digital breast tomosynthesis.

TransparaTM 510(k) Submission

K193229
Warnings and precautions
Transpara™ is an adjunct tool and not intended to replace a physicians’ own review of a
mammogram. Decisions should not be made solely based on analysis by Transpara™.

6. Predicate device comparison
The indication for use of Transpara™ 1.6.0 is similar to that of the predicate device. Bothdevices are intended for concurrent use by physicians interpreting breast images to help
them with localizing and characterizing abnormalities. The devices are not intended as areplacement for the review of a physician or their clinical judgement. Support for DBT has
been added in the indications for use of the subject device compared to the indications
for use of the predicate device. The algorithmic components have been updated to
improve detection accuracy for FFDM and to enable processing of DBT. The subject
device also supports Fujifilm FFDM systems, which was cleared in K192287 (Transpara™
1.5.0).
The overall design of Transpara™ 1.6.0 is the same as that of the predicate device. Bothversions detect and characterize findings in radiological breast images and provide
information about the presence, location, and characteristics of the findings to the user ina similar way.
Changes do not raise different questions of safety and effectiveness of the device whenused as labeled.

7. Summary of non-clinical performance data
In the design and development of Transpara 1.6.0, ScreenPoint applied the following
voluntary FDA recognized standards and guidelines:
Standard ID

Standard Title

ISO 14971:2007

Medical Devices - Application Of Risk 5-40
Management To Medical Devices

IEC 62304:2015

Medical Device Software - Software Life 13-79
Cycle Processes

DEN180005

Decision summary with special controls
for class II radiology device

TransparaTM 510(k) Submission

FDA Recognition #K193229
The following guidance documents were used to support this submission:•••

Guidance for Industry and FDA Staff - Guidance for the Content of Premarket
Submissions for Software Contained in Medical Devices (Issued on May 11, 2005)
Computer-Assisted Detection Devices Applied to Radiology Images andRadiology Device Data – Premarket Notification [510(k)] Submissions (Issued on
July 3, 2012)
Guidance for Industry and FDA Staff - Clinical Performance Assessment:
Considerations for Computer-Assisted Detection Devices Applied to Radiology
Images and Radiology Device Data - Premarket Approval (PMA) and Premarket
Notification [510(k)] Submissions (Issued on July 3, 2012)

Transpara™1.6.0 is a software-only device. The level of concern for the device isdetermined as Moderate Level of Concern.

Stand-alone performance testing

Based on results of verification and validation tests it is concluded that Transpara™ iseffective in the detection of soft lesions and calcifications at an appropriate safety level inmammograms acquired with mammography devices for which the software has beenvalidated.
Verification testing consisted of software unit testing, software integration testing andsoftware system testing. The verification test showed that the software application
satisfied the software requirements.
Validation testing consisted of determining stand-alone performance of the algorithms inTranspara 1.6.0 using an independent multi-vendor test-set of mammography and DBT
exams acquired from multiple centers. This test dataset included mammography and DBT
exams of women undergoing mammography acquired with devices from five
manufacturers: Hologic, GE, Philips, Siemens, and Fujifilm. Validation testing confirmedthat algorithm performance is non-inferior or better in comparison to Transpara 1.3.0 for
the four manufacturers for which the device was already cleared and that for Fujifilm
performance was non-inferior to the performance achieved on the pooled test data ofdevices cleared for use with the predicate device.
Based on results of verification and validation tests it is concluded that Transpara 1.6.0 iseffective in the detection of soft lesions and calcifications at an appropriate safety level.

TransparaTM 510(k) Submission

K193229

8. Summary of clinical tests
A pivotal reader study was conducted with Transpara 1.6.0. This study was designed toprovide evidence for safety and effectiveness of the device.
The objective of the reader study was to determine whether the performance ofradiologists detecting breast cancer in DBT exams increases when they concurrently use
Transpara compared to when they read DBT exams unaided. In the study, both conditions
are tested with a fully-crossed, multi-reader multi-case retrospective study performed byeighteen MQSA qualified radiologists. The study was conducted with an enriched sample
of 240 Siemens Mammomat DBT exams, including 65 exams with breast cancer, 65
exams with benign abnormalities, and 110 normal exams.
The primary hypothesis for the study was superior breast-level area under the receiver
operating characteristic curve (AUC, ROC) between conditions when radiologists use
Transpara™ to read DBT exams at a significance level alpha 0.05.
Secondary objectives of the reader study were to determine if the use of Transpara™ as
an aid leads to: 1) reading time reduction, 2) non-inferior or higher sensitivity, 3) noninferior or higher specificity, and 4) reading time reduction on normal exams. In addition,
it was tested if standalone AUC performance of Transpara™ was non-inferior to theaverage AUC performance of the readers.
Statistical analysis of the reader study results showed that the primary objective and all
pre-specified endpoints of the study were met. Radiologists significantly improved theirdetection performance when using Transpara™ to read DBT exams, with the average
AUC increasing from 0.833 to 0.863 (P = 0.0025), while reading time was significantly
reduced and superior sensitivity was obtained with Transpara™.
Results of the clinical study provide evidence for safety and effectiveness of Transpara™
when used in accordance with the indications for use.

9. Conclusions
The data presented in this 510(k) includes all required information to support the review
by FDA. Standalone performance tests with FFDM demonstrate that Transpara™ 1.6.0
achieves non-inferior or better detection performance compared to the predicate device.
For application with DBT, a clinical reader study and standalone tests demonstrate thatthe device is safe and effective.

TransparaTM 510(k) Submission

K193229
ScreenPoint has applied a risk management process in accordance with FDA recognized
standards to identify, evaluate, and mitigate all known hazards related to Transpara 1.6.0.
These hazards may occur when accuracy of diagnosis is potentially affected, causing
either false-positives or false-negatives. All identified risks are effectively mitigated and it
can be concluded that the residual risk is outweighed by the benefits.
Considering all data in this submission, the data provided in this 510(k) supports the safeand effective use of Transpara 1.6.0 for its indications for use and substantial equivalence
to the predicate device.

TransparaTM 510(k) Submission