K Number
K201948
Device Name
AcroDTI Visualizer
Manufacturer
Date Cleared
2020-09-09

(58 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
AcroDTI Visualizer is an image processing software that allows the user to calculate and display DTI from diffusion MRI (dMRI) data. This software is intended to be utilized by trained physicians to visually evaluate the DTI index maps.
Device Description
AcroDTI Visualizer is a software for processing and viewing Diffusion Tensor Imaging (DTI) from dataset of Diffusion Weighted Imaging (DWI) acquired with Magnetic Resonance Imaging (MRI). AcroDTI Visualizer calculates and displays DTI maps which reveal diffusion properties of local tissue. The software displays the DTI maps in axial, coronal, and sagittal views, and is able to adjust the image brightness and contrast to assist visual evaluation. AcroDTI Visualizer provides support for automated processing of diffusion MRI data in Digital Imaging and COmmunications in Medicine (DICOM) format. The software reads DICOM files in DVD (or CD) exported either from the MR scanner or from a Picture Archiving and Communications System (PACS).
More Information

Not Found

No
The description focuses on standard image processing techniques (calculating and displaying DTI maps) and does not mention AI, ML, or related terms. The performance studies compare the device to legally marketed devices using qualitative and quantitative methods, not AI/ML specific metrics or validation approaches.

No
The software is an image processing tool that calculates and displays DTI maps for visual evaluation by physicians. It does not directly provide therapy or affect the structure or function of the body.

Yes

The device is an image processing software that allows trained physicians to visually evaluate DTI index maps, which are derived from diffusion MRI data. This evaluation helps in understanding diffusion properties of local tissue, supporting a diagnostic process.

Yes

The device description explicitly states it is "software for processing and viewing Diffusion Tensor Imaging (DTI)" and details its functions related to reading, calculating, and displaying data from existing MRI scans. There is no mention of accompanying hardware components or hardware-specific functions beyond processing data from standard medical imaging equipment.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to "calculate and display DTI from diffusion MRI (dMRI) data" and for "trained physicians to visually evaluate the DTI index maps." This describes a tool for processing and visualizing medical images, not a test performed on biological specimens to diagnose or monitor a condition.
  • Device Description: The description reinforces this by stating it's "software for processing and viewing Diffusion Tensor Imaging (DTI) from dataset of Diffusion Weighted Imaging (DWI) acquired with Magnetic Resonance Imaging (MRI)." It calculates and displays maps, which is image processing and visualization.
  • Input: The input is "Diffusion Weighted Imaging (DWI) acquired with Magnetic Resonance Imaging (MRI)," which is medical imaging data, not a biological sample.
  • Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment. This device operates on medical images, which falls under the category of medical image processing and analysis software.

N/A

Intended Use / Indications for Use

AcroDTI Visualizer is an image processing software that allows the user to calculate and display DTI from diffusion MRI (dMRI) data. This software is intended to be utilized by trained physicians to visually evaluate the DTI index maps.

Product codes (comma separated list FDA assigned to the subject device)

LLZ

Device Description

AcroDTI Visualizer is a software for processing and viewing Diffusion Tensor Imaging (DTI) from dataset of Diffusion Weighted Imaging (DWI) acquired with Magnetic Resonance Imaging (MRI). AcroDTI Visualizer calculates and displays DTI maps which reveal diffusion properties of local tissue. The software displays the DTI maps in axial, coronal, and sagittal views, and is able to adjust the image brightness and contrast to assist visual evaluation.

AcroDTI Visualizer provides support for automated processing of diffusion MRI data in Digital Imaging and COmmunications in Medicine (DICOM) format. The software reads DICOM files in DVD (or CD) exported either from the MR scanner or from a Picture Archiving and Communications System (PACS).

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Magnetic Resonance Imaging (MRI)

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained physicians

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 software for this device was considered as a "moderate" level of concern. Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software verification and validation testing results support that all the software specifications have met the acceptance criteria. The human factor engineering file was provided and the human factors validation testing was conducted and showed that the device is safe and effective for the intended users, uses, and use environments.

The performance comparison studies between subject device and legally marketed devices were conducted using qualitative and quantitative methods respectively. Experienced physicians were recruited to evaluate the performance between subject device and legally marketed devices. The results show that AcroDTI Visualizer has high similarity with the legally marketed devices and support the substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

K163294, K170580

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

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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September 9, 2020

Image /page/0/Picture/1 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

AcroViz, Inc. % Yung-Chin Hsu Chief Technology Officer Rm. 6, 11F, No. 152, Sec. 1 Zhongxiao E. Rd., Zhongzheng Dist. Taipei. Taiwan 10050 REPUBLIC OF CHINA

Re: K201948

Trade/Device Name: AcroDTI Visualizer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: June 20, 2020 Received: July 13, 2020

Dear Yung-Chin Hsu:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located 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 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://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 531-542 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 Part 803), please go to https://www.fda.gov/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 the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

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

510(k) Number (if known)

Device Name

AcroDTI Visualizer

Indications for Use (Describe)

AcroDTI Visualizer is an image processing software that allows the user to calculate and display DTI from diffusion MRI (dMRI) data. This software is intended to be utilized by trained physicians to visually evaluate the DTI index maps.

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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510(k) Summary

DateJuly 3, 2020
--------------------

Manufacturer AcroViz Inc. Rm. 6, 11F., No. 152, Sec. 1, Zhongxiao E. Rd., Zhongzheng Dist., Taipei City 10050, Taiwan (R.O.C.)

  • Contact Person Yung-Chin Hsu Chief Technology Officer Rm. 6, 11F., No. 152, Sec. 1, Zhongxiao E. Rd., Zhongzheng Dist., Taipei City 10050, Taiwan (R.O.C.) Phone: +886-982-963-908 E-mail: eric.ychsu@acroviz.com
  • Device Trade Name AcroDTI Visualizer
    • Common Name System, Image Processing, Radiological
  • Picture Archiving and Communications System Classification Name

Device Class II

  • Classification Panel Radiology Devices
    Product Code LLZ

  • Regulation Number 892.2050
    Device Description AcroDTI Visualizer is a software for processing and viewing and Technology Diffusion Tensor Imaging (DTI) from dataset of Diffusion Characteristics Weighted Imaging (DWI) acquired with Magnetic Resonance Imaqinq (MRI). AcroDTI Visualizer calculates and displays DTI maps which reveal diffusion properties of local tissue. The software displays the DTI maps in axial, coronal, and sagittal views, and is able to

4

adjust the image brightness and contrast to assist visual evaluation.

AcroDTI Visualizer provides support for automated processing of diffusion MRI data in Digital Imaging and COmmunications in Medicine (DICOM) format. The software reads DICOM files in DVD (or CD) exported either from the MR scanner or from a Picture Archiving and Communications System (PACS).

  • Indications for Use AcroDTI Visualizer is an image processing software that allows the user to calculate and display DTI from diffusion MRI (dMRI) data. This software is intended to be utilized by trained physicians to visually evaluate the DTI index maps.

Predicate Device(s)

Predicate DevicePredicate SoftwareManufacturer510(K) Number
syngo.MR General;
syngo.MR Cardiology;
syngo.MR NeurologySoftware
syngo.MR
VB20Siemens Medical
Solutions USA,
Inc.K163294
Carestream Vue
PACSCarestream
Vue PACSCarestream
Health, Inc.K170580

Performance Data The following performance data were provided in support of the Non-Clinical Tests substantial equivalence determination.

The software for this device was considered as a "moderate" level of concern. Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software verification and validation testing results support that all the software specifications have met the acceptance criteria. The human factor engineering file was provided and the human factors validation testing was conducted and showed that the device is safe and effective for the intended users, uses, and use environments.

The performance comparison studies between subject device and legally marketed devices were conducted using qualitative and quantitative methods respectively. Experienced physicians

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were recruited to evaluate the performance between subject device and legally marketed devices. The results show that AcroDTI Visualizer has high similarity with the legally marketed devices and support the substantial equivalence.

The following standards/ guidance applies:

  • IEC 62304:2006+AMD1:2015, Medical device software --Software life cycle processes, Ed.1.1
  • IEC 82304-1:2016, Health software Part 1: General । requirements for product safety
  • Guidance for the Content of Premarket Submissions for -Software Contained in Medical Devices
  • -ISO 14971:2019, Medical devices - Application of risk management to medical devices
  • -ASTM D4169-16. Standard Practice for Performance Testing of Shipping Containers and Systems
  • -IEC 62366-1:2015, Medical devices - Part 1: Application of usability engineering to medical devices

Evaluation was completed following above standards and documents. Conformity to these standards demonstrates that the proposed subject device met the standards' established acceptance criteria for the device. This supports substantial equivalence to its predicates.

  • Substantial Equivalence The subject device has same indications for use, technology, operation principle and technical characteristics with the predicate device(s). Verification activities were performed on subject device and all tests were verified to meet the required acceptance criteria. The verification tests demonstrate that the differences in the device do not affect the indications for use of the device or raise any unsolved issues. There are no significant differences between subject device and the predicate device(s) that would adversely affect the use of the product. We conclude that subject device is substantially equivalent to predicate devices.
    • Conclusion In all verification and validation tests, AcroDTI Visualizer meets the pre-specified acceptance criteria that are considered essential for its indications for use and is considered substantially equivalent to the predicate devices.

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K201948

Subject DevicePredicate DevicePrimary Predicate Device
Device NameAcroDTI Visualizersyngo.MR General;
syngo.MR Cardiology;
syngo.MR NeurologyCarestream Vue PACS
510(k)K201948K163294K170580
ApplicantAcroViz Inc.Siemens Medical Solutions USA, Inc.Carestream Health, Inc.
Regulation
Number892.2050892.2050892.2050
Product codeLLZLLZ/ LNHLLZ
ClassificationIIIIII
Prescription or
OTC usePrescriptionPrescriptionPrescription
Indications for
UseAcroDTI Visualizer is an image
processing software that allows the user
to calculate and display DTI from
diffusion MRI (dMRI) data. This software
is intended to be utilized by trained
physicians to visually evaluate the DTI
index maps.The software comprising the syngo.MR post-
processing applications is post-processing
software/applications to be used for viewing
and evaluating the designated images
provided by a magnetic resonance
diagnostic device. All of the software
applications comprising the syngo. MR post-
processing applications have their own
indications for useThe Carestream Vue PACS is an image
management system whose intended use is
to provide completely scalable local and wide
area PACS solutions for hospital and related
institutions/sites, which will archive,
distribute, retrieve and display images and
data from all hospital modalities and
information systems. The system is to be
used by trained professionals including but

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syngo.MR General is a syngo based post- processing software for viewing, manipulating and evaluating MR images.not limited to, physicians and medical technicians. The system contains interactive tools in order to ease the process of analyzing and comparing three dimensional (3D) images. It is a single system that integrates review, dictation and reporting tools to create a productive work environment for the radiologists and physicians.
syngo.MR Cardiology is a syngo based post- processing software for viewing, manipulating and evaluating MR cardiac images.
syngo.MR Neurology is a syngo based post-processing software for viewing, manipulating, and evaluating MR neurological images.The system contains a Perfusion module with interactive tools to analyze and compare Computed Tomography Perfusion (CTP) and MR Perfusion (MRP) images of adult patients. Blood perfusion parameters are automatically calculated and displayed as a set of perfusion maps and perfusion tables. The perfusion tables include the calculation of parameters related to tissue flow (perfusion) and tissue blood volume. The system contains a Diffusion Module with interactive tools to ease the process of analyzing and comparing MR Diffusion Weighted images (DWI) and MR Diffusion Tensor Imaging (DTI) of adult patients. This module is used to visualize local water diffusion properties from the analysis of diffusion- weighted MRI data.

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| | | | The system supports Subtraction with
interactive tools to aid with the analysis of
Digital Subtraction Angiography (DSA)
images in both interventional radiology and
cardiology. Subtraction automatically
subtracts a mask from contrast frames of an
X-Ray Angiography study for visualization of
vascular anatomy and pathology of adult
patients. |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Physical
Characteristics | Software package | Software package | Software package |
| Data Source | MR Images | MR Images | MR Images |
| Technology
and Output | - visualize local water diffusion properties

  • offers the Diffusion Tensor Imaging
    (DTI) maps including Fractional
    Anisotropy (FA) ADC/Mean Diffusivity
    (MD), Axial Diffusivity (AD), Radial
    Diffusivity (RD), Dxx, Dyy, Dzz, Dxy,
    Dxz, Dyz and color FA | - visualize local water diffusion properties
  • offers the capability to generate
    TENSOR data together with all other
    diffusion maps (including b0, ADC,
    TraceW, FA, AD, RD) from raw diffusion
    series. | - visualize local water diffusion properties
  • offers Diffusion Tensor Imaging of the
    following types Fractional Anisotropy
    (FA), Relative Anisotropy (RA), Volume
    Ratio (VR), ADC/Mean Diffusivity
    (ADC), Axial Diffusivity (AD), and
    Relative Diffusivity (RD). |