(555 days)
No
The summary describes image processing and analysis tools but does not mention AI, ML, or related terms, nor does it provide details about training or test sets typically associated with AI/ML development.
No
The device provides image analysis and reporting tools to support diagnosis and evaluation, but it does not directly treat or alleviate a medical condition.
Yes
The "Intended Use / Indications for Use" states that the software can be used "to support the physician quantitatively in the diagnosis, followup evaluation of CT lung tissue images".
Yes
The device description explicitly states "The AVIEW is a software product which can be installed on a PC." and the performance studies focus on software-related testing (Unit test, System test, DICOM test, etc.), indicating it is a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The AVIEW software processes and analyzes medical images (CT scans) of the lungs. It does not perform tests on biological samples.
- Intended Use: The intended use clearly states that it provides CT values for pulmonary tissue from CT datasets and supports physicians in the diagnosis and evaluation of CT lung tissue images. This is image analysis, not in vitro testing.
Therefore, AVIEW falls under the category of medical image processing software, not an IVD.
N/A
Intended Use / Indications for Use
A VIEW provides CT values for pulmonary tissue from CT thoracic datasets. This software can be used to support the physician quantitatively in the diagnosis, followup evaluation of CT lung tissue images by providing image segmentation of sub-structures in the left and right lung (e.g., the five lobes and airway), volumetric and structural analysis, density evaluations and reporting tools. AVIEW is also used to store, transfer, inquire and display CT data sets. A VIEW is not meant for primary image Interpretation in mammography.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The AVIEW is a software product which can be installed on a PC. It shows images taken with the interface from various storage devices using DICOM 3.0 which is the digital image and communication standard in medicine. It also offers functions such as reading, manipulation, analyzing, post-processing, saving and sending images by using the software tools. AVIEW is an image processing software as a medical device. It assists in analyzing pulmonary CT datasets and displaying the analysis results.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT thoracic datasets
Anatomical Site
Pulmonary tissue / left and right lung (five lobes and airway)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician, trained and licensed radiologists, clinicians and referring 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)
Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria. A summary of the conducted tests is as below:
- Unit test
- System test
- DICOM test
- LAA analysis test
- LAA size analysis test
- Airway wall measurement test
- Reliability test
- CT image compatibility test
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.
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.
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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October 31, 2018
Coreline Soft Co., Ltd. % Priscilla Chung Regulatory Affairs Consulting LK Consulting Group USA, Inc 690 Roosevelt IRVINE, CA 92620
Re: K171199
Trade/Device Name: AVIEW Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: October 9, 2018 Received: October 12, 2018
Dear Priscilla Chung:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed Michael by Michael D. D. O'hara - o'hara -s Date: 2018.10.31 For S 16:54:04 -04'00' Robert A. 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) K171199
Device Name AVIEW
Indications for Use (Describe)
A VIEW provides CT values for pulmonary tissue from CT thoracic datasets. This software can be used to support the physician quantitatively in the diagnosis, followup evaluation of CT lung tissue images by providing image segmentation of sub-structures in the left and right lung (e.g., the five lobes and airway), volumetric and structural analysis, density evaluations and reporting tools. AVIEW is also used to store, transfer, inquire and display CT data sets. A VIEW is not meant for primary image Interpretation in mammography.
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
(K171199)
1. Date: 10/09/2018
2. Applicant / Submitter
Coreline Soft Co., Ltd. 4, 5F (Yeonnam-dong), 49, World Cup buk-ro 6-gil, Mapo-gu, Seoul, 03991, Republic of Korea
3. U.S. Designated Agent
Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt Irvine CA 92620 Tel: 714.202.5789 Fax: 714.409.3357 Email: juhee.c@LKconsultingGroup.com
4. Trade/Proprietary Name:
AVIEW
5. Common Name:
Image Processing Software
6. Classification:
System, image processing, radiological (21CFR 892.2050, Product code LLZ, Class 2, Radiology)
7. Device Description:
The AVIEW is a software product which can be installed on a PC. It shows images taken with the interface from various storage devices using DICOM 3.0 which is the digital image and communication standard in medicine. It also offers functions such as reading, manipulation, analyzing, post-processing, saving and sending images by using the software tools.
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8. Indication for Use:
A VIEW provides CT values for pulmonary tissue from CT thoracic datasets. This software can be used to support the physician quantitatively in the diagnosis, followup evaluation and documentation of CT lung tissue images by providing image segmentation of sub-structures in the left and right lung (e.g., the five lobes and airway), volumetric and structural analysis, density evaluations and reporting tools. AVIEW is also used to store, transfer, inquire and display CT data sets. AVIEW is not meant for primary image Interpretation in mammography.
9. Predicate Device:
- Primary Predicate Device: Vitrea CT Lung Density Analysis Software (K151919)
- Reference Predciate Device: Vitrea, Version 7.0 Medical image Processing Software (K150258)
10. Substantial Equivalence:
A VIEW has the same intended use and the principle of operation, and also has similar features to the predicate devices. Vitrea (K150258 and K151919).
There might be slight differences in features and menu, but these differences between the predicate device and the proposed device are not so significant since they do not raise any new or potential safety risks to the user or patient and questions of safety or effectiveness. Based on the results of software validation and verification tests, we conclude that the proposed device is substantially equivalent to the predicate devices.
| | Subject Device | Primary Predicate
Device | Reference Device |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | AVIEW | Vitrea CT Lung Density
Analysis Software | Vitrea, Version 7.0
Medical image Processing
Software |
| Classification Name | System, Image
Processing, Radiological | System, X-ray,
Tomography, Computed | System, Image
Processing, Radiological |
| Regulatory Number | 21 CFR 892.2050 | 21 CFR 892.1750 | 21 CFR 892.2050 |
| Product Code | LLZ | JAK | LLZ |
| Classification | Class II | Class II | Class II |
| Review Panel | Radiology | Radiology | Radiology |
| 510K number | K171199 | K151919 | K150258 |
| Indications for Use | AVIEW provides CT
values for pulmonary
tissue from CT thoracic
datasets. This software | The Vitrea Lung Density
Analysis software
provides CT values for
the pulmonary tissue from | Vitrea is a medical
diagnostic system that
allows the processing,
review, analysis, |
| | can be used to support
the physician
quantitatively in the
diagnosis, followup
evaluation and
documentation of CT
lung tissue images by
providing image
segmentation of sub-
structures in the left and
right lung (e.g., the five
lobes and airway),
volumetric and structural
analysis, density
evaluations and reporting
tools. AVIEW is also
used to store, transfer,
inquire and display CT
data sets. AVIEW is not
meant for primary image
Interpretation in
mammography. | CT thoracic datasets.
Three-dimensional(3D)
segmentation of the left
lung and right lung,
volumetric analysis,
density evaluation and
reporting tools are
integrated in a specific
workflow to offer the
physician a quantitative
support for diagnosis and
follow-up evaluation of
lung tissue images. | communication and media
interchange of multi-
dimensional digital
images acquired from a
variety of imaging
devices. Vitrea is not
meant for primary image.
Interpretation in
mammography. |
| Platform | IBM-compatible PC or
PC network | IBM-compatible PC or
PC network | IBM-compatible PC or
PC network |
| Operation System | Microsoft Window 7, 8,
10 | Microsoft Window XP,
Window VISTA, Window
7, 8 | Microsoft Window XP,
Window VISTA, Window
7, 8 |
| User Interface | Monitor, Mouse,
Keyboard | Monitor, Mouse,
Keyboard | Monitor, Mouse,
Keyboard |
| Image Input Sources | Images can be scanned,
loaded from card
readers, or imported
from a radiographic
imaging device | Images can be scanned,
loaded from digital
cameras or card readers,
or imported from a
radiographic imaging
device | Images can be scanned,
loaded from digital
cameras or card readers,
or imported from a
radiographic imaging
device |
| 32 bit / 64 bit | 64 bit | 32 / 64 bit | 32 / 64 bit |
| Image format | DICOM | DICOM | DICOM |
| Image Measurement
Tools | Ruler (line and 3D),
Tapeline (curve, poly and
3D), Angle (3-point, 4
point, and 3D), pixel
values, area of ROI
(rectangle, circle, ellipse),
volume | Ruler (linear),
Tapeline(curve), Angle (3-
point, 4 point, and 3D),
pixel values, area of a
region of interest, | Ruler (linear),
Tapeline(curve), Angle (3-
point, 4 point, and 3D),
pixel values, area of a
region of interest, |
| Image viewing | Axial, sagittal, and
coronal image, oblique
slice, cube view | Axial, sagittal and coronal
images, oblique slice,
cube view | Axial, sagittal and coronal
images, oblique slice,
cube view |
| Image manipulation | Panning, rotating,
zooming, windowing,
inverting, Coloring,
Oblique, Note (text
overlay) | Panning, rotating,
zooming, windowing,
inverting, text overlay,
volume of interest overlay | Panning, rotating,
zooming, windowing,
inverting, text overlay,
volume of interest overlay |
| | (volume of interest
overlay) | | |
| General Description | AVIEW is an image
processing software as a
medical device. It assists
in analyzing pulmonary
CT datasets and
displaying the analysis
results. | Vitrea CT Lung Density
Analysis assists in
analyzing lung densities
and volumes. It semi-
automatically segments
lung tissues with
quantifiable controls and
renderings to aid
communication with the
pulmonologist. | Vitrea is a medical
diagnostic system that
allows the processing,
review, analysis,
communication, and
media interchange of
multi-dimensional digital
images acquired from a
variety of imaging
devices. |
| DICOM | This receives DICOM
data from CT by DICOM
communication Conducts
DICOM data
communication with
PACS. It also imports
DICOM file directly,
saves by using export
function. | Retrieve image data over
the network via DICOM | Retrieve image data over
the network via DICOM |
| Lung Analysis Functions | Semi-automatic
segmentation of lungs,
lobes and airways
Visualization of multi-
planar reconstructed
(MPR) images and 3D
rendered images, with
color-defined Hounsfield
Unit (HU) ranges
Calculation of LAA
(Lower Attenuation Area)
index with HU density
histogram, volume
measurements and
percentile index
Calculation of LAA
cluster size distribution
with D-slope
Graphical visualization of
the above quantification
results for reporting
Export of quantification
results to CSV tables
Visualization of LAA%
for each of 5 lobes
Measurements of the
airway branches, such as,
lumen area and wall area | Semi-automatic right lung,
left lung, and airway
segmentation
Visualization of lung
density with color-defined
Hounsfield Unit (HU)
range
Lung density result
quantification with HU
density range, volume
measurements, lung density
index, and the PD15%
measurement
Density graph/histogram of
the classified lung voxels'
relative frequencies
Overlay of density
quantification results and
density graph histogram for
reporting
Export of density values
and curves to CSV tables
or copy to clipboard for
insertion into a report
Comparison of upper and
lower lung density index
ratios | N/A |
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6
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11. Technological Characteristics:
A VIEW is a software device that does not contact the patient, nor does it control any life sustaining devices. Results produced by the software tools are dependent on the interpretation of trained and licensed radiologists, clinicians and referring physicians as an adjunctive to standard radiology practices for diagnosis.
12. Performance Data:
Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria. A summary of the conducted tests is as below:
- । Unit test
- System test -
- DICOM test -
- -LAA analysis test
- LAA size analysis test -
- Airway wall measurement test -
- -Reliability test
- CT image compatibility test -
13. Conclusion:
The new device and predicate device are substantially equivalent in the areas of technical characteristics, general functions, application, and intended use. The new device does not introduce a fundamentally new scientific technology, and the nonclinical tests demonstrate that the device is safe and effective. Therefore, it is our opinion that the AVIEW described in this submission is substantially equivalent to the predicate device.