(78 days)
Not Found
No
The summary describes "proprietary techniques and algorithms" for image analysis and measurement, but does not mention AI, ML, or related terms. The performance studies compare the software's results to manual measurements and expert readers, which is a common validation approach for image analysis software, not necessarily indicative of AI/ML.
No
The device is a diagnostic tool that measures IMT (Intima-Media Thickness) to assess cardiovascular health, not a therapeutic device.
Yes
The software measures the Intima-Media Thickness (IMT) of the carotid artery from ultrasound images and generates a report with these values, which is used adjunctively with other medical data by a physician to help assess the cardiovascular health of a patient. This assessment of a patient's health status makes it a diagnostic device.
Yes
The device description explicitly states that AtheroEdge™ is a "software package that runs on a stand-alone computer" and that "There is no dedicated medical equipment required for operation of this software application except for an ultrasound machine that is the source of images". This indicates the device itself is solely the software.
Based on the provided information, the AtheroEdge™ software is not an In Vitro Diagnostic (IVD).
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, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- AtheroEdge™'s Function: AtheroEdge™ analyzes images obtained from an ultrasound system, which is an in vivo (within the living body) imaging modality. It does not examine specimens derived from the human body.
- Intended Use: The intended use is to measure the Intima-Media Thickness (IMT) from ultrasound images of the carotid artery. This is an analysis of anatomical structure visualized through imaging, not a test performed on a biological sample.
Therefore, AtheroEdge™ falls under the category of a medical device that processes and analyzes medical images, but it is not an IVD.
N/A
Intended Use / Indications for Use
The AtheroEdge™ software is a Window's-based application program used on a personal computer for an automatic measurement of the Intima-Media Thickness (IMT) of the carotid artery from images obtained from ultrasound systems.
Product codes
LLZ
Device Description
AtheroEdge™ is a software package that runs on a stand-alone computer running a Microsoft Windows™ XP or Microsoft Windows™ 7.0 Operating System. There is no dedicated medical equipment required for operation of this software application except for an ultrasound machine that is the source of images of the carotid artery. These images are digitally transferred from the ultrasound machine to the computer containing the software application. AtheroEdge™ software provides a means of opening and displaying images in DICOM, ISO Joint Photographic Experts Group (JPEG) Image Compression Standard and Microsoft Windows's BMP formats. AtheroEdge™ then uses proprietary techniques and algorithms to automatically measure the Intima-Media Thickness (IMT) and its variability of the distal (far) wall of the carotid artery in ultrasound image. AtheroEdge™ software provides a means for creating a region of interest on the distal (far) wall image and display by the software. AtheroEdge™ software provides a means of analyzing the content of the image data contained within the region of interest (ROI) and compute the IMT and its variability. AtheroEdge™ can generate, view and print a report indicating what the patient's IMT and its variability values. This information is used adjunctively with other medical data by a physician to help assess the cardiovascular health of a patient. AtheroEdge™ is also capable of storing patient measurement values in the database management system along with the images for future reference.
Mentions image processing
AtheroEdge™ Medical Image Processing Workstation System, Image Processing, Radiological, LLZ
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
carotid artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / 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
The validation study consisted of 200 carotid ultrasound images corresponding to 50 subjects, retrospectively taken from a longitudinal study and laboratory tested off-line. The carotid ultrasound images were scanned with a commercially available ultrasound system using a 13-5 MHz linear transducer of Sonoline Antares ultrasound scanner (Siemens, USA). The acquisition followed echo cardiology standards.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Two types of clinical validation and performance testing were performed:
(i) Benchmarking against the manual caliper measurements of IMT values taken from commercially available ultrasound system.
(ii) Benchmarking against expert reader's measurement of IMT values taken from two radiological expert ultrasound tracers and taking its average.
The validation study consisted of 200 carotid ultrasound images corresponding to 50 subjects, retrospectively taken from a longitudinal study and laboratory tested off-line. The benchmarking results for both validation methods showed that AtheroEdge™ software performed within 5% tolerance of the (i) mean manual caliper measurements of IMT values taken from commercially available ultrasound system and (ii) mean expert reader's measurement of IMT values taken from two radiological expert ultrasound tracers.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Performed within 5% tolerance.
Predicate Device(s)
Reference Device(s)
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).
0
SEP 2 6 2012
510(k) Summary
Submitter's Name: Submitter's Address: Submitter's Telephone: Contact Name:
Date Summary Prepared: Trade or Proprietary: Common or Usual Name: Classification Name:
AtheroPoint™ LLC 208 Otter Glen CT, Roseville, CA, 95661 916-749-5628 Jasjit S. Suri June 21, 2012 AtheroEdge™ Medical Image Processing Workstation System, Image Processing, Radiological, LLZ
Picture Archiving and Communications, 21CFR 892.2050
| Device Name | 510(k) Number |
|---|---|
| SonoCalc | K030223 |
| IMT.LAB | K043360 |
Predicate Devices:
Device Description, Indications of Use and Technology 5.0
5.0.1 Device Description and Its Technology
AtheroEdge™ is a software package that runs on a stand-alone computer running a Microsoft Windows™ XP or Microsoft Windows™ 7.0 Operating System. There is no dedicated medical equipment required for operation of this software application except for an ultrasound machine that is the source of images of the carotid artery. These images are digitally transferred from the ultrasound machine to the computer containing the software application. AtheroEdge™ software provides a means of opening and displaying images in DICOM, ISO Joint Photographic Experts Group (JPEG) Image Compression Standard and Microsoft Windows's BMP formats. AtheroEdge™ then uses proprietary techniques and algorithms to automatically
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measure the Intima-Media Thickness (IMT) and its variability of the distal (far) wall of the carotid artery in ultrasound image. AtheroEdge™ software provides a means for creating a region of interest on the distal (far) wall image and display by the software. AtheroEdge™ software provides a means of analyzing the content of the image data contained within the region of interest (ROI) and compute the IMT and its variability. AtheroEdge™ can generate, view and print a report indicating what the patient's IMT and its variability values. This information is used adjunctively with other medical
data by a physician to help assess the cardiovascular health of a patient. AtheroEdge™ is also capable of storing patient measurement values in the database management system along with the images for future reference.
5.0.2 Device - Indications of Use
The AtheroEdge™ software is a Window's-based application program used on a personal computer for an automatic measurement of the Intima-Media Thickness (IMT) of the carotid artery from images obtained from ultrasound systems.
Device Comparison Table 5.1
AtheroEdge™ is substantially equivalent to other legally marketed products, specifically, the SonoCalc product (K030223) developed by SonoMetric Health, LLC and Esaote's IMT.LAB product (K043360), when SonoCalc and Esaote IMT.Lab is used for automated measurement of the IMT of the carotid artery. The technological characteristics comparison table is shown below:
| Company
| Name | AtheroPoint™ | Sono Metric Health | ESAOTE IMT.LAB |
|---|---|---|---|
| Product Name | AtheroEdge™ | SonoCalc | IMT.LAB |
| 510(k) no | Via this submission | K030223 | K043360 |
| Intended Use | The AtheroEdge™ | ||
| software is a Windows- | |||
| based application | |||
| program used on a |
| The SonoCalc software
is a Windows-based
application program
used on a personal
computer for the
automatic
measurement of the
Intima-Media
thickness (IMT) of the
carotid
Artery from images
obtained from
ultrasound systems. | The IMT.LAB software
is a Windows 2000/XP
software application
package to be used on a
personal computer for
the automatic
measurement of the
Intima-Media thickness
(IMT) of the carotid
artery from video
images obtained from
Esaote Pie ultrasound
systems. |
| Image Source | Ultrasound images. | Ultrasound images. | Ultrasound images. |
| Operating
environment,
system and
hardware | Stand-alone application
program for use on a
personal computer with
Microsoft Windows. | Stand-alone
application program
for use on a personal
computer with
Microsoft Windows. | Stand-alone application
program for use on a
personal computer with
Microsoft Windows. |
| Image Format | DICOM, JPEG and
Windows's BMP | JPEG and Windows
BMP | DICOM, JPEG and
Windows BMP |
| Image storage
and report
generation | Yes | Yes | Yes |
| Automatic
distance
measurement
of the Intima-
Media
thickness of
carotid artery | Yes | Yes | Yes |
| Classification | 90 LLZ
892.2050 | 90 LLZ
892.2050 | 90 LLZ
892.2050 |
| Image
Compression | JPEG Loss-less | JPEG Loss-less | JPEG Loss-less |
AtheroPoint™ LLC Confidential PreMarket Notification - AtheroEdge™ June 21, 2012
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5.2 Performance Testing and benchmarking
There are no Section 514 performance standards for this class of device. The AtheroEdge™ software has been designed to comply with the following voluntary Standards: .
- . Digital Imaging and Communications in Medicine (DICOM).
- . ISO Joint Photographic Experts Group (JPEG) Image.
- . Microsoft Windows Bitmap (BMP) Image Encoding.
- . Two types of clinical validation and performance testing were performed:
- (i) Benchmarking against the manual caliper measurements of IMT values taken from commercially available ultrasound system.
- (ii) Benchmarking against expert reader's measurement of IMT values taken from two radiological expert ultrasound tracers and taking its average.
The validation study consisted of 200 carotid ultrasound images corresponding to 50 subjects, retrospectively taken from a longitudinal study and laboratory tested off-line. The carotid ultrasound images were scanned with a commercially available ultrasound system using a 13-5 MHz linear transducer of Sonoline Antares ultrasound scanner (Siemens, USA). The acquisition followed echo cardiology standards. The benchmarking results for both validation methods showed that AtheroEdge™ software performed within 5% tolerance of the (i) mean manual caliper measurements of IMT values taken from commercially available ultrasound system and (ii) mean expert reader's measurement of IMT values taken from two radiological expert ultrasound tracers.
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5.3 Conclusion
The results of comparing the intended use, function, technological characteristics, mode of operation and specifications of the AtheroEdge™ with those predicate devices demonstrate that the AtheroEdge™ is substantially equivalent to existing products in the market today.
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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
SEP 26 2012
Jasjit S. Suri, PhD Chief Executive Officer (CEO) AtheroPoint™ LLC 208 Otter Gen Court ROSEVILLE CA 95661
Re: K122022
Trade/Device Name: AtheroEdge Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 21, 2012 Received: July 10, 2012
Dear Dr. Suri:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 comply with an the rece orequirements 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nothleate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 11 July 11 Specific and refice of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 I va may ocain other generational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use (IFU)
510(k) Number (if known): Pending
Device Name: AtheroEdge™
The AtheroEdge™ software is a Window's-based application program used on a personal computer for an automatic measurement of the Intima-Media Thickness (IMT) of the carotid artery from images obtained from ultrasound systems.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Radiological Devices
510k K122282 OIVD
AtheroPoint™ LLC Confidential PreMarket Notification - AtheroEdge™ June 21, 2012
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