ATHEROEDGE

{0}------------------------------------------------ K122022 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 {1}------------------------------------------------ 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<br>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™<br>software is a Windows-<br>based application<br>program used on a<br> | The SonoCalc software<br>is a Windows-based<br>application program<br>used on a personal<br>computer for the<br>automatic<br>measurement of the<br>Intima-Media<br>thickness (IMT) of the<br>carotid<br>Artery from images<br>obtained from<br>ultrasound systems. | The IMT.LAB software<br>is a Windows 2000/XP<br>software application<br>package to be used on a<br>personal computer for<br>the automatic<br>measurement of the<br>Intima-Media thickness<br>(IMT) of the carotid<br>artery from video<br>images obtained from<br>Esaote Pie ultrasound<br>systems. | | Image Source | Ultrasound images. | Ultrasound images. | Ultrasound images. | | Operating<br>environment,<br>system and<br>hardware | Stand-alone application<br>program for use on a<br>personal computer with<br>Microsoft Windows. | Stand-alone<br>application program<br>for use on a personal<br>computer with<br>Microsoft Windows. | Stand-alone application<br>program for use on a<br>personal computer with<br>Microsoft Windows. | | Image Format | DICOM, JPEG and<br>Windows's BMP | JPEG and Windows<br>BMP | DICOM, JPEG and<br>Windows BMP | | Image storage<br>and report<br>generation | Yes | Yes | Yes | | Automatic<br>distance<br>measurement<br>of the Intima-<br>Media<br>thickness of<br>carotid artery | Yes | Yes | Yes | | Classification | 90 LLZ<br>892.2050 | 90 LLZ<br>892.2050 | 90 LLZ<br>892.2050 | | Image<br>Compression | JPEG Loss-less | JPEG Loss-less | JPEG Loss-less | AtheroPoint™ LLC Confidential PreMarket Notification - AtheroEdge™ June 21, 2012 {2}------------------------------------------------ ! ・ {3}------------------------------------------------ # 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. - - {4}------------------------------------------------ # 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. {5}------------------------------------------------ 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 {6}------------------------------------------------ #### Page 2 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 {7}------------------------------------------------ # 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 14