CLEARVIEWHD

{0}------------------------------------------------ MAY: 22 2014 K140139 Page 1 of 3 # 5. 510(k) Summary of Safety and Effectiveness This 510(k) summary of safety and effectiveness information is submitted as part of the PreMarket Notification in accordance with the requirements of 21 CFR Part 807, Subpart E and Section 807.92. ## 1. Identification of Submitter: Submitter: ClearView Diagnostics Inc. Address: 371 Hoes Lane Suite 104 Piscataway, NJ 08854 Phone: 732-529-5755 Fax: 732-529-5757 Contact: Christine Podilchuk Title: CEO Phone: 908-616-1945 Fax: 732-529-5757 · Summary Date: January 16, 2014 #### 2. Identification of Product: Device Name: ClearViewHD, Version 1.0 Device Common Name: Image Enhancement System Device Classification: 21 CFR 892.2050, Class II, LLZ (90) Classification Name: Image Processing, System Manufacturer: ClearView Diagnostics Inc. #### 3. Marketed Devices The ClearViewHD System provides post-acquisition image processing of ultrasound images and automatically generates an enhanced image with reduced speckle noise and improved contrast enhancement for viewing and diagnosing. In terms of safety, ClearViewHD is substantially equivalent to the currently marketed post-processing software products that analyze data from medical images. In terms of safety and performance, this software medical device is substantially equivalent to the devices listed below: Model: SharpView Manufacturer: ContextVision AB 510(k) Number: K993802, K024028 Model: Sapheneia Clarity Manufacturer: Sapheneia Commercial Products AB 510(k) Numbers: K063391 510(k) Summary 5-1 {1}------------------------------------------------ ## 4. Device Description The ClearViewHD image processing software reduces noise and enhances contrast of medical ultrasound images. The software is a Windows XP or higher, Windows Embedded, and DICOM-compatible platform that may be installed on a standalone PC, laptop, or tablet The software does not require any specialized hardware but the time to process an image will vary depending on the hardware specifications. ClearViewHD is based on a core noise reduction and contrast enhancement algorithm that uses novel statistical techniques to determine whether each pixel location is due to mostly noise or signal (tissue structure) and attenuates the regions due to noise while preserving and accentuating the regions due to tissue structure. The statistical method is based on the a priori knowledge that the ultrasound signal is sparse and compressive sampling theory can be used to reconstruct the signal with fewer samples than the Nyquist Rate specifies. The Clear ViewHD image processing software is a DICOM node that accepts DICOM3.0 digital medical files from an ultrasound device or another DICOM source. ClearViewHD processes the image and returns the original and/or enhanced image to another DICOM node such as a specific PC/workstation or the PACS system. The ClearViewHD software is designed to be compatible with any of the DICOM-compliant medical devices distributed by various OEM vendors. ## 5. Indications for Use The ClearView Image Enhancement System is intended for use by a qualified technician or diagnostician to reduce speckle noise, enhance contrast and transfer ultrasound images. The software provides a DICOM-compliant ClearViewHD-enhanced image along with the original ultrasound image to assist in image interpretation by the trained physician. ClearViewHD is a software application designed to reduce speckle noise and enhance contrast in medical ultrasound images that are viewed for diagnosis. The software provides a ClearViewHD-enhanced image along with the original ultrasound image for viewing by the trained diagnostician in order to assist in image interpretation and diagnosis. The enhanced image along with the original image may be sent to any other DICOM node. The output is provided in standard DICOM format as an additional series with appropriate descriptors so that it can be displayed on most third-party commercial DICOM workstations. ClearViewHD is intended to be used by physicians and technicians skilled in diagnostic ultrasound imaging. | Product | SharpView<br>(K024028,K993802) | Sapheneia Clarity<br>(K063391) | ClearViewHD | |-----------------|--------------------------------|--------------------------------|---------------------------| | Characteristics | Software for transfer, | Software for transfer, | Software for transfer and | ### 6. Substantial Equivalence Chart {2}------------------------------------------------ | | storage, enhancement<br>and viewing of<br>multimodal medical<br>images. | storage, noise<br>reduction, contrast<br>enhancement and<br>viewing of multimodal<br>medical images. | enhancement of ultrasound<br>images. | |-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The Image Enhancement<br>System is intended for<br>use by a qualified<br>technologist for transfer<br>storage, enhancement,<br>and viewing of<br>multimodal images. | The Sapheneia Clarity<br>is intended for use by<br>radiologists for<br>transfer, storage, noise<br>reduction, contrast<br>enhancement and<br>viewing of multi-<br>modality images from<br>a variety of<br>diagnostic systems | ClearViewHD is intended<br>for use by a qualified<br>technologist for transfer<br>and enhancement of<br>ultrasound images from a<br>variety of diagnostic<br>systems. | | Physical<br>Characteristics | Software Package<br>Operates on off-the-shelf<br>hardware | Software Package<br>Operates on off-the-<br>shelf hardware | Software Package<br>Operates on off-the-shelf<br>hardware | | Computer | PC compatible | PC compatible | Same | | Operating<br>System | Windows 98, NT4.0,<br>2000 and XP | Windows | Windows XP and higher,<br>Windows Embedded | | Storage | Hard disk or any<br>compatible PC Method:<br>Optical, CDROM, ... | | Storage not supported | | Image Input | DICOM3.0 | DICOM3.0 | DICOM3.0 | ### 7. Non-Clinical Performance Data Bench testing on phantoms as well as previously collected clinical images resulted in a reduction in speckle noise energy yielding an average improvement in Signal-to-Noise Ratio (SNR) of 12 dB on 10,000 simulated A-Scans using ClearViewHD. Likewise the Contrast-to-Noise Ratio (CNR) after applying ClearViewHD to the ultrasound images resulted in an average improvement of 2 times the original CNR. ClearViewHD enhanced images were also viewed with the original image and found to visually contain less speckle noise and enhanced contrast. These metrics as well as visual inspection confirm the ability of the ClearViewHD Software Product to reduce speckle noise and enhance contrast. #### 8. Conclusion After analyzing bench testing data, it is the conclusion of ClearView Diagnostics that the ClearViewHD Image Enhancement System is as safe and effective as the predicate devices, has few technological differences, and only a minor change to the indications for use and not supporting storage and viewing compared with the predicate devices, thus rendering it substantially equivalent to the predicate devices. 510(k) Summary {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the symbol. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 28, 2014 Clearview Diagnostics, Inc. % Ms. Christinc Podilchuk President 371 Hoes Lane Suite 104 PISCATAWAY NJ 08854 Rc: K140139 Trade/Device Name: ClearViewHD Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 15, 2014 Received: April 22, 2014 Dear Ms. Podilchuk: 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. 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. 1f your device is classified (see above) into either class 11 (Special Controls) or class 111 (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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable. the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {4}------------------------------------------------ Page 2-Ms. Podilchuk If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/Medica!Devices/ResourcesforYou/Industry/default.htm. Sincerely yours,  for Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K140139 Device Name ClearViewHD #### Indications for Use (Describe) The ClearView Image Enhancement System is intended for use by a qualified technician or diagnostician to reduce speckle noise, enhance contrast, and transfer ultrasound images. The software provides a DICOM-compliant ClearViewHD-enhanced image along with the original ultrasound image interpretation by the trained physician. 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