Eclipse II with Smart Noise Cancellation

{0}------------------------------------------------ April 2, 2021 Image /page/0/Picture/1 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Carestream Health, Inc. % Gina Maiolo Sr. Manager Regulatory Affairs, Clearance & Surveillance 150 Verona Street ROCHESTER NY 14608 # Re: K202441 Trade/Device Name: Eclipse II with Smart Noise Cancellation Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: February 16, 2021 Received: February 19, 2021 # Dear Gina Maiolo: 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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see {1}------------------------------------------------ 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-leam). 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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael D. O'Hara 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K202441 #### Device Name Eclipse II with Smart Noise Cancellation Indications for Use (Describe) "The software performs digital enhancement of a radiographic image generated by an x-ray device. The software can be used to process adult and pediatric x-ray images. This excludes mammography applications." X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary | 510(k) Owner Name | Carestream Health, Inc. | |----------------------------------|--------------------------------------------------------------------------------| | 510(k) Owner Address | 150 Verona Street<br>Rochester, New York 14608 | | 510(k) Owner Contact Information | Gina Maiolo<br>Regulatory Affairs Manager<br>email: gina.maiolo@carestream.com | | Phone (Work) | 585.627.6543 | | Phone (Mobile) | 516.395.0597 | | Date Summary Prepared | March 30 2021 | | Device Trade Name | Eclipse II with Smart Noise Cancellation | | Device Common Name | Solid State X-Ray Imager | | Device Class | Class II | | Product Code | MQB | | Regulation Number | 21 CFR 892.1680 | | Regulation Description | Stationary X-ray system | | Predicate Device | Eclipse II 510(k) K180809 | Carestream Health, Inc. is submitting this Traditional 510(k) premarket notification for modifications to the Eclipse II with Smart Noise Cancellation. Carestream believes that the modified device is substantially equivalent to the cleared device (K180809). # Indications for Use "The software performs digital enhancement of a radiographic image generated by an x-ray device. The software can be used to process adult and pediatic x-ray images. This excludes mammography applications." # Device Description Eclipse software runs inside the ImageView product application software (also namely console software). The Eclipse image processing software II with Smart Noise Cancellation is similar to the predicate Eclipse image processing software (K180809). Eclipse with Smart Noise Cancellation is an optional feature that enhances projection radiography acquisitions captured from digital radiography imaging receptors (Computed Radiography (CR) and Direct Radiography (DR). The modified software is considered an extension of the {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "Carestream" in orange font. The font is sans-serif and appears to be bolded. The word is horizontally oriented and centered in the image. software (it is not stand alone and is to be used only with the predicate device supports the Carestream DRX family of detectors, this includes all CR and DR detectors. The primary difference between the predicate and the subject device is the addition of a Smart Noise Cancellation module. The Smart Noise Cancellation module consists of a Convolutional Network (CNN) trained using clinical images with added simulated noise to represent reduced signal-to-noise acquisitions. Eclipse with Smart Noise Cancellation (modified device) incorporates enhanced noise reduction prior to executing Eclipse II image processing software. ## Technological Characteristics Eclipse software enhances projection radiography acquisitions captured from digital radiography imaging receptors (Computed Radiography (CR) and Direct Radiography (DR) which is the same as the predicate software K180809. The software was modified to include the support for Smart Noise Cancellation. This Smart Noise Cancellation module consists of a Convolutional Network (CNN), trained using clinical images with added simulated noise to represent reduced signal-to-noise acquisitions. The main difference between the modified and predicate device is the Smart Noise Cancellation module only. The comparison chart below demonstrates the similarities to further support that the overall image processing architecture is the same between the predicate and modified device. - . Both the predicate and modified device is software designed for the enhancement of the raw images captured from the digital flat panel detectors (detectors have obtained separate clearances). The enhancement image processing intends to present an image with proper image quality attributes (brightness, latitude, overall contrast and detail, sharpness, and noise appearance) for the purpose of helping radiologists and physicians to make a diagnosis (same as the predicate). - The difference in the modified software is the implementation of noise suppression prior to enhancement . processing. The Smart Noise Cancellation operation passes the acquired preprocessed image through a specially trained Convolutional Network (CNN) based on a U-Net architecture to generate a 2D map of the estimated noise found in the image, identified in the document as a "Noise Field." This change does not raise new questions regarding safety and effectiveness. Risks were assessed in accordance to ISO 14971 and evaluated and reduced as far as possible with risk mitigations and mitigation evidence. - O The modifications to the ImageView software, (acquisition software for digital radiography systems) has been modified to enable/disable the Eclipse II with Smart Noise Cancellation. These user interface changes are described in detail in the Substantial Equivalence discussion and do not introduce new risks or raise new questions pertaining to safety and effectiveness. - . The difference in image processing paths between the predicate and modified device demonstrate that the noise level in images processed thru the modified software (Eclipse II with Smart Noise Cancellation) is greatly reduced when compared with the image processed thru the predicate software. Eclipse II. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "Carestream" in orange font. The font is sans-serif and appears to be bolded. The word is centered in the image and takes up most of the space. The background is white. #### Summary of Non-Clinical Testing There are two non-clinical testing reports to demonstrate substantial equivalence. - . The report for the Analysis of the Difference Images is the images processed with the investigational software (Eclipse II with Smart Noise Cancellation) and the predicate software (Eclipse II). The report focused on the analysis of the residual image artifacts. In conclusion, the images showed no substantial residual edge information within regions of interest. - . The report for the Ideal Observer Evaluation is based on simulated lesions on chest images. The evaluation demonstrated that detectability is preserved or improved with the investigational software for all supported detector types and exposure levels tested. A complete list of the supported detectors: - . DRX Plus 3543 & DRX Plus 4343 (K150766), DRX-L (GOS) (K190611) - DRX Plus 3543C & DRX Plus 4343C (K153142), Lux 3543C (CsI) (K203159) . - . DRX Plus 2530C (K183245) - . Carestream DRX-1 System w/DRX-1 Detector (K090318) - DRX-1C (K120062), DRX 2530C (CsI) (K130464) . #### Summary of Clinical Testing A clinical evaluation was performed by board certified radiologists. The images were evaluated using a 5-point visual difference scale (-2 to +2) tied to diagnostic confidence. Additionally, the overall diagnostic capability of each image was evaluated using the 4-point RadLex scale. The statistical test results and graphical summaries demonstrate that the investigational software delivers diagnostic quality images that exceed the quality of the predicate software over a range of exams, detector types and exposure levels. #### Conclusion of Testing The software modifications do not significantly affect fundamental design, technology, device materials, or packaging. Additionally, the investigational and predicate are substantially equivalent as a result of the following: - . The performance of the investigational software is the same as or better than the predicate software. - The differences within the software do not raise new or different questions of safety and . effectiveness. - . The intended use for both the investigational and predicate software remain the same. {6}------------------------------------------------ # Carestream A comparison chart provides similarities and differences between the modified and predicate device. | Attribute | Eclipse II Predicate Device<br>(K180809) | Eclipse II with Smart<br>Noise Cancellation<br>(K202441) | |-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------| | Indications for Use | "The software performs digital enhancement of a<br>radiographic image generated by an x-ray device. The<br>software can be used to process adult and pediatric x-ray<br>images. This excludes mammography applications." | same | | Grid Suppression | Analysis for and removes grid frequencies from the<br>image. | same | | Image Segmentation | Image analysis that identifies the anatomy of interest<br>by detecting direct exposure and collimator blades. | same | | Recognition | Optional tech assist features on chest exams that<br>provide auto-orientation (head-up), identify clipped<br>lung bases and provide a CNR image quality metric. | same | | Parameter Prediction | Automatic determination of rendering parameters<br>based upon features extracted from histograms of the<br>image in support of (4) to (10) frequency bands. | same | | Enhanced<br>Noise<br>Reduction Support | no | yes | | Rendering (frequency<br>decomposition and<br>enhancement) | (4) to (10) frequency bands. | same |