(102 days)
Not Found
Yes
The device description explicitly states that the Smart Noise Cancellation module consists of a Convolutional Network (CNN) trained using clinical images, which is a form of machine learning.
No
The device is described as software that enhances radiographic images and allows for dose reduction during x-ray acquisitions. It processes diagnostic images but does not directly treat or diagnose a medical condition, nor does it restore a bodily function, which are characteristic of therapeutic devices.
No
The device is described as software that performs digital enhancement of radiographic images to improve image quality and potentially lower radiation dose. It does not perform a diagnosis itself, but rather processes images for viewing by radiologists and physicians.
Yes
The device is described as "software" that "runs inside the Image View product application software" and is an "optional feature (module)". It processes images generated by an x-ray device but does not include the x-ray device itself or any other hardware components.
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 described device is software that performs digital enhancement of radiographic images generated by an x-ray device. It processes images, not biological samples.
- Intended Use: The intended use is to improve the quality of x-ray images for diagnostic purposes by radiologists and physicians. This is related to medical imaging, not in vitro testing.
- Input: The input is radiographic images, not biological samples.
Therefore, the device falls under the category of medical imaging software, not an in vitro diagnostic device.
No
The input text explicitly states "Control Plan Authorized (PCCP) and relevant text: Not Found", indicating no mention of PCCP authorization.
Intended Use / 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 pediatric x-ray images. This excludes mammography applications.
Product codes
MQB
Device Description
Eclipse software runs inside the Image View product application software (not considered stand-alone software). Smart Noise Cancellation is an optional feature (module) that enhances projection radiography acquisitions captured from digital radiography imaging receptors (Computed Radiography (CR) and Digital Radiography (DR). Eclipse II with Smart Noise Cancellation supports the Carestream DRX family of detectors which includes all CR and DR detectors.
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 II with Smart Noise Cancellation incorporates enhanced noise reduction prior to executing Eclipse image processing software. The software has the capability to lower dose up to 50% when processed through the Eclipse II software with SNC, resulting in improved image quality. A 50% dose reduction for CSI panel images and 40% dose reduction for GOS panel images when processed with Eclipse II and SNC results in image quality as good as or better than nominal dose images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes (Convolutional Network (CNN))
Input Imaging Modality
Radiographic image generated by an x-ray device (projection radiography acquisitions captured from digital radiography imaging receptors (Computed Radiography (CR) and Digital Radiography (DR)).
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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.
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)
A concurrence study was performed by board certified radiologists in accordance with FDA "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" and Carestream standard procedure for concurrence studies and Carestream standard procedure for concurrence studies. 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 RadLexscale. The statistical test results and graphical summaries demonstrate that the software delivers diagnostic quality images at 50% dose reduction for Csl panel images and 40% dose reduction for GOS panel reduced radiation doses that are equivalent to or exceed the quality of nominal dose image of exams, detector types and exposure levels.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
January 14, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
Carestream Health, Inc. % Gina Maiolo Regulatory Affairs Manager 150 Verona St ROCHESTER NY 14608
Re: K213307
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: December 10, 2021 Received: December 13, 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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see 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-learn). 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@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurel Burk Assistant Director Diagnostic X-ray Systems Team 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) K213307
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
Image /page/3/Picture/0 description: The image shows the word "Carestream" in orange color. The font is sans-serif and the letters are closely spaced. The background is white.
510(k) Summary
510(k) Owner Name Carestream Health, Inc. 510(k) Owner Address 150 Verona Street Rochester, New York 14608 510(k) Owner Contact Information Gina Maiolo Regulatory Affairs Manager Phone (Work) 585.627.6543 Phone (Mobile) 516.395.0597 Date Summary Prepared Sept 30 2021 Device Trade Name Solid State X-Ray Imager Stationary X-ray system
Device Common Name Classification Name Device Class Device Code Regulation Number Predicate Device
Eclipse II with Smart Noise Cancellation Class II MOB 21 CFR 892.1680 Eclipse II 510(k) K202441
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 Image View product application software (not considered stand-alone software). Smart Noise Cancellation is an optional feature (module) that enhances projection radiography acquisitions captured from digital radiography imaging receptors (Computed Radiography (CR) and Digital Radiography (DR). Eclipse II with Smart Noise Cancellation supports the Carestream DRX family of detectors which includes all CR and DR detectors.
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 II with Smart Noise Cancellation incorporates enhanced noise reduction prior to executing Eclipse image processing software. The software has the capability to lower dose up to 50% when processed through the Eclipse II software with SNC, resulting in improved image quality. A 50% dose reduction for CSI panel images and 40%
4
arestream
dose reduction for GOS panel images when processed with Eclipse II and SNC results in image quality as good as or better than nominal dose images
Technological Characteristics
The technological characteristics of the Eclipse II with Smart Noise Cancellation remain the same. Reference the Comparison Table for a summary of changes.
Eclipse II software enhances projection radiography acquisitions captured from digital radiography imaging receptors (Computed Radiography (CR) and Digital Radiography (DR) which is the same as the predicate software K202441. 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 predicate and modified.
- . 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.
- The modifications to the Image View 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
arestream
Summary of Non-Clinical Testing
No additional non-clinical testing was required to demonstrate substantial equivalence between the predicate device labeling and the modified labeling.
Summary of Clinical Testing
A concurrence study was performed by board certified radiologists in accordance with FDA "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" and Carestream standard procedure for concurrence studies and Carestream standard procedure for concurrence studies.
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 RadLexscale. The statistical test results and graphical summaries demonstrate that the software delivers diagnostic quality images at 50% dose reduction for Csl panel images and 40% dose reduction for GOS panel reduced radiation doses that are equivalent to or exceed the quality of nominal dose image of exams, detector types and exposure levels.
Conclusion of Testing
Clinical testing validates the modifications to the device description.
| | Predicate
(K202441) | Subject Device |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Eclipse II with Smart Noise Cancellation | same |
| Manufacturer | Carestream Health | same |
| Indications for Use | "The software performs digital enhancement of a
adiographic image generated by an x-ray device.
The software can be used to process adult and
pediatric x-ray images. This excludes
mammography applications." | same |
| Grid Suppression | Removes grid frequencies from the image. | same |
| Image Segmentation | Image analysis that identifies the anatomy of
interest by detecting direct exposure and
collimator blades. | same |
| Recognition | Optional tech assist features on chest exams that
provide auto-orientation (head-up), identify
clipped lung bases and provide a CNR image
quality metric. | same |
| Parameter Prediction | Automatic determination of rendering parameters
based upon features extracted from histograms of
the image in support of (4) to (10) frequency
bands. | same |
| Enhanced Noise | Yes | same |
| Reduction Support | | |
| Device Description | Eclipse software runs inside the ImageView
product application software (not considered
stand-alone software). Smart Noise Cancellation is
an optional feature (module) that enhances
| Addition:
The software has the capability to lower
dose up to 50% when processed
through Eclipse II SNC, resulting in
improved image quality. A 50% dose
reduction for CsI panel images and 40%
dose reduction for GOS panel images
when processed with Eclipse II and
SNC results in image quality as good as
or better than nominal dose images |
A comparison chart provides similarities and differences between the modified and predicate device.
6