(85 days)
Not Found
No
The description focuses on frequency decomposition methods for image enhancement, which is a traditional image processing technique, and does not mention AI or ML.
No
The device is described as image processing software to enhance radiographic images, with no mention of treating or ameliorating a disease or condition.
No
Explanation: The device is image processing software that enhances radiographic images. While it aims to produce "diagnostic quality images," its function is to process existing images, not to diagnose conditions itself. It does not generate a diagnosis or provide diagnostic information beyond image enhancement.
Yes
The device is described as "software" that performs "digital enhancement of a radiographic image." The description focuses solely on the software's image processing algorithms and does not mention any associated hardware components that are part of the device itself. It processes images acquired from separate digital radiography imaging receptors.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states that this software performs "digital enhancement of a radiographic image generated by an x-ray device." It processes images, not biological specimens.
- Intended Use: The intended use is to process and enhance radiographic images for diagnostic purposes, which is a function of medical imaging software, not IVD.
Therefore, this device falls under the category of medical imaging software, not an In Vitro Diagnostic.
N/A
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 (comma separated list FDA assigned to the subject device)
MOB, MQB
Device Description
The Eclipse II image processing software, like the original Eclipse image processing software, enhances projection radiography acquisitions captured from digital radiography imaging receptors (computed radiography (CR) and direct radiography (DR)).
The original Eclipse image processing software used a 4 band frequency decomposition method to enhance the output image. By comparison, the Eclipse (subject) image processing software uses 4 or more band frequency decomposition method. The additional number of bands allows for flexibility in frequency adjustments.
Mentions image processing
The software performs digital enhancement of a radiographic image generated by an x-ray device.
The Eclipse II image processing software, like the original Eclipse image processing software, enhances projection radiography acquisitions captured from digital radiography imaging receptors (computed radiography (CR) and direct radiography (DR)).
The original Eclipse image processing software used a 4 band frequency decomposition method to enhance the output image. By comparison, the Eclipse (subject) image processing software uses 4 or more band frequency decomposition method. The additional number of bands allows for flexibility in frequency adjustments.
The image processing chain is the same for both the predicate and the subject devices.
The Eclipse II (subject) software uses a 4 or more frequency band decomposition method.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray device, digital radiography imaging receptors (computed radiography (CR) and direct radiography (DR))
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric x-ray images
Intended User / Care Setting
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance characteristics and operation / usability of the Eclipse II software were evaluated in non-clinical (bench) testing. These studies demonstrated the intended workflow, related performance, overall function, verification and validation of requirements for intended use, and reliability of the software. Non-clinical test results have demonstrated that the device conforms to its specifications.
A clinical Reader Study was performed. Results of the Reader Study demonstrate that the Eclipse II Software provides diagnostic quality images.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 Diane Koetter Sr. Manager, Regulatory Affairs and Quality Systems 150 Verona Street Rochester, New York 14608
June 21, 2018
Re: K180809
Trade/Device Name: Eclipse II Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MOB Dated: March 23, 2018 Received: March 28, 2018
Dear Diane Koetter:
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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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Page 2 - Diane Koetter
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael D. O'Hara For
Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180809
Device Name Eclipse II
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Carestream
"510(k) Summary"
| 510(k) Owner Name:
510(k) Owner Address: | Carestream Health, Inc.
150 Verona Street
Rochester, New York 14608 |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Owner Phone:
510(k) Owner Fax: | 585-627-6505
585-627-8802 |
| Contact Person & Info: | Diane Koetter
Sr. Manager, Regulatory Affairs and Quality Systems
diane.koetter@carestream.com
585-627-6505 |
| Date Summary Prepared: | June 18, 2018 |
| Device Trade Name:
Device Common Name:
Classification Name: | Eclipse II
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Stationary x-ray system |
| Device Class:
Device Code:
Regulation Number: | Class II
MQB
21 CFR 892.1680 |
| Predicate Devices: | Kodak Eclipse Image Processing Software
Manufactured by: Eastman Kodak Company
510(k) No.: K060137 (March 16, 2006) |
Device Description:
The Eclipse II image processing software, like the original Eclipse image processing software, enhances projection radiography acquisitions captured from digital radiography imaging receptors (computed radiography (CR) and direct radiography (DR)).
The original Eclipse image processing software used a 4 band frequency decomposition method to enhance the output image. By comparison, the Eclipse (subject) image processing software uses 4 or more band frequency decomposition method. The additional number of bands allows for flexibility in frequency adjustments.
4
Indications for Use / Intended Use:
The Indications for Use for the device, as described in its labeling, are:
"The software performs digital enhancement of a radiographic image generated by an xray device. The software can be used to process adult and pediatric x-ray images. This excludes mammography applications."
The intended use for this device, as determined by descriptions and the proposed labeling contained in this submission, is similar to the Indications for Use statement provided above.
The subject device's proposed Indications for Use are different from the predicate device. The indications for K060137 are outdated as the statement refers primarily to a computed radiography base product. Therefore, this traditional 510(k) for Eclipse II is proposing an entirely new Indication for Use statement for the modified software device. The proposed Indications for Use of the subject device fall within the Intended Use of the predicate device and can be considered for substantial equivalence. Any variation in features or technical specifications have been identified and addressed through testing (described below) to support a substantial equivalence determination.
Comparison of Technological Characteristics:
Based upon information provided within this submission, we believe that the Eclipse II is substantially equivalent to the legally marketed Eclipse (predicate device). The Eclipse II image processing software, like the original Eclipse image processing software, enhances projection radiography acquisitions captured from digital radiography imaging receptors (computed radiography (CR) and direct radiography (DR)).
The image processing chain is the same for both the predicate and the subject devices. It involves segmenting the image into anatomically relevant image areas and decomposing the image into frequency bands. The frequency bands are enhanced and recombined resulting in the production of an improved diagnostic quality image. The original Eclipse (predicate) software utilizes a 4 frequency band decomposition method. The Eclipse II (subject) software uses a 4 or more frequency band decomposition method. The additional number of bands allows for flexibility in frequency adjustments.
Discussion of Testing
The performance characteristics and operation / usability of the Eclipse II software were evaluated in non-clinical (bench) testing. These studies demonstrated the intended workflow, related performance, overall function, verification and validation of requirements for intended use, and reliability of the software. Non-clinical test results have demonstrated that the device conforms to its specifications.
A clinical Reader Study was performed. Results of the Reader Study demonstrate that the Eclipse II Software provides diagnostic quality images.