(131 days)
Unknown
The description mentions an "algorithm for estimating and removing scatter," which could potentially be an ML algorithm, but the document does not explicitly state that AI/ML is used, nor does it provide details about training data or model architecture typically found in AI/ML submissions.
No
The device is described as software that processes radiographic images to improve contrast and reduce scatter, which are diagnostic functions. It does not provide any treatment or therapy to a patient.
No
The device is described as software that improves the quality of radiographic images. It produces "diagnostic quality images" but does not perform a diagnosis itself; rather, it aids a radiologist in performing a diagnosis.
Yes
The device is described as "SmartGrid software" which is a "software option" and "encapsulates an algorithm". It is accessible through existing "DirectView DR Product application software". The description focuses entirely on the software's function of image processing and does not mention any accompanying hardware components or modifications to existing hardware.
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 SmartGrid feature is a software option that processes radiographic images acquired from a patient's body. It does not analyze biological samples.
- Intended Use: The intended use is to improve the quality of diagnostic radiographic images, not to perform a diagnostic test on a biological sample.
- Input: The input is a radiographic image, not a biological sample.
Therefore, the SmartGrid software falls under the category of medical image processing software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
"SmartGrid feature is a software option that provides, upon request by user, a diagnostic radiograph image with a reduction in visible x-ray scatter similar to the effect of an anti-scatter grid."
Product codes
MOB
Device Description
The SmartGrid software is designed to improve contrast and reduce the appearance of scatter in radiographic images that have been acquired without a physical grid. SmartGrid encapsulates an algorithm for estimating and removing scatter from radiographic images.
The SmartGrid feature is accessible through DirectView DR Product application software. Users will be able to select SmartGrid processing before an image is acquired, or to change whether SmartGrid processing is applied to a previously acquired image.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic images (x-ray)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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
The performance characteristics and operation of SmartGrid (investigational) were evaluated in a radiologist reader study. It was not possible to obtain the predicate device images. Therefore, images of cadaveric specimens and phantoms were acquired and used in the study.
The SmartGrid software performance was compared against two reference systems. In one reference system, images were acquired with grids at 400 speed exposure (grid reference) and processed with the Carestream DirectView V5.7 software (K060137). In the second reference system, images were acquired without grids at 400 speed exposure (non-grid reference) and processed with the same DirectView V5.7 software.
Radiologists reviewed and rated investigational and reference images (both grid and nongrid), for diagnostic quality, using a Radlex subjective diagnostic rating scale. The results demonstrate:
- SmartGrid processing software produces diagnostic quality images.
- At all exposure levels, SmartGrid processing produced images rated as good as or better than the non-grid reference images.
- SmartGrid processing software produces images with statistically equivalent diagnostic quality at lower exposures than the grid reference acquisitions.
Key Metrics
Diagnostic quality (rated using a Radlex subjective diagnostic rating scale)
Predicate Device(s)
Reference Device(s)
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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem featuring a stylized depiction of three human profiles facing to the right. The emblem is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 21, 2017
Carestream Health, Inc. % Ms. Diane C. Koetter Sr. Manager, Regulatory Affairs and Quality Systems 150 Verona Street ROCHESTER NY 14608
Re: K163157
Trade/Device Name: SmartGrid Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: March 13, 2017 Received: March 15, 2017
Dear Ms. 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 (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.
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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/Resourcesfor You/Industry/default.htm. 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 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.
Sincerely yours.
Michael D.'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163157
Device Name SmartGrid
Indications for Use (Describe)
"SmartGrid feature is a software option that provides, upon request by user, a diagnostic radiograph image with a reduction in visible x-ray scatter similar to the effect of an anti-scatter grid."
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: | Carestream Health, Inc. |
|---|---|
| 510(k) Owner Address: | 150 Verona Street |
| Rochester, New York 14608 | |
| 510(k) Owner Phone: | 585-627-6505 |
| 510(k) Owner Fax: | 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: | November 8, 2016 |
| Device Trade Name: | SmartGrid |
| Device Common Name: | Flat Panel Digital Detector System |
| Classification Name: | Stationary x-ray system |
| Device Class: | Class II |
| Device Code: | MQB |
| Regulation Number: | 21 CFR 892.1680 |
| Predicate Device: | FDR D-EVO Flat Panel Detector System (DR- |
| ID600) | |
| Manufactured by FujiFilm Medical Systems USA, | |
| Inc. | |
| 510(k) No. – K141765 (October 3, 2014) |
Device Description:
The SmartGrid software is designed to improve contrast and reduce the appearance of scatter in radiographic images that have been acquired without a physical grid. SmartGrid encapsulates an algorithm for estimating and removing scatter from radiographic images.
The SmartGrid feature is accessible through DirectView DR Product application software. Users will be able to select SmartGrid processing before an image is
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acquired, or to change whether SmartGrid processing is applied to a previously acquired image.
Indications for Use / Intended Use:
The Indications for Use for the SmartGrid Software is:
"SmartGrid feature is a software option that provides, upon request by user, a diagnostic radiograph image with a reduction in visible x-ray scatter similar to the effect of an antiscatter grid."
Comparison of Technological Characteristics:
SmartGrid Software has the same technological characteristics as the predicate device, FDR D-EVO Flat Panel Detector System (DR-ID600). Both are optional software components that allow for reduction in visible x-ray scatter in radiograph images.
Discussion of Testing:
The performance characteristics and operation of SmartGrid (investigational) were evaluated in a radiologist reader study. It was not possible to obtain the predicate device images. Therefore, images of cadaveric specimens and phantoms were acquired and used in the study.
The SmartGrid software performance was compared against two reference systems. In one reference system, images were acquired with grids at 400 speed exposure (grid reference) and processed with the Carestream DirectView V5.7 software (K060137). In the second reference system, images were acquired without grids at 400 speed exposure (non-grid reference) and processed with the same DirectView V5.7 software.
Radiologists reviewed and rated investigational and reference images (both grid and nongrid), for diagnostic quality, using a Radlex subjective diagnostic rating scale. The results demonstrate:
- SmartGrid processing software produces diagnostic quality images.
- . At all exposure levels, SmartGrid processing produced images rated as good as or better than the non-grid reference images.
- SmartGrid processing software produces images with statistically equivalent . diagnostic quality at lower exposures than the grid reference acquisitions.
Substantial Equivalence:
The proposed predicate device, FDR D-EVO Flat Panel Detector System (DR-ID600), has been found substantially equivalent by FDA through the 510(k) process (K141765) and is legally marketed. Its Indications for Use, though not
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identical to the SmartGrid, convey similar information about the intended use of the device and can therefore be considered for substantial equivalence.
Both devices utilize:
- Scatter Factor Estimation
- Scatter Correction
- Noise Reduction and Image Rendering
Both devices depend on the proper estimation of the scatter-to-primary ratio (SPR) to calculate scatter distribution and perform image enhancement. In both applications, the user can adjust SPR if desired.
Both devices suppress noise.
The predicate device differs from the investigation device in the methods for scatter estimation, scatter distribution and noise control.
The differences between SmartGrid and the predicate device do not affect the intended use of the device or alter the fundamental scientific technology of the device. Performance testing and clinical results support a substantial equivalence determination of the SmartGrid to the FDR D-EVO Flat Panel Detector System (DR-ID600).