(188 days)
Not Found
No
The summary describes image processing and analysis for change detection but does not mention AI, ML, or related terms, nor does it provide details about training or test sets typically associated with AI/ML model development.
No
Explanation: A therapeutic device is one that treats, cures, or prevents disease. This device is solely for generating an image to aid in diagnosis, not for treatment.
Yes
Explanation: The device is intended for "improved detection of lung nodules that have changed between the two examinations" and its performance is evaluated in terms of "radiologists' diagnostic performance in the detection of actionable lung nodules". This indicates its use in aiding in the diagnosis of lung nodules.
Yes
The device is described as a "dedicated post-processing application" that operates on existing chest x-ray images. There is no mention of any associated hardware components being part of the device itself. The performance studies focus on the software's impact on image interpretation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body. This device, DeltaView, processes medical images (chest x-rays) taken directly from the patient. It does not analyze blood, urine, tissue samples, or any other biological specimen.
- The intended use clearly describes image processing for diagnostic aid. The device generates a secondary image based on existing medical images to help radiologists detect changes in lung nodules. This is a form of medical image analysis, not in vitro testing.
The description of the device, its input, anatomical site, and intended user all align with a medical image processing device used for diagnostic interpretation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
DeltaView is intended to generate a secondary residual image based on a current and prior chest x-ray image of the same patient, resulting in improved detection of lung nodules. The DeltaView image provides adjunctive information and is not a substitute for the original PA/AP image. This device is intended to be used by trained professionals, such as physicians and radiologists, on patients with risk of having lung nodules, and is not intended to be used on pediatric patients.
Product codes
LLZ
Device Description
DeltaView is a dedicated post-processing application which registers current and prior chest exams to provide an image that shows areas of change.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
chest x-ray image
Anatomical Site
chest, lung
Indicated Patient Age Range
not intended to be used on pediatric patients.
Intended User / Care Setting
trained professionals, such as physicians and radiologists
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)
In a multi-reader multi-case (MRMC) reader study, radiologists interpreted pairs of images in order to compare the radiologists' ability to detect valid change when they were aided by the DeltaView image. Localized receiver operating characteristic curves (in terms of the trade-off between sensitivity and specificity when the decision criteria change) were used to evaluate radiologists' diagnostic performance in the detection of actionable lung nodules on chest radiographs with and without the usage of DeltaView. The results indicated that DeltaView should be a useful adjunct for the interpretation of chest radiographs when looking for a change in a lung nodule.
The objective of the study was to demonstrate that a radiologist's results when using DeltaView images are superior to the radiologist's results when using standard prior and current AP/PA x-ray image pairs alone. Localized Receiver Operating Characteristic (LROC) Analysis and analyses for Sensitivity, Specificity, and Positive and Negative Predictive Value were performed. The research hypothesis indicating superiority was that the upper 95% confidence limit on the differences in the area under the DeltaView LROC curve (AUCDV) subtracted from the area under the Unaided LROC curve (AUCUA) is greater than or equal to 0.0.
There were significant changes when the DeltaView difference image was used. The area under the LROC curve (AUCLROC) increased from 0.477 to 0.536 (12.4%) (p = 2.9E-05)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity, Specificity, and Positive and Negative Predictive Value
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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Traditional 510(k) Premarket Notification DeltaView™M
Riverain Medical Page 6
510(K) SUMMARY 3.0 .
K111776
June 21, 2011 Submission Date:
.
Submitter Information:
| Company Name: | Riverain Medical Group, LLC. |
|---|---|
| Company Address: | 3020 South Tech Blvd., Miamisburg, OH 45342-4860 |
| Contact Person: | Jennifer Vetter Butsch |
| Director, Regulatory Affairs and Quality Assurance | |
| Riverain Medical | |
| 800.990.3387 | |
| 937.425.6493 | |
| jvetter@riverainmedical.com |
Device Information:
| Trade Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code: | DeltaView™
21 CFR §892.2050
System, Image Processing, Radiological
Class II
LLZ |
|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device: | SoftView
(K092363)
Riverain Medical Group, LLC
Class II |
| Device Description: | DeltaView is a dedicated post-processing application which
registers current and prior chest exams to provide an image
that shows areas of change. |
| Intended Use: | DeltaView is intended to generate a secondary residual
image based on a current and prior chest x-ray image of the
same patient. |
| Indications for Use: | DeltaView is intended to generate a secondary residual
image based on a current and prior chest x-ray image of the
same patient, resulting in improved detection of lung
nodules. The DeltaView image provides adjunctive
information and is not a substitute for the original PA/AP
image. This device is intended to be used by trained
professionals, such as physicians and radiologists, on |
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patients with risk of having lung nodules, and is not intended to be used on pediatric patients.
Comparison to Predicate Device:
DeltaView is substantially equivalent to the cited predicate device. Differences in the design and performance from the cited predicate device do not affect either the safety or effectiveness of Delta View for its intended use.
Conclusion: DeltaView is a mathematical model of the current medical practice of manually comparing radiographic images. Radiologists routinely compare prior and current chest x-rays from the same patient, when available, to ascertain whether pathological change has occurred. The comparison requires the radiologist to associate regions of interest and neutralize the acquisition effects. Delta View facilitates the comparison process through the automated formation of a difference image, by registering and subtracting a difference of normalized, bone suppressed image pairs. DeltaView achieves this using a variety of advanced image processing and pattern recognition methods. Just as the cited predicate device removes obstructions from a chest X-ray image in order to enhance the radiologist's detection of suspicious structures, so DeltaView obscures the unchanged portions of patient images taken over time in order to enhance the radiologist's detection of suspicious, changed structures. Furthermore, DeltaView uses the same bone suppression mechanism as the predicate device as part of its residual image algorithm. There are no new issues of safety and effectiveness raised by the incorporation of the predicate device's bone suppression in this new device. Reader Study Results: In a multi-reader multi-case (MRMC) reader study, radiologists interpreted pairs of images in order to compare the radiologists' ability to detect valid change when they were aided by the DeltaView image. Localized receiver operating characteristic curves (in terms of the trade-off between sensitivity and specificity when the decision criteria change) were used to evaluate radiologists' diagnostic performance in the detection of actionable lung nodules on chest radiographs with and without the usage of DeltaView. The results indicated that DeltaView should be
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a useful adjunct for the interpretation of chest radiographs when looking for a change in a lung nodule.
The objective of the study was to demonstrate that a radiologist's results when using DeltaView images are superior to the radiologist's results when using standard prior and current AP/PA x-ray image pairs alone. Localized Receiver Operating Characteristic (LROC) Analysis and analyses for Sensitivity, Specificity, and Positive and Negative Predictive Value were performed. The research hypothesis indicating superiority was that the upper 95% confidence limit on the differences in the area under the DeltaView LROC curve (AUCDV) subtracted from the area under the Unaided LROC curve (AUCUA) is greater than or equal to 0.0.
There were significant changes when the DeltaView difference image was used. The area under the LROC curve (AUCLROC) increased from 0.477 to 0.536 (12.4%) (p = 2.9E-05)
Substantial Equivalence: The reader study described above used similar methods and achieved similar results to the reader study that was reviewed by FDA when clearing the predicate device (K092363). In both cases, an image processing application generates a secondary image for the radiologist to view, and in both cases, the use of this secondary image resulted in a statistically significant improvement in the radiologist's ability to detect actionable lung nodules.
It should also be noted that Delta View automates the current clinical reading practice of manually comparing a current radiographic image with a prior image from the same patient.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Jennifer Vetter Butsch Director, Regulatory Affairs and Quality Assurance Riverain Medical Group, LLC 3020 South Tech Boulevard MIAMISBURG OH 45342-4860
DEC 2 8 2011
Re: K111776
Trade/Device Name: DeltaViewTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 12, 2011 Received: December 14, 2011
Dear Ms. Butsch:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice mouncents as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket wifi anow you to begall mains of substantial equivalence of your device to a legally marketed notification. The I Drice results in for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 11 you desire openie ad receiver you Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 3 150. Theose port 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to under the MDA rogalation (DF of es/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 r ou may ookin of Schell Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Pastel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K111776
Device Name: DeltaView
Indications for Use:
DeltaView is intended to generate a secondary residual image based on a current and prior chest x-ray image of the same patient, resulting in improved detection of lung nodules that have changed between the two examinations. The DeltaView image provides adjunctive information and is not a substitute for the original PA/AP image. This device is intended to be used by trained professionals, such as physicians and radiologists, on patients with risk of having lung nodules, and is not intended to be used on pediatric patients.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Alberto Lutz
Division of Radiologic Office of In Vitro Diagnostic Device Eve
K11726
510K.
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