(354 days)
Not Found
Yes
The device description explicitly mentions the use of a "deep learning algorithm" for automatic prostate gland volume calculation. Deep learning is a subset of machine learning.
No.
This device is described as an "aiding tool for clinicians to review multi-parametric resonance (MR) images" and a "medical diagnostic software." It provides tools for assessment, analysis, and reporting based on imaging data. It does not exert any direct therapeutic action on the patient.
Yes
The "Intended Use / Indications for Use" section states: "PROView is an aiding tool for the clinicians to review multi-parametric resonance (MR) inages following PI-RADS guidelines. It displays acquired and reformatted data for visualization and provides tools for assessment of the prostate gland volume and findings analysis in patients with known or suspected prostate lesions. Measurements and associated scoring are included in a report for communication to referring physicians." This indicates its use in assessing patient conditions for diagnosis. Additionally, the "Mentions image processing" section explicitly states: "PROView is a medical diagnostic software".
Yes
The device is described as a "medical diagnostic software" that processes and analyzes images from MR scanning devices. It does not mention any accompanying hardware components that are part of the device itself.
Based on the provided information, PROView is NOT an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. PROView, on the other hand, processes and analyzes medical images (MR images) acquired directly from the patient's body.
- The intended use clearly states it's an "aiding tool for the clinicians to review multi-parametric resonance (MR) images". This focuses on image analysis and interpretation, not the analysis of biological samples.
- The device description details the processing of image data (segmentation, measurements, scoring of image acquisitions). This aligns with image processing software, not IVD testing.
While PROView is a medical diagnostic software that aids in the diagnostic process, its function is based on the analysis of medical images, not in vitro testing of biological specimens.
No
The letter does not mention FDA review, approval, or clearance of a PCCP for this specific device. The provided text indicates "Not Found" for "Control Plan Authorized (PCCP) and relevant text."
Intended Use / Indications for Use
PROView is an aiding tool for the clinicians to review multi-parametric resonance (MR) images following PI-RADS guidelines. It displays acquired and reformatted data for visualization and provides tools for assessment of the prostate gland volume and findings analysis in patients with known or suspected prostate lesions. Measurements and associated scoring are included in a report for communication to referring physicians. It is intended for use by professionals, such as clinicians, radiologists, or physicians. The clinician remains ultimately responsible for the final assessment and diagnosis based on state-of-the-art practices, clinical judgment and interpretation of prostate images or quantitative data.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
PROView offers a guided workflow for the review, assessment and reporting of multi-parametric MR prostate exams. From inputting clinical information, measuring prostate and lesion volume to scoring lesions to form a comprehensive MR report, PROView offers a simple workflow per PI-RADS™ v2.1 guideline.
PROView Processes data from a single date.
The PROView workflow includes:
- Prostate volume extracted from automatic organ segmentation
- PSA Density
- Lesion(s) mapping to sectors and measurement ●
- Scoring of T2-weighted, diffusion weighted imaging (DWI) and, when ● applicable, dynamic contrast enhanced (DCE) acquisitions.
- Automatically generated report with all measurements and images ●
Prostate volume can be automatically calculated by defining the contours of the prostate gland with the use of a deep learning algorithm, or through a manual method. Users can cancel or switch to manual prostate gland volume definition if the automatic prostate gland segmentation fails or provides unsatisfactory results
Mentions image processing
PROView is a medical diagnostic software that is designed to provide easy processing, analysis, reviewing and communication of 3D reconstructed images and their relationship to originally acquired images from MR Scanning devices. The combination of acquired images, reconstructed images, annotations, and measurements performed by the clinician are intended to provide to the referring physician clinically relevant information that may aid in diagnosis and treatment planning.
Mentions AI, DNN, or ML
Prostate volume can be automatically calculated by defining the contours of the prostate gland with the use of a deep learning algorithm, or through a manual method.
The algorithm provides a fully automatic segmentation of the prostate, based on a deep learning model.
The software provides a fully automatic segmentation of the prostate, based on a deep learning model.
Automatic segmentation of the prostate based on a deep learning model.
Engineering has validated PROView algorithm's capability of automatic segmentation based on deep learning technique by using a database of MRI prostate exams.
Input Imaging Modality
MR, MRI
Anatomical Site
Prostate, Prostate gland
Indicated Patient Age Range
Not Found
Intended User / Care Setting
It is intended for use by professionals, such as clinicians, radiologists, or physicians.
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
Engineering has validated PROView algorithm's capability of automatic segmentation based on deep learning technique by using a database of MRI prostate exams. This database of exams is considered as representative of the clinical scenarios where PROView is intended to be used, with consideration of the different protocols, practices and ethnics factors.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results and feedback concluded that the algorithm meets the acceptance criteria and improves performance on volume accuracy.
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
§ 892.2050 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).
0
November 17, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below the words "U.S. FOOD & DRUG".
GE Medical Systems SCS % Hong Cui Regulatory Affairs Director 3000 North Grandview Boulevard-HQ WAUKESHA WI 53188
Re: K193306
Trade/Device Name: PROView Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: October 21, 2020 Received: October 22, 2020
Dear Hong Cui:
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/cfpmp/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-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,
For
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) K193306
Device Name PROView
Indications for Use (Describe)
PROView is an aiding tool for the clinicians to review multi-parametric resonance (MR) inages following PI-RADS guidelines. It displays acquired and reformatted data for visualization and provides tools for assessment of the prostate gland volume and findings analysis in patients with known or suspected prostate lesions. Measurements and associated scoring are included in a report for communication to referring physicians. It is intended for use by professionals, such as clinicians, radiologists, or physicians. The clinician remains ultinately responsible for the final assessment and diagnosis based on state-of-the-art practices, clinical judgment and interpretation of prostate images or quantitative data.
| 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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Image /page/3/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are three small white curved lines around the outside of the circle, evenly spaced. The logo is simple and recognizable.
GE Healthcare 510(k) Premarket Notification Submission K193306
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | November 26, 2019 |
|---|---|
| Submitter: | GE Medical Systems SCS |
| Establishment Registration Number - 9611343 | |
| 283 rue de la Miniere | |
| 78530 Buc, France | |
| Primary Contact Person: | Hong Cui |
| Regulatory Affairs Director | |
| GE Healthcare, (GE Medical Systems, LLC) | |
| 3000 N Grandview Blvd., | |
| Waukesha, WI - 53188 | |
| Phone: (262) 506-8238 | |
| Email: hong.cui@ge.com | |
| Secondary Contact Person: | Elizabeth Mathew |
| Senior Regulatory Affairs Manager | |
| Phone: (262) 424-7774 | |
| Email: Elizabeth.Mathew@ge.com | |
| Proposed Device: | |
| Device Name: | PROView |
| Common/Usual Name: | MR image analysis software |
| Regulation number/ Product Code: | 21 CFR 892.2050 Picture archiving and communications system/ |
| LLZ |
Classification: Class II
4
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GE Healthcare 510(k) Premarket Notification Submission
Predicate Device:
| Device Name: | DynaCAD |
|---|---|
| 510(k) number: | K192200 cleared on Oct 9, 2019 |
| Regulation number/ | |
| Product Code: | 21 CFR 892.2050 Picture archiving and communication system / |
| LLZ | |
| Classification: | Class II |
| Manufacturer: | Invivo Corporation, USA |
Device Description/
Technology:
PROView offers a guided workflow for the review, assessment and reporting of multi-parametric MR prostate exams. From inputting clinical information, measuring prostate and lesion volume to scoring lesions to form a comprehensive MR report, PROView offers a simple workflow per PI-RADS™ v2.1 guideline.
PROView Processes data from a single date.
The PROView workflow includes:
- Prostate volume extracted from automatic organ segmentation
- PSA Density
- Lesion(s) mapping to sectors and measurement ●
- Scoring of T2-weighted, diffusion weighted imaging (DWI) and, when ● applicable, dynamic contrast enhanced (DCE) acquisitions.
- Automatically generated report with all measurements and images ●
Prostate volume can be automatically calculated by defining the contours of the prostate gland with the use of a deep learning algorithm, or through a manual method. Users can cancel or switch to manual prostate gland volume definition if the automatic prostate gland segmentation fails or provides unsatisfactory results
Intended Use:
PROView is a medical diagnostic software that is designed to provide easy processing, analysis, reviewing and communication of 3D reconstructed images and their relationship to originally acquired images from MR Scanning devices. The combination of acquired images, reconstructed images, annotations, and measurements performed by the clinician are intended to provide to the referring physician clinically relevant information that may aid in diagnosis and treatment planning.
5
Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. There are decorative, wave-like elements surrounding the circle, giving the logo a classic and recognizable appearance.
GE Healthcare 510(k) Premarket Notification Submission
Indication for Use: PROView is an aiding tool for the clinicians to review multi-parametric prostate magnetic resonance (MR) images following PI-RADS guidelines. It displays acquired and reformatted data for visualization and provides tools for assessment of the prostate gland volume and findings analysis in patients with known or suspected prostate lesions. Measurements and associated scoring are included in a report for communication to referring physicians. It is intended for use by professionals, such as clinicians, radiologists, or physicians. The clinician remains ultimately responsible for the final assessment and diagnosis based on state-of-the-art practices, clinical judgment and interpretation of prostate images or quantitative data. Technological Characteristic: The goal of the new PROView software algorithm is to provide an automatic segmentation of the prostate on MRI T2 weighted acquisitions. It is a routine anatomical acquisition (as opposed to functional MRI), routinely done by the clinicians for prostate cancer assessment, as it is part of PIRADS guidelines. The algorithm provides a fully automatic segmentation of the prostate, based on a deep learning model. Comparison: The below comparison identifies the similarities and differences of the proposed
PROView to the DynaCAD Prostate module of the predicate device DynaCAD (K192200) to which substantial equivalency is claimed.:
| Specification | DynaCAD
K192200
(DynaCAD Prostaet) | Proposed Device:
PROView |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Targeted clinical
condition | Male patient with suspected
or known prostate lesions | Male patient with suspected
or known prostate lesions |
| Anatomy | Prostate | Prostate |
| Imaging
modality | MRI | MRI |
| Gland
segmentation | Automatically performs a
3D segmentation of the
gland. Users can alter or
make adjustments to the
segmented results in all
three planes. The resulting
segmentation reports
overall gland volume and
sets the stage for UroNav
MR/US guided fusion | The software provides a fully
automatic segmentation of
the prostate, based on a deep
learning model. Contour of
the prostate gland can be
adjusted by the user. Prostate
volume is extracted from
automatic gland
segmentation. |
6
Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. There are three water droplet shapes surrounding the circle. The logo is simple and recognizable, representing the company's brand identity.
GE Healthcare
510(k) Premarket Notification Submission
| biopsy | ||
|---|---|---|
| Gland volume | The resulting segmentation | |
| reports overall gland | ||
| volume and sets the stage | ||
| for UroNav MR/US guided | ||
| fusion biopsy | Prostate volume is extracted | |
| from automatic gland | ||
| segmentation after validation | ||
| of the contour by the user. | ||
| Segmentation | ||
| algorithm type | Model-based automatic | |
| prostate gland segmentation | Automatic segmentation of | |
| the prostate based on a deep | ||
| learning model. | ||
| Standardized | ||
| report | Following PI-RADS™ v2 | Following PI-RADS™ v2.1 |
Determination of Substantial Equivalence:
PROView has successfully completed the required design control testing per GE's quality system. PROView was designed and will be manufactured under the Quality System Regulations of 21CFR 820 and ISO 13485. The following quality assurance measures have been applied to the development of the device:
- Risk Analysis ●
- . Requirements Reviews
- Design Reviews ●
- Performance testing (Verification) ●
- Safety testing (Verification)
- Algorithm Qualification (Validation) ●
Engineering has validated PROView algorithm's capability of automatic segmentation based on deep learning technique by using a database of MRI prostate exams. This database of exams is considered as representative of the clinical scenarios where PROView is intended to be used, with consideration of the different protocols, practices and ethnics factors. The results and feedback concluded that the algorithm meets the acceptance criteria and improves performance on volume accuracy.
The substantial equivalence was also based on software documentation for a "Moderate" level of concern device.
Conclusion:
GE Healthcare considers PROView to be as safe, as effective, and performance is substantially equivalent to the predicate device.