(261 days)
Not Found
Yes
The predicate device, Arterys Oncology DL (K173542), explicitly includes "DL" in its name, which stands for Deep Learning, a subset of Machine Learning. While the summary for Ezra Plexo doesn't explicitly mention AI/ML, the choice of a predicate device known to utilize DL strongly suggests that Ezra Plexo likely incorporates similar technology for its image processing and analysis functions, especially given its focus on lesion detection and quantification.
No.
The device is a diagnostic application for image viewing, manipulation, and analysis to support oncological workflows, not for direct treatment.
Yes
The intended use explicitly states that the software is a "medical diagnostic application" and is "designed to support the oncological workflow by helping the user to confirm the absence or presence of lesions, including evaluation, quantification, and documentation of any such lesions." These functions are directly related to providing information for diagnosis.
Yes
The device is described as a "medical image application" accessed through a web browser, which processes data files previously generated by other equipment. There is no mention of any accompanying hardware component being part of the device itself. The validation focuses solely on the software's performance with existing image data.
Based on the provided information, Ezra Plexo Software is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVDs analyze samples taken from the human body. IVDs typically work with biological samples like blood, urine, tissue, etc., to provide information about a patient's health status.
- Ezra Plexo Software analyzes images of the human body. The software processes medical images (specifically MR images) that are acquired from the patient, not biological samples.
- The intended use focuses on image visualization and analysis. The description clearly states its purpose is for "viewing, manipulation, 3D- visualization, and comparison of MR medical images" to support the oncological workflow by helping users evaluate lesions. This is a function of medical image processing and analysis, not in vitro testing.
Therefore, Ezra Plexo Software falls under the category of medical image analysis software, not an IVD.
No
The letter does not contain any language indicating that the FDA reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this device. The term "PCCP" is only mentioned in the "Control Plan Authorized (PCCP) and relevant text" section with "Not Found".
Intended Use / Indications for Use
Ezra Plexo Software is a medical diagnostic application for viewing, manipulation, 3D- visualization, and comparison of MR medical images. The images can be viewed in a number of output formats including volume rendering.
Ezra Plexo Software enables visualization of information that would otherwise have to be visually compared disjointedly.
Ezra Plexo Software is designed to support the oncological workflow by helping the user to confirm the absence or presence of lesions, including evaluation, quantification, and documentation of any such lesions.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. Ezra Plexo Software is a complement to these standard procedures.
Product codes
QIH
Device Description
Ezra Plexo is a medical image application for 2D and 3D visualization, comparison, and manipulation of medical images. Plexo can be accessed through a web browser. It provides radiologists the ability to view and manipulate volumetric data such as MRI. The product allows volumetric segmentation of regions of interest, while enabling users to edit such segmentations and to take quantitative measurements.
Plexo does not interface directly with the MR scanner or any other data collection equipment. Instead, it uploads data files previously generated by such equipment. Its functionality is independent of the acquisition equipment vendor. Its analysis results are available on screen and can be saved for review.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR
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
The nonclinical software validation tests were performed on 150 patient exams utilizing consensus ground truth created by five U.S. board certified expert radiologists.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The nonclinical software validation tests were performed on 150 patient exams.
The test results demonstrated that the Ezra Plexo Software performs to its intended use, is deemed acceptable for clinical use, and does not introduce new questions of safety or efficacy. The testing was conducted in accordance to the software validation/verification plans and protocols.
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
§ 892.2050 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a stylized human figure on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The text is in blue, with "FDA" in a square and the rest of the text in a smaller font.
July 10, 2020
Ezra AI Inc. % Mr. David Girard Quality Manager 79 Madison Ave., Ste 545 NEW YORK NY 10016
Re: K192969
Trade/Device Name: Ezra Plexo Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: QIH Dated: June 9, 2020 Received: June 11, 2020
Dear Mr. Girard:
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)
Device Name Ezra Plexo Software
Indications for Use (Describe)
Ezra Plexo Software is a medical diagnostic application for viewing, manipulation, 3D- visualization, and comparison of MR medical images. The images can be viewed in a number of output formats including volume rendering.
Ezra Plexo Software enables visualization of information that would otherwise have to be visually compared disjointedly.
Ezra Plexo Software is designed to support the oncological workflow by helping the user to confirm the absence or presence of lesions, including evaluation, quantification, and documentation of any such lesions.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. Ezra Plexo Software is a complement to these standard procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CER 801 Subnart D) | Over-The-Counter Ise (21 C.FR 801 Subnart C |
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510(k) Summary 1
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR Part 807.92.
Submitter Information 1.1
| Submitter's Name | Ezra Al Inc. |
|---|---|
| Address | 79 Madison Avenue, Suite 545, New York, NY, 10016 USA |
| Telephone Number | 888-402-3972 |
| Contact Person | David Girard |
| Date of Summary Preparation | July 2, 2020 |
Subject Device Information 1.2
| Device Name | Ezra Plexo Software |
|---|---|
| Common Name | Plexo |
| Classification | II |
| Review Panel | Radiology |
| Product Code | QIH |
| Regulations | 892.2050 - Automated radiological image processing software |
1.3 Predicate Device Information
Arterys Oncology DL Device Name 510(k) Number K173542
4
Device Description വ
Ezra Plexo is a medical image application for 2D and 3D visualization, comparison, and manipulation of medical images. Plexo can be accessed through a web browser. It provides radiologists the ability to view and manipulate volumetric data such as MRI. The product allows volumetric segmentation of regions of interest, while enabling users to edit such segmentations and to take quantitative measurements.
Plexo does not interface directly with the MR scanner or any other data collection equipment. Instead, it uploads data files previously generated by such equipment. Its functionality is independent of the acquisition equipment vendor. Its analysis results are available on screen and can be saved for review.
Indications for Use 3
Ezra Plexo Software is a medical diagnostic application for viewing, manipulation, and comparison of medical MR images can be viewed in a number of output formats including volume rendering.
Ezra Plexo Software enables visualization of information that would otherwise have to be visually compared disjointedly.
Ezra Plexo Software is designed to support the oncological workflow by helping the user confirm the absence or presence of lesions, including evaluation, quantification, and documentation of any such lesions.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. Ezra Plexo Software is a complement to these standard procedures.
5
Summary of Technological 4 Characteristics Comparison
Table 1 shows that Plexo Software and the Predicate Device (K173542) are equivalent in technological characteristics.
| Feature | Subject Device:
Ezra Plexo Software | Predicate Device:
Arterys Oncology DL
(K173542) |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Platform | Chrome Desktop | Client-server, Chrome Desktop |
| DICOM Compliant | Yes | Yes |
| Type of Scans | MR | MR, CT |
| Image Navigation
Tools | Pan, zoom, rotate, slice scroll (view
multiple slices)
Adjust window level, minimize/maxi-
mize
Orientation labels, scroll sync, ruler | Pan, zoom, rotate, slice scroll (view
multiple slices)
Adjust window level, minimize/maxi-
mize
Orientation labels, cross-reference in-
dicator |
| Image Display Modes | Yes, static | Yes, static and cine |
| Text Annotation on
the Image | Yes | Yes |
| Layout | Can select a viewport layout
and add series to it | Can select a viewport layout
and add series to it |
| 2D Image Review | Yes | Yes |
| 3D Image Review | Yes, 3D review of segmented region | Yes, 3D review of the full image |
| Create MPR Images | No | Yes |
| Manual Segmentation | Yes | Yes |
| 2D Semi-Automated
Segmentation | Yes, available only for MR prostate
studies | Yes, available only for lung CT and
liver MR studies |
| Linear Dimension Cal-
culation | Yes | Yes |
| Volume Calculation | Yes | Yes |
Table 1: Subject and Predicate Device Comparison
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Performance Testing 5
The Ezra Plexo Software has been developed in a manner consistent with accepted standards for software development and evaluated in accordance with design specifications and applicable performance standards through software verification, validation, and usability testing.
The nonclinical software validation tests were performed on 150 patient exams utilizing consensus ground truth created by five U.S. board certified expert radiologists.
The test results demonstrated that the Ezra Plexo Software performs to its intended use, is deemed acceptable for clinical use, and does not introduce new questions of safety or efficacy. The testing was conducted in accordance to the software validation/verification plans and protocols. A full description of the software functionality, device hazard analysis, software requirements, verification, validation and usability study is provided in this submission.
Conformance Standards б
There are no applicable FDA mandated performance standards for this device. However, voluntary standards have been utilized in the production of the software. The device was designed and developed in accordance to the following conformance standards:
- · ISO 14971:2007- Medical devices Application of risk management to medical devices
- · IEC 62304:2006/A1:2015 Medical device software Software life cycle processes
- · IEC 62366-1:2015 Medical Devices Application of usability engineering to medical devices
- · NEMA PS 3.1-3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) set
Substantial Equivalence Conclusion 7
The Ezra Plexo Software has the same intended use and similar technological characteristics as the predicate Arterys Oncology DL (K173542) device. As demonstrated in this submission, the subject and predicate device are identical in indications for use and intended use. The subject Ezra Plexo Software is substantially equivalent to the predicate Arterys Oncology DL (K173542) device, and the minor differences in the technological characteristics of the subject and predicate device do not raise any new or different questions of safety and effectiveness.