Ezra Plexo Software

K192969 · Ezra Ai, Inc. · QIH · Jul 10, 2020 · Radiology

Device Facts

• Record ID: K192969
• Device Name: Ezra Plexo Software
• Applicant: Ezra Ai, Inc.
• Product Code: QIH · Radiology
• Decision Date: Jul 10, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

Web-based medical diagnostic application; enables 2D/3D visualization, manipulation, and comparison of MR images. Inputs: previously generated MR data files (no direct scanner interface). Processing: volumetric segmentation of regions of interest; manual and semi-automated segmentation tools; linear dimension and volume calculation. Outputs: on-screen analysis results, segmented images, and quantitative measurements. Used by radiologists in clinical settings to support oncological workflows; assists in confirming presence/absence of lesions. Clinician retains ultimate diagnostic responsibility; software serves as a complement to standard clinical practices.

Clinical Evidence

Non-clinical software validation performed on 150 patient exams. Consensus ground truth established by five U.S. board-certified expert radiologists. Testing confirmed device performance against design specifications and intended use; no clinical data provided.

Technological Characteristics

Web-based software (Chrome Desktop); DICOM compliant. Features include 2D/3D visualization, manual and semi-automated segmentation (MR prostate studies), and quantitative measurements. Developed per ISO 14971:2007, IEC 62304:2006/A1:2015, IEC 62366-1:2015, and NEMA PS 3.1-3.20 (2016).

Indications for Use

Indicated for use by clinicians to view, manipulate, 3D-visualize, and compare MR medical images to support oncological workflows, including the evaluation, quantification, and documentation of lesions.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Arterys Oncology DL (K173542)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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#### Indications for Use

510(k) Number (if known)

K192969

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

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#### 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.

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### 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:<br>Ezra Plexo Software | Predicate Device:<br>Arterys Oncology DL<br>(K173542) |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Platform | Chrome Desktop | Client-server, Chrome Desktop |
| DICOM Compliant | Yes | Yes |
| Type of Scans | MR | MR, CT |
| Image Navigation<br>Tools | Pan, zoom, rotate, slice scroll (view<br>multiple slices)<br>Adjust window level, minimize/maxi-<br>mize<br>Orientation labels, scroll sync, ruler | Pan, zoom, rotate, slice scroll (view<br>multiple slices)<br>Adjust window level, minimize/maxi-<br>mize<br>Orientation labels, cross-reference in-<br>dicator |
| Image Display Modes | Yes, static | Yes, static and cine |
| Text Annotation on<br>the Image | Yes | Yes |
| Layout | Can select a viewport layout<br>and add series to it | Can select a viewport layout<br>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<br>Segmentation | Yes, available only for MR prostate<br>studies | Yes, available only for lung CT and<br>liver MR studies |
| Linear Dimension Cal-<br>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.