DeepLook PRECISE

K202084 · Deeplook, Inc. · LLZ · Apr 9, 2021 · Radiology

Device Facts

• Record ID: K202084
• Device Name: DeepLook PRECISE
• Applicant: Deeplook, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Apr 9, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

DeepLook PRECISE is a software device that is integrated into medical Image Viewers and PACS workstations to assist trained professionals in measuring dimensions of objects within a region of interest (ROI) that is identified by the user in DICOM images. The generated information consists of an estimated greatest long-axis and greatest short-axis dimensions, area, volume, and margin of the objects. For illustration purposes, DeepLook PRECISE can optionally provide a colorization of the interior area defined by a margin. DeepLook PRECISE does not make clinical decisions nor is a decision-support tool. The information provided by the software and must not be used in isolation when making patient management decisions. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using and FDA cleared monitor that offers at least 5 Megapixel resolutions and meets other technical specifications reviewed and accepted by FDA. Typical users of this system are trained physicians and radiologists. DeepLook PRECISE, is not intended for use on mobile devices.

Device Story

Software application embedded in PACS/EIS or OEM viewers; processes DICOM images to provide automated measurements of user-selected ROIs. User identifies suspected object via mouse click; device uses shape-recognition algorithms to analyze ROI and generate candidate shapes/boundaries. System returns prioritized stack of candidate shapes; default shape selected via deterministic algorithms based on shape-recognition ratios. User navigates stack via keystrokes/trackball; can manually modify contours to recalculate metrics. Provides estimated long/short-axis, area, volume. Optional interior colorization for visualization. Not a diagnostic or decision-support tool; output used as initial estimate alongside clinical judgment. Operates on Windows OS; supports workstation, local server, or cloud deployment. Integrates via XML messaging protocols. Benefits include consistent measurement and workflow efficiency compared to manual digital calipers.

Clinical Evidence

Bench testing only. Validation testing confirmed all verification and validation activities met predetermined acceptance criteria. No clinical data presented.

Technological Characteristics

Windows OS service; XML-based messaging for integration with PACS/viewers. Uses shape-recognition algorithms for image post-processing. Conforms to DICOM (NEMA PS 3.1-3.20), ISO 14971 (risk management), and IEC 62304 (software lifecycle). Standalone software; non-real-time, non-contacting. Cybersecurity controls per FDA guidance.

Indications for Use

Indicated for trained physicians and radiologists to assist in measuring dimensions (long-axis, short-axis, area, volume) of objects within user-identified ROIs in DICOM images. Not for use on mobile devices. Not for primary interpretation of lossy compressed mammographic or digitized film screen images.

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

• StoneChecker (K191530)

Submission Summary (Full Text)

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April 9, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

DeepLook Inc. % Mr. Carl Alletto Regulatory Consultant OTech Inc. 8317 Belew Drive MCKINNEY TX 75071

Re: K202084

Trade/Device Name: DeepLook PRECISE Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: March 5. 2021 Received: March 15, 2021

Dear Mr. Alletto:

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/cfpmn/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

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devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see 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-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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,

Michael D. O'Hara
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) K202084

Device Name DeepLook PRECISE

#### Indications for Use (Describe)

DeepLook PRECISE is a software device that is integrated into medical Image Viewers and PACS workstations to assist trained professionals in measuring dimensions of objects within a region of interest (ROI) that is identified by the user in DICOM images. The generated information consists of an estimated greatest long-axis and greatest short-axis dimensions, area, volume, and margin of the objects. For illustration purposes, DeepLook PRECISE can optionally provide a colorization of the interior area defined by a margin. DeepLook PRECISE does not make clinical decisions nor is a decision-support tool. The information provided by the software and must not be used in isolation when making patient management decisions.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using and FDA cleared monitor that offers at least 5 Megapixel resolutions and meets other technical specifications reviewed and accepted by FDA. Typical users of this system are trained physicians and radiologists.

DeepLook PRECISE, is not intended for use on mobile devices.

| 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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This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared: March 29, 2011

510(k) Number: K202084

#### I. SUBMITTER

DeepLook Inc. 1220 Burton Street Silver Spring, MD 20910 TEL: [phone] Email: [e-mail]

Contact Person: Mr. Steven Schwadron, Chief Operating Officer

## II. DEVICE

| Name of Device: | DeepLook PRECISE |
|-----------------------|-------------------------------------------|
| Common or Usual Name: | Picture Archive and Communications System |
| Regulation Name: | System, Image Processing, Radiological |
| Regulation: | 21 CFR 892.2050 |
| Product Code: | LLZ |
| Regulatory Class: | II |

# III. PREDICATE DEVICE

| Device Classification Name | System, Image Processing, Radiological |
|------------------------------|-----------------------------------------------------------------------------------------|
| 510(K) Number | K191530 |
| Device Name | StoneChecker |
| Applicant | Imaging Biometrics, LLC<br>13416 Watertown Plank Road, Suite 260<br>Elm Grove, WI 53122 |
| Regulation Number | 892.2050 |
| Regulation Medical Specialty | Radiology |

## IV. DEVICE DESCRIPTION

DeepLook PRECISE, is a software application that works embedded in PACS/EIS or OEM viewers. It provides automated measurement, replacing manual digital calipers currently used to measure objects in digital medical imaging.

It is a Windows OS service that uses XML messaging to receive Commands from the viewer application: it processes results independently and returns requested data to the viewer application via the same XML messaging. The software is not compiled within the viewer's application. As a result, integration is simplified and limited to establishing XML protocols for reciprocal Commands.

DeepLook PRECISE can operate on an individual workstation, local servers or in Cloudbased applications.

The software uses patented shape-recognition processes to analyze Regions of Interest (ROIs) identified by a trained medical user (i.e., imaging technologist, radiologist, phvsician or researcher). When requesting a measurement, the user triggers a set of XML Commands via the viewer interface. The primary Command is a request for a

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measurement of an object located within an ROI designated by the user using a mouse to click on the location of a suspected object.

DeepLook receives the Command, processes the area within the ROI and assembles the candidate shapes (and all relevant metrics) and returns a full set of displays (bundled and prioritized) that depict the possible boundaries of the object. To facilitate initial viewing, DeepLook PRECISE designates a default shape; this shape is recommended as the best depiction of the targeted margin of the object. The selection of the default shape from the display stack is determined by a set of deterministic algorithms that sort for the best candidate shape based on shape recognition ratios developed by DeepLook. Based on training and professional skill, a user can use simple keystroke Commands or a track ball or mouse wheel to move through the entire stack of alternative margins (shapes) and select the one that they conclude best represents the targeted object.

Once a candidate shape has been chosen, the user has the option to extend or contract any specific section of the margin in order to include or exclude a feature they deem relevant. Any alteration of the contours of the displayed margin will recalculate the overall measurement metrics (i.e., calculate two new axis measurements, and the area and estimated volume). The results will instantly appear with the modified margin.

The Commands to accept the default shape-display or select alternative shape-displays and any modification of selected shape-displays are all executed using keystroke or track ball functions that are initiated by the user through the viewer interface. Each resulting shape includes all relevant measurement metrics when displayed, allowing for quick comparison and selection.

For illustrative purposes, the software offers a colorization display of the internal shapes within a candidate margin: each of the shapes within the outer margin of a targeted object or anatomical structure is assigned a calibrated color. This is offered solely to assist the user in distinguishing the shape components when making a final selection. The colorization is not a decision-support or diagnostic tool.

The measurements and graphical display can be saved. Depending on the viewer configuration, this data can be saved 1) to the hard drive of the workstation; 2) to a server on the premises or in the Cloud; 3) in a structured report; or 4) configured to comply with DICOM data fields and saved to the PACS. The location of the saved display will be determined by the viewer manufacturer and/or the user.

The displays of DeepLook PRECISE described above offer the user consistent measurement of each shape. The modification functions provide the user with maximum flexibility to adjust the default shape or any other shapes in the display stack. The user can also decline all suggested shapes generated by DeepLook PRECISE and use standard mouse-operated digital calipers to measure the target object.

The final configuration of the user interface (i.e., keystrokes, track ball and hot-key Commands) will be determined by each vendor that integrates DeepLook PRECISE. To assist the vendor during integration, each XML Command and display option is illustrated separately in this manual. This provides the integrator with the option of selecting some or all the functions and to determine the best Commands to incorporate, consistent with its own user interface.

DeepLook PRECISE is stand-alone Windows OS service designed to permit maintenance and performance improvements without the need to modify established XML protocols used to send and receive Commands. This eliminates the need for additional vendor integrations when patches and/or updates are required to DeepLook PRECISE's Windows OS service.

# V. INDICATIONS FOR USE

DeepLook PRECISE is a software device that is integrated into medical Image Viewers and PACS workstations to assist trained professionals in measuring dimensions of objects within a region of interest (ROI) that is identified by the user in DICOM

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images. The generated information consists of an estimated greatest long-axis and greatest short-axis dimensions, area, volume, and margin of the objects. For illustration purposes, DeepLook PRECISE can optionally provide a colorization of the interior area defined by a margin. DeepLook PRECISE does not make clinical decisions nor is a decision-support tool. The information provided by the software is an initial estimate and must not be used in isolation when making patient management decisions.

Lossy compressed mammoqraphic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using and FDA cleared monitor that offers at least 5 Mega-pixel resolutions and meets other technical specifications reviewed and accepted by FDA. Typical users of this system are trained physicians and radiologists. DeepLook PRECISE, is not intended for use on mobile devices.

## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

| Ref<br># | Technical<br>Characteristic | Subject Device -<br>DeepLook<br>PRECISE | Predicate -<br>StoneChecker<br>K191530 | Difference/Comments |
|--------------------------|------------------------------------------------------------------------------------------------------------|-----------------------------------------|-------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Indications for Use | | | |
| 1 | Statement references<br>a software only<br>device. | Yes | Yes | No significant difference |
| 2 | Statement references<br>DICOM Standard. | Yes | Yes | No significant difference |
| 3 | Statement references<br>the<br>display / view of<br>medical images. | Yes | Yes | No significant difference |
| 4 | Statement references<br>the output of<br>information | Yes | Yes | No significant difference |
| 5 | Statement references<br>the user selection of<br>ROIs | Yes | Yes | No significant difference |
| 6 | Statement references<br>providing the clinician<br>with information<br>about an ROI. | Yes | Yes | No significant difference |
| 7 | Statement references<br>providing the user<br>with information<br>related to kidney<br>stones. | No | Yes | Yes, there is a difference. The<br>subject device can measure any<br>object within a ROI identified by the<br>User and is not intended<br>specifically for kidney stones. The<br>device Intended Use is clearly<br>detailed in the device labeling and<br>does not modify existing risks or<br>raise any new potential safety risks.<br>Therefore, we believe there is no<br>impact on safety or efficacy of the<br>subject device. |
| 8 | Intended Users | Trained<br>physicians,<br>radiologists. | Trained physicians,<br>radiologists. | No Difference |
| 9 | Target population | No restrictions | Patients diagnosed<br>with | Yes, there is a difference. There<br>are no restrictions with the subject device. |
| Ref<br># | Technical<br>Characteristic | Subject Device -<br>DeepLook<br>PRECISE | Predicate -<br>StoneChecker<br>K191530 | Difference/Comments |
| | | | kidney stones that<br>require medical<br>intervention. | device on the target population and<br>is not intended for a specific<br>population as detailed in the<br>labeling. The subject device is<br>applied to DICOM Images and not<br>specific target populations. Target<br>populations are the responsibility of<br>the modalities. This difference does<br>not modify existing risks or raise<br>any new potential safety risks.<br>Therefore, we believe there is no<br>impact on safety or efficacy of the<br>subject device. |
| 10 | Anatomical sites | No restrictions | Kidneys, ureters,<br>and bladder (KUB) | Yes, there is a difference. No<br>anatomical sites are specified in<br>the subject device labeling. This<br>does not modify existing risks or<br>raise any new potential safety risks.<br>Therefore, we believe there is no<br>impact on safety or efficacy of the<br>subject device. |
| 11 | Where used | No restrictions | No restrictions | No significant difference. |
| | Design | | | |
| 1 | Software device that<br>operates on off-the-<br>shelf hardware. | Yes | Yes | No significant difference. |
| 2 | Software device uses<br>a standard windowing<br>user interface. | Yes | Yes | No significant difference. |
| 3 | Software device uses<br>software algorithms<br>for image post<br>processing analysis. | Yes | Yes | No significant difference. The<br>subject device software is used for<br>measurement. |
| 4 | Conforms to DICOM<br>standards (PS 3.10) | Yes | Yes | No significant difference |
| | Features and Capabilities | | | |
| 5 | Data loading of CT<br>image series using<br>DICOM standard | Yes | Yes | DeepLook PRECISE can handle<br>any DICOM image and does not<br>restrictive to a specific modality. |
| 6 | 2D image review | Yes | Yes | No significant difference |
| 7 | Image navigation<br>tools (pan, zoom,<br>scroll, window/level) | No | Yes | DeepLook PRECISE functions are<br>measurement tools. Other image<br>management functions are left to<br>the PACS OEM software which is<br>not part of DeepLook PRECISE.<br>Therefore, it is our determination<br>that this difference does not have a<br>negative impact on safety or<br>efficacy and there are no new |
| Ref<br># | Technical<br>Characteristic | Subject Device -<br>DeepLook<br>PRECISE | Predicate -<br>StoneChecker<br>K191530 | Difference/Comments |
| 8 | Measurement tools<br>(ruler, ROI) | Yes | Yes | No significant difference |
| 9 | Size calculations<br>(area, volume) | Yes | Yes | No significant difference |
| 10 | Statistical<br>calculations | No | Mean, standard<br>deviation (SD),<br>mean of positive<br>pixels, skewness,<br>kurtosis, entropy | Yes, there is a difference.<br>DeepLook PRECISE functions are<br>measurement tool related. The<br>generated information consists of<br>an initial estimated greatest long-<br>axis and greatest short-axis<br>dimensions, area, volume, and<br>positions of objects. Other image<br>management functions are left to<br>the PACS OEM software which is<br>not part of DeepLook PRECISE.<br>This does not modify existing risks<br>or raise any new potential safety<br>risks. Therefore, we believe there is<br>no impact on safety or efficacy of<br>the subject device. |
| 11 | CT texture analysis<br>calculations | No | Yes | Yes. There is a difference.<br>DeepLook PRECISE functions are<br>measurement tools and is<br>integrated with an OEM PACS<br>system which is not part of<br>DeepLook PRECISE. The subject<br>device is applied to any DICOM<br>image and is not modality specific.<br>This is explained in the device<br>Manual. This difference does not<br>modify existing risks or raise any<br>new potential safety risks.<br>Therefore, we believe there is no<br>impact on safety or efficacy of the<br>subject device. |
| 12 | Display output of<br>measurements and<br>information. | Yes | Yes | No significant difference |
| 13 | Report generation | No | Excel | Yes, there is a difference. Reports<br>are not generated by DeepLook<br>PRECISE but are generated by the<br>OEM PACS application which is<br>not part of the subject device. This<br>difference does not modify existing<br>risks or raise any new potential<br>safety risks. Therefore, we believe<br>there is no impact on safety or<br>efficacy of the subject device. |
| Physical Characteristics | | | | |
| Ref<br># | Technical<br>Characteristic | Subject Device -<br>DeepLook<br>PRECISE | Predicate -<br>StoneChecker<br>K191530 | Difference/Comments |
| 14 | Post-processing<br>(non-real-time, non-<br>contacting, non-life<br>supporting and not<br>life sustaining). | Yes | Yes | No significant difference |

The following is a comparison of the subject device and the predicate device:

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# VII. PERFORMANCE DATA

#### Nonclinical Testing:

The subject device has been assessed and tested at the factory to assess all functions and has passed all predetermined testing criteria.

Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met.

The following Standards were used to test the system and DeepLook PRECISE, has met the applicable requirements:

- ISO 14971 Third Edition 2019-12 Medical devices Application of risk management to . medical devices: FDA FR Recognition 5-125.
- . NEMA PS 3.1 - 3.20 (2016, Digital Imaging and Communications in Medicine (DICOM) Set, FDA FR Recognition # 12-300.
- . IEC 62304:2006/A1:2016, Medical device software - Software life cycle processes, FDA FR Recognition # 13-79.
- FDA Guidance on Cyber Security: Content of Premarket Submissions for Management of . Cybersecurity in Medical Devices Document Issued on: October 2, 2014.
- . FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005.

## Conclusion:

The 510(k) Pre-Market Notification for DeepLook PRECISE, software device contains adequate information, data, and nonclinical test results to enable FDA -CDRH to determine substantial equivalence to the predicate device.

The subject device will be manufactured in accordance with the voluntary standards listed in the voluntary standard survey. The new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices.

Nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device.

Therefore, DeepLook PRECISE, is substantially equivalent to the predicate device.