Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description explicitly states the software uses "patented shape-recognition processes" and "deterministic algorithms" to sort candidate shapes. There is no mention of training data, learning, or adaptive behavior characteristic of AI/ML. The user interaction involves selecting from pre-calculated options or manually adjusting contours, not interacting with a system that learns or improves over time.

Therapeutic

No.

Explanation: This device is a software tool that assists in measuring objects in medical images, but it explicitly states it does not make clinical decisions, is not a decision-support tool, and the information it provides must not be used in isolation for patient management, indicating it's not directly therapeutic.

Diagnostic

Yes

Explanation: The device is intended to assist trained professionals in measuring dimensions of objects within a region of interest (ROI) in DICOM images, generating information such as estimated greatest long-axis and short-axis dimensions, area, volume, and margin of objects. While it does not make clinical decisions, its function of providing precise measurements of pathological objects from medical images is a clear diagnostic aid.

SaMD (Software as a Medical Device)

Yes

The device is explicitly described as a "software device" and a "software application" that integrates with existing hardware (medical Image Viewers and PACS workstations) but does not include or require specific hardware components of its own beyond the standard computing environment.

IVD (In Vitro Diagnostic)

Based on the provided information, DeepLook PRECISE is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
DeepLook PRECISE Function: DeepLook PRECISE operates on medical images (DICOM images) and assists in measuring objects within those images. It does not analyze biological specimens.
Intended Use: The intended use clearly states that it assists trained professionals in measuring dimensions of objects within a region of interest in DICOM images. It explicitly states it does not make clinical decisions or is a decision-support tool.
Device Description: The device description reinforces that it works with digital medical imaging and provides automated measurement, replacing manual digital calipers.

Therefore, DeepLook PRECISE falls under the category of medical image processing software, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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.

Product codes (comma separated list FDA assigned to the subject device)

LLZ

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 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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

DICOM images

Anatomical Site

No restrictions

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained professionals, trained 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)

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.

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.

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.

K191530

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

Regulation Number and Section

§ 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).

Summary

0

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

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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: 202.306.0808 Email: Steve.schwadron@DeepLookMedical.com

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
13416 Watertown Plank Road, Suite 260
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

4

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