TeleScan™ is a software application that is intended for use in receiving, processing, manipulating, displaying, printing, and archiving ultrasound medical images and data. Images and data can be stored, communicated, and displayed within the system or across computer systems. TeleScan™ provides various image processing and measurement tools to facilitate the interpretation of ultrasound DICOM medical images and enable diagnosis.

TeleScan™ is used by appropriately trained healthcare professionals. including radiologists, sonographers, technologists, and clinicians, in a medical facility. TeleScan™ may provide information to be used for screening and diagnostic procedures. TeleScar™ allows remote qualified radiologists and clinicians to provide a diagnosis remotely.

Device Description

TeleScan™ is used by trained medical professionals, including radiologists, sonographers, technologists, and clinicians, and may provide information to be used for screening and diagnostic procedures. These individuals are referred to as Healthcare Workers (HCWs) for the purposes of this submission.

Similar to tele-radiology solutions, TeleScan™ allows remote, qualified radiologists and clinicians to provide a diagnosis remotely. TeleScan™ receives ultrasound DICOM images transmitted from leqally marketed ultrasound machines and displays images. This includes videos (cineloops), diagnostics tools for annotation, and a simplified workflow for report creation. TeleScan™ is compatible with ultrasound images acquired by appropriately trained healthcare professionals in medical facilities.

The software provides the Sonographer tools to display patient measurements and observations. The application also calculates gestational age and growth percentiles based on measurements of anatomical structures. Through a diagnostics function, the estimated due date and estimated fetal weight is calculated.

The report is prepared for further interpretation by medical professionals licensed to sign diagnostic reports such as physicians, specialists, and nurse practitioners. For the purposes of this submission, these individuals are referred to as "Physicians".

TeleScan™ is offered as software as a service (SaaS) and complies with digital health and data related laws, including but not limited to HIPAA.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the TeleScan™ device based on the provided document:

This device (TeleScan™) is a medical image management and processing system for ultrasound images. The 510(k) submission states that no clinical studies were performed to support substantial equivalence. The performance testing conducted was non-clinical. Therefore, there are no specific performance criteria or a study that directly proves the device meets those criteria in a clinical setting as would be
expected for AI/ML devices that perform diagnostic, screening or prognostic functions.

The document indicates "The performance testing showed that the overall system demonstrated equivalent performance and equivalent safety and effectiveness as the predicate (Unifi Workspace, K190694) for specific application features."

1. Table of Acceptance Criteria and Reported Device Performance

Since no specific quantitative performance metrics (e.g., sensitivity, specificity, AUC) from clinical studies are provided, the "acceptance criteria" here are inferred from the substantial equivalence claim based on functional and technical comparisons to predicate devices. The device's "performance" is stated as being equivalent in these non-clinical aspects.

Acceptance Criteria Category	Specific Criteria (Inferred)	Reported Device Performance
Functional Equivalence	Ability to receive, process, manipulate, display, print, and archive ultrasound medical images and data.	Demonstrated equivalent performance to predicate devices (Unifi Workspace, K190694, and Viewpoint 6, K203677) for these functions.
Measurement & Calculation	Ability to calculate gestational age, growth percentiles, estimated due date, and estimated fetal weight based on anatomical measurements.	Functionally equivalent to the reference device (Viewpoint 6, K203677).
Image Processing Tools	Provision of image viewing and manipulation tools (Window/Level, Pan, Zoom, Measure, Annotate, Cine, etc.).	Functionally equivalent to predicate and reference devices.
Reporting Capabilities	Ability to enable quick diagnostic reporting with standardized terminology.	Functionally equivalent to predicate and reference devices.
Safety & Effectiveness	No new issues of safety or effectiveness compared to predicate devices.	Non-clinical testing demonstrated equivalent safety and effectiveness.
Software Level of Concern	Moderate	TeleScan™ is a Moderate Level of Concern software, matching both predicate and reference devices.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify a "test set" in the context of clinical data for performance evaluation. The testing described is "nonclinical testing," "bench testing, including functional testing and usability testing." No details on the sample size or provenance of images/data used for this non-clinical testing are provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. As no clinical test set requiring expert ground truth was performed, this information is not provided.

4. Adjudication Method for the Test Set

Not applicable. As no clinical test set was used, no adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. The document explicitly states: "No clinical studies have been performed to support substantial equivalence." TeleScan™ is described as a medical image management and processing system with various tools, not an AI/ML diagnostic algorithm that directly assists human readers in such a way that would be assessed through an MRMC study comparing performance with and without AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. The device is a "software application that is intended for use in receiving, processing, manipulating, displaying, printing, and archiving ultrasound medical images and data," and "provides various image processing and measurement tools to facilitate the interpretation of ultrasound DICOM medical images and enable diagnosis." It is not a standalone diagnostic algorithm that operates without human interaction or interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. Given the nature of the non-clinical testing and the absence of clinical studies, no "ground truth" for diagnostic accuracy (e.g., from pathology or expert consensus on clinical cases) was established or used. The "ground truth" for functional testing would typically involve verifying software outputs against expected calculations or displays.

8. The sample size for the training set

Not applicable. The document describes TeleScan™ as a medical image management and processing system with tools, not an AI/ML model that would require a "training set" in the conventional machine learning sense.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a training set for an AI/ML model.

Summary

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April 14, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

BB Imaging % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114

Re: K220767

Trade/Device Name: TeleScan™ Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: March 15, 2022 Received: March 16, 2022

Dear Prithul Bom:

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

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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 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 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,

For

Jessica Lamb, Ph.D. Assistant 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) K220767

Device Name TeleScan™

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This 510(k) Summary is submitted in accordance with the requirements specified in 21 CFR 807.92.

Date:	March 7, 2022
Submission Sponsor:	BB Imaging9701 Brodie Lane, Suite 200Austin, TX 78748
Contact Person:	Blanca LesmesCEO, BB ImagingTel: 1.844.766.6111
Trade or ProprietaryName:	TeleScan™ (K220767)
Common or Usual Name:	Medical image management and processing system
Regulatory Number:	21 CFR 892.2050
Product Code:	LLZ (System, Image Processing, Radiological)
Device Class:	Class II
Panel:	Radiology
Predicate Device:	Unifi Workspace v1.0.0 (K190694)
510(k) Submitter/Holder:	Hologic, Inc.
Regulatory Number:	21 CFR 892.2050
Product Code:	LLZ
Reference Device:	Viewpoint 6 (K203677)
510(k) Submitter/Holder:	GE Medical Systems Ultrasound and Primary CareDiagnostics
Classification Regulation:	21 CFR 892.2050
Product Code:	LLZ

Device Description:

The software provides the Sonographer tools to display patient measurements and observations. The application also calculates gestational age and growth percentiles based on

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measurements of anatomical structures. Through a diagnostics function, the estimated due date and estimated fetal weight is calculated.

TeleScan™ is offered as software as a service (SaaS) and complies with digital health and data related laws, including but not limited to HIPAA.

Indications for Use:

TeleScan™ is used by appropriately trained healthcare professionals, including radiologists, sonographers, technologists, and clinicians, in a medical facility. TeleScan™ may provide information to be used for screening and diagnostic procedures. TeleScan™ allows remote qualified radiologists and clinicians to provide a diagnosis remotely.

Substantial Equivalence

TeleScan™, Unifi Workspace (predicate device), and Viewpoint 6 (reference device), have the same intended use. The proposed device has similar technological characteristics, application features, operational use as the predicate and reference devices as noted in the comparison matrix below. Specifically, the proposed device is intended to receive, process, manipulate, display, print, and archive ultrasound (US) images which is the same as the predicate device. The technological characteristics of OB/Gyn and fetal measurements, annotation tools, and report features are the same as the Viewpoint 6 reference device. The differences between TeleScan™ and the predicate and reference devices do not raise any questions of safety and effectiveness.

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Table 5-A: Substantial Equivalence Comparison

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	(Primary Predicate)Unifi WorkspaceK190694	(Reference Device)Viewpoint 6K203677	(Proposed Device)TeleScan™K220767
RegulatoryNumber:/CommonName	21 CFR 892.2050 (Medical imagemanagement and processing system)	21 CFR 892.2050 (Medicalimage management andprocessing system)	Same
Device Class	II	II	Same
Software Level ofConcern	Moderate	Moderate	Same
Method of Use	Multi-modality workstation thatprovides various image processingand measurement tools to facilitatediagnostic and non-diagnostic viewingcapabilities.	Software that provides variousimage processing andmeasurement tools to facilitatediagnostic viewing capabilitiesof ultrasound images, as wellas electronic documentation ofexams and generation ofmedical reports.	Software that providesvarious image processing andmeasurement tools tofacilitate diagnostic and non-diagnostic viewingcapabilities of ultrasoundimages, as well as electronicdocumentation of exams andgeneration of medical reports.
Mechanism of Action	Viewing, patient management, studydata management	Viewing, patient management,study data management	Same
Operating System	Windows 10	Windows	Similar; works on MacOS (BigSur & Monterey and beyond)and Windows OS (Windows10, Windows 11 and beyond)
System Access	Local Application	Local application and a cloud-based system	Cloud-based system
Modalities supportedon display	US, MR, MG, BTO, DR, CR, SC, CT,and other DICOM formats	US	US
DICOM Input forMedical Images	Accept and display any valid DICOM-standard object	Accept and display any validDICOM-standard object	Accept and display any validDICOM-standard object
Tomosynthesisimage display	Support for all available BTO images	No, limited to Ultrasound	No, limited to Ultrasound
CAD Support	Yes	No, limited to Ultrasound	No, limited to Ultrasound

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	(Primary Predicate)	(Reference Device)	(Proposed Device)
	Unifi Workspace	Viewpoint 6	TeleScan™
	K190694	K203677	K220767
Image viewing andmanipulation tools	Window/Level, Pan, Zoom, Invert,Flip, Rotate, View/Create,Annotations, Scrolling, Cine,Measurement, Magnify, Link DataSets, Size Mode Control, ToggleStudy/Patient Overlays, Reset,Display text Overlays, MIP, IntelligentRoaming	Window/Level, Pan, Zoom,Rotate, View/Create,Annotations, Scrolling, Cine,Measurement, Magnify, LinkData Sets, ToggleStudy/Patient Overlays, Reset,Display Text Overlays, EllipseTool, Arrow, Brightness,Impression Box	Window/Level, Pan, Zoom,View/Create, Annotations,Scrolling, Cine,Measurement, Magnify, LinkData Sets, ToggleStudy/Patient Overlays,Reset, Display Text Overlays,Ellipse Tool, Arrow,Brightness, Impression Box
Gestational agebased onmeasurements ofanatomical structures	No	Yes	Yes
Growth percentilesbased onmeasurements ofanatomical structures	No	Yes	Yes
Estimated due datebased onmeasurements ofanatomical structures	No	Yes	Yes
Estimated fetalweight based onmeasurements ofanatomical structures	No	Yes	Yes
Enables quickdiagnostic reportingwith standardizedterminology	Yes	Yes	Yes
Ob/Gyn and fetalmeasurements	No	Yes	Same as reference device
Report Capabilities	Yes	Yes	Yes
Application	Yes	Yes	Same

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	(Primary Predicate)Unifi WorkspaceK190694	(Reference Device)Viewpoint 6K203677	(Proposed Device)TeleScan™K220767
SynchronizationSupport

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Summarv of Performance Testing

BB Imaging successfully performed system design control verification and validation tests for TeleScan™, which are summarized in accordance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005) based on a moderate level of concern. Substantial equivalence has been demonstrated by nonclinical testing. Additional bench testing, including functional testing and usability testing, was also performed on TeleScan™. The performance testing showed that the overall system demonstrated equivalent performance and equivalent safety and effectiveness as the predicate (Unifi Workspace, K190694) for specific application features.

No clinical studies have been performed to support substantial equivalence.

Conclusion:

In conclusion, BB Imaging has established substantial equivalence of the subject TeleScan™ to the predicate device. No new issues of safety or effectiveness are introduced by using this device. The intended use, technological characteristics, and operational use are substantially equivalent to the predicate device.

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).