TeleScan® is a software application that is intended for use in receiving, manipulating, displaying, printing, and archiving ultrasound medical 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 diagnostic procedures. TeleScan® allows remote qualified radiologists and clinicians to provide a diagnosis remotely.

Device Description

TeleScan® is used by trained medical professionals, including radiologists, sonographers, and clinicians, and may provide information to be used for diagnostic procedures. These individuals are referred to as healthcare workers for the purposes of this submission.

Like tele-radiology solutions, TeleScan® allows remotely located qualified radiologists and clinicians to provide a diagnosis. TeleScan® receives DICOM images transmitted ultrasound machines and displays the patient images. This includes cineloops (videos), 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.

TeleScan® software provides sonographers with tools to display patient measurements and observations (annotations). The application displays calculated gestational age and growth percentiles based on measurements of anatomical structures. Through a diagnostics function, the estimated fetal weight are calculated.

A draft patient report is prepared for further interpretation by medical professionals licensed to sign diagnostic reports, such as physicians, specialists, and nurse practitioners (providers).

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

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called TeleScan. While it mentions evaluation and validation studies, it does not provide specific quantitative acceptance criteria or detailed results of a comparative effectiveness study (like an MRMC study) in the format requested. The document primarily focuses on demonstrating substantial equivalence to a predicate device and software validation activities.

Therefore, many of the requested details, particularly the quantitative performance metrics and specifics of clinical study designs and outcomes (like MRMC results or standalone algorithm performance), are not present in the provided text. The information is more aligned with a regulatory submission outlining verification and validation activities rather than a detailed scientific paper on performance studies.

However, I can extract and infer some information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document emphasizes "equivalency" and "no differences in performance" compared to the predicate device, especially regarding the switch from PNG to JPG image format and the introduction of a specified output quality setting. Specific quantitative acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy, AUC values) are not reported.

Acceptance Criterion (Inferred from Text)	Reported Device Performance (Inferred from Text)
Diagnostic acceptability of new JPG usage specification and lower limit.	"demonstrate and support the safety and effectiveness of the proposed design update." "no differences in performance as reported with data provided by the physician user group." "continues to meet and satisfy user requirements and the indications for use statement."
Functionality of ultrasound output quality monitoring.	"continues to meet and satisfy user requirements and the indications for use statement." "The same functionality is carried for receiving, processing, manipulating, displaying, printing, and archiving ultrasound (US) images."
Clarity and adequacy of image quality warning messages/labels.	"clarity and adequacy of wording uses for image quality information that is displayed, the pop-up notification...and the permanent messaging added to images." (Implies satisfactory evaluation, but no quantitative metric).
Overall safety and effectiveness maintained with 2.0 software.	"The evaluations and resulting data support that safety and effectiveness are maintained with the proposed TeleScan with the 2.0 software."
Continued equivalency to predicate device.	"The results of the evaluations demonstrate the equivalency of the proposed TeleScan® with 2.0 software update for JPG image type use with a specification, lower limit, and image quality monitoring." "TeleScan® with 2.0 software performs as well as the predicate device."

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

The document mentions a "large group of prenatal sonographers" and a "large group of physicians" for evaluations. However, specific sample sizes (number of images, number of cases, number of subjects) are not provided. The data provenance (country of origin, retrospective/prospective) is also not stated. The nature of the study is framed as "evaluations" and "validations" for a design update rather than a de novo clinical trial.

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

The text states that evaluations involved "a large group of physicians" for "diagnostic acceptability" and "physician diagnosis process acceptability." It also mentions "appropriately trained healthcare professionals, including radiologists, sonographers, technologists, and clinicians" as users.
The expertise for "diagnosis" would typically fall to radiologists or other licensed medical professionals.
However, the exact number of experts for ground truth establishment for a test set and their specific qualifications (e.g., years of experience, board certification) are not explicitly provided.

4. Adjudication Method for the Test Set:

The document describes "sequential and side-by-side image reviews by healthcare professionals." This implies a comparison, but it does not specify an adjudication method (e.g., 2+1, 3+1 consensus, or independent adjudication) to establish a definitive ground truth where disagreements occurred.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study directly comparing human readers with AI assistance versus without AI assistance was not performed or reported. The study described focuses on validating the updated software's performance (specifically the change to JPG and image quality monitoring) and its equivalency to the predicate, not on how an AI component improves human reader performance. The device TeleScan, as described, is a "Medical Image Management And Processing System," which contains "image processing and measurement tools" and facilitates "interpretation" and "diagnosis," but it is not presented as an AI-powered diagnostic aid that makes its own findings or enhances human detection capabilities in the way an MRMC study would typically evaluate.

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

No, a standalone algorithm performance evaluation was not reported. The device is described as a system used "by appropriately trained healthcare professionals" for "receiving, manipulating, displaying, printing, and archiving ultrasound medical images" and providing "image processing and measurement tools." It's a tool for human use, not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used:

The text implies that the "ground truth" or "reference standard" for evaluating the diagnostic acceptability and performance was based on the diagnoses and interpretations of a "large group of physicians". This sounds like expert consensus/opinion based on their review of the images. It does not mention pathology results, long-term outcomes data, or other definitive types of ground truth often used in diagnostic accuracy studies.

8. The Sample Size for the Training Set:

The document describes "non-clinical testing" and "design verification and validation" for a "design update," but it does not mention or specify a training set sample size. This is common for regulatory submissions where the focus is on validation of a completed software update rather than the initial development and training of an AI model.

9. How the Ground Truth for the Training Set was Established:

Since a training set is not explicitly mentioned or implied for an AI model in the context of this submission (which focuses on a software update for image management and processing), the method for establishing ground truth for a training set is not applicable/not provided. The "ground truth" discussed relates to the evaluation of the updated system's functionality and diagnostic acceptability by human experts.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.

BB Imaging % Prithul Bom Most Repsonsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114

Re: K233634

December 12, 2023

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: November 10, 2023 Received: November 13, 2023

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Jessica Lamb

Jessica Lamb Assistant Director Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K233634

Device Name TeleScan®

Indications for Use (Describe)

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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K233634

510(k) Summary

1 Submitter Information

Submitter: BB Imaging Address: 9701 Brodie Lane, Suite 200 Austin Texas 78748 Website: https://www.bbimaging.net/telescan 844-766-6111 Phone Number: Contact Person: Britt Einspahr, Manager of Quality Systems and Regulatory Affairs Date of Summary: December 8, 2023

2 Device Information

Name of Device:	TeleScan®
Common or Usual Name:	Medical Image Management and Processing System
Device Classification Name:	Radiological Image Processing System
Regulatory Classification:	Class II
Regulation Number:	21 CFR 892.2050
Classification Product Code:	LLZ
Panel:	Radiology
Type of 510(k) Submission:	Special
Reason for Submission:	Design Update

3 Predicate Information

Predicate: TeleScan® Predicate 510(k): K220767

4 Device Description

A draft patient report is prepared for further interpretation by medical professionals licensed to sign diagnostic reports, such as physicians, specialists, and nurse practitioners (providers).

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

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5 Indications for Use

6 Comparison with Predicate and Technological Characteristics

Characteristic	Predicate - TeleScan® K220767	TeleScan® K233634
	TeleScan® is a software application that is intended for usein receiving, processing, manipulating, displaying, printing,and archiving ultrasound medical images and data. Imagesand data can be stored, communicated, and displayed withinthe system or across computer systems. TeleScan®provides various image processing and measurement toolsto facilitate the interpretation of ultrasound DICOM medicalIndications for Use images and enable diagnosis.TeleScan® is used by appropriately trained healthcareprofessionals, including radiologists, sonographers,technologists, and clinicians, in a medical facility.TeleScan® may provide information to be used for screeningand diagnostic procedures. TeleScan® allows remotequalified radiologists and clinicians to provide a diagnosisremotely.	Same(With "screening" removed perFDA pre-submission guidance.)
Regulatory Number& Common Name	21 CFR 892.2050Medical image management and processing system	Same
Device Class	Class II	Same
Software Level ofConcern	Moderate	Same
Method of Use	Software that provides various image processing andmeasurement tools to facilitate diagnostic and non-diagnostic viewing capabilities of ultrasound images, as wellas electronic documentation of exams and generation ofmedical reports.	Same
Mechanism ofAction	Viewing, patient management, study data management	Same
Operating System	Similar; works on MacOS (Big Sur & Monterey and beyond)and Windows OS (Windows 10, Windows 11 and beyond)	Same
System Access	Cloud-based system	Same
DICOM Inputfor Medical Images	Accept and display any valid DICOM-standard object	Same
Image viewing andmanipulation tools	Window/Level, Pan, Zoom, View/Create, Annotations,Scrolling, Cine, Measurement, Magnify, Link Data Sets,Toggle Study/Patient Overlays, Reset, Display TextOverlays, Ellipse Tool, Arrow, Brightness, Impression Box	Same
Gestational agebased onmeasurements ofanatomicalstructures	Yes	Same
Characteristic	Predicate - TeleScan® K220767	TeleScan® with 2.0 Software
Growth percentilesbased onmeasurements ofanatomicalstructures	Yes	Same
Estimated due datebased onmeasurements ofanatomicalstructures	Yes	Same
Estimated fetalweight based onmeasurements ofanatomicalstructures	Yes	Same
Enables quickdiagnosticreporting withstandardizedterminology	Yes	Same
Ob/Gyn and fetalmeasurements	Yes	Same
Report Capabilities	Yes	Same
ApplicationSynchronizationSupport	Yes	Same
DICOM StandardApplied andDocumented inLabeling	Yes	Same
DICOMSpecification	Current DICOM Edition(DICOM 3.0 2023b and prior)	Same
Image Format	PNG	JPG
Image QualityDecisions	Under the practice of medicine	Same
Responsibility forEnsuring SufficientImage Quality toAchieveDiagnosticallyAcceptable Goal	Responsible physician	Same
Image Preservationand Archiving	Maintained in same format and quality asreviewed by physician for diagnosis	Same

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Image /page/5/Picture/0 description: The image contains the logo for TeleScan. The logo consists of two parts: a stylized letter 'b' with sound waves emanating from it, and the word 'imaging' below it. To the right of this is the word 'TeleScan' in a blue sans-serif font, with a registered trademark symbol next to it.

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7 Nonclinical Testing

The performance characteristics of TeleScan® with the 2.0 software update were evaluated, verified, and validated for demonstration of performance and data for determination of substantial equivalence. The FDA's guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submissions for Software on Medical Devices" was referenced and followed. The non-clinical evaluations and data summaries are presented in Section 15 for verification and validation activities with a bullet point overview provided below:

Sonographer Evaluation An evaluation was conducted with a large group of prenatal sonographers to assess a range of ultrasound JPG output quality settings to provide data for assessment and establish a specification and lower limit for safe and effective use with TeleScan®,
. Physician Evaluation – A performance validation was performed with a large group of physicians to validate the performance, diagnostic acceptability, and physician diagnosis process acceptability of the determined ultrasound output settings, TeleScan® JPG usage specification, and lower limit to demonstrate and support the safety and effectiveness of the proposed design update,
· Design Verification and Validation Design verification and validation was performed to demonstrate the functionality of the TeleScan with 2.0 software for monitoring the ultrasound output quality factor setting to ensure that it remains at or above the TeleScan® specification or otherwise notifies users with a pop-up message of the lower than expected (out of spec) settings with labeling applied to all associated images until the ultrasound settings issue is resolved. This control ensures that ultrasound output settings are correctly set and maintained and that any accidental or inadvertent change below specification ensures users are made aware to correct the setting with images labeled with messaging until the issue is resolved, and
. Human Factors Validation – A human factors evaluation was performed with users to review the clarity and adequacy of wording uses for image quality information that is displayed, the pop-up notification that occurs with any below specification image received by TeleScan from the ultrasound, and the permanent messaging added to images that are received by TeleScan® that are below the stated specification.

Software design, development, verification, human factors, and validation activities followed all applicable guidelines and standards throughout the software development process, including:

FDA Guidance for Industry and FDA Staff Guidance for the content of premarket submissions for software contained in medical devices (May 11, 2005)
EN ISO 14971:2019 Application of risk management to medical devices
IEC 62304:2006 Medical device software Software life cycle processes
EN 62366-1:2015/A1:2020 Medical Device Part I Application of the Usability Engineering to Medical Devices
. IEC 82304-1:2016 Health Software – Part I General Requirements for Product Safety

The results of the evaluations demonstrate the equivalency of the proposed TeleScan® with 2.0 software update for JPG image type use with a specification, lower limit, and image quality monitoring with no differences in performance as reported with data provided by the physician user group. The evaluations and resulting data support that safety and effectiveness are maintained with the proposed TeleScan with the 2.0 software. The proposed update has been fully documented through internal design control processes with design reviews, risk analyses review and update, design verification, design validation evaluations and data, and design history record updates. The evaluations were performed through sequential and side-by-side image reviews by healthcare professionals in the same method and approached used for the predicate 510k data, submission, and clearance. The validation data demonstrates that TeleScan® with 2.0 software continues to meet and satisfy user requirements and the indications for use statement.

8 Clinical Testing

Testing with patients was not necessary for demonstration of the safety and effectiveness of this update.

9 Performance Summary

Performance testing, data, evaluations, and results, including provisions for risk management, demonstrated conformity to pre-established acceptance criteria, substantial equivalence to the predicate device, and the continued safety and effectiveness of TeleScan® with the 2.0 software and design update.

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Image /page/7/Picture/0 description: The image contains the logo for TeleScan. The logo consists of two parts: a stylized letter 'b' inside a circle with radiating lines, and the word 'imaging' below it. To the right of this is a vertical line, followed by the word 'TeleScan' with the 'Scan' portion in a lighter shade of blue.

10 Conclusion

TeleScan® with 2.0 software performs as well as the predicate device. The validations performed and the resulting data support that TeleScan® continues to perform safely and effectively in accordance with its intended use. No new issues of safety or effectiveness are raised by the design update. The same application features, operational use, and diagnostic and diagnosis performance are maintained. The same functionality is carried for receiving, processing, manipulating, displaying, printing, and archiving ultrasound (US) images with tools for OB/Gyn and fetal measurement, annotation, and report authoring.

11 Substantial Equivalence

TeleScan® with 2.0 software is substantially equivalent to the predicate version of the device. TeleScan® with 2.0 software continues to perform safely and effectively for its intended use.

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).