TeleScan

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K220767 Device Name TeleScan™ #### Indications for Use (Describe) 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. | Type of Use (Select one or both, as applicable) | |-----------------------------------------------------------------------------------------------------------------| | <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | | <span> <span style="font-size: 16px;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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 Imaging<br>9701 Brodie Lane, Suite 200<br>Austin, TX 78748 | | Contact Person: | Blanca Lesmes<br>CEO, BB Imaging<br>Tel: 1.844.766.6111 | | Trade or Proprietary<br>Name: | 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 Care<br>Diagnostics | | Classification Regulation: | 21 CFR 892.2050 | | Product Code: | LLZ | ## 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 {4}------------------------------------------------ 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. ## Indications for Use: 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. 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. {5}------------------------------------------------ ### Table 5-A: Substantial Equivalence Comparison {6}------------------------------------------------ | | (Primary Predicate)<br>Unifi Workspace<br>K190694 | (Reference Device)<br>Viewpoint 6<br>K203677 | (Proposed Device)<br>TeleScan™<br>K220767 | |--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulatory<br>Number:/Common<br>Name | 21 CFR 892.2050 (Medical image<br>management and processing system) | 21 CFR 892.2050 (Medical<br>image management and<br>processing system) | Same | | Device Class | II | II | Same | | Software Level of<br>Concern | Moderate | Moderate | Same | | Method of Use | Multi-modality workstation that<br>provides various image processing<br>and measurement tools to facilitate<br>diagnostic and non-diagnostic viewing<br>capabilities. | Software that provides various<br>image processing and<br>measurement tools to facilitate<br>diagnostic viewing capabilities<br>of ultrasound images, as well<br>as electronic documentation of<br>exams and generation of<br>medical reports. | Software that provides<br>various image processing and<br>measurement tools to<br>facilitate diagnostic and non-<br>diagnostic viewing<br>capabilities of ultrasound<br>images, as well as electronic<br>documentation of exams and<br>generation of medical reports. | | Mechanism of Action | Viewing, patient management, study<br>data management | Viewing, patient management,<br>study data management | Same | | Operating System | Windows 10 | Windows | Similar; works on MacOS (Big<br>Sur & Monterey and beyond)<br>and Windows OS (Windows<br>10, Windows 11 and beyond) | | System Access | Local Application | Local application and a cloud-<br>based system | Cloud-based system | | Modalities supported<br>on display | US, MR, MG, BTO, DR, CR, SC, CT,<br>and other DICOM formats | US | US | | DICOM Input for<br>Medical Images | Accept and display any valid DICOM-<br>standard object | Accept and display any valid<br>DICOM-standard object | Accept and display any valid<br>DICOM-standard object | | Tomosynthesis<br>image 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 | {7}------------------------------------------------ | | (Primary Predicate) | (Reference Device) | (Proposed Device) | |--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Unifi Workspace | Viewpoint 6 | TeleScan™ | | | K190694 | K203677 | K220767 | | Image viewing and<br>manipulation tools | Window/Level, Pan, Zoom, Invert,<br>Flip, Rotate, View/Create,<br>Annotations, Scrolling, Cine,<br>Measurement, Magnify, Link Data<br>Sets, Size Mode Control, Toggle<br>Study/Patient Overlays, Reset,<br>Display text Overlays, MIP, Intelligent<br>Roaming | Window/Level, Pan, Zoom,<br>Rotate, View/Create,<br>Annotations, Scrolling, Cine,<br>Measurement, Magnify, Link<br>Data Sets, Toggle<br>Study/Patient Overlays, Reset,<br>Display Text Overlays, Ellipse<br>Tool, Arrow, Brightness,<br>Impression Box | Window/Level, Pan, Zoom,<br>View/Create, Annotations,<br>Scrolling, Cine,<br>Measurement, Magnify, Link<br>Data Sets, Toggle<br>Study/Patient Overlays,<br>Reset, Display Text Overlays,<br>Ellipse Tool, Arrow,<br>Brightness, Impression Box | | Gestational age<br>based on<br>measurements of<br>anatomical structures | No | Yes | Yes | | Growth percentiles<br>based on<br>measurements of<br>anatomical structures | No | Yes | Yes | | Estimated due date<br>based on<br>measurements of<br>anatomical structures | No | Yes | Yes | | Estimated fetal<br>weight based on<br>measurements of<br>anatomical structures | No | Yes | Yes | | Enables quick<br>diagnostic reporting<br>with standardized<br>terminology | Yes | Yes | Yes | | Ob/Gyn and fetal<br>measurements | No | Yes | Same as reference device | | Report Capabilities | Yes | Yes | Yes | | Application | Yes | Yes | Same | {8}------------------------------------------------ | | (Primary Predicate)<br>Unifi Workspace<br>K190694 | (Reference Device)<br>Viewpoint 6<br>K203677 | (Proposed Device)<br>TeleScan™<br>K220767 | |----------------------------|---------------------------------------------------|----------------------------------------------|-------------------------------------------| | Synchronization<br>Support | | | | {9}------------------------------------------------ ## 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.