Visible Patient Suite

K212896 · Visible Patient, Sas · LLZ · Nov 5, 2021 · Radiology

Device Facts

Record IDK212896
Device NameVisible Patient Suite
ApplicantVisible Patient, Sas
Product CodeLLZ · Radiology
Decision DateNov 5, 2021
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 892.2050
Device ClassClass 2
AttributesSoftware as a Medical Device, Pediatric

Intended Use

Visible Patient Suite is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, and treatment planning for both pediatric and adult patients. Visible Patient Suite accepts DICOM compliant medical images acquired from a variety of imaging devices, including CT, MR. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. The software provides several categories of tools. It includes basic imaging tools for general images, including 2D viewing, volume rendering and 3D volume viewing, orthogonal Multi-Planar Reconstructions (MPR), image fusion, surface rendering, measurements, reporting, storing, general image management and administration tools, etc. It includes a basic image processing workflow and a custom UI to segment anatomical structures, which are visible in the image data (bones, organs, vascular/airway structures, etc.), including interactive segmentation tools, basic image filters, etc. It also includes detection and labeling tools of organ segments (liver, lungs and kidneys), including path definition through vascular/airway, approximation of vascular/airway territories from tubular structures and interactive labeling. The software is designed to be used by trained professionals (including physicians, surgeons and technicians) and is intended to assist the clinician who is solely responsible for making all final patient management decisions.

Device Story

Medical imaging software suite; accepts DICOM-compliant CT/MR images. Transforms inputs via 2D/3D visualization, MPR, image fusion, and segmentation tools. Features include organ segment detection/labeling (liver, lungs, kidneys), vascular/airway path definition, and tubular structure territory approximation. Used by physicians, surgeons, and technicians in clinical settings for anatomical evaluation and surgical/therapy planning. Output consists of 3D anatomical models, measurements, and reports. Clinicians use outputs to assist in patient management decisions; clinician remains solely responsible for final decisions.

Clinical Evidence

Bench testing only. Functionality verified and validated for moderate level of concern software. Volume computation and distance measurement accuracy tested using phantom data with pre-established physical characteristics. Literature study conducted to support device performance.

Technological Characteristics

Software suite comprising three components: VP Sender (anonymization), VP Lab (data management, analysis, processing, 3D modeling), and VP Planning (visualization, analysis). Supports DICOM standard. Implements interactive segmentation, image filters, and organ detection/labeling algorithms. No hardware components.

Indications for Use

Indicated for pediatric and adult patients to aid trained medical professionals in reading, interpreting, and treatment planning using DICOM-compliant CT and MR images. Not for primary diagnostic interpretation of mammography.

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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Visible Patient, SAS % John J. Smith, M.D., J.D. Partner Hogan Lovells US LLP 555 Thirteenth Street, NW WASHINGTON DC 20004 November 5, 2021 Re: K212896 Trade/Device Name: Visible Patient Suite Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: September 10, 2021 Received: September 10, 2021 Dear Dr. Smith: 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR {1}------------------------------------------------ 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 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, 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}------------------------------------------------ 510(k) Number (if known) K212896 Device Name Visible Patient Suite Indications for Use (Describe) Visible Patient Suite is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, and treatment planning for both pediatric and adult patients. Visible Patient Suite accepts DICOM compliant medical images acquired from a variety of imaging devices, including CT, MR. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. The software provides several categories of tools. It includes basic imaging tools for general images, including 2D viewing, volume rendering and 3D volume viewing, orthogonal Multi-Planar Reconstructions (MPR), image fusion, surface rendering, measurements, reporting, storing, general image management and administration tools, etc. It includes a basic image processing workflow and a custom Ul to segment anatomical structures, which are visible in the image data (bones, organs, vascular/ainway structures, etc.), including interactive segmentation tools, basic image filters, etc. It also includes detection and labeling tools of organ segments (liver, lungs and kidneys), including path definition through vascular/airway, approximation of vascular/airway territories from tubular structures and interactive labeling. The software is designed to be used by trained professionals (including physicians, surgeons and technicians) and is intended to assist the clinician who is solely responsible for making all final patient management decisions. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|----------------------------------------------------------------------| | X Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | | 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 conductor 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 ### Visible Patient SAS's Visible Patient Suite #### Submitter # K212896 Visible Patient, SAS RCS Strasbourg TI 794 458 125 8 rue Gustave Adolph HIRN Phone: +33 (0)3 68 66 81 81 Contact Person: Ms. Emeline DEGIVRY Date Prepared: October 29, 2021 Name of Device: Visible Patient Suite Common or Usual Name: Medical Image Processing Software Classification Name: Medical Image Management and Processing System Regulatory Class: Class II Regulation number: 892.2050 Product Code: LLZ #### Predicate Device Visible Patient Suite, Visible Patient, SAS, K151988 #### Indications For Use Visible Patient Suite is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, and treatment planning for both pediatric and adult patients. Visible Patient Suite accepts DICOM compliant medical images acquired from a variety of imaging devices, including CT. MR. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. The software provides several categories of tools. It includes basic imaging tools for general images, including 2D viewing, volume rendering and 3D volume viewing, orthogonal Multi-Planar Reconstructions (MPR), image fusion, surface rendering, measurements, reporting, storing, general image management and administration tools, etc. It includes a basic image processing workflow and a custom UI to segment anatomical structures, which are visible in the image data (bones, organs, vascular/airway structures, etc.), including interactive segmentation tools, basic image filters, etc. It also includes detection and labeling tools of organ segments (liver, lungs and kidneys), including path definition through vascular/airway, approximation of vascular/airway territories from tubular structures and interactive labeling. {4}------------------------------------------------ The software is designed to be used by trained professionals (including physicians, surgeons and technicians) and is intended to assist the clinician who is solely responsible for making all final patient management decisions. #### Technological Characteristics Visible Patient Suite is a software suite and includes three software components: Visible Patient Sender (VP Sender), Visible Patient Lab (VP Lab), and Visible Patient Planning (VP Planning). Visible Patient Lab is the main software component of Visible Patient Suite and includes all modules available in the software suite (except for the DICOM files anonymization module present in the Visible Patient Sender module). #### a) Visible Patient Sender Visible Patient Sender includes only modules dedicated to data management. The software is a simple tool to anonymize multidimensional digital images acquired from a variety of medical imaqinq modalities (DICOM images). There is no 3D data volume interpretation in this software. #### b) Visible Patient Lab Visible Patient Lab includes all Visible Patient Suite modules: data management (except for DICOM files anonymization module), data analysis and data processing. This software offers a flexible solution to help trained medical professionals with image processing knowledge (usually radiologists or radiologist technicians) in (1) the evaluation of patient's anatomy and pathology, and (2) in the creation of a 3D model of the patient's anatomy. This software proposes flexible workflow options: visualization of patient's anatomy and pathology from medical images; creation a 3D model of the patient's anatomical structures, organ segments and volumetric data; creation of an anatomical atlas (a colored image where each color represents a structure); and exports these medical data to be analyzed or reviewed later. #### c) Visible Patient Planning Visible Patient Planning includes modules dedicated to data management and data analysis, and simply contains a subset of the software modules present in Visible Patient Lab. This software offers a flexible visualization solution to help trained medical professionals (clinicians) in the evaluation of patient's anatomy and pathology to plan therapy or surgery. The technological characteristics are the same between the present Visible Patient Suite and the predicate. Minor incremental updates were made to the subject device, however, these differences do not raise different questions of safety and effectiveness. #### Performance Data The company has verified and validated the Visible Patient Suite's moderate level concern software. All functionalities were tested during the test phase of the development. Each feature can be used for pediatric or adult patients. For the volume computation and distance measurement, all tests were performed on phantom data with pre-established physical characteristics (specific measures and volumes). {5}------------------------------------------------ During the validation stage, a literature study was conducted to support device performance. #### Conclusions The subject Visible Patient Suite is as safe and effective as the predicate Visible Patient Suite device (K151988). The Indications for use only differ by the clarification of the patient population (pediatric and adult population). This difference does not alter the Intended use of the device. The Visible Patient Suite has the same technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Visible Patient Suite and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Visible Patient Suite performs as intended and in a manner similar to the predicate devices. Thus, the Visible Patient Suite is substantially equivalent to the predicate.
Innolitics
510(k) Summary
Decision Summary
Classification Order
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