(56 days)
No
The document describes standard medical imaging software tools and image processing techniques, with no mention of AI, ML, or related concepts like deep learning or neural networks. The performance studies described are based on phantom data and literature review, not on training or testing AI/ML models.
No
The device is described as medical imaging software intended to aid in reading, interpreting, and treatment planning by creating 3D models and facilitating analysis of anatomy and pathology. It assists clinicians in making decisions, but it does not directly provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section states that the software is intended to provide tools to aid medical professionals in "reading, interpreting, and treatment planning". It also mentions that Visible Patient Lab helps in "(1) the evaluation of patient's anatomy and pathology". These activities are inherently diagnostic in nature. While it also aids in treatment planning, the software's role in interpreting images and evaluating pathology falls under diagnostic purposes.
Yes
The device description explicitly states that Visible Patient Suite is a "software suite" and includes three "software components." There is no mention of any accompanying hardware being part of the device itself.
Based on the provided text, the Visible Patient Suite is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic purposes. This typically involves tests performed on blood, urine, tissue samples, etc.
- Visible Patient Suite's Intended Use: The intended use of Visible Patient Suite is clearly stated as providing tools to aid trained medical professionals in reading, interpreting, and treatment planning based on medical images (CT, MR). It processes images acquired from imaging devices, not biological specimens.
- Device Description: The device description focuses on software components for data management, image analysis, and image processing to create 3D models and visualize anatomy. This aligns with medical imaging software, not IVD testing.
- Lack of IVD-related information: The text does not mention any analysis of biological samples, diagnostic tests performed on specimens, or any of the typical metrics associated with IVD performance (sensitivity, specificity, etc., in the context of analyzing biological markers).
In summary, Visible Patient Suite is a medical imaging software intended for image processing and visualization to assist in diagnosis and treatment planning, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / 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 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.
Product codes
LLZ
Device Description
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).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM compliant medical images acquired from a variety of imaging devices, including CT, MR.
Anatomical Site
bones, organs, vascular/airway structures (liver, lungs and kidneys)
Indicated Patient Age Range
pediatric and adult patients
Intended User / Care Setting
trained medical professionals (including physicians, surgeons and technicians)
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)
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).
During the validation stage, a literature study was conducted to support device performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Visible Patient Suite, Visible Patient, SAS, K151988
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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
- 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
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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) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. |
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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.
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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.