(90 days)
Not Found
No
The document describes standard image processing and segmentation tools, and explicitly states "Diagnosis is not performed by the software". There is no mention of AI, ML, or related concepts.
No
The device is described as medical imaging software providing tools for reading, interpreting, reporting, and treatment planning, and it explicitly states it is "not intended for use with or for the primary diagnostic interpretation of Mammography images" and "Diagnosis is not performed by the software". Its function is to assist in evaluation and planning, not to directly treat or diagnose.
No
The "Intended Use" section states that the software is "intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning." It also explicitly states, "This product is not intended for use with or for the primary diagnostic interpretation of Mammography images." Furthermore, the "Device Description" states, "Diagnosis is not performed by the software, but by radiologists, clinicians and referring physicians. A physician, provided with ample opportunity for competent human intervention, interprets images and information being displayed." These statements indicate that the device assists in workflows but does not perform diagnosis itself.
Yes
The device description explicitly states, "The Visible Patient Suite is a software device that does not contact the patient, nor does it control any life sustaining devices." It further clarifies that it is a "software suite" composed of three software components. The intended use and device description focus solely on software functionalities for image processing, analysis, and planning, without mentioning any associated hardware components that are part of the medical device itself.
Based on the provided information, the Visible Patient Suite is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Visible Patient Suite's Function: The Visible Patient Suite processes medical images acquired from imaging modalities like CT and MR. It provides tools for viewing, processing, and analyzing these images to aid in interpretation and treatment planning. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for aiding trained medical professionals in reading, interpreting, reporting, and treatment planning based on medical images.
- Device Description: The description emphasizes that the software does not contact the patient and diagnosis is performed by medical professionals, not the software itself.
Therefore, the Visible Patient Suite falls under the category of medical imaging software, not an IVD.
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, reporting, and treatment planning. 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.
Product codes
LLZ
Device Description
The Visible Patient Suite is a software device that does not contact the patient, nor does it control any life sustaining devices. Diagnosis is not performed by the software, but by radiologists, clinicians and referring physicians. A physician, provided with ample opportunity for competent human intervention, interprets images and information being displayed.
In sum, 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).
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 imaging modalities (DICOM images). There is no 3D data volume interpretation in this software.
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.
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR
Anatomical Site
bones, organs, vascular/airway structures, liver, lungs and kidneys
Indicated Patient Age Range
Not Found
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 of concern software. In all instances, the Visible Patient Suite functioned as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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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Image /page/0/Picture/1 description: The image contains the seal of the U.S. Department of Health & Human Services. The seal features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The emblem is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 15, 2015
Visible Patient, SAS % John Smith, M.D., Ph.D. Regulatory Counsel Hogan Lovells US LLP 555 Thirteenth Street, NW WASHINGTON DC 20004
Re: K151988
Trade/Device Name: Visible Patient Suite Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 9, 2015 Received: September 9, 2015
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. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Ocko
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known)
K151988
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. 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 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) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY Visible Patient, SAS's Visible Patient Suite
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Visible Patient, SAS RCS Strasbourg TI 794 458 125 1 place de l'hôpital 67000 Strasbourg, France Phone: 33 (0)3 90 22 42 00 Facsimile: 33 (0)3 88 11 90 99
Contact Person: Ms. Aude PETITJEAN Phone number: 33 (0)3 90 22 42 03
Date Prepared: July 17, 2015
Name of Device and Name/Address of Sponsor
Visible Patient Suite Visible Patient, SAS RCS Strasbourg TI 794 458 125 1 place de l'hôpital 67000 Strasbourg, France
Common or Usual Name
Medical Image Processing Software
Classification Name / Regulation Number / Product Code / Review Panel
Picture Archiving and Communications System / 21 C.F.R. § 892.2050 / Product Code: LLZ / Radiology Review Panel
Predicate Devices
FUJIFILM Medical Systems U.S.A., Inc.'s:
- Synapse 3D Base Tools (K120361) ●
- . Synapse 3D Liver and Kidney Analysis (K142521)
- Synapse 3D Lung and Abdomen Analysis (K130542) .
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, reporting, and treatment planning. 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.
4
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.
Technological Characteristics
The Visible Patient Suite is a software device that does not contact the patient, nor does it control any life sustaining devices. Diagnosis is not performed by the software, but by radiologists, clinicians and referring physicians. A physician, provided with ample opportunity for competent human intervention, interprets images and information being displayed.
In sum, 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).
Visible Patient Sender a)
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 imaging 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.
5
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.
Performance Data
The company has verified and validated the Visible Patient Suite's moderate level of concern software. In all instances, the Visible Patient Suite functioned as intended.
Substantial Equivalence
The Visible Patient Suite is as safe and effective as the Synapse 3D Base Tools (K120361), Synapse 3D Liver and Kidney Analysis (K142521) and Synapse 3D Lung and Abdomen Analysis (K130542). The Visible Patient Suite has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. 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.