(30 days)
Image Management is intended to provide complete and scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, retrieve, process and display medical images and data from hospital medical imaging and information systems. The device contains clinical applications that assist the processing, analyzing and comparing of medical images. It is a single device that integrates the review, dictation and reporting tools to create a productive work environment for the radiologists and physicians.
The Image Management viewers are used for patient exam management by clinicians in order to access and display patient data, medical reports, medical images from different modalities including but not limited to CR, DR, CT, MR, NM, ECG, US, MG*, DBT*, OP and OPT. The device provides wireless and portable access to medical images for remote reading or referral purposes from web browsers using current standard HTML.
*For primary interpretation and review of mammography images, only use display hardware that is specifically designed for and cleared by FDA for mammography.
Image Management V15 is a software based system and is intended to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions/sites, which will archive, distribute, retrieve, process and display images and data from all hospital modalities and information systems. The device is to be used by trained professionals including, but not limited to, physicians and medical technicians. The device contains clinical applications that assist the processing, analyzing and comparing medical images. It is a single device that integrates review, dictation and reporting tools to create a productive work environment for the radiologists and physicians.
IM V15 supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM (Digital Imaging and Communications in Medicine): Computed Tomography (CT), Magnetic Resonance (MR), Nuclear Medicine (NM), Ultrasound (US), X-Ray (XR), X-Ray Angiography (XA), Positron Emission Tomography (PET), Computed Radiography (CR), Digital Radiography (Abbreviation not defined by the DICOM standard) (DR) Radio Fluoroscopy (RF), Radiation Therapy (RT), Mammography (MG), Secondary Capture (SC), Visible Light (VL), Optical Coherence Tomography (OCT), Electrocardiogram (ECG) and Ophthalmic Photography (OP) as well as hospital/radiology information systems.
The provided document, a 510(k) summary for Philips Medical Systems' Image Management V15, does not contain the detailed information necessary to fully answer the request.
Specifically, an AI/algorithm-centric study proving the device meets acceptance criteria for specific performance metrics is not described. The document primarily focuses on demonstrating substantial equivalence to a predicate device (CARESTREAM PACS K110919) based on indications for use, technological characteristics, and compliance with general medical device standards.
However, based on the information provided, here's what can be inferred and what remains unknown regarding acceptance criteria and a "study" of device performance:
Acceptance Criteria and Reported Device Performance:
The document states that "Verification and validation tests have been performed to address intended characteristics, technological use. specifications and risk management results." and that "The test results in this 510(k) premarket notification demonstrate that Image Management v15 complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance documents, and is substantially equivalent to the primary predicate device."
This implies that the acceptance criteria are tied to:
- Compliance with ISO 14971, IEC 62304, and NEMA PS 3.1-3.22 (DICOM Standard).
- Meeting "intended characteristics" and "technological specifications."
- Successful mitigation of risks identified through risk management.
- Demonstrating substantial equivalence to the predicate device.
Without explicit performance metrics (e.g., accuracy, sensitivity, specificity for a specific clinical task), a table of acceptance criteria and reported device performance cannot be generated as requested. The document doesn't provide quantitative results of these "verification and validation tests" beyond a statement of compliance.
*Study Information (Based on what is and is not in the document):
-
A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: As inferred above, these include compliance with specified standards (ISO 14971, IEC 62304, DICOM), meeting intended characteristics and technological specifications, and addressing risk management results. However, no specific quantitative performance metrics (e.g., accuracy, precision, recall) are listed as acceptance criteria, nor are their corresponding reported device performance values provided.
- Reported Device Performance: Not explicitly stated in quantitative terms in this summary. The summary focuses on compliance and equivalence, not on specific performance results that would be typically seen in a study evaluating an AI algorithm's diagnostic capabilities.
-
Sample size used for the test set and the data provenance:
- Not provided. The document mentions "verification and validation tests" but gives no details about the data (e.g., sample size, type of images, country of origin, retrospective/prospective collection). Given the nature of the device as an "Image Management System" (PACS), the testing might involve functional performance, data integrity, and display capabilities rather than diagnostic accuracy on a specific disease.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided. Ground truth establishment is typically relevant for diagnostic AI algorithms. Since this is an image management system, the "ground truth" for its testing would likely be related to correct image archiving, retrieval, processing, and display, rather than a clinical diagnosis.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided. Adjudication methods are relevant for establishing ground truth in diagnostic studies, which is not described here.
-
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 evidence of an MRMC comparative effectiveness study involving AI assistance and human readers is present. The device is described as an "Image Management System" with "clinical applications that assist the processing, analyzing and comparing medical images." While it processes images, it is not described as an AI intended to directly assist or augment human diagnostic performance in the way an AI CADx (Computer-Aided Detection/Diagnosis) system would. Therefore, an MRMC study aimed at quantifying human improvement with AI assistance would not be applicable or described for this type of device based on this summary.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No evidence of a standalone algorithm performance study is present. Again, the summarized device appears to be a PACS system, not a standalone diagnostic AI algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated and likely not applicable in the typical diagnostic sense. For an image management system, "ground truth" would relate to the correctness of data handling, image fidelity, display accuracy, and functionality as per DICOM standards and internal specifications, rather than a clinical diagnosis confirmed by pathology or outcomes.
-
The sample size for the training set:
- Not applicable and not provided. This device is described as a software system primarily for image management. While it may contain "clinical applications that assist the processing, analyzing and comparing medical images," it is not described as a deep learning or machine learning-based AI that requires a "training set" in the conventional sense for a diagnostic task.
-
How the ground truth for the training set was established:
- Not applicable and not provided. (See point 8).
In Summary:
The provided document describes a 510(k) submission for an "Image Management V15" system, which is a PACS. The focus of the submission is on demonstrating substantial equivalence to an existing predicate device and compliance with general medical device standards for software and risk management. It does not describe a clinical study of an AI algorithm with specific diagnostic performance acceptance criteria, test sets, or ground truth establishment relevant to AI diagnostic capabilities. The "clinical applications" mentioned within the PACS are for "processing, analyzing and comparing medical images" and would likely refer to standard image manipulation tools (e.g., 3D reconstruction, volume matching, MPR) rather than novel AI diagnostic algorithms requiring specific performance validation studies as requested in the prompt.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains 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 the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Philips Medical Systems Technologies Ltd. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
April 24, 2024
Re: K240822
Trade/Device Name: Image Management V15 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: March 25, 2024 Received: March 25, 2024
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).
{1}------------------------------------------------
2
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 QS 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 DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
{2}------------------------------------------------
Indications for Use
Submission Number (if known)
Device Name
Image Management V15
Indications for Use (Describe)
Image Management is intended to provide complete and scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, retrieve, process and display medical images and data from hospital medical imaging and information systems. The device contains clinical applications that assist the processing, analyzing and comparing of medical images. It is a single device that integrates the review, dictation and reporting tools to create a productive work environment for the radiologists and physicians.
The Image Management viewers are used for patient exam management by clinicians in order to access and display patient data, medical reports, medical images from different. modalities including but not limited to CR, DR, CT, MR, NM, ECG, US, MG*, DBT*, OP and OPT. The device provides wireless and portable access to medical images for remote reading or referral purposes from web browsers using current standard HTML.
*For primary interpretation and review of mammography images, only use display hardware that is specifically designed for and cleared by FDA for mammography.
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)
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
The Company's 510(k) Summary is provided below on the following page.
{4}------------------------------------------------
510(k) SUMMARY Philips Medical Systems Image Management Application
| K240822 | |
|---|---|
| Company's Name and Address | Philips Medical Systems Technologies Ltd.2 Hapnina Street, P.O. Box 46Raanana Central, Israel 4321538 Phone: +9 7297625555 |
| Contact Person | Shlomit Brandis KeplerSr. Regulatory Affairs Specialistshlomit.brandiskepler@philips.com+972547790828 |
| Date | April 23, 2024 |
| Device Tradename | Image Management V15 |
| Classification Name | System, Image Processing, Radiological |
| Product Code | LLZ |
| Classification | 21 CFR 892.2050 |
| Predicate Device | CARESTREAM PACS (K110919) |
| Reference Devices | Carestream Vue PACS (K122523)Carestream Vue PACS (K170580)Carestream Vue Motion (K151774) |
| Device Description andTechnologicalCharacteristics | Image Management V15 is a software based system and isintended to provide completely scalable local and wide areaPACS (Picture Archiving and Communication System)solutions for hospital and related institutions/sites, whichwill archive, distribute, retrieve, process and display imagesand data from all hospital modalities and informationsystems. The device is to be used by trained professionalsincluding, but not limited to, physicians and medicaltechnicians. The device contains clinical applications thatassist the processing, analyzing and comparing medicalimages. It is a single device that integrates review, dictationand reporting tools to create a productive work environmentfor the radiologists and physicians.IM V15 supports receiving, sending, printing, storing anddisplaying studies received from the following modalitytypes via DICOM (Digital Imaging and Communicationsin Medicine): Computed Tomography (CT), MagneticResonance (MR), Nuclear Medicine (NM), Ultrasound(US), X-Ray (XR), X-Ray Angiography (XA), PositronEmission Tomography (PET), Computed Radiography(CR), Digital Radiography (DX), Digital Radiography(Abbreviation not defined by the DICOM standard) (DR) |
| Radio Fluoroscopy (RF), Radiation Therapy (RT), Mammography (MG), Secondary Capture (SC), Visible Light (VL), Optical Coherence Tomography (OCT), Electrocardiogram (ECG) and Ophthalmic Photography (OP) as well as hospital/radiology information systems. | |
| Indications for Use | Image Management is intended to provide complete and scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve, process and display medical images and data from hospital medical imaging and information systems. |
| The device contains clinical applications that assist the processing, analyzing and comparing of medical images. It is a single device that integrates the review, dictation and reporting tools to create a productive work environment for the radiologists and physicians. | |
| The Image Management viewers are used for patient exam management by clinicians in order to access and display patient data, medical reports, medical data and medical images from different modalities including but not limited to CR, DR, CT, MR, NM, ECG, US, MG*, DBT*, OP and OPT. | |
| The device provides wireless and portable access to medical images for remote reading or referral purposes from web browsers using current standard Html. | |
| *For primary interpretation and review of mammography images, only use display hardware that is specifically designed for and cleared by FDA for mammography. | |
| Substantial Equivalence | Image Management v15 is as safe and effective as its predicate device. Both devices have similar indications for use, technological characteristics, and principles of operation. The minor technological differences between the Image Management and its predicate device raise no new issues of safety or effectiveness. |
| The table below summarizes the substantive feature/technological similarities and differences between the subject and predicate devices. | |
{5}------------------------------------------------
PHILIPS
{6}------------------------------------------------
| Comparison Feature | Subject Device | Primary Predicate Device | |
|---|---|---|---|
| Philips' | Carestream PACS | ||
| Image Management v15 | (K110919) | ||
| Device Class | Class II | Class II | |
| Classification Panel | Radiology | Radiology | |
| Product Code | LLZ | LLZ | |
| RegulationDescription | System, Image Processing,Radiological | System, Image Processing,Radiological | |
| Regulation Number | 892.2050 | 892.2050 | |
| Indications for Use | Image Management is intendedto provide complete and scalablelocal and wide area PACSsolutions for hospital and relatedinstitutions/sites, which willarchive, distribute, retrieve,process and display medicalimages and data from hospitalmedical imaging andinformation systems.The device contains clinicalapplications that assist theprocessing, analyzing andcomparing of medical images. Itis a single device that integratesthe review, dictation andreporting tools to create aproductive work environmentfor the radiologists andphysicians.The Image Management viewersare used for patient exammanagement by clinicians inorder to access and displaypatient data, medical reports,medical data and medicalimages from different modalitiesincluding but not limited to CR,DR, CT, MR, NM, ECG, US,MG*, DBT*, OP and OPT.The device provides wirelessand portable access to medicalimages for remote reading orreferral purposes from web | The CARESTREAM PACS is animage management system whoseintended use is to providecompletely scaleable local andwide area PACS solutions forhospital and relatedinstitutions/sites, which willarchive, distribute, retrieve anddisplay images and data from allhospital modalities andinformation systems.The system contains interactivetools in order to ease the processof analyzing and comparing threedimensional (3D) images. It is asingle system that integrates thereview, dictation and reportingtools that creates a productivework environment for theradiologists and physicians.The CARESTREAM PACSLightweight Viewer softwareprogram is used for patientmanagement by the referralcommunity in order to access anddisplay patient data, medicalreports, and medical images fromdifferent modalities including CR,DR, CT, MR, NM and US afterthe primary reading has beencompleted on dedicated diagnosticworkstations. | |
| Comparison Feature | Subject DevicePhilips'Image Management v15 | Primary Predicate DeviceCarestream PACS(K110919) | |
| browsers using current standardHtml.*For primary interpretation andreview of mammographyimages, only use displayhardware that is specificallydesigned for and cleared byFDA for mammography. | The CARESTREAM PACSLightweight Viewer provideswireless and portable access tomedical images for referralpurposes. It is not intended to beused as, or to replace, a fulldiagnostic workstation or systemand should be used only whenthere is no access to a workstation.This device is not to be used formammography. | ||
| Available Clinical Tools | |||
| Cardiac CTApplication | Yes | Yes | |
| ECG Application | Yes | No | |
| Cardiology(Echocardiography,XA) | Yes | Yes | |
| Coronary ArteryAnalysis application | Yes | Yes | |
| Vessel analysisapplication | Yes | Yes | |
| Digital SubtractionApplication | Yes | No | |
| Calcium Scoringapplication | Yes | Yes | |
| 3D analysisapplication | Yes | Yes | |
| Volume MatchingApplication | Yes | Yes | |
| Hybrid NM viewerapplication | Yes | Yes | |
| Mammography imagedisplay Application | Yes | Yes | |
| PowerViewerapplication | Yes | Yes | |
| MPR application | Yes | Yes | |
| CT Perfusionapplication | Yes | No | |
| MR Perfusionapplication | Yes | No | |
| MR Diffusionapplication | Yes | No | |
| Comparison Feature | Subject DevicePhilips'Image Management v15 | Primary Predicate DeviceCarestream PACS(K110919) | |
| Lesion ManagementApplication | Yes | No | |
| Technological Characteristics | |||
| Supports DICOMstudies received fromdifferent modalitytypes | Yes- CT, MR, NM, US, XR,XA, PET, CR, DX, DR, RF, RT,MG, SC, VL, OPT, ECG andOP | Yes- CR, DR, CT, MR, NM, US,XR, XA, MG, PET, DX, RF, RT,MG, SC and VL | |
| Web DiagnosticViewer | Yes | No | |
| OP & OPT modalitysupport | Yes |
Table 1: Substantial Equivalence
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are gray, and there is a thin black line underneath the word. The background is white, providing a clear contrast that makes the text easily readable.
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are gray, and the background is white. A thin, dark line is located underneath the word.
In addition, the software naming convention is being introduced with a new branding, and will be titled Image Management, versus the previous use of Vue PACS.
Nonclinical Tests Performed
Performance tests have been performed on Image Management v15
Image Management v15 demonstrates compliance with the following International and FDA recognized consensus standards:
- ISO 14971 Medical devices Application of risk 0 management to medical devices
- 0 IEC 62304 Medical device software - Software life cycle processes
- NEMA PS 3.1-3.22 - - Digital Imaging 0 and Communications in Medicine (DICOM) Standard
Image Management V15 has been tested in accordance with Philips verification and validation processes. Verification and validation tests have been performed to address intended characteristics, technological use. specifications and risk management results.
The test results in this 510(k) premarket notification demonstrate that Image Management v15 complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance documents, and is substantially equivalent to the primary predicate device.
{9}------------------------------------------------
Conclusion:
Based on the technological characteristics of the devices, Philips Medical Systems Technologies Ltd. believes that Image Management V15 and the predicate devices selected are substantially equivalent and do not raise new issues of safety or effectiveness.
§ 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).