(267 days)
MediSystem PACS is intended for use as a diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information. MediSystem PACS displays and manages diagnostic quality DICOM images. MediSystem PACS is not intended for diagnostic use with mammography images. Usage for mammography is for referral only. MediSystem PACS is not intended for diagnostic use on mobile devices.
Contraindications: MediSystem PACS is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel.
The MediSystem PACS is a Web-based DICOM medical image viewer that allows downloading. reviewing, manipulating, visualizing and printing medical multi-modality image data in DICOM format, from a client machine. MediSystem PACS is a server-based solution that connects to any PACS and displays DICOM images within the hospital, securely from remote locations, or as an integrated part of an EHR or portal. MediSystem PACS enables health professionals to access, manipulate, measure DICOM images and collaborate real-time over full quality medical images using any web-browser without installing client software. Supported Web browsers are: Microsoft Edge 79 or later, Mozilla Firefox 58 or later, Google Chrome 63 or later.
This document is a 510(k) summary for the MediSystem PACS device, which is a Medical Image Management and Processing System. The purpose of this summary is to demonstrate substantial equivalence to a predicate device (MediLab, K221065). The document primarily focuses on comparing the features and intended use of the new device to the predicate device, rather than providing detailed acceptance criteria and performance data from a standalone or MRMC study.
Based on the information provided in the document, here's what can be extracted and what is not available:
1. A table of acceptance criteria and the reported device performance:
The document does not provide a formal table of acceptance criteria with specific quantitative targets and corresponding reported device performance for clinical endpoints (e.g., accuracy, sensitivity, specificity for diagnostic tasks). Instead, it focuses on demonstrating equivalence in technical characteristics and functional performance to a predicate device.
The only quantitative performance criteria mentioned are for measurement accuracy, which is considered a non-clinical performance test.
| Acceptance Criteria (Non-clinical) | Reported Device Performance (Non-clinical) |
|---|---|
| Measurement accuracy for distance: 1% | 1% for distance |
| Measurement accuracy for angle: 2% | 2% for angle |
| Measurement accuracy for area: 2% | 2% for area |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document refers to "Performance Testing (Measurement Accuracy)" but does not specify the number of images or measurements used in this testing.
- Data Provenance: Not explicitly stated. Given the nature of the device (a PACS viewer), the "data" for measurement accuracy testing would typically be DICOM images designed to test measurement capabilities, not necessarily patient data with specific clinical outcomes. The document does not specify the origin of these test images. It is focused on the device's ability to display and measure images in DICOM format, not on its diagnostic efficacy for specific pathologies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for the type of testing described. The "Performance Testing (Measurement Accuracy)" would likely involve comparing software measurements against known, true physical measurements or highly accurate digital representations, not expert consensus on medical findings. There is no indication that expert radiologists were involved in setting "ground truth" for this specific measurement accuracy testing.
4. Adjudication method for the test set:
- Not applicable for the type of testing described. Since the testing described is focused on objective measurement accuracy rather than subjective diagnostic interpretation, adjudication among experts is not relevant here.
5. 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, an MRMC comparative effectiveness study was not done. The device (MediSystem PACS) is a Medical Image Management and Processing System, primarily a viewer and management tool, not an AI-powered diagnostic aide. Its function is to display diagnostic quality images and provide tools for manipulation and measurement, for use by qualified medical personnel. Therefore, a study to assess human reader improvement with "AI assistance" is not relevant to this device's intended use or claim.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a form of "standalone" performance testing was done for measurement accuracy. The document states: "Performance Testing (Measurement Accuracy) was conducted on the MediSystem PACS to determine measurement accuracy when performing the various distance, area and angle measurements." This evaluates the software's ability to perform these measurements accurately, independent of a human user's diagnostic interpretation.
7. The type of ground truth used:
- For the measurement accuracy testing, the ground truth would typically be known, precise measurements of the objects within the test images. This could be established through physical calibration, highly accurate digital models, or other metrology standards, not expert consensus, pathology, or outcomes data, as the device is not making a diagnostic claim.
8. The sample size for the training set:
- Not applicable. The MediSystem PACS is a PACS viewer and management system, not an AI/ML algorithm that requires a "training set" in the conventional sense for learning patterns from data to make predictions or classifications. Its development is based on software engineering principles and functionality equivalence to a predicate, not machine learning model training.
9. How the ground truth for the training set was established:
- Not applicable. (See point 8).
Summary of Device Performance and Equivalence:
The document focuses on demonstrating substantial equivalence to a predicate device (MediLab, K221065) based on:
- Similar intended use: Both devices are used as diagnostic and analysis tools for medical images, display and manage DICOM images, and are not for mammography (except referral) or mobile devices.
- Similar technical characteristics and functionality: The document provides a detailed comparison table showing identical features such as DICOM image loading/visualization, patient study search, user authentication, image display operations (window level, rotate/pan/zoom, flip, layout, PET fusion, volumetric rendering), measurement functions (line, angle, area), annotations, report generation, export, DICOM windowing, supported imaging modalities (US, CT, MRI, XRay), communications (DICOM), and supported operating systems/browsers.
- Non-clinical performance testing: Measurement accuracy for distance (1%), angle (2%), and area (2%) was verified as comparable to the predicate device.
- Software Verification and Validation: The software was considered a "moderate" level of concern, and V&V documentation was provided as per FDA guidance. This ensures the software functions as intended and does not pose undue risks.
The conclusion is that "there are no differences between the devices that affect the usage, safety and effectiveness, thus no new question is raised regarding the safety and effectiveness." The submission relies heavily on the "feature comparison" and the fact that the new device replicates the functionality and performance of the legally marketed predicate device.
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Medilab Manutencao E Sitemas Ltda Jorge Millan Regulatory Consultant Rua Amaral, 80, Andarai Rio De Janeiro, Rio De Janeiro 20541-155 Brazil
June 23, 2023
Re: K223048
Trade/Device Name: Medisystem Pacs Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: May 22, 2023 Received: May 23, 2023
Dear Jorge Millan:
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
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801 and Part 809); 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 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, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223048
Device Name MediSystem PACS
Indications for Use (Describe)
MediSystem PACS is intended for use as a diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information. MediSystem PACS displays and manages diagnostic quality DICOM images. MediSystem PACS is not intended for diagnostic use with mammography images. Usage for mammography is for referral only. MediSystem PACS is not intended for diagnostic use on mobile devices.
Contraindications: MediSystem PACS is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel.
| 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)
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Image /page/3/Picture/1 description: The image shows the logo for Medilab. The logo consists of a blue square with a white "M" inside, followed by the word "medilab" in black. Below the word "medilab" is the word "SISTEMAS" in a smaller font, and below that is the text "MEDILAB MANUTENCAO E SISTEMAS LTDA" in a larger font.
MediSystem PACS 510K Summary – June 21, 2023
510(K) Summary
Submitter Information
| Submitter | MEDILAB MANUTENCAO E SISTEMAS LTDARUA AMARAL, 80, ANDARAIRio de Janeiro, Brazil 20541-155 |
|---|---|
| Contact: | Jorge Millan, PhD |
| Telephone number | (786) 416-5587 |
| jmillan@sigmabiomedical.com | |
| Date prepared: | June 21, 2023 |
Subject Device Name
| Trade/Proprietary Name: | MediSystem PACS |
|---|---|
| Regulation Number: | 892.2050 |
| Regulation Name: | Medical Image management and processing system |
| Product Code: | LLZ |
| Class | II |
| Panel | Radiology |
Predicate Device
| Predicate Device: | MediLab |
|---|---|
| Sponsor | SIGMA SCIENTIFIC SERVICES LLC |
| 510(K) | K221065 |
| Regulation Number: | 892.2050 |
| Regulation Name: | Medical Image management and processing system |
| Product Code: | LLZ |
| Class | II |
| Panel | Radiology |
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Device Description:
The MediSystem PACS is a Web-based DICOM medical image viewer that allows downloading. reviewing, manipulating, visualizing and printing medical multi-modality image data in DICOM format, from a client machine. MediSystem PACS is a server-based solution that connects to any PACS and displays DICOM images within the hospital, securely from remote locations, or as an integrated part of an EHR or portal. MediSystem PACS enables health professionals to access, manipulate, measure DICOM images and collaborate real-time over full quality medical images using any web-browser without installing client software. Supported Web browsers are: Microsoft Edge 79 or later, Mozilla Firefox 58 or later, Google Chrome 63 or later.
Indications for Use:
MediSystem PACS is intended for use as a diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information. MediSystem PACS displays and manages diagnostic quality DICOM images. MediSystem PACS is not intended for diagnostic use with mammography images. Usage for mammography is for referral only. MediSystem PACS is not intended for diagnostic use on mobile devices.
Contraindications: MediSystem PACS is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel.
Non-Clinical Data:
Non-clinical product evaluation to demonstrate safety and effectiveness was conducted. Non-clinical testing includes:
Software Verification and Validation
Software verification and validation testing were conducted on the MediSystem PACS and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent
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flaw in the software would lead to a delayed delivery of appropriate medical care. Documentation includes level of concern, software requirements and specifications, design architecture, risk analysis and software validation and verification.
Performance Testing (Measurement Accuracy) was conducted on the MediSystem PACS to determine measurement accuracy when performing the various distance, area and angle measurements.
Predicate Devices
MediSystem PACS is equivalent to MediLab by SIGMA SCIENTIFIC SERVICES LLC cleared under K221065.
Comparison with the Predicate Devices [21 CFR 807.92(a) (6)]: MediSystem PACS is comparable
with and substantially equivalent to MediLab System.
Technical Characteristics Comparison:
The basic and main technical features of the subject device are the same as the predicated device
Feature Comparison:
Subject device has similar features and functionality as the predicate device:
Product comparison
| Feature | MEDILAB | MEDISYSTEM PACS |
|---|---|---|
| K# | K221065 | |
| Intended Use | MediLab software is intended for use as a diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information. MediLab displays and manages diagnostic quality DICOM images. Medilab is not intended for diagnostic use with mammography images. Usage for mammography is | MediSystem PACS software is intended for use as a diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information. MediSystem PACS displays and manages diagnostic quality DICOM images. MediSystem PACS is not intended for diagnostic use with |
| for reference and referral only.MediLab is not intended fordiagnostic use on mobile devices.Contraindications: MediLab is notintended for the acquisition ofmammographic image data and ismeant to be used by qualifiedmedical personnel. | mammography images. Usage formammography is for reference andreferral only. MediSystem PACS isnot intended for diagnostic use onmobile devices.Contraindications: MediSystemPACS is not intended for theacquisition of mammographicimage data and is meant to be usedby qualified medical personnel. | |
| Mammographic use | No | No |
| DICOM image loading andvisualization | Yes | Yes |
| Patient study search data | Yes | Yes |
| User authentication | Yes | Yes |
| Window level | Yes | Yes |
| Rotate/pan/zoom/fit to screen | Yes | Yes |
| Image display operations | Flip horizontal, verticalRotate left, rightClear transformMagnificationScrollLayout 1x1 -3x3Thumbnails left, right, top,bottomPET FusionVolumetric rendering | Flip horizontal, verticalRotate left, rightClear transformMagnificationScrollLayout 1x1 -3x3Thumbnails left, right, top,bottomPET FusionVolumetric rendering |
| Measurement functions | Line, angle, area | Line, angle, area |
| Measurement accuracy | 1% for distance2% for angle and distance | 1% for distance2% for angle and distance |
| Annotations | Text | Text |
| Report Generation | Yes | Yes |
| Print reports | ||
| Export | Yes | Yes |
| Export reports to CD | No | No |
| Share function | Yes | Yes |
| DICOM Windowing | Yes | Yes |
| Low Pass Filter | No | No |
| Imaging modalities | US, CT, MRI, XRay | US, CT, MRI, XRay |
| Communications | DICOM | DICOM |
| Operating System for DiagnosticViewing | Windows, Linux, Mac | Windows, Linux, Mac |
| Browser supported | Edge, Firefox, Chrome | Edge, Firefox, Chrome |
| Mobile Device Support for Viewing | No | No |
| Transfer/Storage/Display of Medicalimages | Yes | Yes |
| Network access | Connects to existing PACS |
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Image /page/6/Picture/0 description: The image shows the logo for Medilab Sistemas. The logo features a blue square with a white "m" inside, followed by the word "medilab" in black, sans-serif font. Below the word "medilab" is the word "SISTEMAS" in a smaller, sans-serif font.
MEDILAB MANUTENCAO E SISTEMAS LTDA
MediSystem PACS 510K Summary – June 21, 2023
SECTION 9
Page 4 of 5
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LAB MANUTENCAO E SISTEMAS LTDA
MediSystem PACS 510K Summary - June 21, 2023
Evaluation of similarities and differences:
- MediSystem PACS and MediLab have similar intended use, functionality and similar Web . technologies. In terms of use and functions both systems access, upload and display DICOM images and metadata and provide tools and resources to the physician for study review and analysis. Both systems are hosted in Web servers and are equipped with security features and user authentication.
- There are no differences between both systems. ●
Conclusion:
The subject device has similar technology characteristics and has similar intended use and functionality as the predicate device. Product testing included software validation and performance testing such as distance, area and angle measurement accuracy. These tests show similar and equivalent performance. Thus, there are no differences between the devices that affect the usage, safety and effectiveness, thus no new question is raised regarding the safety and effectiveness. The non-clinical performance test data and software verification and validation demonstrate that the MediSystem PACS performs comparably to and it is as safe and effective as the predicate device. In accordance with the 21 CFR Part 807 and based on the information provided in this premarket notification, MediSystem PACS is substantially equivalent to the predicate that is currently marketed for the same intended use.
§ 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).