MediLab
Device Facts
| Record ID | K221065 |
|---|---|
| Device Name | MediLab |
| Applicant | Sigma Scientific Services, LLC |
| Product Code | LLZ · Radiology |
| Decision Date | Jun 10, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
MediLab 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 for reference and referral only. MediLab is not intended for diagnostic use on mobile devices.
Device Story
MediLab is a server-based DICOM medical image viewer; enables healthcare professionals to download, review, manipulate, visualize, and print multi-modality images (US, CT, MRI, X-Ray, PET). Operates via web browser without client-side installation; connects to existing PACS or integrates with EHR/portals. Provides tools for windowing, rotation, panning, zooming, and measurements (line, angle, area). Supports report generation and export to PDF or CD. Used by radiologists and clinicians for study review and clinical decision-making; facilitates real-time collaboration. Benefits include efficient access to diagnostic-quality images and streamlined workflow for image analysis.
Clinical Evidence
Bench testing only. Software verification and validation conducted per FDA guidance; classified as moderate level of concern. Performance testing confirmed measurement accuracy for distance and area tools. No clinical data presented.
Technological Characteristics
Server-based DICOM viewer; web-browser interface (Edge, Firefox, Chrome). Supports Windows, Linux, Mac OS. Connectivity via network to PACS/EHR. Features include DICOM windowing, volumetric rendering, PET fusion, and measurement tools. Software-based image processing; no hardware-specific materials or energy sources described.
Indications for Use
Indicated for use by qualified medical personnel in hospitals, imaging centers, and reading practices as a diagnostic and analysis tool for DICOM images (US, CT, MRI, X-Ray, PET). Not for diagnostic use with mammography images (reference/referral only) or on mobile devices.
Regulatory Classification
Identification
A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.
Special Controls
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
Predicate Devices
- ZeeroMED View (K200546)
Reference Devices
Submission Summary (Full Text)
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Sigma Scientific Services LLC Jorge Millan Biomedical Director 7737 N University Drive, Suite 101 Tamarac, Florida 33321
Re: K221065
June 10, 2022
Trade/Device Name: MediLab Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: April 5, 2022 Received: April 12, 2022
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
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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 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. 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) k221065
Device Name MediLab
#### Indications for Use (Describe)
MediLab 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 for referral only. MediLab is not intended for diagnostic use on mobile devices.
Contraindications: MediLab 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/0 description: The image shows the logo for Sigma Scientific. The word "Sigma" is written in a large, gray, sans-serif font. Below "Sigma" is the word "Scientific" in a smaller, blue, sans-serif font. The logo is simple and modern.
## 510(K) Summary
# Submitter Information
| Submitter | SIGMA SCIENTIFIC SERVICES LLC<br>7737 N UNIVERSITY DRIVE, SUITE 101<br>TAMARAC, FL 33321 |
|------------------|------------------------------------------------------------------------------------------|
| Contact: | Jorge Millan, PhD<br>Biomedical Director |
| Telephone number | (786) 416-5587 |
| E-mail | sigmabiomedical@gmail.com |
| Date prepared: | June 6, 2022 |
# Subject Device Name
| Trade/Proprietary Name: | MediLab |
|-------------------------|------------------------------------------------------|
| Regulation Number: | 892.2050 |
| Regulation Name: | Medical image management and image processing System |
| Product Code: | LLZ |
| Class | II |
| Panel | Radiology |
# Predicate Device
| Predicate Device: | ZeeroMED View |
|--------------------|------------------------------------------------------|
| Sponsor | O3 ENTERPRISE SRL |
| 510(K) | K200546 |
| Regulation Number: | 892.2050 |
| Regulation Name: | Medical image management and image processing System |
| Product Code: | LLZ |
| Class | II |
| Panel | Radiology |
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Image /page/4/Picture/0 description: The image contains the logo for Sigma Scientific. The word "Sigma" is written in a large, light gray font. Below "Sigma" is the word "Scientific" written in a smaller, dark blue font. The logo is simple and modern.
# Reference Predicates
| Reference Devices: | IMPLANTER DENTAL PLANNING SOFTWARE, K173083<br>aPROMISE X, K220590 |
|--------------------|--------------------------------------------------------------------|
| Regulation Number: | 892.2050 |
| Regulation Name: | Medical image management and image processing System |
| Product Code: | LLZ |
| Class | II |
| Panel | Radiology |
## Device Description:
The MediLab is a DICOM medical image viewer that allows downloading, reviewing, manipulating, visualizing and printing medical multi-modality image data in DICOM format, from a client machine. MediLab 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. MediLab 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.
## Indications for Use:
MediLab 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 for reference and referral only. MediLab is not intended for diagnostic use on mobile devices.
Contraindications: MediLab is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel.
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Image /page/5/Picture/0 description: The image shows the logo for Sigma Scientific. The word "Sigma" is in a large, gray, sans-serif font. Below "Sigma" is the word "Scientific" in a smaller, blue, sans-serif font. The logo is simple and modern.
## 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 MediLab system 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 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 MediLab system to determine measurement accuracy when performing the various distance and area measurements.
## Predicate Devices
Comparison with the Predicate Devices [21 CFR 807.92(a) (6)]: MediLab is comparable with and substantially equivalent to ZeeroMED View by 03 ENTERPRISE cleared under K200546. Medilab is also comparable to the reference devices cleared under K173083 and K220590.
#### 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 and reference devices:
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Image /page/6/Picture/0 description: The image shows the logo for Sigma Scientific. The word "Sigma" is written in a large, gray, sans-serif font. Below "Sigma" is the word "Scientific" in a smaller, blue, sans-serif font. The logo is simple and modern.
## Product comparison to primary predicate
| Feature | ZeeroMED View | MEDILAB | Comparison<br>to Predicate |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| K# | K200546 | K221065 | N/A |
| Intended Use | ZeeroMED View software is<br>intended for use as a diagnostic<br>and analysis tool for diagnostic<br>images for hospitals, imaging<br>centers, radiologists, reading<br>practices and any user who<br>requires and is granted access<br>to patient image, demographic<br>and<br>report<br>information.<br>ZeeroMED<br>View displays and manages<br>diagnostic quality<br>DICOM<br>images. ZeeroMED View is<br>not intended for diagnostic use<br>mammography<br>with<br>images. Usage for<br>mammography is for reference<br>and referral only. ZeeroMED<br>View is not intended for<br>diagnostic<br>use<br>mobile<br>devices.<br>Contraindications:<br>The<br>ZeeroMED<br>View<br>is<br>not<br>intended for the acquisition of<br>mammographic image data<br>and is meant to be used by<br>qualified medical personnel. | The MediLab software is<br>intended for<br>use<br>as<br>a<br>diagnostic and analysis tool<br>for diagnostic images for<br>hospitals, imaging centers,<br>radiologists,<br>reading<br>practices and any user who<br>requires and is granted<br>access to patient image,<br>demographic and<br>report<br>information.<br>MediLab<br>displays<br>and a<br>manages<br>diagnostic quality DICOM<br>images. MediLab is not<br>intended for diagnostic use<br>mammography<br>with<br>images. Usage for<br>mammography<br>is<br>for<br>reference and referral only.<br>MediLab is not intended for<br>diagnostic use on mobile<br>devices.<br>Contraindications: MediLab<br>is not intended for the<br>acquisition<br>of<br>mammographic image data<br>and is meant to be used by<br>qualified medical personnel. | Similar |
| Mammographic use | No | No | No difference |
| DICOM image loading and<br>visualization | Yes | Yes | No difference |
| Patient study search data | Yes | Yes | No difference |
| User authentication | Yes | Yes | No difference |
| Window level | Yes | Yes | No difference |
| Rotate/pan/zoom/fit to screen | Yes | Yes | No difference |
| Image display operations | Flip horizontal, vertical<br>Rotate left, right<br>Reset<br>Magnification<br>Scroll<br>Layout 1x1 -3x3<br>Thumbnails left, right, top,<br>bottom | Flip horizontal, vertical<br>Rotate left, right<br>Clear transform<br>Magnification<br>Scroll<br>Layout 1x1 -3x3<br>Thumbnails left, right,<br>top, bottom | No difference |
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Image /page/7/Picture/0 description: The image shows the logo for Sigma Scientific. The word "Sigma" is written in a large, light gray font. Below "Sigma" is the word "Scientific" written in a smaller, dark blue font. The logo is simple and modern.
| | PET fusion<br>Volumetric rendering | PET Fusion<br>Volumetric rendering | |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------|------------------------------------|--------------------------------------------------------|
| Measurement functions | Line, angle between lines,<br>polyline, area, elliptical<br>area, polygonal area, edit,<br>delete | Line, angle, area, | Medilab has a<br>subset of<br>measurement<br>functions |
| Annotations | Text | Text | No difference |
| Report Generation | Yes | Yes | No difference |
| Print reports | PDF | PDF | No difference |
| Export | Yes | Yes | No difference |
| Export reports to CD | No | Yes | No difference |
| Share function | Yes | Yes | No difference |
| DICOM Windowing | Yes | Yes | No difference |
| Low Pass Filter | Yes | No | No difference |
| Imaging modalities | US, CT, MRI, XRay, PET | US, CT, MRI, XRay,<br>PET | No difference |
| Communications | DICOM | DICOM | No difference |
| Operating System for<br>Diagnostic Viewing | Windows, Linux, Mac | Windows, Linux, Mac | No difference |
| Browser supported | Edge, Firefox, Chrome | Edge, Firefox, Chrome | No difference |
| Mobile Device Support for<br>Viewing | No | No | No difference |
| Transfer/Storage/Display of<br>Medical images | Yes | Yes | No difference |
| Network access | Connects to existing PACS | Connects to existing<br>PACS | No difference |
#### Product comparison to reference predicate devices
| Feature | IMPLANTER<br>DENTAL PLANNING<br>SOFTWARE | aPROMISE X | MEDILAB | Comparison<br>to predicates |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| K# | K173083 | K220590 | K221065 | N/A |
| Intended Use | Implanter Dental Planning<br>Software is a prescription<br>use software used by dentist<br>and dental lab technicians<br>for the visualization and<br>image segmentation of<br>DICOM data from medical<br>scanners such as CT. The<br>software aids the users in | aPROMISE is intended<br>to be used by healthcare<br>professionals and<br>researchers for<br>acceptance,<br>transfer, storage, image<br>display, manipulation,<br>quantification and<br>reporting of digital | The MediLab software<br>is intended for use as a<br>diagnostic and analysis<br>tool for diagnostic<br>images for hospitals,<br>imaging centers,<br>radiologists, reading<br>practices and any user<br>who requires and is | Similar<br>to<br>K220590 |
| | | | | |
| | the creation of 3D models<br>of oral maxillofacial region<br>and in planning dental<br>surgical treatments and<br>placement of dental<br>implants | medical images. The<br>system is intended to be<br>used with images<br>acquired using nuclear<br>medicine (NM) imaging,<br>using PSMA PET/CT.<br>The device provides<br>general Picture<br>Archiving an<br>Communications System<br>(PACS) tools as well as a<br>clinical application for<br>oncology including<br>marking of regions of<br>interest and quantitative<br>analysis. | granted access to patient<br>image, demographic and<br>report<br>information. MediLab<br>displays and manages<br>diagnostic quality<br>DICOM<br>images. MediLab is not<br>intended for diagnostic<br>use with mammography<br>images. Usage for<br>mammography is for<br>reference and referral<br>only. MediLab is not<br>intended for diagnostic use on mobile devices.<br><br>Contraindications:<br>MediLab is not intended<br>for the acquisition of<br>mammographic image<br>data and is meant to be<br>used by qualified<br>medical personnel. | |
| DICOM image<br>loading and<br>visualization | Yes | Yes | Yes | No difference |
| Patient search data | Yes | Yes | Yes | No difference |
| User authentication | Yes | Yes | Yes | No difference |
| Rotate/pan/zoom/fit | Yes | Yes | Yes | No difference |
| Image operations | Yes | Yes | Yes | No difference |
| Measurement<br>functions | Line, angle between lines,<br>polyline, area, elliptical<br>area, polygonal area, edit,<br>delete | Yes | Line, angle, area, | Similar to<br>Implanter<br>(subset of<br>measurements) |
| Report Generation | Yes | Yes | Yes | No difference |
| DICOM<br>Windowing | Yes | Yes | Yes | No difference |
| Low Pass Filter | Yes | -- | No | Difference |
| Imaging modalities | CT | PET, CT | US, CT, MRI, XRay,<br>PET | No difference |
| Communications | DICOM | DICOM | DICOM | No difference |
| Operating System | Windows, Linux, Mac | Windows or mac OS<br>with Chrome browser | Windows, Linux, Mac | No difference |
| Browser supported | Edge, Firefox, Chrome | Chrome | Edge, Firefox,<br>Chrome | No difference |
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Image /page/8/Picture/0 description: The image shows the logo for Sigma Scientific. The word "Sigma" is written in a large, gray, sans-serif font. Below "Sigma" is the word "Scientific" in a smaller, blue, sans-serif font. The logo is simple and modern.
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#### Evaluation of similarities and differences:
- . MediLab and ZeeroMED View 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. Medilab has similar performance metrics in terms of accuracy as compared to the reference device IMPLANTER. Medilab has also similar PET/SPECT/ SUV functionality as the aPROMISE X device cleared under K220590.
- Differences between both systems consist in user interface layout, navigation, icon coloring . and overall system presentation. MediLab provides the functionality to export reports to CD. The primary predicate has a low pass filter functionality which Medilab does not offer. Medilab has a subset of measurements compared to the primary predicate devices. These differences do not impact safety or effectiveness of the Medilab system.
#### Conclusion:
The subject device has similar technology characteristics and has similar intended use and functionality as the predicate and reference devices. 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 MediLab system 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, Medilab is substantially equivalent to the predicate that is currently marketed for the same intended use.
