(59 days)
No
The document describes a standard DICOM image viewer and management system with image processing capabilities, but there is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML devices.
No
The device is described as a "diagnostic and analysis tool" and a "DICOM medical image viewer" used for displaying and managing diagnostic images. It is not intended to treat or prevent a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "MediLab is intended for use as a diagnostic and analysis tool for diagnostic images." Additionally, "MediLab displays and manages diagnostic quality DICOM images." While it has limitations (e.g., not for mammography or mobile devices), its core intended use is diagnostic.
Yes
The device description explicitly states it is a "server-based solution" that connects to PACS and displays images via a web-browser "without installing client software," indicating it is primarily a software system for viewing and managing images. While it interacts with hardware (client machines, servers, PACS), the core medical device functionality described is software-based image viewing and manipulation.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic) in the broader sense of being a medical device used for diagnostic purposes, but it's specifically an in-vivo diagnostic imaging device, not a traditional IVD that analyzes biological samples.
Here's why:
- Intended Use: The intended use clearly states it's a "diagnostic and analysis tool for diagnostic images." It's used by radiologists and other medical professionals to interpret medical images for diagnosis.
- Device Description: It's a "DICOM medical image viewer" that allows reviewing, manipulating, and visualizing medical image data. This is the core function of a diagnostic imaging device.
- Input Imaging Modality: It handles various imaging modalities like US, CT, MRI, XRay, and PET, which are all used for in-vivo diagnostic imaging.
- Intended User: Radiologists and other medical professionals are the intended users, consistent with a diagnostic imaging device.
- Performance Studies: The performance studies focus on measurement accuracy on images, which is relevant to the diagnostic interpretation of those images.
- Predicate and Reference Devices: The predicate and reference devices are also medical image viewing and planning software, further supporting its classification as a diagnostic imaging device.
Why it's not a traditional IVD:
Traditional IVDs analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information. MediLab analyzes images of the body, which are generated through in-vivo imaging techniques.
In summary:
MediLab is a medical device used for in-vivo diagnostic imaging. While it falls under the umbrella of devices used for diagnosis, it's distinct from traditional in-vitro diagnostic devices that analyze biological samples. The term "IVD" is often used more specifically for the latter. However, in the context of regulatory classifications, devices like MediLab are considered medical devices with a diagnostic intended use.
N/A
Intended Use / 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 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.
Product codes
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
US, CT, MRI, XRay, PET
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ZeeroMED View, K200546
Reference Device(s)
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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo 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.
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
1
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
2
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)
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
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
7737 N UNIVERSITY DRIVE, SUITE 101
TAMARAC, FL 33321 |
|------------------|------------------------------------------------------------------------------------------|
| Contact: | Jorge Millan, PhD
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 |
4
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
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.
5
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:
6
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
to Predicate |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| K# | K200546 | K221065 | N/A |
| Intended Use | ZeeroMED View 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.
ZeeroMED
View displays and manages
diagnostic quality
DICOM
images. ZeeroMED View is
not intended for diagnostic use
mammography
with
images. Usage for
mammography is for reference
and referral only. ZeeroMED
View is not intended for
diagnostic
use
mobile
devices.
Contraindications:
The
ZeeroMED
View
is
not
intended for the acquisition of
mammographic image data
and is meant to be used by
qualified medical personnel. | The 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 a
manages
diagnostic quality DICOM
images. MediLab is not
intended for diagnostic use
mammography
with
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. | Similar |
| Mammographic use | No | No | No difference |
| DICOM image loading and
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
Rotate left, right
Reset
Magnification
Scroll
Layout 1x1 -3x3
Thumbnails left, right, top,
bottom | Flip horizontal, vertical
Rotate left, right
Clear transform
Magnification
Scroll
Layout 1x1 -3x3
Thumbnails left, right,
top, bottom | No difference |
SECTION 9
Page 4 of 7
7
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
Volumetric rendering | PET Fusion
Volumetric rendering | |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------|------------------------------------|--------------------------------------------------------|
| Measurement functions | Line, angle between lines,
polyline, area, elliptical
area, polygonal area, edit,
delete | Line, angle, area, | Medilab has a
subset of
measurement
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,
PET | No difference |
| Communications | DICOM | DICOM | No difference |
| Operating System for
Diagnostic Viewing | Windows, Linux, Mac | Windows, Linux, Mac | No difference |
| Browser supported | Edge, Firefox, Chrome | Edge, Firefox, Chrome | No difference |
| Mobile Device Support for
Viewing | No | No | No difference |
| Transfer/Storage/Display of
Medical images | Yes | Yes | No difference |
| Network access | Connects to existing PACS | Connects to existing
PACS | No difference |
Product comparison to reference predicate devices
| Feature | IMPLANTER
DENTAL PLANNING
SOFTWARE | aPROMISE X | MEDILAB | Comparison
to predicates |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| K# | K173083 | K220590 | K221065 | N/A |
| Intended Use | Implanter Dental Planning
Software is a prescription
use software used by dentist
and dental lab technicians
for the visualization and
image segmentation of
DICOM data from medical
scanners such as CT. The
software aids the users in | aPROMISE is intended
to be used by healthcare
professionals and
researchers for
acceptance,
transfer, storage, image
display, manipulation,
quantification and
reporting of digital | The 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 | Similar
to
K220590 |
| | | | | |
| | the creation of 3D models
of oral maxillofacial region
and in planning dental
surgical treatments and
placement of dental
implants | medical images. The
system is intended to be
used with images
acquired using nuclear
medicine (NM) imaging,
using PSMA PET/CT.
The device provides
general Picture
Archiving an
Communications System
(PACS) tools as well as a
clinical application for
oncology including
marking of regions of
interest and quantitative
analysis. | 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. | |
| DICOM image
loading and
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
functions | Line, angle between lines,
polyline, area, elliptical
area, polygonal area, edit,
delete | Yes | Line, angle, area, | Similar to
Implanter
(subset of
measurements) |
| Report Generation | Yes | Yes | Yes | No difference |
| DICOM
Windowing | Yes | Yes | Yes | No difference |
| Low Pass Filter | Yes | -- | No | Difference |
| Imaging modalities | CT | PET, CT | US, CT, MRI, XRay,
PET | No difference |
| Communications | DICOM | DICOM | DICOM | No difference |
| Operating System | Windows, Linux, Mac | Windows or mac OS
with Chrome browser | Windows, Linux, Mac | No difference |
| Browser supported | Edge, Firefox, Chrome | Chrome | Edge, Firefox,
Chrome | No difference |
SECTION 9
8
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.
9
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.