(272 days)
Not Found
Yes
The summary explicitly states "Mentions AI, DNN, or ML: Yes".
No
The device aids physicians in diagnosis by organizing and processing medical images but does not directly provide therapy or treatment.
No
Explanation: The QMENTA Care Platform Family is described as a software medical imaging system designed to receive, organize, store, and display medical images and reports. It integrates "legally marketed applications for clinical use" for image analysis. While it aids physicians who will "base their diagnoses on training and protocols that do not necessarily rely on image maps or image quantifications," the device itself explicitly states it does not directly perform image analysis or provide diagnoses. Instead, it provides a platform for other applications to do so. Therefore, the device itself is an image management and workflow platform, not a diagnostic device.
Yes
The device description explicitly states it is a "software medical imaging system that runs on standard computer hardware" and the performance studies section confirms that it did not require animal testing, biological testing, sterility testing, electrical safety testing or electromagnetic compatibility testing, which are typically associated with hardware components.
Based on the provided information, the QMENTA Care Platform Family is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- QMENTA Care Platform Family Function: The description clearly states that the QMENTA Care Platform Family is a software medical imaging system that processes and analyzes medical images (CT, MR, PET/CT) obtained from imaging modalities. It does not involve the analysis of biological specimens.
- Intended Use: The intended use is to aid physicians in interpreting medical images, not to perform diagnostic tests on biological samples.
- Device Description: The device description focuses on image retrieval, computation of image analysis applications, and report generation based on imaging data.
Therefore, the QMENTA Care Platform Family falls under the category of a medical imaging system, not an In Vitro Diagnostic device.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section explicitly states 'Not Found'.
Intended Use / Indications for Use
QMENTA Care Platform Family is a software medical imaging system used to receive DICOM images and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. QMENTA Care Platform Family consists of two components:
-
A Storage/archiving server for the retrieval of DICOM images from CT and MR modality data, and also PET/CT data from PACS and/or OS-based file storage.
-
A workflow server that allows to integrate legally marketed applications for clinical use into the QMENTA Care Platform Family. The applications are geared toward specific types of image analysis and are marketed with corresponding names.
The results may be saved to a DICOM image file and may be further visualized on an imaging workstation.
QMENTA Care Platform Family is designed to aid suitably qualified physicians, who will base their diagnoses on training and protocols that do not necessarily rely on image maps or image quantifications.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
QMENTA Care Platform Family (QMENTA Care) is a software medical imaging system that runs on standard computer hardware that may compute legally marketed applications for clinical use based on DICOM images captured via MR, CT and PET modalities.
These actions include:
- Retrieval of MR, CT and PET DICOM image studies from PACS and/or OS-based file storage
- . Computation of legally marketed applications for clinical use
- Generation of reports summarizing the computations performed
The resulting output may be provided in a standard DICOM format as additional MR series with possible computed outputs (image overlays, numerical reports, and/or other results) that can be displayed on third-party DICOM workstations and Picture Archive and Communications Systems (PACS).
From a workflow perspective, QMENTA Care can operate as a computing appliance that is capable of supporting DICOM file transfer for input and output of results.
The legally marketed applications for clinical use can be "plugged in" into the QMENTA Care Platform Family. The applications may be geared toward specific types of image analysis and may be marketed with corresponding names.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT, MR, PET/CT
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Suitably qualified physicians / Not Found
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)
All product specifications were verified and validated. Testing was performed according to internal company procedures.
Software testing and validation were conducted according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release. Test results support the conclusion that actual device performance satisfies the design intent.
Verification and validation testing was completed in compliance with the following standards and guidance documents:
- ISO 14971:2012, Medical devices – application of risk management to medical devices
- AAMI ANSI IEC 62304:2006, Medical device software – Software life cycle processes
- . General Principles of Software Validation; Final Guidance for Industry and FDA Staff" (January, 2002)
- . AAMI ANSI IEC 62366:2007, Medical devices – Application of usability engineering to medical devices
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
June 16, 2021
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of this is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Mint Labs, Inc., d/b/a. QMENTA % Paulo Rodrigues CTO, Co-Founder QMENTA Imaging S.L. C/ Roger de Lluria 46, Pral. 1ª 08009 Barcelona. Cataluna 08009 SPAIN
Re: K202718
Trade/Device Name: QMENTA Care Platform Family Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: March 26, 2021 Received: April 1, 2021
Dear Paulo Rodrigues:
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
1
801); 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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202718
Device Name OMENTA Care Platform Family
Indications for Use (Describe)
QMENTA Care Platform Family is a software medical imaging system used to receive DICOM images and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. QMENTA Care Platform Family consists of two components:
-
A Storage/archiving server for the retrieval of DICOM images from CT and MR modality data, and also PET/CT data from PACS and/or OS-based file storage.
-
A workflow server that allows to integrate legally marketed applications for clinical use into the OMENTA Care Platform Family. The applications are geared toward specific types of image analysis and are marketed with corresponding names.
The results may be saved to a DICOM image file and may be further visualized on an imaging workstation.
QMENTA Care Platform Family is designed to aid suitably qualified physicians, who will base their diagnoses on training and protocols that do not necessarily rely on image maps or image quantifications.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image shows the word "QMENTA" in a sans-serif font. The letters are a gradient of teal to blue, with the teal being on the left side of the word and the blue being on the right side. The letters are all capitalized and evenly spaced.
SECTION 5. 510(K) SUMMARY
Submitter:
Mint Labs, Inc., d/b/a. QMENTA One International Place, Suite 3700 Boston, Massachusetts 02110, United States
QMENTA Imaging S.L. C/ Roger de Llúria 46, Pral. 1ª 08009 Barcelona, Spain Phone: +34 933 282 007 Contact Person: Paulo Rodrigues - paulo @qmenta.com Phone: +34 933 282 007 Date prepared: September, 09, 2020
Device:
| Trade/Proprietary Name: | Mint Labs, Inc., d/b/a. QMENTA - QMENTA Imaging S.L. |
|---|---|
| Common Name: | QMENTA CARE PLATFORM FAMILY |
| Classification Name: | Picture archiving and communication systems to |
| medical image management and processing system | |
| 21 CFR 892.2050 | |
| Classification Regulations: | Class II |
| Product Code: | LLZ |
| Review panel: | Radiology |
| Performance standards: | None established under Food Drug and Cosmetic Act |
Predicate device:
The QMENTA Platform Product Family is one product with a predicate. The QMENTA Platform Family is a storage/archiving server for the retrieval of DICOM images from CT and MR modality data, and also PET/CT data from PACS and/or OS-based file storage; and also, a workflow server that may run image processing workflows on image studies. These
4
Image /page/4/Picture/0 description: The image shows the word "QMENTA" in a stylized font. The letters are rounded and have a gradient color scheme, transitioning from a teal color on the left to a blue color on the right. The letters are all capitalized and evenly spaced.
image processing workflows can be different "plugged in" modules from different manufacturers.
Predicate
| Characteristic | Predicate Device | Proposed Device | Explanation of
differences |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Blackford Analysis LTD | Mint Labs, Inc., d/b/a.
QMENTA - QMENTA Imaging
S.L. | - |
| Device Name | Blackford Analysis
Registration Product Family | QMENTA Care Platform
Family | - |
| 510(k)
number | K142337 | N/A | - |
| Device
Classification | Class II | Class II | - |
| Regulation Nº | 892.2050 | 892.2050 | - |
| Product Code | LLZ | LLZ | - |
| Indications for
use: | The Blackford Registration
Product Family consists of
two components:
-
A Workflow Server that
calculates DICOM
registration objects from
CT and MR modality data,
and also PET/CT data via
using the CT data for
registration. -
A localizer tool that
works across studies, or
series in the same study
within a different frame of
reference.
The first intended clinical
use, when reading studies
of the above modalities, is
to aid navigation through,
and comparative
interpretation of a target | QMENTA Care Platform
Family is a software medical
imaging system used to
receive DICOM images and
textual reports, organize
and store them in an
internal format, and to
make that information
available across a network
via web and customized
user interfaces. QMENTA
Care Platform Family
consists of two
components:
- A Storage/archiving
server for the
retrieval of DICOM
images from CT and
MR modality data,
and also PET/CT
data from PACS | The devices are
highly similar in
their indications
for use since they
both focus on the
calculation of
DICOM objects
from CT and MR
modality data, and
also PET/CT data.
Both devices
include a
Workflow Server
component, that
performs the
image processing
operations of the
DICOM objects.
Blackford includes
a localizer tool to
help the user |
| | series with respect to a
source series. Normally,
the source series will be
within a current study and
the target series will be
within a prior study.
However they may also be
within the same study but
have a different frame of
reference. Aiding
navigation may include, but
is not limited to, indicating
corresponding anatomical
locations, synchronized
scrolling, matching
orientations and/or
reference lines in
reformatted series and
fusing two images from
source and target series.
The second clinical use is to
aid presentation of change
between cross-sectional
radiographic studies to
clinical colleagues and
patients.
Registration-aided
interpretation of images
should be carried out by a
suitably qualified physician,
who will base their
diagnoses on training and
protocols that do not
necessarily rely on
registration for navigation | and/or OS-based
file storage.
2. A workflow server
that allows to
integrate legally
marketed
applications for
clinical use into the
QMENTA Care
Platform Family. The
applications are
geared toward
specific types of
image analysis and
are marketed with
corresponding
names.
The results may be saved to
a DICOM image file and may
be further visualized on an
imaging workstation.
QMENTA Care Platform
Family is designed to aid
suitably qualified physicians,
who will base their
diagnoses on training and
protocols that do not
necessarily rely on image
maps or image
quantifications. | navigate through
studies, or series
in the same study.
Similarly, QMENTA
Care provides a
storage and
archiving server
where the user
can navigate
through the
studies or series
within a study. |
| Use Scenario | Registration-aided
interpretation of images
should be carried out by a
suitably qualified physician,
who will base their
diagnoses on training and | QMENTA Care Platform
Family is designed to aid
suitably qualified physicians,
who will base their
diagnoses on training and
protocols that do not | Not a clinically
significant
difference. |
| | protocols that do not
necessarily rely on
registration for navigation. | necessarily rely on image
maps or
quantifications. | Not a clinically
significant
difference. |
| | | | |
| | | | |
| Technological
Characteristics | Multiple applications | Multiple Applications | |
| | Hosts and manages a | Additional legally marketed | |
| | portfolio of Blackford® and | applications for clinical use | |
| | Platform Partner products, | can be "plugged in" into the | |
| | configured and managed | QMENTA Care Platform | |
| | centrally, supporting | Family. The applications are | |
| | automated or triggered | geared toward specific types | |
| | processing of imaging | of image analysis and are | |
| | applications and Al | marketed with | |
| | algorithms. | corresponding names. | |
| | Flexible hosting and cloud | Flexible hosting and cloud | Not a clinically
significant
difference -
hosted using
resources in the
cloud. |
| | deployment | deployment | |
| | Flexible hosting allows | The "plugged in" clinical | |
| | clinical applications to be | applications are hosted on | |
| | locally hosted on VM or | VM or Docker containers. | |
| | Docker containers. Cloud | Studies are routed to | |
| | deployment enables | separate resources in the | |
| | studies to be routed to | cloud, minimizing dataflow. | |
| | separate resource in the | | |
| | cloud, minimizing dataflow | | |
| | Fully DICOM compliant | Fully DICOM compliant | Not a clinically
significant
difference. |
| | DICOM compliant and | DICOM image studies | |
| | integrated with DICOM | retrieved from PACS and/or | |
| | modality worklist to | OS-based file storage. From | |
| | pre-fetch prior studies for | a workflow perspective, | |
| | analysis. | QMENTA Care can operate | |
| | | as a computing appliance | |
| | | that is capable of supporting | |
| | | DICOM file transfer for input | |
| | | and output of results. | |
| | Configurable dataflow | Configurable dataflow | Not a clinically
significant
difference. |
| | Configurable dataflow | QMENTA Care offers | |
| | management offers | configurable dataflow | |
| | multiple adaptable SCPs | management, where image | |
| | that maximize data | studies can be transferred | |
| | ingestion speed, | from multiple SCPs into the | |
| | customizable AE titles for | Storage/Archiving server. | |
| | manual triggering, and | Then images can be | |
| comprehensive
consolidation
multiple sources. | patient automatically processed by
from the configured image
processing applications, and
results can be automatically
transferred back to a third
party DICOM workstation or
PACS.
QMENTA PACS Nexus is a
small application that runs
on a local workstation inside
the hospital network and
automates the task of
exporting images to the
QMENTA Care Platform and
retrieving the results. | | |
| Relevancy Engine
Relevancy engine
determines which studies
to send each clinical
application and collates
descriptor knowledge from
all deployments. It
automates the process of
matching incoming study
information with the
appropriate application,
processes the data, and
ensures results are quickly
sent back to the right
system. | Protocol Adherence Engine
The protocol adherence
engine determines if studies
follow the configured
requirements for a clinical
application, taking into
account description
knowledge and image
parameters available in
DICOM objects, e.g. number
of timepoints, consistent
spacing, etc. | Not a clinically
significant
difference. | |
| Blackford Curated
Marketplace™ provides a
vetted curated marketplace
of regulatory approved
medical imaging analysis
applications and Al
algorithms accessed via
Blackford Platform | QMENTA Software
Development Kit provides
the possibility of integrating
curated legally marketed
third-party applications for
clinical use accessed via
QMENTA Care Platform
Family. | Not a clinically
significant
difference. | |
5
QMENTA
6
Image /page/6/Picture/0 description: The image shows the word "QMENTA" in a sans-serif font. The letters are colored in a gradient, transitioning from a light teal on the left to a light blue on the right. The letters are all lowercase and have rounded edges.
7
Image /page/7/Picture/0 description: The image shows the word "QMENTA" in a sans-serif font. The letters are rounded and have a gradient color scheme, transitioning from a teal color on the left to a blue color on the right. The word is centered and takes up most of the frame.
8
Image /page/8/Picture/0 description: The image shows the word "QMENTA" in a sans-serif font. The letters are a gradient of blue and green, with the left side of the word being green and the right side being blue. The letters are rounded and have a soft, friendly appearance.
Substantial equivalence to the predicate
The subject and predicate device are software programs for the management of multiple imaging applications and Al algorithms, in one system in the cloud.
Both devices provide access to medical imaging analysis and artificial intelligence algorithms incorporated as software packages for use with DICOM objects from CT, MR modalities, and also PET/CT data.
While the subject device's indications for use differ slightly from the predicate device, both devices are intended to simplify the deployment and management of medical imaging applications and Al algorithms.
Both devices are intended for use by radiologists and other clinicians for the purpose of extracting actionable information from radiological medical images.
Device description:
QMENTA Care Platform Family (QMENTA Care) is a software medical imaging system that runs on standard computer hardware that may compute legally marketed applications for clinical use based on DICOM images captured via MR, CT and PET modalities.
These actions include:
- Retrieval of MR, CT and PET DICOM image studies from PACS and/or OS-based file storage
- . Computation of legally marketed applications for clinical use
- Generation of reports summarizing the computations performed
The resulting output may be provided in a standard DICOM format as additional MR series with possible computed outputs (image overlays, numerical reports, and/or other results) that can be displayed on third-party DICOM workstations and Picture Archive and Communications Systems (PACS).
From a workflow perspective, QMENTA Care can operate as a computing appliance that is capable of supporting DICOM file transfer for input and output of results.
The legally marketed applications for clinical use can be "plugged in" into the QMENTA Care Platform Family. The applications may be geared toward specific types of image analysis and may be marketed with corresponding names.
Indications for use
QMENTA Care Platform Family is a software medical imaging system used to receive DICOM images and textual reports, organize and store them in an internal format, and to make that information
9
available across a network via web and customized user interfaces. QMENTA Care Platform Family consists of two components:
-
- A Storage/archiving server for the retrieval of DICOM images from CT and MR modality data, and also PET/CT data from PACS and/or OS-based file storage.
-
- A workflow server that allows to integrate legally marketed applications for clinical use into the QMENTA Care Platform Family. The applications are geared toward specific types of image analysis and are marketed with corresponding names.
The results may be saved to a DICOM image file and may be further visualized on an imaging workstation.
QMENTA Care Platform Family is designed to aid suitably qualified physicians, who will base their diagnoses on training and protocols that do not necessarily rely on image maps or image quantifications.
Performance data
All product specifications were verified and validated. Testing was performed according to internal company procedures.
Software testing and validation were conducted according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release. Test results support the conclusion that actual device performance satisfies the design intent.
Verification and validation testing was completed in compliance with the following standards and guidance documents:
- ISO 14971:2012, Medical devices – application of risk management to medical devices
- AAMI ANSI IEC 62304:2006, Medical device software – Software life cycle processes
- . General Principles of Software Validation; Final Guidance for Industry and FDA Staff" (January, 2002)
- . AAMI ANSI IEC 62366:2007, Medical devices – Application of usability engineering to medical devices
10
The following quality assurance measures were applied to the QMENTA Care Platform Family product:
- Risk Analysis
- Requirements Review
- Design Reviews
- Testing on unit level
- Integration testing
- Performance testing
Results from internal verification and validation testing performed in accordance with QMENTA Imaging design control processes confirm that QMENTA Care Platform Family product specifications have been met. Testing described in this 510(k) consists of verification of all design input requirements and product specifications. All clinical input requirements were validated. Supporting documentation is included in this 510(k) Premarket Notification and supports the claims of substantial equivalence to the predicate device. Cybersecurity is also addressed in this submission. The subject of this submission, QMENTA Care Platform Family, did not require animal testing, biological testing, sterility testing, electrical safety testing or electromagnetic compatibility testing. The subject of this premarket submission, QMENTA Care Platform Family, did not require clinical studies to support substantial equivalence.
The QMENTA Care Platform Family risk analysis was completed and risk control measures were implemented to mitigate unacceptable hazards.
Additionally, usability testing was performed as part of the HFE/Usability Validation process including a minimum of 15 participants. All the participants were selected to reflect the intended use population categories.
Conclusions:
By virtue of its intended use and physical and technological characteristics, QMENTA CARE PLATFORM FAMILY® is substantially equivalent to a device that has been approved for marketing in the United States.
The performance data shows that QMENTA CARE PLATFORM FAMILY® is as safe and effective as the predicate device.