Who is the manufacturer of Qmenta Care Platform Family?

Mint Labs, Inc., D/B/A. Qmenta filed the 510(k) submission for Qmenta Care Platform Family (K202718).

What is the FDA product code for Qmenta Care Platform Family?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Qmenta Care Platform Family?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Qmenta Care Platform Family?

Blackford Analysis Registration Product Family (K142337).

Who can help prepare an FDA 510(k) submission like Qmenta Care Platform Family?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Qmenta Care Platform Family

K202718 · Mint Labs, Inc., D/B/A. Qmenta · LLZ · Jun 16, 2021 · Radiology

Device Facts

Record ID	K202718
Device Name	Qmenta Care Platform Family
Applicant	Mint Labs, Inc., D/B/A. Qmenta
Product Code	LLZ · Radiology
Decision Date	Jun 16, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended 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: 1. 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. 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.

Device Story

Software medical imaging system; receives DICOM images/reports from CT, MR, PET/CT modalities via PACS or file storage; acts as storage/archiving and workflow server; integrates third-party clinical image analysis applications; outputs results as DICOM files (images, overlays, numerical reports) for visualization on workstations; used in clinical settings by radiologists/physicians; aids diagnosis by providing processed image data; benefits patient through streamlined access to advanced analysis tools.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation testing performed per internal procedures and standards (ISO 14971, IEC 62304, IEC 62366). Usability testing conducted with 15 participants representing intended user population.

Technological Characteristics

Software-based medical imaging system; runs on standard computer hardware; utilizes VM or Docker containers for application hosting; cloud-deployed; fully DICOM compliant; supports DICOM file transfer; integrates third-party clinical applications; cybersecurity controls implemented.

Indications for Use

Indicated for use by qualified physicians to aid in the management, storage, and retrieval of DICOM medical images (CT, MR, PET/CT) and to integrate third-party clinical image analysis applications into a workflow server for diagnostic support.

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

Blackford Analysis Registration Product Family (K142337)

Related Devices

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K063294 — TOPACS · Radiological Specialists, Inc. · Jan 24, 2007
K241223 — eRAD PACS · Erad, Inc. · Oct 31, 2024
K032533 — INTELEPACS · Intelerad Medical Systems, Inc. · Oct 16, 2003
K042507 — UBIPACS · Icm Co., Ltd. · Sep 27, 2004

Submission Summary (Full Text)

{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: 1. 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. 2. 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) | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | 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 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: 1. 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. 2. 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: 1. 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. |…