(73 days)
Not Found
Yes
The device name "Quantib AI Node" and the mention of "AI-Rad Companion" as a predicate device strongly suggest the use of AI/ML technology, even though the description focuses on the platform's capabilities rather than the specific algorithms.
No
This device is a software platform for visualization, analysis, and reporting of medical image data, not a therapeutic device designed to treat or alleviate a medical condition.
No
The "Intended Use / Indications for Use" states that the software platform "provides visualization tools and enables external postprocessing extensions for medical images" and "is designed to support in qualitative and quantitative measurement, analysis, and reporting of clinical data." It does not explicitly state that the device is used to diagnose a disease or condition. While it aids in analysis and reporting, which can contribute to diagnosis, it is broadly described as a tool for data handling and visualization rather than a direct diagnostic instrument.
Yes
The device is explicitly described as a "stand-alone software platform" and its functionalities are entirely software-based, focusing on data processing, visualization, and interfacing with other systems. There is no mention of accompanying hardware components.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
- Quantib AI Node's Function: The description clearly states that Quantib AI Node is a software platform for processing and visualizing medical images. It works with data like DICOM images, which are generated by imaging modalities (like MRI, CT, X-ray). This is image analysis, not analysis of biological samples.
- Intended Use: The intended use focuses on qualitative and quantitative measurement, analysis, and reporting of clinical data derived from images, not from biological samples.
- Device Description: The description reinforces that it's a software platform for processing medical images and integrating with systems like PACS.
While the software uses AI and processes clinical data, the nature of the data it processes (medical images) and its function (image analysis and visualization) place it outside the scope of In Vitro Diagnostics. It falls under the category of medical image analysis software.
No
The clearance letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The "Control Plan Authorized (PCCP) and relevant text" section explicitly states "Not Found", which falls under the "No" condition in the Key Decision Rules.
Intended Use / Indications for Use
Quantib AI Node is a software platform that provides visualization tools and enables external postprocessing extensions for medical images.
The software platform is designed to support in qualitative and quantitative measurement, analysis, and reporting of clinical data.
The software platform provides means for storing of data and transferring data from and into other systems such as PACS. The software platform provides an interface to integrate processing extensions and custom input/output modules.
Quantib AI Node functionality includes:
- · Interface for multi-modality and multi-vendor input/output of data, such as DICOM data
- · Initiation of extensions to process the data based on properties of the data
- · Interface for extensions that provide custom data import/output, post-processing, and user interface functionality
- · User interface for visualization and annotation of medical images, and for correction and confirmation of results generated by post-processing extensions
Quantib AI Node is intended to be used by trained medical professionals.
Product codes
LLZ
Device Description
Quantib Al Node (QBX) is a stand-alone software platform that enables external post-processing extensions for medical images and provides visualization and annotation tools. It can automatically process data received via a DICOM connection and automatically export results to external DICOM nodes. It allows for configuring workflows that can contain user-interaction steps to review and correct automatic results.
Mentions image processing
Yes
Mentions AI, DNN, or ML
No
Input Imaging Modality
Multi-modality, multi-vendor, DICOM data
Anatomical Site
Any
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained medical professionals / Hospital
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)
Bench testing is done to show that the system is suitable for its intended use and that the measurement tool performance meets its pre-defined requirements. This did not reveal any issues with the system, demonstrating that the performance of Quantib Al Node is as safe and effective as its predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
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June 15, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue.
Quantib BV % Mrs. Floor van Leeuwen Quality and Regulatory Manager Westblaak 106 Rotterdam, Zuid-Holland 3012 KM THE NETHERLANDS
Re: K200899
Trade/Device Name: Quantib AI Node Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: March 31, 2020 Received: April 3, 2020
Dear Mrs. van Leeuwen:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 mediation-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
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Indications for Use
510(k) Number (if known) K200899
Device Name Quantib AI Node
Indications for Use (Describe)
Quantib AI Node is a software platform that provides visualization tools and enables external postprocessing extensions for medical images.
The software platform is designed to support in qualitative and quantitative measurement, analysis, and reporting of clinical data.
The software platform provides means for storing of data and transferring data from and into other systems such as PACS. The software platform provides an interface to integrate processing extensions and custom input/output modules.
Quantib AI Node functionality includes:
- · Interface for multi-modality and multi-vendor input/output of data, such as DICOM data
- · Initiation of extensions to process the data based on properties of the data
- · Interface for extensions that provide custom data import/output, post-processing, and user interface functionality
- · User interface for visualization and annotation of medical images, and for correction and confirmation of results generated by post-processing extensions
Quantib AI Node is intended to be used by trained medical professionals.
| 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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Quantib Al Node 510(k) Summary
Image /page/3/Picture/1 description: The image shows the logo for Quantib. The logo consists of a blue icon on the left and the word "Quantib" in blue on the right. The icon is a stylized representation of interconnected nodes, with a combination of light blue and dark blue circles connected by lines. The word "Quantib" is written in a sans-serif font.
SUBMITTER 1
Quantib B.V. Westblaak 106 3012 KM Rotterdam, The Netherlands Phone: (+31) 108 41 17 49 Contact Person: Floor van Leeuwen, Quality & Regulatory Manager, Quality@Quantib.com Date Prepared: March 31st, 2020
2 Device Information
Name of Device: Quantib Al Node Common or Usual Name: Quantib Al Node Requlation Description: Picture archiving and communication system Product Code: LLZ Regulation number: 892.2050 Device Class: II
3 Predicate devices
Primary
Device: Al-Rad Companion Manufacturer: Siemens 510(k) Reg. No: K183272 This predicate has not been subject to a design-related recall. Device Class: II Product Code: LLZ
Secondary
Device: IntelliSpace Portal Platform Manufacturer: Philips 510(k) Reg. No: K162025 This predicate has not been subject to a design-related recall. Device Class: II Product Code: LLZ
4
4 Device description
Quantib Al Node (QBX) is a stand-alone software platform that enables external post-processing extensions for medical images and provides visualization and annotation tools. It can automatically process data received via a DICOM connection and automatically export results to external DICOM nodes. It allows for configuring workflows that can contain user-interaction steps to review and correct automatic results.
5 Indications for Use
Indications for use Quantib Al Node
Quantib Al Node is a software platform that provides visualization and annotation tools and enables external post-processing extensions for medical images.
The software platform is designed to support in qualitative and quantitative measurement, analysis, and reporting of clinical data.
The software platform provides means for storing of data and transferring data from and into other systems such as PACS. The software platform provides an interface to integrate processing extensions and custom input/output modules.
Quantib Al Node functionality includes:
- . Interface for multi-modality and multi-vendor input/output of data, such as DICOM data
- . Initiation of extensions to process the data based on properties of the data
- . Interface for extensions that provide custom data import/output, post-processing, and user interface functionality
- . User interface for visualization and annotation of medical images, and for correction and confirmation of results generated by post-processing extensions
Quantib Al Node is intended to be used by trained medical professionals.
Indications for use primary predicate device
Al-Rad Companion (Engine) is a software platform that provides basic visualization and enables external post-processing extension for medical images used for diagnostic purposes. The software platform is designed to support technicians and trained physicians in qualitative and quantitative measurement and analysis of clinical data. The software platform provides means for storing of data and for transferring data into other systems such as PACS systems. The software platform provides an interface to integrate processing extensions.
Al-Rad Companion (Engine) functionality includes:
- Interface for multi-modality and multi-vendor Input / Output of DICOM Data
- · Check of data validity using information for DICOM tags
- · Interface for extensions that provide post-processing functionality
- · Confirmation user interface for visualization of medical images processed by extensions
- · Configuration user interface for configuration of the medical device and extensions
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Indications for use secondary predicate device
Philips IntelliSpace Portal Platform is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network.
The system allows networking, selection, processing and filming of multimodality DICOM images.
This software is for use with off-the-shelf PC computer technology that meets defined minimum specifications.
Philips IntelliSpace Portal Platform is intended to be used by trained professionals, including but not limited to physicians and medical technicians.
This medical device is not to be used for mammography.
The device is not intended for diagnosis of lossy compressed images.
Indications for use comparison
Quantib Al Node includes functionality that can initiate extensions to process data based on its properties. Al-Rad Companion (Engine) includes similar functionality. In Quantib Al Node, processing is initiated by DICOM tag checks and future processing extensions can do final DICOM tag checks for data validity. This is equivalent to the check on validity using DICOM tags that Al-Rad Companion (Engine) does.
Quantib Al Node only supports input and output of DICOM data, but also provides an interface to extend import/output functionality to other data types. This functionality is subject to bench testing (verification and validation). As processing of the data is equal for all input/output data formats, this functionality does not raise any questions on the effectiveness and safety of the device compared to its predicates.
Quantib Al Node provides an interface to extend the system with user interaction steps that can be developed in the context of future applications built on top of Quantib Al Node. This is also available in Al Rad Companion (Engine).
Quantib Al Node by default contains functionality to not only confirm results (such as in Al-Rad Companion (Engine)), but also to correct these results with common editing tools and to make annotations, such as ruler measurements and comments. This functionality is equivalent to that of the secondary predicate device, IntelliSpace Portal Platform.
Quantib Al Node provides functionality to report created annotations which is also part of the predicate devices.
Based on this comparison between the indications for use of Quantib Al Node and its predicate devices, we conclude that the intended use of these devices is equivalent.
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မ Comparison of technological characteristics
| Comparison | Quantib Al Node | Siemens Al-Rad Companion
(Engine) | Philips IntelliSpace Portal
Platform | |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| | | Primary predicate device
K183272 | Secondary predicate device
K162025 | |
| Target users | Trained medical
professionals | Trained medical
professionals | Trained medical
professionals | Equivalent |
| Anatomical site | Any | Any | Any | Equivalent |
| Where used | Hospital | Hospital | Hospital | Equivalent |
| Human factors | User can approve or
reject results | User interface confirmation | User can approve or reject
results | Equivalent -
2nd predicate |
| | User can create and
update ROIs | Not supported | User can create, save and
load ROIs | |
| | User can add and
update annotations to
analysis | Not supported | User can create image
annotations | |
| Design | Platform with an
interface for extensions
that provide custom
data import/output,
post-processing, and
user interface
functionality | Platform with an interface for
extensions that provide post-
processing functionality | Platform that allows multiple
users to remotely access
clinical applications from
compatible computers on a
network. | Equivalent |
| Performance
data | | | | |
| Non-clinical
Performance | Bench testing
performed to test the
functionality of the
system and
measurement tools. | Bench testing performed to
test the functionality of the
system. | Bench testing performed to
test the functionality of the
system. | Equivalent |
| Standards
met | • ISO 14971
• IEC 62304
• IEC 62366 | • ISO 14971
• IEC 62304
• IEC 62366 | • ISO 14971
• IEC 62304 | Equivalent -
1st predicate |
| SW
verification
and validation | Tested in accordance
with verification and
validation processes
and planning. The
testing results support
that all the system
requirements have met
their acceptance criteria
and are adequate for its
intended use. | The testing results support
that all the software
specifications have met the
acceptance criteria. Testing
for verification and validation
for the device was found
acceptable to support the
claims of substantial
equivalence. | The system was tested in
accordance with verification
and validation processes The
system meets the
acceptance criteria and is
adequate for its intended
use. | Equivalent |
| Compatibility
with
environment
and other
devices | Conformance to NEMA
PS 3.1-3.20 (2016)
DICOM set. DICOM
conformance statement
included. | DICOM compatible | DICOM compatible | Equivalent |
| Reported
measures | | | | |
| Ruler tool | Available | Unknown | Unknown, but angle | Partially |
| | | | measurement tool available | equivalent |
| ROI Volume Available | Available | Available | Available | Equivalent |
| Required input | DICOM compatible data | DICOM compatible data | DICOM compatible data | Equivalent |
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For some of the technological characteristics compared above a more detailed description on their equivalency follows:
- . Human factor engineering: The user workflow and user interaction functionalities of Quantib Al Node are partially equivalent to the primary predicate device and equivalent to the secondary predicate device. The user can confirm results in both Quantib AI Node and Al-Rad Companion (Engine). Annotation functionality, such as creating and updating ROIs and adding comments to the analysis, is equivalent to IntelliSpace Portal Platform.
- . Design: The system design of Quantib Al Node is equivalent to both predicate devices. They all encompass a platform that can import (DICOM) data, perform automatic postprocessing, provide the user with confirmation and annotation functionality, and export the resulting (DICOM) data.
- . Reported measures: Quantib Al Node supports two types of standard measurements: a ruler/distance measurement tool and the ROI volume. The ROI volume measurement of Quantib Al Node is equal to the ROI measurement provided by both predicate devices. IntelliSpace Portal Platform contains an angle tool which is also a geometrical measurement tool in the same category of measurement functionality. The difference between the ruler/distance tool and the angle tool does not impact the safety and effectiveness of the device.
7 Performance data
7.1 STANDARDS MET
Quantib Al Node was designed in compliance with the following US recognized consensus standards:
- ANSI AAMI ISO 14971:2007/(R)2010 Medical devices Application of risk . management to medical devices
- . ANSI AAMI IEC 62304:2006/A1:2016 – Medical device software – Software life cycle processes
- ANSI AAMI IEC 62366-1:2015 Medical devices- applications of usability engineering to ● medical devices
7.2 VERIFICATION AND VALIDATION ACTIVITIES
Quantib Al node has been tested in accordance with Quantib verification and validation processes and plan, addressing intended use, product claims, requirement specifications and risk management results. The testing results support that all the system requirements have met their pre-defined acceptance criteria.
The following quality assurance measures were applied to Quantib Al Node development:
- . Risk and hazard analysis
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- Design reviews ●
- Unit level testing
- Integration testing ●
- System testing ●
- Performance testing ●
- . Usability engineering
- Cybersecurity analysis .
7.3 NON-CLINICAL PERFORMANCE TESTING
Bench testing is done to show that the system is suitable for its intended use and that the measurement tool performance meets its pre-defined requirements. This did not reveal any issues with the system, demonstrating that the performance of Quantib Al Node is as safe and effective as its predicate devices.
7.4 SAFETY IMPLICATIONS
The differences between Quantib Al Node and the predicate devices do not affect the safety of the device compared to its predicates. This conclusion is based on:
- . Failure mode and effects analysis on all functionality.
- . Risk category classification of all software components.
Quantib Al Node and the predicate devices are all intended to support trained medical professionals in qualitative and quantitative measurement, analysis, and reporting of clinical data. The software does not make diagnoses; it provides a platform to support extensions that may present automatic measurements that must be interpreted by a trained medical professional before using them. Quantib Al Node and its predicates are all software applications running on off-the-shelve hardware; they do not have hardware components nor are they designed to provide a physical output to the user/patient. In conclusion, Quantib Al Node does not introduce any new safety issues compared to its predicates.
8 CONCLUSIONS
By virtue of its intended use, design features, and technological characteristics, Quantib Al Node is substantially equivalent to a device that has been approved for marketing in the United States. The non-clinical performance data in this 510(k) premarket notification shows that Quantib Al Node is as safe and effective as the predicate devices without raising any new safety and/or effectiveness concerns.