(226 days)
Yes
The device name "AI-Rad Companion Engine" and the mention of "AI-Rad Companion system" strongly suggest the incorporation of AI technology.
No.
The key words for "therapeutic device" are not found, and the device is used for diagnostic purposes.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the software platform "enables external post-processing extensions for medical images used for diagnostic purposes." Additionally, the "Device Description" mentions that "The engine supports DICOM communication, enabling post-processing extensions for medical images to be used for diagnostic purposes." Therefore, the device is intended to facilitate diagnostic processes.
Yes
The device is explicitly described as a "software platform" and "software engine" that provides visualization and post-processing capabilities for medical images. The description focuses solely on software functionalities and interactions with other systems (PACS, modalities, teamplay) via DICOM standards. There is no mention of accompanying hardware components included with the device itself.
Based on the provided information, the AI-Rad Companion Engine is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use describes the software platform as providing visualization and enabling post-processing of medical images for diagnostic purposes. This focuses on the analysis of in vivo (within the living body) images, not in vitro (outside the living body) samples like blood, urine, or tissue.
- Device Description: The description reinforces that the device receives and processes imaging data from modalities or PACS systems. It facilitates the use of clinical extensions that work with these images.
- Lack of IVD Specifics: There is no mention of analyzing biological samples, performing tests on bodily fluids, or providing results related to the chemical, biological, or immunological state of a patient based on in vitro analysis.
While the software is used for diagnostic purposes, its function is centered around the processing and analysis of medical images, which falls under the category of medical imaging software, not IVD.
No
The clearance letter does not mention that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The section "Control Plan Authorized (PCCP) and relevant text" is listed as "Not Found."
Intended Use / Indications for Use
AI-Rad Companion Engine is a software platform that provides basic visualization and enables external post-processing extensions 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 the means for viewing, storing and transferring data into other systems such as PACS systems.
The software platform also provides an interface to integrate additional Siemens Healthineers' clinical processing extensions.
AI-Rad Companion Engine functionality includes:
- Interface for multi-modality and multi-vendor Input/Output of DICOM data
- Check of data validity using information of 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
Product codes
LLZ
Device Description
AI-Rad Companion Engine, as previously cleared under K183272, has been enhanced in version VA20. AI-Rad Companion Engine still provides the platform for all clinical extensions of the AI Rad Companion system and still falls under the same classification regulation as the predicate device. The engine supports DICOM communication, enabling post-processing extensions for medical images to be used for diagnostic purposes.
AI-Rad Companion Engine will receive the imaging data to be processed either from an imaging modality or via auto-routing from the PACS system or a DICOM gateway. The results of the AIRC Extensions will be sent back to a configurable target node also utilizing DICOM standards. The means of data transfer will be handled by the "teamplay" infrastructure. Teamplay Images is an MDDS product, intended for data transfer, display and online storage of medical images and related data.
As an update to the previously cleared device, the following modifications have been made:
-
- Support of software version VA20:
- a. Support for additional clinical extensions
- b. Modified workflow to increase the usability within AI-Rad Companion as well as with respect to informing the user regarding the status of clinical extensions
-
- Subject device claims list
Mentions image processing
AI-Rad Companion Engine is a software platform that provides basic visualization and enables external post-processing extensions for medical images used for diagnostic purposes.
- Interface for extensions that provide post-processing functionality
- Confirmation user interface for visualization of medical images processed by extensions
AI-Rad Companion Engine still provides the platform for all clinical extensions of the AI Rad Companion system and still falls under the same classification regulation as the predicate device. The engine supports DICOM communication, enabling post-processing extensions for medical images to be used for diagnostic purposes.
The results of the AIRC Extensions will be sent back to a configurable target node also utilizing DICOM standards.
The subject device, AI-Rad Companion Engine with new software version VA20, is substantially equivalent to the predicate device with regard to the indications for use, software, operational environment, programming language, operating system, performance, image visualization, image manipulation, distribution, archiving and extendibility to post-processing applications.
While these enhancements offer usability enhancements and additional access to new post-processing clinical extensions compared to the predicate device, the conclusions from verification and validation data suggest that these modifications maintain an equivalent safety and performance profile to the predicate device.
While the new version offers enhancements and improvements to enable the integration with new post-processing clinical extensions, the same fundamental characteristics such as image visualization and image manipulation are the same as the predicate device.
Mentions AI, DNN, or ML
AI-Rad Companion Engine
Input Imaging Modality
Interface for multi-modality and multi-vendor Input / Output of DICOM Data
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
technicians and trained physicians
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 tests were conducted to test the functionality of AI-Rad Companion Engine version VA20. Software validation and bench testing have been conducted to the performance claims as well as the claim of substantial equivalence to the predicate device.
AI-Rad Companion has been tested to meet the requirements of conformity to multiple industry standards. Non-clinical performance testing demonstrated that AI-Rad Companion complies with the FDA guidance document. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) as well as with the following voluntary FDA recognized Consensus Standards listed in Table 1 below.
Software "bench" testing in the form of Unit, System and Integration, were performed to evaluate the performance and functionality of the new features and software updates. All testable requirements in the Requirement Specifications and the Risk Analysis have been successfully verified and traced in accordance with the Siemens Healthineers DH product development (lifecycle) process. Human factor usability validation is addressed in system testing and usability validation test records. The software verification and regression testing have been performed successfully to meet their previously determined acceptance criteria as stated in the test plans.
No clinical tests were conducted to test the performance and functionality of the modifications introduced within AI-Rad Companion Engine VA20. Verification and validation of the enhancements and improvements have been performed and these modifications have been validated for their intended use. The data from these activities were used to support the subject device and the substantial equivalence argument.
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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Siemens Medical Solutions USA, Inc. % Lauren Bentley Senior Manager, Regulatory Affairs 40 Liberty Blvd. Mail Code 65-3 MALVERN PA 19355
July 10, 2020
Re: K193294
Trade/Device Name: AI-Rad Companion Engine Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: June 26, 2020 Received: June 29, 2020
Dear Lauren Bentley:
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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
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)
K193294
Device Name AI-Rad Companion Engine
Indications for Use (Describe)
AI-Rad Companion Engine is a software platform that provides basic visualization and enables external post-processing extensions 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 the means for viewing, storing and transferring data into other systems such as PACS systems.
The software platform also provides an interface to integrate additional Siemens Healthineers' clinical processing extensions.
AI-Rad Companion Engine functionality includes:
- Interface for multi-modality and multi-vendor Input/Output of DICOM data
- Check of data validity using information of 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
| 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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Image /page/3/Picture/1 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the words is a graphic of orange dots arranged in a pattern.
510(K) SUMMARY FOR AI-RAD COMPANION ENGINE
Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Date Prepared: November 25, 2019
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Devices Act of 1990 and 21 CFR §807.92.
1. Submitter
| Importer/Distributor | Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Mail Code: 65-1A
Malvern, PA 19355
Registration Number: 2240869 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturing Site | Siemens Healthcare GmbH
Henkestrasse 127
Erlangen, Germany 91052
Registration Number: 3002808157 |
2. Contact Person
Lauren Bentley Senior Manager, Regulatory Affairs Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Mail Code: 65-3 Malvern, PA 19335 Phone: +1 (610) 241 - 6736 Email: lauren.bentley@siemens-healthineers.com
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Image /page/4/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern.
3. Device Name and Classification
| Product Name: | AI-Rad Companion Engine |
|---|---|
| Trade Name: | AI-Rad Companion Engine |
| Classification Name: | Picture Archiving and Communication System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | LLZ |
4. Predicate Device
| Product Name: | AI-Rad Companion (Engine) |
|---|---|
| Propriety Trade Name: | AI-Rad Companion (Engine) |
| 510(k) Number: | K183272 |
| Clearance Date: | February 1, 2019 |
| Classification Name: | Picture Archiving and Communication System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Primary Product Code: | LLZ |
| Recall Information: | N/A |
5. Intended Use
AI-Rad Companion Engine is a software platform that provides basic visualization and enables external post-processing extensions 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 also provides an interface to integrate additional Siemens Healthineers' clinical processing extensions.
AI-Rad Companion Engine functionality includes:
- Interface for multi-modality and multi-vendor Input / Output of DICOM Data ●
- Check of data validity using information of 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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Image /page/5/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the words is a graphic of orange dots.
6. Device Description
AI-Rad Companion Engine, as previously cleared under K183272, has been enhanced in version VA20. AI-Rad Companion Engine still provides the platform for all clinical extensions of the AI Rad Companion system and still falls under the same classification regulation as the predicate device. The engine supports DICOM communication, enabling post-processing extensions for medical images to be used for diagnostic purposes.
AI-Rad Companion Engine will receive the imaging data to be processed either from an imaging modality or via auto-routing from the PACS system or a DICOM gateway. The results of the AIRC Extensions will be sent back to a configurable target node also utilizing DICOM standards. The means of data transfer will be handled by the "teamplay" infrastructure. Teamplay Images is an MDDS product, intended for data transfer, display and online storage of medical images and related data.
As an update to the previously cleared device, the following modifications have been made:
-
- Support of software version VA20:
- a. Support for additional clinical extensions
- b. Modified workflow to increase the usability within AI-Rad Companion as well as with respect to informing the user regarding the status of clinical extensions
-
- Subject device claims list
7. Technological Characteristics
The subject device, AI-Rad Companion Engine with new software version VA20, is substantially equivalent to the predicate device with regard to the indications for use, software, operational environment, programming language, operating system, performance, image visualization, image manipulation, distribution, archiving and extendibility to post-processing applications.
AI-Rad Companion Engine VA20 offers enhancements and improvements to the existing predicate device, AI-Rad Companion (Engine) (K183272). While these enhancements offer usability enhancements and additional access to new post-processing clinical extensions compared to the predicate device, the conclusions from verification and validation data suggest that these modifications maintain an equivalent safety and performance profile to the predicate device.
8. Nonclinical Bench Testing
Non-clinical tests were conducted to test the functionality of AI-Rad Companion Engine version VA20. Software validation and bench testing have been conducted to the performance claims as well as the claim of substantial equivalence to the predicate device.
AI-Rad Companion has been tested to meet the requirements of conformity to multiple industry standards. Non-clinical performance testing demonstrated that AI-Rad Companion complies with the FDA guidance document. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) as well as with the following voluntary FDA recognized Consensus Standards listed in Table 1 below.
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Image /page/6/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of several orange dots arranged in a circular pattern.
| Recognition
Number | Product Area | Title of Standard | Reference
Number and
Date | Standards
Development
Organization |
|-----------------------|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|------------------------------------------|
| 5-114 | General | Medical Devices—
Application of usability
engineering to medical
devices [including
Corrigendum 1 (2016)] | 62366-1:
2015-02 | IEC |
| 5-40 | General | Medical Devices—
application of risk
management to medical
devices | 14971:2007 | ISO |
| 13-79 | Software/
Informatics | Medical device software—
software life cycle
processes [Including
Amendment 1 (2016)] | 62304:
2006/A1:2016 | AAMI
ANSI
IEC |
| 12-300 | Radiology | Digital Imaging and
Communications in
Medicine (DICOM) Set | PS 3.1 - 3.20
(2016) | NEMA |
| 12-261 | Radiology | Information Technology—
Digital Compression and
coding of continuous -tone
still images: Requirements
and Guidelines [including:
Technical Corrigendum
1(2005)] | 10918-1
1994-02-15 | ISO
IEC |
Table 1: Voluntarv Conformance Standards
Verification and Validation
Software documentation for a Moderate Level of Concern software, per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the subject device during product development.
Software "bench" testing in the form of Unit, System and Integration, were performed to evaluate the performance and functionality of the new features and software updates. All testable requirements in the Requirement Specifications and the Risk Analysis have been successfully verified and traced in accordance with the Siemens Healthineers DH product development (lifecycle) process. Human factor usability validation is addressed in system testing and usability validation test records. The software verification and regression testing have been performed successfully to meet their previously determined acceptance criteria as stated in the test plans.
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Image /page/7/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in green, and the word "Healthineers" is in orange. To the right of the words is a pattern of orange dots.
Siemens Healthineers adheres to the cybersecurity requirements as defined FDA Guidance "Content of Premarket Submissions for Management for Cybersecurity in Medical Devices," issued October 2, 2014 by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient.
9. Clinical Tests
No clinical tests were conducted to test the performance and functionality of the modifications introduced within AI-Rad Companion Engine VA20. Verification and validation of the enhancements and improvements have been performed and these modifications have been validated for their intended use. The data from these activities were used to support the subject device and the substantial equivalence argument.
No animal testing has been performed on the subject device or its modifications.
10. Safety and Effectiveness
The device labeling contains instructions for use and any necessary cautions and warnings to ensure safe and effective use of the device.
Risk management is ensured via ISO 14971:2007 compliance to identify and provide mitigation of potential hazards in a risk analysis early in the design phase and continuously throughout the development of the product. These risks are controlled via measures realized during software development, testing and product labeling.
Furthermore, the device is intended for healthcare professionals familiar with the post-processing of clinical images.
11. Substantial Equivalence and Conclusion
AI-Rad Companion Engine version VA20 is substantially equivalent to the follow predicate device (Table 2):
| Predicate Device | FDA Clearance
Number | FDA Clearance
Date | Main Product Code |
|------------------------------|-------------------------|-----------------------|-------------------|
| AI-Rad Companion
(Engine) | K183272 | February 1, 2019 | LLZ |
Table 2: Predicate device for AI-Rad Companion Engine VA20
AI-Rad Companion Engine with software version VA20 has the same indications for use and similar technological characteristics compared to the predicate device, AI-Rad Companion (Engine) (K183272). While the new version offers enhancements and improvements to enable the integration with new post-processing clinical extensions, the same fundamental characteristics such as image visualization and image manipulation are the same as the predicate device. The results of all testing conducted was found acceptable to support the claim of substantial equivalence.
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The predicate device was cleared based on non-clinical supportive information including bench testing and software validations. The results of these tests demonstrate that the predicate device is adequate for the intended use. The comparison technological characteristics, non-clinical performance data, and software validation demonstrates that the subject device is as safe and effective when compared to the predicate device that is currently marketed for the same intended use and is therefore substantially equivalent to the predicate device.