(246 days)
Not Found
Yes
The device description explicitly states that it is "enabled via artificial intelligence algorithms".
No
This device is a post-processing image analysis software that assists clinicians in viewing, manipulating, analyzing and evaluating MR prostate images for US guided MR-US fusion biopsy support. It provides information and analysis to aid in diagnosis and treatment planning, but does not directly deliver therapy or have a therapeutic effect on the patient.
Yes
This device is a post-processing image analysis software that assists clinicians in viewing, manipulating, analyzing, and evaluating MR prostate images for diagnostic purposes, specifically for US guided MR-US fusion biopsy support. It provides information like prostate volume, lesion location and size, and PSA density, all of which contribute to the diagnostic process and treatment planning.
Yes
The device is explicitly described as "cloud-based image processing software" and its functionalities are purely software-based (segmentation, annotation, calculation, export). There is no mention of accompanying hardware that is part of the medical device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: AI-Rad Companion Prostate MR is a software that processes and analyzes medical images (MR prostate images). It assists clinicians in interpreting these images and preparing for a biopsy procedure. It does not perform any tests on biological samples.
- Intended Use: The intended use is to assist in the viewing, manipulation, analysis, and evaluation of MR prostate images for US guided MR-US fusion biopsy support. This is an image-based diagnostic aid, not an in vitro test.
Therefore, AI-Rad Companion Prostate MR falls under the category of medical image analysis software, which is distinct from in vitro diagnostics.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
AI-Rad Companion Prostate MR is a post-processing image analysis software that assists clinicians in viewing, manipulating, analyzing and evaluating MR prostate images for US guided MR-US fusion biopsy support.
AI-Rad Companion Prostate MR provides the following functionalities:
- Automatic segmentation and quantitative analysis of the prostate gland
- Manual annotation of relevant findings
- Presentation and export of results for further processing and reporting
Product codes
QIH, LNH
Device Description
AI-Rad Companion Prostate MR aims to assist the radiologist in the preparation of MR prostate images for targeted biopsies of the prostate gland using MR-Ultrasound fusion biopsy. It allows the radiologist to communicate the location and spatial extent of lesions and the prostate volume in prostate MR images to a urologist in order to help perform biopsies.
AI-Rad Companion Prostate MR is a cloud-based image processing software that provides quantitative and qualitative information based on prostate MR DICOM images. More specifically, it provides information on the prostate volume which can be used to support the planning of prostate biopsies in the case of ultrasound guided MR-US fusion biopsies of the prostate gland. It is enabled via artificial intelligence algorithms and a cloud infrastructure.
The primary features of AI-Rad Companion Prostate MR include:
- Automatic prostate segmentation and volume estimation, with the possibility of manual adjustments
- Manual determination of location and size of lesions in a suitable user interface
- Calculation of the PSA density, based on the input of the PSA value of the patient by the clinical user
- Export in a suitable format for reading and archiving in PACS, as well as in a second format that can be imported by ultrasound systems (e.g. RTStruct), allowing the urologist to perform targeted MR-US fusion biopsy
Mentions image processing
AI-Rad Companion Prostate MR is a post-processing image analysis software that assists clinicians in viewing, manipulating, analyzing and evaluating MR prostate images for US guided MR-US fusion biopsy support.
AI-Rad Companion Prostate MR is a cloud-based image processing software that provides quantitative and qualitative information based on prostate MR DICOM images.
Mentions AI, DNN, or ML
It is enabled via artificial intelligence algorithms and a cloud infrastructure.
Input Imaging Modality
MR prostate images
Anatomical Site
prostate gland
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologist, urologist, clinicians
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
No clinical tests were conducted to test the performance and functionality of the modifications introduced within AI-Rad Companion Prostate MR. 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
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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July 30, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA) along with the Department of Health & Human Services. The FDA logo features a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below. To the left of the FDA logo is the symbol of the Department of Health & Human Services, which consists of a stylized human figure.
Siemens Medical Solutions USA Inc. % Lauren Bentley Senior Manager, Regulatory Affairs 40 Liberty Blvd. Mail Code 65-3 MALVERN PA 19355
Re: K193283
Trade/Device Name: AI-Rad Companion Prostate MR Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: QIH, LNH Dated: July 2, 2020 Received: July 6, 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) K193283
Device Name
AI-Rad Companion Prostate MR
Indications for Use (Describe)
AI-Rad Companion Prostate MR is a post-processing image analysis software that assists clinicians in viewing, manipulating, analyzing and evaluating MR prostate images for US guided MR-US fusion biopsy support.
AI-Rad Companion Prostate MR provides the following functionalities:
- Automatic segmentation and quantitative analysis of the prostate gland
- Manual annotation of relevant findings
Type of Use (Select one or both, as applicable)
- Presentation and export of results for further processing and reporting
| 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/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern.
510(k) SUMMARY FOR AI-RAD COMPANION PROSTATE MR K193283
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 19355 Phone: +1 (610) 241 - 6736 Email: lauren.bentley@siemens-healthineers.com
4
Healt
3. Device Name and Classification
| Product Name: | AI-Rad Companion Prostate MR |
|---|---|
| Trade Name: | AI-Rad Companion Prostate MR |
| Classification Name: | Picture Archiving and Communication System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.2050 |
| Secondary CFR Section: | 21 CFR §892.1000 |
| Device Class: | Class II |
| Product Code: | QIH |
| Secondary Product Code: | LNH |
4. Predicate Device
| Product Name: | syngo.MR Applications |
|---|---|
| Propriety Trade Name: | syngo.MR Applications |
| 510(k) Number: | K180336 |
| Clearance Date: | April 19, 2018 |
| Classification Name: | Magnetic Resonance Diagnostic Device |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.2050 |
| Secondary CFR Section: | 21 CFR §892.1000 |
| Device Class: | Class II |
| Primary Product Code: | LLZ |
| Secondary Product Code: | LNH |
| Recall Information: | N/A |
5. Intended Use
AI-Rad Companion Prostate MR is a post-processing image analysis software that assists clinicians in viewing, manipulating, analyzing and evaluating MR prostate images for biopsy support.
AI-Rad Companion Prostate MR provides the following functionalities:
- Automatic segmentation and quantitative analysis of the prostate gland
- Manual annotation of relevant findings
- . Presentation and export of results for further processing and reporting
6. Device Description
AI-Rad Companion Prostate MR aims to assist the radiologist in the preparation of MR prostate images for targeted biopsies of the prostate gland using MR-Ultrasound fusion biopsy. It allows the radiologist to communicate the location and spatial extent of lesions and the prostate volume in prostate MR images to a urologist in order to help perform biopsies.
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SIEMEN Healthineers
AI-Rad Companion Prostate MR is a cloud-based image processing software that provides quantitative and qualitative information based on prostate MR DICOM images. More specifically, it provides information on the prostate volume which can be used to support the planning of prostate biopsies in the case of ultrasound guided MR-US fusion biopsies of the prostate gland. It is enabled via artificial intelligence algorithms and a cloud infrastructure.
The primary features of AI-Rad Companion Prostate MR include:
- . Automatic prostate segmentation and volume estimation, with the possibility of manual adjustments
- Manual determination of location and size of lesions in a suitable user interface
- Calculation of the PSA density, based on the input of the PSA value of the patient by the clinical user
- . Export in a suitable format for reading and archiving in PACS, as well as in a second format that can be imported by ultrasound systems (e.g. RTStruct), allowing the urologist to perform targeted MR-US fusion biopsy
With current tools, it is challenging for the radiologist to show the urologist the location of the lesions to be biopsied. The radiologist can mark the lesion on the abstract sketch of the biopsy on the PI-RADS report. Based on this information, the urologist can draw the lesion on the MR images within his fusion biopsy planning software, where often information and accuracy are lost. If the radiologist chooses to draw the lesions for the urologist, the options are either to go to the biopsy machine or to a separate workstation provided by the biopsy software to draw the lesions.
As an update to the previously cleared device, the following modifications have been made:
-
- Modified Indications for Use Statement
-
- Automatic prostate segmentation and volume estimation, with the possibility of manual adjustments
-
- Calculation of the PSA density, based on the input of the PSA value of the patient by the clinical user
-
- Export in a suitable format for reading and archiving in PACS, as well as in a second format that can be imported by ultrasound systems (e.g. RTStruct), allowing the urologist to perform targeted MR-US fusion biopsy
-
- Architectural enhancement for the clinical extension to be deployed with the AI-Rad Companion Engine platform in a cloud-based environment
7. Technological Characteristics
The subject device. AI-Rad Companion Prostate MR is substantially equivalent to the predicate device with regards to software, programming languages, operating system, performance and fundamental technology. AI-Rad Companion Prostate MR offers enhancements and improvements to the existing predicate device, syngo.MR Applications SMRVB30A (K180336).
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While these enhancements and improvements offer additional image viewing and evaluation capabilities compared to the predicate device, the conclusions from all verification and validation data suggest that these modifications do not adversely affect the safety and effectiveness of the predicate device.
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Feature | Siemens | ||
| AI-Rad Companion | |||
| Prostate MR | Siemens | ||
| syngo.MR | |||
| Applications | |||
| (K180336) | Comparison Results | ||
| Software | AI-Rad Companion | ||
| Prostate MR | syngo.MR Applications | ||
| with SMRVB30A | Enhanced The subject | ||
| device supports new | |||
| software version | |||
| offering improvements | |||
| and enhancements over | |||
| the predicate | |||
| Organ | |||
| Segmentation & | |||
| Annotation | Automated | ||
| segmentation of the | |||
| prostate gland with the | |||
| possibility of manual | |||
| adjustment and | |||
| annotation | Manual measurements, | ||
| segmentations and | |||
| marks can be made | |||
| within the prostate | Enhanced The subject | ||
| device automates the | |||
| prostate segmentation, | |||
| while still permitting | |||
| manual manipulation | |||
| and annotation | |||
| Image | |||
| Communication | DICOM compatible | ||
| with RTStruct object | DICOM compatible | Enhanced to provide | |
| additional output format | |||
| Configuration | Confirmation UI | syngo.via GUI | Equivalent The subject |
| device has been | |||
| modified to specific | |||
| functionality for the | |||
| Prostate MR extension | |||
| Confirmation | Configuration UI | syngo.via GUI - | |
| configuration | Equivalent The subject | ||
| device has been | |||
| modified to expose | |||
| configuration options of | |||
| existent extensions. | |||
| Architecture | Cloud only solution | ||
| with no components | |||
| deployed on customer | |||
| premise. | Client-server | ||
| architecture where the | |||
| server processes and | |||
| renders the data from | |||
| the connected | |||
| modalities. Client | |||
| provides the UI for | |||
| interactive image | |||
| viewing and processing. | Modified Architecture | ||
| of the clinical extension | |||
| is adapted to AI-Rad | |||
| Companion Engine and | |||
| cloud-based | |||
| deployment. |
A tabular comparison of the subject device is provided in Table 1 below.
Table 1: Predicate Device Comparison Table
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Image /page/7/Picture/0 description: The image shows 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 orange dots arranged in a circular pattern.
8. Nonclinical Tests
Non-clinical tests were conducted to test the functionality of AI-Rad Companion Prostate MR. Software validation and bench testing have been conducted to assess the performance claims as well as the claim of substantial equivalence to the predicate device.
AI-Rad Companion Prostate MR has been tested to meet the requirements of conformity to multiple industry standards. Non-clinical performance testing demonstrated that AI-Rad Companion Prostate MR 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 2 below.
| 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 2: Voluntary 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
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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 tests 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. Software verification and regression testing have been performed successfully to meet their previously determined acceptance criteria as stated in the test plans.
Siemens Healthineers adheres to the cybersecurity requirements as defined the 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 Prostate MR. 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.
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 magnetic resonance images.
11. Substantial Equivalence and Conclusion
AI-Rad Companion Prostate MR version VA20 is substantially equivalent to the follow predicate device (Table3):
| Predicate Device | FDA Clearance
Number | FDA Clearance
Date | Main Product Code |
|-----------------------|-------------------------|-----------------------|-------------------|
| syngo.MR Applications | K180336 | April 19, 2018 | LLZ, LNH |
Table 3: Predicate device for AI-Rad Companion Prostate MR
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Image /page/9/Picture/0 description: The image shows 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 orange dots arranged in a circular pattern.
AI-Rad Companion Prostate MR has the same intended use and basic technical characteristics compared to the predicate device, syngo.MR Applications SMRVB30A (K180336), with respect to the software features and functionalities. While Al-Rad Companion Prostate MR offers enhancements and improvements to the already cleared basic MR workflow and applications, the conclusions from all verification and validation data suggest that the modifications do not adversely impact the safety and effectiveness of the predicate device. The modifications and improvements enhance the user's workflow and reduce the complexity of certain MR imaging procedures. Siemens is of the opinion that AI-Rad Companion Prostate MR is substantially equivalent to the currently marketed device syngo.MR Applications SMRVB30A (K180336).