(260 days)
Yes
The device description explicitly states that the device "utilizes machine and deep learning algorithms".
No.
This device is image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images, which is not a therapeutic function. It supports clinicians in the evaluation and assessment of disease, but does not directly treat or alleviate a condition.
Yes
The device provides "quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians... in the evaluation and assessment of disease of the lungs," which directly aids in diagnosis.
Yes
The device is explicitly described as "image processing software" and its functionality is solely based on analyzing previously acquired DICOM images. While it mentions integration with other medical devices (syngo.CT Lung CAD and syngo.CT Extended Functionality), its core function is software-based analysis of existing data. The description of the "edge" deployment also focuses on where the software processing occurs, not on the inclusion of new hardware components.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes medical images: The AI-Rad Companion (Pulmonary) processes previously acquired Computed Tomography (CT) DICOM images. It analyzes the images themselves, not biological samples.
The device falls under the category of medical image processing software, which is a different type of medical device than an IVD.
No
The provided text does not explicitly state that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
Al-Rad Companion (Pulmonary) is image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of disease of the lungs.
It provides the following functionality:
· Segmentation and measurements of complete lung and lung lobes
- · Identification of areas with lower Hounsfield values in comparison to a predefined threshold for complete lung and lung lobes
- · Providing an interface to external Medical Device syngo.CT Lung CAD
- · Segmentation and measurements of solid lung nodules
- · Dedication of found lung nodules to corresponding lung lobe
- · Correlation of segmented lung nodules of current scan with known priors and quantitative assessment of changes of the correlated data.
- · Identification of areas with elevated Hounsfield values, where areas with elevated versus high opacities are distinguished.
The software has been validated for data from Siemens (filtered backprojection and iterative reconstruction), GE Healthcare (filtered backprojection reconstruction), and Philips (filtered backprojection reconstruction).
Only DICOM images of adult patients are considered to be valid input.
Product codes
JAK, QIH
Device Description
AI-Rad Companion (Pulmonary) SW version VA20 is an enhancement to the previously cleared device AI-Rad Companion (Pulmonary) K183271 that utilizes machine and deep learning algorithms to provide quantitative and qualitative analysis to computed tomography DICOM images to support qualified clinicians in the evaluation and assessment of disease of the thorax.
As an update to the previously cleared device, the following modifications have been made:
- Modified Indications for Use Statement The indications for use statement was updated to include descriptive text for the lung lesion follow feature.
- Updated Subject Device Claims List The claims list was updated to include claim pertaining to the lung lesion follow up feature.
- Lung Lesion Follow-up Assessment of current and prior lesions This feature provides the possibility to compare currently segmented lung lesions with corresponding priors and changes to the correlated data are assessed quantitatively.
- Pulmonary Density Assessment
This feature provides the possibility to segment opacity regions inside the lung using an AI algorithm. AI-Rad Companion (Pulmonary) counts image voxels inside opacity regions and calculates the percentages of these voxels relative to the total number of voxels per lobe. lung and in total. Afterwards, each of the five lung lobes is assigned a score ranging from 0 to 4 based on the percentage of opacity as follows: 0 (0%), 1 (1%-25%), 2 (26%-50%), 3 (51%-75%), or 4 (76%-100%). Then a summation of the five lobe scores (range of possible scores, 0-20) are generated in the device outputs. This functionality is commercially available on the Siemens syngo.CT Extended Functionality (K203699).
- . Bi-Directional Lesion Diameter
This feature provides an additional measurement derived from the existing segmentation contour of a lung lesion. The existing list of measurements is extended with the maximum orthogonal diameter in 2D (short axis diameter) which is orthogonal to the lesion's maximum 2D diameter (2D diameter, long axis diameter). This functionality is commercially available on the Siemens syngo.CT Extended Functionality (K203699). - . Architecture Enhancement for on premise Edge deployment
- The system supports the existing cloud deployment as well as an on premise "edge" deployment. The system remains hosted in the teamplay digital health platform and remains driven by the AI-Rad Companion Engine. Now the edge deployment implies that the processing of clinical data and the generation of results can be performed onpremises within the customer network. The edge system is fully connected to the cloud for monitoring and maintenance of the system from remote.
Mentions image processing
AI-Rad Companion (Pulmonary) is image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of disease of the lungs.
Mentions AI, DNN, or ML
AI-Rad Companion (Pulmonary) SW version VA20 is an enhancement to the previously cleared device AI-Rad Companion (Pulmonary) K183271 that utilizes machine and deep learning algorithms to provide quantitative and qualitative analysis to computed tomography DICOM images to support qualified clinicians in the evaluation and assessment of disease of the thorax.
This feature provides the possibility to segment opacity regions inside the lung using an AI algorithm.
Input Imaging Modality
Computed Tomography DICOM images
Anatomical Site
lungs, thorax, lung lobes
Indicated Patient Age Range
adult patients
Intended User / Care Setting
radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice
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 (unit, integration and system) were conducted on AI-Rad Companion (Pulmonary) during product development. Additionally, the lesion follow-up feature was validated with a non-clinical bench test to assess the identification of lesion pairs. In an evaluation of 200 cases to identify lesion pairs, the algorithm had a sensitivity of 94.3% and an average PPV of 99.1% across all subgroups.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity of 94.3% and an average PPV of 99.1% across all subgroups.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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August 11, 2022
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 in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
Siemens Healthcare GmBh % Kira Kuzmenchuk Regulatory Affairs Specialist 40 Liberty Blvd. Mail Code 65-1A MALVERN PA 19355
Re: K213713
Trade/Device Name: AI-Rad Companion (Pulmonary) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK, QIH Dated: July 15, 2022 Received: July 18, 2022
Dear Kira Kuzmenchuk:
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 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,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K213713
Device Name AI-Rad Companion (Pulmonary)
Indications for Use (Describe)
Al-Rad Companion (Pulmonary) is image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of disease of the lungs.
It provides the following functionality:
· Segmentation and measurements of complete lung and lung lobes
- · Identification of areas with lower Hounsfield values in comparison to a predefined threshold for complete lung and lung lobes
- · Providing an interface to external Medical Device syngo.CT Lung CAD
- · Segmentation and measurements of solid lung nodules
- · Dedication of found lung nodules to corresponding lung lobe
- · Correlation of segmented lung nodules of current scan with known priors and quantitative assessment of changes of the correlated data.
- · Identification of areas with elevated Hounsfield values, where areas with elevated versus high opacities are distinguished.
The software has been validated for data from Siemens (filtered backprojection and iterative reconstruction), GE Healthcare (filtered backprojection reconstruction), and Philips (filtered backprojection reconstruction).
Only DICOM images of adult patients are considered to be valid input.
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 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.
510(k) SUMMARY FOR AI-RAD COMPANION (Pulmonary) SW version VA20
Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Date Prepared: November 23, 2021
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
Malvern, PA 19355
Mail Code: 65-1A
Registration Number: 2240869 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturing Site | Siemens Healthcare GmbH
Henkestrasse 127
Erlangen, Germany 91052
Registration Number: 3002808157 |
2. Contact Person
Kira Kuzmenchuk Regulatory Affairs Manager Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Mail Code: 65-3 Malvern, PA 19335 Phone: +1 (484) 901 - 9471 Email: kira.kuzmenchuk@siemens-healthineers.com
3. Device Name and Classification
Product Name:
AI-Rad Companion (Pulmonary)
4
| Trade Name: | AI-Rad Companion (Pulmonary) |
|---|---|
| Classification Name: | Computed Tomography X-Ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Secondary CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | JAK |
| Secondary Product Code: | QIH |
4. Predicate Device
| Product Name: | AI-Rad Companion (Pulmonary) |
|---|---|
| Propriety Trade Name: | AI-Rad Companion (Pulmonary) |
| 510(k) Number: | K183271 |
| Clearance Date: | July 26, 2019 |
| Classification Name: | Computed Tomography X-Ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Secondary CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Primary Product Code: | JAK |
| Secondary Product Code: | LLZ |
| Recall Information: | N/A |
5. Indications for Use
AI-Rad Companion (Pulmonary) is image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of disease of the lungs.
It provides the following functionality:
- Segmentation and measurements of complete lung and lung lobes ●
- Identification of areas with lower Hounsfield values in comparison to a ● predefined threshold for complete lung and lung lobes
- Providing an interface to external Medical Device syngo.CT Lung CAD
- Segmentation and measurements of solid lung nodules
- Dedication of found lung nodules to corresponding lung lobe
- Correlation of segmented lung nodules of current scan with known priors and quantitative assessment of changes of the correlated data.
- Identification of areas with elevated Hounsfield values, where areas with elevated versus high opacities are distinguished.
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Image /page/5/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 orange dots arranged in a circular pattern.
The software has been validated for data from Siemens Healthineers (filtered backprojection and iterative reconstruction), GE Healthcare (filtered backprojection reconstruction), and Philips (filtered backprojection reconstruction).
Only DICOM images of adult patients are considered to be valid input.
6. Device Description
AI-Rad Companion (Pulmonary) SW version VA20 is an enhancement to the previously cleared device AI-Rad Companion (Pulmonary) K183271 that utilizes machine and deep learning algorithms to provide quantitative and qualitative analysis to computed tomography DICOM images to support qualified clinicians in the evaluation and assessment of disease of the thorax.
As an update to the previously cleared device, the following modifications have been made:
- Modified Indications for Use Statement The indications for use statement was updated to include descriptive text for the lung lesion follow feature.
- Updated Subject Device Claims List The claims list was updated to include claim pertaining to the lung lesion follow up feature.
- Lung Lesion Follow-up Assessment of current and prior lesions This feature provides the possibility to compare currently segmented lung lesions with corresponding priors and changes to the correlated data are assessed quantitatively.
- Pulmonary Density Assessment
This feature provides the possibility to segment opacity regions inside the lung using an AI algorithm. AI-Rad Companion (Pulmonary) counts image voxels inside opacity regions and calculates the percentages of these voxels relative to the total number of voxels per lobe. lung and in total. Afterwards, each of the five lung lobes is assigned a score ranging from 0 to 4 based on the percentage of opacity as follows: 0 (0%), 1 (1%-25%), 2 (26%-50%), 3 (51%-75%), or 4 (76%-100%). Then a summation of the five lobe scores (range of possible scores, 0-20) are generated in the device outputs. This functionality is commercially available on the Siemens syngo.CT Extended Functionality (K203699).
- . Bi-Directional Lesion Diameter
This feature provides an additional measurement derived from the existing segmentation contour of a lung lesion. The existing list of measurements is extended with the maximum orthogonal diameter in 2D (short axis diameter) which is orthogonal to the lesion's maximum 2D diameter (2D diameter, long axis diameter). This functionality is commercially available on the Siemens syngo.CT Extended Functionality (K203699).
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Image /page/6/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 pattern.
- . Architecture Enhancement for on premise Edge deployment
- The system supports the existing cloud deployment as well as an on premise "edge" deployment. The system remains hosted in the teamplay digital health platform and remains driven by the AI-Rad Companion Engine. Now the edge deployment implies that the processing of clinical data and the generation of results can be performed onpremises within the customer network. The edge system is fully connected to the cloud for monitoring and maintenance of the system from remote.
7. Technological Characteristics
The comparison between the above referenced predicate device are listed at a high-level in the following table.
| Feature | Subject Device
AI-Rad Companion (Pulmonary)
VA20 | Predicate Device
AI-Rad Companion (Pulmonary)
(K183271) |
|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Modality | CT | CT |
| Segmentation
of lungs | Creation of a lung segmentation mask
by combining the segmentation masks
of 5 lung lobes. | Creation of a lung segmentation mask
by combining the segmentation masks
of 5 lung lobes. |
| Segmentation
of lung lobes | Computation of segmentation masks
of the five lung lobes (right upper
(RUL), right middle (RML), right
lower (RLL), left upper (LUL) and
left lower (LLL) lobe) for a given CT
data set of the chest. | Computation of segmentation masks
of the five lung lobes (right upper
(RUL), right middle (RML), right
lower (RLL), left upper (LUL) and
left lower (LLL) lobe) for a given CT
data set of the chest. |
| Parenchyma
evaluation | The parenchyma evaluation uses the
lobe mask, counts all voxels per lobe,
counts image voxels below -950 HU,
and calculates the percentages of
these voxels relative to the total
number of voxels. Additionally, it
sums the individual lobe results and
calculates the percentage for the
complete lung. | The parenchyma evaluation uses the
lobe mask, counts all voxels per lobe,
counts image voxels below -950 HU,
and calculates the percentages of
these voxels relative to the total
number of voxels. Additionally, it
sums the individual lobe results and
calculates the percentage for the
complete lung. |
| Parenchyma
Ranges | The percentages are likewise
dedicated to the 4 ranges. Name of
ranges and their ranges are
configurable by the user. | The percentages are likewise
dedicated to the 4 ranges. Name of
ranges and their ranges are
configurable by the user. |
| Pulmonary
Density | AI-based identification of areas with
elevated Hounsfield values.
Threshold-based identification of
highest elevated Hounsfield values | N/A |
| | inside these elevated regions, by a
predefined threshold of -200 HU | |
| Visualization
of
segmentation
and
parenchyma
results | Color overlay of MPR and VRT with
evaluation results | Color overlay of MPR and VRT with
evaluation results |
| Interface to
LungCAD | Interface to syngo.CT LungCAD | Interface to syngo.CT LungCAD |
| Lesion
segmentation | Segmentation of lung lesions
including the following data:
• Relative change of maximum
2D diameter [%]
• relative change of maximum
orthogonal 2D diameter [%]
• relative change of mean 2D
diameter [%],
• relative change of maximum
3D diameter [%]
• Relative change of volume
(volume doubling time [d],
negative growth [%]) | Segmentation of lung lesions with the
following data (not shown to the
user):
• Relative change of maximum
2D diameter [%]
• relative change of maximum
orthogonal 2D diameter [%]
• relative change of mean 2D
diameter [%],
• relative change of maximum
3D diameter [%]
• Relative change of volume
(volume doubling time [d],
negative growth [%]) |
| Visualization
of lesion
segmentation
results | Color overlay of MPR and VRT with
evaluation | Color overlay of MPR and VRT with
evaluation |
| Lesion
follow-up | Correlation of segmented lung lesions
with known priors using the data from
the lesion segmentation. | N/A |
| Deployment | Cloud and Edge (on-premise)
deployments | Cloud deployment |
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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.
Table 1: Technological Comparisons
8. Nonclinical Tests
Non-clinical tests were conducted to test the functionality of AI-Rad Companion (Pulmonary). 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 has been tested to meet the requirements of conformity to multiple industry standards. Non-clinical performance testing demonstrates that AI-Rad Companion (Pulmonary)
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Image /page/8/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 orange dots.
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.
| 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 |
| 5-125 | General | Medical Devices – application
of risk management to medical
devices | 14971:2019 | 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. Nonclinical tests were conducted on the subject device during product development.
Non-clinical tests (unit, integration and system) were conducted on AI-Rad Companion (Pulmonary) during product development. Additionally, the lesion follow-up feature was validated with a non-clinical bench test to assess the identification of lesion pairs. In an evaluation of 200 cases to identify lesion pairs, the algorithm had a sensitivity of 94.3% and an average PPV of 99.1% across all subgroups.
Siemens Healthineers adheres to the cybersecurity requirements as defined the FDA Guidance "Content of Premarket Submission for Management of Cybersecurity in Medical Devices:
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Image /page/9/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" are several orange dots.
Guidance for Industry and Food and Drug Administration Staff" (October 18, 2018) 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 (Pulmonary). 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 14971:2019 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 (Pulmonary) is substantially equivalent to the follow predicate device (Table 2):
| Predicate Device | FDA Clearance
Number | FDA Clearance
Date | Main Product Code |
|---------------------------------|-------------------------|-----------------------|-------------------|
| AI-Rad Companion
(Pulmonary) | K183271 | July 26, 2019 | JAK |
Table 2: Predicate device for AI-Rad Companion (Pulmonary)
AI-Rad Companion (Pulmonary) has the same intended use and technical characteristics compared to the predicate device. AI-Rad Companion (Pulmonary) [K183271], with respect to the software features, functionalities and core algorithms. The enhancements and improvements provided in AI-Rad Companion (Pulmonary) increase the clinical utility and reduce the complexity of the imaging workflow for the clinical user. The conclusions from all verification and validation data suggest that these enhancements are equivalent with respect to safety and effectiveness of the predicate device. These modifications do not change the intended use of the product. Siemens is of the opinion that AI-Rad Companion (Pulmonary) is substantially equivalent to the currently marketed predicate device.