(86 days)
Yes
The document explicitly mentions the use of "Convolutional Networks (CNN)" and "CNN-based classifier," which are types of deep learning models, a subset of machine learning.
No
The device is a computer-aided detection (CAD) tool designed to assist radiologists in the detection of pulmonary nodules. It does not directly provide therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is a "computer-aided detection (CAD) tool designed to assist radiologists in the detection of solid and subsolid pulmonary nodules" and is an "adjunctive tool to alert the radiologist to regions of interest (ROI) that may be otherwise overlooked." This indicates its role in assisting with diagnosis.
Yes
The device is described as a software algorithm that processes images and sends data to a separate visualization application. It explicitly states it does not have its own user interface component for displaying marks, relying on a "Hosting Application" or "visualization application" for this function. This indicates it is a software component designed to be integrated into a larger system, not a standalone hardware device or a system that includes dedicated hardware.
Based on the provided information, 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 syngo.CT Lung CAD device processes medical images (CT scans) to assist in the detection of pulmonary nodules. It does not interact with or analyze biological samples.
The device is clearly described as a software tool that processes imaging data to aid radiologists in their interpretation of CT scans. This falls under the category of medical image analysis software, not In Vitro Diagnostics.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section explicitly states 'Not Found'.
Intended Use / Indications for Use
syngo.CT Lung CAD device is a computer-aided detection (CAD) tool designed to assist radiologists in the detection of solid and subsolid pulmonary nodules during review of multi-detector computed tomography (MDCT) from multivendor examinations of the chest. The software is an adjunctive tool to alert the radiologist to regions of interest (ROI) that may be otherwise overlooked.
The syngo.CT Lung CAD device may be used as a concurrent first reader followed by a full review of the case by the radiologist or as second reader after the radiologist has completed his/her initial read.
The syngo.CT Lung CAD device may also be used in "solid-only" mode, where potential (or suspected) sub-solid and/or fully calcified CAD findings are filtered out.
The software device is an algorithm which does not have its own user interface component for displaying of CAD marks. The Hosting Application incorporating syngo. CT Lung CAD is responsible for implementing a user interface.
Product codes
OEB
Device Description
Siemens Healthcare GmbH intends to market the syngo.CT Lung CAD which is a medical device that is designed to perform CAD processing in thoracic CT examinations for the detection of solid pulmonary nodules (between 3.0 mm and 30.0mm) and subsolid nodules (between 5.0 mm and 30.0mm) in average diameter. The device processes images acquired with multi-detector CT scanners with 16 or more detector rows recommended.
The syngo.CT Lung CAD device supports the full range of nodule locations (central, peripheral) and contours (round, irregular).
The syngo.CT Lung CAD sends a list of nodule candidate locations to a visualization application, such as syngo MM Oncology, or a visualization rendering component, which generates output images series with the CAD marks superimposed on the input thoracic CT images to enable the radiologist's review. syngo MM Oncology (FDA clearanceK211459 and subsequent versions ) is deployed on the syngo.via platform (FDA clearance K191040 and subsequent versions), which provides a common framework for various other applications implementing specific clinical workflows (but are not part of this clearance) to display the CAD marks. The syngo.CT Lung CAD device may be used either as a concurrent first reader, followed by a review of the case, or as a second reader only after the initial read is completed
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
multi-detector computed tomography (MDCT)
Anatomical Site
thorax (chest)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists, trained professionals, Hospital, clinical setting
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
The same retrospectively collected 712 CT thoracic cases, as used in the submission for the predicate device VD20 (K203258), were included in this evaluation. The data came from 3 sources: The UCLA study (232 cases), the original PMA study (145 cases) and some additional cases (335 cases). Each CT scan had been performed using a routine clinical protocol that was standard for each participating institution. The reference standard for the UCLA data was determined as part of the reader study (K203258). For the cases coming from the PMA study, ground truth was established by 18 readers, where 9 of 18 readers are needed for declaring as a true nodule. For the addition cases, ground truth was established by 7 readers, where 4 of the 7 readers are needed for declaring a finding as a true nodule. There were 929 true nodules from 412 cases. Of the 3560 lung lobes, 647 contained at least one true nodule and 2913 contained no true nodules, as determined by the reference standard.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The standalone performance analysis was designed to demonstrate the substantial equivalence between syngo.CT Lung CAD VD30A (VD30) and the predicate device syngo.CT Lung CAD VD20. It included two parts. The first one, focused on demonstrating that
- the sensitivity of VD30 in solid-only mode is not inferior to VD20 in standard mode. i)
- ii) the mean number of false positives per subject is significantly lower with VD30 in solid-only mode and
- iii) that the 2 CAD systems overlap in TPs and FPs;
while the second part focused on comparing the lesion-level sensitivity and mean number of FPs/subject of the 2 CAD systems, both in standard mode, for identifying any nodules and showing that the sensitivity and mean number of FPs/subject of VD30 in standard mode are not inferior to VD20 in standard mode.
The same retrospectively collected 712 CT thoracic cases, as used in the submission for the predicate device VD20 (K203258), were included in this evaluation.
All endpoints of the analyses were satisfactorily met.
The statistical analyses have provided the required evidence to demonstrate that the primary as well as the secondary endpoints were met; thus, demonstrating that the new device syngo.CT Lung CAD VD30 is substantially equivalent to the predicate syngo.CT Lung CAD VD20.
Hence, the new device was shown to be: (a) as safe and effective as the legally marketed predicate device and (b) not to raise questions of safety and effectiveness compared to the predicate device with respect to the extensions of the indication for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
sensitivity, mean number of false positives per subject
Predicate Device(s)
Reference Device(s)
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).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. The full name reads "U.S. Food & Drug Administration" with the word "Administration" on the second line.
July 19, 2023
Siemens Healthcare GmbH % Abhineet Johri Regulatory Affairs Manager Siemensstr. 1 Forchheim, 91301 GERMANY
Re: K231157
Trade/Device Name: syngo.CT Lung CAD (Version VD30) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: OEB Dated: June 28, 2023 Received: June 30, 2023
Dear Abhineet Johri:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT8B: Division of Radialogical 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)
K231157
Device Name syngo.CT Lung CAD (Version VD30)
Indications for Use (Describe)
syngo.CT Lung CAD device is a computer-aided detection (CAD) tool designed to assist radiologists in the detection of solid and subsolid pulmonary nodules during review of multi-detector computed tomography (MDCT) from multivendor examinations of the chest. The software is an adjunctive tool to alert the radiologist to regions of interest (ROI) that may be otherwise overlooked.
The syngo.CT Lung CAD device may be used as a concurrent first reader followed by a full review of the case by the radiologist or as second reader after the radiologist has completed his/her initial read.
The syngo.CT Lung CAD device may also be used in "solid-only" mode, where potential (or suspected) sub-solid and/or fully calcified CAD findings are filtered out.
The software device is an algorithm which does not have its own user interface component for displaying of CAD marks. The Hosting Application incorporating syngo. CT Lung CAD is responsible for implementing a user interface.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
|X| Prescription Use (Part 21 CFR 801 Subpart D)
O Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS: BELOW
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff© fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
Date prepared: July 18th, 2023
1. Submitter (Legal Manufacturer):
Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen Germany
Establishment Registration Number: 3004977335
2. Contact Person:
Mr. Abhineet Johri Regulatory Affairs Manager Siemens Healthcare GmbH, 40 Liberty Blvd Malvern, PA 19355. U.S.A E-mail: abhineet.johri@siemens-healthineers.com Telephone: +1 (484) 680-8723
3. Device Name and Classification:
| Trade Name: | syngo.CT Lung CAD (Version VD30) |
|---|---|
| Classification Name: | Medical image management and processing system |
| Classification Panel: | Radiology |
| Common Name: | Lung computed tomography system, computer-aided detection |
| CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | OEB |
4. Legally Marketed Predicate Device:
| Trade Name: | syngo.CT Lung CAD (Version VD20) |
|---|---|
| 510(k) Clearance: | K203258 |
| Clearance Date: | March 31, 2021 |
| Classification Name: | Medical image management and processing system |
4
| Classification Panel: | Radiology |
|---|---|
| Common Name: | Lung computed tomography system, computer-aided detection |
| CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | OEB |
| Recall Information: | This predicate device has not been the subject of any |
| design related recalls. |
5. Device Description:
Siemens Healthcare GmbH intends to market the syngo.CT Lung CAD which is a medical device that is designed to perform CAD processing in thoracic CT examinations for the detection of solid pulmonary nodules (between 3.0 mm and 30.0mm) and subsolid nodules (between 5.0 mm and 30.0mm) in average diameter. The device processes images acquired with multi-detector CT scanners with 16 or more detector rows recommended.
The syngo.CT Lung CAD device supports the full range of nodule locations (central, peripheral) and contours (round, irregular).
The syngo.CT Lung CAD sends a list of nodule candidate locations to a visualization application, such as syngo MM Oncology, or a visualization rendering component, which generates output images series with the CAD marks superimposed on the input thoracic CT images to enable the radiologist's review. syngo MM Oncology (FDA clearanceK211459 and subsequent versions ) is deployed on the syngo.via platform (FDA clearance K191040 and subsequent versions), which provides a common framework for various other applications implementing specific clinical workflows (but are not part of this clearance) to display the CAD marks. The syngo.CT Lung CAD device may be used either as a concurrent first reader, followed by a review of the case, or as a second reader only after the initial read is completed
The subject device and predicate device have the same basic technical characteristics. This does not introduce new types of safety or effectiveness concerns as demonstrated by the statistical analyses and additional evaluations results documented in the Statistical Analysis.
6. Intended Use:
syngo.CT Lung CAD software device is a Computer-Aided Detection (CAD) tool designed to assist radiologists in the detection of pulmonary nodules during review of multi-detector computed tomography(MDCT) examinations of the thorax (chest). The software is an adjunctive tool to alert the radiologist to regions of interest (ROI) that may otherwise be overlooked.
5
7. Indications for Use:
syngo.CT Lung CAD device is a computer-aided detection (CAD) tool designed to assist radiologists in the detection of solid and subsolid pulmonary nodules during review of multi-detector computed tomography (MDCT) from multivendor examinations of the chest. The software is an adjunctive tool to alert the radiologist to regions of interest (ROI) that may be otherwise overlooked.
The syngo.CT Lung CAD device may be used as a concurrent first reader followed by a full review of the case by the radiologist, or as a second reader after the radiologist has completed his/her initial read.
The syngo.CT Lung CAD device may also be used in "solid-only" mode, where potential (or suspected) sub-solid and/or fully calcified CAD findings are filtered out.
The software device is an algorithm which does not have its own user interface component for displaying of CAD marks. The Hosting Application incorporating syngo.CT Lung CAD is responsible for implementing a user interface.
Safety and Effectiveness Information
Software design description, hazard analysis, and technical and safety information have also been completed and provided in support of this device. The results of the hazard analysis, combined with the appropriate preventive measures taken indicate the device is of moderate level of concern, as per Guidance for the Content of Premarket Submission for Software Contained in Medical Devices, May 2005.
The device has no PHI and is utilized only by trained professionals. The output of the device is evaluated by trained professionals as a concurrent first reader or as a second reader. Use of this device does not impact the quality or status of the original acquired data.
Substantial Equivalence:
This premarket notification assesses that while Siemens syngo.CT Lung CAD VD30 introduces changes to the cleared device (syngo.CT Lung CAD VD20, K203258) in the indications for use, the technological characteristics for of the product have remained unchanged.
Specifically, both the predicate VD20 and the subject device VD30 share the same algorithm based on Convolutional Networks (CNN) and the same basic architectural workflow. However, VD30 extends the indication for use of VD20 by introducing:
- The syngo.CT Lung CAD device may also be used in "solid-only" mode, I. where potential (or suspected) sub-solid and/or fully calcified CAD findings are filtered out.
6
This extension does not introduce new types of safety or effectiveness questions. As demonstrated by the statistical analysis and the results of the standalone benchmark evaluation:
- I. The standalone accuracy has shown that the sensitivity of VD30 in solidonly mode is not inferior to VD20 in standard mode
- II. The mean number of false positives per subject is significantly lower with VD30 in solid-only mode
In summary, Siemens Healthcare GmbH is of the opinion that the syngo.CT Lung CAD software, as described within this document, does not pose any unmitigated safety risks and is substantially equivalent to the predicate device.
8. Summary of Differences between the Subject Device and the Predicate Device:
The differences between the subject device described in this premarket notification and the predicate device are summarized in the following comparison Table 1 and Table 2 below.
7
| Subject
Device
Characteristic | Current Predicate
Device
syngo.CT Lung CAD
(VD20) (K203258) | New Device
syngo.CT Lung CAD
(VD30) | Type of Change and
Impact to Safety & Ef-
fectiveness |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Manufacturer | Siemens Healthcare
GmbH | Siemens Healthcare
GmbH | [Unchanged]
No Impact |
| Detection target | Solid and subsolid pul-
monary nodules in
screening and diagnos-
tic chest CT acquisi-
tions | Solid and subsolid
pulmonary nodules in
screening and diag-
nostic chest CT acqui-
sitions | [Unchanged]
No Impact |
| Intended Use | syngo.CT Lung CAD
software device is a
Computer-Aided De-
tection (CAD) tool de-
signed to assist radiol-
ogists in the detection
of pulmonary nodules
during review of multi-
detector computed to-
mography (MDCT) ex-
aminations of the
thorax (chest). The
software is an adjunc-
tive tool to alert the ra-
diologist to regions of
interest (ROI) that may
otherwise be
overlooked. | syngo.CT Lung CAD
software device is a
Computer-Aided De-
tection (CAD) tool
designed to assist ra-
diologists in the de-
tection of pulmonary
nodules during review
of multi-detector com-
puted tomography
(MDCT) examina-
tions of the thorax
(chest). The software
is an adjunctive tool
to alert the radiologist
to regions of interest
(ROI) that may other-
wise be overlooked. | [Unchanged]
No impact |
| Indications For Use | | | [Updated] |
| The syngo.CT Lung CAD device is a computer-aided detection (CAD) tool designed to assist radiologists in the detection of solid and subsolid pulmonary nodules during review of multivendor, multi-detector computed tomography (MDCT) examinations of the chest. The software is an adjunctive tool to alert the radiologist to regions of interest (ROI) that may be otherwise overlooked. The syngo.CT Lung CAD device is to be used either as a concurrent first reader, followed by radiologist review, or as a second reader after the radiologist has completed his/her initial read. The software device is an algorithm which does not have its own user interface component for displaying of CAD marks. The hosting Application incorporating syngo.CT Lung CAD is responsible for implementing a user interface. | syngo.CT Lung CAD device is a computer-aided detection (CAD) tool designed to assist radiologists in the detection of solid and subsolid pulmonary nodules during review of multi-detector computed tomography (MDCT) from multivendor examinations of the chest. The software is an adjunctive tool to alert the radiologist to regions of interest (ROI) that may be otherwise overlooked. The syngo.CT Lung CAD device may be used as a concurrent first reader followed by a full review of the case by the radiologist or as a second reader after the radiologist has completed his/her initial read. The syngo.CT Lung CAD device may also be used in "solid-only" mode, where potential (or suspected) sub-solid and/or fully calcified CAD findings are filtered out. The software de- | Included a solid only mode to enable only displaying solid nodules (excluding fully calcified nodules and non-solid nodules) | |
| | | algorithm which
does not have its
own user interface
component for
displaying of
CAD marks. The
hosting Applica-
tion incorporating
syngo.CT Lung
CAD is responsi-
ble for implement-
ing a user inter-
face. | |
| Nodule
Characteristics | Size
Solid ≥ 3 mm and
≤ 30mm Subsolid ≥ 5 mm
and ≤ 30 mm Locations
full range: central,
peripheral Contours:
round, irregular | Diameter
Solid ≥ 3 mm and
≤ 30mm Subsolid ≥ 5 mm
and ≤ 30 mm Locations
full range: central,
peripheral Contours:
round, irregular | [Unchanged]
No impact |
| Reader
Workflow | concurrent first reader
OR
second reader work-
flow | concurrent first reader
OR
second reader work-
flow | [Unchanged]
No impact |
| Input scanning param-
eters | Scanners
Multi-vendor and
multi-detector CT
(MDCT) scanners. | Scanners
Multi-vendor and
multi-detector CT
(MDCT) scanners. | [Unchanged]
No Impact |
| | Detector rows
16 or more detector
rows recommended | Detector rows
16 or more detector
rows recommended | [Unchanged]
No impact |
| | Scan area
The scan area needs to
comprise the entire
thorax covering the
lung apices to the bases
(single breath hold rec-
ommended) | Scan area
The scan area needs to
comprise the entire
thorax covering the
lung apices to the ba-
ses (single breath hold
recommended) | [Unchanged]
No impact |
| | Scan direction
Cranio-caudal or cau-
dal cranial | Scan direction
Cranio-caudal or cau-
dal cranial | [Unchanged]
No Impact |
| Voltage | Voltage | [Unchanged] | |
| 100-140 kVp | 100-140 kVp | No impact | |
| Collimation | Collimation | [Unchanged] | |
| 1 mm or less | 1 mm or less | No Impact | |
| Slice Thickness | Slice Thickness | [Unchanged] | |
| Up to and including
2.5 mm with
1.25 mm preferred | Up to and including
2.5 mm with
1.25 mm preferred | No Impact | |
| Slice overlap | Slice Overlap | [Unchanged] | |
| 0-50%
Note: Reconstruction
overlap is allowed, but
gaps are not permitted | 0-50%
Note: Reconstruction
overlap is allowed,
but gaps are not per-
mitted | No impact | |
| Kernel | Kernel | [Unchanged] | |
| Consistent with tho-
racic CT protocols and
in line with patient
safety
guidelines. Kernels
were grouped as to
their profile. Typical
kernels
validated by the reader | Consistent with tho-
racic CT protocols
and in line with pa-
tient safety
guidelines. Kernels
were grouped as to
their profile. Typical
kernels
validated by the
reader study were: | No impact | |
| study were: | | | |
| Smooth: B, B30f,
Standard, FC10.
Medium: C, B45f,
B50f, Lung, FC50,
FC51, Bv49d_2,
I50f_2, B60f.
Sharp: D, B70f, Bone,
FC52 | Smooth: B, B30f,
Standard, FC10.
Medium: C, B45f,
B50f, Lung, FC50,
FC51, Bv49d_2,
I50f_2, B60f.
Sharp: D, B70f, Bone,
FC52 | | |
8
9
10
11
| Dose | Dose | [Unchanged] | |
|---|---|---|---|
| Consistent with tho- | Consistent with tho- | No impact | |
| racic CT protocols and | racic CT protocols | ||
| in line with patient | and in line with pa- | ||
| safety guidelines. | tient safety guidelines. | ||
| Typical values are: | Typical values are: | ||
| CTDIvol $! The third filter was added in VD30. |
14
Table 2 Functional Components for syngo.CT Lung CAD VD20 (predicate) and syngo.CT Lung CAD VD30 (Subject device)
9. Statistical Analysis Summary
The standalone performance analysis was designed to demonstrate the substantial equivalence between syngo.CT Lung CAD VD30A (VD30) and the predicate device syngo.CT Lung CAD VD20. It included two parts. The first one, focused on demonstrating that
- the sensitivity of VD30 in solid-only mode is not inferior to VD20 in standard mode. i)
- ii) the mean number of false positives per subject is significantly lower with VD30 in solid-only mode and
- iii) that the 2 CAD systems overlap in TPs and FPs;
while the second part focused on comparing the lesion-level sensitivity and mean number of FPs/subject of the 2 CAD systems, both in standard mode, for identifying any nodules and showing that the sensitivity and mean number of FPs/subject of VD30 in standard mode are not inferior to VD20 in standard mode.
The same retrospectively collected 712 CT thoracic cases, as used in the submission for the predicate device VD20 (K203258), were included in this evaluation. The data came from 3 sources: The UCLA study (232 cases), the original PMA study (145 cases) and some additional cases (335 cases). Each CT scan had been performed using a routine clinical protocol that was standard for each participating institution. The reference standard for the UCLA data was determined as part of the reader study (K203258). For the cases coming from the PMA study, ground truth was
15
established by 18 readers, where 9 of 18 readers are needed for declaring as a true nodule. For the addition cases, ground truth was established by 7 readers, where 4 of the 7 readers are needed for declaring a finding as a true nodule. There were 929 true nodules from 412 cases. Of the 3560 lung lobes, 647 contained at least one true nodule and 2913 contained no true nodules, as determined by the reference standard.
All endpoints of the analyses were satisfactorily met.
The statistical analyses have provided the required evidence to demonstrate that the primary as well as the secondary endpoints were met; thus, demonstrating that the new device syngo.CT Lung CAD VD30 is substantially equivalent to the predicate syngo.CT Lung CAD VD20.
Hence, the new device was shown to be: (a) as safe and effective as the legally marketed predicate device and (b) not to raise questions of safety and effectiveness compared to the predicate device with respect to the extensions of the indication for use.
10. Non-clinical Performance Testing:
Non-clinical tests were conducted for the device syngo.CT Lung CAD (during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.
Siemens Healthcare GmbH claims conformance to the following standards:
- -ISO 14971:2019 Third Edition 2019-12IEC 62304 Edition 1.1 2015-06 Consolidated Version
- -IEC 62366-1 Edition 1.0 2015-02
11.Software 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 device syngo.CT Lung CAD during product development.
The Risk Analysis was completed, and risk control implemented to mitigate identified hazards. 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.
16
Summarv:
Performance tests were conducted to test the functionality of the device syngo.CT Lung CAD . These tests have been performed to assess the functionality of the subject device. Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence.
12. Safety and Effectiveness Information:
Software specifications, design descriptions, hazard analysis, and labeling information are submitted in support of this premarket notification. The device labeling contains instructions for use with cautions to provide for safe and effective use of the device.
The results of the hazard analysis combined with the appropriate preventive measures taken indicate the device is of moderate level of concern, as per the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005).
13. Conclusion as to Substantial Equivalence:
This premarket notification assesses that while Siemens syngo. CT Lung CAD VD30 introduces change to the cleared device (syngo.CT Lung CAD VD20) in the indication for use, the technological characteristics of the product and intended use have remained unchanged.
Specifically, both the predicate VD20 and VD30 share the same algorithm based on Convolutional Neural Networks (CNN) and the same basic architectural workflow. The bug fixes and addition of the postfiltering do not introduce new types of safety or effectiveness questions as demonstrated in the statistical analysis.
The substantial equivalence comparison is performed with the previously cleared VD20 version of this device, as reflected in the predicate labeling and provided in the 510(k) cleared in March 2021 (K203258).
In summary, Siemens Healthcare GmbH is of the opinion that the syngo.CT Lung CAD software, as described within this document, does not pose any unmitigated safety risks and is substantially equivalent to the predicate device since its accuracy has been shown to be superior to the predicate device and the marks are reasonably consistent.