(65 days)
Not Found
Unknown
The description mentions "automated segmentation" and "automatic segmentation," which can be achieved through various methods, including traditional image processing or AI/ML. Without explicit mention of AI, ML, or specific algorithms commonly associated with these technologies, it's not possible to definitively confirm their use. The training and testing data descriptions are also not conclusive evidence of AI/ML.
No
The device is a software application for assessing knee cartilage condition based on MRI, providing quantitative measurements and reports, which aids in diagnosis and monitoring but does not directly treat or alleviate a condition.
Yes
The device "allows assessment of knee cartilage condition" and performs "volumetry and thickness calculation," providing "statistical evaluation of the assessment" and generating "output maps" and "3D models." This information directly aids healthcare professionals in diagnosing and monitoring patient conditions, which aligns with the definition of a diagnostic device.
Yes
The device is described as a "musculoskeletal post-processing software application" that operates on MRI data. It is explicitly stated as "software version VA10A" and functions within a software framework (syngo OpenApps/syngo.via). The description focuses entirely on the software's processing capabilities and outputs, with no mention of accompanying hardware components that are 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 medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Chondral Quant's Function: Chondral Quant processes imaging data (MRI) of the knee. It does not analyze biological samples taken from the patient. Its purpose is to provide quantitative information about the cartilage based on the visual information from the MRI.
Therefore, Chondral Quant falls under the category of medical imaging software or post-processing software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Chondral Quant is a musculoskeletal post-processing software application that allows assessment of knee cartilage condition based on Magnetic Resonance Imaging (MRI).
Product codes (comma separated list FDA assigned to the subject device)
LLZ, LNH
Device Description
The medical device Chondral Quant, software version VA10A, is a musculoskeletal postprocessing application that allows evaluating the status of knee cartilage based on Magnetic Resonance Imaging (MRI).
The software is part of the syngo OpenApps framework and can be used from within syngo.via like any other syngo.via workflow.
Version VA10A is the initial version of this medical device.
Chondral Quant processes a morphological 3D series of the knee joint and performs an automated segmentation of the knee's cartilage. The segmentation may be modified by the user. Chondral Quant will also perform a sub-segmentation of the knee cartilage. Chondral Quant additionally performs volumetry and thickness calculation on the segmented areas. Optionally, it is possible to provide a parametric map as secondary input to Chondral Quant. Commonly, this will be a T2 or T2* map. Chondral Quant will perform a registration of the morphological image and the parametric map and transfer the segmentation to the parametric map.
A statistical evaluation of the mapping results for the 21 sub zones will be additionally provided in this case.
All output will be provided in the form of a table showing statistical evaluation of the assessment (volume and mean, median and standard deviation of thickness and mapping results for every region). Additionally, Chondral Quant will generate output maps (segmentation map, cartilage thickness map) and 3D models of the segmented cartilage (zone model and thickness model). Finally, a PDF report containing the table values and the 3D models will be generated as output.
Alternatively, the application Chondral Quant may also be executed in a "PACS-ready" mode, i.e. fully-automated and without user interaction. The results will be sent to PACS automatically. In this case the series names will be marked with a prefix "AUTO GENERATED" for a clear indication of the automatic mode.
The subject device, Chondral Quant with software VA10A, consists of new and modified features that are similar to what is currently offered on the predicate device. The subject device includes the following modifications in comparison to the predicate device: new body region compared to predicate device:
- -Automatic segmentation and volumetry of the cartilage
- -Thickness calculation
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
MRI Image Series
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found. (The document states "Furthermore, the device is intended for healthcare professionals," but does not explicitly state the intended user/care setting.)
Description of the training set, sample size, data source, and annotation protocol
Training data: more than 31 cases, Equipment: 3T MRI systems
Description of the test set, sample size, data source, and annotation protocol
Testing data: more than 100 cases, Equipment: 3T MRI systems; more than 11 cases, Equipment: 7T MRI systems; more than 9 cases, Equipment: 1.5T MRI systems
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Tests were conducted:
- Subsystem Verification Report
- Solution Validation Summary Report
Non-clinical tests such as unit test, integration testing, and system test are passed.
The system test results indicate that open defects were identified which had no impact on safety and effectiveness of Chondral Quant with software version VA10A.
No clinical tests were conducted for the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 13, 2023
Siemens Medical Soultions USA, Inc. % Milind Dhamankar Clinical Affairs Professional 40 Liberty Boulevard Malvern, Pennsylvania 19335
Re: K231351
Trade/Device Name: Chondral Quant Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ, LNH Dated: April 28, 2023 Received: May 9, 2023
Dear Milind Dhamankar:
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
1
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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices 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) K231351
Device Name
Chondral Quant
Indications for Use (Describe)
Chondral Quant is a musculoskeletal post-processing software application that allows assessment of knee cartilage condition based on Magnetic Resonance Imaging (MRI).
| Type of Use (Select one or both , as applicable) |
|---|
| ---------------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image contains the text "K231351" at the top. Below that is the Siemens Healthineers logo. The Siemens part of the logo is in teal, and the Healthineers part is in orange. There are also some orange dots to the right of the Healthineers text.
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act 1990 and 21 CFR § 807.92.
| 1. General Information | |
|---|---|
| Establishment: | Siemens Medical Solutions USA, Inc. |
| 40 Liberty Boulevard | |
| Malvern, PA 19355, USA | |
| Registration Number: 2240869 | |
| Date Prepared: | July 12, 2023 |
| Manufacturer: | Siemens Healthcare GmbH |
| Henkestr. 127 | |
| 91052 Erlangen | |
| Germany | |
| Registration Number: 3002808157 | |
| 2. Contact Information | |
| Milind Dhamankar | |
| Clinical Affairs Professional | |
| Siemens Medical Solutions USA, Inc. | |
| 40 Liberty Boulevard | |
| Malvern, PA 19355, USA | |
| Phone: +1(610) 517-9484 | |
| Fax: (610) 448-6547 | |
| E-mail: milind.dhamankar@siemens- | |
| healthineers.com | |
| 3. Device Name and Classification | |
| Device/ Trade name: | |
| Classification Name: | Chondral Quant |
| System, Image Processing, Radiological | |
| Picture Archiving and Communications | |
| System | |
| Classification Panel: | |
| CFR Code: | |
| Classification: | |
| Product Code: | Radiology |
| 21 CFR § 892.2050 | |
| II | |
| Primary: LLZ |
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Image /page/4/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 word "Healthineers" is a cluster of orange dots.
4. Legally Marketed Predicate Device1
Trade name:
510(k) Number: Classification Name:
Classification Panel: CFR Code: Classification: Product Code:
syngo.MR Applications - syngo.MR Brain Morphometry K182904 Picture Archiving and Communication System (PACS) Radiology 21 CFR § 892.2050 11 Primary: LLZ Secondary: LNH
5. Intended Use / Indications for Use
Chondral Quant is a musculoskeletal post-processing software application that allows assessment of knee cartilage condition based on Magnetic Resonance Imaging (MRI).
6. Device Description
The medical device Chondral Quant, software version VA10A, is a musculoskeletal postprocessing application that allows evaluating the status of knee cartilage based on Magnetic Resonance Imaging (MRI).
The software is part of the syngo OpenApps framework and can be used from within syngo.via like any other syngo.via workflow.
Version VA10A is the initial version of this medical device.
Chondral Quant processes a morphological 3D series of the knee joint and performs an automated segmentation of the knee's cartilage. The segmentation may be modified by the user. Chondral Quant will also perform a sub-segmentation of the knee cartilage. Chondral Quant additionally performs volumetry and thickness calculation on the segmented areas. Optionally, it is possible to provide a parametric map as secondary input to Chondral Quant. Commonly, this will be a T2 or T2* map. Chondral Quant will perform a registration of the morphological image and the parametric map and transfer the segmentation to the parametric map.
A statistical evaluation of the mapping results for the 21 sub zones will be additionally provided in this case.
All output will be provided in the form of a table showing statistical evaluation of the assessment (volume and mean, median and standard deviation of thickness and mapping results for every region). Additionally, Chondral Quant will generate output maps (segmentation map, cartilage thickness map) and 3D models of the segmented cartilage
1 The predicate device has not been subject to a design-related recall.
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Image /page/5/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern.
(zone model and thickness model). Finally, a PDF report containing the table values and the 3D models will be generated as output.
Alternatively, the application Chondral Quant may also be executed in a "PACS-ready" mode, i.e. fully-automated and without user interaction. The results will be sent to PACS automatically. In this case the series names will be marked with a prefix "AUTO GENERATED" for a clear indication of the automatic mode.
The subject device, Chondral Quant with software VA10A, consists of new and modified features that are similar to what is currently offered on the predicate device. The subject device includes the following modifications in comparison to the predicate device: new body region compared to predicate device:
- -Automatic segmentation and volumetry of the cartilage
- -Thickness calculation
7. Substantial Equivalence
Chondral Quant with software version VA10A is substantially equivalent to the following predicate device:
| Predicate Device | FDA Clearance Number
and Date | Product
Code | Manufacturer |
|----------------------------------------------------------|----------------------------------|-----------------|----------------------------|
| syngo.MR Applications –
syngo.MR Brain
Morphometry | K182904 - July 5, 2019. | LLZ, LNH | Siemens Healthcare
GmbH |
The following summary comparison provides an overview of changes Chondral Quant with software VA10A compared to the predicate device. Hardware comparison is not applicable as Chondral Quant is a SW-only device.
| | Subject Device
Chondral Quant VA10A | Predicate Device
syngo.MR Applications - syngo.MR
Brain Morphometry (K182904) |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Purpose | Chondral Quant is a musculoskeletal
post-processing software application
that allows assessment of knee cartilage
condition based on Magnetic
Resonance Imaging (MRI).
Chondral Quant processes a
morphological 3D series of the knee
joint and performs an automated
segmentation of the knee's cartilage.
Chondral Quant additionally performs
volumetry and thickness calculation on
the segmented areas. | syngo.MR Applications is a syngo based
postacquisition image processing
software for viewing, manipulating,
evaluating, and analyzing MR, MR-PET,
CT, PET, CT-PET images and MR spectra.
syngo.MR Brain Morphometry offers a
comprehensive package for the
automatic calculation of the volume
properties of different brain structures
using MPRAGE datasets, which are
typically acquired for a typical MR
examination of the head. |
| Features / Functionalities | | |
| Integration into
general syngo.via
workflow concept | Yes | Yes |
| Support Images
Modalities | MR | MR |
| Data
Acquisition Protocol | MRI Image Series | MRI Image Series |
| Body Region | Knee | Brain |
| Clinical Use Case | Automatic segmentation and
volumetry of the cartilage | Automatic segmentation and
volumetry of different brain structures |
| | Segmentation
algorithm | |
| Template registration | | Yes |
| | Atlas-based initialization for the bone
segmentation | Free tissue classification |
| Bias field correction | Yes | Yes |
| | Preprocessing bias field correction | - |
| Skull-stripping | No | Yes |
| Tissue classification | Yes | Yes |
| | Cartilage segmentation | Brain tissue classification |
| Segmentation quality
check | No | Yes |
| | Volumetry | Yes |
| Volume calculation | | Lobe-wise GM volumes |
| Thickness calculation | Yes | No |
| | 3D Segmentation | Yes |
| Clinical sub-regions | 21 clinical sub-regions | 57 clinical sub-regions |
| | Output | - DICOM
- Maps and statistical evaluations |
| Workflow | - PACS-ready without user interaction - Interactive mode (manual changes by user possible) | |
| Normative References
/ Deviation Maps | No | Yes |
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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 word "Healthineers" is a graphic of orange dots arranged in a circular pattern.
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Image /page/7/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 word "Healthineers" is a graphic of orange dots arranged in a circular pattern.
8. Technological Characteristics
The subject device Chondral Quant with software version VA10A is substantially equivalent to the predicate device with regard to the operational environment, programming language, operating system and performance.
The subject device conforms to the standard for medical device software (IEC 62304).
9. Nonclinical Tests
The following performance testing was conducted on the subject devices.
| Performance Test | Tested Software | Source/Rationale for test |
|---|---|---|
| Subsystem | ||
| Verification Report | Chondral Quant VA10A | Guidance for the Content of |
| Premarket Submissions for | ||
| Software Contained in Medical | ||
| Devices | ||
| Solution Validation | ||
| Summary Report |
| Algorithm | Cases | Equipment: |
|---|---|---|
| Training data: | more than 31 | 3T MRI systems |
| Testing data: | more than 100 cases | 3T MRI systems |
| more than 11 cases | 7T MRI systems | |
| more than 9 cases | 1.5T MRI systems |
Non-clinical tests such as unit test, integration testing, and system test are passed.
The system test results indicate that open defects were identified which had no impact on safety and effectiveness of Chondral Quant with software version VA10A.
10. Clinical Tests / Publications
No clinical tests were conducted for the subject device.
Clinical publications and other support documents were referenced to provide information on the use, testing and validation of the Subject Device.
No animal testing has been performed.
11. 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 a risk analysis in compliance with ISO 14971, to identify and provide mitigation of potential hazards early in the design cycle and continuously throughout the development of the product. Siemens Healthcare GmbH adheres to recognized and established industry standards, to minimize hazards. Furthermore, the device is intended for healthcare professionals.
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| Recognition
Number | Product
Area | Title of Standard | Reference Number
and date | Standards
Development
Organization |
|-----------------------|--------------------------|-----------------------------------------------------------------------------------------|---------------------------------------------------------|------------------------------------------|
| 5-125 | General I
(QS/
RM) | Medical devices - Application of
risk management to medical
devices | 14971 Third Edition
2019-12 | ISO |
| 5-114 | General I
(QS/
RM) | Medical devices - Part 1:
Application of usability engineering
to medical devices | 62366-1:2015,
Edition 1.0 2015-02 | ANSI AAMI IEC |
| 13-79 | Software/
Informatics | Medical device software - Software
life cycle processes | 62304 Edition 1.1
2015-06
CONSOLIDATED
VERSION | IEC |
Chondral Quant with software version VA10A conforms to the following standards:
12. Conclusion as to Substantial Equivalence
The extensive testing of Chondral Quant with software version VA10A has been successfully completed. All risk mitigations, as identified in the Risk Analysis and all relevant SSRS/FS requirements for Chondral Quant with software version VA10A have been tested and verified successfully.
Verification and validation of the product within the meaning of the Quality System Regulation (21 CFR § 820.30) have been performed by trained personnel. Chondral Quant with software version VA10A has been found to be validated for its intended use.
Indications for Use for subject device is different compared to the predicate device, however the intended use is the same. syngo.via is the hosting platform for both the subject device and the predicate device. Both the devices are integrated into the already cleared and marketed general syngo.via workflow concept. Chondral Quant processes a morphological 3D series of the knee joint and performs an automated segmentation of the knee's cartilage. Chondral Quant additionally performs volumetry and thickness calculation on the segmented areas and optionally performs registration of a parametric map while syngo.MR Brain Morphometry processes a morphological 3D data series and offers a comprehensive package for the automatic calculation of the volume properties of different brain structures.
The difference between the predicate device and the subject device doesn't impact the safety and effectiveness of the subject device.
Therefore, it is Siemens' opinion that the safety and effectiveness of the subject device have been fully verified by objective evidence, and that the subject device performs as safely and effectively as the predicate device (K182904) and the subject device is substantially equivalent to the predicate device.