(262 days)
Not Found
Unknown
The summary describes "automatic calculation of the volume properties of different brain structures" and validation against a reference, which could potentially involve AI/ML, but the document does not explicitly mention these terms or provide details about the underlying algorithms.
No
The device is described as "post-acquisition image processing software for viewing, manipulating, evaluating, and analyzing MR, MR-PET, CT, PET, CT-PET images and MR spectra" and for "automatic calculation of the volume properties of different brain structures". It provides data for clinical evaluation but does not directly deliver therapy.
Yes
The "Intended Use / Indications for Use" states that the software is for "viewing, manipulating, evaluating, and analyzing MR, MR-PET, CT, PET, CT-PET images and MR spectra," and the "Device Description" mentions its use for "structured evaluation of MR images" and "automatic calculation of the volume properties of different brain structures," which are all activities associated with diagnostics. The performance studies also highlight its use in evaluating patients with Alzheimer's and mild cognitive impairment.
Yes
The device description explicitly states that syngo.MR Applications are "syngo based post-processing software/applications" and the submission introduces a "new functionality syngo.MR Brain Morphometry" which is also described as software. The device processes images provided by other medical devices (MR, CT, PET, etc.) but is not itself a hardware component that acquires images or interacts physically with the patient.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for "post-acquisition image processing software for viewing, manipulating, evaluating, and analyzing MR, MR-PET, CT, PET, CT-PET images and MR spectra." This involves processing medical images obtained from imaging modalities, not analyzing biological samples (like blood, urine, tissue) in vitro.
- Device Description: The description reinforces this by stating it's "syngo based post-processing software/applications to be used for viewing and evaluating MR images provided by a magnetic resonance diagnostic device."
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any other elements typically associated with in vitro diagnostics. The focus is entirely on image analysis.
Therefore, this device falls under the category of medical image processing software, not an IVD.
N/A
Intended Use / Indications for Use
syngo.MR Applications is a syngo based post-acquisition image processing software for viewing, manipulating, evaluating, and analyzing MR, MR-PET, CT, PET, CT-PET images and MR spectra.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, LNH
Device Description
The syngo.MR Applications are syngo based post-processing software/applications to be used for viewing and evaluating MR images provided by a magnetic resonance diagnostic device and enabling structured evaluation of MR images. syngo.MR Brain Morphometry extends the MR Neurology workflow and 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.
With this premarket submission, the new functionality syngo.MR Brain Morphometry is introduced to extend the MR Neurology workflow that is a part of the formerly cleared medical device syngo.MR Applications (K180336).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR, MR-PET, CT, PET, CT-PET
Anatomical Site
Brain structures (specifically, different brain structures, grey matter, hippocampus, white matter, and ventricular system)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Performance of the new feature functionality was demonstrated by quantifying accuracy, repeatability and reproducibility of brain structure volume estimations by syngo.MR Brain Morphometry on a dataset of 1200 subjects, consisting of Alzheimer's patients (AD), mild cognitive impaired patients (MCI) and healthy controls (HC). The accuracy of the volumetric results was validated by comparing the automated results to a reference. Repeatability and reproducibility studies were conducted to demonstrate the robustness of volume measures estimated by syngo.MR Brain Morphometry with respect to both instrumental and patient noise within a single scanning session on one hand, and to significant changes to instrument, i.e., field strength and vendor as well as patient positioning, on the other hand.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Accuracy, repeatability, and reproducibility study.
Sample Size: 1200 subjects (Alzheimer's patients (AD), mild cognitive impaired patients (MCI) and healthy controls (HC)).
Key Results: The correlation between the volumes estimated by syngo.MR Brain Morphometry and a reference device was 0.95 for grey matter, 0.80 for the hippocampus and 0.92 for white matter. The correlation of obtained volumes in the repeatability experiments was 0.96 for grey matter, hippocampus and white matter, 0.99 for the ventricular system. Volume correlation in the reproducibility experiments was 0.97 for grey matter, 0.94 for the hippocampus and 0.98 for white matter. In all validation experiments, syngo.MR Brain Morphometry passed the acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation
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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Siemens Medical Solutions USA, Inc. % Cordell L. Fields, Esq. Regulatory Affairs Specialist 40 Liberty Blvd., Mailcode 65-1A MALVERN PA 19355
Re: K182904
Trade/Device Name: syngo.MR Applications Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ, LNH Dated: June 5, 2019 Received: June 6, 2019
Dear Mr. Fields:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
July 5, 2019
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | |
---|---|
Indications for Use | Form Approved: OMB No. 0910-0120 |
Expiration Date: 06/30/2020 | |
See PRA Statement below. | |
510(k) Number (if known) | K182904 |
Device Name | syngo.MR Applications |
Indications for Use (Describe) | syngo.MR Applications is a syngo based post-acquisition image processing software for viewing, manipulating, evaluating, and analyzing MR, MR-PET, CT, PET, CT-PET images and MR spectra. |
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) |
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:
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"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."
Siemens 510(k) Traditional Premarket Notification
3
SIEMEN
Section 5 510(k) Summary
This 510(k) summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92.
Company: | Siemens Medical Solutions USA, Inc. |
---|---|
---------- | ------------------------------------- |
40 Liberty Boulevard, 65-1A Malvern, PA 19355
Date Prepared: October 15, 2018
1. General Information
Importer/Distributor:
Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, Mail Code 65-1A Malvern, PA 19355, USA Establishment Registration Number: 2240869
Manufacturing Sites:
Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen, Germany Establishment Registration Number: 3002808157
2. Contact Person:
Cordell L. Fields, Esq. Regulatory Affairs Technical Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Mail Code 65-1A Malvern, PA 19355, USA Phone: (610) 448-6469 Fax: (610) 448-1787 E-mail: cordell.fields@siemens-healthineers.com
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3. Device Name and Classification:
Device Name | syngo.MR Applications |
---|---|
Trade Name | syngo.MR Applications: syngo.MR Brain |
Morphometry | |
Classification Name: | Picture Archiving and Communication System (PACS) |
Classification Panel: | Radiology |
Regulation Number: | 21 CFR § 892.2050 |
Device Class: | II |
Primary Product Code: | LLZ |
Secondary Product Code: | LNH |
Legally Marketed Predicate Device: 4.
Device Name | syngo.MR Applications SMRVB30A |
---|---|
510(k) Number: | K180336, cleared April 19, 2018 |
Classification Name: | Picture Archiving and Communication System (PACS) |
Classification Panel: | Radiology |
Regulation Number: | 21 CFR § 892.2050 |
Device Class: | II |
Primary Product Code: | LLZ |
Secondary Product Code: | LNH |
5. Intended Use
The indications for use for the subject device are the same as the predicate device:
syngo.MR Applications is a syngo based post-acquisition image processing software for viewing, manipulating, evaluating, and analyzing MR, MR-PET, CT, PET, CT-PET images and MR spectra.
5
6. Device Description:
The syngo.MR Applications are syngo based post-processing software/applications to be used for viewing and evaluating ' MR images provided by a maqnetic resonance diagnostic device and enabling structured evaluation of MR images. syngo.MR Brain Morphometry extends the MR Neurology workflow and 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.
With this premarket submission, the new functionality syngo.MR Brain Morphometry is introduced to extend the MR Neurology workflow that is a part of the formerly cleared medical device syngo.MR Applications (K180336).
7. Technological Characteristics
syngo.MR Applications with SMRVB30A offers a new feature, syngo.MR Brain Morphometry, compared to the predicate device syngo.MR Applications SMRVB30A (K180336; cleared April 19, 2018). While this is a feature that offers additional image viewing and evalution capabilities than the predicate device, the conclusions from all verification and validation data suggest that the feature bears an equivalent safety and performance profile to the predicate device.
The subject device is substantially equivalent to the predicate device with regard to the software, hardware, operational environment, programming language, operating system and performance.
syngo.MR Brain Morphometry for syngo.MR Applications SMRVB30A conforms to the standard for software medical devices (IEC 62304:2006), IEC as well as NEMA standards.
8. Nonclinical Tests
The following performance testing was conducted on the subject device:
-
Software verification and validation testing was completed in accordance with i the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005)
The following performance testing was conducted on the subject device: -
Performance of the new feature functionality was demonstrated by quantifying accuracy, repeatability and reproducibility of brain structure volume estimations by syngo.MR Brain Morphometry on a dataset of 1200 subjects, consisting of Alzheimer's patients (AD), mild cognitive impaired patients (MCI) and healthy controls (HC). The accuracy of the volumetric results was validated by comparing the automated results to a reference. Repeatability and reproducibility studies were conducted to demonstrate
1 While viewing (i.e. assessing) of images from other vendors is always possible; for advanced post-processing applications, some of the post-processing steps may depend on information contained in private DICOM tags; therefore, the evaluation and processing of images can´t be guaranteed for other vendors.
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the robustness of volume measures estimated by syngo.MR Brain Morphometry with respect to both instrumental and patient noise within a single scanning session on one hand, and to significant changes to instrument, i.e., field strength and vendor as well as patient positioning, on the other hand. Acceptance criteria for performance tests were defined based on a literature review. In all validation experiments, syngo.MR Brain Morphometry passed the acceptance criteria. The correlation between the volumes estimated by syngo.MR Brain Morphometry and a reference device was 0.95 for grey matter, 0.80 for the hippocampus and 0.92 for white matter. The correlation of obtained volumes in the repeatability experiments was 0.96 for grey matter, hippocampus and white matter, 0.99 for the ventricular system. Volume correlation in the reproducibility experiments was 0.97 for grey matter, 0.94 for the hippocampus and 0.98 for white matter.
9. Clinical Tests
No clinical tests were conducted to test the performance and functionality of the new feature syngo.MR Brain Morphometry feature.
Verification and validation and a performance evaluation of the syngo.MR Applications SMR VB30A with the new feature syngo.MR Brain Morphometry has been performed and the new functionality has been validated for its intended use. The data from these activities were used to support the subject device and the substantial equivalence argument. Clinical publications are referenced to provide further information on the use and functionality of the feature.
No animal testing has been performed on the subject device and its new feature.
10. Safety and Effectiveness
syngo.MR Brain Morphometry extends the MR Neurology workflow which was cleared with the medical device syngo.MR Applications with software SMRVB30A (K180336) and is covered by the Intended Use of the synqo.MR Applications.
conclusions from the non-clinical data suggest that the additional The functionality bears an equivalent safety and performance profile to the predicate device (Table 2). Additionally, the indications for use remains the same.
Therefore, this workflow enhancement with syngo.MR Brain Morphometry is considered to be substantially equivalent to the predicate device syngo.MR Applications SMRVB30A.
synqo.MR Applications: synqo.MR Brain Morphometry conforms to the applicable FDA recognized and international IEC, ISO and NEMA standards with regards to performance and safety as recommended by the respective MR FDA Guidance Document as stated in the following Table 1.
| Recognition
Number | Product Area | Title of Standard | Reference Number
and date | Standards
Development
Organization |
----------------------- | -------------- | ------------------- | ------------------------------ | ------------------------------------------ |
---|
Siemens 510(k) Traditional Premarket Notification
7
| Recognition
Number | Product Area | Title of Standard | Reference Number
and date | Standards
Development
Organization |
|-----------------------|--------------|------------------------------------------------------------------------------------------|----------------------------------------|------------------------------------------|
| 5-40 | General | Medical devices - Application of
risk management to medical
devices | 14971 Second
edition 2007-03-
01 | ISO |
| 5-96 | General | Medical devices - Application of
usability engineering to medical
devices | 62366-1:2015 | AAMI ANSI
IEC |
| 13-32 | Software | Medical device software -
Software life cycle processes | 62304:2006 | AAMI ANSI
IEC |
| 12-300 | Radiology | Digital Imaging and
Communications in Medicine
(DICOM) Set 03/16/2012
Radiology | PS 3.1 - 3.20
(2016) | NEMA |
Table 1: Standard requirements for syngo.MR Applications: syngo.MR Brain Morphometry
Substantial Equivalence and Conclusion 11.
The syngo.MR Applications with software SMRVB30A including the new feature syngo.MR Brain Morphometry is substantially equivalent to the following predicate device (Table 2).
Predicate Device | FDA Clearance Number | FDA Clearance Date | Main Product Code |
---|---|---|---|
syngo.MR | |||
SMRVB30A Applications | K180336 | April 19, 2018 | LLZ, LNH |
Table 2: Predicate device for syngo.MR Brain Morphometry for syngo.MR Applications SMRVB30A
The subject device, syngo.MR Applications SMRVB30A, has been modified to include the new feature syngo.MR Brain Morphometry. No other modifications have been made.
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SIEMENS
syngo.MR Applications: syngo.MR Brain Morphometry has the same intended use and one different technological characteristic compared to the predicate device, syngo.MR Applications with SMRVB30A (K180336), with respect to the software features and functionalities. While the new feature varies with respect to the predicate device with expanded post-processing capabilities for the automatic calculation of the volume properties of different brain structures using MPRAGE datasets, the conclusions from all verification and validation data suggest that the feature bears an equivalent safety and performance profile to the predicate device. The new feature offers the user additional possibilities for the image viewing and evaluation. The modification aims to improve user workflow and reduce the complexity of the imaging procedure and does not change the intended use. The completed performance testing supports the substantial equivalence of the subject device to the predicate device.
In summary, synqo.MR Applications: syngo.MR Brain Morphometry has the same functionalities as the predicate device and, based on the aforementioned information, does not introduce new issues of safety or effectiveness. Therefore, Siemens is of the opinion that syngo.MR Applications: syngo.MR Brain Morphometry is substantially equivalent to the currently marketed device synqo.MR Applications with SMRVB30A (K180336).