(144 days)
Not Found
No
The summary describes image processing software with specific enhancements for prostate biopsy support and oncology evaluation, but it does not mention AI, ML, or related terms. The focus is on extending existing workflows and functionalities.
No.
The device is described as "post-acquisition image processing software for viewing, manipulating, evaluating, and analyzing" medical images, which is not a therapeutic function.
Yes
The device is a post-acquisition image processing software for viewing, manipulating, evaluating, and analyzing various medical images (MR, MR-PET, CT, PET, CT-PET) and MR spectra, which are activities fundamental to diagnosis. The "Prostate Biopsy Support" and "ADC-based whole-body diffusion evaluation" also suggest its use in clinical assessment for diagnostic purposes.
Yes
The device is described as "post-acquisition image processing software" and the description focuses solely on software enhancements and validation, without mentioning any associated hardware components included with the device itself.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the software as a post-acquisition image processing tool for viewing, manipulating, evaluating, and analyzing medical images (MR, MR-PET, CT, PET, CT-PET) and MR spectra. This is focused on processing and interpreting images obtained from the patient, not on analyzing samples taken from the patient (like blood, urine, tissue, etc.).
- Device Description: The description details software enhancements for image analysis workflows, such as Prostate Biopsy Support and ADC-based whole-body diffusion evaluation. These are image-based analyses.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components associated with in vitro diagnostics.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device operates on medical images, which are a different type of data.
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
syngo.MR Applications with new software version SMR VB40A consists of the following enhancements and improvements to extend the different workflows and applications which are currently offered on the predicate device, syngo.MR Applications with SMRVB30A (K180336):
Enhanced functionality within the syngo.MR General application:
- Prostate Biopsy Support
Renaming and enhanced functionality within the syngo.MR Oncology application: - syngo.MR OncoCare will be renamed to syngo.MR OncoTrend.
- ADC-based whole-body diffusion evaluation
Mentions image processing
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR, MR-PET, CT, PET, CT-PET
Anatomical Site
Prostate, whole-body (for diffusion evaluation)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.
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)
- Software verification and validation testing was completed in accordance with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005)
- Performance Evaluation of the described modifications were completed
The results from each set of tests demonstrate that the device performs as intended and is therefore substantially equivalent to the predicate device to which it has been compared.
No clinical tests were conducted to test the performance and functionality of the modifications introduced within syngo.MR Applications with software version SMRVB40A.
Verification and validation of the enhancements and improvements have been performed and these modifications have been validated for their intended use. The data from these activities were used to support the subject device and the substantial equivalence argument.
Key Metrics (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).
0
Image /page/0/Picture/0 description: The image shows 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 in blue. Underneath the FDA logo is the word "ADMINISTRATION" in a smaller font.
Siemens Medical Solutions USA, Inc. % Cordell L. Fields, Esq. Sr. Regulatory Affairs Specialist 40 Liberty Boulevard, MailCode 65-1A MALVERN PA 19355
Re: K192462
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: January 8, 2020 Received: January 9, 2020
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
January 31, 2020
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The word is written in all capital letters. The color of the text is a light teal.
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
| Food and Drug Administration | Form Approved: OMB No. 0910-0120 |
|---|---|
| Expiration Date: 06/30/2020 | |
| See PRA Statement below. | |
| Indications for Use | |
| 510(k) Number (if known) | |
| 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."
FORM FDA 3881 (7/17) !DOCTYPE html>
Siemens 510(k) Traditional Premarket Notification
3
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.
- Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355, USA
Date Prepared: September 6, 2019
1. General Information
| Importer / Distributor | Siemens Medical Solutions USA, Inc. |
|---|---|
| 40 Liberty Boulevard | |
| Mail Code 65-1A | |
| Malvern, PA 19355, USA | |
| Registration Number: 2240869 |
Manufacturer Siemens Healthcare GmbH Henkestrasse 127 Erlangen, Bayern, Germany 91052 Registration Number: 3002808157
2. Contact Information
Cordell L. Fields, Esq. Sr. Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355, USA Phone: (610) 448-6469 Fax: (610) 448-1787 E-mail: cordell.fields@siemens-healthineers.com
3. Device Name and Classification
| Device Name: | syngo.MR Applications |
|---|---|
| Trade Name: | syngo.MR Applications |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.2050 |
| Classification: | Class II |
Siemens 510(k) Traditional Premarket Notification
4
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| Product Code: | Primary: LLZ, Secondary: LNH |
|---|---|
| --------------- | ------------------------------ |
4. Legally Marketed Predicate Device
| Trade Name: | syngo.MR Applications SMRVB30A |
|---|---|
| 510(k) Number: | K180336, cleared April 19, 2018 |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.2050 |
| Classification: | Class II |
| Product Code: | Primary: LLZ, Secondary: LNH |
5. Intended Use
The indications for use for the subject device is 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.
6. Device Description
syngo.MR Applications with new software version SMR VB40A consists of the following enhancements and improvements to extend the different workflows and applications which are currently offered on the predicate device, syngo.MR Applications with SMRVB30A (K180336):
Enhanced functionality within the syngo.MR General application:
-
Prostate Biopsy Support ●
Renaming and enhanced functionality within the syngo.MR Oncology application: -
syngo.MR OncoCare will be renamed to syngo.MR OncoTrend .
-
. ADC-based whole-body diffusion evaluation
7. Technological Characteristics
The subject device, synqo.MR Applications with new software version SMR VB40A, is substantially equivalent to the predicate device with regard to the software, hardware, operational environment, programming language, operating system, and performance.
syngo.MR Applications with new software version SMR VB40A offers enhancements and improvements to the existing predicate device syngo.MR Applications SMRVB30A
Siemens 510(k) Traditional Premarket Notification
5
(K180336). While these enhancements and improvements offer additional image viewing and evaluation capabilities compared to the predicate device, the conclusions from all verification and validation data suggest that these modifications bear an equivalent safety and performance profile to the predicate device.
8. Nonclinical Tests
The following performance testing was conducted on the subject device:
- -Software verification and validation testing was completed in accordance with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005)
- Performance Evaluation of the described modifications were completed -
The results from each set of tests demonstrate that the device performs as intended and is therefore substantially equivalent to the predicate device to which it has been compared.
9. Clinical Tests
No clinical tests were conducted to test the performance and functionality of the modifications introduced within syngo.MR Applications with software version SMRVB40A.
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 arqument.
No animal testing has been performed on the subject device and its modifications.
10. Safety and Effectiveness
The device labeling contains instructions for use and any necessary cautions and warnings to ensure safe and effective use of the device.
Risk management is ensured via ISO 14971:2007 compliance to identify and provide mitigation of potential hazards in a risk analysis early in the design phase and continuously throughout the development of the product. These risks are controlled via measures realized in hardware and software development, testing, and product labeling.
6
Furthermore, the device is intended for healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.
syngo.MR Applications with new software version SMR VB40A conforms to the following FDA recognized and international IEC, ISO and NEMA standards (Table 1):
| 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 2nd econd
edition 2007-03-
01 | ISO |
| 5-114 | 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 with SMR VB40A
11. Substantial Equivalence and Conclusion
syngo.MR Applications with new software version SMR VB40A is substantially equivalent to the following predicate device (Table 2):
| Predicate Device | FDA Clearance Number and Date | Product code | Manufacturer |
|---|---|---|---|
| syngo.MR Applications SMR VB30A | K180336, | ||
| cleared April 19, 2018 | LLZ, LNH | Siemens Healthcare | |
| GmbH |
Table 2: Predicate device for syngo.MR Applications with software version SMRVB40A
syngo.MR Applications with new software version SMR VB40A has the same intended use and basic technological characteristics compared to the predicate device, syngo.MR Applications with SMRVB30A (K180336), with respect to the software features and functionalities. While the new version SMRVB40A offers enhancements and improvements of the already cleared basic, neurological, oncological and cardiological workflows and applications, the conclusions from all verification and validation data suggest that the modifications bear an equivalent safety and performance profile to the predicate device. The enhancements and improvements offer additional possibilities for the image viewing and evaluation. The modifications aim to
Siemens 510(k) Traditional Premarket Notification
7
improve user workflow and reduce the complexity of the imaging procedure and do not change the intended use.
In summary, syngo.MR Applications with new software version SMR VB40A has the same general 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 with new software version SMR VB40A is substantially equivalent to the currently marketed device syngo.MR Applications with SMRVB30A (K180336).
Siemens believes that syngo.MR Applications with new software version SMR VB40A is substantially equivalent to the currently marketed device syngo.MR Applications with SMRVB30A (K180336).