(102 days)
No
The document describes post-processing software for viewing and evaluating medical images, but there is no mention of AI, ML, or related concepts like deep learning, algorithms that learn from data, or adaptive capabilities.
No
The device is described as "post-processing software" for "viewing, manipulating, and evaluating" images from diagnostic devices like MRI, PET, and CT. Its purpose is to assist healthcare professionals in evaluating diagnostic images, not to directly treat or act therapeutically on a patient.
No
The software is explicitly described as "post-processing software / applications" for "viewing and evaluating the designated images provided by a magnetic resonance diagnostic device," not as a diagnostic device itself. It processes images from a diagnostic device.
Yes
The device is described solely as "post-processing software / applications" for viewing, manipulating, and evaluating medical images, with no mention of accompanying hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this software is for post-processing and evaluating images obtained from magnetic resonance, PET, and CT diagnostic devices. It works with images, not biological samples.
- Intended Use: The intended use is for viewing and evaluating images provided by diagnostic devices, not for performing tests on patient samples.
Therefore, this device falls under the category of medical image processing software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The software comprising the syngo.MR post-processing applications are postprocessing software / applications to be used for viewing and evaluating the designated images provided by a magnetic resonance diagnostic device. All of the software applications comprising the syngo.MR post-processing applications have their own indications for use.
syngo.mMR General is a syngo based post-processing software for viewing, manipulating, and evaluating MR, PET, and CT images as well as MR-PET and CT-PET images.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, LNH
Device Description
syngo.mMR General is a syngo.via-based post-processing software / application to be used for viewing and evaluating MR images provided by a magnetic resonance diagnostic device and enabling structured evaluation of MR images. syngo.mMR General comprises the following: While viewing (i.e. assessing) of images from other vendors is always possible; for advanced postprocessing applications, some of the post-processing steps may depend on information contained in private DICOM tags ,therefore evaluation and processing of images can't be guaranteed for other vendors.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR, PET, and CT images as well as MR-PET and CT-PET images.
Anatomical Site
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
SIEMENS
Traditional 510(k) Submission for: syngo.MR Post-Processing Softwar
syngo.mMR General 510(k) Summary:
This 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.
Date of Summary Preparation: April 7, 2014
l. General Information
| Importer / Distributor | Siemens Medical Solutions USA, Inc |
|---|---|
| 51 Valley Stream Parkway | |
| Mail Code D02 | |
| Malvern, PA 19355, USA |
2240869 Registration Number:
Siemens AG Manufacturer Medical Solutions Henkestrasse 127 D-91052 Erlangen, Germany
3002808157 Registration Number:
Contact Person:
Cordell L. Fields, Esq Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Pkwy Mail Code D02 Malvern, PA 19355, USA Phone: (610) 219-8518 Fax: (610) 448-1787 Email: Cordell.Fields@siemens.com
JUL 1 8 2014
1
| Data | Details |
|---|---|
| Trade name / | |
| Device Proprietary | |
| Name: | syngo.mMR General (NEW Indications for Use) |
| syngo.mMR General is available as single application. | |
| Classification | |
| Name: | Regulation Description: |
- Picture Archiving and Communication System (PACS) |
| Classification
Panel: | Radiology |
| Device
Classification: | Class II devices |
| Regulation number: | 21 CFR § 892.2050 |
| Product Code: | Primary: LLZ, Secondary: LNH |
Device Name and Classification
II. Safety and Effectiveness Information Supporting Substantial Equivalence
Intended Use
The software comprising the syngo.MR post-processing applications are postprocessing software / applications to be used for viewing and evaluating the designated images provided by a magnetic resonance diagnostic device. All of the software applications comprising the syngo.MR post-processing applications have their own indications for use.
syngo.mMR General is a syngo based post-processing software for viewing, manipulating, and evaluating MR, PET, and CT images as well as MR-PET and CT-PET images.
Device Description
syngo.mMR General is a syngo.via-based post-processing software / application to be used for viewing and evaluating MR images provided by a magnetic resonance diagnostic device and enabling structured evaluation of MR images. syngo.mMR General comprises the following:
While viewing (i.e. assessing) of images from other vendors is always possible; for advanced postprocessing applications, some of the post-processing steps may depend on information contained in private DICOM tags ,therefore evaluation and processing of images can't be guaranteed for other vendors.
2
11
Table 1: syngo.mMR General and its content; new applications for this submission are denoted (New); all other applications are currently cleared.
| Medical device /
post-processing
| application | covered single and engines applications |
|---|---|
| syngo.mMR | |
| General | syngo.mMR General (NEW Indications for USE) |
| syngo.mMR General is a syngo based post-processing | |
| software for viewing, manipulating, and evaluating MR, PET, | |
| and CT images as well as MR-PET and CT-PET images. |
General Safety and Effectiveness Concerns
Instructions for use are included within the device labeling which enables the user to operate the device in a safe and effective manner.
Product Risk Management is accomplished through a process in compliance with ISO 14971:2009 to identify and provide mitigation to potential hazards in a Risk Analysis beginning early in the design phase and continuing throughout the development of the product. These risks are controlled via measures realized in software development. SW testing and product labeling. To minimize risks, Siemens adheres to recognized and established industry practices and standards. Furthermore, the operators are healthcare professionals familiar with and responsible for the evaluating and post-processing of MR images.
syngo.mMR General 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.
Substantial Equivalence
syngo.mMR General is substantially equivalent to the following current legally marketed device:
| Predicate Device Name | FDA
Clearance
Number | FDA Clearance
Date | Product Code |
|-------------------------------------------------------|----------------------------|-----------------------|--------------|
| syngo.MR Post-Processing
Software Version SMRVA16B | K133401 | March 11, 2014 | LLZ
LNH |
Table 2: Predicate device for syngo.mMR General
Conclusion as to Substantial Equivalence ·
The syngo.MR post-processing application is intended for similar indications as cleared in the predicate device.
In summary, Siemens is of the opinion that the syngo.MR post-processing application does not raise new questions of safety or effectiveness and are substantially equivalent
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K140897
Page 4 of 4
to the currently marketed device syngo.MR Post-Processing Software Version SMRVA16B (K133401 cleared on March 11, 2014)
There are minor changes to the indications for use for the subject device with regards to syngo.mMR General. The differences give the device greater capabilities than the predicate, but the technological characteristics and functionalities are similar.
Therefore, Siemens believes that the subject device, the syngo.MR post-processing application, is substantially equivalent to the predicate device listed above in Table 2.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Goly Silver Spring, MD 20993-0002
July 18, 2014
SIEMENS MEDICAL SOLUTIONS USA, INC. CORDELL FIELDS, ESQ. 51 VALLEY STREAM PARKWAY MALVERN PA 19355
Re: K140897
Trade/Device Name: syngo.mMR General Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, LNH Dated: June 18, 2014 Received: June 19, 2014
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. 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 cither 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041
5
Page 2—Mr. Fields
or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D. O'Hara
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140897
Device Name syngo.mMR General
Indications for Use (Describe)
The software comprising the syngo.MR post-processing applications are post-processing software/applications to be used for viewing and evaluating the designated images provided by a magnetic resonance diagnostic device. All of the software applications comprising the syngo.MR post-processing applications have their own indications for use.
syneo.mMR General is a syngo based post-processing software for viewing, and evaluating MR, PET, and CT images as well as MR-PET and CT-PET images.
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)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Michael D. O'Hara
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."
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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FORM FDA 3881 (1/14)