(104 days)
No
The summary describes improvements to existing MR and PET imaging sequences and hardware (head coil), focusing on image quality and compliance with standards. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is used to detect, localize, and diagnose diseases, not to treat them.
Yes
The "Intended Use / Indications for Use" section states: "These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders."
No
The device description explicitly states it is "system software" for a combined MR-PET system and mentions hardware components like the "mMR 32 Head coil" and "RF transmission mode." The performance studies also include testing of the head coil and image quality assessments related to hardware.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The description of the Siemens MR-PET system clearly states it is an imaging system that produces images and measures distributions within the human body using MR and PET technologies.
- The intended use is for imaging and aiding in the detection, localization, and diagnosis of diseases and disorders through imaging. This is distinct from analyzing biological samples for diagnostic information.
- The device description focuses on hardware (coils) and software for image acquisition and processing. There is no mention of reagents, assays, or analysis of biological specimens, which are hallmarks of IVDs.
Therefore, this device falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Siemens MR-PET system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.
These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders.
The MR is intended to produce transverse, sagittal, coronal and obligue crosssectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their label ing. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles.
The PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.
The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.
Product codes
OUO, LNH, LNI, KPS
Device Description
The subject device, syngo MR E11P-AP01 system software for the Biograph mMR system, is a modification of the previously cleared predicate device Biograph mMR with syngo MR E11P system software (K163234, cleared February 28, 2017). The subject device has been modified to include the new mMR 32 Head coil for combined MR-PET usage as well as improvements to the system software syngo MR E11P.
- Improvement of the SPACE pulse sequence type with:
- CAIPIRINHA acquisition technique named as CAIPIRINHA o SPACE (migrated from previously cleared reference device K173592)
- Additional magnetization preparation mode "Non-sel. T2 prep. IR" o for brain imaging with improved dark-fluid contrast.
- Implementation of "CP-only" RF transmission mode based on the requirements of 60601-2-33 Ed. 3.2:2015.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Positron Emission Tomography (PET)
Anatomical Site
Human body (general)
Brain (specific for improved dark-fluid contrast)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
appropriately trained health care professionals
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)
Nonclinical Tests:
- Sample clinical images were taken with the modified sequences and the migrated mMR 32Ch Head Coil.
- Image quality assessments of the modified sequences and the mMR 23Head coil were completed.
- Quantitative image evaluations of the mMR 32 Head Coil for MR and PET images were completed.
- Validation of the newly generated attenuation map by phantom testing
- 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"
Clinical Tests:
- Clinical images are provided to support the migrated coil as well as the improved software features of the subject device.
Key results: The results from each set of tests demonstrate that the device performs as intended and is thus substantially equivalent to the predicate devices to which it has been compared.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.
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, 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.
Siemens Medical Solutions USA, Inc. % Cordell L. Fields, Esq. Regulatory Affairs Professional 40 Liberty Boulevard, Mail Code 65-1A MALVERN PA 19355
May 11, 2020
Re: K200213
Trade/Device Name: Biograph mMR with syngo MR E11P-AP01 system software Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: OUO, LNH, LNI, KPS Dated: April 10, 2020 Received: April 16, 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
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 bold, sans-serif font. The color of the text is a bright teal. The letters are evenly spaced and the word is horizontally oriented. The background is white.
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)
Device Name
Biograph mMR with syngo MR E11P-AP01 system software
Indications for Use (Describe)
The Siemens MR-PET system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined sys tem maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.
These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders.
The MR is intended to produce transverse, sagittal, coronal and obligue crosssectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their label ing. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles.
The PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.
The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.
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:
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."
FORM FDA 3881 (7/17)
Page 1 of 1
3
Image /page/3/Picture/0 description: The image contains the word "SIEMENS" in a bold, sans-serif font. The text is a teal color. The letters are evenly spaced and the word is horizontally oriented.
510(k) Summary: Biograph mMR with syngo MR E11P-AP01
Company:
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard, 65-1A
Malvern, PA 19355
Date Prepared: January 22, 2020
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.
-
- General Information
Importer/Distributor: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard. Mail Code 65-1A Malvern, PA 19355, USA Establishment Registration Number: 2240869
- General Information
Manufacturing Site: Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany Establishment Registration Number: 3002808157
2. Contact Person:
Mr. Cordell L. Fields, Esq. Regulatory Affairs Technical Specialist Siemens Medical Solutions USA, Inc. Phone: (610) 448-6469 E-mail: cordell.fields@siemens-healthineers.com
Device Name and Classification: 3.
| Common / Usual Name | mMR Biograph |
|---|---|
| Trade Name | Biograph mMR with syngo MR E11P-AP01 system |
| software | |
| Classification Name | Emission Computed Tomography System |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR § 892.1200 |
| Device Class: | II |
Siemens 510(k) Traditional Premarket Notification
January 22, 2020
syngo MR E11P-AP01 Software for Siemens Healthcare GmbH MR Systems Biograph mMR
4
Primary Product Code: ouo Secondary Product Code: LNH, LNI, KPS
4. Intended Use
The Siemens MR-PET system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.
These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders.
The MR is intended to produce transverse, sagittal, coronal and oblique crosssectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles.
The PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.
The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.
5. Device Description:
The subject device, syngo MR E11P-AP01 system software for the Biograph mMR system, is a modification of the previously cleared predicate device Biograph mMR with syngo MR E11P system software (K163234, cleared February 28, 2017). The subject device has been modified to include the new mMR 32 Head coil for combined MR-PET usage as well as improvements to the system software syngo MR E11P.
- Improvement of the SPACE pulse sequence type with:
5
Image /page/5/Picture/1 description: The image shows the word "SIEMENS" in a sans-serif font. The text is a teal color. The background is white.
- CAIPIRINHA acquisition technique named as CAIPIRINHA o SPACE (migrated from previously cleared reference device K173592)
- Additional magnetization preparation mode "Non-sel. T2 prep. IR" o for brain imaging with improved dark-fluid contrast.
- Implementation of "CP-only" RF transmission mode based on the । requirements of 60601-2-33 Ed. 3.2:2015.
6. Summary of Technological Characteristics
While there are differences in technological characteristics between the subject device Biograph mMR with software syngo MR E11P-AP01 and the predicate device Biograph mMR with syngo MR E11P (K163234, cleared February 28, 2017), these differences have been tested and the conclusions from the nonclinical data suggests that the feature bear an equivalent safety and performance profile as that of the predicate device.
The new mMR 32Ch Head Coil for combined MR-PET usage is essentially based on the 32Ch Head Coil, initially cleared with K072909 (November 05, 2007), most recently cleared with MAGNETOM Verio with syngo MR E11D (K181613). The improvement of SPACE pulse sequence type is transferred unchanged from MAGNETOM Skyra with Software syngo MR E11C-AP04, cleared with K173592.
Syngo MR E11P-AP01 SW conforms to the standard for software medical devices (IEC 62304:2006) and IEC as well as NEMA standards.
Nonclinical Tests 7.
The following performance testing was conducted on the subject device
- . Sample clinical images were taken with the modified sequences and the migrated mMR 32Ch Head Coil.
- . Image quality assessments of the modified sequences and the mMR 23Head coil were completed.
- . Quantitative image evaluations of the mMR 32 Head Coil for MR and PET images were completed.
- Validation of the newly generated attenuation map by phantom testing ●
- 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"
6
The results from each set of tests demonstrate that the device performs as intended and is thus substantially equivalent to the predicate devices to which it has been compared.
8. Clinical Tests
Clinical images are provided to support the migrated coil as well as the improved software features of the subject device.
9. Safety and Effectiveness
The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.
Risk management is ensured via a risk analysis in compliance with ISO 14971:2007 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, such as the IEC 60601-1 series, to minimize electrical and mechanical risk. Furthermore, the operators are healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.
The Biograph mMR with syngo MR E11P-AP01 conforms to the applicable FDA recognized and international IEC, ISO and NEMA standards.
| Recognition
Number | Product
Area | Title of Standard | Reference
Number and date | Standards
Development
Organization |
|-----------------------|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|------------------------------------------|
| 19-4 | General | Medical electrical equipment - part 1:
general requirements for basic safety
and essential performance | ES60601-
1:2005/(R) 2012
and A1:2012 | AAMI / ANSI |
| 19-8 | General | Medical electrical equipment - Part 1-
2: General requirements for basic
safety and essential performance -
collateral standard: electromagnetic
disturbances - requirements and tests. | 60601-1-2
Edition 4.0
2014-02 | IEC |
| 12-295 | Radiology | Medical electrical equipment - Part 2-
33: Particular requirements for the
basic safety and essential
performance of magnetic resonance
equipment for medical diagnosis | 60601-2-33 Ed.
3.2:2015 | IEC |
Siemens 510(k) Traditional Premarket Notification
January 22, 2020
syngo MR E11P-AP01 Software for Siemens Healthcare GmbH MR Systems Biograph mMR
7
SIEMEN
| 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 |
| 5-114 | 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 Edition
1.1 2015-06 | IEC |
| 12-232 | Radiology | Acoustic Noise Measurement
Procedure for Diagnosing Magnetic
Resonance Imaging Devices | MS 4-2010 | NEMA |
| 12-300 | Radiology | Digital Imaging and Communications
in Medicine (DICOM) Set 03/16/2012
Radiology | PS 3.1 - 3.20
(2016) | NEMA |
| 2-220 | Biocom-
patibility | Biological evaluation of medical
devices -- part 1: evaluation and
testing within a risk management
process. (Biocompatibility) | 10993-
1:2009/(R) 2013 | AAMI
ANSI
ISO |
| 12-288 | Radiology | Characterization of Phased Array Coils
for Diagnostic Magnetic Resonance
Images (MRI) | MS 9-2008 | NEMA |
| 12-265 | Radiology | Performance measurements of
positron emission tomographs | NU 2-2012 | NEMA |
10. Substantial Equivalence
The subject device, Biograph mMR with syngo MR E11P-AP01, was developed from the previous software version VE11P.
| Predicate Device | FDA Clearance Number | Product Code | Manufacturer |
|---|---|---|---|
| Biograph mMR with Software syngo MR E11P | K163234, cleared February 28, 2017 | OUO, LNH, LNI, KPS | Siemens AG / Siemens Healthcare GmbH |
11. Conclusion as to Substantial Equivalence
syngo MR E11P-AP01 software for the Biograph mMR has the same intended use and different technological characteristics as the predicate device Biograph mMR with syngo MR E11P (K163234).
While there are differences in technological characteristics between the subject device and predicate device, these differences have been tested and the
8
SIEMENS
conclusions from the non-clinical data suggests that the feature bear an equivalent safety and performance profile as that of the predicate device.
The new features on the Biograph mMR with syngo MR E11P-AP01 provides improved capabilities and options to the user; and reduces image artifacts.
The differences between the subject device and the predicate device, include incorporation / adaptation of the mMR 32 Head coil and improvements on the SPACE pulse sequence type as well as the implementation of "CP-only" RF transmission mode based on the requirements of 60601-2-33 Ed. 3.2:2015.
Therefore, Siemens believes that the subject device, Biograph mMR System with software syngo MR E11P-AP01 does not raise new questions of safety or effectiveness and is substantially equivalent to the currently marketed device Biograph mMR with syngo MR E11P.