(22 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on the hardware and software integration of existing MR and PET technologies, without mentioning any AI/ML-specific functionalities.
No
The device is used for diagnosis and detection of diseases, not for treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the systems are intended "to aid in the detection, localization, and diagnosis of diseases and disorders."
No
The device description explicitly states that the new software version includes "coil modifications and other modified hardware for the Biograph mMR systems," indicating it is not solely software.
Based on the provided text, the Siemens MR-PET system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Siemens MR-PET system is an imaging device that directly scans the human body using magnetic resonance and positron emission tomography. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states that the system is used to "aid in the detection, localization, and diagnosis of diseases and disorders" by producing images and measuring the distribution of radiopharmaceuticals within the human body.
Therefore, the Siemens MR-PET system falls under the category of in vivo diagnostic imaging devices, not in vitro diagnostic devices.
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 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.
Product codes
QUO
Device Description
The Biograph mMR systems are combined Maqnetic Resonance Imaging and Positron Emission Tomography scanners. The Biograph mMR systems provide registration and fusion of high-resolution metabolic, physiologic and anatomic information from the two major components of each system (PET and MR) acquired simultaneously and isocentrically.
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 alianed MR and PET image coordinate systems.
Software syngo MR B20P is a new software version for the Siemens Biograph mMR systems that were previously cleared under K103429 (running software version syngo MR B18P).
New scanners will be manufactured with syngo MR B20P; existing scanners can be upgraded to this software version. The new software version includes new software features, coil modifications and other modified hardware for the Biograph mMR systems.
Summary of New Features with Biograph mMR Software syngo MR B20P:
Software
- New applications/software/sequences
- Reconstruction improvements
- Usability improvements 0
- Quality control improvements 0
- New sequences (e.g. for joints and liver imaging) o
- Multi-Nuclear Spectroscopy 0
Hardware
- Modified coils:
- 4 Channel Special Purpose Coil o
- mMR Head/Neck Coil o
- mMR Breast Coil O
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging, Positron Emission Tomography
Anatomical Site
Human body (general), joints, liver
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
The following performance testing was conducted on the subject device:
- . The coils were tested for SNR, image uniformity, heating, and hybrid mode.
- The performance parameters of MNO Spectroscopy were phantom-. : tested.
- All software features were verified and validated. .
- PET performance testing in accordance with NEMA NU:2 .
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.
CLINICAL TESTS
There were not any clinical tests conducted to support the subject device and the substantial equivalence argument, however clinical images are provided to better support the descriptions in Section 11 of the modified features of the subject device.
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
SIEMENS
Special 510(k) Submission
K13326
Page 1 of 5
This 510(k) summary is being submitted in accordance with 21 CFR § 807.92.
5.1 General Information
| Establishment | Siemens Medical Solutions USA, Inc.
51 Valley Stream Parkway
Mail Code D02
Malvern, PA 19355, USA
Registration Number 2240869 | NOV 1 2 2013 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Manufacturer | Siemens AG
Henkestrasse 127
D-91052 Erlangen, Germany
Registration Number 3002808157 | |
| | SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.
Siemens MRI Center
Hi-Tech Industrial park (middle)
Gaoxin C. Ave., 2nd
Shenzhen 518057, P.R. CHINA
Registration Number 3004754211 | |
| Contact Person | Ms. Nadia Sookdeo
Regulatory Affairs Technical Specialist
Siemens Medical Solutions USA, Inc.
51 Valley Stream Parkway
Mail Code D02
Malvern, PA 19355, USA
Phone: (610) 448-4918
E-mail: Nadia.Sookdeo@siemens.com | |
| Device Name | Software syngo MR B20P for Biograph mMR | |
| CFR Code | 21 CFR § 892.1200 | |
| Classification | Class II | |
| Product Codes | QUO | |
| Classification Name | Magnetic Resonance Diagnostic Device (MRDD) | |
1
SIEMENS
5.2 Information Supporting Substantial Equivalence
DEVICE DESCRIPTION
The Biograph mMR systems are combined Maqnetic Resonance Imaging and Positron Emission Tomography scanners. The Biograph mMR systems provide registration and fusion of high-resolution metabolic, physiologic and anatomic information from the two major components of each system (PET and MR) acquired simultaneously and isocentrically.
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 alianed MR and PET image coordinate systems.
Software syngo MR B20P is a new software version for the Siemens Biograph mMR systems that were previously cleared under K103429 (running software version syngo MR B18P).
New scanners will be manufactured with syngo MR B20P; existing scanners can be upgraded to this software version. The new software version includes new software features, coil modifications and other modified hardware for the Biograph mMR systems.
Summary of New Features with Biograph mMR Software syngo MR B20P:
Software
- . New applications/software/sequences
- o Reconstruction improvements
- Usability improvements 0
- Quality control improvements 0
- New sequences (e.g. for joints and liver imaging) o
- Multi-Nuclear Spectroscopy 0
Hardware
- . Modified coils:
- 4 Channel Special Purpose Coil o
- mMR Head/Neck Coil o
- mMR Breast Coil O
2
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.
NONCLINICAL TESTS
The following performance testing was conducted on the subject device:
- . The coils were tested for SNR, image uniformity, heating, and hybrid mode.
- The performance parameters of MNO Spectroscopy were phantom-. : tested.
- All software features were verified and validated. .
- PET performance testing in accordance with NEMA NU:2 .
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.
CLINICAL TESTS
3
SIEMENS
There were not any clinical tests conducted to support the subject device and the substantial equivalence argument, however clinical images are provided to better support the descriptions in Section 11 of the modified features of the subject device.
SUBSTANTIAL EQUIVALENCE
Biograph mMR System with software syngo MR B20P is substantially equivalent to the following predicate devices:
| Primary
Predicate Device | FDA
Clearance
Number | FDA Clearance
Date | Main
Product
Code |
|---------------------------------------------|----------------------------|-----------------------|-------------------------|
| Biograph mMR with
software syngo MR B18P | K103429 | June 8, 2011 | OUO |
| Supporting
Devices for
Components | FDA
Clearance
Number | FDA Clearance
Date | Main
Product
Code |
|---------------------------------------------|----------------------------|-----------------------|-------------------------|
| syngo MR B19 for
MAGNETOM Verio | K123938 | February 12, 2013 | LNH |
| Biograph mCT with
software PETsyngo VG50 | K123737 | January 29, 2013 | 90 KPS
and 90 JAK |
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 beginning early in the design cycle and continuing throughout the development of the product. Siemens Medical Solutions USA, Inc. and Siemens AG adhere to recognized and established industry standards, such as the IEC 60601-1 series, to minimize electrical and mechanical hazards.
The Biograph mMR System with software syngo MR B20P conform 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.
4
SIEMENS
SUBSTANTIAL EQUIVALENCE CONCLUSION
There are no changes to the Indications for Use for the subject device, compared to that of the predicate Biograph mMR system with and the Biograph mMR System with software syngo MR B20P.
While the new hardware and software provides the user with additional capabilities compared to the subject system with the previous software version syngo MR B18P, it has the same technological characteristics as that of the predicate devices. The Biograph mMR is evolving with respect to the Biograph mCT with software PETsyngo VG50 (K123737) and the MAGNETOM Verio with syngo MR B19 (K123938). The new features on the Biograph mMR with syngo MR B20P make the systems and software more user-friendly. These modifications improve the user's workflow and reduce the complexity of certain imaging procedures; providing additional output, information, and options to the user; and reduce image artifacts.
The differences between the subject device and the predicate devices, include incorporation / adaptation of cleared features from the Biograph mCT with software PETsyngo VG50 (K123737), the MAGNETOM Verio with syngo MR B19 (K123938). and extensions of syngo MR B18P features (K103429). which give the Biograph mMR system similar capabilities with respect to the predicate devices, but have the same technological characteristics as the predicate devices, and do not introduce any new issues of safety or effectiveness. Therefore, Siemens believes that the subject device, Biograph mMR System with software syngo MR B20P is substantially equivalent to the predicate devices. Biograph mMR with syngo MR B18 and the MAGNETOM Verio with syngo MR B19.
5
Image /page/5/Picture/0 description: The image shows a black and white logo for the Department of Health & Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with three curved lines representing its wings or feathers.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 12, 2013
SIEMENS MEDICAL SOLUTIONS USA, INC. NADIA SOOKDEO REGULATORY AFFAIRS TECHNICAL SPECIALIST 51 VALLEY STREAM PARKWAY MAILCODE D02 MALVERN PA 19355
Re: K133226
Trade/Device Name: Biograph mMR Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: OUO Dated: October 18, 2013 Received: October 21, 2013
Dear Ms. Sookdeo:
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. Ilisting 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 (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.
6
Page 2-Ms. Sookdeo
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 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" (21CFR 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/defaylt.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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address hup://www.lda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Melvin M. Oza
for
JANINE MORRIS Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
Indications for Use
K133226 510(k) Number (if known) __
Software syngo MR B20P for Biograph mMR Device Name:
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 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.
Prescription Use x (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH. Office of In Viro Diagnostics and Radiological Health (OIR) ・・・ . Haras ----------------------------------------------------------------------------------------------------------------------------------------------------------------------(Division Sign Off) "" Division of Radiological Health Office of In Fitro Diagnostic and Radiological Health 510(k) K133226 Page 1 of