(198 days)
Not Found
No
The document describes a combined MR-PET system and its components, software, and intended use. While it mentions image reconstruction and processing, there is no explicit mention of AI, ML, or related terms like deep learning or neural networks in the provided text. The focus is on the integration of the two imaging modalities and standard image processing techniques.
No
The device is described as a diagnostic tool used to aid in the detection, localization, and diagnosis of diseases and disorders, not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is intended "to aid in the detection, localization, and diagnosis of diseases and disorders."
No
The device description clearly states it is a combined system of Magnetic Resonance Diagnostic Devices (MRDD) and Positron Emission Tomography (PET) scanners, which are hardware components. While it includes software, it is not solely software.
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 Siemens MR-PET system is an imaging device that uses magnetic resonance and positron emission tomography to create images of the internal structure and function of the human body. It does not analyze samples 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 providing imaging information. This is consistent with the function of an imaging device, not an IVD.
The device is a medical imaging system used for diagnostic purposes, but it operates by acquiring images of the body directly, not by analyzing samples in a laboratory setting.
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 cross-sectional MRimages, 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 MRsafe 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, OUO
Device Description
The Biograph mMR systems are combined Magnetic Resonance Diagnostic Devices (MRDD) and Positron Emission Tomography (PET) scanners. These systems are designed for whole body oncology, neurology and cardiology examinations. The Biograph mMR systems provide reqistration and fusion of high-resolution metabolic and anatomic information from the two major components of each system (MR and PET). Additional components of the system include: a patient bed and both, the acquisition and processing, workstations with associated software.
The Biograph mMR includes a 3T superconducting magnet, gradient coil, body coil and local RF coils based on those of the predicate MAGNETOM Verio 3T system. The Biograph mMR PET detectors have been updated from those of the predicate Biograph mCT to allow them to be integrated into the bore of the MR. This allows for simultaneous, precisely aligned whole body MR and PET acquisition.
Biograph mMR software is based on a combination of MAGNETOM Verio with B17 software, and Biograph mCT software. It is used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.
The Biograph mMR system, the subject of this application, is substantially equivalent to the commercially available devices above with modifications made to integrate the two modalities together into a whole-body system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR), Positron Emission Tomography (PET)
Anatomical Site
whole body
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K072237, K082427, K101550, K081453
Reference Device(s)
Not Found
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 Biograph mMR
510(k) Premarket Notification
・・
| Identification of the Submitter | JUN - 8 2011 | ||
|---|---|---|---|
| Establishment: | Siemens Medical Solutions USA, Inc. | ||
| 51 Valley Stream Parkway | |||
| Mail Code G01 | |||
| Malvern, PA 19355, USA | |||
| Establishment Registration Number 2240869 | |||
| Manufacturer: | Siemens AG | ||
| Henkestrasse 127 | |||
| D-91052 Erlangen, Germany | |||
| Establishement Registration Number 8010024 | |||
| Contact Person: | Alaine Medio, RAC | ||
| PET and PCS Regulatory Projects Manager | |||
| Siemens Medical Solutions USA, Inc. | |||
| 810 Innovation Drive | |||
| Knoxville, TN 37934 | |||
| Alaine.medio@siemens.com | |||
| Phone (865) 218-2703 | |||
| FAX (865)218-3019 | |||
| Date of Submission: | November 19, 2010 | ||
| Identification of the product | |||
| Device Proprietary Name: | Biograph mMR | ||
| Common Name: | Magnetic Resonance Diagnostic Device | ||
| Positron Emission Tomography (PET) System | |||
| Classification Name: | Emission Computed Tomography System per 21 CFR | ||
| 892.1200 | |||
| Product Code: | QUO | ||
| Classification Panel: | Radiology | ||
| Device Class: | Class II | ||
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Marketed Devices to which Equivalence is claimed
| Device | Manufacturer | 510(k) Number |
|---|---|---|
| MAGNETOM Verio | Siemens AG | K072237 |
| MR B17 Software | ||
| Update | Siemens AG | K082427 |
| Biograph mCT-X and | ||
| mCT-S (Biograph HD) | Siemens Medical Solutions USA, | |
| Inc. | K101550 and K081453 |
Device Description:
The Biograph mMR systems are combined Magnetic Resonance Diagnostic Devices (MRDD) and Positron Emission Tomography (PET) scanners. These systems are designed for whole body oncology, neurology and cardiology examinations. The Biograph mMR systems provide reqistration and fusion of high-resolution metabolic and anatomic information from the two major components of each system (MR and PET). Additional components of the system include: a patient bed and both, the acquisition and processing, workstations with associated software.
The Biograph mMR includes a 3T superconducting magnet, gradient coil, body coil and local RF coils based on those of the predicate MAGNETOM Verio 3T system. The Biograph mMR PET detectors have been updated from those of the predicate Biograph mCT to allow them to be integrated into the bore of the MR. This allows for simultaneous, precisely aligned whole body MR and PET acquisition.
Biograph mMR software is based on a combination of MAGNETOM Verio with B17 software, and Biograph mCT software. It is used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.
The Biograph mMR system, the subject of this application, is substantially equivalent to the commercially available devices above with modifications made to integrate the two modalities together into a whole-body system.
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 IEC 60601-1 series to minimize electrical and mechanical hazards.
2
Siemens Biograph mMR 510(k) Premarket Notification
The Biograph mMR conforms to the applicable FDA recognized and international IEC, ISO and NEMA standards with regards to performance and safety as required by the respective MR and PET FDA Guidance Documents.
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 cross-sectional MRimages, 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 MRsafe 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.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings and body. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is written around the border of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
Ms. Alaine Medio, RAC PET and PCS Regulatory Projects Manager Siemens Medical Solutions USA. Inc. 810 Innovation Drive KNOXVILLE TN 37932-2751
JUN - 8 2011
Re: K103429
Trade/Device Name: Biograph mMR Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: OUO Dated: April 19, 2011 Received: April 20, 2011
Dear Ms. Medio:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Biograph mMR
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 cross-sectional MR-images. spectroscopic images andlor 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) AND/OR
Over the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S. Postel
Division Sign-Off)
Division of Radiological Devices
Office of in Vitro Diagnostic Device Evaluation and Safety
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