(79 days)
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Not Found
No
The summary describes image acquisition and reconstruction techniques, and postprocessing for parametric image generation, but does not mention AI, ML, or related concepts.
No
The device is described as assisting in diagnosis by providing imaging information, not by directly treating a medical condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the BOLD images, when interpreted by a trained physician, "yield information that may assist in diagnosis." This directly indicates its role in the diagnostic process.
No
The device is described as a "postprocessing option for the MAGNETOM VISION and MAGNETOM SYMPHONY Systems," which are hardware MRI systems. While the package itself might be software, it is presented as an add-on or feature for existing hardware, not a standalone software device.
Based on the provided information, 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 BOLD MRI Package is a software package that processes Magnetic Resonance (MR) images acquired from a patient's body. It does not analyze samples taken from the body.
- Input: The input is MR imaging data, not biological samples.
- Output: The output is parametric images derived from the MR data, which are then interpreted by a physician.
Therefore, the BOLD MRI Package falls under the category of medical imaging software or a postprocessing tool for medical imaging, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BOLD MRI Package for MAGNETOM VISION and SYMPHONY MR systems. provides dedicated acquisition and reconstruction techniques which offer the possibility of visualization of small susceptibility changes, due to increased levels of oxygen, by parametric images. The parametric images provide parameter information, instead of anatomical information. These parametric images can be overlaid on the anatomical images to optimize the presentation of information to support the diagnostic process. These BOLD images when interpreted by a trained physician, yield information that may assist in diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
90 LNH
Device Description
The BOLD MRI Package is an postprocessing option for the MAGNETOM VISION and MAGNETOM SYMPHONY Systems
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
MRI
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
trained physician
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Laboratory and clinical testing were performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
0/12/99.
SIEMENS
198422
510 (k) Summary
This summary of 510(k), safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
I. General Information.
Establishment:
- . Address: Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, N.J. 08830
Registration Number: 2240869
| Contact Person: | Ms. Kathleen Rutherford
Manager, Regulatory Submissions |
|-----------------|------------------------------------------------------------|
| Telephone: | (732) 321-4779 |
| FAX: | (732) 321-4841 |
Date of Summary Preparation: 4/18/97
Device Name:
BOLD MRI Package for MAGNETOM VISION and MAGNETOM Trade Name: SYMPHONY MR Systems
| | • Systems Classification Name: Magnetic Resonance Diagnostic
Device, CFR $\alpha$ 892.1000 |
|-----------------------|-----------------------------------------------------------------------------------------------|
| Classification | : Class II |
| Performance Standards | : None established under Section 514 the Food, Drug,
and Cosmetic Act. |
1
ਟੀEMENS
II. Safety and Effectiveness Information Supporting Substantial Equivalence.
· Device Description:
The BOLD MRI Package is an postprocessing option for the MAGNETOM VISION and MAGNETOM SYMPHONY Systems
• Intended Use
The BOLD MRI Package for MAGNETOM VISION and SYMPHONY MR systems. provides dedicated acquisition and reconstruction techniques which offer the possibility of visualization of small susceptibility changes, due to increased levels of oxygen, by parametric images. The parametric images provide parameter information, instead of anatomical information. These parametric images can be overlaid on the anatomical images to optimize the presentation of information to support the diagnostic process. These BOLD images when interpreted by a trained physician, yield information that may assist in diagnosis.
• Technological Characteristics
The magnet, RF system, and gradient system, of the MAGNETOM VISION and MAGNETOM SYMPHONY configured with the BOLD MRI Package is substantially equivalent to the standard MAGNETOM V4SION and MAGNETOM SYMPHONY systems.
· General Safety and Effectiveness Concerns:
Operation of the MAGNETOM VISION and MAGNETOM SYMPHONY with the BOLD MRI Package is substantially equivalent to standard operation of the MAGNETOM VISION and MAGNETOM SYMPHONY systems. The following MR safety and performance parameters are unaffected by the modification:
[Safety]
- . Maximum Static Field
- . Rate of Change of Magnetic Field
- . RF Power Deposition
- . Acoustic Noise Levels
- . Specification Volume
[Performance]
- . Signal to Noise
- . Image Uniformity
- . Geometric Distortion
- . Slice Profile, Thickness and Gap
- . High Contrast Spatial Resolution
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• Substantial Equivalence:
Laboratory and clinical testing were performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to safety and effectiveness.
Kathleen M. Rutherford
Manager, Regulatory Submissions
1/19/99
Date
..
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle's head in profile, with three lines representing the feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle's head.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 1999
Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830
Re:
BOLD MRI Package for MAGNETOM VISION AND MAGNETOM SYMPHONY MR SYSTEMS Dated: November 24, 1998 Received: November 25, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH
Dear Ms. Rutherford:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 vour device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Cant. Daniel C. Schultz, M.D.
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal. Ear. Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known) K984221
Device Name: BOLD MRI Package for MAGNETOM VISION and SYMPHONY MR
Indications for Use:
The BOLD MRI Package for MAGNETOM VISION and SYMPHONY MR systems, provides dedicated acquisition and reconstruction techniques which offer the possibility of visualization of small susceptibility changes, due to increased levels of oxygen, by parametric images. The parametric images provide parameter information, instead of anatomical information. These parametric images can be overlaid on the anatomical images to optimize the presentation of information to support the diagnostic process. These BOLD images when interpreted by a trained physician, yield information that may assist in diagnosis.
(please do not write below this line- continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation Prescription Use V OR Over-The-Counter Use
David A. Legan
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Dev 510(k) Number