(69 days)
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No
The summary describes software for displaying temporal variations and creating parametric images from MR data, but there is no mention of AI, ML, or related concepts like training sets or performance metrics typically associated with AI/ML algorithms.
No
The device is described as a software package that supports the diagnostic process by providing time intensity curves or creating parametric images, assisting trained physicians in diagnosis. It does not perform any therapy.
Yes
The device is described as supporting the "diagnostic process" and assisting in "diagnosis," specifically mentioning its use in "diagnosis of lesions by temporal analysis of tumor enhancement."
No
The device is described as a "post processing option for the MAGNETOM VISION and SYMPHONY MR system," indicating it is a software component integrated with existing MR hardware systems, not a standalone software-only 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 such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Device Function: The Perfusion Package for MAGNETOM Vision and Symphony MR Systems is a software package that processes MR imaging data. It analyzes changes in contrast over time within the body, based on the MR scan.
- No Sample Analysis: The device does not analyze biological samples taken from the patient. It works directly with the imaging data acquired by the MR system.
Therefore, while it is a medical device used in the diagnostic process, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Perfusion Package for MAGNETOM VISION and SYMPHONY MR Systems is a software package which allows the display of temporal variations in dynamis MR Datasets, showing changes in contrast over time. Its purpose is to provide either time intensity curves or the creation of parametric images for parameters like time to peals that support the diagnostic process. These images when interpreted by a trained physician, yield information that may assist in diagnosis. One clinical application where this could be useful is the diagnosis of lesions by temporal analysis of tumor enhancement.
Product codes (comma separated list FDA assigned to the subject device)
90 LNH
Device Description
The Perfusion Package is a post processing option for the MAGNETOM VISION and SYMPHONY MR system.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
MR
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
SIEMENS
FEB 2 1999
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 (732) 321-4841 FAX:
Date of Summary Preparation: 10/29/98
Device Name:
| • Trade Name: | Perfusion Package for Magnetom Vision and
Symphony MR systems. |
|--------------------------------|----------------------------------------------------------------------------|
| • Systems Classification Name: | Magnetic Resonance Diagnostic
Device, 21 CFR § 892.1000 |
| • Classification : | Class II |
| • Performance Standards : | None established under Section 514 of the Food,
Drug, and Cosmetic Act. |
1
SiEMENS
II. Safety and Effectiveness Information Supporting Substantial Equivalence.
· Device Description:
The Perfusion Package is a post processing option for the MAGNETOM VISION and SYMPHONY MR system.
· Intended Use
The Perfusion Package for MAGNETOM VISION and SYMPHONY MR Systems is a software package which allows the display of temporal variations in dynamis MR Datasets, showing changes in contrast over time. Its purpose is to provide either time intensity curves or the creation of parametric images for parameters like time to peals that support the diagnostic process. These images when interpreted by a trained physician, yield information that may assist in diagnosis. One clinical application where this could be useful is the diagnosis of lesions by temporal analysis of tumor enhancement.
• Technological Characteristics
The magnet, RF system, and gradient system, of the MAGNETOM VISION and SYMPHONY configured with the Perfusion Package is substantially equivalent to the standard MAGNETOM Vision and Symphony system.
• General Safety and Effectiveness Concerns:
Operation of the MAGNETOM VISION and SYMPHONY system, with the Perfusion Package is substantially equivalent to standard operation of the MAGNETOM VIGION and SYMPHONY system. 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
2
SIEMENS
STATE FOR STORES PORTER PLANES PERFECT PERFECT PERFECT PARTY PERSENT PARTY PERSENT PARTY PERSENT PARTY PERSEASE
• 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
ﮧ ﭘﯿﻨ
Kathleen M. Rutherford Manager, Regulatory Submissions
1/19/99
Date
3
Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and is likely the header of a document or a sign. The words are all capitalized and evenly spaced.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 1999 FEB
Kathleen Rutherford Manager, Regulatory Submission Siemens Medical Systems, Inc. Sales and Service 186 Wood Avenue South Iselin, NJ 08830
Re:
K984224 Magnetic Resonance (MR) Diagnostic Device Accessory 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,
.
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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Device Name: Perfusion Package for MAGNETOM Vision and Symphony Systems
Indications for Use:
The Perfusion Package for MAGNETOM Vision and Symphony MR Systems is a software package which allows the display of temporal variations in dynamic MR Datasets, showing changes in contrast over time. Its purpose is to provide either time intensity curves or the creation of parametric images for parameters like time to peak that support the diagnostic process. These images when interpreted by a trained physician, yield information that may assist in diagnosis. One clinical application where this could be useful is the diagnosis of lesions by temporal analysis of tumor enhancement.
(please do not write below this line- continue on another page if needed)
OR
Concurrence of CDRH, Office of Device Evaluation
Prescription Use \
Over-The-Counter Use
Whil L. Segmon
(Division Sign-Off)
Division of Reproductive, Abdominal, EN and Radiological Devi 510(k) Number