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.

Device Description

The Perfusion Package is a post processing option for the MAGNETOM VISION and SYMPHONY MR system.

AI/ML Overview

The provided 510(k) summary for the Siemens Perfusion Package for Magnetom Vision and Symphony MR systems does not contain the detailed information requested regarding specific acceptance criteria, a quantitative study proving it meets those criteria, or a comparative effectiveness study.

Instead, the submission focuses on demonstrating substantial equivalence to existing devices and assuring that the new software package does not raise new questions of safety and effectiveness compared to the standard operation of the base MR system.

Here's an breakdown of what can be extracted or inferred, and what is explicitly missing based on the provided document:

Extracted/Inferred Information:

The core "acceptance criteria" here are implied by the FDA's substantial equivalence pathway, meaning the device must be as safe and effective as a legally marketed predicate device. The document explicitly states that the technological differences (the Perfusion Package) do not raise any new safety or effectiveness concerns.

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Safety:
- Maximum Static Field unaffected	- Unaffected
- Rate of Change of Magnetic Field unaffected	- Unaffected
- RF Power Deposition unaffected	- Unaffected
- Acoustic Noise Levels unaffected	- Unaffected
- Specification Volume unaffected	- Unaffected
Performance (Imaging):
- Signal to Noise unaffected	- Unaffected
- Image Uniformity unaffected	- Unaffected
- Geometric Distortion unaffected	- Unaffected
- Slice Profile, Thickness and Gap unaffected	- Unaffected
- High Contrast Spatial Resolution unaffected	- Unaffected
Clinical Efficacy (Qualitative):
- Provides time intensity curves to support diagnosis	- Product provides this feature
- Creates parametric images (e.g., time to peak) to support diagnosis	- Product provides this feature
- Assists in diagnosis of lesions by temporal analysis of tumor enhancement when interpreted by a trained physician	- Intended use claims this assistance
No New Safety/Effectiveness Questions	- Laboratory and clinical testing were performed to support this claim

2. Sample size used for the test set and the data provenance:

Not specified. The document mentions "Laboratory and clinical testing were performed," but provides no details on sample size, data origin (country), or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified. "Trained physician" is mentioned in the intended use, but there's no information on expert involvement in testing or ground truth establishment.

4. Adjudication method for the test set:

Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

Not specified. There is no mention of an MRMC study or any comparison of human readers with vs. without AI assistance. The focus is on the software being equivalent to the standard operation of the MR system, not on improving human reader performance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Partially addressed. The device is a "post processing option" and its "purpose is to provide either time intensity curves or the creation of parametric images...These images when interpreted by a trained physician, yield information that may assist in diagnosis." This implies it's an algorithm-only output that a human then interprets, rather than an AI assisting in real-time reading. However, the performance metrics are related to the MR system's underlying capabilities, not specific diagnostic accuracy of the generated curves/images.

7. The type of ground truth used:

Not specified. The document implies the "ground truth" is primarily based on the functional equivalence of the MR system with and without the software package, as well as the qualitative ability to generate time-intensity curves and parametric images for interpretation by a physician. There's no mention of specific clinical ground truth (e.g., pathology, outcomes data) beyond supporting the diagnostic process.

8. The sample size for the training set:

Not applicable / Not specified. This appears to be more of a post-processing software package applied to existing MR data rather than a machine learning model that requires a dedicated "training set" in the modern sense. If there was an ML component, its training data details are not provided.

9. How the ground truth for the training set was established:

Not applicable / Not specified. (See point 8)

Conclusion:

This 510(k) summary, typical for its era (1999), focuses on demonstrating substantial equivalence by asserting that the Perfusion Package does not alter the fundamental safety and established performance of the Siemens MAGNETOM Vision and Symphony MR systems. It does not provide the kind of detailed quantitative performance study, sample sizes, expert qualifications, or ground truth methodologies that are common in submissions for AI/ML-based medical devices today. The "acceptance criteria" are predominantly those associated with maintaining the safety and performance standards of the base MR imaging system rather than a new diagnostic claim in itself.

Summary

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K984224

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 andSymphony MR systems.
• Systems Classification Name:	Magnetic Resonance DiagnosticDevice, 21 CFR § 892.1000
• Classification :	Class II
• Performance Standards :	None established under Section 514 of the Food,Drug, and Cosmetic Act.

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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

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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

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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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Image /page/4/Picture/0 description: The image shows the word "SIEMENS" in large, bold letters. Below the word "SIEMENS", there is the text "510(k) Number (if known)" followed by the number "K984224". The text and number are smaller than the word "SIEMENS".

Device Name: Perfusion Package for MAGNETOM Vision and Symphony Systems

Indications for Use:

(please do not write below this line- continue on another page if needed)

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

Regulation Number and Section

§ 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.