The MAGNETOM Rhapsody system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The MAGNETOM Rhapsody system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculoskeletal, vascular, cardiac, and neuro systems. The images produced by the Rhapsody system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spinspin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

Due to the 'open' design of the system, the Rhapsody may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles.

Device Description

The Modified MAGNETOM Rhapsody System is a 1.0 T open superconducting magnet designed scanner. It consists of the same types of hardware (with a modified SAFE designed bearing in the currently available MAGNETOM Rhapsody systems. These original systems were cleared under premarket notification K003628.

AI/ML Overview

This document does not contain information about explicit acceptance criteria or a study designed to prove the device meets those criteria. Instead, it is a 510(k) summary for a modification to an existing MRI system (Modified MAGNETOM Rhapsody System). The core approach to demonstrating safety and effectiveness relies on substantial equivalence to a legally marketed predicate device (the original MAGNETOM Rhapsody System, cleared under K003628).

Here's an analysis of the provided text based on your request:

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

Acceptance Criteria	Reported Device Performance
Safety Parameters (with action levels)	The modified device will conform to FDA recognized NEMA Standards and international IEC standard for safety issues.
Maximum Static Field	Operation is "substantially equivalent" to the commercially available MAGNETOM Rhapsody System.
Rate of Change of Magnetic Field	Operation is "substantially equivalent" to the commercially available MAGNETOM Rhapsody System.
RF Power Deposition	Operation is "substantially equivalent" to the commercially available MAGNETOM Rhapsody System.
Acoustic Noise Levels	Operation is "substantially equivalent" to the commercially available MAGNETOM Rhapsody System.
Performance Levels	The modified device will conform to FDA recognized NEMA Standards for the measurement of performance.
Specification Volume	Operation is "substantially equivalent" to the commercially available MAGNETOM Rhapsody System.
Signal to Noise	Operation is "substantially equivalent" to the commercially available MAGNETOM Rhapsody System.
Image Uniformity	Operation is "substantially equivalent" to the commercially available MAGNETOM Rhapsody System.
Geometric Distortion	Operation is "substantially equivalent" to the commercially available MAGNETOM Rhapsody System.
Slice Profile, Thickness and Gap	Operation is "substantially equivalent" to the commercially available MAGNETOM Rhapsody System.
High Contrast Spatial Resolution	Operation is "substantially equivalent" to the commercially available MAGNETOM Rhapsody System.

Explanation: The document states that the "Operation of the Modified MAGNETOM Rhapsody System is substantially equivalent to the commercially available MAGNETOM Rhapsody System." It then lists key safety and performance parameters. The acceptance criteria are implicitly the performance and safety levels specified by the FDA guidance document for MR Diagnostic Devices and NEMA/IEC standards. The reported device performance is that the modified device will conform to these standards and is "substantially equivalent" to the predicate. There are no specific numerical values provided for acceptance criteria or for the modified device's performance in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission relies on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with a specific test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. As no new clinical study data is presented, there is no discussion of a test set requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided. The device is an MRI system, not an AI-powered diagnostic tool, and the submission does not mention any MRMC studies or AI assistance for human readers.

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

This information is not provided. The device is an MRI system, not a standalone algorithm. Its output (images) is explicitly intended to be interpreted by a "trained physician."

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This information is not provided. Since no new clinical study data is presented, the concept of "ground truth" for a new test set does not apply in this submission. The "ground truth" for the predicate device would have been established through its own clearance process, but that detail is not in this document.

8. The sample size for the training set

This information is not provided. The device is a hardware modification (modified bearing) to an existing MRI system, not an AI/software device that would typically involve a training set.

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

This information is not provided. (See explanation for point 8).

Summary

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Ko 2 05 73

2 Appendix: 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.

General Information. I.

Establishment:

Address:

Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, N.J. 08830

2240869 Registration Number:

Contact Person: Mr. Jamie Yieh Technical Specialist, Regulatory Affairs (732) 321-4625 (732) 321-4841
Date of Summary Preparation:

January 25, 2002

Device Name:

· Trade Name: Modified MAGNETOM Rhapsody System

· Classification Name: Magnetic Resonance Diagnostic Device, CFR § 892.1000

·Classification: Class II

· Performance Standards: None established under Section 514 the Food, Drug, and Cosmetic Act.

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II. Safety and Effectiveness Information Supporting Substantial Equivalence.

· Device Description:

· Intended Use

The MAGNETOM Rhapsody system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Rhapsody system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, system is marouted for asges of the internal structures and organs of the entire body, including, but not limited to, the musculoskeletal, vascular, cardiac, and neuro systems. The images produced by the Rhapsody system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin the minge upportation of thow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

Due to the 'open' design of the system, the Rhapsody may also be used for Due to the 'open' design of tall procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles.

· Technological Characteristics

· General Safety and Effectiveness Concerns:

Operation of the Modified MAGNETOM Rhapsody System is substantially equivalent to the commercially available MAGNETOM Rhapsody System. The following are the safety parameter with action levels:

Maximum Static Field
Rate of Change of Magnetic Field
RF Power Deposition
Acoustic Noise Levels

and performance levels

Specification Volume
Signal to Noise
Image Uniformity
Geometric Distortion
Slice Profile, Thickness and Gap
High Contrast Spatial Resolution

specified by the FDA guidance document for MR Diagnostic Devices that will be operation The modified MAGNETOM Rhapsody will conform to the FDA recognized

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NEMA Standards for the measurement of performance and safety parameters and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices. This will assure that the performance of this device can be considered safe and effective with respect to the currently available MAGNETOM Rhapsody system.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on a circular seal. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 2002

Mr. Jamie Yieh Technical Specialist, Regulatory Affairs Siemens Medical Solutions USA, Inc. 186 Wood Avenue South ISELIN NJ 08830

Re: K020573

Trade/Device Name: Modification to Magnetom Rhapsody System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: January 25, 2002 Received: January 28, 2002

Dear Mr. Yieh:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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); 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.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1 Appendix: Indications for Use Statement

In accordance with FDA requirements (as of 1/1/96), the indications for use statement is attached on a separate page.

510(k) Number (if known) KC 2 0573

Modified MAGNETOM Rhapsody System Device Name:

Indications for Use:

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


Evaluation
Prescription Use ✓	OR	Over-The-Counter Use
(Division Sign-Off)Division of Reproductive, Abdominal,and Radiological Devices
510(k) Number	K020753

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.