The MAGNETOM system with the 6 Channel Body Coil is a whole body scanner. The MAGNETOM system with the 6 Channel Body Coil is indicated for use as diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the body. The images produced by the MAGNETOM system with the 6 Channel Body Coil reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR properties that determine the image appearance are proton density; spin lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

Device Description

AI/ML Overview

This document is a 510(k) summary for a 6 Channel Body Coil for MAGNETOM MR systems. It describes a device that is an accessory to an existing Magnetic Resonance imaging system, rather than an AI/ML powered device. As such, many of the requested categories are not applicable to the provided text.

Here's an analysis of the provided text based on the questions, with explanations for why some information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

For an accessory like an MRI coil, the "acceptance criteria" are typically demonstrating that the new component does not negatively impact existing safety and performance standards of the overall MR system, and that key imaging parameters are equivalent to or better than a predicate device.

Acceptance Criteria (Stated as Unaffected or Equivalent)	Reported Device Performance (Reference to submission)
Safety Parameters:
Maximum Static Field Strength	Unaffected by modifications
Rate of Change in Magnetic Field	Unaffected by modifications
RF Power deposition	Unaffected by modifications
Acoustic Noise Levels	Unaffected by modifications
Performance Parameters:
Specification Volume	Unaffected by modifications
Signal to Noise (SNR)	Equivalent with predicate devices (Results presented in submission)
Image Uniformity	Equivalent with predicate devices (Results presented in submission)
Geometric distortion	Unaffected by modifications
High contrast spatial resolution	Unaffected by modifications
Slice profile, thickness and gap	Unaffected by modifications

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

The document states "Laboratory and clinical testing were performed to support this claim of substantial equivalence," but does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). This is common for accessory 510(k)s where the focus is on hardware performance rather than clinical outcomes of a new diagnostic algorithm.

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

Not Applicable. This document pertains to an MRI coil, a hardware accessory. The "ground truth" concept as applied to medical imaging interpretation (e.g., presence/absence of disease) is not relevant for this type of submission. The performance metrics are technical imaging parameters. The "trained physician" is mentioned in the "Indications for Use" as interpreting the images for diagnosis, but not in the context of establishing ground truth for the device's technical performance.

4. Adjudication method for the test set

Not Applicable. As the “ground truth” related to clinical interpretation or diagnosis is not part of the device's performance evaluation for this 510(k), no adjudication method for a test set of clinical cases is mentioned.

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

Not Applicable. This is a hardware accessory (an MRI coil), not an AI/ML software device. Therefore, an MRMC study to compare human reader performance with and without AI assistance was not performed and is not relevant to this submission.

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

Not Applicable. This is a hardware accessory, not a standalone algorithm.

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

The "ground truth" for the device's performance characteristics (like SNR, Image Uniformity) would be physical measurements against established technical specifications and/or comparison to the predicate device's measured performance. It is not clinical ground truth derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not Applicable. This is a hardware accessory. There is no AI/ML model for which a "training set" would be used.

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

Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.

Summary

{0}------------------------------------------------

Appendix 11: 510(k) Summary

11 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.

I. General Information.

Establishment:

Address: Siemens Medical Solutions, Inc. ● 186 Wood Avenue South Iselin, N.J. 08830
Registration Number: 2240869

Contact Person: Mr. Jamie Yieh Senior Technical Specialist, Regulatory Affairs Telephone: (732) 321-4625 Fax: (732) 321-4841 Email: jamie.yieh@siemens.com

Date of Summary Preparation:

October 23, 2002

Device Name:

•Trade Name: 6 Channel Body Coil

· 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.

{1}------------------------------------------------

II. Safety and Effectiveness Information Supporting Substantial Equivalence.

· Device Description:

• Intended Use

· Technological Characteristics

The MAGNETOM systems with the new 6 Channel Body Coil is substantially equivalent to the predicate MAGNETOM systems.

· General Safety and Effectiveness Concerns:

Operation of the MAGNETOM Symphony/Sonata and Upgrades to Symphony/Sonata systems with the 6 Channel Body Coil is substantially equivalent to standard operation of the commercially available MAGNETOM Symphony/Sonata/Upgrades to Symphony/Sonata systems. The following safety parameter with action levels:

-Maximum Static Field Strength
Rate of Change in Magnetic Field -
RF Power deposition -
Acoustic Noise Levels -

and performance levels:

Specification Volume -
Signal to Noise -
Image Uniformity -
-Geometric distortion
High contrast spatial resolution -
Slice profile, thickness and gap -

specified by the FDA guidance document for MR Diagnostic Devices are unaffected by the modifications described within this notification. The 6 Channel Body Coil was tested for SNR and Image uniformity and the results

{2}------------------------------------------------

presented in this submission show that they are equivalent with the predicate devices described in this submission.

• 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.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

NOV 20 2002

d and Drug Administration 200 Corporate Boulevard lockville MD 20850

Mr. Jamie Yieh Senior Technical Specialist, Regulatory Affairs . Siemens Medical Systems, Inc. 186 Wood Avenue South ISELIN NI 08830

Re: K023571

Trade/Device Name: 6 Channel Body Coil for MAGNETOM Systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II

Product Code: 90 MOS Dated: October 23, 2002 Received: October 24, 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, listing 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.

{4}------------------------------------------------

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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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

Enclosure

Page 2

{5}------------------------------------------------

3 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) _ K ( 2 - 3 5 7 /

Device Name: 6 Channel Body Coil for MAGNETOM 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__

(Division Sign-Off)

Division of Reproductive, Abdominal

SPECIAL 510(k)

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.