The MAGNETOM C! is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The MAGNETOM C! 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 MAGNETOM C! system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission outlines performance levels that the MAGNETOM C! system will conform to, largely by referencing NEMA and IEC standards for established MRI safety and performance parameters. It states that the device "will conform" to these standards, implying that meeting these standards serves as the acceptance criteria. However, explicit numerical performance metrics for the MAGNETOM C! are not provided in the summary. Instead, it relies on substantial equivalence to predicate devices (MAGNETOM 0.2 T Concerto and MAGNETOM 1.0 T Harmony) that presumably already meet these standards.

Acceptance Criteria (Performance Levels)	Reported Device Performance (MAGNETOM C!)	Notes
Maximum Static Field	Conforms to FDA-recognized NEMA Standards and international IEC standard for safety.	No specific value given for MAGNETOM C! (likely 0.2T based on predicate). Assumed to be similar to predicate, which is 0.2T for Concerto or 1.0T for Harmony.
Rate of Change of Magnetic Field	Conforms to FDA-recognized NEMA Standards and international IEC standard for safety.	No specific value given.
RF Power Deposition	Conforms to FDA-recognized NEMA Standards and international IEC standard for safety.	No specific value given.
Acoustic Noise Levels	Conforms to FDA-recognized NEMA Standards and international IEC standard for safety.	No specific value given.
Specification Volume	Conforms to FDA-recognized NEMA Standards for measurement of performance.	No specific value given.
Signal to Noise	Conforms to FDA-recognized NEMA Standards for measurement of performance.	No specific value given.
Image Uniformity	Conforms to FDA-recognized NEMA Standards for measurement of performance.	No specific value given.
Geometric Distortion	Conforms to FDA-recognized NEMA Standards for measurement of performance.	No specific value given.
Slice Profile, Thickness and Gap	Conforms to FDA-recognized NEMA Standards for measurement of performance.	No specific value given.
High Contrast Spatial Resolution	Conforms to FDA-recognized NEMA Standards for measurement of performance.	No specific value given.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not describe a specific clinical test set or data provenance for the MAGNETOM C! device. The submission relies on demonstrating substantial equivalence to existing cleared devices (Siemens MAGNETOM 0.2 T Concerto and Siemens MAGNETOM 1.0 T Harmony) by stating that its operation is "substantially equivalent" and that it "will conform" to established industry standards (NEMA and IEC) for safety and performance. This implies that the standards themselves (NEMA and IEC) are the basis for evaluation, not a new clinical study with a specific patient dataset.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Since no specific clinical test set data is described, there is no information provided regarding experts used to establish ground truth. The evaluation is based on technical specifications and conformance to industry standards, not on human interpretation of specific images from a test set.

4. Adjudication Method for the Test Set

As there is no described clinical test set for the MAGNETOM C! in this submission, no adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned or described in the provided text. The submission focuses on technical performance and substantial equivalence, not on comparing human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The MAGNETOM C! is a diagnostic device (MRI scanner), not an AI algorithm. Therefore, a standalone study for an algorithm's performance is not applicable and not included in this submission. The device itself is the "algorithm" in a sense, as it generates the images, but its performance is measured by its output quality and safety parameters, not by its diagnostic interpretation independent of a human.

7. Type of Ground Truth Used

The "ground truth" in this context is implicitly the established safety and performance metrics defined by FDA-recognized NEMA Standards and international IEC standards for MRI devices. The device's performance is assessed against these technical and safety specifications rather than against clinical outcomes, pathology, or expert consensus on specific patient cases.

8. Sample Size for the Training Set

As this is a submission for an MRI device and not an AI algorithm, the concept of a "training set" in the context of machine learning does not apply to the information provided. The development and testing of an MRI scanner involve engineering and physics principles, not a data-driven training approach.

9. How the Ground Truth for the Training Set Was Established

Since there is no "training set" as understood in AI/ML, this question is not applicable to the provided information.

Summary

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K0411111

Section 2: 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92.

I. General Information

Establishment	Siemens Medical Solutions. Inc.51 Valley Stream ParkwayMalvern. PA 19355
Registration Number	2240869
Manufacturer	Siemens Mindit Magnetic Resonance Ltd.R1-B1, Hi-Tech Industrial Park, Shennan Ave.Shenzhen 518057P.R. China
Registration Number	Application is Progress (See Attachment 3)
Contact Person	Ms. Nealie HartmanTechnical Specialist. Regulatory Submissions51 Valley Stream Parkway E50Malvern. PA 19355Phone: (610) 448-1769Fax: (610) 448-1787
Device Name	Trade Name: MAGNETOM C! SystemClassification Name: Magnetic Resonance Diagnostic DeviceCFR Code: 21 CFR § 892.1000Classification: 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.

Intended Use

The MAGNETOM C! 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 MAGNETOM C! system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times.

Substantial Equivalence

The system is substantially equivalent to the following cleared medical devices:

Predicate Device Name	FDA ClearanceNumber	FDA ClearanceDate
Siemens MAGNETOM 0.2 T Concerto	K003192	12/21/2000
Siemens MAGNETOM 1.0 T Harmony	K970852	06/05/1997

General Safety and Effectiveness Concerns:

Operation of the MAGNETOM C! System is substantially equivalent to the commercially available MAGNETOM 0.2 T Concerto System and 1.0 T Harmony System. Specified by the FDA guidance document for MR Diagnostic Devices that will be evaluated, below are the safety parameter with the following levels:

Action Levels

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

Performance Levels

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

The MAGNETOM C! will conform to the FDA recognized 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 Concerto and Harmony systems.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle symbol. The logo is simple, clean, and easily recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 6 2004

Ms. Nealie Hartman Technical Specialist Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway MALVERN PA 19355

Re: K041111

Trade/Device Name: MAGNETOM C! Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device

Regulatory Class: II Product Code: 90 LNH Dated: April 26 , 2004 Received: April 28, 2004

Dear Ms. Hartman:

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 such 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 Section 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 the 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" (21CFR Part 807.97) you may obtain. 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. Bugden

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

Enclosure

Page 2

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SECTION 4: INDICATIONS FOR USE STATEMENT

510(k) Number (if known) ___ K 0 4 1/ 1/

Device Name: MAGNETOM C!

Indications for Use:

The MAGNETOM C! is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, (WITDB) and irroges and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The MAGNETOM C! 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

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

Concurrence of CDRH, Office of Device Evaluation

Prescription Use	✓	OR	Over-The-Counter Use
------------------	---	----	----------------------	--

Nancy C Bugdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number	K041111
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CONFIDENTIAL

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.