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, which is was described in premarket notification K041111 which received FDA clearance on July 16, 2004. Siemens further market the Body spine XL coil, Wrist Array coil with 4 channels, Cordless Coil, Breast Array coil, Breast biopsy device, MR guided procedure Package, In Room MRC, Foot switch and the software update for the existing MAGNETOM C! MR system.

AI/ML Overview

The provided text describes the acceptance criteria for the MAGNETOM C! MR System and the study used to demonstrate its substantial equivalence to predicate devices, rather than a study proving the device meets acceptance criteria in the context of an AI/algorithm-driven device.

Here's a breakdown of the requested information based on the provided text, and where the information requested for AI-related studies is not applicable or not present in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Levels)	Reported Device Performance (Compliance)
Signal to Noise	Will conform to FDA recognized NEMA Standards for the measurement of performance and safety parameters.
Image Uniformity	Will conform to FDA recognized NEMA Standards for the measurement of performance and safety parameters.
Safety issues with Magnetic Resonance Imaging Devices	Will conform to the international IEC standard for safety issues.

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

Sample size for test set: Not applicable/not specified. The provided text describes a submission for substantial equivalence based on established performance parameters for an MRI system, not an algorithm's performance on a specific test set of cases.
Data provenance: Not applicable/not specified. This is a submission for an entire MRI device, not an AI algorithm.

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

Not applicable. Ground truth for an AI algorithm's performance is not relevant to this type of device submission. The device produces images "when interpreted by a trained physician yield information that may assist in diagnosis."

4. Adjudication method for the test set

Not applicable.

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 not an AI-assisted device.

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

Not applicable. This is a medical imaging device, not a standalone algorithm.

7. The type of ground truth used

Not applicable in the context of an AI algorithm's performance validation. For the MRI system itself, the ground truth relates to its physical performance parameters (Signal to Noise, Image Uniformity) as measured against NEMA and IEC standards, which represent established engineering and safety benchmarks for device functionality.

8. The sample size for the training set

Not applicable. There is no AI algorithm being described as part of this submission.

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

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The study described is an assessment of substantial equivalence for the MAGNETOM C! MR system, which is an upgrade to an existing system, including new coils and software updates. It's not a study validating an AI algorithm's performance.

The "acceptance criteria" for this device are its performance levels (Signal to Noise, Image Uniformity) and safety compliance. The study demonstrates that the device will conform to established industry and international standards.

Criteria:
- Signal to Noise
- Image Uniformity
- Compliance with safety requirements
Methodology: The submission asserts that the MAGNETOM C! will conform to:
- FDA recognized NEMA Standards for the measurement of performance and safety parameters (specifically for Signal to Noise and Image Uniformity).
- International IEC standard for safety issues with Magnetic Resonance Imaging Devices.
Conclusion: By demonstrating conformity to these recognized standards, Siemens believes the device can be considered safe and effective and is substantially equivalent to the predicate devices (Siemens MAGNETOM 0.2 T Concerto, Siemens MAGNETOM 1.0 T Harmony, and Siemens MAGNETOM 0.35 T C!). This approach assures that the performance of the device meets the necessary safety and effectiveness requirements.

Summary

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

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	9063112
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 DevCFR Code: 21 CFR § 892.1000Classification: Class II

Performance Standards

None established under Section 514 the Food, Drug and Cosmetic Act.

CONFIDENTIAL

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

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

Substantial Equivalence

Siemens believes that, within the meaning of the Safe Medical Device Act of 1990, the MAGNETOM C!, which is configured with a new Body spine XL Coil, Wrist Array Coil with 4 channels, Cordless Coil, Breast Array Coil, Breast Biopsy Device, MR Guided Procedure Package, In Room MRC, Foot switch and the software update, is substantially equivalent to the following cleared medical devices, which offers the same applications and handling:

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
Siemens MAGNETOM 0.35 T C !	K041111	07/16/2004

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

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. Below are the parameter specified by the FDA guidance document for MR Diagnostic Devices that will be evaluated with the following levels:

Performance Levels

· Signal to Noise
· Image Uniformity

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.

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

Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 9 2004

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

Re: K043030

Trade/Device Name: 0.35 T MAGNETOM C! MR System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II

Product Code: 90 LNH Dated: October 29, 2004 Received: November 3, 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 (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 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 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 this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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

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

SECTION 4: INDICATIONS FOR USE STATEMENT

510(k) Number (if known)_ K 04 3 03 0

Device Name: MAGNETOM C!

Indications for 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

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

Concurrence of CDRH, Office of Device Evaluation

Prescription Use V

Over-The-Counter Use

Daniel R. Szyman

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