MAGNETOM C! MR SYSTEM

K043030 · Siemens Medical Solutions · LNH · Dec 9, 2004 · Radiology

Device Facts

• Record ID: K043030
• Device Name: MAGNETOM C! MR SYSTEM
• Applicant: Siemens Medical Solutions
• Product Code: LNH · Radiology
• Decision Date: Dec 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

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 Story

MAGNETOM C! is an open, whole-body magnetic resonance diagnostic device (MRDD). System acquires magnetic resonance signals to produce transverse, sagittal, coronal, and oblique cross-sectional images and spectroscopic data. Operated by trained clinicians in clinical settings; used for diagnostic visualization of internal structures and functions of head, body, and extremities. Supports interventional procedures via MR-compatible accessories like biopsy needles and in-room displays. Output consists of images/spectra interpreted by physicians to assist in clinical diagnosis. System configuration includes specialized coils (Body spine XL, Wrist Array, Cordless, Breast Array) and software updates to enhance resolution and reduce scan times.

Clinical Evidence

Bench testing only. Performance evaluated against NEMA standards for signal-to-noise ratio and image uniformity, and IEC standards for safety. No clinical data presented.

Technological Characteristics

Open, whole-body MR scanner. Components: Body spine XL coil, 4-channel Wrist Array coil, Cordless coil, Breast Array coil, Breast biopsy device, MR-guided procedure package, in-room display, foot switch. Conforms to NEMA standards for performance and IEC standards for safety. Software-based image reconstruction.

Indications for Use

Indicated for patients requiring diagnostic MR imaging of the head, body, or extremities; includes interventional procedures using MR-compatible devices. No specific age or gender contraindications stated.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Siemens MAGNETOM 0.2 T Concerto (K003192)
• Siemens MAGNETOM 1.0 T Harmony (K970852)
• Siemens MAGNETOM 0.35 T C ! (K041111)

Submission Summary (Full Text)

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# 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.<br>51 Valley Stream Parkway<br>Malvern. PA 19355 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration Number | 2240869 |
| Manufacturer | Siemens Mindit Magnetic Resonance Ltd.<br>R1-B1, Hi-Tech Industrial Park, Shennan Ave.<br>Shenzhen 518057<br>P.R. China |
| Registration Number | 9063112 |
| Contact Person | Ms. Nealie Hartman<br>Technical Specialist. Regulatory Submissions<br>51 Valley Stream Parkway E50<br>Malvern. PA 19355<br>Phone: [phone]<br>Fax: [phone] |
| Device Name | Trade Name: MAGNETOM C! System<br>Classification Name: Magnetic Resonance Diagnostic Dev<br>CFR Code: 21 CFR § 892.1000<br>Classification: Class II |

#### Performance Standards

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

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#### CONFIDENTIAL

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### II. Safety and Effectiveness Information Supporting Substantial Equivalence.

#### Intended Use

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.

#### 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 Clearance<br>Number | FDA Clearance<br>Date |
|---------------------------------|-------------------------|-----------------------|
| 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 |

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### 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.

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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.

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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 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 [phone] or [phone] 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

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# 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! 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

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

OR

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 ________________________________________________________________________________________________________________________________________________________________