MAGNETOM OPEN VIVA WITH PERMANENT MAGNET

K994316 · Siemens Medical Corp. · LNH · Jan 14, 2000 · Radiology

Device Facts

• Record ID: K994316
• Device Name: MAGNETOM OPEN VIVA WITH PERMANENT MAGNET
• Applicant: Siemens Medical Corp.
• Product Code: LNH · Radiology
• Decision Date: Jan 14, 2000
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The MAGNETOM OPEN viva with the Permanent magnet is an open, whole body scanner. The MAGNETOM Open Viva with the Permanent magnet is indicated for use as diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the MAGNETOM OPEN with the permanent magnet 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 relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

Device Story

Open, whole-body MRI scanner; utilizes permanent magnet technology. Inputs: magnetic resonance signals from hydrogen nuclei (protons) in patient tissues. Transformation: system detects spatial distribution of protons; processes NMR properties (proton density, T1, T2, flow) to reconstruct cross-sectional images. Output: transversal, sagittal, coronal, and oblique diagnostic images. Used in clinical settings; operated by trained medical professionals. Physician interprets images to assist in clinical diagnosis. Benefits: provides non-invasive visualization of internal anatomy for diagnostic purposes.

Clinical Evidence

Bench testing only. No clinical data presented. Performance verified through laboratory testing of safety and imaging parameters including signal-to-noise ratio, image uniformity, geometric distortion, slice profile, and spatial resolution.

Technological Characteristics

Open, whole-body MRI scanner utilizing a permanent magnet. Operates via magnetic resonance imaging principles. Safety and performance specifications (static field, RF power, acoustic noise, image uniformity, spatial resolution) remain consistent with the predicate MAGNETOM OPEN viva System.

Indications for Use

Indicated for diagnostic imaging of internal head or body structures in patients requiring MRI. Produces transversal, sagittal, coronal, and oblique images based on proton density, T1, T2, and flow properties.

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

• MAGNETOM OPEN viva System

Submission Summary (Full Text)

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K99 4316

#### 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 Systems, Inc. 186 Wood Avenue South Iselin, N.J. 08830
Registration Number: 2240869

- Contact Person: Mr. Jamie Yieh Technical Specialist, Regulatory Submissions Phone: [phone] Fax: [phone]
#### Date of Summary Preparation: 12/21/99

#### Device Name:

- Trade Name: Magnetom Open Viva with Permanent Magnet
- 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 OPEN viva with the Permanent magnet is an open, whole body scanner. The MAGNETOM Open Viva with the Permanent magnet is indicated for use as diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the MAGNETOM OPEN with the permanent magnet 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 relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

## · Technological Characteristics

The MAGNETOM OPEN viva with the new Permanent Magnet is substantially equivalent to the currently available MAGNETOM OPEN viva System.

## · General Safety and Effectiveness Concerns:

Operation of the MAGNETOM OPEN viva with the new Permanent Magnet is substantially equivalent to standard operation of the MAGNETOM OPEN viva 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 are unaffected by the modifications described within this notification.

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## • Substantial Equivalence:

Laboratory 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.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 2000

Jamie Yieh Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830

Re:

K994316 Magnetom Open Viva with Permanent Magnet Dated: December 21, 1999 Received: December 22, 1999 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Mr. Yieh:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, 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 vour 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sinceraty yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) _ 1943 ملا

Device Name: Magnetom Open viva

#### Indications for Use:

The MAGNETOM OPEN viva with the Permanent magnet is an open, whole body scanner. The MAGNETOM Open Viva with the Permanent magnet is indicated for use as diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the MAGNETOM OPEN with the permanent magnet 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 relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

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

OR

Concurrence of CDRH, Office of Device Evaluation

Prescription Use

Over-The-Counter Use

David A. Segner

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Devic 510(k) Number