KINEMATIC KNEE DEVICE/MAGNETOM OPEN SYSTEM

K961121 · Siemens Medical Solutions USA, Inc. · LNH · Jun 19, 1996 · Radiology

Device Facts

• Record ID: K961121
• Device Name: KINEMATIC KNEE DEVICE/MAGNETOM OPEN SYSTEM
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNH · Radiology
• Decision Date: Jun 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The new kinematic knee device will enable the physician to evaluate the anatomy of the knee and dynamic interaction of the different tissues (ligaments, cartilage, bone, muscle, fat). Such dynamic evaluation may be useful for patellar tracking.

Device Story

Kinematic knee positioning device for use with MAGNETOM Open MRI system; enables dynamic knee imaging. Device manually operated; adjustable up to 100-degree angle; accommodates left or right knee. No active components or motors; constructed without ferromagnetic materials to prevent scan field interference. Physician uses device to position patient during MRI scan to evaluate knee anatomy and dynamic tissue interaction, specifically for patellar tracking. Output is MR image data used by physician for clinical assessment of knee joint function.

Clinical Evidence

No clinical data provided; bench testing only. Device is a passive mechanical positioning accessory; safety and effectiveness supported by design characteristics and equivalence to predicate.

Technological Characteristics

Passive, manually operated knee positioning device. Adjustable up to 100 degrees. Constructed of non-ferromagnetic materials to ensure compatibility with MR environment. No active components, motors, or electronic circuitry. Does not alter technological characteristics of the host MAGNETOM Open MRI system.

Indications for Use

Indicated for patients requiring kinematic MRI evaluation of the knee, including assessment of anatomy and dynamic tissue interaction (ligaments, cartilage, bone, muscle, fat) and patellar tracking.

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

• Resonex Kinematic MRI package (K924154)

Submission Summary (Full Text)

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Appendix 8: 510(k) Summary

JUN 19 1996

K961121

Appendix 8:
510(k) Summary

MAGNETOM Open
Kinematic Knee Device
510(k)
03/20/96
Appendix 8

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SIEMENS

# 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:** Kathleen M. Rutherford
Manager, Regulatory Submissions
[phone]

- **Date of Summary Preparation:** March 20, 1996

### Device Name:

- **Trade Name:** Kinematic Knee Device/OPEN

- **Classification Name:** Magnetic Resonance Diagnostic Device, CFR § 892.1000

- **Classification:** Class II

- **Performance Standards:** None established under Section 514 of the Food, Drug, and Cosmetic Act.

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

### Device Description:

Siemens is introducing a new positioning device that will be used for kinematic MRI studies of the knee. The new positioning device can be used for the left or right knee and is adjustable up to a maximum angle of 100 degrees.

MAGNETOM Open
Kinematic Knee Device
03/20/96
510(k) Summary: Page 1

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SIEMENS

## Intended Use

The new kinematic knee device will enable the physician to evaluate the anatomy of the knee and dynamic interaction of the different tissues (ligaments, cartilage, bone, muscle, fat). Such dynamic evaluation may be useful for patellar tracking.

## Technological Characteristics

The MAGNETOM OPEN is a magnetic resonance (MR) imaging system which uses time-varying magnetic field gradients and rf energy to spatially encode the anatomy of a patient. Introduction of the new kinematic knee device will not affect the technological characteristics of this system.

The new device accessory is a positioning device which is manually operated by the user. No active components (i.e., motors) are used and there are no ferromagnetic materials that could affect the scan field.

## General Safety and Effectiveness Concerns:

The kinematic knee device will not affect the safety and performance parameters specified for the MAGNETOM OPEN system.

## Substantial Equivalence:

The Siemens Kinematic Knee Device is substantially equivalent to the commercially available Resonex Kinematic MRI package. The Resonex Kinematic MRI Package was described in K924154 which received FDA premarket clearance on 11/23/92.


3/20/96 Date

MAGNETOM Open
Kinematic Knee Device
03/20/96
510(k) Summary: Page 2