KINEMATIC POSITIONING DEVICES; C-SPINE, KNEE,SHOULDER

K964752 · Philips Medical Systems (Cleveland), Inc. · LNH · Feb 24, 1997 · Radiology

Device Facts

• Record ID: K964752
• Device Name: KINEMATIC POSITIONING DEVICES; C-SPINE, KNEE,SHOULDER
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: LNH · Radiology
• Decision Date: Feb 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Picker International Outlook system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. The Kinematic Positioning Devices enable the physician to evaluate the anatomy and the functional interactions of the surrounding tissues (ligaments, cartilage, bone, muscle and fat). The Kinematic Positioning Devices are indicated for use in the Cervical Spine, Knee and Shoulder.

Device Story

Kinematic positioning devices for Outlook MRI system; used to constrain patient anatomy (c-spine, knee, shoulder) in specific positions during imaging. C-spine device allows flexion, extension, lateral movement, and rotation. Knee device allows flexion and extension. Shoulder device allows abduction, adduction, and rotation. Devices include integrated holders for multipurpose receiver coils. Manually operated by clinician; no active components or motors. Enables physician to evaluate dynamic tissue interactions; aids in diagnostic interpretation of MRI images.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Non-ferromagnetic materials; manually operated mechanical positioning frames; integrated receiver coil holders; no active energy sources or motors; dimensions/form factor specific to anatomical region (c-spine, knee, shoulder).

Indications for Use

Indicated for patients requiring MRI imaging of the cervical spine, knee, or shoulder to evaluate anatomy and functional tissue interactions (ligaments, cartilage, bone, muscle, fat).

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

• Siemen's Kinematic Knee Device for the Magnetom Open System (K961121)

Submission Summary (Full Text)

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# FEB 24 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS

(As required by 21 CFR 807.92)

## 1. General Information

K964752

Classification: Class II
Magnetic Resonance (MR) Imaging System

Common/Usual Name: Magnetic Resonance Imaging Accessories

Proprietary Name: Kinematic Positioning Devices: C-Spine, Knee and Shoulder

Establishment Registration

Manufacturer: Picker Nordstar, Inc.
P.O. Box 33
FIN-00511 Helsinki, FINLAND
Phone: [phone]
Fax: [phone]
FDA Facility Registration #9680194

United States Representative: Picker International, Inc.
595 Miner Road
Cleveland, OH 44143
FDA Owner Number #1580240

Performance Standards: No applicable performance standards have been issued under section 514 of the Food, Drug and Cosmetic Act.

## 2. Intended Uses

The Picker International Outlook system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Kinematic Positioning Devices enable the physician to evaluate the anatomy and the functional interactions of the surrounding tissues (ligaments, cartilage, bone, muscle and fat). The Kinematic Positioning Devices are indicated for use in the Cervical Spine, Knee and Shoulder.

PICKER INTERNATIONAL, INC.

(KINE)

2/19/97

{1}

12:48

3. Device Description

C-Spine Positioning Device

The Outlook C-spine positioning device is designed to keep the head of the patient constrained in different positions while the C-spine is being imaged in the Outlook scanner. The device allows flexion, extension, lateral movement and lateral rotation. There is also a possibility to set the distance between the horizontal (flexion/extension) axis and the vertical axis (lateral motion). The device has an integrated holder for the Multipurpose receiver coil.

Knee Positioning Device

The Outlook Knee positioning device is designed to keep the leg constrained in different positions while the knee joint is imaged in the Outlook system with a Multipurpose coil. The device is used for flexion and extension of the knee.

Shoulder Positioning Device

The Outlook Knee positioning device is designed to keep the arm of the patient constrained in different positions while the shoulder joint is being imaged in the Outlook scanner. The device allows abduction, adduction and internal/external rotation. The device has an integrated holder for the Multipurpose receiver coil.

4. Safety and Effectiveness

The Picker International Kinematic Positioning Devices for the Outlook are similar in technological characteristics and intended use to the Siemen's Kinematic Knee Device for the Magnetom Open System (K961121). The following chart has been created to demonstrate their substantial equivalence.

PICKER INTERNATIONAL, INC. (KINE) 2/19/97 I-2

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# SUBSTANTIAL EQUIVALENCE CHART

| Parameter | Kinematic Positioning Devices for the Outlook | Predicate Device Kinematic Knee Device for the Magnetom Open System (K961121) |
| --- | --- | --- |
| Material | Same | No ferromagnetic materials which could affect the scan field. |
| Device operation | Same | Manually operated by the user. No active components such as motors. |
| Indications for Use | C-Spine, Knee, Shoulder scanning | Knee scanning |
| Intended use | The Siemens Magnetom Open is a magnetic resonance imaging system which uses time-varying magnetic field gradients and rf energy to spatially encode the anatomy of the patient. The 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).

The Picker International Outlook system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Kinematic Positioning Devices enable the physician to evaluate the anatomy and the functional interactions of the surrounding tissues (ligaments, cartilage, bone, muscle and fat). | |

PICKER INTERNATIONAL, INC.

(KINE)

2/19/97