MRGP OPTICAL TRACKING UNIT

K991943 · Philips Medical Systems (Cleveland), Inc. · LNH · Aug 23, 1999 · Radiology

Device Facts

• Record ID: K991943
• Device Name: MRGP OPTICAL TRACKING UNIT
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: LNH · Radiology
• Decision Date: Aug 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Outlook system is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and 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 MRGP Optical Tracking Unit is designed to support and guide diagnostic and therapeutic interventional procedures, such as needle biopsies and drainages.

Device Story

MRGP Optical Tracking Unit functions as an accessory to MRI systems to assist in interventional procedures. Input consists of infrared signals from a Position Sensor Assembly (PSA) reflected off markers on specialized tools. System transforms these spatial inputs into guidance for imaging planes; software reformats 3D image sets and provides graphical overlays for planning and intraoperative use. Used in clinical settings by physicians to shorten time required to identify correct imaging trajectories, particularly for complex double oblique planes. Benefits include improved accuracy and efficiency during needle biopsies and drainages.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison of technological characteristics and performance specifications.

Technological Characteristics

System includes infrared digitizer hardware, specialized tracking tools, and software for image plane guidance. Tool bodies constructed of Polyethermide and Polyphenylsulfone. Digitizer operates at 30 Hz max rate with 1m x 1m active volume. Connectivity is integrated with Outlook MRI system. Sterilization: steam for tool bodies, ETO for reflective spheres. Software provides 3D slice reformatting and graphical overlays.

Indications for Use

Indicated for patients requiring diagnostic or therapeutic interventional procedures, such as needle biopsies and drainages, guided by MRI imaging.

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

• Picker MRGP Basic Package (K983342)
• Picker ViewPoint Passive Tool Option (K990868)

Submission Summary (Full Text)

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AUG 23 1999

99 1943

## SUMMARY OF SAFETY AND EFFECTIVENESS

(As required by 21 CFR 807.92)

#### General Information 1.

| Classification: | Class II<br>Magnetic Resonance Imaging (MRI) System |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Magnetic Resonance Imaging (MRI) Option |
| Proprietary Name: | MRGP Optical Tracking Unit |
| Establishment Registration: | Manufacturer:<br>Picker Nordstar, Inc.<br>Ayritie 4, Vantaa<br>FIN-01510 Vantaa Finland<br>FDA Facility Registration: #9680194<br>United States Representative:<br>Picker International, Inc.<br>World Headquarters<br>595 Miner Road<br>Highland Heights, Ohio 44143<br>Contact: Elaine K. Keeler, Ph.D.<br>Phone: [phone]<br>FDA Owner Number: #1580240<br>FDA Registration Number: #1525965 |
| Performance Standards: | No applicable performance standards have been<br>issued under section 514 of the Food, Drug and<br>Cosmetic Act. |

#### 2. Intended Uses

The Outlook system is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and 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 MRGP Optical Tracking Unit is designed to support and guide diagnostic and therapeutic interventional procedures, such as needle biopsies and drainages.

| PICKER INTERNATIONAL, INC. | (MRGP-OP) | 05/27/99 | I.- |
|----------------------------|-----------|----------|-----|
|----------------------------|-----------|----------|-----|

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#### 3. Device Description

,

The main features in the Optical Tracking Unit include: 1) infrared digitizer hardware; 2) specialized tools and tracking devices for procedures; 3) software that guides the imaging plane based on information from the digitizer; 4) software utilities that allow for slice reformatting of 3D image sets and 5) MRGP graphical overlays for planning and intraoperative use.

This guidance mechanism shortens the time needed to find the correct imaging plane, and is useful in cases that require a difficult trajectory (i.e. double oblique imaging planes).

#### Safety and Effectiveness 4.

The following substantial equivalence chart has been compiled to demonstrate the equivalence of the MRGP Optical Tracking Unit described in this submission with the Picker MRGP Basic Package (K983342) and the Picker ViewPoint Passive Tool Option (K990868).

| Parameter | MRGP Optical Tracking<br>Unit | Predicate Devices |
|-------------------------|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| System Compatibility | Same. | 0.23T Outlook,<br>0.23T Outlook Proview<br>(See K983342) |
| Software | Special MRGP Software for<br>the Outlook. | Standard Outlook Software.<br>(See K983342) |
| Imaging Plane Selection | Optically Guided. | Manual. (See K983342) |
| Sequence type | Same. | 2D/3D Gradient echo, FSE, Single-<br>shot FSE. (See K983342) |
| Sequence capabilities | Same. | Dynamic imaging with auto start and<br>keyhole imaging capabilities.<br>Typical reconstruction of 200 ms<br>per image. (See K983342) |
| Sequence resolution | Same. | FOV- 4 to 40 cm<br><br>Slice thickness-<br>2D: 1-100mm (0.1mm steps)<br>3D: 0.4-100mm (0.1mm steps)<br>Matrix- up to 512<br>(See K983342) |

## Substantial Equivalence Chart

PICKER INTERNATIONAL, INC.

(MRGP-OP)

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| Parameter | MRGP Optical Tracking<br>Unit | Predicate Devices |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type of Digitizer | Same. | Infrared signals emitted from the<br>Position Sensor Assembly (PSA) are<br>reflected off reflective markers<br>mounted on the tool. The reflected<br>signal is detected by the PSA with<br>two optical detectors.<br>(See K990868) |
| Max. Digitizer Rate | Same. | 30 Hz for one or two tools; for three<br>tools, the rate is 30 Hz for one of<br>the tools and 15 Hz for the other<br>two. (See K990868) |
| Active Digitizer Volume | Same. | Silo shape, with 1 meter diameter<br>and 1 meter length. (See K990868) |
| Type of Sterilization | Same. | Tool bodies are steam sterilized and<br>the reflective spheres are sterilized<br>with ETO. (See K990868) |
| Material Composition of<br>tool bodies | Polyethermide and<br>Polyphenylsulfone | Aluminum, titanium or stainless steel<br>(See K990868) |
| Indications for Use | The MRGP Optical Tracking<br>Unit is designed to support and<br>guide diagnostic and<br>therapeutic interventional<br>procedures, such as needle<br>biopsies and drainages. | The MRGP Basic Package is<br>designed to support and guide<br>diagnostic interventional procedures,<br>such as needle biopsies and<br>drainages. (See K983342) |

PICKER INTERNATIONAL, INC.

:

(MRGP-OP)

05/27/99

.

I - 3

.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 3 1999

Elaine Keeler, Ph.D. Manager, Clinical Science Picker International, Inc. 595 Miner Road Highland Heights, Ohio 44143

K991943 Re:

MRGP Optical Tracking Unit (Interventional MRI Accessory) Dated: June 7, 1999 Received: June 9, 1999 Regulatory Class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Dr. Keeler:

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, 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 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 Requlations, 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 regulation (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".

Sincerely 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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Page I of 1

# 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

MRGP Optical Tracking Unit Device Name:

### Indications for Use:

The Outlook system is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (TI), and 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 MRGP Optical Tracking Unit is designed to support and guide diagnostic and therapeutic interventional procedures, such as needle biopsies and drainages.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|--------------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K991943 |

| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use (Optional Format 1-2-96) |
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