MR-GUIDE 2000

K013150 · Ultraguide , Ltd. · LNH · Oct 18, 2001 · Radiology

Device Facts

• Record ID: K013150
• Device Name: MR-GUIDE 2000
• Applicant: Ultraguide , Ltd.
• Product Code: LNH · Radiology
• Decision Date: Oct 18, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The MR-Guide 2000 system is a frameless stereotactic guiding accessory for Magnetic Resonance (MR) systems. The system is MRI-compatible. It displays the simulated image of a rigid insertion instrument, such as a biopsy needle or an aspiration needle, on a computer monitor screen that also shows the MR image of the target organs and the projected future path of the interventional instrument, compensating for respiratory movements of the patient. The device is intended to be used in clinical interventions and for anatomical structures where magnetic resonance is currently used for visualizing such structures.

Device Story

MR-Guide 2000 is a frameless stereotactic guiding accessory for MR imaging. It utilizes a magnetic tracking system (MiniBird) to monitor the position and orientation of rigid interventional instruments (biopsy/aspiration needles). Inputs include real-time magnetic tracking data and MRI scanner images. A computer processor calculates the instrument's relative position and predicted path, overlaying this as a graphic on the MR image displayed on a monitor. The system compensates for patient respiratory movement. Used in clinical settings by physicians to guide needle placement during interventions. Benefits include improved visual guidance for instrument navigation within anatomical structures visualized by MRI.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety, electromagnetic compatibility, and accuracy validation using phantoms.

Technological Characteristics

Magnetic tracking system (MiniBird) for instrument localization; PC-based data processor for image overlay; MRI-compatible; frameless stereotactic guidance; software-based graphic overlay of instrument position and predicted path; respiratory motion compensation.

Indications for Use

Indicated for use as a frameless stereotactic guiding accessory for MR systems during clinical interventions requiring visualization of anatomical structures. Used for guiding rigid interventional instruments (e.g., biopsy or aspiration needles) by displaying instrument position and projected path relative to target organs, including compensation for patient respiratory movement.

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

• MR-Guide 3000 (K011418)
• CT-Guide 1010 (K002258)

Submission Summary (Full Text)

{0}------------------------------------------------

2 Page B

## OCT 1 8 2001

UltraGuide Ltd.

KO13150

510(k) Summary

MR-Guide 2000

I. Submitter Information

A. Name: UltraGuide Ltd.

Tirat Hacarmel Industrial Park B. Address: POB 2070 Tirat Hacarmel 30200 Israel

C. Contact Person: Dr. George Myers, 201-727-1703, Fax [phone]

January 2, 2001 D. Date of preparation:

II. Device Data

A. Trade Name: UltraGuide MR - Guide 2000

B. Common Name: Guiding System for Interventional Instruments for clinical interventions performed under imaging by magnetic resonance

C. Classification Name: Accessory for System, Nuclear Magnetic Resonance Imaging, 90 LNH, Regulation Number 892.1000

III. Legally marketed predicate devices.

A. MR-Guide 3000, K011418

B. CT-Guide 1010, K002258

IV. Description

The MR-Guide 2000 provides visual guiding information of the interventional instrument by overlaying graphics depicting its relative position and its predicted future path on the MR image of the internal organs all displayed on the monitor of a personal computer.

V. Intended Use

{1}------------------------------------------------

The MR-Guide 2000 system is a frameless stereotactic guiding accessory for Magnetic Resonance (MR) systems. The system is MRI-compatible. It displays the simulated image of a rigid insertion instrument, such as a biopsy needle or an aspiration needle, on a computer monitor screen that also shows the MR image of the target organs and the projected future path of the interventional instrument, compensating for respiratory movements of the patient.

The device is intended to be used in clinical interventions and for anatomical structures where magnetic resonance is currently used for visualizing such structures.

VI. Technological characteristics

The device uses a magnetic tracking system comprising transmitters and sensors, sold under the trade name "MiniBird," to determine the location and orientation of the interventional instrument. This magnetic tracking system has been used on medical devices cleared by the FDA. The position and orientations of the interventional device tool, and the MRI images acquired by the MRI scanner, are transmitted to a data processor (computer), which makes the necessary calculations to provide the guidance graphic overlay depicting the interventional instrument on the MRI image.

VII. Testing

A. Non-clinical tests

The MR-Guide 2000 has undergone extensive bench tests for electrical safety and electromagnetic compatibility to validate all design changes. The major components (the computer and optical tracker) are all commercial devices with published environmental and physical specifications.

Accuracy tests were done in phantoms.

B. Clinical Test

Since this system uses the same technology as the predicate device, a clinical test is not necessary.

VIII. Conclusion

The tests show that the UltraGuide MR-Guide 2000 is equivalent to the predicate devices in safety and efficacy.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows a black and white logo for the Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the agency's mission. The words "DEPARTMENT OF HEALTH &" are visible along the left side of the logo, curving to follow the circular shape. The words "HUMAN SERVICES" are visible along the right side of the logo, curving to follow the circular shape.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 1 8 2001

UltraGuide, Ltd. % George H. Myers, Sc.D. Medsys Inc. 377 Route 17 South HASBROUCK HEIGHTS NJ 07601 Re: K013150

Trade/Device Name: UltraGuide MR-Guide 2000, Guilding System for Interventional Instruments Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: July 27, 2001 Received: September 20, 2001

Dear Dr. Myers:

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 (PMA), it may be subject to 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.

{3}------------------------------------------------

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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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

{4}------------------------------------------------

Page / of of __ / ____________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

MR-Guide 2000 Device Name:

## Indications for Use:

Indications for USC.
The MR-Guide 2000 system is a frameless stereotactic guiding accessory for Magnetic The MR-Guide 2000 systems a maneness iconceing the position and future path of a rigid interventional instrument, such as a biopsy needle or an aspiration needle, on a Itigid interventional instrument, sach as a crops of the target organs. MR-Guide Computer monitor berebes monitoring the respiratory phase of the patient.

The device is intended to be used in clinical interventions and for anatomical structures where magnetic resonance imaging is currently used for visualizing such structures.

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

*Prescription Use*

Nancy Bearden

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K013150
510(k) Number