IMAGEFUSION 2.0

K990071 · Radionics, Inc. · MUJ · Feb 8, 1999 · Radiology

Device Facts

• Record ID: K990071
• Device Name: IMAGEFUSION 2.0
• Applicant: Radionics, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Feb 8, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

A pre-processing registration tool for use with other stereotactic surgical and neurosurgical treatment planning systems.

Device Story

ImageFusion 2.0 is image registration software for fusing 3D image sets (CT/CT, CT/MR, or MR/MR). Inputs include CT and MR (T1-weighted or non-T1-weighted) image sets. The system performs registration by matching bone or intensity features, eliminating the need for stereotactic rods or specific image slices. Non-stereotactic images are re-sampled to match the stereotactic coordinates of a reference image. The software is used by clinicians in neurosurgical or radiotherapy planning contexts. Output consists of registered 3D image data, which assists clinicians in tumor identification and treatment planning. The device benefits patients by enabling the use of non-stereotactic imaging data within a stereotactic surgical framework.

Clinical Evidence

Bench testing only. System and unit testing verified the accuracy of the registration process, including bone segmentation, intensity matching, and landmark alignment. Registration accuracy was reported as 1.7 mm average and 2.9 mm maximum for individual landmarks.

Technological Characteristics

Image registration software for 3D image sets. Employs bone segmentation, intensity matching, and landmark alignment algorithms. Operates on CT and MR (T1-weighted or non-T1-weighted) image data. Re-samples non-stereotactic images to stereotactic coordinates. Standalone software application.

Indications for Use

Indicated for use as a pre-processing registration tool for stereotactic surgical and neurosurgical treatment planning systems to aid in the identification of brain tumors prior to radiotherapy or surgery.

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• ImageFusion System (K960071)

Submission Summary (Full Text)

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# K990071

## ImageFusion 2.0 - 510(k) Summary

This Summary of the 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 8807.92.

## Submitter of Premarket Notification:

Nancy MacDonald Sr. Regulatory Engineer Radionics Software Applications, Inc. 22 Terry Ave. Burlington, MA 01803 Telephone: [phone], ext. 296 Fax: [phone]

Establishment Registration Number: 1222895

#### Performance Standards: None established under Section 514.

This summary was prepared on January 6, 1999.

Device Name: ImageFusion 2.0

Common Name: Image Correlation System

### Safety Summary:

Radionics Software Applications' ImageFusion 2.0 system testing verifies that the registration of MR images in stereotactic CT space is accurate and is approximately 1.7 mm on average and 2.9 mm maximum for individual landmarks. Further, system and unit testing verify that features such as bone segmentation, intensity match and landmark alignment, which form the basis of a fusion session, are accurate.

#### Predicate Device:

ImageFusion System: 510(k) number K960071, dated April 17, 1996.

## Intended Use:

The intended use for ImageFusion 2.0 is: A pre-processing registration tool for use with other stereotactic surgical and neurosurgical treatment planning systems.

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## ImageFusion 2.0 510(k) Summary _ cont.

#### Device Description:

ImageFusion 2.0, aids in identification of brain tumors prior to radiotherapy or stereotactic neurosurgical treatment planning. ImageFusion 2.0 has been enhanced to allow fusion of MR/MR images, in addition to CT/CT and CT/MR fusions that the previous version was capable of performing. The fusion process is based on the matching of bone or intensity and does not rely on matching of stereotactic rods or image slices. Therefore, a non-stereotactic MR or CT image can be re-sampled according to the stereotactic coordinates of the reference CT or MR image and further used in a stereotactic capacity.

ImageFusion 2.0 is image registration software for fusing a pair of 3D image sets. Both the reference and secondary image sets can be CT or MR images. The MR scans can be T1-weighted or non T1-weighted.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1999 FEB

Nancy C. MacDonald Senior Regulatory Engineer Radionics Software Applications, Inc. 22 Terry Avenue Burlington, MA 01803-2516

Re:

K990071

ImageFusion 2.0 Dated: January 8, 1999 Received: January 11, 1999 Regulatory class; II 21 CFR 892.5050/Procode: 90 MUJ

Dear Ms. MacDonald:

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 manteed production as now the energes that have been reciassified 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 be dayse to outlieral controlly Extrans. 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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510(k) Number (if known):

Device Name: ImageFusion 2.0

Indications for use:

A pre-processing registration tool for use with other stereotactic surgical and neurosurgical treatment planning systems.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109

OR

Over-The-Counter Use **__**
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K990071