INTEGRA RADIONICS IMAGEFUSION 3

K063230 · Integra Radionics, Inc. · MUJ · Dec 21, 2006 · Radiology

Device Facts

• Record ID: K063230
• Device Name: INTEGRA RADIONICS IMAGEFUSION 3
• Applicant: Integra Radionics, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Dec 21, 2006
• 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

Integra Radionics ImageFusion 3 is a software-based pre-processing registration tool; inputs include CT, MR, and PET scans; software performs image fusion (registration) of stereotactic and nonstereotactic scans; provides QA tools for users to evaluate fusion results; results exported for use in other Integra Radionics applications; operates on HP UNIX or Linux workstations; used by clinicians in surgical/neurosurgical planning contexts; assists in spatial alignment of diagnostic images to support treatment planning; benefits patient by enabling accurate image-guided surgical navigation.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Software-based image registration tool; operates on HP UNIX or Linux workstations; intended for CT, MR, and PET scan processing; provides QA evaluation tools.

Indications for Use

Indicated for use as a pre-processing registration tool for stereotactic and nonstereotactic scans in conjunction with stereotactic surgical and neurosurgical treatment planning systems.

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

• Radionics ImageFusion 2 (K990071)

Submission Summary (Full Text)

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## Section 6: 510(k) Summary

## Integra Radionics ImageFusion 3 510(k) Summary DEC 2 1 2006

This 510(k) Summary information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. 807.92.

1.0 The submitter of this premarket notification is:

Kevin J. O'Connell Regulatory Affairs Manager Integra Radionics, Inc. 22 Terry Avenue Burlington, MA 01803 Tel.: [phone] Fax: [phone]

This summary was prepared on October 24, 2006.

- 2.0 The name of the device is the Integra Radionics ImageFusion 3. The common name is System, Image Correlation and its classification name is Medical charged-particle radiation therapy system.
- 3.0 The above device is substantial equivalent to the Radionics ImageFusion 2, 510(k), K990071
- 4.0 The above system is a pre-processing registration (fusion) software for CT, MR and PET scans. The software provides QA tools for the user to evaluate the fusion results. The results are used with other Integra Radionics applications. The software can be used on a HP UNIX or Linux workstation.
- 5.0 The device like its predicates is intended for registering (fusing) stereotactic and nonstereotactic scans. The indications for use are: A pre-processing registration tool for use with other stereotactic surgical and neurosurgical treatment planning systems
- 6.0 The technological characteristics are the same or similar to those found with the predicate devices.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Kevin J. O'Connell Regulatory Affairs Manager Integra Radionics, Inc. 22 Terry Avenue BURLINGTON MA 01803-2516

Re: K063230

Trade/Device Name: Integra Radionics ImageFusion 3 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: November 21, 2006 Received: November 22, 2006

DEC 2 1 2006

Dear Mr. O'Connell:

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 (Premarket Approval), it may be subject to such 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.

Image /page/1/Picture/9 description: The image shows a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are prominently displayed in the center of the logo. Three stars are located below the word "Centennial". The logo appears to be a commemorative emblem for the centennial anniversary of the FDA.

*Protecting and Promoting Public Health*

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Page 2 -

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.

This letter will allow you to begin marketing your device as described in your Section 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:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K063230

Device Name: Integra Radionics ImageFusion 3

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

PRESCRIPTION USE X (Part 21 CFR 801 Subpart D) ANDIOR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. Seym

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 5 : O(k) Number ______________________________________________________________________________________________________________________________________________________________