INTEGRA RADIONICS XKNIFE RT 4

K061893 · Integra Radionics, Inc. · MUJ · Jul 25, 2006 · Radiology

Device Facts

• Record ID: K061893
• Device Name: INTEGRA RADIONICS XKNIFE RT 4
• Applicant: Integra Radionics, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Jul 25, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

XKnife RT 4 is a radiosurgery and radiotherapy treatment planning system intended for use in stereotactic and non-stereotactic (frameless), collimated beam, computer planned, LINAC based treatment

Device Story

Integra Radionics XKnife RT 4 is a stereotactic treatment planning system for LINAC-based radiation therapy. It processes medical imaging data, including PET scans, to facilitate computer-planned, collimated beam radiation delivery. Operated by clinicians in a clinical setting, the software runs on a Linux workstation to assist in planning both stereotactic and non-stereotactic (frameless) procedures. The system transforms imaging inputs into treatment plans, which healthcare providers use to guide radiation delivery, potentially improving treatment precision and patient outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stereotactic treatment planning software; Linux workstation platform; supports PET scan image integration; collimated beam LINAC-based radiation planning.

Indications for Use

Indicated for patients requiring radiosurgery and radiotherapy treatment planning for stereotactic and non-stereotactic (frameless), collimated beam, computer-planned, LINAC-based treatment.

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 XKnife RT 3 with Non Stereotactic Module (K041997)

Submission Summary (Full Text)

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KD6/893

### Section 6: 510(k) Summary

JUL 25 2006

### Integra Radionics XKnife RT 4 510(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 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 June 30, 2006.

- 2.0 The name of the device is the Integra Radionics XKnife RT 4. The common name is Stereotactic Radiation Treatment Planning System and Accessories, and its classification name is X-ray radiation therapy system.
- 3.0 The above device is substantial equivalent to the Radionics XK.nife RT 3 with Non Stereotactic Module 510(k), K041997.
- 4.0 The above system is a stereotactic treatment planning software with the ability to be used on a Linux workstation, and the ability to use PET scans as an additional image source.
- 5.0 The device like its predicates is intended for use in stereotactic, conformal, computer planned, LINAC (linear accelerator) based radiation. The indications for use are: XKnife RT 3 with Non-Stereotactic Module is a radiosurgery and radiotherapy treatment planning system intended for use in stereotactic and non-stereotactic (frameless), collimated beam, computer planned, LINAC based treatment .
- 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

## JUL 25 2006

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

Re: K061893

Trade/Device Name: Integra Radionics XKnife RT 4 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE and MUJ Dated: June 30, 2006 Received: July 3, 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.

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Protecting and Promoting Public Health

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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 (OS) 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/edrh/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): _ Ko 6 1 8 9 3

Device Name: Integra Radionics XKnife RT 4

Indications For use: XKnife RT 4 is a radiosurgery and radiotherapy treatment planning system intended for use in stereotactic and non-stereotactic (frameless), collimated beam, computer planned, LINAC based treatment

PRESCRIPTION USE XX (Part 21 CFR 801 Subpart D) AND/OR

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)

Y. Alvarez Garcia

(Division Sign n
Division of Reproducere andominal,
and Radiological Devices
510(k) Number