RADIONICS XKNIFE HDRT SYSTEM

K083414 · Integra Radionics, Inc. · MUJ · Mar 2, 2009 · Radiology

Device Facts

• Record ID: K083414
• Device Name: RADIONICS XKNIFE HDRT SYSTEM
• Applicant: Integra Radionics, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Mar 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The Radionics XKnife HDRT System is indicated for use in radiotherapy procedures to aid in the positioning of patients immediately prior to therapy.

Device Story

Radionics XKnife HDRT System is a radiation therapy treatment planning system used to assist in patient positioning immediately before therapy. The device inputs 3D images obtained from Varian Trilogy Linear Accelerators (via CBCT) and compares them to pretreatment planning images. Using image fusion technology, the system calculates patient adjustment data to compensate for positioning errors and internal organ movement. The output is used by clinicians to ensure accurate patient alignment for radiation delivery, potentially improving treatment precision.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based radiation therapy treatment planning system. Utilizes DICOM image data from external CBCT devices. Employs image fusion algorithms to compare 3D image sets for spatial alignment. Operates as a networked software application.

Indications for Use

Indicated for use in radiotherapy procedures to aid in patient positioning immediately prior to therapy.

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

• Varian Medical Systems Trilogy Radio Therapy System (K081188)

Reference Devices

• Integra Radionics ImageFusion 3 software (K063230)

Submission Summary (Full Text)

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MAR - 2 2009

K083414

### Radionics XKnife HDRT System 510(k) Summary

### Submitter's Name and Address:

Integra Radionics 22 Terry Avenue Burlington, MA 01803 Tel: [phone] Fax: [phone]

### Contact Person and Telephone Number:

Kevin J. O'Connell Director Regulatory Affairs and Quality Assurance Integra Radionics, Inc. kevin.oconnell(@Integra-ls.com Tel .: [phone] Fax: [phone]

### Date Summary was Prepared: November 17, 2008

### Name of the Device:

| Trade Name: | Radionics XKnife HDRT System |
|-----------------------|------------------------------------------------------------------------------------|
| Common Name: | Radiation Therapy Treatment Planning System |
| Classification Name: | Medical charged-particle radiation therapy system<br>Products Code 90 IYE / 90 MUJ |
| Classification Panel: | Radiology |

### Substantial Equivalence:

The Radionics XKnife HDRT System is indicated for use in radiotherapy procedures to aid in the positioning of patients immediately prior to therapy.

The technological characteristics are similar to those found in the:

Varian Medical Systems Trilogy Radio Therapy System 510(k) k081188

HDRT software is based on Integra Radionics ImageFusion 3 software (K063230) in that it compares multiple 3D images. In the case of HDRT the images compared are: the pretreatment planning images obtained immediately before treatment. The images immediately before treatment are obtained from Varian Trilogy Linear

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Accelerators which incorporate CBCT devices capable of exporting DICOM images to shared drives. Based on the comparison of the images, HDRT specifies patient adjustment data, to insure that the patient is appropriately positioned for treatment. This functionality allows for slight errors in positioning of the patient to be compensated for, it also compensates for movement of internal organs.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a bird or abstract human figure with outstretched arms. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 . . .

# MAR - 2 2009

Mr. Kevin J. O'Connell

Director Regulatory Affairs and Quality Assurance

Integra Radionics, Inc.

22 Terry Avenue

BURLINGTON MA 01803-2516

Re: K083414

Trade/Device Name: Radionics XKnife HDRT System

Regulation Number: 21 CFR 892.5050

Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II

Product Code: MUJ

Dated: January 20, 2009

Received: January 21, 2009

### 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 (PMA), 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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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 os 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) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.

Sincerely yours,

Janine M. Morris

Janine M. Morris Acting 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 Statement

510(k) Number (if known):

K083414ψ

Device Name: Radionics XKnife HDRT System

Indications For Use:

The Radionics XKnife HDRT System is indicated for use in radiotherapy procedures to aid in the positioning of patients immediately prior to therapy.

PRESCRIPTION USE (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)

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**(Division Sign-Off)**

Division of Reproductive, Abdominal and Radiological Devices 510(k) Numbér

XKnife HDRT System 510(k)

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