XPLAN 2.2 WITH THE BODY SYSTEM

K013661 · Radionics, A Division of Tyco Healthcare Group LP · MUJ · Dec 3, 2001 · Radiology

Device Facts

• Record ID: K013661
• Device Name: XPLAN 2.2 WITH THE BODY SYSTEM
• Applicant: Radionics, A Division of Tyco Healthcare Group LP
• Product Code: MUJ · Radiology
• Decision Date: Dec 3, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

XPlan 2.2 software is a stereotactic LINAC-based ration treatment planning system. XPlan 2.2 with the Body System localizes lesions to be treated using CT scans, MR scans, and digitized angiographic film. XPlan 2.2 provides stereotactic planning system for treatment of tumors. The conformal stereotactic radiation therapy treatments are delivered over multiple fractions.

Device Story

XPlan 2.2 with the Body System is a stereotactic radiation treatment planning system used in clinical settings to plan LINAC-based radiation therapy. The system integrates software for treatment planning with hardware for patient immobilization and localization. Inputs include CT scans, MR scans, and digitized angiographic film. The software processes these inputs to localize tumors and generate conformal stereotactic radiation plans for multi-fraction delivery. The system is operated by clinical staff to assist in the precise targeting of radiation to tumors, potentially improving treatment accuracy and patient outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to predicate devices.

Technological Characteristics

System comprises stereotactic treatment planning software and patient immobilization/localization hardware. Designed for LINAC-based radiation therapy. Connectivity and specific software architecture details are not provided.

Indications for Use

Indicated for patients requiring stereotactic, conformal, LINAC-based radiation therapy for the treatment of tumors. Localizes lesions using CT, MR, and digitized angiographic film.

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 XPlan 2.1 Stereotactic Radiation Treatment Planning System Software (K001700)
• Med-Tec (Medical Intelligence) BodyFix System (K001052)

Submission Summary (Full Text)

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## Section 6: 510(k) Summary

K013661

## DEC 0 3 2001 XPlan 2.2 with the BodySystem 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 Senior Regulatory Associate Radionics, a division of Tyco Healthcare Group LP 22 Terry Avenue Burlington, MA 01803 Tel .: [phone] Fax: [phone]

This summary was prepared on November 2, 2001.

- 2.0 The name of the device is the Radionics XPlan 2.2 with the Body System. 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 XPlan 2.1 Stereotactic Radiation Treatment Planning System Software was cleared via 510(k), K001700, on June 28, 2000 and the Med-Tec (Medical Intelligence) BodyFix System was cleared via 510(k), K001052, on August 30, 2000.
- 4.0 The above system consists of stereotactic treatment planning software and hardware to immobilize and localize the patient.
- 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: XPlan 2.2 software is a stereotactic LINAC-based ration treatment planning system. XPlan 2.2 localizes lesions to be treated using CT scans, MR scans, and digitized angiographic film. XPlan 2.2 provides stereotactic planning system for treatment of tumors. The conformal stereotactic radiation therapy treatments are delivered over multiple fractions.
- 6.0 The technological characteristics are the same or similar to those found with the predicate device.

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 3 2001

Mr. Kevin J. O'Connell Senior Regulatory Associate Radionics, a division of Tyco Health Care Group LP 22 Terry Avenue BURLINGTON MA 01803

Re: K013661

Trade/Device Name: XPLAN 2.2 With the Body System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II

Product Code: 90 MUJ Dated: November 2, 2001 Received: November 6, 2001

Dear Mr. O'Connell:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becall be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to commerce proc to May 20, 1977, in accordance with the provisions of the Federal Food, Drug, de necs that have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tou may, ulcretore, market and act include requirements for annual registration, listing of general controls provisions of ractice, 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 your device is classified (600 a0010). Existing major regulations affecting your device can be it may of subjoct to actively soulations, 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 I loast of advised that I Dr o resum that your device complies with other requirements of the Act that I Dri has intace a coulations administered by other Federal agencies. You must or any I oderal bather act 's requirements, including, but not limited to: registration and listing Compry with and rece broquientently as 801); good manufacturing practice requirements as set (21 CFR Part 607), acoming (21 CFR Part 820); and if applicable, the electronic fordin in the quality bytochlo (QB) 28) 285 (sections 531-542 of the Act); 21 CFR 1000-1050.

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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

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## ODE Indications for Use Statement

510(k) Number (if known): K013661

Device Name: Radionics XPlan 2.2 with the Body System

Indications for Use:

XPlan 2.2 software is a stereotactic LINAC-based ration treatment planning system. XPlan 2.2 with the Body System localizes lesions to be treated using CT scans, MR XPlan 2.2 Willi the Body System Noaniao 100 with the Body System provides scans, and digitized anglographic film. At har and of the 2015 - 1991 - 1991 - 1991 - 1991 therapy treatments are delivered over multiple fractions.

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Concurrence of CDRH, Office of Device Evaluation (ODE) Over-the-Counter Use OR Prescription Use (Per 21 CFR § 801.109)

(Division Sign-Off))
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K013661

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