XPLAN-1

K972905 · Radionics Software Applications, Inc. · IYE · Oct 28, 1997 · Radiology

Device Facts

• Record ID: K972905
• Device Name: XPLAN-1
• Applicant: Radionics Software Applications, Inc.
• Product Code: IYE · Radiology
• Decision Date: Oct 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Computer planned LINAC-based stereotactic radiotherapy procedures

Device Story

XPlan-1 is a stereotactic radiation treatment planning system for LINAC-based radiotherapy. It processes input data from CT scans, MR scans, and digitized angiographic film to localize lesions. The system performs image acquisition, localization, contouring, and beam planning. It supports conformal collimation, including LINAC jaws, MLCs, and wedges to modify beam shape and attenuation. The system generates DRRs (Digitally Reconstructed Radiographs), 3D Beam's Eye Views, 2D beam visualizations, and dose-volume histograms. It includes QA verification tools like the Laser Angio Target Localizer (LATL) to confirm system alignment at isocenter and patient positioning. Used in clinical settings by trained professionals, the system assists clinicians in planning radiation delivery to tumors in the head and skull. The output allows clinicians to visualize dose distribution and target volumes, facilitating precise treatment planning to benefit patients requiring stereotactic radiotherapy.

Clinical Evidence

Bench testing only. Testing verified beam shaping function, aperture generation, dose display accuracy in Geometry Viewer and Dose Summary, PTV generation, Block and MLC generation, and DRR display accuracy.

Technological Characteristics

Stereotactic radiation treatment planning software. Features include image acquisition, localization, contouring, and beam planning modules. Supports conformal collimation (LINAC jaws, MLCs, wedges). Includes QA verification tools (LATL). Connectivity supports integration with imaging modalities (CT, MR, angiography).

Indications for Use

Indicated for stereotactic LINAC-based radiation treatment planning for tumors < 7 cm in the skull and head. Localizes lesions using CT, MR, and digitized angiographic film. Supports conformal stereotactic radiotherapy delivered over multiple fractions.

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

• RSA XKnife-3 System
• CMS Focus System

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness

K972905

# OCT 28 1997

| OCT 28 1997 | |
|------------------------------------|----------------------------------------------------------------------------------|
| General Information | |
| Classification: | Class II |
| Common Name: | Stereotactic Radiation Treatment Planning System |
| Device Trade Name: | XPlan-1 |
| Intended Uses: | Computer planned LINAC-based stereotactic<br>radiotherapy procedures |
| Predicate Device: | RSA XKnife-3 System and CMS Focus System |
| Establishment Name and Address: | Radionics Software Applications, Inc.<br>22 Terry Avenue<br>Burlington, MA 01803 |
| Contact Name and Phone: | Renee J. Thibeault or Linda Jalbert, [phone] |
| Establishment Registration Number: | 1222895 |
| Performance Standard: | None established under Section 514 |

#### Substantial Equivalence Determination

A summary of the information contained in this premarket notification that addresses safety and effectiveness follows.

#### Safety Summary

RSA XPlan-1 system testing verifies that the beam shaping function generated the correct aperture and that the dose displays in the Geometry Viewer and Dose Summary are correct. Further, it verifies that the PTV generation, Block and MLC generation, DRR display and other new features are accurate.

#### General Safety and Effectiveness

The device labeling contains instructions for use. It includes indications for use, cautions, warnings and user quality assurance procedures. The training and installation sessions provide assurance that the user understands all aspects of the XPlan-1 System; mechanical, computer and software, plus its intended functionality. This information promotes safe and effective use of the device.

#### Description of the Device and the Basis for Substantial Equivalence

The XPlan-1 system has the same intended use and similar technological characteristics as the commercially available XKnife-3 Stereotactic Radiation Treatment Planning System. Like XKnife-3, the XPlan-1 system includes the same image acquisition, localizing, contouring and beam planning techniques. In addition, XPlan-1 and XKnife-3 both contain methods of QA verification for targeting setup and delivery. XPlan-1 includes modifications of the XKnife-3 system, such as the ability to use conformal collimation devices and a modification to the dose algorithm to account for the use of conformal collimation devices. XPlan-1 also supports the use of the Laser Angio Target Localizer (LATL) as an additional QA check to verify the orientation and position of the LINAC jaws and gantry, the collimator and couch rotation. Like the XKnife-3 use of the Rectilinear Phantom Pointer (RLPP) and Laser Target Localizer Frame (LTLF), XPlan-1 supports the use of the LATL to confirm system alignment at isocenter and to position the patient at isocenter.

XPlan-1 is also substantially equivalent to the commercially available Conformal Radiation Treatment Planning System, FOCUS. Like FOCUS, XPlan-1 supports the use of LINAC jaws, MLCs and wedges to modify the shape and attenuation of the beam. Both

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XPlan-1 and FOCUS also have the ability to model the total on the taget.
volume and surrounding tissue via a 3D Beam's Eye View and 2D beam visualization.
Both systems, also addition to the dose-volume histogram.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Renee J. Thibeault Radionics Software Applicants, Inc. 22 Terry Avenue Burlington, MA 01803-2516

Re:

K972905 Xplan-1 Stereotactic Radiation Treatment Planning System Dated: August 5, 1997 Received: August 6, 1997 Regulatory class: II OCT 28 1997 21 CFR 892.5050/Procode: 90 IYE

Dear Ms. Thibeault:

We have reviewed your Section 510K) notification of intent to market the device and we have determined the device is substantially equivalent for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 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 Federal Regulations. Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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 question 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/dsmamain.html".

Sincerely yours.

H. William Yu

Lillian Yin, Ph.D. 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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### Indications for Use

The following are the indications for use of the XPlan-1 system:

XPlan-1 is a stereotactic LINAC-based radiation treatment planning system. XPlan-1 A Flail-T IS a steleolacite Ell Tre Oase Tacianon Cleiting and digitized angiographic film.
Iocalizes lesions to be treated using CT scans, MR scans and digitized angiographi XPlan-1 provides a stereotactic planning system, for treatment of turnors < 7 cm in
XPlan-1 provides a stereotactic planning system, for treatment of turns of creation AF lan-1 provides a sices of skull and head. The conformal stereotactic chameler at sites Juen as on are delivered over multiple fractions.

Givind A. Slegyson

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

Prescription Use (Per 21 CFR 801.109)