XIO RADIATION TREATMENT PLANNING SYSTEM

K032762 · Computerized Medical Systems, Inc. · IYE · Dec 2, 2003 · Radiology

Device Facts

• Record ID: K032762
• Device Name: XIO RADIATION TREATMENT PLANNING SYSTEM
• Applicant: Computerized Medical Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Dec 2, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two- or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up. Optionally, the user may elect to generate plans using Dynamic Conformal Arc Therapy capability. Dynamic Conformal Arc Therapy is a treatment modality in which the gantry rotates in an arc (or multiple arcs) over user-specified angles while the leaves of a multileaf collimator (MLC) continually reshape the beam to conform to the targer.

Device Story

XiO Radiation Treatment Planning System (RTP) assists clinicians (dosimetrists/physicists) in planning radiation therapy. Inputs include patient diagnostic images (CT/MR/film) and linear accelerator dosimetry data. Users define target volumes and avoidance structures on images. For Dynamic Conformal Arc Therapy, system plans treatment over arcs with continuous multi-leaf collimator (MLC) reshaping. System calculates dose distributions; outputs include on-screen displays and hard-copy reports for patient files. Unlike predicate devices, XiO does not directly control MLC hardware; it exports leaf positions to standard linac MLCs. Output informs clinical decision-making by identifying plans that maximize target dose while minimizing healthy tissue exposure, potentially improving therapeutic outcomes.

Clinical Evidence

No clinical testing performed. Substantial equivalence demonstrated via bench testing, including clinically oriented validation test cases executed in-house and algorithm test cases to verify dose calculation accuracy for Dynamic Conformal beams.

Technological Characteristics

Software-based radiation treatment planning system. Uses existing validated algorithms for dose calculation. Calculates dose distribution as sum of multiple fixed beam dose distributions across specified arcs. Connectivity: exports leaf position data to standard linear accelerator MLCs. Standalone software application.

Indications for Use

Indicated for cancer patients prescribed external beam radiation therapy or brachytherapy.

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

• BrainLAB BrainSCAN Conformal RT Module (K971367)
• 3D Line DMLC IV – ERGO (K001163)

Submission Summary (Full Text)

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# 6 \$327 62 510(k) Summary of Safety and Effectiveness XiO Radiation Treatment Planning System Dynamic Conformal

| Submitter Name: | Computerized Medical Systems, Inc. |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 1145 Corporate Lake Drive<br>St. Louis, MO 63132-1716 |
| Submitter Phone: | 314 993 0003 |
| Submitter Fax: | 314 993 0075 |
| Contact Person: | Michael A. Parsons - Director - Quality Assurance<br>and Regulatory Affairs or<br>Kathryn Stinson - Regulatory Affairs Associate |
| Date Summary Prepared: | September 2003 |
| Device Trade Name: | XiO Radiation Treatment Planning System |
| Device Common Name: | Radiation Treatment Planning System |
| Device Classification: | System, Simulator, Radiation Therapy per<br>21CFR892.5840 |
| Substantial Equivalence: | BrainLAB BrainSCAN Conformal RT Module,<br>K971367<br>3D Line DMLC IV – ERGO, K001163 |

Device Description: The XiO Radiation Treatment Planning system accepts a) patient diagnostic imaging data from CT and MR scans, or from films, and b) "source" dosimetry data, typically from a linear accelerator. The system then permits the user to display and define (contour) a) the target volume to be treated and b) critical structures which must not receive above a certain level of radiation, on these diagnostic images.

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## Kp32762 510(k) Summary of Safety and Effectiveness XiO Radiation Treatment Planning System Dynamic Conformal Page 2 of 3

Based on the prescribed dose, the user, typically a Dosimetrist or Medical Physicist can then create multiple treatment scenarios involving the type, number, position(s) and energy of radiation beams and the use of treatment aids between the source of radiation and the patient (wedges, blocks, ports, etc.). The XiO system then produces a display of radiation dose distribution within the patient, indicating not only doses to the target volume but to surrounding tissue and structures. The "best" plan satisfying the prescription is then selected, one that maximizes dose to the target volume while minimizing dose to surrounding healthy volume. The parameters of the plan are output in hard-copy format for later reference and for placement in the patient file.

This Premarket Notification addresses the addition of support for Dynamic Conformal Therapy. Dynamic Conformal is a treatment modality in which radiation beams are continuously shaped to conform to a target while the gantry rotates and the beam is on. In XiO, the user chooses the target, defines structures to avoid, optional margin(s), and treatment angles. XiO then plans a treatment over a specified arc and with specified beam increments, with the leaves of the multi-leaf collimator (MLC) continually reshaping the beam to conform to the target. The target receives a homogenous dose while the structures designated as "avoidance structures" are avoided absolutely.

Dose calculation is performed using existing, validated algorithms within XiO. Determination of dose at the specified angles is calculated in the same way as conventional and asymmetric arc beams; the calculated dynamic beam dose distribution is determined as the sum of multiple fixed beam dose distributions across the specified arc.

### Device Intended Use:

The XiO RTP System will continue to be used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.

The system will calculate and display, both on-screen and in hard copy, cither two- or three-dimensional radiation dose distributions within a patient for a given treatment plan sct-up.

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032762

### 510(k) Summary of Safety and Effectiveness XiO Radiation Treatment Planning System Dynamic Conformal Page 3 of 3

Summary of Technological Characteristics Compared to Predicate Devices: Like the XiO Dynamic Conformal feature, the predicate devices are used to generate plans for treatments that use a combination of rotational radiation beams and dynamic MLCs to conform the beam to the target while the gantry rotates and the beam is on.

Both predicate devices (BrainSCAN RTP System with Conformal RT Module and ERGO) are sold with companion micro-MLCs that are directly controlled by the RTP software. The XiO system does not include an MLC and does not directly control the MLC leaves. Instead, XiO exports the leaf positions to any standard linac MLC.

Detailed comparison information can be found in Section 6 of this submittal.

Summary of Clinical Testing: Actual testing in a clinic was not performed as part of the development of this feature. Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness of the device. Clinically oriented validation test cases were written and executed in-house by CMS customer support personnel.

Summary of Non-Clinical Testing: Algorithm test cases were written and executed to ensure that the system is calculating dose correctly for Dynamic Conformal beams. Results of this testing can be found in the XiO Dynamic Conformal Algorithm Test Report, included in section 9 of this submittal.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract design resembling an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 2 2003

Mr. Michael A. Parsons Director, Quality Assurance and Regulatory Affairs Computerized Medical Systems, Inc. 1145 Corporate Lake Drive Suite 100 ST LOUIS MO 63132

Re: K032762 Trade/Device Name: XiO RTP System with Dynamic Conformal Arc Therapy Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged particle radiation therapy system Regulatory Class: II Product Code: IYE and MUJ Dated: September 4, 2003

Received September 5, 2003

Dear Mr. Parsons:

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.

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.

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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 the 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" (21CFR Part 807.97) you may obtain. 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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#### Statement of Indication for Use

510(k) Number: K032762

Device Name: XiO RTP System with Dynamic Conformal Arc Therapy

Indication for use: The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two- or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up.

Optionally, the user may elect to generate plans using Dynamic Conformal Arc Therapy capability. Dynamic Conformal Arc Therapy is a treatment modality in which the gantry rotates in an arc (or multiple arcs) over user-specified angles while the leaves of a multileaf collimator (MLC) continually reshape the beam to conform to the targer.

Concurrence of the Center for Devices and Radiological Health,
Office of Device Evaluation (ODE)

| Prescription Use | <div> <img alt="Tick mark" src="prescription_tick.png"/> </div> | OR per 21 CFR 801.109 | Over the Counter Use ________ |
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(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

| 510(k) Number | K032762 |
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|---------------|---------|

Computerized Medical Systems - XiO Radiation Treatment Planning System Dynamic Conformal 510(K)