ACCUSOFT, ACCUSOFT XL

K062032 · Direx Systems Corp. · MUJ · Oct 5, 2006 · Radiology

Device Facts

• Record ID: K062032
• Device Name: ACCUSOFT, ACCUSOFT XL
• Applicant: Direx Systems Corp.
• Product Code: MUJ · Radiology
• Decision Date: Oct 5, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

AccuSoft-XL is to be used for the computation, display, evaluation and output of radiation dose estimations to be submitted for independent clinical review and judgment prior to use in radiation therapy.

Device Story

AccuSoft-XL is a radiation treatment planning system (RTPS) software suite. It ingests medical images (CT, MRI, PET) in DICOM format. The system performs image fusion, target delineation, and beam planning. It supports various treatment modes: Conformal, Blocks and Wedges, Cones, and IMRT (including IMAT, DIMRT, and Step-and-Shoot). The software calculates beam radiation dose distributions to maximize dose to lesions while sparing surrounding tissues. It generates configuration parameters for Linacs and proprietary Cone Changer/MMLC devices. Used in clinical settings by radiation oncology staff; output is reviewed by clinicians for final treatment planning decisions. Benefits include precise beam shaping and optimized dose delivery to irregular lesions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and validation of software modules and algorithmic performance.

Technological Characteristics

Radiation treatment planning software. Operates on standard computing hardware. Supports DICOM image integration. Features include image fusion, beam planning, and dose calculation algorithms. Complies with IEC 60601-1-4 for programmable electrical medical systems. Software-based; no specific hardware materials or sterilization requirements.

Indications for Use

Indicated for radiation treatment planning, including computation, display, and evaluation of radiation dose estimations for patients undergoing radiation therapy, including Conformal, Blocks and Wedges, Cones, and Intensity Modulated Radiation Therapy (IMRT).

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

• AccuSoft v3.14 (K040474)
• PerMedics' Odyssey (K042861)

Submission Summary (Full Text)

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#### 510(K) SUMMARY

# AccuSoft, AccuSoft XL 510(k) Number kob 2032

OCT - 5 2006

#### Applicant's Name:

Direx Systems Corp. 437 Turnpike Street Canton, MA 02021 United States of America

### Contact Person:

Larisa Gershtein Direx Systems Corp. 437 Turnpike Street Canton, MA 02021 Tel: [phone] Fax: [phone] E-mail: [e-mail]

#### Trade Name:

AccuSoft, AccuSoft-XL

#### Model:

AccuSoft-XL

Common Name:

Radiation Treatment Planning System

### Classification Name:

System, Planning, Radiation Therapy Treatment

#### Classification:

The FDA has classified this type of devices as class II (product code 90 MUJ, Regulation No. 892.5050), review by the Radiology Panel.

#### Predicate Devices:

- The Company's AccuSoft v3.14 (K040474)
- PerMedics' Odyssey (K042861)

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# Performance Standards:

No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act.

However, AccuSoft-XL complies with the following voluntary standards:

- . Guidance for FDA Reviewers and Industry - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; May 11, 2005.
- IEC 60601-1-4 Consol. Ed. 1.1 Medical Electrical Equipment -. Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems (1996) + A1 (1999).
- Guidance for Industry, FDA Reviewers and Compliance on Off-The-. Shelf Software Use in Medical Devices; September 9, 1999.

# Intended Use:

AccuSoft-XL is to be used for the computation, display, evaluation and output of radiation dose estimations to be submitted for independent clinical review and judgment prior to use in radiation therapy.

# Device Description:

AccuSoft-XL is a radiation treatment planning system (RTPS), consisting of a collection of software modules that execute algorithms to produce estimates of beam radiation dose distribution in body tissues. It includes the image, delineation and beam planning techniques.

AccuSoft-XL is an upgraded version of the Company's proprietary AccuSoft v3.14. It is designed to operate with Cones, Blocks and Wedges, as well as with a Micro-Multi-Leaf Collimator (MMLC), such that the shape of the radiation beam conforms to the irregular, shape of the lesion. The ability to shape the radiation beam enables maximization of the radiation dose to the lesion, while minimizing the radiation dose to the surrounding normal tissue and critical structures.

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AccuSoft-XL is used for computation, display, evaluation, and output of dose estimations, including those for several modes of treatment, such as Conformal, Blocks and Wedges, Cones and Intensity Modulated Radiation Therapy (IMRT). There are several IMRT treatment modes: (1) Intensity Modulated Arc Therapy (IMAT) – in which an irradiating Linac rotates while leaves form a sequence of apertures (arcs), (2) Dynamic Intensity Modulated Radiation Therapy (DIMRT) – in which irradiating Linac is stationary while leaves form a sequence of apertures, as well as (3) Intensity Modulated Radiation Therapy (also called Step-and-Shoot), during which apertures are formed prior to irradiation

The Linac and Cones / MMLC configuration parameters shall be written to a file to be sent to both the Linac and the Company's proprietary Cone Changer / MMLC devices.

In the AccuFusion module, AccuSoft-XL combines two different types of axial images. This enables to enhance the display of various materials or tissues and to perform target delineation on fused images. Thus, CT images and Secondary Images (CT, MRI, PET, etc.) in DIOOM format from the same patient can be combined, resulting in an improved single image.

# Substantial Equivalence:

AccuSoft-XL is essentially similar to AccuSoft v3.14 predicate device. It incorporates additional features, such as Fusion of axial images, Treatment Plan for Blocks and Wedges, and Cones, featured in the predicate device Odyssey.

Based on validations and performance testing results, Direx Systems Corp. believes that AccuSoft-XL is substantially equivalent to the above predicate devices without raising new safety and/or effective uss issues.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an abstract human figure with three flowing lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the graphic.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

# OCT - 5 2006

Ms. Larisa Gershtein QA Manager Direx Systems Corp. 437 Turnpike Street CANTON MA 02021

Re: K062032

Trade/Device Name: AccuSoft-XL Regulation Number: 21 CFR §892.5050j Regulation Name: Medical charge-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: September 11, 2006 Received: September 12, 2006

Dear Ms. Gershtein:

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.

Image /page/3/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. Below that is the text "FDA" in large, bold letters. Below that is the text "Centennial" in a smaller font. There are three stars below the word "Centennial". The logo is surrounded by a dotted border.

Promoting Public . J

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#### Page 2 -

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 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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C Hodgdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Finclosure

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# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K062032

Device Name:

AccuSoft-XL

Indications for Use:

AccuSoft-XL is to be used for the computation, display, evaluation and output of radiation dose estimations to be submitted for independent clinical review and judgment prior to use in radia fon therapy.

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

David C. Bowman

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

Prescription Use

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