CROSSPLAN / ACCUSOFT-XL V.4.04

K063482 · Direx Systems Corp. · MUJ · Dec 14, 2006 · Radiology

Device Facts

• Record ID: K063482
• Device Name: CROSSPLAN / ACCUSOFT-XL V.4.04
• Applicant: Direx Systems Corp.
• Product Code: MUJ · Radiology
• Decision Date: Dec 14, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Accusoft-XL v.4.04 / CrossPlan 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

Radiation treatment planning system (RTPS) software; processes medical images (CT) and RT objects (RT Plan, RT Structure Set) to estimate beam radiation dose distribution. Supports Cones, Blocks, Wedges, and Micro-Multi-Leaf Collimators (MMLC) to conform radiation beams to lesion shapes. Enables Intensity Modulated Radiation Therapy (IMRT) modes: Intensity Modulated Arc Therapy (IMAT), Dynamic Intensity Modulated Radiation Therapy (DIMRT), and Step-and-Shoot. Performs image fusion of registered images to enhance tissue/material display. Used by clinicians to maximize dose to lesions while minimizing dose to surrounding normal tissue/critical structures. Output consists of dose estimations for independent clinical review and judgment prior to therapy delivery. Data import supported via DICOM server.

Clinical Evidence

No clinical data. Performance validation conducted via bench testing to ensure compliance with software and safety standards.

Technological Characteristics

Radiation treatment planning software; operates on standard computing hardware. Supports DICOM connectivity for image/data import. Complies with IEC 60601-1-4 for programmable electrical medical systems. Software-based dose calculation algorithms for conformal and IMRT treatment planning.

Indications for Use

Indicated for radiation therapy planning, specifically the computation, display, evaluation, and output of radiation dose estimations for clinical review prior to treatment.

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-XL v. 4.01 (K062032)
• Pinnacle3 RTP v. 6.6 (K032724)

Submission Summary (Full Text)

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## SECTION 5 -- 510(k) SUMMARY

K 0634/82

[Submitted pursuant to 21 CFR 807.92(a). All data included in this document are accurate and complete to the best of DSC's knowledge.]

| 1. Submitter Information | | DEC 14 2006 |
|--------------------------------------|--------------------------------------------------------------------------------------------|-------------|
| Date:<br>Submitter: | November 3, 2006<br>Direx Systems Corporation<br>437 Turnpike Street<br>Canton<br>MA 02021 | |
| Telephone:<br>Fax:<br>Contact Person | [phone]<br>[phone]<br>Larisa Gershtein<br>QA Manager | |
| Contact Person e-mail address: | [e-mail] | |
| 2. Device | | |
| Trade/Proprietary Name: | AccuSoft-XL v. 4.04, will also be<br>marketed as CrossPlan | |
| Classification Name: | System, Planning, Radiation<br>Therapy Treatment | |
| Regulation Number: | 21 CFR 892.5050 | |
| Regulatory Class: | Class II (special controls) | |
| Product code: | 90 MUJ | |
| Panel: | Radiology Devices | |

### 3. Predicate Devices

| Direx Systems Corp | AccuSoft-XL v. 4.01 | (K062032) |
|------------------------|----------------------|-----------|
| ADAC Laboratories Inc, | Pinnacle3 RTP v. 6.6 | (K032724) |

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#### 4. Intended Use:

CrossPlan / AccuSoft-XL v. 4.04 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.

### 5. Device Description

CrossPlan / AccuSoft-XL v. 4.04 is an upgraded version of the Company's proprietary AccuSoft-XL. CrossPlan / AccuSoft-XL v. 4.04 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.

CrossPlan / AccuSoft-XL v. 4.04 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.

CrossPlan / AccuSoft-XL v. 4.04 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

As an option, some of the data can be imported via DICOM server that will include information of RT objects (RT Plan, RT Structure Set, RT Images) and CT Images.

5-2

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CrossPlan / AccuSoft-XL v. 4.04 is able to combine two registered images to create a fusion image. This is often used to combine two images acquired differently but from a single source to enhance the display of various materials or tissues.

### 6. Performance Testing

No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act. However, CrossPlan / AccuSoft-XL v. 4.04 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.

### 7. Substantial Equivalence

CrossPlan / AccuSoft-XL v. 4.04 is a modification of its predicate AccuSoft-XL (K062032).

CrossPlan / AccuSoft-XL v. 4.04 differences relative to its predicate devices do not raise additional safety or effectiveness issue as evidenced by performance validation.

Based on the descriptive information and the performance testing we believe that CrossPlan / AccuSoft-XL v. 4.04 is substantially equivalent to its predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUM." written around the top half of the circle. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Ms. Larisa Gershtein QA Manager DIREX System Corporation 437 Turnpike Street CANTON MA 02021

#### DEC 1 4 2006

Re: K063482

Trade/Device Name: Accusoft-XL v.4.04 (also be marketed under the name CrossPlan) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: November 15, 2006 Received: November 17, 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 seal with text and symbols. The text "1906-2006" is at the top of the seal. The letters "FDA" are in the center of the seal. The word "Centennial" is at the bottom of the seal. There are three stars below the word "Centennial".

oting Public S.

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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/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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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Image /page/5/Picture/0 description: The image shows the logo for Direx Systems Corp. The word "Direx" is in large, bold, black letters with a line underneath. Below the line, the words "SYSTEMS CORP." are in smaller, black letters.

Section 4: Indications for Use Statement

# Indications for Use STATEMENT

510(k) Number (if known): K063482

Device Name:

Accusoft-XL v.4.04 (also be marketed under the name CrossPlan)

Indications for Use:

Accusoft-XL v.4.04 / CrossPlan 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.

Prescription Use ✔ (Per 21 CFR § 801.109)

OR

Over the Counter Use

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

Nancy Broadon

(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number _

437 Turnpike Street ♦ Canton, MA 02021 Phone: [phone] ♦ Fax: [phone] e - mail p r o m o @ @ d i r e x u s a . c o m