K Number
K062032
Device Name
ACCUSOFT, ACCUSOFT XL
Date Cleared
2006-10-05

(79 days)

Product Code
Regulation Number
892.5050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 radia fon 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. 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.
More Information

Not Found

No
The description focuses on traditional radiation treatment planning algorithms and image fusion techniques, with no mention of AI or ML.

No.
The device is a radiation treatment planning system (RTPS) used for computation, display, evaluation and output of radiation dose estimations. It does not directly deliver or produce a therapeutic effect on the patient. The estimations are for clinical review and judgment prior to use in radiation therapy, implying it's a planning tool, not a treatment delivery device.

No

Explanation: The device is a radiation treatment planning system that computes, displays, evaluates, and outputs radiation dose estimations, which are then used to plan radiation therapy. It does not provide a diagnosis of a patient's condition or disease.

Yes

The device is described as a "collection of software modules" and a "radiation treatment planning system (RTPS)" that "execute algorithms". While it interacts with hardware (Linac, Cone Changer / MMLC devices), the core functionality described is software-based computation, display, evaluation, and output of dose estimations. The description focuses on the software's capabilities and algorithms, not on the hardware itself being part of the submitted device.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
  • AccuSoft-XL's Function: AccuSoft-XL is a radiation treatment planning system. Its purpose is to compute, display, and evaluate radiation dose estimations for use in radiation therapy. It processes medical images (CT, MRI, PET) and plans the delivery of radiation to a patient's body.
  • No Specimen Examination: The device does not involve the collection, preparation, or examination of specimens taken from the human body. It works with images of the body and plans treatment on the body.

Therefore, based on the provided information, AccuSoft-XL falls under the category of a medical device used for treatment planning, not an In Vitro Diagnostic device.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

90 MUJ

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.

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT, MRI, PET

Anatomical Site

Body tissues, surrounding normal tissue and critical structures, lesion

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K040474, K042861

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

0

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: (339) 502 6013 Fax: (339) 502 6018 E-mail: Igershtein@direxusa.com

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:

1

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.

2

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.

3

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

4

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
Other240-276-0100

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 (800) 638-2041 or (240) 276-3150

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