ACCUSOFT

K032171 · Direx Systems Corp. · IYE · Dec 15, 2003 · Radiology

Device Facts

• Record ID: K032171
• Device Name: ACCUSOFT
• Applicant: Direx Systems Corp.
• Product Code: IYE · Radiology
• Decision Date: Dec 15, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

AccuSoft is intended to be used for the computation, display, evaluation, and output documentation of radiation dose estimations that are to be submitted for independent clinical review and verification by a physicist or physician prior to use. The application provides output data in the form of displays or hardcopy printouts to guide a physician in selecting the optimum patient treatment plan. It is intended to provide a report to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist or dosimetrist.

Device Story

AccuSoft is a radiation treatment planning software system; executes algorithmic approaches to produce radiation dose estimations. Inputs include patient image data for localization and delineation; supports static radiation beams shaped via Micro-Multi-Leaf Collimator (MMLC) to conform to irregular lesion shapes. Outputs consist of displays or hardcopy reports documenting dose estimations. Used in clinical settings by radiation oncologists, medical physicists, therapists, or dosimetrists to guide selection of optimum treatment plans. Benefits include maximizing radiation dose to lesions while minimizing dose to surrounding normal tissue and critical structures. Requires independent clinical review and verification by physicist or physician prior to use.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by validation and performance testing results.

Technological Characteristics

Software-based radiation treatment planning system. Features static beam planning and MMLC shaping. Complies with IEC 601-1-4 (Programmable electrical medical systems) and EN 1441 (Risk analysis).

Indications for Use

Indicated for radiation treatment planning in patients requiring radiation therapy. Used by radiation oncologists, medical physicists, radiation therapists, or dosimetrists to compute, display, and evaluate radiation dose estimations for treatment planning. No specific patient age or gender contraindications stated.

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

• PerMedics' OptiRad (K993895)

Submission Summary (Full Text)

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# 510(K) SUMMARY AccuSoft 510(k) Number K_03217/

## Applicant's Name:

Direx Systems Corp. 11 Mercer Road, Natick Business park Natick, MA 01760 United States of America Tel: [phone] Fax: [phone]

### Contact Person:

Larisa Gershtein Direx Systems Corp. 11 Mercer Road Natick, MA 01760 Tel: [phone] Fax: [phone] E-mail: [e-mail]

## Trade Name:

AccuSoft™

### Model:

AccuSoft

### Classification Name:

System, Planning, Radiation Therapy Treatment

### Classification:

The FDA has classified this type of devices as class II (product code 90 IYE, Regulation No. 892.5050) and they are reviewed by the Radiology Panel.

### Predicate Devices:

PerMedics' OptiRad k993895

### Performance Standards:

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

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KØ32171

However, AccuSoft 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. IEC 601-1-4, Medical electrical equipment - Part 1:General requirements for safety - 4. Collateral Standard: Programmable electrical medical systems."

FDA/CDRH/ODE Draft Document - Guidance for Off-the-Shelf Software Use in Medical Devices (June 4, 1997).

EN 1441 (1997) - Medical Devices: Risk analysis;

Collateral Standard: Programmable electrical medical systems and IEC 60812 (1985) - Failure Mode and Effects Analysis.

#### Intended Use:

AccuSoft is intended to be used for the computation, display, evaluation, and output documentation of radiation dose estimations that are to be submitted for independent clinical review and verification by a physicist or physician prior to use.

The application provides output data in the form of displays or hardcopy printouts to guide a physician in selecting the optimum patient treatment plan. It is intended to provide a report to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist or dosimetrist.

#### Device Description:

AccuSoft is a radiation treatment planning system. It consists of a software package that executes accepted algorithmic approaches to produce radiation dose estimations and of extensive verification and quality assurance (QA) procedures to enable the proper system and patient setup and adequate radiation delivery. It includes the same image acquisition, localizing, delineation and beam planning techniques. AccuSoft is designed with stationary or "static" radiation beams. These beams can be shaped with a shaping device, 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 the user to treat irregularly shaped lesions, maximizing the radiation dose to the lesion, while minimizing the radiation dose to the surrounding normal tissue and critical structures.

#### Substantial Equivalence:

Based on validations and performance testing results, Direx Systems Corp. believes that AccuSoft is substantially equivalent to the predicate device cited above without raising new safety and/or effectiveness issues.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 5 2003

Ms. Larisa Gershtein QA Manager DiREX Systems Corporation 11 Mercer Road NATICK MA 01760

Re: K032171 Trade/Device Name: AccuSoft Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: November 6, 2003 Received: November 10, 2003

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 (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)

I his lotter will and in your your 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 11 you toon 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

Page 2

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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: AccuSoft Indications for Use:

AccuSoft is to be used for the computation, display, evaluation, and output documentation of radiation dose estimations to be submitted for independent clinical review and judgment by a physicist or physician prior to use. The device provides output data in the form of displays or hardcopy printouts to guide a physician in selecting the optimum patient treatment plan. It is intended to provide a report to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist or dosimetrist.

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Prescription Use __

Daniela. bezzam

(Division Sign-Off) Division of Reproductive, Abdomis and Radiological Devic 5 10(k) Number