EQUAL DOSE

K103515 · Nucletron Corporation · MUJ · Sep 15, 2011 · Radiology

Device Facts

• Record ID: K103515
• Device Name: EQUAL DOSE
• Applicant: Nucletron Corporation
• Product Code: MUJ · Radiology
• Decision Date: Sep 15, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

MUV 4.0 is a quality assurance (QA) tool intended for independent verification of the dose calculations performed during treatment planning for external beam therapy. The intended user is a medical physicist or someone well familiar with the dosimetric concepts that are of importance in external beam therapy.

Device Story

EQUAL Dose 4.0 is a software-based quality assurance tool for independent verification of external beam radiation therapy dose calculations. Input consists of treatment plan data imported via DICOM RT Plan format. The software performs point-based dose calculations for megavoltage photon beams (4-30 MV) and electron beams (4-30 MeV) using established pencil beam and Gaussian pencil beam algorithms. It is operated by medical physicists or qualified dosimetrists in a clinical setting. Users cannot edit treatment delivery parameters but can adjust calculation point coordinates and depths. Output provides verified dose data to assist the clinician in confirming the accuracy of treatment planning systems. This independent verification helps ensure the safety and precision of radiation delivery to patients.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Software-based QA tool for point-based dose calculation. Supports megavoltage photon beams (4-30 MV) and electron beams (4-30 MeV). Algorithms: Pencil Beam (photons) and Gaussian Pencil Beam (electrons). Operates on Windows XP, Vista, and 7 (32-bit). Connectivity via DICOM RT Plan import.

Indications for Use

Indicated for independent verification of dose calculations in external beam radiation therapy. Intended for use by medical physicists or professionals familiar with dosimetric concepts. No specific patient population or contraindications defined.

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

• EQUAL Dose 1.0 (K073273)

Reference Devices

• TMS v5.1 (K010682)

Submission Summary (Full Text)

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Traditional 510(k) Nucletron EQUAL Dose 40

SEP 15 2011

K103515

-Page 28
March 2007

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NUCLETRON B.V. Waardgelder 1 3905 TH Veenendaal P.O.Box 930 3900 AX Veenendaal The Netherlands Phone [phone] [phone] Fax

Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 807.92(c)

# Submitter of 510(k):

Company name: Registration number: Address:

| Phone: |
|----------------|
| Fax: |
| Correspondent: |

Nucletron Corporation 1121753 8671 Robert Fulton Drive Columbia, MD 21046 410-312-4100 410-312-4197 Manal Yousof, Quality Assurance & Regulatory Affairs Manager

#### New Device Name:

Trade/Proprietary Name: Common/Usual Name: Classification Name: Classification:

EQUAL Dose 4.0 Radiation Therapy Verification Tool System, Planning, Radiation Therapy Treatment 21Cfr892.5050 Class II

# Legally Marketed Device(s)

Our new device is based on the legally marketed device cited in the table below:

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#### Description:

MUV 4.0 is a quality assurance (QA) tool intended for independent verification of the dose calculations performed during treatment planning for external beam therapy. The intended user is a medical physicist or someone well familiar with the dosimetric concepts that are of importance in external beam therapy.

The software requires beam data for individual treatment plans to be imported through the DICOM RT Plan format. The parameters associated with the treatment delivery on the accelerator can not be edited within the software, although parameters related to the calculation inside the patient/phantom, such as the coordinates and depths of the calculation points, are open for editing.

The software is validated for broad megavoltage photon beams in the range from 4 up to 30 MV and broad electron beams from 4 to 30 MeV, delivered by standard medical linear accelerators (linacs). ·

The software runs on a Windows XP, windows Vista and windows 7 systems (32 bit)

#### Intended use:

The legally marked predicate device (K073273) has the same intended use as the new device cited:

#### Equal Dose 4.0

Equal Dose 4.0 is a quality assurance (QA) tool intended for independent verification of the dose calculations performed during treatment planning for external beam therapy.

The intended user is a medical physicist or someone well familiar with the dosimetric concepts that are of importance in external beam therapy.

. Cleared EQUAL Dose1.0 K073273 > same intended use and intended user

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# Summary of technological considerations:

- Cleared (TMS v5.1) K010682 ✈ Treatment Planning Method: External Beam
- · Treatment modalities: Photon beams and electron beams
- · Dose Calculation:
- · Photons: Collapsed Cone or Pencil Beam algorithm
- Electrons: Gaussian Pencil Beam
- ·Dimension: 3D
- . Cleared EQUAL Dose1.0 K073273 ✈ Treatment Planning Method: External Beam • Treatment modalities: Photon beams
- ·Dose Calculation:
- · Photons: Pencil Beam algorithm

· Dimension: Point Calculation

| (EQUAL Dose) 4.0<br>(not applicable) | • Treatment Planning Method: External Beam<br>• Treatment modalities: Photon beams and electron beams<br>• Dose Calculation:<br>•Photons: Pencil Beam algorithm<br>Electrons: Gaussian Pencil Beam<br>•Dimension: Point Calculation |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

The cleared device TMS v5.1(K010682)has a wider Scientific Technology than the new device "EQUAL Dose 4.0". The new device is merely a verification tool while TMS v5.1 is a complete treatment planning system

Sept. 20, 2010
Date

Name: John Lapre Title: Vice President Research & Development Nucletron BX Veenendage, The Netherlands

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Public Health Service

Scree 1 5 2011

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 .

Mr. Manal Yousof Quality Assurance and Regulatory Affairs Manager Nucletron Corporation 7021 Columbia Gateway Drive, Suite 200 COLUMBIA MD 21046

Re: K103515

Trade/Device Name: EQUAL Dose 4.0 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: 11 Product Code: MUJ Dated: July 29, 2011 Received: July 29, 2011

Dear Mr. Yousof:

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 class II (Special Controls). it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809): medical device reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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.

ff you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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### Traditional 510(k) Nucletron EQUAL Dose 40

# Indications for Use

510(k) Number

Device Name

Indications for Use

K0103515

EQUAL Dose 4.0

MUV 4.0 is a quality assurance (QA) tool intended for independent verification of the dose calculations performed during treatment planning for external beam therapy.

The intended user is a medical physicist or someone well familiar with the dosimetric concepts that are of importance in external beam therapy.

Prescription Use _ X (Part 21 CFR 801 subpart D)

AND/OR

Over-The-Counter Use_ (Part 21 CFR 801 subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary S Pastil

in Gision Sign-Off D ... . of Radiological Device ാി Haulological
Costic Device Evaluation and Safety Office of In Ville

510K K103515

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