K Number
K073273
Device Name
EQUAL DOSE 1.0
Date Cleared
2007-12-11

(20 days)

Product Code
Regulation Number
892.5050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EQUAL Dose 1.0 is a quality assurance (QA) tool intended for independent verification of the dose calculations performed during treatment planning for external beam therapy, prior to the clinical treatment start. The intended user is a medical physicist or someone well familiar with the dosimetric concepts that are of importance in external beam therapy.
Device Description
MUV 1.0 is a quality assurance (QA) tool intended for independent verification of the dose calculations performed during treatment planning for external beam therapy, prior to the clinical treatment start. 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 reliated 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, delivered by standard medical linear accelerators (linacs), The software runs on a Windows XP platform.
More Information

Not Found

No
The summary describes a software tool for dose calculation verification based on imported beam data and editable parameters, with no mention of AI, ML, or related concepts. The description of the software running on Windows XP further suggests a more traditional software architecture.

No.
The device is described as a "quality assurance (QA) tool intended for independent verification of the dose calculations performed during treatment planning for external beam therapy," not for directly treating a patient.

No

The device is described as a "quality assurance (QA) tool" used for independent verification of dose calculations in treatment planning, not for diagnosing medical conditions.

Yes

The device description explicitly states it is "software" and describes its function as a "quality assurance (QA) tool" for verifying dose calculations, which is a software-based task. It also mentions running on a "Windows XP platform," further indicating a software-only nature. There is no mention of any accompanying hardware components.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
  • Device Function: The description clearly states that EQUAL Dose 1.0 is a "quality assurance (QA) tool intended for independent verification of the dose calculations performed during treatment planning for external beam therapy." It works with beam data and treatment plans, not biological samples from a patient.
  • Intended Use: The intended use is for verifying dose calculations prior to clinical treatment start, which is a quality control step in the radiotherapy process, not a diagnostic test on a patient sample.

Therefore, EQUAL Dose 1.0 falls under the category of a medical device used in the planning and quality assurance of external beam therapy, but it does not meet the definition of an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

EQUAL Dose 1.0 is a quality assurance (QA) tool intended for independent verification of the dose calculations performed during treatment planning for external beam therapy, prior to the clinical treatment start. The intended user is a medical physicist or someone well familiar with the dosimetric concepts that are of importance in external beam therapy.

Product codes

IYE

Device Description

MUV 1.0 is a quality assurance (QA) tool intended for independent verification of the dose calculations performed during treatment planning for external beam therapy, prior to the clinical treatment start. 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 reliated 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, delivered by standard medical linear accelerators (linacs),

The software runs on a Windows XP platform.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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

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

Not Found

Key Metrics

Not Found

Predicate Device(s)

K011246

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

Traditional 510(k) Nucletron EQUAL Dose 1.0

K073273

Page 31
March 2007

Image /page/0/Picture/2 description: The image contains the word "Nucletron" in bold, sans-serif font, next to a square logo. The logo contains a black circle with two white circles on opposite sides of the black circle. The logo and the word "Nucletron" are aligned horizontally.

NUCLETRON B.V.

Waardgelder 1 3905 TH Veenendaal P.O.Box 930 3900 AX Veenendaal The Netherlands Phone +31 318 557133 Fax +31 318 550485

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

DEC 1 1 2007

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

Submitter of 510(k):

Company name:Nucletron Corporation
Registration number:1121753
Address:8671 Robert Fulton Drive
Columbia, MD 21046
Phone:410-312-4100
Fax:410-312-4197
Correspondent:Lisa Dimmick
Director Assurance & Regulatory Affairs

New Device Name:

Trade/Proprietary Name:EQUAL Dose 1.0
Common/Usual Name:Radiation Therapy Verification Tool
Classification Name:System, Planning, Radiation Therapy Treatment
Classification:21Cfr892.5050 Class II

Legally Marketed Device(s)

:

Our device is substantially equivalent to the legally marketed predicate device cited in the table below:

ManufacturerDevice510(k) #
MDS NordionDCM1.0K011246

Description:

MUV 1.0 is a quality assurance (QA) tool intended for independent verification of the dose calculations performed during treatment planning for external beam therapy, prior to the clinical treatment start. The intended user is a medical physicist or someone well familiar with the dosimetric concepts that are of importance in external beam therapy.

1

Received Event (Event Succeeded)

Date:2007-08-30Time:04:35
Duration:2 min 30 secSender:---
Fax Number:

Traditional 510(k) Nucletron EQUAL Dose 1.0

Page 32 March 2007

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 reliated 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, delivered by standard medical linear accelerators (linacs),

The software runs on a Windows XP platform.

Intended use:

The legally marked predicate device has a wider intended use as the new device cited:

DCM1.0 (510K # K011246)→ DCM is a three-dimensional radiotherapy dose engine for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. Based on quality assured radiation therapy input data Dose Calculation Module (DCM) is used to plan radiation treatment with:

  • Linear accelerators with X-ray energies from 4 to 50MV .
  • . Cobalt-60 units

DCM will calculate dose for 3D radiotherapy treatment approaches of combined modality plans, asymmetric and non-copianar fields; total body irradiation; modality plans;
dynamic wodanar fields; total body irradiation; multi-leaf collimators; motorized and dynamic wedges; customized blocking.

EQUAL Dose 1.0 → MUV 1.0 is a quality assurance (QA) tool intended for independent thereove aries to the stime to a quiations performed during for external beam therapy, prior to the clinical treatment start.

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

Summary of technological considerations:

The cleared predicate device, DCM1.0, 510(K)#: K011246, has a wide intended use than the new device EQUAL Dose 1.0. EQUAL Dose is merely a verification tool.

e

2007-08-30

Date

Name: Paul van den Biggelaar Title: Director Oncentra Nucletron B.V. Veenendaal, The Netherlands

2

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans. The eagle is depicted in a simple, abstract style with bold lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 2007

Nucletron Corporation % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Service 2307 E. Aurora Rd., Unit B7 TWINSBURG OH 44087

Re: K073273

Trade/Device Name: EQUAL Dose 1.0 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: November 20, 2007 Received: November 21, 2007

Dear Mr. Lehtonen:

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.

3

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx(Gastroenterology/Renal/Urology)240-276-0115
21 CFR 884.xxxx(Obstetrics/Gynecology)240-276-0115
21 CFR 892.xxxx(Radiology)240-276-0120
Other240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.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

4

Image /page/4/Picture/0 description: The image shows the word "Nucletron" in bold, black font next to a square logo. The logo contains a black circle with two white circles on either side. The logo is enclosed in a black square.

Nucletron Corporation 7080 Columbia Gateway Drive Columbia, MD 21046-2133 U.S.A. 410-312-4100 Phone 410-312-4197 Fax

Indications for Use

510(k) Number

EQUAL Dose 1.0 Device Name

Indications for Use

EQUAL Dose 1.0 is a quality assurance (QA) tool intended for independent verification of the dose calculations performed during treatment planning for external beam therapy, prior to the clinical treatment start. 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)

Aori M. Whay
(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number