MILLCOMP

K011845 · Math Resolutions, LLC · IYE · Dec 4, 2001 · Radiology

Device Facts

• Record ID: K011845
• Device Name: MILLCOMP
• Applicant: Math Resolutions, LLC
• Product Code: IYE · Radiology
• Decision Date: Dec 4, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

MillComp is used to manufacture compensators that are designed for radiation therapy treatment beams. MillComp may be used with any system that can design compensators such that the thickness over the area of the beam is specified at some known source to compensator distance in a plane perpendicular to the central axis. The thickness on an evenly spaced grid may be specified on divergent rays or on rays perpendicular to the plane of the compensator which is perpendicular to the central ray. If on divergent rays, the milled surface may be specified as towards the x-ray source or as towards the patient.

Device Story

MillComp is a software program used to generate tool path instructions for milling radiation therapy compensators. Input consists of compensator specifications derived from therapy treatment planning systems, converted into a standard file format. The software processes these specifications to define the compensator surface and calculates the necessary tool paths for a three-axis end milling machine. The device is operated by clinical staff to produce physical attenuators from materials such as lead or cerrobend. These compensators are subsequently inserted into x-ray beams to modify field distribution, aiding in precise radiation delivery to the patient. The system facilitates the creation of patient-specific beam modifiers, improving the accuracy of radiation therapy treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based tool path generator for three-axis end milling machines. Processes compensator surface geometry from grid-based thickness specifications. Compatible with various materials including lead and cerrobend. Operates as a standalone software program.

Indications for Use

Indicated for the manufacture of radiation therapy compensators used to modify x-ray beam field distribution for patients undergoing radiation therapy.

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.

Submission Summary (Full Text)

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MillComp File: m510ksum.doc Date: May 4, 2001

DEC 0 4 2001

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## 510(k) Summary

MillComp is a program that will write the tool path program to mill radiation therapy compensators on an end mill. Compensators are attenuators that are to be inserted into the x-ray beams for the purpose of modifying the field distribution over the area of the treatment beam. MillComp takes as input a compensator specification. The compensator specification will come from multiple sources, such as current therapy treatment planning systems, and is converted into a standard specification file format that MillComp can read. The conversion programs to read a compensator specification and write out the standard file format will be written on an as need basis according to the customer's needs. MillComp will read the specification file, generate the surface defined in the specification, and compute the tool paths necessary to cut the surface in solid lead, cerrobend, or other material, on a three axis end milling machine.

Document Approved by: Wendel Dean Renner Date: Title: President

Wendel Dean Kenner
May 30, 2001

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 4 2001

Mr. Wendel Dean Renner President Math Resolutions, LLC 5975 Gales Lane COLUMBIA MD 21045

Re: K011845

Trade/Device Name: Millcomp Version 1.0 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system

Regulatory Class: II Product Code: 90 IYE Dated: September 18, 2001 Received: September 20, 2001

Dear Mr. Renner:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bectorn of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosale) to tegain) at the Medical Device Amendments, or to conimeres prior to May 20, 1977) is accordance with the provisions of the Federal Food, Drug, de necs that have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, therefore, mains 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 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 or any I vathatos a 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 (21 Or It I ar our of ); faceming (21 CFR Part 820); and if applicable, the electronic form in the quality of evel 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 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:

| 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" (21 CFR Part 807.97). 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/dsmaldsmamain.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

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K011845

MillComp File: 4 May 2001 Date: minduse.doc

510(k) number: Device name: MillComp Indications for Use:

MillComp is used to manufacture compensators that are designed for radiation therapy treatment beams. MillComp may be used with any system that can design compensators such that the thickness over the area of the beam is specified at some known source to compensator distance in a plane perpendicular to the central axis. The thickness on an evenly spaced grid may be specified on divergent rays or on rays perpendicular to the plane of the compensator which is perpendicular to the central ray. If on divergent rays, the milled surface may be specified as towards the x-ray source or as towards the patient.

Document Approved by: Wendel Dean Renner Date: Title: President

Wendell Dean Kenna
May 30, 2001

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

Nancy Brogdon

(Division Sign Off)
Division of Reproductive, Abdomina
and Radiological Devices K011845
510(k) Number

(Optional Formal 1-2-96)