MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE

K013875 · Med-Tec,Inc. · IXI · Sep 27, 2002 · Radiology

Device Facts

• Record ID: K013875
• Device Name: MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE
• Applicant: Med-Tec,Inc.
• Product Code: IXI · Radiology
• Decision Date: Sep 27, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5710
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Software translates the ASCII output from a treatment plan to G code for use on a milling machine. Works with various treatment plan outputs and translates the treatment plan into G code that can be used on a milling machine to produce a compensating shield.

Device Story

Device is software designed for radiation therapy workflow; inputs ASCII data from treatment planning systems; transforms data into G-code instructions; output drives milling machines to fabricate physical compensating shields; used in clinical settings by radiation therapy staff; facilitates precise beam-shaping for patient treatment; improves efficiency in shield production.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based translation tool; converts ASCII treatment plan data to G-code for CNC milling machines; standalone software application.

Indications for Use

Indicated for use in radiation therapy to translate treatment plan ASCII output into G-code for milling machines to fabricate compensating shields.

Regulatory Classification

Identification

A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the edge. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 7 2002

Mr. Donald Riibe Regulatory Affairs RA Department MED-TEC, Inc. 1401 Eighth Street SE P.O. Box 320 ORANGE CITY IA 51041 Re: K013875 Trade/Device Name: MED-TEC Compensator Block Cutter Software Regulation Number: 21 CFR §892.5710 Regulation Name: Radiation therapy beam-shaping block Regulatory Class: II Product Code: 90 IXI Dated: June 24, 2002 Received: July 1, 2002

Dear Mr. Riibe:

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 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 (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.

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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/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

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## ATTACHMENT 9.2a

Page __ 1_ of __ 1_

510(k) Number (if known):__k013875_

Device Name: _ MED-TEC Compensator Block Cutter Software

Indications For Use:

Software translates the ASCII output from a treatment plan to G code for use on a milling machine.

Works with various treatment plan outputs and translates the treatment plan into G code that can be used on a milling machine to produce a compensating shield.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Digman

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

Prescription Use V Per 21 CFR 801.109

OR

Over-The-Counter USE

(Optional Format 1-2-96)