MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02

K023293 · Med-Tec,Inc. · IYE · Dec 23, 2002 · Radiology

Device Facts

• Record ID: K023293
• Device Name: MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02
• Applicant: Med-Tec,Inc.
• Product Code: IYE · Radiology
• Decision Date: Dec 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Indications for Use

The intended use of this device is to provide a cutout for displacement of the small bowel from the treatment area. The belly board can be used by it's self or with MED-TEC's HipFix system. The MED-TEC bellyboard is placed on the treatment table and has a cutout that aids in the displacement of the small bowel from the treatment area .

Device Story

Bellyboard is a patient positioning accessory for radiation therapy; placed on treatment table; features a cutout to facilitate displacement of small bowel from radiation treatment field. Used in clinical radiation oncology settings; operated by radiation therapists. Can be used standalone or integrated with MED-TEC HipFix system. Device provides physical support and anatomical positioning to minimize radiation exposure to small bowel; improves treatment precision.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Patient positioning board with cutout; designed for use on radiation therapy treatment tables. Compatible with MED-TEC HipFix system. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients undergoing radiation therapy requiring displacement of the small bowel from the treatment area.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICE

Image /page/0/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 "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem that resembles an abstract bird or eagle with three curved lines forming its body and wings.

#### Public Health Service

Food and Drug Administra 9200 Cornorate Boulevard

**DEC 23 2002**

Mr. Donald F. Riibe Regulatory Affairs MED-TEC, Inc. 1401 8th St. SE P.O. Box 320 ORANGE CITY IA 51041 Re: K023293 Trade/Device Name: Bellyboard Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle . radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: September 18, 2002 Received: October 2, 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,

Henry C. Grigdon

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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E-3.4 TTACHMENT

Page 1 of 1

510(k) Number (if known):

Device Name: __ Bellyboard

Indications For Use:

The intended use of this device is to provide a cutout for displacement of the small bowel from the treatment area.

The belly board can be used by it's self or with MED-TEC's HipFix system.

The MED-TEC bellyboard is placed on the treatment table and has a cutout that aids in the displacement of the small bowel from the treatment area .

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Symm

(Division Sion Andominal, 3 - 23 Der

Prescription Use
Per 21 CFR 801.109

OR

Over-The-Counter USE

(Optional Format 1-2-96)

Traditional 510(k)

DFR