CARBON FIBER BREAST BOARD

K974703 · Medtec, Inc. · IYE · Mar 10, 1998 · Radiology

Device Facts

• Record ID: K974703
• Device Name: CARBON FIBER BREAST BOARD
• Applicant: Medtec, Inc.
• Product Code: IYE · Radiology
• Decision Date: Mar 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The intended use of the MED-TEC, INC. Carbon Fiber Breast Board is to support and aid in positioning a patient during radiologic and other medical procedures.

Device Story

Carbon Fiber Breast Board is a stationary radiographic table accessory; used to support and position patients during radiologic and medical procedures. Device operates similarly to conventional breast boards; provides stable platform for patient alignment during imaging. Used in clinical settings by healthcare professionals to facilitate accurate patient positioning for diagnostic or therapeutic procedures. Benefits include improved patient stability and consistent positioning during medical imaging.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Constructed of carbon fiber; stationary radiographic table top design. Class II device used with Class II radiographic equipment. No electronic components, software, or energy sources.

Indications for Use

Indicated for supporting and positioning patients during radiologic and other medical procedures.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 1998

Donald F. Riibe Medtec Corporation 1401 8th Street S.E. P.O. Box 602 Orange City, IA 51041 Re:

K974703 Carbon Fiber Breast Board Dated: December 12, 1997 Received: December 16, 1997 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Mr. Riibe:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for the indications for use stated in the enclosure) to 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). 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further amouncements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

W. Liao Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Not assigned yet

Device Name: _Carbon Fiber Breast Board_

Indications For Use:

MED-TEC, INC. has a Table, Radiographic, Stationary Top System to be manufactured by MED-TEC, INC.

Classification Name: Breast Board Common/Usual Name: Table, Radiographic, Stationary Top Proprietary Name: Carbon Fiber Breast Board

The intended use of this device is to The MED-TEC, INC. Carbon Fiber Breast Board operates in the same manner as ordinary breast boards. or The intended use of the MED-TEC, INC. Carbon Fiber Breast Board is to support and aid in positioning a patient during radiologic and other medical procedures. .

Classification: Since this device, The MT-350, is used with Class II equipment, we believe the Carbon Fiber Breast Board is a Class II device.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Gamil A. Seymore

Division Sign-Off) n of Reproductive. Abdominal.

Prescription Use ✓

OR

Over - The - Counter Use

Per 21 CFR 801.109)

1-2-96)

(Optional Format