(190 days)
The intended use of this device is to help provide dose uniformity for electron beam profile.
MED-TEC, INC. has a Block, Beam-Shaping, Radiation system to be manufactured by MED-TEC, INC.
This document is an FDA 510(k) clearance letter for the "Electron Wedge MT-EW-1000" by Med-Tec, Inc. It indicates that the device has been found substantially equivalent to a predicate device and can therefore be marketed.
However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. It is purely a regulatory clearance notice.
Therefore, I cannot provide the requested information from the given input.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 5 1998
Donald F. Riibe Vice President of Operations Med-Tec. Inc. P.O. Box 320 Orange City, Iowa 51041
Re: K981992 Electron Wedge MT-EW-1000 Dated: September 22, 1998 Received: September 24, 1998 Regulatory class: II 21 CFR 892.5710/Procode: 90 IXI
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 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 redassified 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 (Special Controls) or 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition. FDA may publish further announcements 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requiried, "Misbranding by reference to premarket notfication"(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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Capt. Daniel G. Schultz, M.D. Acting 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): K981992
Device Name: MED-TEC Electron Wedge
Indications For Use:
MED-TEC, INC. has a Block, Beam-Shaping, Radiation system to be manufactured by MED-TEC, INC.
| Classification Name: | Radiation Beam-Shaping Block |
|---|---|
| Common/Usual Name: | Block, Beam-Shaping, Radiation |
| Proprietary Name: | Electron Wedge |
The intended use of this device is to help provide dose uniformity for electron beam profile.
Classification: Since this device, attaches to class II accelerator, we believe it is a Class II device.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David h. Symm
(Division Sign-Off)
Division of Reproductive, Abdominal, EN and Radiological 510(k) Number
Prescription Use Per 21 CFR 801.109)
OR
Over - The - Counter Use
(Optional Format 1-2-96)
§ 892.5710 Radiation therapy beam-shaping block.
(a)
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.(b)
Classification. Class II.