(52 days)
Interface between treatment planning system and the MED-TEC Pro Series Couch; or: Software for MED-TEC Pro Series Couch (6 Degree Axis Couch) .
Not Found
This FDA 510(k) letter for the "Pro Series Couch Software" by MED-TEC, Inc. (K034054) is a regulatory clearance document. It does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria.
The letter explicitly states that the device is determined to be "substantially equivalent" to legally marketed predicate devices. This means that the FDA has not conducted a de novo review of performance or efficacy in the way that would typically involve acceptance criteria and detailed study results. Instead, the focus is on whether the new device is as safe and effective as devices already on the market.
Therefore, I cannot provide answers to the requested points based on the provided document. The document pertains to regulatory clearance based on substantial equivalence, not a detailed performance study with acceptance criteria.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three overlapping human figures, possibly representing people or families. The figures are depicted in a simple, abstract manner with flowing lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 0 2004
Mr. Donald Francis Riibe Regulatory Affairs MED-TEC, Inc. P.O. Box 320 1401 800 Street SE ORANGE CITY IA 51041-0320 Re: K034054
Trade/Device Name: Pro Series Couch Software Regulation Number: 21 CFR 892.5770 Regulation Name: Powered radiation therapy patient support assembly Regulatory Class: II Product Code: 90 JAI Dated: December 15, 2003 Received: December 30, 2003
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 such 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 Section 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 the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brydon
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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Section D - Statement of Indications for use :
Attachment ... D-2.1
Intended Use
Pro Series Couch Software
Intended Use Statement
MED-TEC, INC. has a Treatment Couch to be manufactured by MED-TEC, INC.
Powered Radiation Therapy Patient Support Assembly Software Classification Name: Treatment Couch Software Common/Usual Name: Proprietary Name: Pro Series Couch Software
The intended use of this device is to:
Interface between treatment planning system and the MED-TEC Pro Series Couch; or:
Software for MED-TEC Pro Series Couch (6 Degree Axis Couch) .
Classification: Since this device is used with a class II device, we believe it to be a Class II device.
We have the safety and effectiveness information on file and available to the public.
Prescription Use
(Per 21 CFR 801.109)
Daniela Layman
(Division Sign-Off) Division of Reproductive. Abdominal. and Radiological Devices 510(k) Number
§ 892.5770 Powered radiation therapy patient support assembly.
(a)
Identification. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.(b)
Classification. Class II.