MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC

K031866 · Med-Tec,Inc. · JAI · Aug 14, 2003 · Radiology

Device Facts

• Record ID: K031866
• Device Name: MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC
• Applicant: Med-Tec,Inc.
• Product Code: JAI · Radiology
• Decision Date: Aug 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5770
• Device Class: Class 2

Intended Use

The intended use of this device is to support a patient during radiation therapy; or The intended use of the MED-TEC 6 degree axis couch is to support and aid in positioning a patient during radiologic, radiation therapy, and other medical procedures.

Device Story

The MED-TEC 6 degree axis couch is a patient support assembly used in radiation therapy and radiologic procedures. It provides six degrees of freedom for patient positioning: X, Y, Z, Yaw, Pitch, and Roll. By adding Pitch and Roll capabilities to standard X, Y, Z, and Yaw motions, the device enables precise patient alignment without requiring manual repositioning. The couch is operated by clinical staff in a radiation therapy or radiology environment to facilitate accurate treatment delivery. It improves workflow efficiency and patient comfort by simplifying the alignment process.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered radiation therapy patient support assembly. Provides 6-degree-of-freedom movement (X, Y, Z, Yaw, Pitch, Roll). Class II device. Product code: JAI.

Indications for Use

Indicated for patients requiring support and positioning during radiologic, radiation therapy, and other medical procedures.

Regulatory Classification

Identification

A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.

Submission Summary (Full Text)

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## Public Health Service

AUG 1 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Donald Francis Riibe Regulatory Affairs MED-TEC. Inc. P.O. Box 320 1401 8th Street S.E. ORANGE CITY IA 51041-0320 Re: K031866 Trade/Device Name: MED-TEC 6 degree axis couch Regulation Number: 21 CFR 892.5770 Regulation Name: Powered radiation therapy patient support assembly Regulatory Class: II Product Code: 90 JAI Dated: June 6, 2003 Received: June 18, 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 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 | [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" (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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

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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MED-TEC, INC.

Traditional 510(k)

Attachment... E-3.4

Page 1 of of le

510(k) Number (if known): __

Device Name: __ MED-TEC 6 degree axis couch

Indications For Use:

The intended use of this device is to support a patient during radiation therapy; or The intended use of the MED-TEC 6 degree axis couch is to support and aid in positioning a patient during radiologic, radiation therapy, and other medical procedures.

The 6 degree axis couch adds Pitch and Roll to the normal X, Y, Z. and Yaw motions. The additional Pitch and Roll make patient alignment simpler without the need to manually move the patent on the table.

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

David A. Sayre

(Division Sign-Off Division of Reproductive and Radiological D 510k) Num

Prescription Use
Per 21 CFR 801.109

OR

Over-The-Counter USE

(Optional Format 1-2-96)

TR

Traditional 510(k)

June 6, 2003