PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100

K034054 · Med-Tec,Inc. · JAI · Feb 20, 2004 · Radiology

Device Facts

• Record ID: K034054
• Device Name: PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100
• Applicant: Med-Tec,Inc.
• Product Code: JAI · Radiology
• Decision Date: Feb 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5770
• Device Class: Class 2

Intended Use

Interface between treatment planning system and the MED-TEC Pro Series Couch; or: Software for MED-TEC Pro Series Couch (6 Degree Axis Couch) .

Device Story

Pro Series Couch Software functions as an interface between a treatment planning system and the MED-TEC Pro Series Couch (6 Degree Axis). It enables communication and control of the patient support assembly during radiation therapy procedures. Operated by clinical staff in a radiation therapy environment, the software facilitates the positioning of the patient support assembly based on data from the treatment planning system. By automating or streamlining the interface, it assists in accurate patient alignment, potentially improving the precision of radiation delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software interface for 6-degree axis powered radiation therapy patient support assembly. Operates as a bridge between treatment planning systems and hardware. Class II device.

Indications for Use

Indicated for use as a software interface for the MED-TEC Pro Series Couch (6 Degree Axis Couch) in radiation therapy patient support applications.

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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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 | [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 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