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

• K Number: K031866
• Device Name: MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC
• Manufacturer: MED-TEC,INC.
• Date Cleared: 2003-08-14 ( 59 days)
• Product Code: JAI
• Regulation Number: 892.5770

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. 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.

Device Description

MED-TEC 6 degree axis couch

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical couch with additional degrees of freedom for patient positioning, with no mention of AI or ML.

Therapeutic

No
The device is described as a couch used to support and position a patient during medical procedures, specifically radiation therapy, rather than actively treating a condition.

Diagnostic

No.
The device's intended use is to support and aid in positioning patients during medical procedures like radiation therapy, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states "MED-TEC 6 degree axis couch," which is a physical piece of hardware used to support and position patients.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states that the device is used to "support a patient during radiation therapy" and "support and aid in positioning a patient during radiologic, radiation therapy, and other medical procedures." This describes a device used on a patient for treatment and positioning, not a device used to examine specimens in vitro (outside of the body) to diagnose or monitor a condition.
• Device Description: The description of a "6 degree axis couch" further supports its role as a patient support and positioning system.
• Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological specimens (blood, urine, tissue, etc.)
  • Detecting or measuring analytes
  • Providing diagnostic information

Therefore, the device described is a medical device used for patient support and positioning during medical procedures, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

90 JAI

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. Inside the circle is a stylized image of an eagle with three curved lines extending from its head, resembling wings or feathers. The logo is black and white and appears to be a seal or emblem.

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.

1

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

2

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