MODIFICATION TO HEXAPOD RT COUCH TOP

K062639 · Medical Intelligence Medizintechnik-GmbH-An Elekta · JAI · Sep 21, 2006 · Radiology

Device Facts

• Record ID: K062639
• Device Name: MODIFICATION TO HEXAPOD RT COUCH TOP
• Applicant: Medical Intelligence Medizintechnik-GmbH-An Elekta
• Product Code: JAI · Radiology
• Decision Date: Sep 21, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5770
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The intended use of the device is to support and aid in positioning a patient during radiation therapy.

Device Story

HexaPOD RT Couch Top is a powered patient support assembly for radiation therapy. Device consists of two platforms connected by six powered, length-adjustable linear elements; enables movement in all three spatial dimensions and rotation around three axes, providing six degrees of freedom (6DOF) positioning. Operated via cable-connected hand control or external PC-based graphical user interface (GUI). Used in clinical radiation therapy settings to accurately position patients for treatment delivery. Evolutionary changes from predicate include iBEAM Couch Top, table top extension, modified actuator geometry, and additional safety functions. Device does not contact patient directly; requires sheet between patient and support surface.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Powered radiation therapy patient support assembly; 6DOF robotic platform; six linear, rigid, length-adjustable powered actuators; PC-based GUI control; cable-connected hand control; no direct patient contact (requires sheet).

Indications for Use

Indicated for patients undergoing radiation therapy requiring precise positioning support.

Regulatory Classification

Identification

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

Predicate Devices

• HexaPOD RT Couch Top (K062639)

Submission Summary (Full Text)

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medical
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## PREMARKET NOTIFICATION

| | 510(k) SUMMARY | K06 2639 |
|-----|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Applicant: | Medical Intelligence Medizintechnik GmbH |
| 2. | Address: | Feyerabendstrasse 13 - 15<br>86830 Schwabmünchen<br>Germany |
| 3. | Contact Person: | Christian Hieronimi<br>Tel. [phone] |
| 4. | Preparation Date: | February 15, 2006 |
| 5. | Device Submitted: | HexaPOD™ RT Couch Top |
| 6. | Proprietary Name: | HexaPOD™ RT CouchTop |
| 7. | Common Name: | Hexapod |
| 8. | Classification Name: | Powered radiation therapy patient support assembly<br>Product Code JAI |
| 9. | Substantial Equivalence: | The HexaPOD is substantially equivalent to the<br>following legally marketed device:<br>Medical Intelligence's "HexaPOD RT Couch Top".<br>The characteristics of this device are similar to those<br>of the predicate device identified on the comparison<br>chart, which is provided with the premarket notification<br>submission. It is our opinion that the HexaPOD does<br>not have technological characteristics that raise<br>additional types of questions related to terms of safety<br>and effectiveness. |
| | | SEP 21 2006 |
| | | |
| | | K062639 |
| 10. | Device Description: | The HexaPOD consists of two platforms, which are<br>connected by six linear, rigid but length adjustable<br>elements which are powered. By appropriate<br>coordinative adjustment of these elements, the system<br>is able to move the upper platform relative to the lower<br>one. The movement can occur in all three dimensions<br>in space. Additionally the upper platform can rotate<br>around these three axes which results in a tilt or a<br>rotation of the upper platform relative to the lower one.<br>Finally an accurate positioning within all six degrees of<br>freedom (6DOF) can be provided. The HexaPOD<br>consists of a controller unit which is directed by a<br>cable connected hand control. Additionally it can be<br>directed via an external graphics user interface (GUI)<br>which is installed on a PC. |
| 11. | Intended Use: | The intended use of the device is to support and aid in<br>positioning a patient during radiation therapy. |
| 12. | Summary of the Product<br>Change: | The only modification made to the product are the<br>following evolutionary hardware changes:<br>• Table top changed to iBEAM Couch Top<br>• Table top extension<br>• Geometric locations of actuators changed<br>• Implementing additional safety functions |
| 13. | Summary of the Product<br>Similarities to predicate<br>device | The HexaPOD is identical with the predicate device<br>concerning:<br>• Intended use<br>• Behaviour of movement<br>• Control software<br>• Electronic and electro-mechanical components |
| 12. | Biocompatibility: | The HexaPOD is not in direct contact with the patient.<br>At any time when in use a sheet is to be placed<br>between the patient's skin surface and the treatment<br>support when in use. Additionally there are no new<br>materials introduced in the manufacture of the<br>HexaPOD. Therefore, no biocompatibility studies were<br>undertaken for this device. |
| 13. | Performance Data: | No performance data is required for this Class II<br>device nor requested by the Food and Drug<br>Administration (Office of Device Evaluation). |

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## HexaPOD RT Couch Top – Special 510(k)

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

## SEP 2 1 2006

Medical Intelligence Medizintechnik GmbH c/o Mr. Stefan Preiss Responsible Third Party Official TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891

Re: K062639

> Trade/Device Name: HexaPOD™ RT Couch Top Regulation Number: 21 CFR §892.5770 Regulation Name: Powered radiation therapy patient support assembly Regulatory Class: II Product Code: JAI Dated: August 21, 2006 Received: September 6, 2006

Dear Mr. Preiss:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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na and Promoting Public He

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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.

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 this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy Chogdon

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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## Indications for Use

510(k) Number (if known):

K062639

Device Name:

HexaPOD™ RT Couch Top

Indications For Use:

The intended use of the device is to support and aid in positioning a patient during radiation therapy.

Prescription Use "Yes (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David L. Seymour

(Division Sign-Off) Division of Reproductive, Abde and Radiological Devices 510(k) Number

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