HEXAPOD RT COUCH TOP

K071870 · Medical Intelligence Medizintechnik GmbH · JAI · Jul 8, 2007 · Radiology

Device Facts

• Record ID: K071870
• Device Name: HEXAPOD RT COUCH TOP
• Applicant: Medical Intelligence Medizintechnik GmbH
• Product Code: JAI · Radiology
• Decision Date: Jul 8, 2007
• 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 patient support assembly for radiation therapy. It consists of two platforms connected by six powered, length-adjustable linear elements. This configuration allows for 6-degree-of-freedom (6DOF) positioning, enabling movement in three spatial dimensions and rotation around three axes. The device is operated via a cable-connected hand control or an external PC-based graphical user interface (GUI). It is used in clinical radiation therapy settings to accurately position patients for treatment. The device does not contact the patient directly; a sheet is placed between the patient and the support surface. The system is designed to improve positioning accuracy, which facilitates precise radiation delivery.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Powered radiation therapy patient support assembly (Product Code JAI). Features two platforms with six linear, length-adjustable actuators for 6DOF positioning. Controlled via hand-held unit or PC-based GUI. No new materials introduced; device does not contact patient directly.

Indications for Use

Indicated for supporting and positioning patients during radiation therapy.

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

• Medical Intelligence HexaPOD RT Couch Top (K062639)

Submission Summary (Full Text)

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K07/870

JUL 1 8 2007

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

edical
intelligence

| 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>• Implementing additional safety functions<br>• Added enable switch board |
| 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)

Image /page/1/Picture/1 description: The image shows the words "medical intelligence" stacked on top of each other. To the left of the words is a circle with a line going through the middle. The words are in a sans-serif font and are black in color. The image is simple and straightforward.

### PREMARKET NOTIFICATION

### 510(k) SUMMARY

| 1. | Applicant: | Medical Intelligence Medizintechnik GmbH |
|----|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Address: | Robert-Bosch-Str. 8<br>86830 Schwabmünchen<br>Germany |
| 3. | Contact Person: | Christian Hieronimi<br>Tel. [phone] |
| 4. | Preparation Date: | April 10, 2007 |
| 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. |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

#### UL 1 8 2007

Medical Intelligence Medizintechnik GmbH c/o Mr. Stefan Preiss TÜV SÜD America, Inc. 1775 Old Highwav 8 NW. Ste. 104 NEW BRIGHTON MN 55112-1891

Re: K071870

> 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: July 4, 2007 Received: July 6, 2007

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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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.xxxx | (Gast |
|-----------------|-------|
| 21 CFR 884.xxxx | (Obs |
| 21 CFR 892.xxxx | (Rad |
| Other | |

roenterology/Renal/Urology) 240-276-0115 tetrics/Gynecology) 240-276-0115 iology); 240-276-0120 240-276-0100

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html

Sincerely yours.

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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### Indications for Use

510(k) Number (if known):

510(k) Number (if known): K062639 K071870

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)

Heleneer

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

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