IGUIDE SYSTEM

K062611 · Medical Intelligence Medizintechnik-GmbH-An Elekta · IYE · Sep 20, 2006 · Radiology

Device Facts

• Record ID: K062611
• Device Name: IGUIDE SYSTEM
• Applicant: Medical Intelligence Medizintechnik-GmbH-An Elekta
• Product Code: IYE · Radiology
• Decision Date: Sep 20, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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

Device Story

iGUIDE System is a powered radiation therapy support assembly designed to control patient positioning. It interfaces with the Medical Intelligence HexaPOD RT CouchTop (a 6-degree-of-freedom radiographic treatment table) and integrates an NDI Polaris 3D Tracking System to monitor positioning accuracy. The system comprises a PC workstation and a graphical user interface (GUI) for table control. It is intended for use in clinical radiotherapy environments, integrated with Elekta, Varian, and Siemens radiation therapy systems via an interlock connection. By automating and monitoring table movement, the device assists clinicians in achieving precise patient alignment, potentially improving the accuracy of radiation delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System consists of a PC workstation, GUI software, and NDI Polaris 3D Tracking System. Controls 6-degree-of-freedom (DOF) movement of the HexaPOD RT CouchTop. Integrates with external radiation therapy systems via interlock connection. No patient contact.

Indications for Use

Indicated for the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• BrainLab ExacTrac system (K003285)

Reference Devices

• Medical Intelligence HexaPOD RT CouchTop (K041448)

Submission Summary (Full Text)

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K062611

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## PREMARKET NOTIFICATION

SEP 2 0 2006

## 510(k) SUMMARY

| 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: | iGUIDE® System |
| 6. | Proprietary Name: | iGUIDE® System |
| 7. | Common Name: | iGUIDE |
| 8. | Classification Name: | Medical charged-particle radiation therapy<br>Product Code IYE |
| 9. | Substantial<br>Equivalence: | The iGUIDE® System is substantially equivalent to the<br>following legally marketed devices:<br>BrainLab "ExacTrac system" (K003285).<br>The characteristics of this device are similar to those of the<br>predicate devices identified on the comparison chart, which is<br>provided with the premarket notification submission. It is our<br>opinion that the iGUIDE® System does not have<br>technological characteristics that raise additional types of<br>questions related to terms of safety and effectiveness. |
| 10. | Device Description: | The iGUIDE® System controls the movement of the Medical<br>Intelligence HexaPOD™ RT CouchTop (K041448), a<br>radiographic treatment table with 6 DOFs (Degrees of<br>freedom). With the integrated 3D Tracking System the<br>device controls also the accuracy of the patient positioning.<br><br>The iGUIDE® System consists of a PC workstation, a<br>graphics user interface to the treatment table (software) and<br>the NDI Polaris 3D Tracking System.<br><br>The iGUIDE® System is integrated into radiation therapy<br>systems of Elekta, Varian, and Siemens and is connected to<br>them with an Interlock connection. |
| 11. | Intended Use: | The intended use of the device is to control the movement<br>and aid in positioning a patient during radiation therapy. |
| 12. | Biocompatibility: | No patient contact - medical software |
| 13. | Performance Data: | No performance data is required for this Class II device nor<br>requested by the Food and Drug Administration (Office of Device Evaluation) |

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Description: The iGUIDE system is a powered radiation therapy support assembly.

> The iGUIDE system controls the movement of the Medical Intelligence HexaPOD RT CouchTop (K041448), a radiographic treatment table with 6 DOFs (Degrees of Freedom). With the integrated 3D Tracking System the device controls also the accuracy of the patient positioning.

The iGUIDE system consists of a PC workstation, a graphics user interface th the treatment table (software) and the NDI Polaris 3D Tracking System.

The iGUIDE system is integrated into radiation therapy systems of Elekta, Varian and Siemens and is connected to them with an Interlock connection.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

SEP 2 0 2006

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

Re: K062611

Trade/Device Name: iGuide System Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: August 31, 2006 Received: September 5, 2006

Dear Mr. Preiss:

We have reviewed your Section 510(k) premarket notification of intent to market the devices in we have reviewed your Section 510(x) prematics is substantially equivalent (for the indications for referenced above and nave decemined the devices marketed in interstate commerce on to devices that use stated in the enclosure) to regally manectou proadical Device Amendments, or to devices that prior to May 28, 1970, the enactions of the Medical Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Featureliation (RMA) - You may have been reclassified in accordatics will the provinsition (PMA). You may,
Act (Act) that do not require approval of a premarket approval application (Phe general Act (Act) that do not require approval or a promations of the Act . The general therefore, market the device, subject to the general vegistration, listing of devices, good
controls provisions of the Act include requirements for annual registration, controls provisions of the Ace merade requirements .
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 If your device is classified (see above) into entrols. Existing major regulations affecting your Approval), it may be subject to such additions, Title A , Pars 800 to 898. In addition, FDA
device can be found in the Code of Federal Regulations, Title Al, Parister device can be found in the Soucerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image shows the FDA Centennial logo, which includes the years 1906-2006. Below the logo, the text "Protecting and Promoting Public Health" is written in a decorative font. The logo is circular and contains the letters FDA in a stylized font. The text is centered below the logo.

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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 (OS) 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/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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).

K062611

Device Name:

iGUIDE system

Indications For Use:

The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment

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 h. Leyman

(Division Sign-Off) Division of Reproductive and Radiological Dev 510(k) Number

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