IGUIDE SYSTEM

K072079 · Medical Intelligence Medizintechnik-GmbH-An Elekta · IYE · Aug 14, 2007 · Radiology

Device Facts

• Record ID: K072079
• Device Name: IGUIDE SYSTEM
• Applicant: Medical Intelligence Medizintechnik-GmbH-An Elekta
• Product Code: IYE · Radiology
• Decision Date: Aug 14, 2007
• 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 the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.

Device Story

iGUIDE System is a powered radiation therapy support assembly for patient positioning prior to treatment. Components include: iGUIDE Reference Frame with optical markers; iGUIDE Calibration Phantom; NDI Polaris Tracking System; iGUIDE Workstation (control room); iGUIDE Terminal (treatment room). System operates by tracking patient position via 3D tracking technology to ensure accurate alignment. Used in radiotherapy clinics by radiation therapy staff. Output consists of positioning data used to guide the HexaPOD RT CouchTop. Enhances treatment precision by facilitating accurate patient setup. Modifications include software safety functions, TCP/IP connection for serial emulation, and reassignment of enable switch board to the couch top.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered radiation therapy support assembly. Includes optical tracking (NDI Polaris), reference frames, and calibration phantoms. Connectivity via TCP/IP. Software-controlled positioning system. No direct patient contact; no biocompatibility testing required.

Indications for Use

Indicated for patient positioning control in a radiotherapy environment using a 3D tracking system.

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

• iGUIDE System (K072079)

Reference Devices

• HexaPOD RT CouchTop (k041448)
• Elektra Precise Treatment System with Precise Table (k983678)
• Varian Trilogy Radiotherapy Delivery System (k033343)
• Clinac 2300 C/D with Exact Couch (K913119)
• Siemens PRIMUS or ONCOR Linear Accelerator with Siemens ZXT Treatment Table (k910971)

Submission Summary (Full Text)

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medical
intelligence

#### 572079 V

# PREMARKET NOTIFICATION

### 510(k) SUMMARY

| 1. | Applicant: | Medical Intelligence Medizintechnik GmbH | |
|----|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 2. | Address: | Robert-Bosch-Straße 8<br>86830 Schwabmünchen<br>Germany | AUG 14 2007 |
| 3. | Contact Person: | Christian Hieronimi<br>Tel. [phone] | |
| 4. | Preparation Date: | April 10, 2007 | |
| 5. | Device Submitted: | iGUIDE® System | |
| 6. | Proprietary Name: | iGUIDE® System | |
| 7. | Common Name: | iGUIDE | |
| 8. | Classification Name: | System, Radiation Therapy, Charged-Particle, Medical<br>Product Code IYE | |
| 9. | Substantial Equivalence: | The iGUIDE is substantially equivalent to the following<br>legally marketed device:<br>Medical Intelligence's "iGUIDE System".<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 iGUIDE does not<br>have technological characteristics that raise additional<br>types of questions related to terms of safety and<br>effectiveness. | |

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# iGUIDE System - Special 510(k)

The iGUIDE System is a powered radiation therapy 10. Device Description: support assembly which provides patient positioning control before radiotherapy treatment. The iGUIDE System consists of the following system components: iGUIDE Reference Frame with optical markers, iGUIDE Calibration Phantom (calibration phantom for KV-imaginq). NDI Polaris Tracking System, iGUIDE Workstation with iGUIDE software (control room) and iGUIDE Terminal (treatment room). The iGUIDE System is intended to be used together with the HexaPOD RT CouchTop (k041448), which is intended to be used together with the following radiation therapy systems: Elektra Precise Treatment System with Precise Table (k983678), Varian Trilogy Radiotherapy Delivery System (k033343), Clinac 2300 C/D with Exact Couch (K913119),and Siemens PRIMUS or ONCOR Linear Accelerator with Siemens ZXT Treatment Table (k910971) The intended use of the device is to control accurate 11. Intended Use: patient positioning with the assistance of a 3D Tracking system in a radiotherapy environment. The only modification made to the product are the 12. Summary of the Product Change: following evolutionary hardware changes: Implementing additional safety functions to the . software Emulation two serial connection by one TCP/IP . connection Erased enable switch board and assigned to . the HexaPOD RT CouchTop (k041448) 13. Summary of the Product The iGUIDE is identical with the predicate device Similarities to predicate concerning: device . Intended use Electronic components 12. Biocompatibility: The iGUIDE System is not in direct contact with the patient. Therefore, no biocompatibility studies were undertaken for this device. 13. Performance Data: No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation).

medical

intelligence

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a circular logo with the words "Department of Health & Human Services USA" written around the edge. In the center of the logo are three stylized lines that resemble a person's profile. The lines are arranged in a way that suggests movement or progress.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG 1 4 2007

Medical Intelligence Medizintechnik GmbH % Mr. Stefan Preiss Responsible Third Party Official TÜV Product Service 1775 Old Hwy 8 NW, Ste 104 NEW BRIGHTON MN 55112-1891

Re: K072079

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: July 25, 2007 Received: July 30, 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.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 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):

KO72079

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)

Nancy Brogdon
(Division Sign Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

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