iGuide 2.1

K143485 · Medical Intelligence Medizintechnik GmbH · IYE · Mar 4, 2015 · Radiology

Device Facts

• Record ID: K143485
• Device Name: iGuide 2.1
• Applicant: Medical Intelligence Medizintechnik GmbH
• Product Code: IYE · Radiology
• Decision Date: Mar 4, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

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 2.1 is a powered radiation therapy support assembly for patient positioning. It integrates with the HexaPOD evo RT System (robotic couchtop with six degrees of freedom). Input data includes patient positioning data received automatically from external systems (XVI, Sentinel, Brainlab ExacTrac V6.1). The system uses a 3D tracking system, reference frame, and calibration tool to calculate and control couch movement. It provides remote automatic table movement, replacing manual prepositioning. Used in radiotherapy clinics by radiation therapists/physicians. Output is controlled robotic couch positioning. Benefits include improved accuracy, enhanced usability, and reduced use errors through automated data transfer and remote movement control.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation testing confirmed that physical parameters, specifically system accuracy (0.35mm tracking accuracy; <1mm total system accuracy), meet performance requirements and support substantial equivalence to the predicate.

Technological Characteristics

Powered radiation therapy support assembly. Components: workstation, software, 3D tracking system, reference frame, calibration tool, isolation transformer, KVM extender. Connectivity: automated data transfer from external systems (XVI, Sentinel, Brainlab ExacTrac). Movement control: remote automatic table movement via HexaPOD evo RT Couchtop (6 degrees of freedom). Software safety classification: Class C (Major Level of Concern).

Indications for Use

Indicated for patient positioning control in a radiotherapy environment. No specific patient population, age, or disease state contraindications are defined.

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 evo RT Couchtop (K072898)
• HexaPOD Couchtop (K071870)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 4, 2015

Medical Intelligence Medizintechnik GmbH % Mr. Michael Wolff Regulatory Affairs Manager Robert-Bosch-Strasse 8 Schwabmunchen, 86830 GERMANY

Re: K143485

Trade/Device Name: iGUIDE 2.1 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: November 4, 2014 Received: December 8, 2014

Dear Mr. Wolff:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No.0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K143485

Device Name
iGUIDE 2.1

Indications for Use (Describe)

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

| Type of Use (Select one or both, as applicable) | | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| ZJ Prescription Use (Part 21 CFR 801 Subpart D) | D Over-The-Counter Use (21 CFR 801 Subpart C) | | | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | | | | |
| *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW . | | | | |
| The burden time for this collection is estimated to average 79 hours per response, including the<br>time to review instructions, search existing data sources, gather and maintain the data needed and complete<br>and review the collection of information. Send comments regarding this burden estimate or any other aspect<br>of this information collection, including suggestions for reducing this burden, to: | | | | |
| Reduction Act (PRA) Staff<br>PRAStaff(@fda.hhs.qov | Department of Health and Human Services<br>Food and Druq Administration Office<br>of Chief Information Officer Paperwork | | | |
| | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of<br>information unless it displays a currently valid OMB number." | | | |

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# Traditional 510(k) 510(k) Summary

## iGUIDE 2.1

### iGUIDE 2.1- 510(k) Summary

| 1. | Applicant | Medical Intelligence Medizintechnik GmbH | |
|--------------------|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 2. | Address | Robert-Bosch-Straße 8 | |
| | | 86830 Schwabmünchen | |
| | | Germany | |
| 3. | Contact Person | Michael Wolff, [phone] | |
| 4. | Preparation Date | December 2nd, 2014 | |
| 5. | Device Submitted | iGUIDE® 2.1 System | |
| 6. | Proprietary Name | iGUIDE® 2.1 System | |
| 7. | Common Name | iGUIDE® 2.1 | |
| 8. | Classification Name | Accelerator, Linear, Medical (21 CFR 892.5050, Product Code<br>IYE) | |
| 9. | Substantial<br>Equivalence | The iGUIDE® 2.1 is substantially equivalent to the following<br>currently marketed device:<br>iGUIDE® System (K072079)<br><br>iGUIDE® 2.1 is an advancement of the iGuide® System and has<br>similar technological characteristics as the predicate device. | |
| Device Description | | The iGUIDE 2.1 System is a powered radiation therapy support<br>assembly which provides patient positioning control prior to<br>radiotherapy treatment. iGUIDE 2.1 System consists of the<br>iGUIDE workstation with software, a tracking system, reference<br>frame, calibration tool, isolation transformer, KVM Extender and<br>monitors for the workstation and terminal.<br><br>The iGUIDE software controls the combined working of the<br>HexaPOD evo RT System components and provides status<br>detection via the software GUI to the user. The HexaPOD evo RT<br>System consists of iGUIDE and the HexaPOD evo RT Couchtop, a<br>robotic patient-positioning platform with six degrees of freedom,<br>which is cleared under K072898. | |
| 10. | Indications for Use | The intended use of the device is to control accurate patient | |

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## Traditional 510(k) 510(k) Summary

### iGUIDE 2.1

positioning with assistance of a 3D Tracking System in a radiotherapy environment.

- 11. Summary of Product
#### Changes

- o Compatibility with the Brainlab ExacTrac® V6.1 system
- Control of the Elekta Precise Treatment Table .
- Enhanced usability and elimination of use errors through: .
- Automatic receipt of patient data o
- Use of Remote Automatic Table Movement interface; o manual prepositioning function is no longer supported
- Automated data transfer from XVI to iGUIDE & o Sentinel to iGUIDE
- 12. Summary of iGUIDE® 2.1 is similar to the predicate device in terms of:

Similarities

- Intended use .
- product components ●
- . technological characteristics (regarding design, material, energy source)

#### 13. Comparison with predicate device

| Manufacturer | Medical Intelligence<br>Medizintechnik GmbH | Medical Intelligence<br>Medizintechnik GmbH |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | iGUIDE 2.1 System | iGUIDE System |
| PreMarket Notification<br>Number | Proposed | K072079 |
| Indications for Use | The intended use of the device is<br>to control accurate patient<br>positioning with assistance of a<br>3D Tracking System in a<br>radiotherapy environment. | The intended use of the device is<br>to control accurate patient<br>positioning with assistance of a<br>3D Tracking System in a<br>radiotherapy environment. |
| Components | Software Tracking System Workstation Monitor KVM Extender Isolation Transformer Reference Frame Calibration Tool | Software Tracking System Workstation Monitor KVM Extender Isolation Transformer Reference Frame Calibration Tool |
| Protection Class | IB | IB |

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# Traditional 510(k) 510(k) Summary

### iGUIDE 2.1

| Manufacturer | Medical Intelligence<br>Medizintechnik GmbH | Medical Intelligence<br>Medizintechnik GmbH |
|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Device Name | iGUIDE 2.1 System | iGUIDE System |
| Software Safety<br>Classification | C<br>(Major Level of Concern) | C<br>(Major Level of Concern) |
| Hardware Platform | Part of the HexaPOD evo RT<br>System - consisting of HexaPOD<br>evo Couchtop (K072898) and<br>iGUIDE components (see below) | Part of the HexaPOD RT System -<br>consisting of HexaPOD Couchtop<br>(K071870) and iGUIDE<br>components (see below) |
| Position control by 3D<br>tracking System | yes | yes |
| HexaPOD evo RT Couch<br>Top as treatment couch | yes | yes |
| Movement Control | yes | yes |
| Table Movement | Remote Automatic Table<br>Movement | Manual prepositioning function |
| Accuracy of 3D Tracking<br>System | 0.35mm | 0.35mm |
| Accuracy of total system<br>(Treatment table +<br>tracking system) | <1mm;<br>C195: <0,5mm | < 0.5 mm (translation)<br>< 0.25° (rotation) |
| Receiving patient data | Automatic data transfer to iGUIDE | Manual data transfer to iGUIDE |
| Sending patient data | Automated data transfer from<br>iGUIDE | Manual data transfer from iGUIDE |
| Enable switches | Interrupts directly the power of the moving component In control room and treatment room | Interrupts directly the power of the moving component In control room and treatment room |
| Interlock connection to<br>Linac | Overrides the enable switch<br>control | Overrides the enable switch<br>control |

#### 14. Summary of Performance Testing

The Performance Testing is based on Benchmark Testing only.

- Rationale: As the iGUIDE 2.1 is a positioning device which does not perform any treatment on its own but helps to position and re-position the patient, only physical parameters characterize the system (e.g. accuracy) and give information about substantial equivalence of the modified system compared to the predicate (unmodified) system which was cleared under K072079.
The results of the verification and validation and bench testing demonstrate that the iGUIDE 2.1 System with the extended compatibility and improved usability satisfies the intended use as described above and supports the claim of substantial equivalence.