(86 days)
No
The summary describes a robotic patient positioning system controlled by software, but there is no mention of AI or ML in the device description, intended use, or performance studies. The rationale for testing focuses on physical parameters and substantial equivalence to a predicate device without AI/ML capabilities.
No
The device is described as a patient positioning system used prior to radiotherapy treatment and does not perform the treatment itself.
No
The device is for patient positioning control in a radiotherapy environment, not for diagnosing medical conditions. It assists with accuracy and re-positioning, and its performance studies focus on physical parameters like accuracy, not diagnostic metrics.
No
The device description explicitly lists multiple hardware components beyond just software, including a workstation, tracking system, reference frame, calibration tool, isolation transformer, KVM Extender, and monitors.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment." This describes a device used in vivo (on a living patient) for positioning during a medical procedure (radiotherapy).
- Device Description: The description details a system for patient positioning, including a workstation, tracking system, and robotic platform. This aligns with a device used directly with a patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any interaction with biological specimens or diagnostic purposes.
Therefore, the iGUIDE 2.1 System is a medical device used for patient positioning during radiotherapy, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
IYE
Device Description
The iGUIDE 2.1 System is a powered radiation therapy support assembly which provides patient positioning control prior to radiotherapy treatment. iGUIDE 2.1 System consists of the iGUIDE workstation with software, a tracking system, reference frame, calibration tool, isolation transformer, KVM Extender and monitors for the workstation and terminal.
The iGUIDE software controls the combined working of the HexaPOD evo RT System components and provides status detection via the software GUI to the user. The HexaPOD evo RT System consists of iGUIDE and the HexaPOD evo RT Couchtop, a robotic patient-positioning platform with six degrees of freedom, which is cleared under K072898.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key results:
Accuracy of 3D Tracking System: 0.35mm
Accuracy of total system (Treatment table + tracking system):
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
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.
1
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
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 | ||||
| time to review instructions, search existing data sources, gather and maintain the data needed and complete | ||||
| and review the collection of information. Send comments regarding this burden estimate or any other aspect | ||||
| of this information collection, including suggestions for reducing this burden, to: | ||||
| Reduction Act (PRA) Staff | ||||
| PRAStaff(@fda.hhs.qov | Department of Health and Human Services | |||
| Food and Druq Administration Office | ||||
| of Chief Information Officer Paperwork | ||||
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of | ||||
| information unless it displays a currently valid OMB number." |
3
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, +49 (0) 8232 9692 701 | |
| 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 | |
| IYE) | |||
| 9. | Substantial | ||
| Equivalence | The iGUIDE® 2.1 is substantially equivalent to the following | ||
| currently marketed device: | |||
| iGUIDE® System (K072079) |
iGUIDE® 2.1 is an advancement of the iGuide® System and has
similar technological characteristics as the predicate device. | |
| Device Description | | The iGUIDE 2.1 System is a powered radiation therapy support
assembly which provides patient positioning control prior to
radiotherapy treatment. iGUIDE 2.1 System consists of the
iGUIDE workstation with software, a tracking system, reference
frame, calibration tool, isolation transformer, KVM Extender and
monitors for the workstation and terminal.
The iGUIDE software controls the combined working of the
HexaPOD evo RT System components and provides status
detection via the software GUI to the user. The HexaPOD evo RT
System consists of iGUIDE and the HexaPOD evo RT Couchtop, a
robotic patient-positioning platform with six degrees of freedom,
which is cleared under K072898. | |
| 10. | Indications for Use | The intended use of the device is to control accurate patient | |
4
Traditional 510(k) 510(k) Summary
iGUIDE 2.1
positioning with assistance of a 3D Tracking System in a radiotherapy environment.
-
- 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
-
- 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
Medizintechnik GmbH | Medical Intelligence
Medizintechnik GmbH |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | iGUIDE 2.1 System | iGUIDE System |
| PreMarket Notification
Number | Proposed | K072079 |
| Indications for Use | The intended use of the device is
to control accurate patient
positioning with assistance of a
3D Tracking System in a
radiotherapy environment. | The intended use of the device is
to control accurate patient
positioning with assistance of a
3D Tracking System in a
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 |
5
Traditional 510(k) 510(k) Summary
iGUIDE 2.1
| Manufacturer | Medical Intelligence
Medizintechnik GmbH | Medical Intelligence
Medizintechnik GmbH |
|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Device Name | iGUIDE 2.1 System | iGUIDE System |
| Software Safety
Classification | C
(Major Level of Concern) | C
(Major Level of Concern) |
| Hardware Platform | Part of the HexaPOD evo RT
System - consisting of HexaPOD
evo Couchtop (K072898) and
iGUIDE components (see below) | Part of the HexaPOD RT System -
consisting of HexaPOD Couchtop
(K071870) and iGUIDE
components (see below) |
| Position control by 3D
tracking System | yes | yes |
| HexaPOD evo RT Couch
Top as treatment couch | yes | yes |
| Movement Control | yes | yes |
| Table Movement | Remote Automatic Table
Movement | Manual prepositioning function |
| Accuracy of 3D Tracking
System | 0.35mm | 0.35mm |
| Accuracy of total system
(Treatment table +
tracking system) |