(15 days)
No
The summary describes a system for controlling a radiotherapy couch using a 3D tracking system and software, without mentioning any AI or ML components or capabilities.
No.
The device's intended use is for accurate patient positioning in a radiotherapy environment, which is a supportive function for a therapeutic procedure (radiotherapy) rather than a therapeutic treatment itself.
No
The device is designed for accurate patient positioning during radiotherapy, not for diagnosing medical conditions.
No
The device description explicitly states that the iGUIDE® System consists of a PC workstation and the NDI Polaris 3D Tracking System, in addition to the software. This indicates the presence of hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment." This describes a system used for patient setup and alignment during radiation therapy, which is a treatment process, not a diagnostic test performed on samples from the body.
- Device Description: The description details a system that controls a treatment table and uses a 3D tracking system for positioning. It does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) to diagnose diseases or conditions.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples.
- Detection or measurement of analytes (substances in the body).
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition based on sample analysis.
The device's function is clearly focused on the physical positioning of a patient for a medical treatment (radiotherapy), not on performing diagnostic tests on biological specimens.
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 (comma separated list FDA assigned to the subject device)
IYE
Device Description
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 to 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
medical
intelligence
simming and on an
Versinn 01
ﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ
PREMARKET NOTIFICATION
SEP 2 0 2006
510(k) SUMMARY
| 1. | Applicant: | Medical Intelligence Medizintechnik GmbH |
|---|---|---|
| 2. | Address: | Feyerabendstrasse 13 - 15 |
| 86830 Schwabmünchen | ||
| Germany | ||
| 3. | Contact Person: | Christian Hieronimi |
| Tel. +49 (0) 8232 9692-0 | ||
| 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 |
| Product Code IYE | ||
| 9. | Substantial | |
| Equivalence: | The iGUIDE® System is substantially equivalent to the | |
| following legally marketed devices: | ||
| BrainLab "ExacTrac system" (K003285). | ||
| The characteristics of this device are similar to those of the | ||
| predicate devices identified on the comparison chart, which is | ||
| provided with the premarket notification submission. It is our | ||
| opinion that the iGUIDE® System does not have | ||
| technological characteristics that raise additional types of | ||
| questions related to terms of safety and effectiveness. | ||
| 10. | Device Description: | 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 to 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. |
| 11. | Intended Use: | The intended use of the device is to control the movement
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
requested by the Food and Drug Administration (Office of Device Evaluation) |
1
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.
Page 2 of _2 _________________________________________________________________________________________________________________________________________________________________
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
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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Page 2 -
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 (800) 638-2041 or (240) 276-3150
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
4
Indications for Use
510(k) Number (if known).
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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