(15 days)
The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment
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.
The provided document is a 510(k) summary for the Medical Intelligence iGUIDE® System, submitted in 2006. It focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and performance data for a standalone AI device.
Therefore, much of the requested information regarding acceptance criteria, specific study design, expert involvement, and AI performance metrics is not available in this document. The document explicitly states:
"No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)"
This indicates that the regulatory pathway for this device at the time did not necessitate a clinical study demonstrating performance against specific acceptance criteria in the way a modern AI/ML device submission would. The focus was on establishing substantial equivalence to existing devices through technological characteristics and intended use.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or reported device performance metrics are provided in the document. The submission focuses on establishing substantial equivalence to a predicate device (BrainLab "ExacTrac system" K003285) rather than meeting defined performance thresholds in a clinical study.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable, as no performance data from a test set is reported.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable, as no ground truth establishment for a test set is reported.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no test set requiring adjudication is reported.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The iGUIDE® System is described as a device that controls movement and aids in patient positioning during radiation therapy, not an AI system that assists human readers in interpreting medical images or data.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The iGUIDE® System is a standalone device in the context of its function (controlling the treatment table and patient positioning). However, it is not an "algorithm only" device meant for diagnosis or interpretation. It is a system that physically aids in positioning, potentially with automated components, but it's not a diagnostic AI. The document does not describe "standalone" performance in the modern sense of an AI algorithm's diagnostic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no ground truth for diagnostic or interpretive performance is reported. The "accuracy of patient positioning" is mentioned, which would be the relevant "ground truth" if performance data were collected, but no specific methodology for its establishment is detailed in this document.
8. The sample size for the training set
Not applicable, as this submission pre-dates the common concept of "training sets" for AI/ML models in medical device submissions. The iGUIDE® System is not described as an AI/ML device that requires training data in the modern sense.
9. How the ground truth for the training set was established
Not applicable, as this information is not relevant to the type of device and submission described.
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medical
intelligence
simming and on an
Versinn 01
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PREMARKET NOTIFICATION
SEP 2 0 2006
510(k) SUMMARY
| 1. | Applicant: | Medical Intelligence Medizintechnik GmbH |
|---|---|---|
| 2. | Address: | Feyerabendstrasse 13 - 1586830 SchwabmünchenGermany |
| 3. | Contact Person: | Christian HieronimiTel. +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 therapyProduct Code IYE |
| 9. | SubstantialEquivalence: | The iGUIDE® System is substantially equivalent to thefollowing legally marketed devices:BrainLab "ExacTrac system" (K003285).The characteristics of this device are similar to those of thepredicate devices identified on the comparison chart, which isprovided with the premarket notification submission. It is ouropinion that the iGUIDE® System does not havetechnological characteristics that raise additional types ofquestions related to terms of safety and effectiveness. |
| 10. | Device Description: | The iGUIDE® System controls the movement of the MedicalIntelligence HexaPOD™ RT CouchTop (K041448), aradiographic treatment table with 6 DOFs (Degrees offreedom). With the integrated 3D Tracking System thedevice controls also the accuracy of the patient positioning.The iGUIDE® System consists of a PC workstation, agraphics user interface to the treatment table (software) andthe NDI Polaris 3D Tracking System.The iGUIDE® System is integrated into radiation therapysystems of Elekta, Varian, and Siemens and is connected tothem with an Interlock connection. |
| 11. | Intended Use: | The intended use of the device is to control the movementand 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 norrequested 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.
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
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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
Page 1 of 2
§ 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.