(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 is a powered radiation therapy 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 provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.
The 510(k) summary explicitly states:
"No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)."
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
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medical
intelligence
572079 V
PREMARKET NOTIFICATION
510(k) SUMMARY
| 1. | Applicant: | Medical Intelligence Medizintechnik GmbH | |
|---|---|---|---|
| 2. | Address: | Robert-Bosch-Straße 886830 SchwabmünchenGermany | AUG 14 2007 |
| 3. | Contact Person: | Christian HieronimiTel. +49 (0) 8232 9692-0 | |
| 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, MedicalProduct Code IYE | |
| 9. | Substantial Equivalence: | The iGUIDE is substantially equivalent to the followinglegally marketed device:Medical Intelligence's "iGUIDE System".The characteristics of this device are similar to thoseof the predicate device identified on the comparisonchart, which is provided with the premarket notificationsubmission. It is our opinion that the iGUIDE does nothave technological characteristics that raise additionaltypes of questions related to terms of safety andeffectiveness. |
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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.
Image /page/2/Picture/10 description: The image shows a logo with the letters FDA in the center. The logo also includes the words "Centennial" and "1906-2006". The logo is surrounded by a circle with stars around it. Below the logo, there is some text in cursive.
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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 (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 (800) 638-2041 or (240) 276-3150
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
Page 1 of
§ 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.