(55 days)
The Precision THUNIS 800+ is a digital remote R&F system intended to generate fluoroscopic and spot-film images of the patient during diagnostic procedures.
The system is indicated also for use in generating radiographic images of human anatomy in general purpose diagnostic procedures.
The system is not intended for mammographic or dental applications.
Precision THUNIS 800+ is a Radiographic and Fluoroscopic system which consists of a tilting patient support table with both local and remote motion controls, a High-Voltage generator, a touch screen X-ray control console in control room (protected area), a X-ray tube assembly, a beam limiting device, a 9" inch Image Intensifier with Charge Coupled Device (CCD) video Camera, a removable 14"X17" film cassette tray, a Power Distribution Unit for whole system, an integrated control console including a workstation, Image Display, remote controls of tilting patient support table, collimator controls, spot film control and Fluoroscopic exposure control.
An in-room image display and in-room Fluoroscopic control foot switch are provided as an option for certain procedure which may need local X-ray loading and imaging.
No traditional spot film device using a film changer is provided with this system, spot-film image acquisition is fulfilled through digital image frame grabber and video camera.
The provided document is a 510(k) summary for the GE Healthcare Precision THUNIS 800+ X-ray system. This type of document is typically for demonstrating substantial equivalence to a predicate device, focusing on technological characteristics and intended use, rather than presenting detailed acceptance criteria and performance studies that would be common for new medical algorithms or AI-driven devices.
Based on the content, there are no acceptance criteria, device performance results, or a study described in this document that proves the device meets specific performance criteria.
Here's why and what information is available:
- Device Type: The Precision THUNIS 800+ is a "Stationary Diagnostic Radiographic and Fluoroscopic X-ray System." This is a hardware device for image acquisition, not an algorithm or AI system for image analysis.
- 510(k) Purpose: A 510(k) submission primarily aims to demonstrate "substantial equivalence" to a legally marketed predicate device. This often involves showing similar technological characteristics and intended use, rather than conducting new clinical performance studies with specific statistical endpoints like sensitivity, specificity, etc., which would be typical for an AI/algorithm-driven device.
- Content Focus: The document focuses on:
- Identifying the submitter and the device.
- Comparing the Precision THUNIS 800+ with its predicate device (Prestige V, VH & VHD) in terms of generic name, classification, class, product code, and technological characteristics (X-ray imaging technology, materials, energy source).
- Stating the intended use, which is "to generate fluoroscopic and spot-film images... during diagnostic procedures" and "generating radiographic images... in general purpose diagnostic procedures."
- Confirming compliance with safety standards (UL60601-1:2003 and IEC60601 series).
Therefore, I cannot populate the requested table or answer most of the questions because the information is not present in this 510(k) submission. This document does not describe a study to prove a device's performance against specific acceptance criteria in the manner that would be expected for a diagnostic algorithm.
Summary of available information relevant to your questions:
- 1. A table of acceptance criteria and the reported device performance: Not available. The document asserts substantial equivalence based on technological characteristics and intended use, not performance metrics.
- 2. Sample sized used for the test set and the data provenance: Not applicable/available. No test set or data provenance is discussed as this is not a study of an algorithm's performance.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/available.
- 4. Adjudication method for the test set: Not applicable/available.
- 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. This is a hardware device, not an AI or image interpretation algorithm.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable/available.
- 8. The sample size for the training set: Not applicable/available.
- 9. How the ground truth for the training set was established: Not applicable/available.
Conclusion from the document: GE Healthcare states that the Precision THUNIS 800+ is "substantially equivalent" to the predicate device (Prestige V, VH & VHD) because they share "the same indications for use and meets the similar standards," and utilize "the same technological characteristics" (X-ray imaging technology, video camera, image intensifier, and compliant construction materials). The regulatory body (FDA) concurred with this substantial equivalence determination, allowing the device to be marketed.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized font, enclosed within a circular frame. The letters and the frame are black, while the background is white, creating a high-contrast design.
Kobe 1028
Page 1 of 2
GE Healthcare
510(k) Summary
JUN - 7 2006
This 510(k) summary is prepared in accordance with the requirements of 21 CFR Part 807.87(h) and Part 807.92.
(1) Identification of Submitter:
| Submitter:Address:Tel.Contact Person:Summary Prepared: | GE Healthcare3000 N. Grandview Blvd. Waukesha, WI 53118(262) 544-3894Larry A. Kroger, Ph.D. (Senior Regulatory Programs Manager)04/10/2006 |
|---|---|
| (2) Information of Device: | |
| GE Model Name:Generic Name:Classification Name:Device Class:Product Code: | Precision THUNIS 800+Stationary Diagnostic Radiographic and Fluoroscopic X-ray System (Remote)Image-intensified fluoroscopic x-ray system (21CFR § 892.1650)Class IIJAA |
| (3) Predicate Device: | |
| 510(k) Number: | K043805 |
| 510(k) Number: | K943805 |
|---|---|
| GE Model Name: | Prestige V, VH & VHD |
| Generic Name: | Stationary Diagnostic Radiographic and Fluoroscopic X-ray System (Remote |
| Classification Name: | Image-intensified fluoroscopic x-ray system (21CFR § 892.1650) |
| Device Class: | Class II |
| Product Code: | JAA |
(4) Device Description and Specification
Precision THUNIS 800+ is a Radiographic and Fluoroscopic system which consists of a tilting patient support table with both local and remote motion controls, a High-Voltage generator, a touch screen X-ray control console in control room (protected area), a X-ray tube assembly, a beam limiting device, a 9" inch Image Intensifier with Charge Coupled Device (CCD) video Camera, a removable 14"X17" film cassette tray, a Power Distribution Unit for whole system, an integrated control console including a workstation, Image Display, remote controls of tilting patient support table, collimator controls, spot film control and Fluoroscopic exposure control.
An in-room image display and in-room Fluoroscopic control foot switch are provided as an option for certain procedure which may need local X-ray loading and imaging.
No traditional spot film device using a film changer is provided with this system, spot-film image acquisition is fulfilled through digital image frame grabber and video camera.
Precision THUNIS 800+
SECTION 5
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows a handwritten text that appears to be a signature or a short note. The text is written in a cursive style, with some characters overlapping and connecting to each other. The writing is in black ink on a white background, and the overall impression is that of a quick, informal inscription.
For an illustration of the whole system and detailed product structure, please refer to Size titled "Device Description".
(5) Statement of Intended Use
The Precision THUNIS 800+ is a digital remote R&F system intended to generate fluoroscopic and spot-film images of the patient during diagnostic procedures.
The system is indicated also for use in generating radiographic images of human anatcmy in general purpose diagnostic procedures.
The system is not intended for mammographic or dental applications.
See SECTION 4 for a formal declaration of "Indications for Use".
See SECTION 12 for a comparison of Intended uses with the identified predicate device.
(6) Technological Characteristics Comparison
Precision THUNIS 800+ uses the same technological characteristics as the predicate device. Below is a brief summary.
- Precision THUNIS 800+ use the same X-ray imaging technology, same kind of film -Design: screen cassettes for Radiographic applications, same kind of video camera (Charge Coupled Device) and Image Intensifier for Fluoroscopic applications.
- All construction materials are compliant with latest UL60601-1:2003 and applicacle Material: IEC60601 series standards which are comparable with the old UL 187 and IEC standards.
Chemical Composition:
Chemical composition of materials is not critical for this kind of device, because no material is implanted or inserted into the patient body or orifice to contact body tissues or fluids. Patient contact is not required for proper functioning of the device. See SECTION 15 for a statement of patient support tabletop material.
Energy Source: Precision THUNIS 800+ system uses the same kind of energy source as its predicate device: 3-Phase Mains Supply with Grounding, rated voltages can be set as any one of 380/400/415/440/480Vac, 50/60Hz.
Conclusions:
GE Healthcare considers the Precision THUNIS 800+ to be substantially equivalent to the identified predicate device which has the same indications for use and meets the similar standards.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUN -7 2006
Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems, LLC 3000 N. Grandview Blvd. W-440 WAUKESHA WI 53188
Re: K061028
Trade/Device Name: Precision THUNIS 800+ Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: April 10, 2006 Received: April 13, 2006
Dear Dr. Kroger:
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 the FDA Centennial logo. The logo is a circular seal with the words "1906-2006" at the top and "Centennial" in the center. The words "Protecting and Promoting Public Health" are written in a decorative font below the logo. The logo is black and white.
{3}------------------------------------------------
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.xxxx | (Gastroenterology/Renal/Urology) 240-276-0115 | |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology). | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, which has decorative swirls or flourishes at various points around the circumference.
GE Healthcare
Indications For Use Statement
510(k) Number (if known):
Device Name:
Precision THUNIS 800+
Indications for Use:
The Precision THUNIS 800+ is a digital remote R&F system intended to generate fluoroscopic and spot-film images of the patient during diagnostic procedures.
The system is indicated also for use in generating radiographic images of human anatomy in general purpose diagnostic procedures.
The system is not intended for mammographic or dental applications.
Prescription Use (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 C Brogdon
(Division Sign-Off))
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061028
Precision THUNIS 800+
SECTION 4
Page 1 of 1
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.