(55 days)
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for obtaining fluoroscopic radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts.
The FluoroPro RF Digital Imaging System is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications where general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed. The FluoroPro RF Digital Imaging System allows the operator to view and enhance 1000 line fluoroscopy. High resolution digital spot images (1024) may be acquired at single or rapid acquisition rates, up to 30 fps. Images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques. Images can be stored locally for medium term storage. The FluoroPro RF Digital Imaging System enables the operator to hardcopy image with a laser printer or send images over a network for longer term storage. The major system components include: a fluoroscopic TV camera, monitors, and an image processor.
The provided documentation describes the FluoroPro RF Digital Imaging System, a fluoroscopic X-Ray system, and its substantial equivalence to a predicate device. The core of the submission focuses on demonstrating similarity to a legally marketed device rather than proving performance against specific acceptance criteria in a comparative clinical study.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The submission does not present explicit "acceptance criteria" in the traditional sense of a clinical trial (e.g., target sensitivity, specificity). Instead, it demonstrates performance by showing equivalence to a predicate device based on technical characteristics. The table below summarizes these characteristics and how the new device compares to the predicate.
| Characteristic | Predicate Device (Infimed Orion Digital Imaging System, K012490) | FluoroPro RF Digital Imaging System (New Device) | Performance Against "Acceptance Criteria" (Equivalence) |
|---|---|---|---|
| Intended Use | Acquisition, display, storage, and transmission of fluoroscopic images | SAME | Meets (Identical) |
| Power source | 120 VAC 50/60 HZ 7 amps | 120 VAC 50/60 HZ 2.5 amps | Different, but considered acceptable (likely an improvement in efficiency) |
| Image acquisition | Up to 15 FPS (spot), up to 30 fps (fluoro) | SAME | Meets (Identical) |
| File compatibility | DICOM | SAME | Meets (Identical) |
| CCD | Innovision CCD | Thales CCD | Different, but not deemed a substantial difference affecting safety/effectiveness |
| Digital Resolution | 1024 x 1024 12 bit | SAME | Meets (Identical) |
| Performance Standard | US FDA | SAME | Meets (Identical) |
| Electrical safety | SAME | SAME | Meets (Identical) |
Study that Proves the Device Meets the Acceptance Criteria:
The documentation states: "The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices." and "After analyzing both bench and user testing data, it is the conclusion of Virtual Imaging that the FluoroPro RF Digital Imaging System is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device."
This indicates that the "study" was primarily bench testing (evaluating technical specifications, performance parameters, and compliance with standards) and user testing (likely validation by trained personnel in a simulated or controlled environment to confirm functionality and usability). The goal of these tests was to demonstrate substantial equivalence to the predicate device, not to meet specific quantitative clinical performance metrics like sensitivity or specificity.
2. Sample sized used for the test set and the data provenance
The document does not provide details on the sample size used for the "bench and user testing." It also does not specify the provenance of any data (e.g., country of origin, retrospective/prospective), as it relies on technical and operational comparisons rather than clinical data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. Given that the submission focuses on substantial equivalence based on technical specifications and functional testing, it's unlikely that "ground truth" for diagnostic accuracy was established by medical experts in the way it would be for an AI-powered diagnostic device. The "user testing" likely involved qualified technicians or doctors evaluating the system's operational aspects, image quality for diagnostic interpretation (compared to the predicate), and ease of use.
4. Adjudication method for the test set
This information is not provided. As "ground truth" from experts for diagnostic accuracy in a clinical context isn't explicitly mentioned, an adjudication method for such a ground truth would not be detailed.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this submission. This device is a digital imaging system (hardware and software for image acquisition and display), not an AI-powered diagnostic tool, so the concept of human readers improving with AI assistance is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. The device itself is an imaging system; its "performance" is tied to its ability to acquire and display images comparable to a predicate device, and it is intended for use by a "qualified/trained doctor or technician." It is not an autonomous diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device (a digital fluoroscopic x-ray system), the "ground truth" used for validation would primarily relate to its technical performance and image quality, not disease diagnosis. This would involve:
- Technical Specifications: Confirming that the system meets its stated parameters (resolution, frame rate, power consumption, etc.) through engineering tests.
- Image Quality Assessment: Evaluating the acquired images against established standards or by comparison to the predicate device for clarity, contrast, and diagnostic interpretability by a qualified user. This often involves phantoms and possibly human users assessing image quality visually.
- Safety Standards: Adherence to electrical safety and other relevant performance standards (e.g., US FDA performance standards mentioned).
There is no mention of ground truth established via expert consensus, pathology, or outcomes data related to diagnostic accuracy from patient images.
8. The sample size for the training set
This information is not applicable and therefore not provided. The FluoroPro RF Digital Imaging System is a digital X-ray system, not a machine learning or AI algorithm that requires a "training set" in the computational sense.
9. How the ground truth for the training set was established
This information is not applicable and therefore not provided, as there is no "training set" for this device.
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APR 5 - 2007
EXHIBIT 2 S10(k) Summar
Image /page/0/Picture/3 description: The image shows the words "VIRTUAL IMAGING" in bold, sans-serif font. The words are stacked on top of each other, with "VIRTUAL" on the top line and "IMAGING" on the bottom line. To the left of the words is a black and white graphic that is partially obscured. The graphic appears to be a logo or symbol of some kind.
720 S. Powerline Road Suite E Deerfield Beach, FL 33442 954-428-6191 (Office) 954-428-6195 (Fax) January 18, 2007 Contact: Chris Duca, COO
- l. Identification of the Device: Proprietary-Trade Name: FluoroPro RF Digital Imaging System Classification Name: System, x-ray, fluoroscopic, image-intensified Product Code Product Code JAA and LLZ. Common/Usual Name: Fluroscopic X-Ray System
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- Equivalent legally marketed device: Infimed Orion Digital Imaging System, K012490 (Now called PlatinumOne RF)..
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- Indications for Use (intended use) Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for obtaining fluoroscopic radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts. .
- Description of the Device: The FluoroPro RF Digital Imaging System is a high resolution, ব digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications where general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed. The FluoroPro RF Digital Imaging System allows the operator to view and enhance 1000 line fluoroscopy. High resolution digital spot images (1024) may be acquired at single or rapid acquisition rates, up to 30 fps. Images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques. Images can be stored locally for medium term storage. The FluoroPro RF Digital Imaging System enables the operator to hardcopy image with a laser printer or send images over a network for longer term storage. The major system components include: a fluoroscopic TV camera, monitors, and an image processor ..
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- Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices.
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| Characteristic | Infimed OrionDigital ImagingSystem, K012490(Now calledPlatinumOne RF). | FluoroPro RFDigital ImagingSystem |
|---|---|---|
| Intended Use: | Acquisition, display,storage andtransmission offluoroscopic images | SAME |
| Power source | 120 VAC 50/60 HZ7 amps | 120 VAC 50/60 HZ2.5 amps |
| Image acquisition | Up to 15 FPS (spot),up to 30 fps (fluoro) | SAME |
| File compatibility | DICOM | SAME |
| CCD | Innovision CCD | Thales CCD |
| Digital Resolution | 1024 x 1024 12 bit | SAME |
| PerformanceStandard | US FDA | SAME |
| Electrical safety | SAME | SAME |
6. Substantial Equivalence Chart, "FluoroPro RF Digital Imaging System"
7. Conclusion
After analyzing both bench and user testing data, it is the conclusion of Virtual Imaging that the FluoroPro RF Digital Imaging System is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in bold and is left-aligned. The words are all capitalized. The text is likely part of a document or letterhead.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
Virtual Imaging, Inc. % Mr. Daniel Kamm Principal Consultant Kamm & Associate PO Box 7007 DEERFIELD IL 60015
AUG 21 2013
Re: K070390
Trade/Device Name: FluoroPro RF Digital Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: February 2, 2007 Received: February 9, 2007
Dear Mr. Kamm:
This letter corrects our substantially equivalent letter of April 5, 2005.
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K070 390
Device Name: FluoroPro RF Digital Imaging System
Indications For Use:
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for obtaining fluoroscopic radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Ingram
Division Sign-Off Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number
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§ 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.