(133 days)
The RFVision 9.9D is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications when general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed. The RFVision 9.9D allows the operator to view and enhance digital fluoroscopic images. High resolution digital spot images may be acquired at single or rapid acquisition rates. Images may be viewed and enhanced enabling the operator to bring out diagnostic details.
RFVision 9.9 D is an advanced remote controlled 90/90 Digital RF system with floating table top for radiographic and fluoroscopy procedures. Reliable, time tested generator. High quality image intensifier and digital imaging system improves diagnostic capabilities assures filmless operations and smooth integration in digital PACS environment.
The provided text is a 510(k) summary for the RFVision 9.9D Image Intensified Fluoroscopic System. It does not contain any information regarding specific acceptance criteria, device performance metrics, or study details (like sample sizes, ground truth establishment, or expert qualifications) for proving the device meets acceptance criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (K061173, CPIVision Digital Imaging System). The "Safety and Effectiveness, comparison to predicate device" section broadly states: "The results of bench, test laboratory and clinical testing indicates that the new device is as safe and effective as the predicate devices." However, it does not elaborate on what those tests were, what specific criteria they measured, or what the results were.
The "Substantial Equivalence Chart" primarily lists characteristics that are "SAME" as the predicate device, such as intended use, performance standard (21 CFR 1020.30), generator, and electrical safety. This indicates that the device is deemed effective and safe because it is similar to an already approved device, not because it underwent independent testing against new, specific performance criteria.
Therefore, I cannot provide the requested table or answer most of the specific questions as the necessary information is not present in the provided document.
Here's what I can extract or infer based on the document's content, with many fields remaining blank due to lack of information:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Overall Safety & Effectiveness | "as safe and effective as the predicate devices" (K061173) | "as safe and effective as the predicate devices" |
| Intended Use | Same as predicate | Same as predicate (High resolution, digital imaging for general fluoroscopy, interventional fluoroscopy, angiography, cardiac imaging; replaces conventional film; allows viewing/enhancement of digital fluoroscopic images; acquires high-resolution digital spot images) |
| Performance Standard | 21 CFR 1020.30 | Complies with 21 CFR 1020.30 |
| Electrical Safety | IEC-60601, UL listed | Complies with IEC-60601, CSA listed |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified, only generally referred to as "bench, test laboratory and clinical testing." No mention of country of origin or whether data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified. The document indicates "user testing data" but provides no details on how "ground truth" (if applicable in this context) was established or by whom.
4. Adjudication method for the test set
- Not specified.
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 MRMC study information is provided. This device is an image-intensified fluoroscopic system, not explicitly an AI-assisted device in the context of this 510(k) summary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not specified. This is a hardware imaging system, not an algorithm being evaluated without human interaction.
7. The type of ground truth used
- Not specified. Given the nature of a fluoroscopic system, "ground truth" would likely relate to image quality assessment, radiation dose, system reliability, and functional performance rather than diagnostic accuracy like in an AI algorithm. No details are given.
8. The sample size for the training set
- Not applicable/Not specified. There is no mention of a "training set" as this is a hardware device submission, not an AI/ML algorithm submission that would typically involve training data.
9. How the ground truth for the training set was established
- Not applicable/Not specified. As above, no training set is mentioned.
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AUG - 6 2008
510(k) Summary 510(k) Number K080847 Almana Medical Imaging P.O. Box 3568 Alkhobar 31952 Kingdom of Saudi Arabia T: +966 3 8679400 F: +966 3 8962421 Date Prepared: May 11, 2008 Contact: Mohammed Irfanullah Farooqui, Sales and Marketing Manager
- l . Identification of the Device: Proprietary-Trade Name: RFVision 9.9D Image Intensified Fluoroscopic System Classification Name: Image intensified fluoroscopic system, Product Code 90 JAA FOND Common/Usual Name: Fluoroscopic X-Ray
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- Equivalent legally marketed device: K061173, Device Name: Cpivision Digital Imaging System, Communications & Power Industries Canada, Inc.
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- Indications for Use (intended use) The RFVision 9.9D is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications when general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed. The RFVision 9.9D allows the operator to view and enhance digital fluoroscopic images. High rcsolution digital spot images may be acquired at single or rapid acquisition rates. Images may be viewed and enhanced enabling the operator to bring out diagnostic details.
-
- Description of the Device: RFVision 9.9 D is an advanced remote controlled 90/90 Digital RF system with floating table top for radiographic and fluoroscopy procedures. Reliable, time tested generator. High quality image intensifier and digital imaging system improves diagnostic capabilities assures filmless operations and smooth integration in digital PACS environment.
-
- Safety and Effectivencss, comparison to predicate device. The results of bench, test laboratory and clinical testing indicates that the new device is as safe and effective as the predicate devices.
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| 6. Substantial Equivalence Chart | ||
|---|---|---|
| Characteristic | K061173, Device Name: CPIVision Digital Imaging System, Communications & Power Industries Canada, Inc. | Almana RFVision 9.9D Image Intensified Fluoroscopic System |
| Intended Use: | The CPIVision is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications when general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed. The CPIVision allows the operator to view and enhance digital fluoroscopic images. High resolution digital spot images may be acquired at single or rapid acquisition rates. Images may be viewed and enhanced enabling the operator to bring out diagnostic details... | SAME |
| Performance Standard | 21 CFR 1020.30 | SAME |
| Generator | Communications & Power Industries Canada, Inc | SAME |
| Electrical safety | Electrical Safety per IEC-60601. UL listed | SAME, CSA listed |
ర్ Substantial Equivalence Chart
7. Conclusion
Alter analyzing both bench and user testing data as well as external laboratory testing to applicable standards, it is the conclusion of Almana Medical Imaging that the RFVision Fluoroscopic Systems are as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate devices.
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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 features a stylized eagle with its wings spread, symbolizing protection and care. The eagle is positioned to the right of a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The logo is rendered in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
FEB 1 9 2013
Almana Medical Imaging % Mr. Daniel Kamm, P.E. Regulatory Engineer, Submission Correspondent Kamm & Associates PO Box 7007 DEERFIELD IL 60015
Re: K080847
Trade/Device Name: RFVision 9.9D Image Intensified Fluoroscopic System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: July 21, 2008 Received: July 23, 2008
Dear Mr. Kamm:
This letter corrects our substantially equivalent letter of August 6, 2008.
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): K080847
Device Name: RFVision 9.9D Image Intensified Fluoroscopic System
Indications For Use:
The RFVision 9.9D is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications when general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed.
The RFVision 9.9D allows the operator to view and enhance digital fluoroscopic images. High resolution digital spot images may be acquired at single or rapid acquisition rates. Images may be viewed and enhanced enabling the operator to bring out diagnostic details.
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)
Hulu Revi
(Division Sign-Off) Division of Reproductive, Abdominal a 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.