(35 days)
The D'RF Digital Dynamic Remote System Is indicated for use in generating fluoroscopic Images of human anatomy for vascular angiography, diagnostic and interventional procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.
D'RS is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Canon Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography and is detachable and portable for direct projections to create a unique and highly versatile 3-in-1 imaging solution. The receptor panel directly converts the X-ray Images captured by the LANMIT (Large Area New MIS Sensor and TFT) sensor into a high-resolution digital Images. The instrument is suited for use inside a patient environment. This unit converts the X-rays into digital signals. The unit can acquire still and moving images. The system includes a remotely controlled tilting/elevating table.
The provided document is a 510(k) summary for a Digital Fluoroscopic X-Ray System (D'RF Digital Dynamic Remote System). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of acceptance criteria and device performance in the manner requested.
Here's a breakdown of the information that can be extracted and what is explicitly not mentioned in the summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not provide a table of acceptance criteria with specific quantitative metrics or reported device performance data in the way a clinical study would.
Instead, it broadly states:
| Criterion Type | Acceptance Statement | Reported Performance |
|---|---|---|
| Technological Characteristics | "Comparison with the predicate shows the technological characteristics of the D'RF are equal to or better than the predicate device. The units are functionally identical." | No specific quantitative performance metrics are provided. The "reported performance" is implicitly that it meets or exceeds the predicate's technological characteristics. |
| Safety and Effectiveness | "Tests were performed on the device which demonstrated that the device is safe and effective, performs comparably to and is substantially equivalent to the predicate device." | No specific quantitative safety or effectiveness metrics are provided. |
| Performance Testing | "Tests include: Performance testing and Software Validation." | No specific quantitative results of performance testing are provided. |
| Electrical Safety & EMC | "Electrical safety and Electromagnetic Compatibility testing has been performed. The unit complies with the US Performance Standard for radiographic equipment." | This indicates compliance with relevant standards, but no numerical data is given. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. The document mentions "Performance testing" but does not detail the size or nature of any test set (e.g., number of patients, images, or phantom studies). There is no mention of data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the 510(k) summary. Given the nature of a substantial equivalence submission for fundamental X-ray technology, a clinical study involving expert ground truth might not be a primary requirement for this type of device.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size
An MRMC study is not mentioned in the 510(k) summary. The focus is on demonstrating equivalence to the predicate, not necessarily comparative effectiveness with human readers.
6. If a Standalone (algorithm only without human-in-the-loop performance) study was done
This concept is not applicable in the context of this device. The D'RF Digital Dynamic Remote System is a physical X-ray imaging system, not an AI algorithm. Its "performance" refers to the quality of the images it generates and its operational characteristics, which are ultimately interpreted by a human.
7. The type of ground truth used
This information is not provided as there is no detailed study described. For X-ray imaging systems, "ground truth" often relates to image quality metrics (e.g., spatial resolution, contrast-to-noise ratio) measured using phantoms, rather than clinical outcomes or pathology from patient data for a diagnostic algorithm.
8. The Sample Size for the Training Set
This information is not applicable as the D'RF Digital Dynamic Remote System is a physical X-ray imaging system, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the reasons stated in point 8.
In summary:
The provided 510(k) summary for the D'RF Digital Dynamic Remote System focuses on demonstrating substantial equivalence to a predicate device (Canon Dynamic/Static DR Model URS-50RF Fluoroscopic Digital X-Ray System K093688). It broadly states that the device's technological characteristics are "equal to or better than" the predicate and that it is "safe and effective."
The document does not contain the detailed clinical study information, specific acceptance criteria with quantitative metrics, sample sizes, expert ground truth details, or MRMC study results that your request is looking for. These types of detailed performance studies are more common for novel diagnostic algorithms or devices with highly specific quantitative performance claims, rather than for a new iteration of a well-established imaging modality like an X-ray system seeking substantial equivalence. The "performance testing" mentioned likely refers to engineering and quality control tests to ensure the system meets its specifications and regulatory standards, rather than a clinical trial with patient ground truth.
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510(k) SUMMARY
Stephanix Radiological Systems Rue Jean Moulin - ZI du Bayon La Ricamarie - FRANCE · Tel : + 33 4 77 47 81 60 Fax : + 33 4 77 37 55 19
OCT 7 2010
KL107529
Page 1 of 2, 510(k) Summary: D RF Digital Dynamic Remote System
| Date Prepared | August 11, 2010 |
|---|---|
| Summary prepared by: | Sandie Perret, Quality Manager |
| Device Name | Digital Fluoroscopic X-Ray System |
| Trade Name | Model D'RF Digital Dynamic Remote System |
| Common Name | Image-intensified fluoroscopic x-ray system |
| Classification | Class: IIProduct Code:OWB, JAA, IZ1Regulation: 21 CFR § 892.1650 |
| Identification ofPredicate Devices andSummary of SubstantialEquivalence | Canon Dynamic/Static DR Model URS-50RF Fluoroscopic DigitalX-Ray System K093688, Virtual Imaging |
| Device Description | D'RS is a direct digital dynamic remote-controlled fluoroscopy andradiography system equipped with the latest generation of CanonFlat Panel Detector (FPD). The single FPD can perform bothfluoroscopy and radiography and is detachable and portablefor direct projections to create a unique and highly versatile 3-in-1imaging solution. The receptor panel directly converts the X-rayImages captured by the LANMIT (Large Area New MIS Sensor andTFT) sensor into a high-resolution digital Images. The instrument issuited for use inside a patient environment. This unit converts theX-rays into digital signals. The unit can acquire still and movingimages. The system includes a remotely controlledtilting/elevating table. |
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| Intended Use andIndications | The D'RF is Indicated for use in generating fluoroscopic Images ofhuman anatomy for vascular angiography, diagnostic andinterventional procedures. It is also Indicated for generatingfluoroscopic Images of human anatomy for cardiology, diagnostic,and interventional procedures. It is intended to replacefluoroscopic images obtained through Image Intensiflertechnology. Not intended for mammography applications. |
|---|---|
| TechnologicalCharacteristics andSubstantial Equivalence | Comparison with the predicate shows the technologicalcharacteristics of the D'RF are equal to or better than thepredicate device. The units are functionally identical. |
| PerformanceTesting/Data | Tests were performed on the device which demonstrated that thedevice is safe and effective, performs comparably to and issubstantially equivalent to the predicate device.Tests include: Performance testing and Software Validation.Electrical safety and Electromagnetic Compatibility testing hasbeen performed. The unit complies with the US PerformanceStandard for radiographic equipment. |
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Page 2 of 2, 510(k) Summary: D2RF Digital Dynamic Remote System (Fluoroscopic Digital X-Ray System)
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of two parts: a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol is a stylized human figure embracing a sphere, and the text is written in a clear, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Stephanix Radiological Solutions % Mr. Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello CT NAPLES FL 34114
JUL 3 0 2012
Re: K102529
Trade/Device Name: DeRF Digital Dynamic Remote System (Digital Fluoroscopic X-Ray System) Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA and IZI Dated: August 26, 2010 Received: September 2, 2010
Dear Mr. Kamm:
This letter corrects our substantially equivalent letter of October 7, 2010.
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): K10
Pevice Name: D'RF Digital Dynamic Remote System (Digital Fluoroscopic X-Ray System)
The D'RF Digital Dynamic Remote System Is indicated for use in generating fluoroscopic Images of human anatomy for vascular angiography, diagnostic and interventional procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.
Prescription Use _X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Division Sign-Off)
(Division Sign-Off)
Division of Radiological Devices
Office of in Vitro Diagnostic Device Evaluation and Safety
K102529
610K
Page 1 of 1
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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.