D2RF DIGITAL DYNAMIC REMOTE SYSTEM

K102529 · Stephanix Radiological Systems · OWB · Oct 7, 2010 · Radiology

Device Facts

• Record ID: K102529
• Device Name: D2RF DIGITAL DYNAMIC REMOTE SYSTEM
• Applicant: Stephanix Radiological Systems
• Product Code: OWB · Radiology
• Decision Date: Oct 7, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The D'RF 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 Intensifler technology. Not intended for mammography applications.

Device Story

D'RF is a remote-controlled digital fluoroscopy and radiography system; utilizes Canon Flat Panel Detector (FPD) with LANMIT (Large Area New MIS Sensor and TFT) technology; converts X-ray inputs into high-resolution digital still and moving images. System includes a remotely controlled tilting/elevating table; operated by clinicians in a patient environment. Device replaces traditional image intensifier technology; provides digital output for diagnostic and interventional decision-making. Benefits include versatile 3-in-1 imaging capability via detachable/portable FPD.

Clinical Evidence

Bench testing only. Performance testing and software validation were conducted to demonstrate safety and effectiveness. Electrical safety and electromagnetic compatibility testing performed. Device complies with US Performance Standard for radiographic equipment.

Technological Characteristics

Digital fluoroscopic/radiographic system; Canon Flat Panel Detector (FPD) with LANMIT (Large Area New MIS Sensor and TFT) technology; remotely controlled tilting/elevating table; digital signal conversion; complies with US Performance Standard for radiographic equipment.

Indications for Use

Indicated for human anatomy fluoroscopic imaging for vascular angiography, cardiology, diagnostic, and interventional procedures. Not for mammography.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Canon Dynamic/Static DR Model URS-50RF Fluoroscopic Digital X-Ray System (K093688)

Submission Summary (Full Text)

{0}------------------------------------------------

## 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: II<br>Product Code:<br>OWB, JAA, IZ1<br>Regulation: 21 CFR § 892.1650 |
| Identification of<br>Predicate Devices and<br>Summary of Substantial<br>Equivalence | Canon Dynamic/Static DR Model URS-50RF Fluoroscopic Digital<br>X-Ray System K093688, Virtual Imaging |
| Device Description | D'RS is a direct digital dynamic remote-controlled fluoroscopy and<br>radiography system equipped with the latest generation of Canon<br>Flat Panel Detector (FPD). The single FPD can perform both<br>fluoroscopy and radiography and is detachable and portable<br>for direct projections to create a unique and highly versatile 3-in-1<br>imaging solution. The receptor panel directly converts the X-ray<br>Images captured by the LANMIT (Large Area New MIS Sensor and<br>TFT) sensor into a high-resolution digital Images. The instrument is<br>suited for use inside a patient environment. This unit converts the<br>X-rays into digital signals. The unit can acquire still and moving<br>images. The system includes a remotely controlled<br>tilting/elevating table. |

Paga 18 of 1452

{1}------------------------------------------------

| Intended Use and<br>Indications | The D'RF is Indicated for use in generating fluoroscopic Images of<br>human anatomy for vascular angiography, diagnostic and<br>interventional procedures. It is also Indicated for generating<br>fluoroscopic Images of human anatomy for cardiology, diagnostic,<br>and interventional procedures. It is intended to replace<br>fluoroscopic images obtained through Image Intensifler<br>technology. Not intended for mammography applications. |
|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics and<br>Substantial Equivalence | Comparison with the predicate shows the technological<br>characteristics of the D'RF are equal to or better than the<br>predicate device. The units are functionally identical. |
| Performance<br>Testing/Data | Tests were performed on the device which demonstrated that the<br>device is safe and effective, performs comparably to and is<br>substantially equivalent to the predicate device.<br>Tests include: Performance testing and Software Validation.<br>Electrical safety and Electromagnetic Compatibility testing has<br>been performed. The unit complies with the US Performance<br>Standard for radiographic equipment. |

:

・

## Page 2 of 2, 510(k) Summary: D2RF Digital Dynamic Remote System (Fluoroscopic Digital X-Ray System)

ﺮ

Paga 19 cl 1452

・

{2}------------------------------------------------

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

{3}------------------------------------------------

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 [phone]. 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 [phone] or [phone] 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

{4}------------------------------------------------

## 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

Page 18 ol 1452