Who is the manufacturer of D2RS_AT Digital Dynamic Remote System?

Stephanix Radiological Solutions filed the 510(k) submission for D2RS_AT Digital Dynamic Remote System (K150306).

What is the FDA product code for D2RS_AT Digital Dynamic Remote System?

JAA. It is classified under 21 CFR 892.1650 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for D2RS_AT Digital Dynamic Remote System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like D2RS_AT Digital Dynamic Remote System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

D2RS_AT Digital Dynamic Remote System

Q: What are the predicate devices for D2RS_AT Digital Dynamic Remote System?

Stephanix D²RF Digital Dynamic Remote System (K102529).

K150306 · Stephanix Radiological Solutions · JAA · Oct 10, 2015 · Radiology

Device Facts

Record ID	K150306
Device Name	D2RS_AT Digital Dynamic Remote System
Applicant	Stephanix Radiological Solutions
Product Code	JAA · Radiology
Decision Date	Oct 10, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1650
Device Class	Class 2

Intended Use

The D-RS AT Digital Dynamic Remote System Is indicated for use in generating fluoroscopic images of human anatomy for diagnostic procedures. It Is intended to replace fluoroscopic images obtained through image intensionaly. Not intended for mammography applications.

Device Story

D2RS AT is a direct digital dynamic remote-controlled fluoroscopy and radiography system. It uses Trixell Flat Panel Detectors (FPD) to capture X-rays and convert them into high-resolution digital images. The system includes a remotely controlled tilting/elevating table and is used in clinical environments. It supports both still and moving image acquisition. The system is operated by X-ray technicians to facilitate diagnostic procedures. The digital output is viewed by radiologists to assess human anatomy. The device benefits patients by providing high-quality real-time imaging while optimizing patient throughput through digital technology.

Clinical Evidence

Clinical evaluation consisted of a review by a board-certified radiologist of both static and moving images generated by the system. The radiologist determined the images were of good diagnostic quality. No formal clinical trial with patient outcomes was required; evidence relies on bench performance testing and expert image quality assessment.

Technological Characteristics

Direct digital dynamic remote-controlled X-ray system. Uses Trixell Pixium RF 4343/4343FL flat-panel detectors (indirect conversion, CsI scintillator). Features 16-bit AD conversion, 148 μm pixel pitch, and 3.4 lp/mm spatial resolution. System includes a remotely controlled tilting/elevating table. Connectivity via DICOM 3.0. Conforms to IEC 60601-1, IEC 60601-1-3, IEC 60601-2-54, IEC 60601-1-2, and 21 CFR 1020.30-32.

Indications for Use

Indicated for generating fluoroscopic images of human anatomy for diagnostic procedures. Not intended 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

Stephanix D²RF Digital Dynamic Remote System (K102529)

Reference Devices

Trixium Pixium 3543EZ (K131314)
Trixium Pixium 3543EZ (K141440)
Trixium Pixium 3543EZ (K142718)

Related Devices

K213479 — D²RS and D²RS 9090 · Stephanix · Dec 23, 2021
K102529 — D2RF DIGITAL DYNAMIC REMOTE SYSTEM · Stephanix Radiological Systems · Oct 7, 2010
K221335 — D²RS and D²RS 9090 · Stephanix · Jun 7, 2022
K131766 — PLATINUM DRF IMAGING SYSTEM · Apelem-Dms Group · Dec 12, 2013
K203087 — CombiDiagnost R90 · Philips Medical Systems Dmc GmbH · Dec 3, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines extending from the bottom of the profiles. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 10, 2015 Stephanix Radiological Solutions % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114 Re: K150306 Trade/Device Name: DeRS AT Digital Dynamic Remote System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: September 2, 2015 Received: September 9, 2015 Dear Mr. Kamm: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Robert Ochs Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) # K150306 Device Name D2RS_AT Digital Dynamic Remote System #### Indications for Use (Describe) The D-RS AT Digital Dynamic Remote System Is indicated for use in generating fluoroscopic images of human anatomy for diagnostic procedures. It Is intended to replace fluoroscopic images obtained through image intensionaly. Not intended for mammography applications. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) SUMMARY K150306 # 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 | Date Prepared | August 6, 2015 | |--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Summary prepared by: | Sandie Perret, Quality Manager | | Device Name/Trade Name | D²RS_AT Digital Dynamic Remote System | | Common Name | Image-intensified fluoroscopic x-ray system | | Classification | Class: II, Product Code: JAA Regulation: 21 CFR § 892.1650 Regulation name: Image-intensified fluoroscopic x-ray system | | Identification of Predicate Device, Classification regulation, classification name and product code | Stephanix D²RF Digital Dynamic Remote System, K102529 21 CFR § 892.1650, System, x-ray, fluoroscopic, image-intensified and system, x-ray, angiographic, Product Code JAA | ## D2RS AT Digital Dynamic Remote System ## Device Description The D2RS AT Digital Dynamic Remote System is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Trixell 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 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. Panel information: Based on a flat-panel digital detector with the largest field-of-view in the market, the Pixium RF 4343 FL is designed for easy integration in classical R&F tables. It allows manufacturers to offer radiologists an all-digital real-time system, generating high-quality images for both routine dynamic applications and high-end static ones. Digital technology facilitates the work of X-ray technicians and speeds up the process, allowing medical centers to optimize patient throughput. Universal: a single detector for both Radiography and Fluoroscopy. An optional static panel may be added to the system: Trixell Pixium 3543EZ. The 3543EZ panel has already been cleared in various 510(k)s including K131314 and K141440. That panel is not mounted and can be moved around by the technician. The system must always have either the Pixium RF 4343, Pixium RF 4343FL for the system to be able to perform fluoroscopy. These fluoroscopic panels were not to our knowledge previously cleared by FDA, so complete performance information as requested by the FDA guidance document on solid state x-ray panels has been provided. | Indications for Use | The D²RS_AT Digital Dynamic Remote System Is indicated for use in generating fluoroscopic images of human anatomy for diagnostic procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications. | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| {4}------------------------------------------------ | Technological Characteristics and Substantial Equivalence | Comparison with the predicate shows the technological characteristics of theD2RS_AT Digital Dynamic Remote System are equivalent to the predicate device because the images produced by the new panels have equivalent image quality, MTF, DQE, and safety test results. The units are functionally identical. Only the digital panel and the connected computer have changed. | |--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| ## Comparison Table | | D²RF K102529 | D²RS_AT Digital Dynamic Remote System | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications Statement | The D²RF 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. | The D²RS_AT Digital Dynamic Remote System Is indicated for use in generating fluoroscopic images of human anatomy for diagnostic procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications. | | Photo of Digital Panel | Image: D2RF K102529 Digital Panel | Image: D2RS_AT Digital Panel | | DICOM 3 | YES | YES | | Workstation Photo(s) | Image: D2RF K102529 Workstation | Image: D2RS_AT Digital Workstation | # Digital Panel Comparison Table | Name | CXDI-50RF (Predicate K102529) | Pixium RF 4343 (NEW) | Pixium RF 4343 FL (NEW) | |--------------------|-------------------------------|----------------------|-------------------------| | Dimension | 493 x 503 mm | 508 x 518 mm | 500 x 490 mm | | Useful Area | 360 x 430 mm | 426 x 420 mm | 426 x 420 mm | | Type of conversion | Indirect | Indirect | Indirect | {5}------------------------------------------------ | Name | CXDI-50RF (Predicate K102529) | Pixium RF 4343 (NEW) | Pixium RF 4343 FL (NEW) | |-----------------------|----------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------| | Scintillator | Csl | Csl | Csl | | Pixel pitch | 160 μm | 148 μm | 148 μm | | Spatial resolution | 3,2 lp/mm | 3,4 lp/mm | 3,4 lp/mm | | Matrix | 2208 x 2688 | 2874 x 2840 | 2874 x 2840 | | AD conversion | 14 bits | 16 bits | 16 bits | | DQE | 72% (0 cy/mm) 60% (1 cy/mm) 42% (2cy/mm) 24% (3cy/mm) | 65% (0 cy/mm) 52% (1 cy/mm) 42% (2cy/mm) 28% (3cy/mm) | 65% (0 cy/mm) 52% (1 cy/mm) 42% (2cy/mm) 28% (3cy/mm) | | MTF | 57% (1 cy/mm) 32% (2cy/mm) 18% (3cy/mm) | 62% (1 cy/mm) 25% (2cy/mm) 18% (3cy/mm) | 62% (1 cy/mm) 25% (2cy/mm) 18% (3cy/mm) | | Fps Max | 30 fps | 30 fps | 30 fps | | Binning max | 2 x 2 | 3 x 3 | 3 x 3 | | Operating temperature | 5- 35°C | 15-40°C | 15-40°C | | Optional Panel | Not Applicable | Pixium 3543 EZ, Static Panel cleared in K142718 | | | Bench/Perform ance Testing/Data | 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. Tests included: Performance testing and Software Validation. Electrical safety and Electromagnetic Compatibility testing has been performed. The unit complies with the US Performance Standard for radiographic equipment. We assessed and showed conformity to IEC 60601-1, IEC 60601-1-3, IEC 60601-2-54, IEC 60601-1- 2, 21CFR Subchapter J as well as the DICOM 3 Standard. We also assessed compliance with the guidance document, "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices." The MTF and DQE comparisons in the table above show the new digital panels perform better in some measurements and slightly worse in other measurements, but such numbers should be compared with caution because of measurement uncertainty error. Spatial resolution and pixel pitch are superior for the new panels. The device conforms to the requirements of the DHHS performance standard pursuant to 1020.30, 1020.31 and 1020.32. | |---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Clinical Evaluation | In accordance with the guidance document, "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices," a board certified radiologist reviewed both static and moving images and found them to be of good diagnostic quality. | | Conclusion | Based on our comparison of technological characteristics and our bench and clinical results, our conclusion is that the modified system is as safe and effective as our predicate device and is therefore substantially equivalent. |