D2RS & D2RS9090 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.

Device Description

The D2RS & D2RS9090 are direct digital dynamic remote-controlled fluoroscopy and radiography systems 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 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. A new tilting table has been introduced (D2RS9090). This new variant of D2RS consists of a modification of the foot of the remote controlled table. Instead of being down the table, this one is now behind. This allows a tilting from -90 to +90° (versus -25 to 90° with previous version) and an elevation from 368 to 1455 cm (versus 640 to 930 cm with previous version). The control console has been updated to a more modern looking design but is functionally identical to the predicate.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called D2RS & D2RS9090 Digital Dynamic Remote System. The submission aims to establish substantial equivalence to a predicate device (D2RF Digital Dynamic Remote System). Here's a breakdown of the requested information based on the provided text, with notes where information is not explicitly stated.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied to be "as safe and effective as the predicate device" and compliance with relevant IEC standards and FDA guidances. The performance is assessed against these implicit criteria and through a comparison of technological characteristics.

Acceptance Criteria (Implied / Explicit)	Reported Device Performance and Evidence
Technological Equivalence / Superiority (Implicit)	Comparison Table (New Device vs. Predicate):
Indicatons for Use remain unchanged	Same Indications for Use: D2RS & D2RS9090 is indicated for generating fluoroscopic images of human anatomy for vascular angiography, diagnostic, and interventional procedures, and for cardiology, diagnostic, and interventional procedures. Intended to replace image intensifier technology, not for mammography. (Matches predicate)
Updated Digital Panel Performance (Superior or Equivalent)	New Panel: Canon CXDI-RF Wireless B1 (Predicate used Canon CXDI-50RF) - Dimension: 480 x 460 mm (vs. 492.8 x 503.1 mm) - Useful Area: 42 x 43 cm (vs. 35 x 43 cm) - Superior - Scintillator: CsI (Same) - Pixel Pitch: 160 µm (Same) - Spatial Resolution: 3.1 lp/mm (Same) - Matrix: 2592 x 2656 pixels (vs. 2208 x 2688 pixels) - Superior - AD Conversion: 16 bits (vs. 14 bits) - Superior - DQE: 60% (0.5 lp/mm) (vs. 59% (0.5 lp/mm)) - Superior - MTF: 38% (2 lp/mm) (vs. 30% (2 lp/mm)) - Superior - Fps Max: 30 fps (Same) - Interface: Ethernet/Wireless WiFi (vs. Ethernet) - Superior - DICOM 3: YES (Same) - Operating Temperature: 15-40°C (Same)
New Tilting Table Functionality (Superior or Equivalent)	New Tilting Table (D2RS9090): Tilting from -90 to +90° (vs. -25 to 90° for predicate) - Superior. Elevation from 368 to 1455 cm (vs. 640 to 930 cm for predicate) - Superior.
Compliance with International Standards and FDA Guidance (Explicit)	Bench/Performance Testing Data: Systems covering all generator/panel combinations were assembled and tested and found to be operating properly. Software validated per FDA Guidance for Software. Cybersecurity recommendations followed per FDA Guidance. New digital x-ray panel tested per FDA Guidance for Solid State X-ray Imaging Devices. Compliance with: IEC 60601-1, IEC 60601-1-3, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-28, IEC 60601-2-54, IEC 62304. Unit complies with US Performance Standard for radiographic equipment.
Diagnostic Quality of Images (Implicit based on indications for use)	Clinical Evaluation: A board certified radiologist reviewed both static and moving images and found them to be of excellent diagnostic quality.
Overall Safety and Effectiveness (Conclusion for Substantial Equivalence Dt.)	Conclusion: Based on comparison of technological characteristics and bench/clinical results, the modified and updated system is as safe and effective as the predicate device and is therefore substantially equivalent.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated. The text mentions "both static and moving images" were reviewed, but doesn't quantify the number of images or cases.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: "A board certified radiologist" (singular) was used.
Qualifications: "board certified radiologist." Specific experience level (e.g., years of experience) is not mentioned.

4. Adjudication method for the test set

Adjudication Method: "A board certified radiologist reviewed... and found them to be of excellent diagnostic quality." This implies a single-reader review rather than an adjudication process involving multiple experts. No formal adjudication method (like 2+1 or 3+1) is mentioned.

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

MRMC Study: No, an MRMC comparative effectiveness study was not explicitly done. The study described is a single-reader review for diagnostic image quality, comparing the device's output to an implicit standard of "excellent diagnostic quality," likely in comparison to the predicate device's expected performance. This submission is for an imaging system, not an AI-assisted diagnostic tool.
Effect Size: Not applicable, as no MRMC study with AI assistance was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable in the context of this submission. The device is an X-ray imaging system, where human interpretation of the images is inherent to its use. The "algorithm" here refers to the system's image acquisition and processing capabilities, not an AI for diagnosis. The clinical evaluation focuses on the quality of the images produced for human interpretation.

7. The type of ground truth used

Type of Ground Truth: The ground truth for the clinical evaluation was based on the subjective assessment of a "board certified radiologist" who determined the images to be of "excellent diagnostic quality." This is an expert opinion/consensus implicitly benchmarked against diagnostic standards. It is not pathology, or outcomes data.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. The device described is an X-ray imaging system, not an AI/machine learning algorithm that requires a training set in the conventional sense. The "training" of such a system involves engineering and calibration to produce high-quality images according to technical specifications and clinical needs, rather than learning from a dataset.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable. As mentioned above, this is an X-ray imaging system, not an AI/ML algorithm that generates a "ground truth" during a training phase.

In summary, the submission focuses on demonstrating substantial equivalence primarily through technological comparison to a predicate device, adherence to relevant technical standards, and a qualitative assessment of image quality by a radiologist. It is not an AI-based diagnostic device; therefore, many of the questions related to AI studies (MRMC, training sets, etc.) are not directly applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 23, 2021

Stephanix % Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES, FL 34114

Re: K213479

Trade/Device Name: D2RS and D2RS 9090 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA, IZI Dated: October 28, 2021 Received: October 29, 2021

Dear Daniel 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213479

Device Name D2RS & D2RS9090 Digital Dynamic Remote System

Indications for Use (Describe)

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)

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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 D2RS & D2RS9090 Digital Dynamic Remote System

Date Prepared: October 28, 2021 Summary prepared by: Sandie Perret, Quality Manager

1. Trade/Device Name: D2RS & D2RS9090 Digital Dynamic Remote System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB,, JAA, IZI
1. Identification of Predicate Device: K102529 Manufacturer: Stephanix Radiological Systems Trade/Device Name: D2RF Digital Dynamic Remote System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB,, JAA, IZI
1. Device Description: As compared to the predicate system, we have added a newer model Canon Digital Dynamic X-ray receptor panel, model: CXDI-RF Wireless B1. The original Canon panel remains available. System components and the "look" of the system have been updated and modernized. The D2RS & D2RS9090 are direct digital dynamic remote-controlled fluoroscopy and radiography systems 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 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 CANON CXDI-RF Wireless B1 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 or Fluoroscopy. A new tilting table has been introduced (D2RS9090). This new variant of D2RS consists of a modification of the foot of the remote controlled table. Instead of being down the table, this one is now behind. This allows a tilting from -90 to +90° (versus -25 to 90° with previous

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version) and an elevation from 368 to 1455 cm (versus 640 to 930 cm with previous version). The control console has been updated to a more modern looking design but is functionally identical to the predicate.

1. Indications for Use: The D2RS 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.
1. Technological Characteristics and Substantial Equivalence Comparison with the predicate shows the technological characteristics of the modified devices are equal to or better than the predicate device. Please see the detailed comparison table below. The units are functionally identical. Only the digital panel has changed. The new panel is the CANON CXDI-RF Wireless B1. A new tilting table has been introduced (D2RS9090). This new variant of D2RS consists of a modification of the foot of the remote controlled table. Instead of being down the table, this one is now behind. This allows a tilting from -90 to +90° (versus -25 to 90° with previous version) and an elevation from 368 to 1455 cm (versus 640 to 930 cm with previous version).

Comparison Table
	D2RF Digital Dynamic Remote SystemK102529	D2RS & D2RS9090 Digital Dynamic RemoteSystem
IndicationsStatement	The D2RS Digital Dynamic Remote System isindicated for use in generating fluoroscopicimages of human anatomy for vascularangiography, diagnostic, and interventionalprocedures. It is also indicated for generatingfluoroscopic images of human anatomy forcardiology, diagnostic, and interventionalprocedures. It is intended to replacefluoroscopic images obtained through imageintensifier technology. Not intended formammography applications.	D2RS & D2RS9090 Digital Dynamic RemoteSystem is indicated for use in generatingfluoroscopic images of human anatomy forvascular angiography, diagnostic, andinterventional procedures. It is also indicatedfor generating fluoroscopic images of humananatomy for cardiology, diagnostic, andinterventional procedures. It is intended toreplace fluoroscopic images obtained throughimage intensifier technology. Not intended formammography applications. SAME THEINDICATIONS FOR USE HAS NOT CHANGED
Unit Photos	Image: D2RF Digital Dynamic Remote System	Image: D2RS & D2RS9090 Digital Dynamic Remote System

Comnarison Tahle

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	D2RF Digital Dynamic Remote SystemK102529	D2RS & D2RS9090 Digital Dynamic RemoteSystem
ControlConsole		Updated Look

	D2RF Digital Dynamic RemoteSystem K102529	D2RS & D2RS9090 Digital Dynamic RemoteSystem
Name	Canon CXDI-50RF panel(The panel itself was cleared in 2009:K092439)	New Panel: Canon CXDI-RF Wireless B1Note: The Canon CXDI-50RF panel (cleared inour original submission K102529) remainsavailable
Dimension	$492.8 \times 503.1$ mm	480 x 460 mm
Useful Area	35 x 43 cm	42 x 43 cm
Photo	Image: Canon CXDI-50RF panel	Image: Canon CXDI-RF Wireless B1 panel
Scintillator	Csl	Csl
Pixel pitch	160 μm	160 μm
Spatial resolution	3.1 lp/mm	3.1 lp/mm
Matrix	$2208 \times 2688$ pixels	$2592 \times 2656$ pixels
AD conversion	14 bits	16 bits
DQE	59% (0.5 lp/mm)	60% (0.5 lp/mm)
MTF	30% (2 lp/mm)	38% (2 lp/mm)
	D2RF Digital Dynamic RemoteSystem K102529	D2RS & D2RS9090 Digital Dynamic RemoteSystem
Fps Max	30 fps	30 fps
Interface	Ethernet	Ethernet/Wireless WiFi
DICOM 3	YES	YES
Operating temperature	15-40°C	15-40°C

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1. Bench/Performance Testing Data: Systems covering all generator/panel combinations were assembled and tested and found to be operating properly. Software was validated according to the FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (for a moderate level of concern.) Because the system uses Wi-Fi and Ethernet, we observed the recommendations contained in the FDA Guidance Document: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff. For the new digital x-ray panel we provided testing according to the FDA guidance document: Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices Guidance for Industry and Food and Druq Administration Staff.
  The X-Ray Units and digital panels have been tested to be in compliance with the following International Standards:

IEC 60601-12005 + CORR. 1 (2006) + CORR. 2 (2007), AMD1:2012. Medical electrical equipment Part 1: General requirements for basic safety and essential performance

IEC 60601-1-3:2008, AMD1:2013 for use in conjunction with IEC 60601-1:2005, AMD1:2012 Part 1-3: General Requirements for Radiation Protection in Diagnostic X-Ray Equipment

IEC 60601-1-2:2014 (Edition 4.0) General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility - requirements and tests

IEC 60601-1-3:2008+A1:2013 (Edition 2.1) Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment

IEC 60601-1-6:2010 + A1:2013 (Edition 3.1) Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability

IEC 60601-2-28:2010 (Edition 2.0) Medical electrical equipment – Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis

IEC 60601-2-54:2009+A1:2015 (Edition 1.1) Medical electrical equipment – Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy.

IEC 62304:2006 + A1:2016 (Edition 1.1) . Medical device software life-cycle processes The unit complies with the US Performance Standard for radiographic equipment.

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1. Clinical Evaluation. As required by the FDA Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices Guidance for Industry and Food and Drug Administration Staff A board certified radiologist reviewed both static and moving images and found them to be of excellent diagnostic quality.
1. Conclusion: Based on our comparison of technological characteristics and our bench and clinical results, our conclusion is that the modified and updated system is as safe and effective as our predicate device and is therefore substantially equivalent.

Regulation Number and Section

§ 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.