(29 days)
No
The summary focuses on hardware components (digital panels, table modifications) and standard software validation/compliance, with no mention of AI, ML, or advanced image processing beyond basic digital conversion.
No
The device is an imaging system (X-ray) used for diagnostic purposes, specifically to generate fluoroscopic images of human anatomy for various medical procedures. It does not provide any treatment or therapy.
Yes.
The "Intended Use / Indications for Use" states that the device is indicated for "diagnostic" procedures in vascular angiography and cardiology.
No
The device description clearly details physical hardware components such as a Digital Dynamic X-ray receptor panel, a tilting/elevating table, and a control console, indicating it is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The D2RS & D2RS9090 Digital Dynamic Remote System is an X-ray imaging system. It generates fluoroscopic and radiographic images of the human anatomy directly, without requiring any specimens to be taken from the patient.
- Intended Use: The intended use clearly states it's for generating images of human anatomy for diagnostic and interventional procedures. This is consistent with medical imaging, not in vitro testing.
Therefore, based on the provided information, the device is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
OWB, JAA, IZI
Device Description
As compared to the predicate system, we have added a newly compatible Digital Dynamic X-ray receptor panel, model: Pixium RF 4343 FL (Model 4). This panel has already received FDA clearance (reference device above). The original Canon panels remain available. 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 Pixium RF 4343 FL (Model 4) 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Drug Administration Staff.
In addition, we addressed all the items detailed in the FDA publication: "Pediatric Information for X-ray Imaging Device Premarket Notifications."
The X-Ray Units and digital panels have been tested to be in compliance with the following International Standards:
IEC 60601-1:2005 + 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, featuring a stylized depiction of a human figure. To the right of the HHS logo is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 7, 2022
Stephanix Radiological Systems % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114
Re: K221335
Trade/Device Name: D2RS and D2RS 9090 Digital Dynamic Remote System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA, IZI Dated: May 6, 2022 Received: May 9, 2022
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 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
1
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 mediation-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,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT 8B: Division of Radiological Imaging and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221335
Device Name
D2RS & D2RS9090 Digital Dynamic Remote System
Indications for Use (Describe)
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.
| 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) |
===
(1)
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3
510(k) SUMMARY K221335
Image /page/3/Picture/1 description: The image shows the logo for Stephanix Medical Imaging Solutions. The logo features a blue square with a stylized "X" inside, followed by the word "STEPHANIX" in large, bold, blue letters. Below the company name, the words "MEDICAL IMAGING SOLUTIONS" are written in smaller, lighter blue letters.
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: June 1, 2022 Summary prepared by: Sandie Perret, Quality Manager
-
- 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
-
- Identification of Predicate Device: K213479 Manufacturer: Stephanix Radiological Systems 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
-
- Reference Device: K202235 Trade/Device Name: ArtPIX DRF Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: JAA, MQB
-
- Device Description: As compared to the predicate system, we have added a newly compatible Digital Dynamic X-ray receptor panel, model: Pixium RF 4343 FL (Model 4). This panel has already received FDA clearance (reference device above). The original Canon panels remain available. 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 Xrays into digital signals. The unit can acquire still and moving images. The system includes a
4
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 (Model 4) is designed for easy integration in classical R&F tables. It allows manufacturers to offer radiologists an alldigital 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 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.
-
- 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.
-
- 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 Pixium RF 4343 FL (Model 4). 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).
| D2RS & D2RS9090 Digital Dynamic Remote System K213479 | D2RS & D2RS9090 Digital Dynamic Remote System | |
|---|---|---|
| Indications | ||
| Statement | 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. | 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. SAME THE | ||
| INDICATIONS FOR USE HAS NOT CHANGED |
Comparison Table
5
| | D2RS & D2RS9090 Digital Dynamic
Remote System K213479 | D2RS & D2RS9090 Digital Dynamic
Remote System |
|--------------------|----------------------------------------------------------|--------------------------------------------------|
| Unit Photos | | |
| Control
Console | | |
| Digital Panel Comparison Table | ||
|---|---|---|
| D2RS & D2RS9090 Digital Dynamic | ||
| Remote System K213479 | D2RS & D2RS9090 Digital Dynamic Remote | |
| System | ||
| Name | Canon CXDI-RF Wireless B1 | Pixium RF 4343 FL (Model 4) |
| Dimension | 480 x 460 mm | 500 x 490 mm |
| Useful Area | 42 x 43 cm | 43 x 43 cm |
6
| | D2RS & D2RS9090 Digital Dynamic
Remote System K213479 | D2RS & D2RS9090 Digital Dynamic Remote
System |
|--------------------------|--------------------------------------------------------------|------------------------------------------------------|
| Photo | Image: D2RS & D2RS9090 Digital Dynamic Remote System K213479 | Image: D2RS & D2RS9090 Digital Dynamic Remote System |
| Scintillator | Csl | Csl |
| Pixel pitch | 160 μm | 148 μm |
| Matrix | 2592 × 2656 pixels | 2874 x 2840 pixels |
| AD conversion | 16 bits | 16 bits |
| DQE | 60% (0.5 lp/mm) | 73 % typ (0 lp/mm) Similar performance |
| MTF | 38% (2 lp/mm) | 35 % typ. (2 lp/mm) Similar performance |
| Fps Max | 30 fps | 30 fps |
| Interface | Ethernet/Wireless WiFi | Ethernet |
| DICOM 3 | YES | YES |
| Operating
temperature | 15-40°C | 15-40°C |
-
- 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 Drug Administration Staff. In addition, we addressed all the items detailed in the FDA publication: "Pediatric Information for X-ray Imaging Device Premarket Notifications."
The X-Ray Units and digital panels have been tested to be in compliance with the following International Standards:
- 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 Drug Administration Staff. In addition, we addressed all the items detailed in the FDA publication: "Pediatric Information for X-ray Imaging Device Premarket Notifications."
7
IEC 60601-1:2005 + 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.
-
- Clinical Evaluation. Because the added compatible digital x-ray receptor panel had previously received FDA clearance (reference device) the clinical studies 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 Druq Administration Staff were not required.
-
- 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.