(243 days)
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.
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.
This document describes the D²RS_AT Digital Dynamic Remote System, an image-intensified fluoroscopic x-ray system seeking 510(k) clearance. The provided text outlines the device's characteristics, its comparison to a predicate device, and the testing conducted to demonstrate its safety and effectiveness.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly defines acceptance criteria through comparison to a predicate device (Stephanix D²RF K102529) and adherence to various standards and guidance documents. Explicit quantitative acceptance criteria are not provided as a list with pass/fail thresholds. Instead, performance metrics are presented for both the new device's panels and the predicate device's panel, and the conclusion states that the new device performs "comparably to and is substantially equivalent to the predicate device."
| Performance Characteristic | Predicate Device Panel (CXDI-50RF) Reported Performance | New Device Panels (Pixium RF 4343 / 4343 FL) Reported Performance | Acceptance Criterion/Comparison |
|---|---|---|---|
| Image Quality | - MTF (Modulation Transfer Function) | - MTF (Modulation Transfer Function) | The technological characteristics are equivalent to the predicate. 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. This implies that the performance should be "comparable" or "substantially equivalent" to the predicate, accounting for measurement variability. The conclusion states "images produced by the new panels have equivalent image quality." |
| - DQE (Detective Quantum Efficiency) | DQE: 72% (0 cy/mm), 60% (1 cy/mm), 42% (2cy/mm), 24% (3cy/mm) | DQE: 65% (0 cy/mm), 52% (1 cy/mm), 42% (2cy/mm), 28% (3cy/mm) | |
| Spatial Resolution | 3.2 lp/mm | 3.4 lp/mm | The new panels' spatial resolution is superior. This implicitly means it meets or exceeds an acceptable level. |
| Pixel Pitch | 160 µm | 148 µm | The new panels' pixel pitch is superior (smaller). This implicitly means it meets or exceeds an acceptable level. |
| Frame Rate (Fps Max) | 30 fps | 30 fps | Equivalent to the predicate. This implies meeting the predicate's performance. |
| Binning Max | 2x2 | 3x3 | This is a different capability, not directly comparable in terms of "better" or "worse" performance against a single metric for acceptance, but rather a functional characteristic that is part of the overall "equivalent" functional identity. |
| Software Validation | Not explicitly detailed for predicate | Performed | Compliance with safety and effectiveness standards. |
| Electrical Safety | Not explicitly detailed for predicate | Performed, complies with IEC 60601-1, IEC 60601-1-3, IEC 60601-2-54, 21CFR Subchapter J | Compliance with relevant safety standards. |
| EMC (Electromagnetic Compatibility) | Not explicitly detailed for predicate | Performed, complies with IEC 60601-1-2 | Compliance with relevant EMC standards. |
| DICOM 3 Standard | YES | YES | Compliance with interoperability standards. |
| Indications for Use | Similar, primarily diagnostic procedures. | The D²RS_AT Digital Dynamic Remote System is indicated for use in generating fluoroscopic images of human anatomy for diagnostic procedures. Not intended for mammography. | The new device's indications are consistent with a cleared fluoroscopic system and are comparable to the predicate's, demonstrating it's suitable for its intended purpose. |
| Guidance Document Compliance | Not explicitly detailed for predicate | Compliance with "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices." | Adherence to FDA-specific guidance for similar devices. |
| US Performance Standard | Not explicitly detailed for predicate | Complies with 1020.30, 1020.31, 1020.32 | Compliance with US performance standards for radiographic equipment. |
Study Proving Acceptance Criteria:
The study conducted to prove the device meets the acceptance criteria is detailed under "Bench/Performance Testing/Data" and "Clinical Evaluation."
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated. The "Clinical Evaluation" mentions a "board certified radiologist reviewed both static and moving images." This implies a qualitative assessment of some images, but the number of images or cases reviewed is not specified.
- Data Provenance: The document does not specify country of origin for the data or whether it was retrospective or prospective. Given that the device is manufactured in France (Rue Jean Moulin - ZI du Bayon La Ricamarie - FRANCE), it's plausible testing was conducted there or in another location appropriate for device evaluation. The context of a 510(k) submission typically involves data collected specifically for the regulatory submission, making it akin to a prospective study for that purpose, even if the cases themselves might be simulated or representative.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: "a board certified radiologist reviewed..." indicates one radiologist.
- Qualifications of Experts: "board certified radiologist." Specific experience (e.g., "10 years of experience") is not provided.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable or "none" for multiple readers. Since only one radiologist is mentioned as reviewing the images, there was no multi-reader consensus or adjudication process described. The single radiologist's assessment served as the "truth" for the clinical evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not explicitly described. The "Clinical Evaluation" section mentions a single board-certified radiologist reviewing images but does not present a comparison of human reader performance with and without AI assistance, nor does it quantify an effect size of improvement. The study focuses on the device's image quality for diagnostic purposes rather than the reader's comparative performance with different aids.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone study (or rather, non-human-in-the-loop performance evaluation) was done as part of the bench testing. The "Bench/Performance Testing/Data" section discusses objective metrics like MTF, DQE, spatial resolution, and pixel pitch. These are measurements of the device's inherent image quality characteristics, independent of a human observer's interpretation.
7. The Type of Ground Truth Used:
- For Bench/Performance Testing: The ground truth is objective physical measurements of the system's performance characteristics (e.g., specific X-ray phantom designs for MTF/DQE, calibrated measurement tools for spatial resolution, etc.).
- For Clinical Evaluation: The "ground truth" was established by the subjective assessment of "good diagnostic quality" by a single board certified radiologist. This is an expert opinion-based ground truth.
8. The Sample Size for the Training Set:
- Not Applicable / Not Provided. This device is an X-ray imaging system, not an AI / machine learning algorithm that typically requires a training set of data. The document describes a physical medical imaging device and its components (flat panel detectors). Therefore, no "training set" in the context of machine learning is applicable or mentioned.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable / Not Provided. As there is no mention of an AI/ML component requiring a training set, the establishment of ground truth for such a set is not relevant to this submission.
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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.
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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
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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)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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: JAARegulation: 21 CFR § 892.1650Regulation name: Image-intensified fluoroscopic x-ray system |
| Identification of PredicateDevice, Classificationregulation, classificationname and product code | Stephanix D²RF Digital Dynamic Remote System, K10252921 CFR § 892.1650, System, x-ray, fluoroscopic, image-intensifiedand 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 forUse | The D²RS_AT Digital Dynamic Remote System Is indicated for use ingenerating fluoroscopic images of human anatomy for diagnosticprocedures. It is intended to replace fluoroscopic images obtained throughimage intensifier technology. Not intended for mammography applications. |
|---|---|
| ------------------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| TechnologicalCharacteristics andSubstantialEquivalence | Comparison with the predicate shows the technological characteristics oftheD2RS_AT Digital Dynamic Remote System are equivalent to the predicatedevice because the images produced by the new panels have equivalentimage quality, MTF, DQE, and safety test results. The units are functionallyidentical. Only the digital panel and the connected computer have changed. |
|---|---|
| -------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Comparison Table
| D²RF K102529 | D²RS_AT Digital Dynamic Remote System | |
|---|---|---|
| IndicationsStatement | The D²RF 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. | The D²RS_AT Digital Dynamic Remote System Isindicated for use in generating fluoroscopic images ofhuman anatomy for diagnostic procedures. It isintended to replace fluoroscopic images obtainedthrough image intensifier technology. Not intended formammography applications. |
| Photo ofDigital Panel | Image: D2RF K102529 Digital Panel | Image: D2RS_AT Digital Panel |
| DICOM 3 | YES | YES |
| WorkstationPhoto(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 |
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| 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/PerformanceTesting/Data | Tests were performed on the device which demonstrated that the device issafe and effective, performs comparably to and is substantially equivalent tothe predicate device. Tests included: Performance testing and SoftwareValidation. Electrical safety and Electromagnetic Compatibility testing has beenperformed. The unit complies with the US Performance Standard forradiographic 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 asthe DICOM 3 Standard. We also assessed compliance with the guidancedocument, "Guidance for the Submission of 510(k)'s for Solid State X-rayImaging Devices." The MTF and DQE comparisons in the table above show thenew digital panels perform better in some measurements and slightly worse inother measurements, but such numbers should be compared with cautionbecause of measurement uncertainty error. Spatial resolution and pixel pitchare superior for the new panels. The device conforms to the requirements ofthe DHHS performance standard pursuant to 1020.30, 1020.31 and 1020.32. |
|---|---|
| ClinicalEvaluation | In accordance with the guidance document, "Guidance for the Submission of510(k)'s for Solid State X-ray Imaging Devices," a board certified radiologistreviewed both static and moving images and found them to be of gooddiagnostic quality. |
| Conclusion | Based on our comparison of technological characteristics and our bench andclinical results, our conclusion is that the modified system is as safe andeffective as our predicate device and is therefore substantially equivalent. |
§ 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.