(243 days)
No
The summary describes a standard digital X-ray and fluoroscopy system with a flat panel detector. There is no mention of AI, ML, or advanced image processing techniques that would typically indicate the use of such technologies. The performance metrics and testing described are standard for this type of imaging device.
No
The device is indicated for generating fluoroscopic images for diagnostic procedures, not for treatment or therapy.
Yes
This device is a diagnostic device because its "Intended Use" states that it generates images "for diagnostic procedures" and a "board certified radiologist reviewed both static and moving images and found them to be of good diagnostic quality."
No
The device description clearly details hardware components such as a Flat Panel Detector (FPD), X-ray sensor, and a remotely controlled tilting/elevating table, indicating it is a hardware system with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "generating fluoroscopic images of human anatomy for diagnostic procedures." This involves imaging the inside of the body using X-rays, which is an in vivo (within a living organism) diagnostic method, not in vitro (outside of a living organism, typically involving samples like blood or tissue).
- Device Description: The description details an X-ray imaging system with a flat panel detector, table, and remote control. This is consistent with medical imaging equipment used on patients, not equipment for analyzing biological samples.
- Input Imaging Modality: The input modality is X-ray, which is used for imaging the body directly.
- Anatomical Site: The anatomical site is "human anatomy," further indicating in vivo use.
- Intended User/Care Setting: The intended users are radiologists, X-ray technicians, and medical centers, which are involved in patient care and imaging.
- Performance Studies and Metrics: The performance studies and metrics (MTF, DQE, spatial resolution, pixel pitch) are related to the quality and performance of an X-ray imaging system, not the analytical performance of an IVD.
IVD devices are typically used to examine specimens obtained from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on biological samples.
N/A
Intended Use / 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 intensionaly. Not intended for mammography applications.
Product codes
JAA
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.
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
Bench/Performance 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.
Key Metrics
DQE:
CXDI-50RF (Predicate K102529): 72% (0 cy/mm), 60% (1 cy/mm), 42% (2cy/mm), 24% (3cy/mm)
Pixium RF 4343 (NEW): 65% (0 cy/mm), 52% (1 cy/mm), 42% (2cy/mm), 28% (3cy/mm)
Pixium RF 4343 FL (NEW): 65% (0 cy/mm), 52% (1 cy/mm), 42% (2cy/mm), 28% (3cy/mm)
MTF:
CXDI-50RF (Predicate K102529): 57% (1 cy/mm), 32% (2cy/mm), 18% (3cy/mm)
Pixium RF 4343 (NEW): 62% (1 cy/mm), 25% (2cy/mm), 18% (3cy/mm)
Pixium RF 4343 FL (NEW): 62% (1 cy/mm), 25% (2cy/mm), 18% (3cy/mm)
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/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)
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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. |