pixium 4343RCE
Device Facts
| Record ID | K170113 |
|---|---|
| Device Name | pixium 4343RCE |
| Applicant | Philips Medical Systems Dmc GmbH |
| Product Code | MQB · Radiology |
| Decision Date | Feb 9, 2017 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1680 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
As a part of a radiographic system, the Pixium 4343RCE is intended to acquire digital radiographic images. The Pixium 4343RCE is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.
Device Story
Pixium 4343RCE is a stationary digital X-ray detector integrated into Philips DigitalDiagnost systems. It uses a cesium iodide (CsI) scintillator to absorb X-ray photons, converting them into visible light, which is then captured by a thin-film transistor (TFT) photodetector array. This array generates an electrical charge representation of the X-ray input, which is digitized and transmitted via 1 Gbit/s Ethernet to the Philips Eleva Workspot for image processing and display. The device is operated by trained healthcare professionals (radiographers/technicians) in clinical settings. The output provides digital images for medical diagnosis. The system includes grid line suppression features. The device benefits patients by enabling high-quality, efficient digital radiographic imaging for routine and specialized diagnostic needs.
Clinical Evidence
No clinical data. Substantial equivalence was demonstrated through non-clinical performance testing, including verification and validation of design features, software, and imaging performance metrics (MTF, DQE, SENR) compared to the predicate device.
Technological Characteristics
Stationary digital X-ray detector; CsI scintillator; TFT readout; 16-bit ADC; 1 Gbit/s Ethernet connectivity; 500 x 490 x 45 mm form factor; 148 µm pixel size. Complies with ISO 14971 (risk management), IEC 62304 (software lifecycle), IEC 60601-1-2 (EMC), and NEMA PS 3.1-3.20 (DICOM).
Indications for Use
Indicated for routine digital radiographic imaging in patients of all ages, including intensive care, trauma, and pediatric applications. Contraindicated for fluoroscopy, angiography, and mammography.
Regulatory Classification
Identification
A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Special Controls
*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.
Predicate Devices
- Philips pixium 4343RC (K131483)
Reference Devices
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 9, 2017
Philips Medical Systems DMC GmbH % Ming Xiao Regulatory Affairs Specialist, North America Roentgenstrasse 24-26 Hamburg, 22335 GERMANY
Re: K170113
Trade/Device Name: pixium 4343RCE Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: January 13, 2017 Received: January 17, 2017
Dear Ming Xiao:
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.
Michael O'Hara
For
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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## 5. Statement of Indication for Use
| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120 |
|-------------------------------------------------------------------------|---------------------------------------------------------------|
| Indications for Use | Expiration Date: January 31, 2017<br>See PRA Statement below. |
| 510(k) Number (if known) | K170113 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | pixium 4343RCE |
| Indications for Use (Describe) | As a part of a radiographic system, the Pixium 4343RCE is intended to acquire digital radiographic images. The Pixium 4343RCE is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography. |
| Type of Use (Select one or both, as applicable) | <span> X Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
pixium 4343RCE Notification – Special 510(k)
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## 6. 510(k) Summary
## 510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
- February 03, 2017 Date Prepared: Manufacturer: Philips Medical Systems DMC GmbH Roentgenstrasse 24-26 22335 Hamburg GERMANY Establishment registration number: 3003768251 Contact Person: Ming Xiao Regulatory Affairs Specialist, North America Phone: +49 40 5078-2306 Fax: +49 40 5078-2425 E-mail: ming.xiao@philips.com Device Name: pixium 4343RCE Classification: Classification Name: Stationary x-ray system, Classification Regulation: 21CFR 892.1680 Classification Panel: 90 -- Radiology Class II Device Class: Product code: MQB Predicate Device: Trade Name: Philips pixium 4343RC Manufacturer: Philips Medical Systems DMC GmbH 510(k) Clearance: K131483 - October 07, 2013 Classification Name: Stationary x-ray system Classification Regulation: 21CFR 892.1680 Classification Panel: 90 -- Radiology Device Class: Class II MQB Product code:
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The pixium 4343RCE is a Stationary x-ray system that converts x-ray Device patterns into electrical signals. The signals are converted into visible Description: images for use in medical diagnosis. In the device, a cesium iodide scintillator absorbs the input x-ray photons. The scintillator in turn emits visible spectrum photons that illuminate an array of photodetectors that create an electrical charge representation of the x-ray input. A matrix scan of the array converts the integrated charges into a modulated electrical signal.
> The detector is permanently installed and intended to be integrated into an x-ray system, where it constitutes an x-ray receptor for direct x-ray imaging. It is electrically powered by and connected with the x-ray system. The device is connected to the Philips Eleva Workspot to create a complete x-ray imaging chain, and it is intended to be used in Philips x-ray systems such as the DigitalDiagnost.
- Detector Size: 500 x 490 x 45 mm3
- Image Size (Pixel): 2840 x 2874
- Pixel Size: 148 um
- Image Resolution up to 3.4 LP/mm
A similar detector (pixium 4343RC) has received pre-market clearance under K131483 (October 7, 2013), for use with the following currently marketed Philips x-ray systems:
- Philips DigitalDiagnost (K141736 July 25, 2014), .
- . Philips Eleva Workspot (K153318 - Dec 22, 2015)
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## Description of Modification
The modifications are restricted to the mechanical integration of the pixium 4343RCE into the Philips DigitalDiagnost x-ray system, slight electronic modifications inside the detector, and adaptation of the proposed pixium 4343RCE x-ray detector software interface with the Philips Eleva Workspot with SkyFlow software to facilitate communication. The mechanical integration into the Philips DigitalDiagnost system consists of a minor modification to the Bucky trays for the x-ray table DigitalDiagnost TH2 and the vertical wall stands DigitalDiagnost VM and Bucky Diagnost VS. The electrical integration consists of a new power supply (safety extra low voltage) for the detector, and a new interface connector for the detector.
Note: the pixium 4343RCE is only intended to be integrated with the Philips DigitalDiagnost x-ray system and the Philips Eleva Workspot with SkyFlow.
These changes do not raise any new questions on safety or efficacy. In particular, these changes do not necessitate nor cause any modifications to the following:
- A the x-ray tube,
- the x-ray generator, A
- the anti-scatter grid, A
- A the x-ray control, or
- A the collimator of the Philips DigitalDiagnost system.
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| Comparison of the currently marketed and predicate pixium 4343RC versus the proposed pixium<br>4343RCE | | | | |
|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Predicate Device<br>pixium 4343RC<br>(K131483) | Proposed Device<br>pixium 4343RCE<br>(K170113) | Discussion | |
| Design Features | | | | |
| X-Ray Absorber | CsI Scintillator | CsI Scintillator | Identical; no impact to<br>safety and effectiveness. | |
| Installation type | Stationary, permanently<br>installed | Stationary, permanently<br>installed | Identical; no impact to<br>safety and effectiveness. | |
| Readout<br>Mechanism | Thin Film Transistor | Thin Film Transistor | Identical; no impact to<br>safety and effectiveness. | |
| Detector Size | 500 x 490 x 45.5 mm³ | 500 x 490 x 45 mm³ | Similar, proposed detector<br>has a slightly smaller<br>detector size however,<br>there is no impact to safety<br>or effectiveness. | |
| Detector Weight | <14 kg | 11.7kg ± 0.85kg | Similar, proposed detector<br>is slightly lighter however,<br>there is no impact to safety<br>or effectiveness. | |
| Image Size<br>(Pixel) | 2840 x 2874 | 2840 x 2874 | Identical; no impact to<br>safety and effectiveness. | |
| Image Size (X-<br>ray field) | 420 x 425 mm² | 420 x 425 mm² | Identical; no impact to<br>safety and effectiveness. | |
| Distance Image<br>to Rim | 34.9 mm | 40mm | Similar, proposed detector<br>has a slightly greater<br>distance image to rim how-<br>ever, there is no impact to<br>safety or effectiveness. | |
| Pixel Size | 148µm | 148µm | Identical; no impact to<br>safety and effectiveness. | |
| Nyquist<br>Frequency: | 3.37 lp/mm | 3.37 lp/mm | Identical; no impact to<br>safety and effectiveness. | |
| ADC<br>Digitization | 16 bit | 16 bit | Identical; no impact to<br>safety and effectiveness. | |
| Signal to<br>Electronic Noise<br>Ratio (SENR) | 42.3 dB (@ 1 µGy) | 42.3 dB (@ 1 µGy) | Identical; no impact to<br>safety and effectiveness. | |
| Maximum X-ray<br>Dose for Linear<br>Response | 50 µGy | 50 µGy | Identical; no impact to<br>safety and effectiveness. | |
| Image Readout<br>Duration | 1.6 s | 1.36 s | The image readout<br>duration is slightly faster<br>and therefore does not<br>impact safety and<br>effectiveness. | |
| Number of<br>Modes | 2 | 3 | An additional default mode<br>is included with the<br>proposed detector. There<br>is no impact safety and<br>effectiveness. | |
| Comparison of the currently marketed and predicate pixium 4343RC versus the proposed pixium<br>4343RCE | | | | |
| | Predicate Device<br>pixium 4343RC<br>(K131483) | Proposed Device<br>pixium 4343RCE<br>(K170113) | Discussion | |
| Exposure<br>Window<br>Durations | 1-8192 ms | 0-8191 ms | Similar, proposed detector<br>has a minimal decrease in<br>the exposure window<br>duration, however it is<br>insignificant and thus there<br>is no impact to safety or<br>effectiveness. | |
| Sequence Time<br>Detector | 6 s | 6 s | Identical; no impact to<br>safety and effectiveness. | |
| Image Data | 16.3 MBytes | 16.3 MBytes | Identical; no impact to<br>safety and effectiveness. | |
| Use w and w/o<br>Radiographic<br>Grid? | Yes | Yes | Identical; no impact to<br>safety and effectiveness. | |
| Maximum<br>Lifetime Dose | 100 Gy | 100 Gy | Identical; no impact to<br>safety and effectiveness. | |
| Warm-up<br>Duration before<br>Calibration | 4 h | 2 h | The warm-up duration<br>before calibration has been<br>decreased, thus there is no<br>impact to safety or<br>effectiveness. | |
| Digital Sub-<br>traction Angio-<br>graphy (DSA) | None (exempt from intended<br>use) | None (exempt from<br>intended use) | Identical; no impact to<br>safety and effectiveness. | |
| Positioning<br>Mode | None | None | Identical; no impact to<br>safety and effectiveness. | |
| Stitching Mode<br>(Implemented in<br>Detector) | None | None | Identical; no impact to<br>safety and effectiveness. | |
| Binning | None (1 x 1) | None (1 x 1) | Identical; no impact to<br>safety and effectiveness. | |
| Framespeed:<br>Dynamic<br>Imaging - Pulsed | None | None | Identical; no impact to<br>safety and effectiveness. | |
| Data Interface to<br>Workstation | 100 Mbit/s Ethernet | 1 Gbit/s Ethernet | The data interface to<br>workstation has been<br>increased. There is no<br>impact to safety or<br>effectiveness. | |
| Power<br>Consumption | 20.4W | Avg: 8W. Max: 15W | The power consumption<br>has been decreased. There<br>is no impact to safety or<br>effectiveness. | |
| Cover Factor<br>(Optical Fill<br>Factor) | 60.3% | 63% | Similar, the cover factor is<br>essentially the same and<br>thus there is no impact to<br>safety or effectiveness. | |
| Comparison of the currently marketed and predicate pixium 4343RC versus the proposed pixium<br>4343RCE | | | | |
| | Predicate Device<br>pixium 4343RC<br>(K131483) | Proposed Device<br>pixium 4343RCE<br>(K170113) | Discussion | |
| Modulation<br>Transfer<br>Function (MTF) | 1 lp/mm 64%<br>2 lp/mm 32%<br>3 lp/mm 17%<br>Nyquist 13%<br>(3.37 lp/mm) | 1 lp/mm 62%<br>2 lp/mm 35%<br>3 lp/mm 19%<br>Nyquist 15%<br>(3.37 lp/mm) | Similar, the MTF has<br>remained essentially the<br>same, with some<br>improvements and one<br>very minimal decrease,<br>thus, overall, there is no<br>impact to safety and<br>effectiveness. | |
| Detective<br>Quantum<br>Efficiency<br>(DQE) | DQE at 2 µGy<br>lp/mm %<br>0.05 65<br>1 52<br>2 42<br>3 25<br>3.37 18 | DQE at 2 µGy<br>lp/mm %<br>0.05 67<br>1 51<br>2 42<br>3 27<br>3.37 18 | Similar, the DQE has<br>remained essentially the<br>same, with one<br>improvement and one very<br>minimal decrease, thus,<br>overall, there is no impact<br>to safety and effectiveness. | |
| Image<br>Processing | XD-S Eleva Workstation<br>(previously "XD-S Direct<br>Workstation/Package")<br>(K063781)<br>UNIQUE<br>also: UM, DRR, and UNIQUE<br>for PCR storage phosphor<br>cassettes | Philips Eleva WorkSpot<br>with SkyPlate<br>(K153318)<br>UNIQUE<br>also: UM, DRR, and<br>UNIQUE for PCR storage<br>phosphor cassettes | Similar; The Eleva<br>WorkSpot with SkyPlate is<br>a cleared device. There is<br>no impact to safety and<br>effectiveness. | |
| Grid line<br>suppression | Mechanical Grid Oscillation or<br>Image Pre-Processing ("Grid<br>Suppression") | Mechanical Grid<br>Oscillation or Image Pre-<br>Processing ("Grid<br>Suppression") | Identical; no impact to<br>safety and effectiveness. | |
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The Indication for Use for the pixium 4343RCE is as follows: Indications for As a part of a radiographic system, the pixium 4343RCE is intended to Use: acquire digital radiographic images. The pixium 4343RCE is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.
- Fundamental The fundamental scientific technology of the pixium 4343RCE is that it is a device that converts x-ray patterns into electrical signals, which are then Scientific Technology: converted into visible images for use in medical diagnosis.
Based on the information provide above, the basic fundamental scientific technology of the pixium 4343RCE remains unchanged from the currently marketed and predicate pixium 4343RC (K131483, October 7, 2013) thus demonstrating substantial equivalence.
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Summary of Non-clinical Performance Data:
The pixium 4343RCE complies with the following international and FDArecognized consensus standards:
- International and FDA-recognized consensus standards: .
- ISO 14971: Medical Devices Application of risk management o to medical devices
- NEMA PS 3.1-3.20 Digital Imaging and Communication in o Medicine (DICOM) Set
- AAMI ANSI IEC 62304:2006 Medical Device Software o Software lifecycle processes
- IEC 60601-1-2:2007 Medical electrical equipment Part 1-2: o General requirements for basic safety and essential performance -Collateral Electromagnetic -Requirements and tests
- · Device specific guidance document:
- "Guidance for the Submission of 510(k)s for Solid State X-ray O Imaging Device (September 1, 2016)"
- "Guidance for the Content of Premarket Submissions for O Software Contained in Medical Devices" (May 11th, 2005)"
Non-clinical verification and validation tests have been performed with regards to the intended use, technical claims, requirement specifications, and risk management results.
The software for the pixium 4343RCE is of a moderate level of concern. Software documentation in support of a moderate level of concern, as outlined in the FDA's software guidance has been provided in the premarket notification.
Non-clinical verification and validation test results demonstrate that the pixium 4343RCE:
- . Complies with the aforementioned international and FDArecognized consensus standards and device specific guidance document entitled "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Device (September 1, 2016)"
- Meets the acceptance criteria and is adequate for its intended use. .
Therefore, the pixium 4343RCE is substantially equivalent to the currently marketed and predicate pixium 4343RC (K131483, October 7, 2013) thus demonstrating substantial equivalence.
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The pixium 4343RCE did not require a clinical study since substantial Summary of equivalence to the currently marketed and predicate device was Clinical Data: demonstrated with the following attributes:
- Design features; ●
- . Indication for use:
- Fundamental scientific technology; ●
- Non-clinical performance testing including validation; and ●
- Safety and effectiveness. ●
Substantial The technological characteristics, comparison of of non-clinical Equivalence performance data, safety testing, software validation, and clinical image concurrence data demonstrates that the device is as safe, as effective, and Conclusion: performs as well or better than the predicate device.
> The pixium 4343RCE has the same indications for use and intended use, has identical or equivalent technological characteristics, provides images of equivalent diagnostic capability, and does not introduce new potential hazards or safety risks.
> The pixium 4343RCE is substantially equivalent to the currently legally marketed predicate device (K131483, October 7, 2013) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. Additionally, substantial equivalence was demonstrated with non-clinical performance (verification and validation) tests, which complied with the requirements specified in the international and FDA-recognized consensus standards: IEC 62304 and ISO 14971. The results of these tests demonstrate that the pixium 4343RCE met the acceptance criteria and is adequate for its intended use.
