(28 days)
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.
The pixium 4343RCE is a Stationary x-ray system that converts x-ray patterns into electrical signals. The signals are converted into visible 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.
The provided text describes the Philips pixium 4343RCE, a stationary x-ray system. The document is a 510(k) summary for premarket notification to the FDA, asserting substantial equivalence to a predicate device (Philips pixium 4343RC, K131483).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present specific numerical acceptance criteria (e.g., minimum DQE, MTF values that must be met) for the pixium 4343RCE, nor does it provide a direct side-by-side comparison of claimed performance data against such defined criteria. Instead, the acceptance criteria are implicitly stated as demonstrating similar performance to the predicate device and compliance with various standards. The "Discussion" column in the comparison table serves as the "reported device performance" against the implicitly accepted criterion of not negatively impacting safety or effectiveness compared to the predicate.
Here's a table summarizing relevant performance metrics and the discussion provided, which indicates how the device meets (or is considered to meet) implied acceptance criteria of non-inferiority or slight improvement:
| Feature | Predicate Device pixium 4343RC (K131483) | Proposed Device pixium 4343RCE (K170113) | Discussion / Performance vs. Implied Acceptance Criteria |
|---|---|---|---|
| Design Features | |||
| X-Ray Absorber | CsI Scintillator | CsI Scintillator | Identical; no impact to safety and effectiveness. |
| Installation type | Stationary, permanently installed | Stationary, permanently installed | Identical; no impact to safety and effectiveness. |
| Readout Mechanism | Thin Film Transistor | Thin Film Transistor | Identical; no impact to safety and effectiveness. |
| Detector Size | 500 x 490 x 45.5 mm³ | 500 x 490 x 45 mm³ | Similar, slightly smaller; no impact to safety or effectiveness. |
| Detector Weight | <14 kg | 11.7kg ± 0.85kg | Similar, slightly lighter; no impact to safety or effectiveness. |
| Image Size (Pixel) | 2840 x 2874 | 2840 x 2874 | Identical; no impact to safety and effectiveness. |
| Image Size (X-ray field) | 420 x 425 mm² | 420 x 425 mm² | Identical; no impact to safety and effectiveness. |
| Distance Image to Rim | 34.9 mm | 40mm | Similar, slightly greater; no impact to safety or effectiveness. |
| Pixel Size | 148µm | 148µm | Identical; no impact to safety and effectiveness. |
| Nyquist Frequency | 3.37 lp/mm | 3.37 lp/mm | Identical; no impact to safety and effectiveness. |
| ADC Digitization | 16 bit | 16 bit | Identical; no impact to safety and effectiveness. |
| SENR (@ 1 µGy) | 42.3 dB | 42.3 dB | Identical; no impact to safety and effectiveness. |
| Max X-ray Dose for Linear Response | 50 µGy | 50 µGy | Identical; no impact to safety and effectiveness. |
| Image Readout Duration | 1.6 s | 1.36 s | Slightly faster; no impact to safety and effectiveness. |
| Number of Modes | 2 | 3 | Additional default mode included; no impact safety and effectiveness. |
| Exposure Window Durations | 1-8192 ms | 0-8191 ms | Minimal decrease; insignificant, no impact to safety or effectiveness. |
| Sequence Time Detector | 6 s | 6 s | Identical; no impact to safety and effectiveness. |
| Image Data | 16.3 MBytes | 16.3 MBytes | Identical; no impact to safety and effectiveness. |
| Use w and w/o Radiographic Grid? | Yes | Yes | Identical; no impact to safety and effectiveness. |
| Maximum Lifetime Dose | 100 Gy | 100 Gy | Identical; no impact to safety and effectiveness. |
| Warm-up Duration before Calibration | 4 h | 2 h | Decreased; no impact to safety or effectiveness. |
| Data Interface to Workstation | 100 Mbit/s Ethernet | 1 Gbit/s Ethernet | Increased; no impact to safety or effectiveness. |
| Power Consumption | 20.4W | Avg: 8W. Max: 15W | Decreased; no impact to safety or effectiveness. |
| Cover Factor (Optical Fill Factor) | 60.3% | 63% | Essentially the same; no impact to safety or effectiveness. |
| Image Quality | |||
| Modulation Transfer Function (MTF) | 1 lp/mm 64%, 2 lp/mm 32%, 3 lp/mm 17%, Nyquist 13% (3.37 lp/mm) | 1 lp/mm 62%, 2 lp/mm 35%, 3 lp/mm 19%, Nyquist 15% (3.37 lp/mm) | Similar, with some improvements and one minimal decrease; no impact to safety and effectiveness. |
| Detective Quantum Efficiency (DQE) at 2 µGy | 0.05 lp/mm 65%, 1 lp/mm 52%, 2 lp/mm 42%, 3 lp/mm 25%, 3.37 lp/mm 18% | 0.05 lp/mm 67%, 1 lp/mm 51%, 2 lp/mm 42%, 3 lp/mm 27%, 3.37 lp/mm 18% | Similar, with one improvement and one minimal decrease; no impact to safety and effectiveness. |
The study that proves the device meets the acceptance criteria is detailed as "Non-clinical verification and validation tests." These tests cover the intended use, technical claims, requirement specifications, and risk management results. The document explicitly states: "Non-clinical verification and validation test results demonstrate that the pixium 4343RCE... Meets the acceptance criteria and is adequate for its intended use." The basis for this is "compliance with the aforementioned international and FDA-recognized consensus standards and device specific guidance document" and showing "identical or equivalent technological characteristics," "equivalent diagnostic capability," and no "new potential hazards or safety risks" compared to the predicate.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a separate "test set" in the context of data used for a clinical performance evaluation, as it explicitly states that no clinical study was required. The non-clinical verification and validation tests are performed on the device itself (hardware and software) and against established technical specifications and standards (e.g., ISO, IEC, NEMA, FDA guidance). Therefore, there is no mention of a "sample size" of patient data or "data provenance" (country of origin, retrospective/prospective) for a clinical test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Since no clinical study was conducted, there was no "test set" of patient data requiring expert consensus for ground truth.
4. Adjudication Method for the Test Set
Not applicable as no clinical test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a digital x-ray detector, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the device itself (the x-ray detector) as a standalone component without human interpretation being part of the primary evaluation. The "Summary of Non-clinical Performance Data" and the "Comparison" tables effectively serve as the standalone performance assessment. The device's performance metrics (MTF, DQE, SENR, image readout speed, etc.) are evaluated directly for the detector. The conclusion is that "the device is as safe, as effective, and performs as well or better than the predicate device" in terms of its technological characteristics and ability to produce images.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance evaluation, the "ground truth" is based on technical specifications, international and FDA-recognized consensus standards, and device-specific guidance documents. For instance, the MTF and DQE values are compared against those of the predicate device, with the implicit ground truth being that comparable or improved values demonstrate equivalent performance.
8. The sample size for the training set
Not applicable. The document describes an x-ray detector, not an AI algorithm that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable as there is no training set mentioned for this device.
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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 SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120 |
|---|---|
| Indications for Use | Expiration Date: January 31, 2017See 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) | X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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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 pixium4343RCE | ||||
|---|---|---|---|---|
| Predicate Devicepixium 4343RC(K131483) | Proposed Devicepixium 4343RCE(K170113) | Discussion | ||
| Design Features | ||||
| X-Ray Absorber | CsI Scintillator | CsI Scintillator | Identical; no impact tosafety and effectiveness. | |
| Installation type | Stationary, permanentlyinstalled | Stationary, permanentlyinstalled | Identical; no impact tosafety and effectiveness. | |
| ReadoutMechanism | Thin Film Transistor | Thin Film Transistor | Identical; no impact tosafety and effectiveness. | |
| Detector Size | 500 x 490 x 45.5 mm³ | 500 x 490 x 45 mm³ | Similar, proposed detectorhas a slightly smallerdetector size however,there is no impact to safetyor effectiveness. | |
| Detector Weight | <14 kg | 11.7kg ± 0.85kg | Similar, proposed detectoris slightly lighter however,there is no impact to safetyor effectiveness. | |
| Image Size(Pixel) | 2840 x 2874 | 2840 x 2874 | Identical; no impact tosafety and effectiveness. | |
| Image Size (X-ray field) | 420 x 425 mm² | 420 x 425 mm² | Identical; no impact tosafety and effectiveness. | |
| Distance Imageto Rim | 34.9 mm | 40mm | Similar, proposed detectorhas a slightly greaterdistance image to rim how-ever, there is no impact tosafety or effectiveness. | |
| Pixel Size | 148µm | 148µm | Identical; no impact tosafety and effectiveness. | |
| NyquistFrequency: | 3.37 lp/mm | 3.37 lp/mm | Identical; no impact tosafety and effectiveness. | |
| ADCDigitization | 16 bit | 16 bit | Identical; no impact tosafety and effectiveness. | |
| Signal toElectronic NoiseRatio (SENR) | 42.3 dB (@ 1 µGy) | 42.3 dB (@ 1 µGy) | Identical; no impact tosafety and effectiveness. | |
| Maximum X-rayDose for LinearResponse | 50 µGy | 50 µGy | Identical; no impact tosafety and effectiveness. | |
| Image ReadoutDuration | 1.6 s | 1.36 s | The image readoutduration is slightly fasterand therefore does notimpact safety andeffectiveness. | |
| Number ofModes | 2 | 3 | An additional default modeis included with theproposed detector. Thereis no impact safety andeffectiveness. | |
| Comparison of the currently marketed and predicate pixium 4343RC versus the proposed pixium4343RCE | ||||
| Predicate Devicepixium 4343RC(K131483) | Proposed Devicepixium 4343RCE(K170113) | Discussion | ||
| ExposureWindowDurations | 1-8192 ms | 0-8191 ms | Similar, proposed detectorhas a minimal decrease inthe exposure windowduration, however it isinsignificant and thus thereis no impact to safety oreffectiveness. | |
| Sequence TimeDetector | 6 s | 6 s | Identical; no impact tosafety and effectiveness. | |
| Image Data | 16.3 MBytes | 16.3 MBytes | Identical; no impact tosafety and effectiveness. | |
| Use w and w/oRadiographicGrid? | Yes | Yes | Identical; no impact tosafety and effectiveness. | |
| MaximumLifetime Dose | 100 Gy | 100 Gy | Identical; no impact tosafety and effectiveness. | |
| Warm-upDuration beforeCalibration | 4 h | 2 h | The warm-up durationbefore calibration has beendecreased, thus there is noimpact to safety oreffectiveness. | |
| Digital Sub-traction Angio-graphy (DSA) | None (exempt from intendeduse) | None (exempt fromintended use) | Identical; no impact tosafety and effectiveness. | |
| PositioningMode | None | None | Identical; no impact tosafety and effectiveness. | |
| Stitching Mode(Implemented inDetector) | None | None | Identical; no impact tosafety and effectiveness. | |
| Binning | None (1 x 1) | None (1 x 1) | Identical; no impact tosafety and effectiveness. | |
| Framespeed:DynamicImaging - Pulsed | None | None | Identical; no impact tosafety and effectiveness. | |
| Data Interface toWorkstation | 100 Mbit/s Ethernet | 1 Gbit/s Ethernet | The data interface toworkstation has beenincreased. There is noimpact to safety oreffectiveness. | |
| PowerConsumption | 20.4W | Avg: 8W. Max: 15W | The power consumptionhas been decreased. Thereis no impact to safety oreffectiveness. | |
| Cover Factor(Optical FillFactor) | 60.3% | 63% | Similar, the cover factor isessentially the same andthus there is no impact tosafety or effectiveness. | |
| Comparison of the currently marketed and predicate pixium 4343RC versus the proposed pixium4343RCE | ||||
| Predicate Devicepixium 4343RC(K131483) | Proposed Devicepixium 4343RCE(K170113) | Discussion | ||
| ModulationTransferFunction (MTF) | 1 lp/mm 64%2 lp/mm 32%3 lp/mm 17%Nyquist 13%(3.37 lp/mm) | 1 lp/mm 62%2 lp/mm 35%3 lp/mm 19%Nyquist 15%(3.37 lp/mm) | Similar, the MTF hasremained essentially thesame, with someimprovements and onevery minimal decrease,thus, overall, there is noimpact to safety andeffectiveness. | |
| DetectiveQuantumEfficiency(DQE) | DQE at 2 µGylp/mm %0.05 651 522 423 253.37 18 | DQE at 2 µGylp/mm %0.05 671 512 423 273.37 18 | Similar, the DQE hasremained essentially thesame, with oneimprovement and one veryminimal decrease, thus,overall, there is no impactto safety and effectiveness. | |
| ImageProcessing | XD-S Eleva Workstation(previously "XD-S DirectWorkstation/Package")(K063781)UNIQUEalso: UM, DRR, and UNIQUEfor PCR storage phosphorcassettes | Philips Eleva WorkSpotwith SkyPlate(K153318)UNIQUEalso: UM, DRR, andUNIQUE for PCR storagephosphor cassettes | Similar; The ElevaWorkSpot with SkyPlate isa cleared device. There isno impact to safety andeffectiveness. | |
| Grid linesuppression | Mechanical Grid Oscillation orImage Pre-Processing ("GridSuppression") | Mechanical GridOscillation or Image Pre-Processing ("GridSuppression") | Identical; no impact tosafety 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.
§ 892.1680 Stationary x-ray system.
(a)
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.(b)
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.