(28 days)
No
The summary describes a standard digital x-ray detector and system integration, with no mention of AI/ML algorithms for image processing, analysis, or interpretation. The performance studies focus on standard verification and validation against predicate devices and consensus standards.
No.
The device is used to acquire digital radiographic images for medical diagnosis, it does not provide any therapy or treatment.
No
The device is an x-ray detector that converts x-ray patterns into electrical signals, which are then used to create visible images for medical diagnosis. It does not perform the diagnosis itself.
No
The device description clearly details hardware components (scintillator, photodetectors, electrical charge conversion) and its integration into a physical x-ray system. It is not solely software.
Based on the provided information, the Pixium 4343RCE is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is "intended to acquire digital radiographic images" as part of a radiographic system. This is for imaging the human body, not for examining specimens in vitro (outside the body).
- Device Description: The description details how the device converts X-ray patterns into electrical signals to create visible images for medical diagnosis. This is a process of capturing images of internal structures, not analyzing biological samples.
- Input Imaging Modality: The input is X-ray, which is used for imaging the body, not for analyzing biological samples.
- No mention of analyzing biological samples: The entire description focuses on the acquisition and processing of X-ray images of the patient. There is no mention of blood, urine, tissue, or any other biological specimen.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. The Pixium 4343RCE's function is to create images of the body itself.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MOB
Device Description
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.
- Detector Size: 500 x 490 x 45 mm^3
- Image Size (Pixel): 2840 x 2874
- Pixel Size: 148 um
- Image Resolution up to 3.4 LP/mm
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical verification and validation tests have been performed with regards to the intended use, technical claims, requirement specifications, and risk management results. The pixium 4343RCE complies with ISO 14971, NEMA PS 3.1-3.20 DICOM Set, AAMI ANSI IEC 62304:2006, IEC 60601-1-2:2007, and device specific guidance documents "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Device (September 1, 2016)" and "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11th, 2005)". Non-clinical verification and validation test results demonstrate that the pixium 4343RCE meets the acceptance criteria and is adequate for its intended use.
The pixium 4343RCE did not require a clinical study since substantial equivalence to the currently marketed and predicate device was demonstrated with the following attributes: Design features; Indication for use; Fundamental scientific technology; Non-clinical performance testing including validation; and Safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
| Food and Drug Administration | Form Approved: OMB No. 0910-0120 |
|---|---|
| Indications for Use | Expiration Date: January 31, 2017 |
| 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) | 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 pixium
| 4343RCE | ||||
|---|---|---|---|---|
| Predicate Device | ||||
| pixium 4343RC | ||||
| (K131483) | Proposed Device | |||
| pixium 4343RCE | ||||
| (K170113) | Discussion | |||
| 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, proposed detector | |
| has a slightly smaller | ||||
| detector size however, | ||||
| there is no impact to safety | ||||
| or effectiveness. | ||||
| Detector Weight | 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.