(28 days)
Not Found
No
The summary describes a standard R/F X-ray system with digital image processing. There is no mention of AI or ML in the device description, intended use, or performance studies. The software components are described as image handling, acquisition, and image processing, which are typical for digital imaging systems and do not inherently indicate AI/ML.
No
This device is described as a multi-functional general X-ray system for radiography and fluoroscopy exams, which are diagnostic imaging procedures, not therapeutic treatments.
Yes
The device is described as a multi-functional general Radiography/Fluoroscopy (R/F) system, suitable for "all routine radiography and fluoroscopy exams" and capable of acquiring, processing, storing, displaying, and exporting digital fluoroscopy and radiographic images. These functions are inherently diagnostic as they provide visual information used by healthcare professionals to identify and evaluate medical conditions.
No
The device description clearly outlines numerous hardware components, including a patient support table, scan unit with tube and detector, workstation, monitors, generator, and various accessories. While it includes software for image handling and processing, it is an integral part of a larger hardware system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states it's a "multi-functional general R/F system" for "all routine radiography and fluoroscopy exams." This describes an imaging device used to visualize internal structures of the body, not a device used to examine specimens from the human body (like blood, urine, or tissue) outside of the body.
- Device Description: The description details an X-ray system with a table, scan unit, detector, generator, and software for acquiring, processing, and displaying digital X-ray images. This aligns with the description of a medical imaging device, not an IVD.
- Input Imaging Modality: The input modality is X-ray, which is a form of medical imaging, not a method used for in vitro diagnostics.
IVD devices are specifically designed to perform tests on biological samples to provide information for diagnosis, monitoring, or treatment. This device is designed to produce images of the body using X-rays.
N/A
Intended Use / Indications for Use
ProxiDiagnost N90 / Precision CRF is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.
Product codes (comma separated list FDA assigned to the subject device)
JAA, KPR
Device Description
Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, Substantial Equivalent (SE) date on September 21, 2021), the proposed ProxiDiagnost N90 / Precision CRF is a multi-functional general Radiography/ Fluoroscopy (R/F) system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.
Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, SE date on September 21, 2021), the proposed ProxiDiagnost N90 / Precision CRF is a nearby controlled fluoroscopy system in combination with high-end digital radiography system consisting of a floor-mounted tilt adjustable patient support table and a scan unit consisting of a tube and a flat panel dynamic detector, Pixium FE4343F, for the fluoroscopy examinations. The tabletop can be moved by a motor in the lateral and longitudinal direction and can be tilted at -85° to +90° degrees. The scan unit tilts with the table and can be moved in the longitudinal and lateral direction, relative to the table and to the patient. The system is suitable for routine X-ray examinations and fluoroscopy examinations on patients in standing, seated, or lying positions. Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, SE date on September 21, 2021), the proposed ProxiDiagnost N90 / Precision CRF retrieves images by means of a Cesium Iodide flat panel detector.
Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, SE date on September 21, 2021), the proposed ProxiDiagnost N90 / Precision CRF consists of the Basic unit ("geometry" or "table unit"), Workstation Eleva Workspot (with integrated generator control, hand switch, keyboard, mouse, touch screen and PC), dual screen-monitor, Spot film device (digital camera or flat panel detector). Fixed Detector (Fluoroscopy). X-ray Generator for R/F applications, X-ray tube assembly. The optional components like wireless portable detectors small and large, Bucky tray for wireless portable detectors SkyPlate detector, Ceiling Suspension, Fixed Vertical stand, Ceiling Suspension for monitors, monitor trolley, Remote control for R/F (Radiography-fluoroscopy) viewer, accessories for "Stitching Stand", are also available.
Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, SE date on September 21, 2021), the Eleva software of the proposed ProxiDiagnost N90 / Precision CRF is based on a workstation i.e., Eleva Workspot (computer, keyboard, display, and mouse) that is used by an operator to preset examination data and to generate, process and handle digital x-ray images. The Eleva Software system is decomposed into software components. These components are clustered in three component collections like the image handling focused Backend (BE), the acquisition focused Front-end (FE) and Image Processing (IP). The Eleva software is intended to acquire, process, store, display and export digital fluoroscopy and radiographic images.
The accessories for the proposed ProxiDiagnost N90 / Precision CRF are the same as the predicate device ProxiDiagnost N90 (K212837).
The list of the accessories for the proposed ProxiDiagnost N90 / Precision CRF:
- Footrest
- Hand Grips
Radiation Protection Accessories - Flexible Radiation Protection Apron
- Front Radiation Protection Apron
Additional Accessories (Optional) - Monitor Trolley
- Monitor Ceiling Suspension
- Parking Frame for Accessories
- Shoulder Support
- Side bar
- Compression Belt
- Adjustable Lateral Cassette Holder
- Leg Supports
- Infusion Bottle Holder
- Arm Support for Catheterization
- Ankle Clamps
- Overhead Hand Grip
- Adult Headrest
- Mattress
- Rotatable Stool for Footrest
- Pediatric Micturition Set
- Stretch Grip for Wall Stand
- Bar Code Scanner
- Patient Support
- Stitching Ruler
Accessories for the SkyPlate Detector (Optional)
- Mobile Detector Holder
- Detector Holder Patient Bed
- Portable Panel Protector
- Detector Handle
- WPD Bags
- Grids for SkyPlate Detector large
The Components for the proposed ProxiDiagnost N90 / Precision CRF are the same as the predicate device ProxiDiagnost N90 (K212837).
The list of the Components for the proposed ProxiDiagnost N90 / Precision CRF:
- Eleva Workspot and RF Viewer
- UPS for Eleva Workspot (Optional)
- Table
- Indication Box
- Foot Switch
- Ceiling Suspension Motorized CSM3 (Optional)
- Wall Stand (Vertical Stand VS2) (Optional)
- SkyPlate / Portable Detector (Optional)
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray, Fluoroscopy
Anatomical Site
Not specified, but mentions: angiography, pediatric work, chest (for bone suppression), leg, hand (for SkyFlow).
Indicated Patient Age Range
Not specified, but explicitly mentions "pediatric work" as an area of use.
Intended User / Care Setting
Operator in a medical setting (e.g., examination room, control room).
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 performance testing was conducted according to FDA recognized standards and guidance documents.
Key results:
- System verification testing: Pass. System verification test activities substantiate that the system conforms to the system requirements.
- Software verification testing: Pass. Software verification test activities substantiate that the software conforms to the requirements.
- Risk control: Pass. System meets the defined risk control measures.
- Cybersecurity testing: Pass. Results demonstrate that the test complies with the Cybersecurity requirements.
No clinical data was submitted.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol on the left is a stylized depiction of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "FOOD & DRUG" are larger than the other words.
January 11, 2024
Philips Medical Systems DMC GmbH % Ming Xiao Regulatory Affairs Manager Roentgenstrasse 24 Hamburg, Hamburg 22335 GERMANY
Re: K233945
Trade/Device Name: ProxiDiagnost N90 / Precision CRF (706110, 706400) Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: JAA, KPR Dated: December 14, 2023 Received: December 14, 2023
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
ProxiDiagnost N90 / Precision CRF (706110, 706400)
Indications for Use (Describe)
ProxiDiagnost N90 / Precision CRF is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.
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 of Safety and Effectiveness
This 510(k) summary of safety and effectiveness is prepared in accordance with 21 CFR క్తి807.92.
| Preparation Date: | December 14th., 2023 |
|---|---|
| 510(k) Owner: | Philips Medical Systems DMC GmbH |
| Röntgenstrasse 24 | |
| 22335 Hamburg, GERMANY | |
| Establishment registration number: 3003768251 | |
| Primary Contact: | Ming Xiao |
| Regulatory Affairs Manager Diagnostic X-Ray (DXR) | |
| Phone: +49(40) 34971-2306 | |
| E-mail: ming.xiao@philips.com | |
| Secondary Contact: | Shalin Dave |
| Head of Regulatory Affairs Diagnostic X-Ray (DXR) | |
| Phone: +31(6) 42532604 | |
| E-mail: shalin.dave@philips.com | |
| Proposed Device | |
| Device Name | ProxiDiagnost N90 / Precision CRF (706110, 706400) |
| Legal Manufacturer | Philips Medical Systems DMC GmbH |
| Röntgenstrasse 24 | |
| 22335 Hamburg, GERMANY | |
| Classification Name: | Image-intensified Fluoroscopic X-ray System |
| Classification Regulation: | 21 CFR Part 892.1650 |
| Classification Panel: | 90 - Radiology |
| Device Class: | Class II |
| Classification Product Code: | JAA |
| Subsequent Product Code: | KPR |
| Predicate Device | |
| Device Name | ProxiDiagnost N90 (K212837, September 21, 2021) |
| Legal Manufacturer | Philips Medical Systems DMC GmbH |
| Röntgenstrasse 24 | |
| 22335 Hamburg, GERMANY | |
| Classification Name: | Image-intensified Fluoroscopic X-ray System |
| Classification Regulation: | 21 CFR Part 892.1650 |
| Classification Panel: | 90 – Radiology |
| Device Class: | Class II |
| Classification Product Code: | JAA |
| Subsequent Product Code: | KPR |
4
Device Description
Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, Substantial Equivalent (SE) date on September 21, 2021), the proposed ProxiDiagnost N90 / Precision CRF is a multi-functional general Radiography/ Fluoroscopy (R/F) system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.
Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, SE date on September 21, 2021), the proposed ProxiDiagnost N90 / Precision CRF is a nearby controlled fluoroscopy system in combination with high-end digital radiography system consisting of a floor-mounted tilt adjustable patient support table and a scan unit consisting of a tube and a flat panel dynamic detector, Pixium FE4343F, for the fluoroscopy examinations. The tabletop can be moved by a motor in the lateral and longitudinal direction and can be tilted at -85° to +90° degrees. The scan unit tilts with the table and can be moved in the longitudinal and lateral direction, relative to the table and to the patient. The system is suitable for routine X-ray examinations and fluoroscopy examinations on patients in standing, seated, or lying positions. Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, SE date on September 21, 2021), the proposed ProxiDiagnost N90 / Precision CRF retrieves images by means of a Cesium Iodide flat panel detector.
Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, SE date on September 21, 2021), the proposed ProxiDiagnost N90 / Precision CRF consists of the Basic unit ("geometry" or "table unit"), Workstation Eleva Workspot (with integrated generator control, hand switch, keyboard, mouse, touch screen and PC), dual screen-monitor, Spot film device (digital camera or flat panel detector). Fixed Detector (Fluoroscopy). X-ray Generator for R/F applications, X-ray tube assembly. The optional components like wireless portable detectors small and large, Bucky tray for wireless portable detectors SkyPlate detector, Ceiling Suspension, Fixed Vertical stand, Ceiling Suspension for monitors, monitor trolley, Remote control for R/F (Radiography-fluoroscopy) viewer, accessories for "Stitching Stand", are also available.
Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, SE date on September 21, 2021), the Eleva software of the proposed ProxiDiagnost N90 / Precision CRF is based on a workstation i.e., Eleva Workspot (computer, keyboard, display, and mouse) that is used by an operator to preset examination data and to generate, process and handle digital x-ray images. The Eleva Software system is decomposed into software components. These components are clustered in three component collections like the image handling focused Backend (BE), the acquisition focused Front-end (FE) and Image Processing (IP). The Eleva software is intended to acquire, process, store, display and export digital fluoroscopy and radiographic images.
The accessories for the proposed ProxiDiagnost N90 / Precision CRF are the same as the predicate device ProxiDiagnost N90 (K212837).
The list of the accessories for the proposed ProxiDiagnost N90 / Precision CRF:
- Footrest ●
- Hand Grips 0
Radiation Protection Accessories
- Flexible Radiation Protection Apron 0
5
-
Front Radiation Protection Apron ●
Additional Accessories (Optional) -
Monitor Trolley ●
-
Monitor Ceiling Suspension
-
Parking Frame for Accessories ●
-
Shoulder Support ●
-
Side bar ●
-
Compression Belt ●
-
Adjustable Lateral Cassette Holder
-
Leg Supports
-
o Infusion Bottle Holder
-
Arm Support for Catheterization
-
Ankle Clamps
-
Overhead Hand Grip
-
Adult Headrest
-
Mattress
-
Rotatable Stool for Footrest
-
Pediatric Micturition Set
-
Stretch Grip for Wall Stand
-
Bar Code Scanner o
-
Patient Support ●
-
o Stitching Ruler
Accessories for the SkyPlate Detector (Optional)
- Mobile Detector Holder ●
- Detector Holder Patient Bed ●
- Portable Panel Protector ●
- Detector Handle ●
- WPD Bags ●
- o Grids for SkyPlate Detector large
The Components for the proposed ProxiDiagnost N90 / Precision CRF are the same as the predicate device ProxiDiagnost N90 (K212837).
The list of the Components for the proposed ProxiDiagnost N90 / Precision CRF:
- Eleva Workspot and RF Viewer ●
- UPS for Eleva Workspot (Optional) ●
- Table ●
- Indication Box ●
- Foot Switch
- Ceiling Suspension Motorized CSM3 (Optional) ●
- Wall Stand (Vertical Stand VS2) (Optional)
- SkyPlate / Portable Detector (Optional) 0
The proposed device complies to 'Guidance for the Submission of 510(k)'s for Solid State Xray Imaging Devices, dated September 1, 2016'. The solid-state imaging components including the detector in the proposed device have the same physical, functional, and operational characteristics as the predicate device (K212837). Also, other image chain components like Xray tube and generator, which are used for exposure characteristics and clinical performance evaluation remains the same. Hence all the features and characteristics potentially influencing
6
image quality of the proposed are in accordance with FDA guidance document. Additionally, image quality testing has been performed on the proposed device for the changes that are affecting the image quality.
Indication for Use:
ProxiDiagnost N90 / Precision CRF is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.
Comparison to Predicate Device / Design Changes Summary:
The proposed ProxiDiagnost N90 / Precision CRF uses the same workflow as the predicate device ProxiDiangost N90 (K212837) with only the following modifications. Differences on the proposed device with respect to the predicate device ProxiDiagnost N90 (K212837) are as follows:
-
- Change #1: Modifications to System Software Baseline upgrade releases for ProxiDiagnost N90
- Release Version R1.1.0 was internally released only, never released a) for production, based on predicate device ProxiDiagnost N90 (K212837)
- b) Release Version R1.1.1 was released based on design changes on Software updates
- c) Release Version R1.1.2 was aborted
- Release Version R1.1.3 is for proposed device ProxiDiagnost N90 d) per current submission
The modifications have no impacts on product safety, Intended Use, effectiveness, functionality and performance.
2) Change #2: Modifications to Ceiling Suspension Motorized (CSM/CSM3)
This is an optional component for radiography examinations only.
- a) Replacing the Beta rotation lock mechanism parts
- b) Introduction of dual sourcing for CSM/CSM3 Tube mounts
- c) Improvements for Metallic Flakes CS Telescopic End Cover Kit
The modifications have no impacts on product safety, Intended Use, effectiveness, functionality and performance.
3) Change #3: Modifications to Wall Stand (VS2)
- a) Replacing the Adapter parts for Bucky Unit 2
- b) Update VS2 combined family label
- c) VS2 Firmware change from FW 10.01.09 to FW 10.01.10 Version
The modifications have no impacts on product safety, Intended Use, effectiveness, functionality and performance.
4) Change #4: Modifications to Patient Table
- a) Improvement on cable sleeve material
- b) Replacing SGCU PCBA parts
- c) Improvement on under table Collimator
- d) Changes in the M shield
- Replacing the Emergency stop switch e)
7
The modifications have no impacts on product safety, Intended Use, effectiveness, functionality and performance.
5) Change #5: Modification to Monitor ceiling suspensions (MCS)
a) Introduction of Ceiling Connection Box for MCS
The modification has no impacts on product safety, Intended Use, effectiveness, functionality and performance.
6) Change #6: Modifications to accessory and components
- a) Replacing the Motor Gear Drive
- b) Replacing the Microcontroller IC for Bucky Unit family
- c) Replacing the Power Supply boards PCBAs
The modifications have no impacts on product safety, Intended Use, effectiveness, functionality and performance.
7) Change #7: Serviceability features: Introduction of Service parts for PC AWS-DI
The change has no impacts on product safety, Intended Use, effectiveness, functionality and performance.
8) Change #8: Modification to subsystem detector Pixium 4343RCE2
This change was necessitated by the supplier's discontinuation of the detector model Pixium 4343RCE used in predicate device ProxiDiagnost N90 (K212837). The key parameters like pixel size, pixel array, scintillator and readout mechanism remain unchanged.
The change has no impacts on product safety, Intended Use, effectiveness, functionality and performance.
9) Change #9: Software Package 1.0.1 for Precision CRF
The change has no impacts on product safety, Intended Use, effectiveness, functionality and performance.
Fundamental Scientific Technology:
The proposed ProxiDiagnost N90 / Precision CRF is substantially equivalent to the manufacturer's legally marketed devices:
- Predicate Device: ProxiDiagnost N90, (K212837, SE date September 21, 2021), Philips . Medical Systems DMC GmbH
A detailed comparison of the proposed and predicate device (K212837) is provided in Table 1.
Design control activities for each change identified along with associated verification. validation, and risk mitigation activities performed to ensure that the proposed modifications do not affect device safety and / or effectiveness.
| | Predicate Device,
ProxiDiagnost N90 (K212837) | Proposed Device,
ProxiDiagnost N90 / Precision CRF |
|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Legal Manufacturer | Philips Medical Systems DMC GmbH
Röntgenstrasse 24
22335 Hamburg
Germany | Identical |
| | Predicate Device,
ProxiDiagnost N90 (K212837) | Proposed Device,
ProxiDiagnost N90 / Precision CRF |
| Classification | Class II per 21 CFR Part 892.1650,
Primary Product code: JAA
Secondary Product code: KPR | Identical |
| Regulation Name | Stationary x-ray system | Identical |
| Class | II | Identical |
| Review Panel | Radiology | Identical |
| Indications for Use | ProxiDiagnost N90 is a multi-functional
general R/F system. It is suitable for all
routine radiography and fluoroscopy
exams, including specialist areas like
angiography or pediatric work, excluding
mammography. | ProxiDiagnost N90 / Precision CRF is a
multi-functional general R/F system. It is
suitable for all routine radiography and
fluoroscopy exams, including specialist
areas like angiography or pediatric work,
excluding mammography.
Equivalent; No impact to safety and
effectiveness of the device. |
| Energy Source | X-ray | Identical
Equivalent; No impact to safety and
effectiveness of the device. |
| Principle of
Operation | ProxiDiagnost N90 systems are intended
for the medical application procedures for
fluoroscopy and Radiography. ProxiDiag-
nost N90 systems allow radiography (with
optional 2nd Tube on Ceiling suspension)
and fluoroscopy on a patient in supine,
seated or standing position, depending on
the specific indication. Depending on the
specific indication, X-ray procedures vary
in patient positioning and the modification
of radiographic parameters | Identical
Equivalent; No impact to safety and
effectiveness of the device. |
| Table Features | | |
| Working height
(tabletop center to
floorplate) | 833 mm | Identical
Equivalent; No impact to safety and
effectiveness of the device. |
| Table tilt movement | +90° to -85°
Speed of tilt $ Other Components | | |
| Generator | Philips Velara GCF/RF, 65 kW, optional 80 kW | Identical for ProxiDiagnost N90
For Precision CRF, only 80 kW is applicable.
Equivalent; No impact to safety and effectiveness of the device. |
| Tube | Philips SRM 2250 ROTGS 504 or SRO 2550 ROT380 | Identical
Equivalent; No impact to safety and effectiveness of the device. |
| Fixed Detector (Fluoroscopy) | Pixium FE 4343F | Identical
Equivalent; No impact to safety and effectiveness of the device. |
| Modulation Transfer Function (MTF) (according to IEC 62220-1-3 standard) | lp/mm %
1 66
2 35
3 19
3.4 15 | Identical
Equivalent; No impact to safety and effectiveness of the device. |
| Detective Quantum Efficiency (DQE) | DQE at 1 μGy
lp/mm % | Identical |
| | Predicate Device,
ProxiDiagnost N90 (K212837) | Proposed Device,
ProxiDiagnost N90 / Precision CRF |
| (according to IEC
62220-1-3 standard) | 0.05
1
2
3
3.4
65
51
41
27
18 | Equivalent; No impact to safety and
effectiveness of the device. |
| System Control | Nearby | Identical
Equivalent; No impact to safety and
effectiveness of the device. |
| Collimator
(Fluoroscopy) | Rectangular collimation | Identical
Equivalent; No impact to safety and
effectiveness of the device. |
| Grid | Parkable | Identical
Equivalent; No impact to safety and
effectiveness of the device. |
| Picture archiving
and communication
system | Available | Identical
Equivalent; No impact to safety and
effectiveness of the device. |
| Extended reviewing options | | |
| Remote Control | Infrared remote control for Image
Navigation | Identical
Equivalent; No impact to safety and
effectiveness of the device. |
| Reference monitor
(Optional) | Additional monitor for reference image
support [Change #1b] is available.
The additional reference monitor is made
available for the display of a reference
image in the Examination Room and
optionally in Control Room. | Identical
Equivalent; No impact to safety and
effectiveness of the device. |
| Image processing | | |
| Image processing functionality | | |
| DSA (Digital
Subtraction
Angiography)
(Optional) | Digital Subtraction Angiography
functionality is available. It is used for
angiography and provides interactive
viewing operations on a vascular run, so
that the vascular anatomy becomes visible. | Identical
Equivalent; No impact to safety and
effectiveness of the device. |
| Predefined
annotations
integrated into the
dynamic viewer | Predefined annotations are available which
enables the user to assign annotation to the
image with the help of a set of predefined
annotations. This speeds the user
workflow. | Identical
Equivalent; No impact to safety and
effectiveness of the device. |
| Image processing functionality | | |
| Bone Suppression
(Optional) | Bone Suppression post-processing
application is available. It is intended to | Identical for ProxiDiagnost N90
Bone suppression is not applicable for
Precision CRF |
| | Predicate Device,
ProxiDiagnost N90 (K212837) | Proposed Device,
ProxiDiagnost N90 / Precision CRF |
| | image of the chest by suppressing bones from the original image. | Equivalent; No impact to safety and effectiveness of the device. |
| UNIQUE | Dynamic UNIQUE (fluoroscopy modality only)- no change UNIQUE 2 (radiography modality only) | Identical
Equivalent; No impact to safety and effectiveness of the device. |
| Intuitive User
Interface for
Processing
Parameters | An intuitive way of modifying the available parameters is introduced (e.g., contrast, brightness, noise limit, detail enhancement etc.) on the Eleva user interface. | Identical
Equivalent; No impact to safety and effectiveness of the device. |
| Deviation and
Target Exposure
Indices | Deviation Index (DI) function is available to quantify the deviation of the Exposure Index (EI s) from the Target Exposure Index (EI T). This feature is used by the clinical user only to identify whether a certain image has been correctly exposed. | Identical
Equivalent; No impact to safety and effectiveness of the device. |
| SkyFlow (Optional) | Skyflow is extended to imaging of other anatomies (e.g., Leg, hand etc.) including the chest AP/PA imaging, with Skyplate detector. | Identical for ProxiDiagnost N90
SkyFlow is not applicable for Precision CRF.
Equivalent; No impact to safety and effectiveness of the device. |
| Access to and
Export of Original
Image Data | Access to and Export of Original Image Data feature enables the access to an export of original image data (clean raw images without any modification) on the system. | Identical
Equivalent; No impact to safety and effectiveness of the device. |
| One Button Stores
All (OBSA):
Content and
performance
Improvement | System can additionally use OBSA for sending logfile (Alert files) to central database (RSN, e.g., RADAR or M2M server) frequently by single button click. | Identical
Equivalent; No impact to safety and effectiveness of the device. |
| View Selection for
Changed X-Ray
Generation Data
Sets | Users can change a data set only for current examination or the examinations that are using this data set.
In addition to the current examinations, the user can select to apply the changes to subset of all examinations too that are using this data set. | Identical
Equivalent; No impact to safety and effectiveness of the device. |
| Avoid Ghosting in
Verification Images
of Portable
Detectors | The feature to avoid ghosting in verification images of portable detectors is available. It enables the system to display verification images on wireless (SkyPlate) detector without ghosting artifacts | Identical
Equivalent; No impact to safety and effectiveness of the device. |
| | Predicate Device,
ProxiDiagnost N90 (K212837) | Proposed Device,
ProxiDiagnost N90 / Precision CRF |
| Software | | |
| Operating System | Windows 10 | Identical
Equivalent; No impact to safety and
effectiveness of the device. |
| Image Chain
(fluoroscopy) | Philips Dynamic Eleva Image Chain | Identical
Equivalent; No impact to safety and
effectiveness of the device. |
| Image acquisition | Eleva Workspot (Increment 42) | Identical
Eleva Workspot (Increment 42.3) is
applicable for ProxiDiagnost N90.
Eleva Workspot (Increment 42.2) is
applicable for Precision CRF.
Equivalent; No impact to safety and
effectiveness of the device. |
| | Ceiling Suspension (optional) for Radiography examinations only | |
| Type | Four-part aluminum telescopic column
with spring counter balanced holder for X-
ray tube assembly; adaptable to individual
room heights | Identical
Equivalent; No impact to safety and
effectiveness of the device. |
| Movement | 3440 mm to 6140 mm | Identical
Equivalent; No impact to safety and
effectiveness of the device. |
| Transverse travel | 1500 mm to 3220 mm | Identical
Equivalent; No impact to safety and
effectiveness of the device. |
| Vertical travel | 1650mm to 1705mm | Identical
Equivalent; No impact to safety and
effectiveness of the device. |
| X-ray tube assembly
rotation | • around vertical axis: ±180°, lock-in
position every 45°
• around horizontal axis: ±115°,
lock-in position at 0°, ±90° | Identical
Equivalent; No impact to safety and
effectiveness of the device. |
| Tube Head control | • Tube head operation user interface:
The User interface on Eleva tube
head is touch control.
• Display: 12" color graphics display
with touch control functionality for
tube head operation. Eleva screen
display in the examination room
enables the user to use all the con-
trol room parameters from exami-
nation room as well. | Identical
Equivalent; No impact to safety and
effectiveness of the device. |
| | Predicate Device,
ProxiDiagnost N90 (K212837) | Proposed Device,
ProxiDiagnost N90 / Precision CRF |
| | Control Handle: Control handle with flat capacitive sensor for releasing brakes for the ceiling suspension movement. | |
| Collimator | Ralco P 225 ACS DHHS Motorized automatic collimation Manual overrule possible With light field indicator Live Camera (optional) on tube head for patient positioning support With 2 Lasers (inside the collimator) Detector Calibration with a Filter integrated into the Collimator | Identical
Equivalent; No impact to safety and
effectiveness of the device. |
| Fixed vertical stand
(Optional) | Hardware-Counterbalanced rugged column for motorized and manual vertical movement of the detector, Vertical travel - 30 cm to 180 cm Installation-Floor and wall attachment or floor only | Identical
Equivalent; No impact to safety and
effectiveness of the device. |
| Fixed Detector
(Optional) in vertical
stand (Radiography) | Pixium 4343RCE | Pixium 4343RCE2
This change was necessitated by the sup-
plier's discontinuation of the detector model
Pixium 4343RCE used in predicate device
ProxiDiagnost N90 (K212837). The key pa-
rameters like pixel size, pixel array, scintilla-
tor and readout mechanism remain un-
changed.
Equivalent; No impact to safety and
effectiveness of the device. |
| Wireless detector
(Optional) in vertical
stand and table
bucky
(Radiography) | SkyPlate Large (Pixium 3543EZ) SkyPlate Small (Pixium 2430EZ) | Identical for ProxiDiagnost N90
Only SkyPlate Large (Pixium 3543EZ) is
applicable for Precision CRF.
Equivalent; No impact to safety and
effectiveness of the device. |
| SkyPlate Detector
Sharing | Yes | Identical
Equivalent; No impact to safety and
effectiveness of the device. |
| Tube | High power X-ray Tube,
Philips SRO 33100 | Identical
Equivalent; No impact to safety and
effectiveness of the device. |
| Automatic Image
Stitching (Optional) | Yes | Identical
Equivalent; No impact to safety and
effectiveness of the device. |
| | Predicate Device,
ProxiDiagnost N90 (K212837) | Proposed Device,
ProxiDiagnost N90 / Precision CRF |
| Service Features | | |
| Monitoring and Firmware Updates for Field Service | | |
| Firmware for the
dynamic detector | This service tool provides functionality to
perform firmware updates of the detector. | Identical
Equivalent; No impact to safety and
effectiveness of the device. |
| Monitoring of
system key
parameters | Service logs contain system parameters
that can be monitored on the system for
both the predicate device and the proposed
device. However, in the proposed device, a
provision is made to allow service
personnel to extract logs of defined key
system parameters for offline analysis too. | Identical
Equivalent; No impact to safety and
effectiveness of the device. |
| Remote access for the field service | | |
| Additional DICOM
Information to
Support
Performance Bridge | Additional DICOM information is
collected by the Performance Bridge Data
collector for logs generation. | Identical
Equivalent; No impact to safety and
effectiveness of the device. |
| Remote Silent
Logfile Export | It is provided to remotely export the log
files for offline analysis of the service
engineers. | Identical
Equivalent; No impact to safety and
effectiveness of the device. |
| Configurable Philips
Remote Server
Upload | This feature is enabled with the activation
of remote silent logfile export refer. In this
feature, the automatic upload of the log
file is configured to the Philips Remote
service Server. | Identical
Equivalent; No impact to safety and
effectiveness of the device. |
8
9
10
11
12
13
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The outcome of this technological characteristics comparison and risk assessment demonstrate that the minor differences in the technological characteristics do not affect the safety or effectiveness of the proposed ProxiDiagnost N90 / Precision CRF, when compared to the legally marketed predicate device ProxiDiagnost N90 (K212837). This thus demonstrates the substantial equivalence of the proposed device ProxiDiugnost N90 / Precision CRF with the predicate device ProxiDiagnost N90 (K212837).
Summary of Non-Clinical and Clinical Performance Data:
These 510(K) premarket notifications includes non-clinical performance testing. Tests were performed on the proposed ProxiDiagnost N90 / Precision CRF according to the following FDA recognized standards and guidance documents:
The verification and validation methods (test methods and acceptance criteria) used to evaluate the proposed ProxiDiagnost N90 / Precision CRF are the same as those used for the predicate device (K212837) and follow FDA-recognized consensus standards and guidance documents applicable to this device type:
- . ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Recognition #19-4)
- . IEC 60601-1-2 Edition 4.0 2014-02, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic
15
disturbances - Requirements and tests (Recognition #19-8)
- . IEC 60601-1-3 Edition 2.1 2013-04, Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-rav equipment (Recognition # 12-269)
- . IEC 60601-1-6 Edition 3.1 2013-10, Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability (Recognition # 5-89)
- IEC 60601-2-54 Edition 1.2 2018-06, Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (Recognition # 12-317)
- . IEC 62304 Edition 1.1 2015-06, Medical device software - Software life cycle processes (Recognition # 13-79)
- . ANSI AAMI ISO 14971: 2007/(R)2010, Medical devices-Application of risk management to medical devices (Recognition # 5-125)
- . ISO 10993-1, Fifth edition 2018-08, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (Recognition # 2-258)
- IEC 62366-1 Edition 1.1 2020-06 Consolidated Version, Medical devices - Part 1: Application of usability engineering to medical devices (Recognition #5-129)
- . IEC 60601-2-28 Edition 3.0 2017-06, Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (Recognition #12-309)
- IEC 6220-1-3 Edition 1.0 2008-06, Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging (Recognition 12-214)
- Guidance for the Submission of 510(k)s for Solid State X-Ray Imaging Devices, issued September 1, 2016
- . Guidance for Pediatric Information for X-ray Imaging Device Premarket Notifications, issued November 2017
- Guidance for Radio Frequency Wireless Technology in Medical Devices, issued August 14, ● 2013
- Guidance for Management of Cybersecurity in Medical Devices, issued October 2, 2014
- Content of Premarket Submissions for Device Software Functions Guidance, 14 June 2023
- . Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, October 2014
- Off-The-Shelf (OTS) Software Use in Medical Devices, August 11, 2023
- Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, ● January 14, 2005
- General Principles of Software Validation, January 11, 2002
- . Guidance for Management of Cybersecurity in Medical Devices, issued October 2, 2014
- . Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, September 2023
The proposed device ProxiDiagnost N90 / Precision CRF complies with the Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices. The solid-state imaging components including the detector in the proposed device have the same physical, functional, and operational characteristics as the predicate device (K212837). Also, other image chain components like X-ray tube and generator. which are used for exposure characteristics and clinical performance evaluation remain the same. Hence, all the features and characteristics potentially influencing image quality of the proposed are in accordance with FDA guidance
16
document 'Guidance for the Submission of 510(k)'s for Solid State X-rav Imaging Devices, dated September 1, 2016'. Additionally, Image quality testing has been performed on the proposed device for the changes that are affecting the image quality.
The proposed device ProxiDiagnost N90 / Precision CRF complies with the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005. The changes to the proposed device do not alter the intended use or the fundamental scientific technology when compared to the predicate device (K212837). The software for the proposed device ProxiDiagnost N90 / Precision CRF has the same 'Level of concern (Moderate)' as that of the predicate device (K212837). The software verification testing has been conducted as per the level of concern.
The proposed device ProxiDiagnost N90 / Precision CRF complies with the Guidance for Pediatric Information for X-ray Imaging Device Premarket Notifications, issued November 2017. The changes made to the proposed device do not affect the pediatric application. The indication for use of the proposed device is the same as the predicate device (K212837).
The proposed device ProxiDiagnost N90 / Precision CRF complies with Guidance for Radio Frequency Wireless Technology in Medical Devices, issued August 14, 2013. All the radiofrequency components of the predicate device (K212837) and proposed device are the same except for the replacement of Bluetooth remote control in the predicate device by infrared remote control in the proposed device. The verification testing has been conducted for the safety and efficacy of the remote control.
The proposed device ProxiDiagnost N90 / Precision CRF complies with the Guidance for Management of Cybersecurity in Medical Devices, issued October 2, 2014. A set of cybersecurity controls to assure proposed device's cybersecurity and maintain medical device functionality and safety are in place. Cybersecurity plan and risk document are prepared to assess the proposed device for the following:
- o Identification of assets, threats, and vulnerabilities;
- o Assessment of the impact of threats and vulnerabilities on device functionality and end users/patients:
- o Assessment of the likelihood of a threat and of a vulnerability being exploited;
- o Determination of risk levels and suitable mitigation strategies;
- o Assessment of residual risk.
Table 2 for the non-clinical testing that were performed on the proposed device with respect to the changes. Test results demonstrate that the proposed ProxiDiagnost N90 / Precision CRF meets acceptance criteria and is adequate for its intended use. Risk assessment activities show that the risks are sufficiently mitigated.
| Tests | Document number | Test results |
|---|---|---|
| System Verification | ||
| testing | • System Verification Report | Pass |
| System verification test | ||
| activities substantiate that | ||
| the system conforms to the | ||
| system requirements |
Testing performed on the Proposed device Table 2
17
| Software
verification testing | Software Verification Report SBOM | Pass
Software verification test
activities substantiate that
the software conforms to
the requirements |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Risk control | System Risk Matrix Status Report System Risk Management Report Software Risk Matrix Status Report Software Risk Management Report | Pass
System meets the defined
risk control measures |
| Cybersecurity
testing | Cyber Security Management Plan Cyber Security Risk Management
summary Product security vulnerability analysis
report Manufacturer Disclosure Statement for
Medical Device Security | Pass
Results demonstrate that
the test complies with the
Cybersecurity
requirements |
There is no clinical data submitted in this 510(k) premarket notification.
Substantial Equivalence Conclusion:
The proposed device ProxiDiagnost N90 / Precision CRF is substantially equivalent to the currently marketed and predicate device ProxiDiagnost N90 (K212837) in terms of the of design features, technological characteristics, indications for use, and safety and effectiveness.
Additionally, substantial equivalence was demonstrated with non-clinical performance tests and testing as per FDA-recognized consensus standards. The test results demonstrate that the device conforms to its specifications and is safe and effective for its intended use.