(14 days)
No
The summary describes a standard R/F system with image processing features, but there is no mention of AI or ML in the intended use, device description, or performance studies.
No
Explanation: The device is described as a multi-functional general R/F system used for routine radiography and fluoroscopy exams, which are diagnostic imaging procedures, not therapeutic treatments.
Yes
The device is a multi-functional general X-ray and fluoroscopy system suitable for routine radiography and fluoroscopy exams, including angiography or pediatric work, which are diagnostic procedures used to visualize internal structures and identify medical conditions.
No
The device description explicitly details hardware components such as a floor-mounted table, scan unit with tube and detector, workstation, monitors, generator, and X-ray tube assembly. While it includes software, it is an integral part of a larger hardware system.
Based on the provided text, the ProxiDiagnost N90 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use/Indications for Use: The description clearly states it's a "multi-functional general R/F system" suitable for "routine radiography and fluoroscopy exams." These are imaging techniques that examine the internal structures of the body using X-rays.
- Device Description: The description details the physical components of an X-ray system (patient support table, scan unit, tube, detector, generator, etc.) and the software used for acquiring, processing, and displaying X-ray images.
- Input Imaging Modality: The input modality is explicitly stated as "X-ray."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a physiological state, health, or disease. IVD devices typically involve reagents, assays, or other methods for analyzing biological samples.
Therefore, the ProxiDiagnost N90 is a medical imaging device, specifically an X-ray system, and not an IVD.
N/A
Intended Use / 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.
Product codes
JAA, KPR
Device Description
The ProxiDiagnost N90 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.
The ProxiDiagnost N90 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 by -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. The ProxiDiagnost N90 retrieves images by means of a Cesium Iodide flat panel detector.
Philips fluoroscopy systems (standard configuration) consist 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.
The Eleva software of the proposed ProxiDiagnost N90 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 Back-end (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 ProxiDiagnost N90 uses the same workflow from the currently marketed and predicate device, ProxiDiagnost N90 (K173433) with only the following modifications:
- Inclusion of Extended reviewing options (like the optional reference monitor & remote control),
- Inclusion of some image processing features
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
This 510(K) premarket notification includes non-clinical performance testing.
Tests were performed on the proposed ProxiDiagnost N90 according to the following FDA recognized standards and guidance documents:
• 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 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-ray equipment (Recognition # 12-260)
• 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 1.1 2015-04, Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (Recognition # 12-296)
• 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 # 5-40)
• 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)
• Guidance for the Submission of 510(k)s for Solid State X-Ray Imaging Devices, issued September 1, 2016
• Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005
• 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
No clinical data was submitted.
Key Metrics
Not Found
Predicate Device(s)
ProxiDiagnost N90 (K173433, February 5, 2018)
Reference Device(s)
CombiDiagnost R90 (K203087, December 3rd, 2020), DigitalDiagnost C90 (K202564, September 30th, 2020)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
September 21, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Philips Medical Systems DMC GmbH % Supriya Dalvi Regulatory Operations Specialist Roentgenstrasse 24-26 Hamburg, Hamburg 22335 GERMANY
Re: K212837
Trade/Device Name: ProxiDiagnost N90 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: JAA, KPR Dated: September 3, 2021 Received: September 7, 2021
Dear Supriya Dalvi:
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. 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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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,
Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for Laurel M. Burk-S. The date of the signature is 2021.09.21, and the time is 14:29:22 -04'00'.
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212837
Device Name
ProxiDiagnost N90
Indications for Use (Describe)
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.
| 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
K212837
This 510(k) summary of safety and effectiveness is prepared in accordance with 21 CFR §807.92.
| Preparation
| Date: | September 3rd 2021 | |
|---|---|---|
| 510(k) | ||
| Owner: | Philips Medical Systems DMC GmbH | |
| Roentgenstrasse 24 | ||
| 22335 Hamburg | ||
| GERMANY | ||
| Establishment registration number: 3003768251 | ||
| Contact: | Dr. Supriya A. Dalvi | |
| Regulatory Operations Specialist | ||
| Phone: +91 9825604544 / +91 8733918445 | ||
| Fax: +49 40 5078-2425 | ||
| E-mail: supriya.dalvi@philips.com | ||
| Proposed | ||
| Device | Device Name | ProxiDiagnost N90 |
| Legal Manufacturer | Philips Medical Systems DMC GmbH | |
| Classification Name: | Image-intensified fluoroscopic x-ray System | |
| Classification Regulation: | 21 CFR Part 892.1650 | |
| Classification Panel: | 90 – Radiology | |
| Device Class: | Class II | |
| Product Code: | JAA; KPR | |
| Predicate | ||
| Device | Device Name | ProxiDiagnost N90 (K173433, February 5, 2018) |
| Legal Manufacturer | Philips Medical Systems DMC GmbH | |
| Classification Name: | Image-intensified fluoroscopic x-ray system | |
| Classification Regulation: | 21 CFR Part 892.1650 | |
| Classification Panel: | 90 – Radiology | |
| Device Class: | Class II | |
| Product Code: | OWB; JAA | |
| Reference | ||
| Device # 1 | Device Name | CombiDiagnost R90 (K203087, December 3rd, 2020) |
| Legal Manufacturer | Philips Medical Systems DMC GmbH | |
| Classification Name: | Image-intensified fluoroscopic x-ray System | |
| Classification Regulation: | 21 CFR Part 892.1650 | |
| Classification Panel: | 90 – Radiology | |
| Device Class: | Class II | |
| Product Code: | JAA, KPR, MQB | |
| Reference | ||
| Device # 2 | Device Name | |
| Legal Manufacturer | ||
| Classification Name: | ||
| Classification Regulation: | ||
| Classification Panel: | ||
| Device Class: | ||
| Product Code: | DigitalDiagnost C90 (K202564, September 30th, 2020) | |
| Philips Medical Systems DMC GmbH | ||
| Stationary x-ray system | ||
| 21 CFR 892.1680 | ||
| 90 – Radiology | ||
| Class II | ||
| KPR, MQB, LLZ | ||
| Device | ||
| Description: | The ProxiDiagnost N90 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. |
The ProxiDiagnost N90 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 by -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. The ProxiDiagnost N90 retrieves images by means of a
Cesium Iodide flat panel detector.
Philips fluoroscopy systems (standard configuration) consist 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.
The Eleva software of the proposed ProxiDiagnost N90 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 Back-end (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 ProxiDiagnost N90 uses the same workflow from the currently marketed and
predicate device, ProxiDiagnost N90 (K173433) with only the following
modifications:
- Inclusion of Extended reviewing options (like the optional reference monitor &
remote control), - Inclusion of some image processing features | |
4
5
| Indications
for Use: | Updates to Operating system and Eleva application Software to include state-of-
art operating system and incorporate the changes
Replacement of the ceiling suspension with that of reference device,
DigitalDiagnost C90 (K202564)
Updates to improve serviceability
Option for upgradability of Predicate device (K173433) to include the above
changes
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. | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fundamental
Scientific
Technology: | The proposed ProxiDiagnost N90 employs the same basic construction, fundamental
scientific technology and workflow as the predicate device, ProxiDiagnost N90
(K173433,) with regards to the functionality of all its components. It has the same high
voltage generator, X-ray tube, Collimator, detectors, workstation (ELEVA) for images
post-processing, storage and viewing.
The changes with respect to the predicate are mainly with the incorporation of the
features that are already cleared on the reference devices; CombiDiagnost R90
(K203087) & DigitalDiagnost C90 (K202564). These changes are evaluated through
ISO 14971 risk analysis procedures. These changes are addressed by the system and
software verification testing of the proposed device. The test results support that the
proposed ProxiDiagnost N90 is safe and effective. Refer Table 1 below for comparison
of the technological characteristics of the proposed device and predicate device,
ProxiDiagnost N90 (K173433)
Table 1: Comparison of the Technological Characteristics of the proposed device and
predicate device, ProxiDiagnost N90 (K173433) | | |
| | Predicate device,
ProxiDiagnost N90 (K173433) | | Proposed device,
ProxiDiagnost N90 |
| | Legal
Manufacturer | Philips Medical Systems DMC
GmbH | Identical |
| | Classification | Class II per 21 CFR Part
892.1650, Primary Product code:
OWB
Secondary Product code: JAA | Class II per 21 CFR Part 892.1650,
Primary Product code: JAA
Secondary Product code: KPR
The proposed device is not
interventional X-ray system |
| | 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. | Identical | |
| Principle of
Operation | ProxiDiagnost N90 systems are
intended for the medical
application procedures for
fluoroscopy and Radiography.
ProxiDiagnost 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 | |
| | Table features | Identical | |
| | Generator | Identical | |
| Components | Tube | Identical | |
| | Fixed Detector (Fluoroscopy) | Identical | |
| | Collimator (Fluoroscopy) | Identical | |
| | Grid | Identical | |
| | System Control | Identical | |
| Extended
reviewing
options | Bluetooth remote control | Infrared remote control for Image
Navigation
It is identical to the reference
device, CombiDiagnost R90
(K203087) | |
| | Optional Reference monitor not
available | Additional monitor for reference
image support is available. It is
identical to the reference device,
CombiDiagnost R90 (K203087) | |
| Image
processing
functionality | Optional DSA (Digital Subtraction
Angiography) feature not available | Digital Subtraction Angiography
functionality is available and used
for angiography and provides
interactive viewing operations on a
vascular run, so that the vascular
anatomy becomes visible.
It is identical to that on the reference
device, CombiDiagnost R90
(K203087) | |
| | Predefined annotations integrated
into the dynamic viewer not
available | This feature enables the user to
assign annotation to the image with | |
| | | | the help of set of predefined
annotations.
It is identical to that on the
reference device, CombiDiagnost
R90 (K203087) |
| | Optional Bone Suppression feature
not available | Bone Suppression is a available
which is a post-processing
application intended to generate a
secondary digital radiographic
image of the chest.
It is identical to that on the
reference device, DigitalDiagnost
C90 (K202564) | |
| | Dynamic UNIQUE
(Fluoroscopy only) UNIQUE (radiography
modality) | Dynamic UNIQUE
(fluoroscopy modality only)-
no change UNIQUE 2 (radiography
modality only)- It is an
improved ability for global
contrast enhancement and a
more sophisticated noise
suppression. It is identical to
that on the reference device,
DigitalDiagnost C90
(K202564) | |
| | Less intuitive user interface and
parameter names used in UNIQUE
not self-explanatory. | An intuitive way of modifying the
available parameters is introduced
on the Eleva user interface.
It is identical to that on the
reference device, DigitalDiagnost
C90 (K202564). | |
| | Deviation and Target Exposure
Indices not available | Deviation Index (DI) is available
which quantifies the deviation of
the Exposure Index (EI_s) from the
Target Exposure Index (EI_T). This
feature is used by the clinical user
to identify whether a certain image
has been correctly exposed.
It is identical to that on the
reference device, DigitalDiagnost
C90 (K202564). | |
| | Optional SkyFlow function (grid-
like image contrast for
examinations) is activated only for
chest AP/PA imaging. | Optional Skyflow is extended to
imaging of other anatomies with
Skyplate detector.
It is identical to that on the
reference device, DigitalDiagnost
C90 (K202564) | |
| | Access to and Export of Original
Image Data not available | Access to and Export of Original
Image Data is available. This
feature enables the access an
export of original image data (clean
raw images without any
modification) on the system. | |
| One Button Stores All (OBSA)
Content and performance
Improvement intended to save
multiple active information /
changes made by the user by click
of a single button | It is identical to that on the
reference device, DigitalDiagnost
C90 (K202564)
OBSA additionally used by system
for sending logfile (Alert files) to
central data base (RSN, e.g.,
RADAR or M2M server) frequently
by single button click. | | |
| View Selection for Changed X-
Ray Generation Data Sets are
enabled for change a data set only
for current examination or the
examinations that are using this
data set. | These data sets can be additionally
applied to subset of all
examinations too that are using this
data set. This feature is mainly used
by the Philips clinical education
Specialist.
It is identical to that on the
reference device, DigitalDiagnost
C90 (K202564). | | |
| Avoid Ghosting in Verification
Images of Portable Detectors
feature not available | The feature for avoiding Ghosting
in Verification Images of Portable
Detectors is available. It enables the
system to display verification
images on wireless (SkyPlate)
detector without ghosting artifacts.
It is identical to that on the
reference device, DigitalDiagnost
C90 (K202564). | | |
| Software | Windows 7 Operating System | Windows 10 operating system.
The upgrade to Window 10 is a part
of routine software upgrade done
by Microsoft.
It is identical to that on the
reference device, CombiDiagnost
R90 (K203087) | |
| | Philips Dynamic Eleva Image
Chain | Identical | |
| | Image acquisition - Eleva
Workspot (Increment 39) | Eleva Workspot (Increment 42)
The Eleva software is upgraded to
incorporate the new features.
It is identical to that on the
reference device, CombiDiagnost
R90 (K203087) | |
| Ceiling
Suspension
(optional) for
Radiography
examinations
only) | Dimensions & Components
Tube Head control
• Foil buttons for tube head
operation
• The monochrome text display
on the Tube Control Handle
• The central break release
switch on the control handle for | Identical
• The User interface on Eleva tube
head is touch control.
• 12" color graphics display with
touch control functionality for
tube head operation.
• Control handle with flat
capacitive sensor for releasing | |
| | | | |
| Service
Features | | the ceiling suspension
movement | brakes for the ceiling suspension
movement
It is identical to that on the
reference device, DigitalDiagnost
C90 (K202564) |
| | | Collimator
• Ralco P 225 ACS DHHS
• Motorized automatic collimation
• Manual overrule possible
• With light field indicator
• Two lasers (external to the
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 |
| | | | |
| | | | |
| | | | |
| | | | • Detector Calibration with a Filter
external to the Collimator |
| | | | Remote access for Firmware
updates for the dynamic detector is
available to perform firmware
updates of the detector.
It is identical to that on the
reference device, CombiDiagnost
R90 (K203087) |
| | | Remote access for Firmware
updates for the dynamic detector
not available | |
| | | Additional provision is made in the
proposed device to allow service
personnel to extract logs of defined
key system parameters for offline
analysis too.
It is identical to that on the
reference device, CombiDiagnost
R90 (K203087) | |
| | Monitoring of system key
parameters is available | | |
| | | Additional provision is made in the
proposed device for collection of
DICOM information by the
Performance Bridge Data collector
for logs generation.
It is identical to that on the
reference device, CombiDiagnost
R90 (K203087) | |
| | Performance Bridge is available | | |
| | | Provision is made for remotely
exporting the log files for offline
analysis of the service engineers
It is identical to that on the
reference device, CombiDiagnost
R90 (K203087) | |
| | Remote Silent Logfile Export is
not available | | |
| | | Automatic upload of the log file is
configured to the Philips Remote
service Server.
It is identical to that on the
reference device, CombiDiagnost
R90 (K203087) | |
| | Configurable Philips Remote
Server Upload not available | | |
| | SAN pulse diagram is used for | SAN pulses introduced for | |
| | | monitoring SAN pulses during an | monitoring with the dynamic |
| | | image acquisition with the static
detectors. | detector in addition to the static
detectors
It is identical to that on the
reference device, CombiDiagnost
R90 (K203087) |
| | | Diagnostic for Detectors -
Communication quality indicator
is not available | Diagnostic for Detectors feature
enables the collection of diagnostic
information from static
(radiography) detector
communication logs for monitoring
and logging purpose
It is identical to that on the
reference device, DigitalDiagnost
C90 (K202564). |
| | | Indication for Rough Detector
Handling on Eleva UI Including
History is not available | Indication for Rough Detector
Handling feature provides
information/ feedback to the user in
case of rough handling of the
wireless (SkyPlate detectors)
handling on the Eleva user interface
It is identical to that on the
reference device, DigitalDiagnost
C90 (K202564). |
| | | No option for Alpha drive
Upgradeability, Serviceability &
Spare parts | Alpha drive Upgradeability,
Serviceability & Spare parts feature
provides the option of alpha
movement on the system and the
relevant serviceability and spare
parts introduction
It is identical to that on the
reference device, DigitalDiagnost
C90 (K202564). |
| | | 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, when compared to the
legally marketed predicate device (K173433). This thus demonstrates the substantial
equivalence of the proposed device with the predicate device (K173433). | |
| Summary of
Non-Clinical
and Clinical
Performance
Data: | This 510(K) premarket notification includes non-clinical performance testing.
Tests were performed on the proposed ProxiDiagnost N90 according to the following
FDA recognized standards and guidance documents:
• 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 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-ray equipment (Recognition # 12-
260) | | |
6
7
8
9
10
11
| • | 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 1.1 2015-04, Medical electrical equipment - Part 2-54:
Particular requirements for the basic safety and essential performance of X-ray
equipment for radiography and radioscopy (Recognition # 12-296) |
| • | 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 # 5-40) |
| • | 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) |
| • | Guidance for the Submission of 510(k)s for Solid State X-Ray Imaging Devices,
issued September 1, 2016 |
| • | Guidance for the Content of Premarket Submissions for Software Contained in
Medical Devices, issued May 11, 2005 |
| • | 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 |
12
| | 2e. Intuitive User Interface
for Processing Parameters | Sub-system Verification (Eleva software) | |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| | 2f. Deviation and Target
Exposure Indices | Sub-system Verification (Eleva
software)
System Verification | |
| | 2g. Update of optional
Skyflow feature | Sub-system Verification (Eleva
software)
System Verification | |
| | 2h. Access to and Export of
Original Image Data | System Verification | |
| | 2i. Improved OBSA (one
button store all) for Content
and performance
Improvement | Sub-system Verification (Eleva
software)
System Verification | |
| | 2j. View Selection for
Changed X-Ray Generation
Data Sets | Sub-system Verification (Eleva
software) | |
| | 2k. Avoid Ghosting in
Verification Images of
Portable Detectors | System Verification | |
| | 3a. Operating system upgrade
to state of art operating
system i.e. Microsoft
Windows 10 | Sub-system Verification (Eleva
software)
System Verification | Test protocol identical to reference
device, CombiDiagnost R90
(K203087) |
| | 3b. Upgrade of Eleva
Application software to
increment 42 to accommodate
software changes for all the
relevant changes (Change #
1,2, 4, 5) | All the relevant Software
functions are tested at system
and subsystem level. (Refer
testing for change # 1, 2, 4 and
5) | |
| | 4a. Tube head control | System Verification | Test protocol identical to reference
device, DigitalDiagnost C90
(K202564) |
| | 4b. Collimator | System Verification | Test protocol identical to reference
device, DigitalDiagnost C90
(K202564) |
| | 5a. Monitoring and
Firmware Updates for Field
Service | System Verification | Test protocol identical to reference
device, CombiDiagnost R90
(K203087) |
| | 5b. Remote access for the
field service Engineer | Sub-system Verification (Eleva
software) | |
| | 5c. Service Diagnostic | System Verification | Test protocol identical to reference
device, CombiDiagnost R90
(K203087) & DigitalDiagnost C90
(K202564) |
| | 5d. Hardware upgrades | System Verification | Test protocol identical to reference
device, DigitalDiagnost C90
(K202564) |
| | 6. Option for upgradebility of
Predicate device | All the relevant Software functions are tested at system and
subsystem level. (Refer testing for change # 1, 2, 3 and 5 a,b,c) | |
| | There is no clinical data submitted in this 510(k) premarket notification. | | |
| Substantial
Equivalence
Conclusion: | The comparison of intended use, design features, technological characteristics, non-
clinical performance data, and safety testing demonstrates the proposed ProxiDiagnost
N90 is substantially equivalent to the predicate device (K173433), demonstrating the
proposed device to be safe and effective. | | |