(25 days)
No
The summary mentions image processing but does not explicitly mention AI, ML, deep learning, or any related terms. The description of modifications and testing focuses on hardware changes, software updates for service features, and standard performance and safety testing, not AI/ML model validation.
No
The device is an imaging system (digital radiography system) used to acquire, process, store, display, and export digital radiographic images, which are used for diagnosis, not therapy.
Yes
The device is described as a "digital radiography system" intended to "acquire, process, store, display and export digital radiographic images," which are used in "routine radiography examinations." Radiography is a diagnostic imaging technique used to visualize the internal structures of the body to aid in diagnosis.
No
The device description explicitly states it is a "high-end digital radiography system consisting of a height adjustable patient support table and a ceiling suspension consisting of a tube including a control handle used to acquire images with a flat panel fixed RAD detector." This indicates significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for acquiring, processing, storing, displaying, and exporting digital radiographic images. This is related to medical imaging, not in vitro testing of biological samples.
- Device Description: The description details a digital radiography system with components like an X-ray tube, flat panel detector, patient support table, and vertical stands. These are all components of an imaging system, not a device used for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes associated with in vitro diagnostics.
The device is a medical imaging system used for diagnostic purposes, but it operates by capturing images of the body using X-rays, not by performing tests on samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The DigitalDiagnost is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography.
Product codes
KPR, MQB, LLZ
Device Description
The proposed DigitalDiagnost is a high-end digital radiography system consisting of a height adjustable patient support table and a ceiling suspension consisting of a tube including a control handle used to acquire images with a flat panel fixed RAD detector. Additionally, different vertical stands for the radiography examinations are available. The ceiling suspension can be moved in longitudinal and lateral directions and additionally the tube can be tilted and rotated as well. The system is configured with a Philips x-ray generator and a flat panel fixed RAD detector, Pixium 4343RCE. Together with the tube these components form the radiography Image Chain. The additional option of the portable wireless detector i.e. the SkyPlates family can be used for free exposures as well as in the patient support table or in the vertical stand.
The proposed DigitalDiagnost is a modification of the predicate device, DigitalDiagnost C90 (K202564). The modifications include change of colour of the table, stand and ceiling suspension; changes in ceiling suspension, service features and a software update. The changes related to the software updates and service features have been recently cleared in the reference device, CombiDiagnost R90 (K203087).
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)
This 510(K) premarket notification includes non-clinical verification and validation tests. Tests were performed on the proposed DigitalDiagnost 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 # 12-269)
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 1.1 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)
Tests:
- System Verification testing: Identical to predicate device, DigitalDiagnost C90 (K202564) except for the service features in Change # 5 (Monitoring of key system parameters, Remote Silent Logfile Export, Configurable Philips Remote Server Upload, Additional DICOM Information to Support Performance Bridge and Migrate Eleva software logging platform from HSDP PF1.0 to HSDP PF2.0 APIs).
- Test results: Pass. System verification test activities substantiate that the system conforms to the system requirements
- Software verification testing: The protocols for these service features are identical to the previously cleared reference device, CombiDiagnost R90 (K203087) except for the service feature 'Monitoring of key system parameters'. The feature 'Monitoring of key system parameters' is newly introduced in the proposed device.
- Test results: Pass. Software verification test activities substantiate that the software conforms to the requirements
- Risk control measure verification testing: Identical to Predicate device, DigitalDiagnost C90 (K202564)
- Test results: Pass. System meets the defined risk control measures
- Image quality testing: Identical to Predicate device, DigitalDiagnost C90 (K202564)
- Test results: Pass. Results demonstrate that the tested equipment complies with the applicable Imaging Performance requirements
- Usability Engineering: Identical to Predicate device, DigitalDiagnost C90 (K202564) and in compliance to the FDA consensus standards, IEC 60601-1-6 Edition 3.1 2013-10 (Recognition number 5-89)
- Test results: Pass. Results demonstrate that the test complies with the usability requirements
There is no clinical data submitted in this 510(k) premarket notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Philips Medical Systems DMC GmbH % Supriya Dalvi Regulatory Affairs Specialist Roentgenstrasse 24-26 Hamburg, Hamburg 22335 GERMANY
Re: K210692
Trade/Device Name: DigitalDiagnost Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB, LLZ Dated: March 3, 2021 Received: March 8, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
April 2, 2021
1
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,
For
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) K210692
Device Name DigitalDiagnost
Indications for Use (Describe)
The DigitalDiagnost is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and 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
| Preparation
| Date: | March 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 | DigitalDiagnost | |
| Legal Manufacturer | Philips Medical Systems DMC GmbH | ||
| Classification Name: | Stationary x-ray system | ||
| Classification Regulation: | 21 CFR 892.1680 | ||
| Classification Panel: | 90 - Radiology | ||
| Device Class: | Class II | ||
| Primary Product Code: | KPR | ||
| Secondary Product Codes: | MQB, LLZ | ||
| Predicate | |||
| Device | Device Name | DigitalDiagnost C90 (K202564, cleared September | |
| 30th, 2020) | |||
| Legal Manufacturer | Philips Medical Systems DMC GmbH | ||
| Classification Name: | Stationary X-Ray System | ||
| Classification Regulation: | 21 CFR Part 892.1680 | ||
| Classification Panel: | 90 - Radiology | ||
| Device Class: | Class II | ||
| Primary Product Code: | KPR | ||
| Secondary Product Codes: | MQB, LLZ | ||
| Reference | |||
| Device | Device Name | CombiDiagnost R90 (K203087, cleared December 3rd, |
-
| |
| | Legal Manufacturer | Philips Medical Systems DMC GmbH | |
| | Classification Name: | Image-intensified fluoroscopic x-ray System | |
| | Classification Regulation: | 21 CFR Part 892.1650 | |
This 510(k) summary of safety and effectiveness is prepared in accordance with 21 CFR §807.92.
4
| Classification Panel: | 90 - Radiology | ||
|---|---|---|---|
| Device Class: | Class II | ||
| Primary Product Code: | JAA | ||
| Secondary Product Codes: | KPR, MQB | ||
| Device Description: | The proposed DigitalDiagnost is a high-end digital radiography system consisting of a height adjustable patient support table and a ceiling suspension consisting of a tube including a control handle used to acquire images with a flat panel fixed RAD detector. Additionally, different vertical stands for the radiography examinations are available. The ceiling suspension can be moved in longitudinal and lateral directions and additionally the tube can be tilted and rotated as well. The system is configured with a Philips x-ray generator and a flat panel fixed RAD detector, Pixium 4343RCE. Together with the tube these components form the radiography Image Chain. The additional option of the portable wireless detector i.e. the SkyPlates family can be used for free exposures as well as in the patient support table or in the vertical stand. | ||
| The proposed DigitalDiagnost is a modification of the predicate device, DigitalDiagnost C90 (K202564). The modifications include change of colour of the table, stand and ceiling suspension; changes in ceiling suspension, service features and a software update. The changes related to the software updates and service features have been recently cleared in the reference device, CombiDiagnost R90 (K203087). | |||
| Indications for Use: | The DigitalDiagnost is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography. | ||
| Fundamental Scientific Technology: | The proposed DigitalDiagnost employs the same basic construction, fundamental scientific technology and workflow as the predicate device, DigitalDiagnost C90 (K202564) 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 solid state imaging including the detector for proposed device are same as predicate device (K202564) having the same physical, functional and operational characteristics. Also, other image chain components like X-ray tube and generator, which are used for exposure characteristics and clinical performance evaluation remains same. Hence all the features and characteristics potentially influencing image quality are same as predicate device, in accordance to FDA guidance document 'Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, dated September 1, 2016'.
The changes with respect to the predicate device are mainly to accommodate users with a focused need for core functionality, some of the optional features of the predicate device have been replaced or modified to result in the proposed DigitalDiagnost. These changes do not affect the clinical or functional outcome of the device. The modifications have been evaluated per the ISO 14971 risk assessment. Design control and risk management activities show that all risks are sufficiently mitigated and that the overall residual risks are acceptable. Refer Table 1 below for comparison of the technological characteristics of the proposed device and predicate device, DigitalDiagnost C90 | | |
| | Predicate device,
DigitalDiagnost C90
(K202564) | Proposed device,
DigitalDiagnost | |
| Legal
Manufacturer | Philips Medical Systems DMC GmbH | Identical | |
| Classification | Class II per 21 CFR 892.1680,
Product codes KPR, MQB LLZ | Identical | |
| Regulation
Name | Stationary X-ray system | Identical | |
| Class | II | Identical | |
| Review Panel | Radiology | Identical | |
| Indications
for Use | The DigitalDiagnost C90 is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost C90 is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography. | Identical except updated trade name | |
| Principle of
Operation | DigitalDiagnost C90 is intended to acquire, process, store, display and export digital radiographic images. It is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography. The system consists of several components that can be combined to create a variety of different Xray configurations. | Identical | |
| Components | Height adjustable table (TH2) | Identical except color of table
(Change #1) | |
| | Single side suspended table (TH-S) | Identical except color of table
(Change #1) | |
| | Vertical moveable stand (VM) | Identical except color of VM
(Change #1) | |
| | Fixed Vertical Stand (VS) | Identical except color of fixed
vertical stand (Change #1) | |
| | Other components like Fixed RAD Detector, Wireless Static Detector, Generator, Tube | Identical | |
| | Digital wireless flat detector
Celling Suspension CSM | Identical
Identical except change in color of
CSM (Change #1) | |
| Collimator | Ralco P 225 ACS DHHS
• Motorized automatic | Identical except
- no live camera (Change #2) | |
| | | | |
| | With light field indicator Live Tube Head Camera for patient positioning support With 2 Lasers (inside the collimator) | | |
| Tube Head
Control | Touch control functionality for tube
head operation
The User interface on Eleva tube
head is touch control. Eleva screen
display in the examination room
enables the user to use all the
control room parameters from
examination room as well | Mechanical buttons for tube head
operation (Change #3)
The User interface on tube head
has mechanical buttons. Only few
functions can be used on tube head
screen in the examination room
with help of these mechanical
buttons. However, all the
functionalities can still be
controlled from AWS (Acquisition
workstation) in the control room | |
| Tube Head -
control
handle | Control handle with flat capacitive
smart-sensor for releasing brakes for
the CSM movement | Control handle with a mechanical
button for releasing brakes for the
CSM movement (Change #3) | |
| Detector
calibration
filter | Integrated in collimator (0.5 mm Cu
- 2 mm Al filter) | External to the collimator (21mm
Al filter (Change #4)
21mm Al filter used in the
proposed device is equivalent to
the 0.5 mm Cu + 2 mm Al filter
used in the predicate device. | |
| Service
Features | Monitoring of system parameters is
as a part of overall service log | Monitoring of system parameters
is a part of overall service log,
additionally in the proposed
device, a provision is made to
allow service personnel to extract
logs of defined key system
parameters for offline analysis.
(Change #5) | |
| | Remote Silent Logfile Export is not
present | Remote Silent Logfile Export is
present.
Service feature to remotely export
the log file of a system; Identical
to the feature used in the reference
device (K203087).
(Change #5) | |
| | Configurable Philips Remote Server
Upload is not present | Configurable Philips Remote
Server Upload is present.
Service feature where automatic
upload of the log file to the Philips
Remote Server shall be
configurable via the Service Tool.
Identical to the feature used in the
reference device (K203087)
(Change #5) | |
| | Additional DICOM Information to
Support Performance Bridge is not
present | Additional DICOM Information to
Support Performance Bridge is
present. | |
| | | | |
| | Software | Eleva Logging HSDP PF1.0 | Service feature where DICOM data will be used by the PerformanceBridge Data collector tool, which is a customer dashboard for system performance monitoring.
Identical to the feature used in the reference device (K203087) (Change #5)
Eleva Logging HSDP PF2.0.
Service feature involving update of software logging infrastructure.
Identical to the feature used in the reference device (K203087) (Change #5) |
| | Software | Eleva Software, Version 41 | Eleva Software, Version 42 (Change #6)
Identical to the software used for radiography in the reference device (K203087). |
| | Image
processing | Windows 10 Operating system
Eleva workstation | Identical
Identical |
| Summary of
Non-Clinical
and Clinical
Performance
Data: | | | 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 DigitalDiagnost, when compared to the legally marketed predicate device (K202564).
This 510(K) premarket notification includes non-clinical verification and validation tests. Tests were performed on the proposed DigitalDiagnost 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 # 12-269) 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 1.1 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) |
5
6
7
8
| Tests | Protocol | Test results |
|---|---|---|
| System | ||
| Verification | ||
| testing | Identical to predicate device, DigitalDiagnost | |
| C90 (K202564) except for the service features | ||
| in Change # 5 (Monitoring of key system | ||
| parameters, Remote Silent Logfile Export, | ||
| Configurable Philips Remote Server Upload, | ||
| Additional DICOM Information to Support | ||
| Performance Bridge and Migrate Eleva | ||
| software logging platform from HSDP PF1.0 | ||
| to HSDP PF2.0 APIs). | Pass | |
| System verification test | ||
| activities substantiate that | ||
| the system conforms to the | ||
| system requirements | ||
| Software | ||
| verification | ||
| testing | The protocols for these service features are | |
| identical to the previously cleared reference | ||
| device, CombiDiagnost R90 (K203087) | ||
| except for the service feature 'Monitoring of | ||
| key system parameters'. The feature | ||
| 'Monitoring of key system parameters' is | ||
| newly introduced in the proposed device. | Pass | |
| Software verification test | ||
| activities substantiate that | ||
| the software conforms to the | ||
| requirements | ||
| Risk control | ||
| measure | ||
| verification | ||
| testing | Identical to Predicate device, DigitalDiagnost | |
| C90 (K202564) | Pass. | |
| System meets the defined | ||
| risk control measures | ||
| Image quality | ||
| testing | Identical to Predicate device, DigitalDiagnost | |
| C90 (K202564) | Pass. | |
| Results demonstrate that the | ||
| tested equipment complies | ||
| with the applicable Imaging | ||
| Performance requirements | ||
| Usability | ||
| Engineering | Identical to Predicate device, DigitalDiagnost | |
| C90 (K202564) and in compliance to the FDA | ||
| consensus standards, IEC 60601-1-6 Edition | ||
| 3.1 2013-10 (Recognition number 5-89) | Pass. | |
| Results demonstrate that the | ||
| test complies with the | ||
| usability requirements |
9
| 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 DigitalDiagnost | |
| is substantially equivalent to the manufacturer's legally marketed predicate device | |
| (K202564), demonstrating the subject device to be safe and effective. |