(51 days)
No
The summary describes standard image processing and system functionality for a radiography/fluoroscopy system, with no mention of AI or ML.
No.
The device is described as a multi-functional general X-ray system used for routine radiography and fluoroscopy exams to acquire, process, store, display and export digital images, which are diagnostic purposes, not therapeutic.
Yes
The device is described as a multi-functional general RF system suitable for "all routine radiography and fluoroscopy exams," which are inherently diagnostic procedures used to visualize and assess internal body structures for medical diagnosis. The device "retrieves images" and the software is intended to "acquire, process, store, display and export digital Fluoroscopy and radiographic images," all of which are steps involved in the diagnostic imaging workflow.
No
The device description clearly outlines numerous hardware components including the basic unit, workstation, monitors, detectors, generator, tube assembly, and optional components like wireless detectors and wall stands. While the Eleva software is a key part of the system, it is described as operating on a workstation and interacting with these hardware components to acquire, process, store, display, and export images. The device is a complete R/F system, not just software.
Based on the provided information, the CombiDiagnost R90 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a "multi-functional general RF system" for "routine radiography and fluoroscopy exams." These are imaging procedures performed on a patient's body, not tests performed on samples taken from the body.
- Device Description: The description details an X-ray system with components like an X-ray tube, detector, and workstation for acquiring and processing images of the patient. This aligns with an in-vivo imaging device, not an in-vitro diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in-vitro diagnostics.
Therefore, the CombiDiagnost R90 is an in-vivo medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
CombiDiagnost R90 is a multi-functional general RF 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, MOB
Device Description
The CombiDiagnost R90 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 CombiDiagnost R90 is a remote-controlled fluoroscopy system in combination with high-end digital radiography. The system is suitable for routine X-ray examinations and special examinations on patients in standing, seated or lying positions. The CombiDiagnost R90 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), Dynamic detector, Fixed detector, X-ray Generator Velara, X-ray tube assembly, Receptor (Flat panel detector). The optional component like Skyplate wireless portable detectors small and large, Ceiling Suspension (CSM3), Vertical Wall stand (VS2), Ceiling Suspension for monitors, monitor trolley, Remote control for RF viewer, accessories for "Stitching on the Table", are also available.
The Eleva software of the proposed CombiDiagnost R90 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. As part of the radiographic system, the Eleva software is intended to acquire, process, store, display and export digital Fluoroscopy and radiographic 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 Front-end Software is intended to acquire images.
- The Back-end Software is intended to query patient data from Radiology Information System (RIS), store, display and export digital radiographic images to Picture Archiving and Communication System (PACS)
- The Image Processing Software is intended to perform the pre and post processing on the acquired raw images.
The CombiDiagnost R90 uses the same workflow from the currently marketed and predicate device, CombiDiagnost R90 (K163210) with only the following modifications:
- additional optional components (like the reference monitor, remote control),
- -Eleva Workspot updated to incorporate new imaging features mainly from the previously approved reference device, DigitalDiagnost C90 (K202564) along with functional clusters like Digital Subtraction Imaging and stitching on the table
- updates to improve usability and serviceability.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not specified, but covers "all routine radiography and fluoroscopy exams" and "angiography or pediatric work".
Indicated Patient Age Range
Adult, Pediatric
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 contains technical documentation which includes non-clinical verification and validation tests as well as image quality testing. Tests were performed on the CombiDiagnost R90 according to the following FDA recognized standards and guidance documents as well as additional non-standard performance tests:
- . AAMI ANSI ISO 14971:2007/ (R) 2010, Medical devices. Application of risk management to medical devices
- AAMI ES60601-1:2005/(R)2012 and . C1:2009/(R)2012 ANSI and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- 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
- 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
- . IEC 60601-2-54 Edition 1.1 2015-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
- . IEC 6220-1-1 Edition 1.0 2015-03 Medical electrical equipment-Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiency Detectors used in radiographic imaging
- IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software -● Software life cvcle processes
- 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
Additional non-standard performance tests have been performed to demonstrate the safety and effectiveness as follows:
- . System Verification Test
- . Image Quality Test
- Human Factors and Usability Engineering Test
The test results of Non-Clinical testing demonstrate that the CombiDiagnost R90 meets the acceptance criteria and is adequate for its intended use. Additionally, the risk management activities show that all risks are sufficiently mitigated and overall residual risks are acceptable.
The CombiDiagnost R90 did not require a clinical study since substantial equivalence to the currently marketed and predicate device, CombiDiagnost R90 (K163210) was demonstrated with the following attributes:
- Design features;
- Indication for use;
- Fundamental scientific technology; ●
- Non-clinical performance testing and
- Safety and effectiveness. ●
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
§ 892.1650 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 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Philips Medical Systems DMC GmbH % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114
Re: K203087
Trade/Device Name: CombiDiagnost R90 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: JAA, KPR, MOB Dated: November 23, 2020 Received: November 24, 2020
Dear Prithul Bom:
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
December 3, 2020
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)
K203087
Device Name CombiDiagnost R90
Indications for Use (Describe)
CombiDiagnost R90 is a multi-functional general RF 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
510(K) Number : K203087
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
| Issue Date: | July 17th, 2020 | ||
|---|---|---|---|
| Manufacturer: | Philips Medical Systems DMC GmbH | ||
| Roentgenstrasse 24-26 | |||
| 22335 Hamburg | |||
| GERMANY | |||
| Establishment registration number: 3003768251 | |||
| Contact Person: | Dr. Supriya A. Dalvi | ||
| Regulatory Operations Specialist | |||
| Phone: +91 9825604544 / +91 | |||
| 8733918445 | |||
| Fax: +49 40 5078-2425 | |||
| E-mail: supriya.dalvi@philips.com | |||
| Device Trade | |||
| Name: | CombiDiagnost R90 | ||
| Classification: | Classification Name: | Image-intensified fluoroscopic x-ray system | |
| Classification Regulation: | 21CFR 892.1650 | ||
| Classification Panel: | 90 - Radiology | ||
| Device Class: | Class II | ||
| Primary Product Code: | JAA | ||
| Secondary Product Code: | KPR, MQB | ||
| Predicate | |||
| Device: | Trade Name: | CombiDiagnost R90 | |
| Manufacturer: | Philips Medical Systems DMC | ||
| 510(k) Clearance: | K163210 - January 31, 2017 | ||
| Classification Name: | Image-intensified fluoroscopic x-ray system | ||
| Classification Regulation: | 21CFR 892.1650 | ||
| Classification Panel: | Radiology |
4
| Device Class: | Class II |
|---|---|
| Primary Product Code: | JAA |
| Secondary Product Codes: | KPR, MQB |
| Reference Device: | |
| Trade Name: | DigitalDiagnost C90 |
| Manufacturer: | Philips Medical Systems DMC GmbH |
| 510(k) Clearance: | K202564 - September 30, 2020 |
| Classification Name: | Stationary x-ray system |
| Classification Regulation: | 21CFR 892.1680 |
| Classification Panel: | 90 -- Radiology |
| Device Class: | Class II |
| Product code: | MQB, KPR, LLZ |
Device Description:
The CombiDiagnost R90 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 CombiDiagnost R90 is a remote-controlled fluoroscopy system in combination with high-end digital radiography. The system is suitable for routine X-ray examinations and special examinations on patients in standing, seated or lying positions. The CombiDiagnost R90 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), Dynamic detector, Fixed detector, X-ray Generator Velara, X-ray tube assembly, Receptor (Flat panel detector). The optional component like Skyplate wireless portable detectors small and large, Ceiling Suspension (CSM3), Vertical Wall stand (VS2), Ceiling Suspension for monitors, monitor trolley, Remote control for RF viewer, accessories for "Stitching on the Table", are also available.
The Eleva software of the proposed CombiDiagnost R90 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. As part of the radiographic system, the Eleva software is intended to acquire, process, store, display and export digital Fluoroscopy and radiographic 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).
5
-
The Front-end Software is intended to acquire images.
-
The Back-end Software is intended to query patient data from Radiology Information System (RIS), store, display and export digital radiographic images to Picture Archiving and Communication System (PACS)
-
The Image Processing Software is intended to perform the pre and post processing on the acquired raw images.
The CombiDiagnost R90 uses the same workflow from the currently marketed and predicate device, CombiDiagnost R90 (K163210) with only the following modifications:
- additional optional components (like the reference monitor, remote control), -
- -Eleva Workspot updated to incorporate new imaging features mainly from the previously approved reference device, DigitalDiagnost C90 (K202564) along with functional clusters like Digital Subtraction Imaging and stitching on the table
- updates to improve usability and serviceability. -
Indications for Use:
CombiDiagnost R90 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 CombiDiagnost R90 employs the same basic construction and fundamental scientific technology as the currently marketed and predicate device. CombiDiagnost R90 (K163210), with regards to the functionality of all its components with the same high voltage generator, X-ray tube, Collimator, Wireless portable detectors, workstation (ELEVA) for images post-processing, storage and viewing. Many of the modifications to the CombiDiagnost R90 are already FDA cleared in reference device, DigitalDiagnost C90 (K202564). All features characteristics that potentially have an influence on image quality are assessed and verified according to FDA Guidance for Industry and Food and Drug Administration Staff: Guidance for the Submission of 510/k)'s for Solid State X-ray Imaging Devices; issued on September 1, 2016. Further the Non-clinical information sufficiently supports the substantial equivalence as per chapter VII- Non clinical Considerations of FDA Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices.
These modifications have been evaluated in safety risk assessment report. The risks associated with these changes are considered in the risk management report and risk management activities show that all risks are sufficiently mitigated and that the overall residual risks are acceptable.
The outcome of this technological characteristics comparison between the CombiDiagnost R90 and currently marketed and predicate device, CombiDiagnost R90 (K163210) also demonstrate that the minor differences in the technological characteristics do not affect the safety or effectiveness of the CombiDiagnost R90 when compared to the currently marketed predicate.
6
Summary of technological characteristics:
The CombiDiagnost R90 has the same indications for use and technological characteristics as the currently marketed and predicate device, CombiDiagnost R90 (K163210) demonstrating its substantial equivalence to the predicate device. Refer Table 1 below for comparisons of the technological characteristics of CombiDiagnost R90 and the predicate device and Table 2 for comparison between CombiDiagnost R90 and the reference device, DigitalDiagnost C90 (K202564)
Table 1: Comparison of the Technological Characteristics and Indications for use of the CombiDiagnost R90 and the Currently Marketed and Predicate device, CombiDiagnost R90
| | Predicate device:
CombiDiagnost R90
(K163210) | CombiDiagnost R90 | Discussion |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation
number | 21CFR 892.1650 | Identical | - |
| Classification
Panel | 90 - Radiology | Identical | - |
| Device Class | Class II | Identical | - |
| Product codes | JAA, KPR, MQB | Identical | - |
| Table Features | | | |
| Working height
(table top center
to floorplate) | 65 cm - 133 cm | Identical | Substantially Equivalent; No
impact to safety and
effectiveness of the device. |
| Table tilt
movement | -90° to +90° | Identical | Substantially Equivalent; No
impact to safety and
effectiveness of the device. |
| Table top
suspension | Two sides suspensions | Identical | Substantially Equivalent; No
impact to safety and
effectiveness of the device. |
| Table top
material | Plastic laminate or carbon
fiber | Identical | Substantially Equivalent; No
impact to safety and
effectiveness of the device. |
| Table top
movement | Lateral: 32 cm (12.6") (± 16
cm (6.3"))
Longitudinal: Only detector
movements to
improve patient comfort | Identical | Substantially Equivalent; No
impact to safety and
effectiveness of the device. |
| Table top
absorption | Plastic, with Carbon fiber:
0.6mm Al @ 100kV,
HVL = 3.6mm Al | Identical | Substantially Equivalent; No
impact to safety and
effectiveness of the device. |
| Maximum
patient weight | 284 kg (626 lbs) | Identical | Substantially Equivalent; No
impact to safety and
effectiveness of the device. |
| Lateral scan
distance | 32 cm ± 16 cm | Identical | Substantially Equivalent; No
impact to safety and
effectiveness of the device. |
| Lateral scan
speed | 5 cm/s, soft start and stop
Auto centering | Identical | Substantially Equivalent; No
impact to safety and
effectiveness of the device. |
| Longitudinal
scan distance | 148 cm (58.3") longitudinal, motorized | Identical | Substantially Equivalent; No
impact to safety and
effectiveness of the device. |
| Longitudinal
scan speed /
Detector
movement | 3 cm – 20 cm / sec | Identical | Substantially Equivalent; No
impact to safety and
effectiveness of the device. |
| Table column
angulation | -40° to +40° | Identical | Substantially Equivalent; No
impact to safety and
effectiveness of the device. |
| Source image
distance | 113cm – 183cm | Identical | Substantially Equivalent; No
impact to safety and
effectiveness of the device. |
| Collimator | Motorized automatic
collimation | Identical | Substantially Equivalent; No
impact to safety and
effectiveness of the device. |
| Preparation time
for exposure | 1 sec (approximately) | Identical | Substantially Equivalent; No
impact to safety and
effectiveness of the device. |
| Grid | Parkable | Identical | Substantially Equivalent; No
impact to safety and
effectiveness of the device. |
| Auto Grid
Selection | Yes | Identical | Substantially Equivalent; No
impact to safety and
effectiveness of the device. |
| Automatic pre-
position of the
table | Yes | Identical | Substantially Equivalent; No
impact to safety and
effectiveness of the device. |
| Picture archiving
and
communication
system | Yes | Identical | Substantially Equivalent; No
impact to safety and
effectiveness of the device. |
| Image chain
(fluoroscopy) | Philips dynamic Eleva
Image Chain | Identical | Substantially Equivalent; No
impact to safety and
effectiveness of the device. |
| Detector | Pixium FE 4343F (cleared
via K080859 – Villa Sistemi
Medicali S.p.A.) | Identical | Substantially Equivalent; No
impact to safety and
effectiveness of the device. |
| Generator | Philips Velara 65kW,
optional 80 kW | Identical | Substantially Equivalent; No
impact to safety and
effectiveness of the device. |
| Tube | Philips SRO 33100 ROT
380 or SRM 0608 ROT GS
505 | Identical | Substantially Equivalent; No
impact to safety and
effectiveness of the device. |
| System Control | Remote, optional nearby
with nearby control trolley | Identical | Substantially Equivalent; No
impact to safety and
effectiveness of the device |
| Image
Acquisition | Eleva WorkSpot | Updated Eleva WorkSpot
to include new imaging
features UNIQUE 2 and
Bone Suppression from the
reference device,
DigitalDiagnost C90
(K202564) along with | The basis and functionality of
the Image acquisition remains
same. The Eleva software is
upgraded to incorporate the
new features for better
imaging was tested and
verified to have no impact on |
7
8
| | | Subtraction Imaging and
stitching on the table | the device. Thus
demonstrating Substantial
Equivalence |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating
System | Microsoft Windows 7 | Microsoft Windows 10 | The upgrade to Window 10 is
a part of routine software
upgrade done by Microsoft.
Further verification tests
demonstrates no impact on the
safety and effectiveness of the
device. Thus demonstrating
Substantial Equivalence |
| Image
Processing | UNIQUE (fluoroscopy +
radiography modality) | UNIQUE (fluoroscopy
modality only)
UNIQUE 2 (radiography
modality only) | UNIQUE 2 is only used for
radiography workflows for
the subject device. It is
intended to provide improved
image processing, reduced
noise, and improved contrast
compared to UNIQUE for
radiography only.
UNIQUE 2 does not replace
UNIQUE for fluoroscopy or
alter the clinical workflow,
hence there is no change to
the safety or effectiveness of
the device. Both UNIQUE
and UNIQUE 2 are embedded
in their respective workflows
and cannot be used cross-
modality. |
| Reference
monitor | No | Yes | The additional reference
monitor is made available for
the display a reference image
in the Control Room and the
Examination Room. This does
not impact safety and
effectiveness of the device.
Thus, demonstrating
Substantial Equivalence |
| Firmware for the
dynamic detector | No | Yes | This is a service tool to
provide functionality to
perform firmware updates of
the detector. It doesn't
impact safety and
effectiveness of the device.
Thus, demonstrating
Substantial Equivalence |
| Indications for
Use | CombiDiagnost R90 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 | Substantially Equivalent; No
impact to safety and
effectiveness of the device. |
| | CombiDiagnost R90 | Reference Device
DigitalDiagnost C90
(K202564) | Discussion |
| Image
Acquisition | Updated Eleva WorkSpot to
include new imaging
features UNIQUE 2 and
Bone Suppression from the
reference device,
DigitalDiagnost C90
(K202564) along with
functional clusters, Digital
Subtraction Imaging and
stitching on the table | Eleva WorkSpot | The basis and functionality of
the Image acquisition remains
same. The Eleva software is
upgraded to incorporate the
new features for better
imaging was tested and
verified to have no impact on
the safety or effectiveness of
the device. |
| Operating
System | Microsoft Windows 10 | Identical | No impact on safety and
effectiveness of the device.
Further testing has been
carried to confirm the safety
and effectiveness |
| Image
Processing | UNIQUE 2 (radiography
modality only) | UNIQUE 2 (radiography
modality only) | No impact on safety and
effectiveness of the device as
the feature is included only in
the radiography workflow of
the subject device, which is
same as the reference device
Further testing has been
carried to confirm the safety
and effectiveness |
| Post-processing
application | Bone Suppression | Identical | No impact on safety and
effectiveness of the device.
Further testing has been
carried to confirm the safety
and effectiveness |
| Scatter
correction | Skyflow Plus | Identical | No impact on safety and
effectiveness of the device.
Further testing has been
carried to confirm the safety
and effectiveness |
| Tube Head | Eleva Tube head with
optional live camera
package | Identical | No impact on safety and
effectiveness of the device.
Further testing has been
carried to confirm the safety
and effectiveness |
9
Table 2: Comparison of the Technological Characteristics of the CombiDiagnost R90 and the reference device, DigitalDiagnost C90
Summary of Non-Clinical Data:
This 510(k) premarket notification contains technical documentation which includes non-clinical verification and validation tests as well as image quality testing. Tests were performed on the CombiDiagnost R90 according to the following FDA recognized standards and guidance documents as well as additional non-standard performance tests:
10
- . AAMI ANSI ISO 14971:2007/ (R) 2010, Medical devices. Application of risk management to medical devices
- AAMI ES60601-1:2005/(R)2012 and . C1:2009/(R)2012 ANSI and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- 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
- 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
- . IEC 60601-2-54 Edition 1.1 2015-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
- . IEC 6220-1-1 Edition 1.0 2015-03 Medical electrical equipment-Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiency Detectors used in radiographic imaging
- IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software -● Software life cvcle processes
- 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
Additional non-standard performance tests have been performed to demonstrate the safety and effectiveness as follows:
- . System Verification Test
- . Image Quality Test
- Human Factors and Usability Engineering Test
The test results of Non-Clinical testing demonstrate that the CombiDiagnost R90 meets the acceptance criteria and is adequate for its intended use. Additionally, the risk management activities show that all risks are sufficiently mitigated and overall residual risks are acceptable.
Based on the supporting data provided in this 510(k) premarket notification, the CombiDiagnost R90 is substantially equivalent to the currently marketed and predicate device, CombiDiagnost R90 (K163210) in terms of safety and effectiveness.
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Summary of Clinical Data:
The CombiDiagnost R90 did not require a clinical study since substantial equivalence to the currently marketed and predicate device, CombiDiagnost R90 (K163210) was demonstrated with the following attributes:
- Design features;
- Indication for use;
- Fundamental scientific technology; ●
- Non-clinical performance testing and
- Safety and effectiveness. ●
Substantial Equivalence Conclusion:
The comparison of technological characteristics, non-clinical performance data, safety testing demonstrates that CombiDiagnost R90 is substantially equivalent to the currently marketed and predicate device, CombiDiagnost R90 (K163210) and is safe and effective.