(77 days)
No
The summary describes a standard X-ray fluoroscopy system and does not mention any AI or ML capabilities, image processing features that typically utilize AI/ML, or performance studies related to AI/ML algorithms.
No
The device is described as an R/F system suitable for routine radiography and fluoroscopy exams, which are diagnostic procedures, not therapeutic ones.
Yes
The device is described as a "multi-functional general R/F system" suitable for "all routine radiography and fluoroscopy exams," which are diagnostic imaging procedures. The predicate device's name, "EasyDiagnost Eleva," also suggests a diagnostic function.
No
The device description clearly outlines multiple hardware components including a patient support, scan unit with tube and flat panel detector, touch screen console, and displays, indicating it is a physical medical device system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "multi-functional general R/F system" for "routine radiography and fluoroscopy exams." These are imaging techniques used to visualize internal structures of the body, not to examine specimens in vitro (outside the body).
- Device Description: The description details an X-ray system with a patient support, scan unit, detector, and associated hardware. This is consistent with an imaging device, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes related to in vitro testing.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device is designed to produce images of the human body using X-rays.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JAA, KPR, MQB
Device Description
The CombiDiagnost R90 is a multi-functional remote controlled fluoroscopy system in combination with a high-end digital radiography system consisting of a floor-mounted tilt- and heightadjustable patient support and a scan unit consisting of a tube and a flat panel detector, Pixium FE 4343F. The tabletop can be moved by a motor in the lateral direction and can be tilted +/- 90 degrees. The scan unit tilts with the table and can be moved in the longitudinal direction, relative to the table and to the patient. The fully integrated system is provided with a touch screen console, glass or metal x-ray tube(s) with collimator and high resolution displays. As a fully integrated system, the proposed CombiDiagnost R90 can be configured with a Philips generator, the flat panel detector Pixium FE 4343F, and the Philips Dynamic Eleva Image Chain acquisitionstation also provided with the currently marketed and reference device, Eleva Workspot with SkyFlow (Eleva Workspot). The proposed CombiDiagnost R90 uses the same workflow from the currently marketed and reference device, Eleva Workspot with SkyFlow. The only modification to the Eleva Workspot is integration with the Pixium FE 4343F detector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified/trained doctors or technicians / hospitals
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 proposed CombiDiagnost R90 according to the following international and FDA-recognized consensus standards:
- ISO 14971, Medical devices. Application of risk management to . medical devices
- IEC 60601-1, Medical electrical equipment. General requirements for safety.
- IEC 60601-1-2. Medical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests
- 60601-1-3. Medical equipment. IEC General requirements for basic safety and essential performance. Collateral Standard: Radiation protection in diagnostic X-ray equipment
- 60601-2-54, Medical electrical equipment. IEC Particular requirements for the basic safety and essential performance of Xray equipment for radiography and radioscopy
- IEC 62220-1. Medical electrical equipment. Characteristics of digital X-ray imaging devices. Determination of the detective quantum efficiency
- IEC 62304, Medical device software. Software life-cycle processes
The test results demonstrate that the proposed CombiDiagnost R90 meets the acceptance criteria and is adequate for its intended use.
The proposed CombiDiagnost R90 did not require a clinical study since substantial equivalence to the currently marketed and predicate device was demonstrated with the following attributes:
- Design features;
- Indication for use;
- Fundamental scientific technology;
- Non-clinical performance testing including validation; and
- Safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus, with three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 31, 2017
Philips Medical Systems DMC GmbH % Ming Xiao Regulatory Affairs Specialist North America Roentgenstrasse 24-26 Hamburg, 22335 GERMANY
Re: K163210 Trade/Device Name: CombiDiagnost R90 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA, KPR and MQB Dated: January 17, 2017 Received: January 25, 2017
Dear Ming Xiao:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D.'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K163210
Device Name CombiDiagnost R90
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
7. 510(k) Summary
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
| Date Prepared: | January 26, 2017 | ||
|---|---|---|---|
| Manufacturer: | Philips Medical Systems DMC GmbH | ||
| Roentgenstrasse 24-26 | |||
| 22335 Hamburg | |||
| GERMANY | |||
| Establishment registration number: 3003768251 | |||
| Primary Contact | |||
| Person: | Ming Xiao | ||
| Regulatory Affairs Specialist | |||
| North America | |||
| Phone: +49 40 5078-2306 | |||
| Fax: +49 40 5078-2425 | |||
| E-mail: ming.xiao@philips.com | |||
| Device Name: | 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 Codes: | KPR, MQB | ||
| Primary Predicate | |||
| Device: | Trade Name: | Philips EasyDiagnost Eleva | |
| Manufacturer: | Philips Medical Systems DMC | ||
| 510(k) Clearance: | K031535 – June 17, 2003 | ||
| Classification Name: | Image-intensified fluoroscopic x-ray | ||
| system; Stationary x-ray system; Spot- | |||
| film device; Tilting Radiographic table | |||
| Classification Regulation: | 21CFR 892.1650; 21CFR 892.1680; | ||
| 21CFR 892.1670; 21CFR 892.1980 | |||
| Classification Panel: | Radiology | ||
| Device Class: | Class II | ||
| Product Codes: | JAA, KPR, IXL and IXR | ||
| Reference Device: | Trade Name: | Eleva Workspot with SkyFlow | |
| Manufacturer: | Philips Medical Systems | ||
| 510(k) Clearance: | K153318 – Dec 22, 2015 | ||
| Classification Name: | Stationary X-Ray System | ||
| Classification Regulation: | 21CFR 892.1680 | ||
| Classification Panel: | 90 -- Radiology | ||
| Device Class: | Class II | ||
| Product codes: | MQB, LLZ |
4
Device The CombiDiagnost R90 is a multi-functional remote controlled Description: fluoroscopy system in combination with a high-end digital radiography system consisting of a floor-mounted tilt- and heightadjustable patient support and a scan unit consisting of a tube and a flat panel detector, Pixium FE 4343F. The tabletop can be moved by a motor in the lateral direction and can be tilted +/- 90 degrees. The scan unit tilts with the table and can be moved in the longitudinal direction, relative to the table and to the patient. The fully integrated system is provided with a touch screen console, glass or metal x-ray tube(s) with collimator and high resolution displays. As a fully integrated system, the proposed CombiDiagnost R90 can be configured with a Philips generator, the flat panel detector Pixium FE 4343F, and the Philips Dynamic Eleva Image Chain acquisitionstation also provided with the currently marketed and reference device, Eleva Workspot with SkyFlow (Eleva Workspot). The proposed CombiDiagnost R90 uses the same workflow from the currently marketed and reference device, Eleva Workspot with SkyFlow. The only modification to the Eleva Workspot is integration with the Pixium FE 4343F detector.
Indications for CombiDiagnost R90 is a multi-functional general R/F system. It is Use: suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.
Fundamental R90 is a multi-functional remote controlled CombiDiagnost Scientific fluoroscopy system in combination with high-end digital radiography Technology: consisting of a floor-mounted tilt- and height-adjustable patient -
5
support and a scan unit consisting of a tube and a flat detector. It is designed for fluoroscopy examinations of the recumbent, standing or seated patient and also for lateral exposures. Fine positioning of the tube and collimator on the patient is easy to carry out using control grips and control buttons on table or tube user interfaces. It is quite convenient to be operated in hospitals. CombiDiagnost R90 is intended for use in generating radiographs of human anatomy by qualified/trained doctors or technicians. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
Based on the information provided above, the CombiDiagnost R90 is considered substantially equivalent to the primary currently marketed and predicate device EasyDiagnost Eleva (K031535, June 17, 2003) in terms of fundamental scientific technology.
This modified device has the same indications for use and Summary of technological characteristics as the primary predicate device, technological Eleva. Comparisons of the technological characteristics: EasyDiagnost characteristics demonstrate the substantial equivalence to the primary predicate device.
| | Primary Predicate Device:
EasyDiagnost Eleva
(K031535) | Proposed Device:
CombiDiagnost R90
(K163210) | Discussion |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Table Features | | | |
| Working height
(table top center to
floorplate) | 83cm | 62 cm – 142 cm | Similar; the range of working
height does not affect the
safety or effectiveness of the
device. |
| Table tilt
movement | -20° to +90°
Optional:
-30° to +90°
-45° to +90°
-85° to +90° | -90° to +90° | Similar: The table tilt
movement does not affect the
safety or effectiveness of the
device. |
| Table top
suspension | Back and sides | Two sides suspensions | Similar: Two side table side
suspension does not affect the
safety or effectiveness of the
device. |
| Table top material | Plastic laminate or carbon
fiber | Same | Equivalent. |
| Table top
movement | Lateral: -10 cm to + 9 cm
Longitudinal: ± 83 cm | Same | Equivalent |
| Table top
absorption | 0.7mm typical (@ 100kV,
2.7mm Al HVL) | Plastic, with Carbon fiber:
0.6mm Al @ 100kV,
HVL = 3.6mm Al | Similar: Minor differences in
the table top absorption does
not affect the safety or
effectiveness of the device. |
| Maximum patient
weight | 180 kg | 284 kg (626 lbs) | The proposed CombiDiagnost
R90 is able to hold more |
| | Primary Predicate Device:
EasyDiagnost Eleva
(K031535) | Proposed Device:
CombiDiagnost R90
(K163210) | Discussion |
| | | | patient weight; this does not
affect the safety or effective-
ness of the device. |
| Lateral scan
distance | 22 cm | 32 cm ± 16 cm | Similar: The range of lateral
scan distances provided with
the proposed CombiDiagnost
R90 does not affect the safety
or effectiveness of the device. |
| Lateral scan speed | Manual Movement | 5 cm/s, soft start and stop
Auto centering | The automated lateral scan
speed provided with the
proposed CombiDiagnost R90
does not affect the safety or
effectiveness of the device. |
| Longitudinal scan
distance | 75 cm | 160 cm longitudinal,
motorized | Similar: The extended
longitudinal motorized scan
distance of the proposed
CombiDiagnost R90 does not
affect the safety or effective-
ness of the device. |
| Longitudinal scan
speed | Manual Movement (Servo
Support) | 3 cm - 20 cm / sec | Similar: The longitudinal scan
speed provided with the
proposed CombiDiagnost R90
does not affect the safety or
effectiveness of the device |
| Table column
angulation | N/A | -40° to +40° | The table angulation provided
with the proposed
CombiDiagnost R90 does not
affect the safety or effective-
ness of the device. |
| Source image
distance | 73cm - 103cm,
88cm - 118cm with Geomat
in extended position | 113cm - 183cm | Similar: The source image
distance provided with the
proposed CombiDiagnost R90
does not affect the safety or
effectiveness of the device. |
| Collimator | Square / rectangular plus
Iris | Motorized automatic
collimation | The motorized collimator
provided with the proposed
CombiDiagnost R90 does not
affect the safety or
effectiveness of the device. |
| Preparation time
for exposure | 0.4 - 1.8 sec (depends on X-
ray Tube and technique) | 1 sec (approximately) | Similar: The minor difference
in the preparation time does
not affect the safety or
effectiveness of the device. |
| Grid | Parkable | Same | Equivalent: No effect on the
safety or effectiveness of the
device. |
| Auto Grid
Selection | Yes | Same | Equivalent: No effect on the
safety or effectiveness of the
device. |
| Automatic pre-
position of the
table | No | Yes | The automatic pre-position of
the table provided with the
proposed CombiDiagnost R90
does not affect the safety or
effectiveness of the device. |
| | Primary Predicate Device:
EasyDiagnost Eleva
(K031535) | Proposed Device:
CombiDiagnost R90
(K163210) | Discussion |
| Picture archiving
and
communication
system | Yes | Same | Equivalent: No effect on the
safety or effectiveness of the
device. |
| Image chain
(fluoroscopy) | Philips Image Intensifier /
CCD TV / Digital Imaging | Philips dynamic Eleva
Image Chain | The proposed
CombiDiagnost R90 includes
the cleared Philips Eleva
WorkSpot of the reference
device (K153318) as part of
the image chain. Therefore,
no effect on the safety or
effectiveness of the device |
| Detector | Image Intensifier 23 cm, 31
cm or 38 cm | Pixium FE 4343F (cleared
via K080859 – Villa
Sistemi Medicali S.p.A.) | No impact on the safety or
effectiveness of the device.
The detector data is from the
reference device Philips
Eleva WorkSpot (K153318) |
| Generator | Philips Velara RF 50kW,
65kW or 80kW | Philips Velara 65kW,
optional 80 kW | Equivalent; The proposed
CombiDiagnost R90 uses a
Philips generator that
operates in the same manner. |
| Tube | Philips SRO 2550 or SRM
2250 GS | Philips SRO 33100 ROT
380 or SRM 0608 ROT
GS 505 | Equivalent; The proposed
CombiDiagnost R90 uses
Philips tubes that operate in
the same manner. |
| System Control | Near by | Remote | The proposed
CombiDiagnost R90 uses a
remote system control. This
does not affect the safety and
effectiveness. |
| Indications for
Use | The Philips EasyDiagnost
Eleva intended use is for the
following applications: As a
multi-functional/ universal
system, general R/F, Fluoro-
scopy, Radiography and
Angiography can be
performed along with
pediatric examinations and
some more specialized
interventional applications. | 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. | Equivalent; The Indications
for Use for the proposed
CombiDiagnost R90 is more
general in nature. |
6
7
This 510(k) premarket notification contains technical documentation Summary of Non-Clinical which includes non-clinical verification and validation tests as well as image quality testing. Tests were performed on the proposed Data: CombiDiagnost R90 according to the following international and FDArecognized consensus standards:
- ISO 14971, Medical devices. Application of risk management to . medical devices
- · IEC 60601-1, Medical electrical equipment. General
8
requirements for safety. Collateral standard. Safety requirements for medical electrical systems
- . IEC 60601-1-2. Medical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests
- 60601-1-3. Medical equipment. IEC General requirements for basic safety and essential performance. Collateral Standard: Radiation protection in diagnostic X-ray equipment
- 60601-2-54, Medical electrical equipment. IEC Particular requirements for the basic safety and essential performance of Xray equipment for radiography and radioscopy
- . IEC 62220-1. Medical electrical equipment. Characteristics of digital X-ray imaging devices. Determination of the detective quantum efficiency
- IEC 62304, Medical device software. Software life-cycle ● processes
The test results demonstrate that the proposed CombiDiagnost R90 meets the acceptance criteria and is adequate for its intended use.
Based upon the same intended use, similar technology, software functionalities, same product configuration and administration, and similarity of materials, it can be concluded the proposed CombiDiagnost R90 is substantially equivalent to the primary predicate device EasyDiagnost Eleva, in terms of intended use, design characteristics, and safety and effectiveness.
Summary of The proposed CombiDiagnost R90 did not require a clinical study since Clinical Data: substantial equivalence to the currently marketed and predicate device was demonstrated with the following attributes:
- . Design features;
- Indication for use;
- . Fundamental scientific technology;
- Non-clinical performance testing including validation; and ●
- . Safety and effectiveness.
Substantial comparison of technological characteristics, non-clinical The Equivalence performance data, safety testing, software validation, and clinical image Conclusion: concurrence data demonstrates that the device is as safe and effective as the predicate device. Philips Medical Systems concludes that the proposed CombiDiagnost R90 is substantially equivalent to the legally marketed primary predicate device, EasyDiagnost Eleva.