(95 days)
No
The summary describes a standard R/F system with mechanical and digital components, but there is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is used for diagnostic imaging (radiography and fluoroscopy exams) to visualize internal structures, not for treating any medical condition.
Yes
This device is a multi-functional general R/F system used for routine radiography and fluoroscopy exams, which are diagnostic imaging procedures. It generates X-ray images that are used by medical professionals to diagnose various conditions.
No
The device description clearly outlines significant hardware components including a patient support table, scan unit with tube and detector, displays, x-ray generator, and ceiling suspension. While software is likely involved in controlling these components, the device is fundamentally a hardware system.
Based on the provided information, the ProxiDiagnost N90 is not an IVD (In Vitro Diagnostic) device.
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 procedures performed on a patient, not tests performed on biological samples outside the body.
- Device Description: The description details an X-ray system with a patient support table, scan unit, tube, detector, and displays. This is consistent with an imaging device, not a device used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or laboratory procedures.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ProxiDiagnost N90 is an imaging device used to visualize the internal structures of the body using X-rays.
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 (comma separated list FDA assigned to the subject device)
OWB, JAA
Device Description
The ProxiDiagnost N90 is a multi-functional nearby controlled fluoroscopy system in combination with a 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 -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 fully integrated system is provided with a x-ray tube(s) with collimator and high resolution displays. The ProxiDiagnost N90 is configured with a Philips x-ray generator and a flat panel dynamic detector, Pixium FE4343F, components of the Philips radiography/fluoroscopy Image Chain. As additional options, the ProxiDiagnost N90 can be used as a digital radiography system consisting of a mounted tube in a ceiling suspension together with the portable or fixed detector in the vertical stand.
Mentions image processing
Not Found
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 contains technical documentation which includes nonclinical verification and validation tests as well as image quality tests were performed on the proposed ProxiDiagnost N90 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. Collateral standard. Safety requirements for medical electrical systems
- IEC 60601-1-2, Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests
- IEC 60601-1-3. Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard: Radiation protection in diagnostic X-ray equipment
- IEC 60601-2-54. Medical electrical equipment. Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
- IEC 6220-1, 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
- 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
- Pediatric Information for X-ray Imaging Device Premarket Notifications, Draft, issued May 10, 2012
- Guidance for the Submission of Premarket Notifications for Medical Image Management Device, issued July 27, 2000
- 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
The test results demonstrate that the proposed ProxiDiagnost N90 meets the acceptance criteria and is adequate for its intended use.
The proposed ProxiDiagnost N90 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.
K163210, K153318, K170113, K171461
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.
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Philips Medical Systems DMC GmbH % Ming Xiao Regulatory Affairs Manager North America Roentgenstrasse 24-26 22335 Hamburg GERMANY
February 5, 2018
Re: K173433
Trade/Device Name: ProxiDiagnost N90 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA Dated: November 9, 2017 Received: November 13, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'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) K173433
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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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.
Establishment registration number: 3003768251
- Date Prepared: January 29, 2018 Manufacturer: Philips Medical Systems DMC GmbH Roentgenstrasse 24-26 22335 Hamburg GERMANY
- Contact Person: Ming Xiao Regulatory Affairs Manager, North America Phone: +49 40 5078-2306 Fax: +49 40 5078-2425 E-mail: ming.xiao@philips.com
- Device Name: ProxiDiagnost N90
- Classification: Classification Name: Image-intensified fluoroscopic x-ray system Classification Regulation: 21CFR 892.1650 Classification Panel: 90 -- Radiology Device Class: Class II OWB Classification Product Code: Secondary Product Codes: JAA Philips EasyDiagnost Eleva Predicate Device: Trade Name: Manufacturer: Philips Medical System 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 Classification Panel: 90 -- Radiology
ProxiDiagnost N90 Premarket Notification – Traditional 510(k) Page 43 of 135
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| Device Class: | Class II | |
|---|---|---|
| Product code: | JAA | |
| Reference | ||
| Device_1: | Trade Name: | CombiDiagnost R90 |
| Manufacturer: | Philips Medical System DMC | |
| 510(k) Clearance: | K163210 - Jan 31, 2017 | |
| Classification Name: | Image-intensified fluoroscopic x-ray | |
| system | ||
| Classification Regulation: | 21CFR 892.1650 | |
| Classification Panel: | 90 -- Radiology | |
| Device Class: | Class II | |
| Product code: | ||
| Secondary Product Codes: | JAA | |
| KPR, MQB | ||
| Reference | ||
| Device_2: | Trade Name: | Eleva Workspot with SkyFlow |
| Manufacturer: | Philips Medical System DMC | |
| 510(k) Clearance: | K153318 - Dec 22, 2015 | |
| Classification Name: | Solid State X-Ray Imager (Flat | |
| Panel/Digital Imager) | ||
| Classification Regulation: | 21CFR 892.1680 | |
| Classification Panel: | 90 -- Radiology | |
| Device Class: | Class II | |
| Product code: | ||
| Secondary Product Codes: | MQB | |
| LLZ | ||
| Reference | ||
| Device_3: | Trade Name: | Pixium 4343RCE |
| Manufacturer: | Philips Medical System DMC | |
| 510(k) Clearance: | K170113 – Feb 9, 2017 | |
| Classification Name: | Solid State X-Ray Imager (Flat | |
| Panel/Digital Imager) | ||
| Classification Regulation: | 21CFR 892.1680 | |
| Classification Panel: | 90 -- Radiology | |
| Device Class: | Class II | |
| Product code: | MQB | |
| Reference | Trade Name: | SkyPlate Detector For Philips |
ProxiDiagnost N90 Premarket Notification – Traditional 510(k)
Page 44 of 135
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Radiography/Fluoroscopy Systems Manufacturer: Philips Medical System DMC K171461 – July 7, 2017 510(k) Clearance: Classification Name: Solid State X-Ray Imager (Flat Panel/Digital Imager) Classification Regulation: 21CFR 892.1680 90 -- Radiology Classification Panel: Device Class: Class II Product code: MQB
Device Description:
The ProxiDiagnost N90 is a multi-functional nearby controlled fluoroscopy system in combination with a high-end digital radiography system consisting of a floor-mounted tiltadjustable 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 -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 fully integrated system is provided with a x-ray tube(s) with collimator and high resolution displays. The ProxiDiagnost N90 is configured with a Philips x-ray generator and a flat panel dynamic detector, Pixium FE4343F, components of the Philips radiography/fluoroscopy Image Chain. As additional options, the ProxiDiagnost N90 can be used as a digital radiography system consisting of a mounted tube in a ceiling suspension together with the portable or fixed detector in the vertical stand.
The ProxiDiagnost N90 uses the same workflow as the currently marketed and predicate device, Philips EasyDiagnost Eleva (K031535, cleared June 17, 2003). The ProxiDiagnost N90 incorporates the following features, previously cleared by FDA in the following reference devices:
| Design Feature/ Attribute | Currently Marketed and Reference Device |
|---|---|
| Philips Medical Systems | |
| Image Chain acquisition-station and workflow | |
| (Eleva Workspot) | Eleva Workspot with SkyFlow (K153318, December 22, 2015) |
| Dynamic flat detector, PixiumFE4343F and | |
| motorized collimator (in ceiling suspensions) | CombiDiagnost R90 (K163210, January 31, 2017) |
| Wireless portable detector | SkyPlate Detector for Radiography/Fluoroscopy |
| Systems (K171461, July 7, 2017) | |
| Fixed static detector | Pixium 4343 RCE (K170113, February 9, 2017) |
Device 4:
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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.
Fundamental Scientific Technology:
The ProxiDiagnost N90 employs the same basic construction and fundamental scientific technology as the currently marketed and predicate EasyDiagnost Eleva (K031533), with regards to the functionality of the following components: table, system-control, X-Ray tube, and generator (see the comparison table comparing the ProxiDiagnost N90 to the currently marketed and predicate EasyDiagnost Eleva provided below).
The ProxiDiagnost N90 employs the following cleared features: fixed detector (Pixium FE 4343F K163210), wireless detectors (Pixium 4343RCE, K170113, February 9, 2017; SkyPlate Detector for R/F Systems, K171461, July 7, 2017) and the image chain acquisitionstation and workflow (fluoroscopy) (Eleva Workspot with SkyFlow, K153318, Dec 22, 2015). The fixed detector, wireless portable detectors, and the image chain and workstation of the ProxiDiagnost N90 are identical to the fixed detector, wireless portable detectors, and the image chain and workstation of the currently marketed and reference devices. Therefore, the fixed detector, wireless portable detectors, and the image chain and workstation employ identical fundamental scientific technology.
The outcome of this comparison demonstrates that the minor differences in the technological characteristics do not affect the safety or effectiveness of the ProxiDiagnost N90 when compared to the currently marketed and predicate EasyDiagnost Eleva.
Summary of technological characteristics:
The ProxiDiagnost N90 has similar indications for use and technological characteristics as the predicate device, EasyDiagnost Eleva. Comparisons of the technological characteristics demonstrate the substantial equivalence to the predicate device.
| | Primary Predicate Device:
EasyDiagnost Eleva
( K031535 ) | Proposed Device:
ProxiDiagnost R90
( K173433 ) | Discussion |
|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Table Features | | | |
| Working height
(table top center
to floorplate) | 83cm | 83.3cm | 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°
movement speed with
variable 1 to 6°/s | Similar: The table tilt
movement does not affect the
safety or effectiveness of the
device. |
| Table top
suspension | Two sides suspensions | Two sides suspensions | Equivalent; No impact to
safety or effectiveness of the
device. |
| Table top | Plastic laminate or carbon | Sandwich of laminate, | Similar: The table top |
| | Primary Predicate Device:
EasyDiagnost Eleva
(K031535) | Proposed Device:
ProxiDiagnost R90
(K173433) | Discussion |
| material | fiber | carbon and foam | material movement does not affect the safety or effectiveness of the device. |
| Table top
movement | Lateral: -10 cm to + 9 cm
Longitudinal: ± 83 cm | Lateral: -10 cm to + 9 cm
Longitudinal: ± 83.5 cm | Equivalent; No impact to safety or effectiveness of the device. |
| Table top
absorption | 0.7mm typical (@ 100kV,
2.7mm Al HVL) | 0.6mm Al typical @
100kV | Similar: Minor differences in the table top absorption does not affect the safety or effectiveness of the device. |
| Maximum
patient weight | 180 kg | static: 300 kg
tilt: 250 kg
all movements: 185 kg | The proposed ProxiDiagnost N90 is able to hold more patient weight; this does not affect the safety or effectiveness of the device. |
| Lateral scan
distance | 22 cm | 22 cm | Equivalent; No impact to safety or effectiveness of the device. |
| Lateral scan
speed | Manual Movement | Manual Movement | Equivalent; No impact to safety or effectiveness of the device. |
| Longitudinal
scan distance | 75 cm mechanical range | 75 cm mechanical range | Equivalent; No impact to safety or effectiveness of the device. |
| Table column
angulation | -85° to +90° | -85° to +90° | Equivalent; No impact to safety or effectiveness of the device. |
| Source image
distance | 73 cm – 103 cm,
88 cm – 118 cm with
Geomat in extended
position | 81 cm – 130 cm | Similar: The source image distance provided with the proposed ProxiDiagnost N90 does not affect the safety or effectiveness of the device. |
| Collimator | Square / rectangular plus
Iris | rectangular collimation | The rectangular collimator provided with the proposed ProxiDiagnost N90 does not affect the safety or effectiveness of the device. It is the same collimator used in the currently marketed and reference device, CombiDiagnost R90 (K163210) |
| Grid | Parkable | Parkable | Equivalent; No impact to safety or effectiveness of the device. |
| Picture archiving
and
communication
system | Yes | Yes | Equivalent; No impact to safety or effectiveness of the device. |
| Image chain
(fluoroscopy) | Philips Image Intensifier /
CCD TV / Digital Imaging | Philips Dynamic Eleva
Image Chain | The proposed ProxiDiagnost N90 includes the currently marketed and reference |
| | Primary Predicate Device:
EasyDiagnost Eleva
(K031535) | Proposed Device:
ProxiDiagnost R90
(K173433) | Discussion |
| Detector | Image Intensifier 23 cm, 31
cm or 38 cm | Pixium FE 4343F | (K153318) as part of the
image chain. In addition, this
same image chain is used in
the currently marketed and
reference device,
CombiDiagnost R90
(K163210). Therefore, there
is no impact on the safety or
effectiveness of the device.
The proposed ProxiDiagnost
N90 includes the fixed
detector Pixium FE 4343F
used in the currently
marketed and reference
device, CombiDiagnost R90
(K163210). Therefore, there
is no impact on the safety or
effectiveness of the device. |
| Modulation
Transfer
Function (MTF)
(according to IEC
62220-1-3 standard) | Not available | lp/mm
%
1 66
2 35
3 19
3.4 15 | The proposed ProxiDiagnost
N90 includes the fixed
detector Pixium FE 4343F
used in the currently
marketed and reference
device, CombiDiagnost R90
(K163210). Therefore, there
is no impact on the safety or
effectiveness of the device. |
| Detective
Quantum
Efficiency
(DQE)
(according to IEC
62220-1-3 standard) | Not available | DQE at 1 µGy
lp/mm %
0.05 65
1 51
2 41
3 27
3.4 18 | The proposed ProxiDiagnost
N90 includes the fixed
detector Pixium FE 4343F
used in the currently
marketed and reference
device, CombiDiagnost R90
(K163210). Therefore, there
is no impact on the safety or
effectiveness of the device. |
| Wireless Static
Detector for
Radiographic
Exams | Wireless Portable Detector
Pixium4600 (previous
version of SkyPlate
Detector) | SkyPlate Detector | The proposed ProxiDiagnost
N90 includes the currently
marketed and reference
device, SkyPlate Detectors
for R/F Systems (K171461).
Therefore, there is no impact
on the safety or effectiveness
of the device. |
| Wireless Static
Detector for
Radiographic
Exams | N/A | Pixium RCE | The proposed ProxiDiagnost
N90 includes the currently
marketed and reference
device, Pixium RCE
(K170113). Therefore, there
is no impact on the safety or
effectiveness of the device. |
| Generator | Philips Velara GCF/RF, | Philips Velara GCF/RF, | Equivalent; No impact to |
| | 50kW.65kW or 80kW | 65 kW, optional 80 kW | safety or effectiveness of the |
| | Primary Predicate Device:
EasyDiagnost Eleva
(K031535) | Proposed Device:
ProxiDiagnost R90
(K173433) | Discussion |
| | | | device. |
| Tube | Philips SRO 2550 or SRM
2250 GS | Philips SRM 2250 ROT-
GS 504 or
SRO 2550 ROT380 or
SRO 33100 ROT380
(optional in CSM) | Equivalent; No impact to
safety or effectiveness of the
device. |
| System Control | Near by | Nearby | Equivalent; No impact to
safety or effectiveness of the
device. |
| 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. | 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. | Equivalent; The Indications
for Use for the proposed
ProxiDiagnost N90 is more
general in nature and exactly
the same as the currently
marketed and reference
device, CombiDiagnost R90
(K163210). |
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Image /page/8/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and appear to be a sans-serif font. The background is plain white, which makes the blue letters stand out.
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Based on the information provided above, the ProxiDiagnost N90 is considered substantially equivalent to the currently marketed and predicate device, EasyDiagnost Eleva (K031535, June 17, 2003) in terms of fundamental scientific technology.
Summary of Non-Clinical Data:
This 510(k) premarket notification contains technical documentation which includes nonclinical verification and validation tests as well as image quality tests were performed on the proposed ProxiDiagnost N90 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. . Collateral standard. Safety requirements for medical electrical systems
- IEC 60601-1-2, Medical electrical equipment. General requirements for basic safety ● and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests
- IEC 60601-1-3. Medical electrical equipment. General requirements for basic safety . and essential performance. Collateral Standard: Radiation protection in diagnostic Xray equipment
- . IEC 60601-2-54. Medical electrical equipment. Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
- IEC 6220-1, 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 ●
- Guidance for the Submission of 510(k)s for Solid State X-Ray Imaging Devices, issued September 1, 2016
ProxiDiagnost N90 Premarket Notification – Traditional 510(k) Page 49 of 135
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- . Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005
- Pediatric Information for X-ray Imaging Device Premarket Notifications, Draft, issued May 10, 2012
- Guidance for the Submission of Premarket Notifications for Medical Image ● Management Device, issued July 27, 2000
- 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
The test results demonstrate that the proposed ProxiDiagnost N90 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 ProxiDiagnost N90 is substantially equivalent to the predicate device, Philips EasyDiagnost Eleva, in terms of intended use, design characteristics, and safety and effectiveness.
Summary of Clinical Data:
The proposed ProxiDiagnost N90 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.
Substantial Equivalence Conclusion:
The comparison of technological characteristics, non-clinical performance data, safety testing, software validation, and clinical image concurrence data demonstrates that the device is as safe and effective as the predicate device. Philips Medical Systems concludes that the proposed ProxiDiagnost N90 is substantially equivalent to the legally marketed predicate device, EasyDiagnost Eleva.