(26 days)
No
The summary does not mention AI, ML, or any related terms, and the performance studies focus on standard non-clinical testing and substantial equivalence to a predicate device without AI/ML capabilities.
No
The device is an imaging system (digital radiography) used for diagnosis, not for treating conditions.
No
The device is described as an imaging system intended to acquire, process, store, display, and export digital radiographic images, which are then interpreted by a human for diagnosis. It does not perform the diagnosis itself.
No
The device description explicitly details hardware components such as a patient support table, ceiling suspension, tube, flat panel detectors (fixed and wireless portable), and an x-ray generator, indicating it is a physical medical device system, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for acquiring, processing, storing, displaying, and exporting digital radiographic images. This is related to medical imaging, not in vitro diagnostic testing.
- Device Description: The description details a digital radiography system with components like an X-ray generator, detectors, and patient support. This is consistent with an imaging device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis, which are key characteristics of IVDs.
The device is a medical imaging system used for diagnostic purposes, but it does not perform in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The DigitalDiagnost C90 is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost C90 is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography.
Product codes
MQB, KPR, LLZ
Device Description
The proposed DigitalDiagnost C90 is same as the 510(K) approved predicate (K182973) as mentioned below. It is a high-end digital radiography system consisting of a height adjustable patient support table and a ceiling suspension consisting of a tube including a control handle used to acquire images with a flat panel fixed RAD detector. Additionally, different vertical stands for the radiography examinations are available. The ceiling suspension can be moved in longitudinal and lateral directions and additionally the tube can be tilted and rotated as well. The proposed DigitalDiagnost C90 is configured with a Philips x-ray generator and a flat panel fixed RAD detector, Pixium 4343RCE, together with the tube these components form the radiography Image Chain. The proposed DigitalDiagnost C90 introduces a new wireless portable detector, pixium 3543DR i.e. SkyPlate E (cleared in reference device 510(K) K191813) and their relevant grids, in addition to the family of SkyPlate detectors (pixium 3543EZ i.e. Large and pixium 2430EZ i.e. Small) that are already integrated in the currently marketed (predicate) DigitalDiagnost C90 (K182973).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data: This 510(k) premarket notification contains the technical documentation, which demonstrates that the proposed DigitalDiagnost C90 is substantially equivalent to the currently marketed predicate DigitalDiagnost C90 (K182973, January 11, 2019). The technical documentation includes non-clinical verification / validation tests. These tests have been performed on the proposed DigitalDiagnost C90 according to the following international and FDA-recognized consensus standards, as well as additional non-standard performance tests: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, IEC 62220-1, IEC 62304, IEC 60601-1-6, ISO 14971. Additional non-standard performance tests include System Verification Test, Image Quality Test, and Human Factors and Usability Engineering Test. Non-Clinical performance testing confirmed the proposed DigitalDiagnost C90: Complies with the aforementioned international and FDA-recognized consensus standards and meets the acceptance criteria of the non-standard performance tests and is adequate for its intended use. The results of testing support that the proposed DigitalDiagnost C90 is substantially equivalent to the currently marketed and predicate device DigtalDiagnost C90 (K182973, January 11, 2019) in terms of safety and effectiveness.
Summary of Clinical Data: The proposed DigitalDiagnost C90 did not require 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, 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
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
September 30, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "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: K202564
Trade/Device Name: DigitalDiagnost C90 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB, KPR, LLZ Dated: September 2, 2020 Received: September 4, 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
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
Image /page/2/Picture/0 description: The image shows the word "PHILIPS" in a sans-serif font. The letters are a light blue color. The word is written in all capital letters and is centered in the image. The background is white.
5. Statement of Indication for Use/Intended Use
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below. |
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------- |
|---|
Indications for Use
| 510(k) Number (if known) | K202564 |
|---|---|
| Device Name | DigitalDiagnost C90 |
| Indications for Use (Describe) |
The DigitalDiagnost C90 is intended to acquire, process, store, display and export digital radiographic images. The
DigitalDiagnost C90 is suitable for all routine radiography examinations, including specialist areas like intensive care,
trauma or pediatric work, excluding fluoroscopy, angiography and mammography.
| 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) |
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
"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."
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
3
Image /page/3/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are sans-serif and evenly spaced. The background is plain white, which makes the blue letters stand out.
K202564
6. 510(k) Summary
SPECIAL 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: | September 23, 2020 |
|---|---|
| Manufacturer: | Philips Medical Systems DMC GmbH |
| Röntgenstraße 24 | |
| 22335 Hamburg, GERMANY | |
| Establishment registration number: 3003768251 | |
| Contact Person: | Ming Xiao |
| Regulatory Affairs Manager | |
| Phone: +49 40 34971-2306 | |
| Fax: +49 40 5078-2147 | |
| E-mail: ming.xiao@philips.com | |
| Device Name: | DigitalDiagnost C90 |
| Classification: | |
| Trade Name: DigitalDiagnost C90 | |
| Classification Name: Solid State X-Ray Imager (Flat Panel/Digital Imager) | |
| Classification Regulation: 21CFR 892.1680 | |
| Regulation Description: Stationary x-ray system | |
| Classification Panel: 90 -- Radiology | |
| Device Class: Class II | |
| Classification Product Code: MQB, KPR, LLZ | |
| Predicate Device: | |
| Trade Name: DigitalDiagnost C90 | |
| Manufacturer: Philips Medical Systems DMC GmbH | |
| 510(k) Clearance: K182973- January 11, 2019 | |
| Classification Regulation: 21CFR 892.1680 | |
| Classification Name: Solid State X-Ray Imager (Flat Panel/Digital Imager) | |
| Classification Panel: 90 - Radiology | |
| Device Class: Class II | |
| Product Code: MQB, KPR, LLZ | |
| Reference Device for SkyPlate E Detector: | |
| Trade Name : MobileDiagnost wDR 2.2 | |
| Manufacturer: Sedecal S.A | |
| 510(K) Clearance: K191813- August 2, 2019 | |
| Classification Regulation: | 21CFR 892.1720 |
| Classification Name: | Mobile X-ray Systems |
| Classification Panel: | 90- Radiology |
| Device Class: | Class II |
| Product Code: | IZL, MQB |
DigitalDiagnost C90 Premarket Notification – Special 510(k)
4
Image /page/4/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.
| Device
Description | The proposed DigitalDiagnost C90 is same as the 510(K) approved predicate
(K182973) as mentioned below | Predicate Device: | Proposed Device: | Discussion & Conclusion | |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | It is a high-end digital radiography system consisting of a height adjustable patient
support table and a ceiling suspension consisting of a tube including a control handle
used to acquire images with a flat panel fixed RAD detector. Additionally, different
vertical stands for the radiography examinations are available. The ceiling suspension
can be moved in longitudinal and lateral directions and additionally the tube can be
tilted and rotated as well. The proposed DigitalDiagnost C90 is configured with a
Philips x-ray generator and a flat panel fixed RAD detector, Pixium 4343RCE,
together with the tube these components form the radiography Image Chain.
The proposed DigitalDiagnost C90 introduces a new wireless portable detector,
pixium 3543DR i.e. SkyPlate E (cleared in reference device 510(K) K191813) and
their relevant grids, in addition to the family of SkyPlate detectors (pixium 3543EZ
i.e. Large and pixium 2430EZ i.e. Small) that are already integrated in the currently
marketed (predicate) DigitalDiagnost C90 (K182973). | DigitalDiagnost
C90 (K182973-
January 11,
2019) | DigitalDiagnost
C90 (K202564) | | |
| Indications for
Use/Intended
Use: | The Indication for Use of the proposed DigitalDiagnost C90 is identical to that of the
currently marketed and predicate device, DigtalDiagnost C90 (K182973- January 11,
2019) and is as follows: | Table Features | | | |
| | The DigitalDiagnost C90 is intended to acquire, process, store, display and export
digital radiographic images. The DigitalDiagnost C90 is suitable for all routine
radiography examinations, including specialist areas like intensive care, trauma or
pediatric work, excluding fluoroscopy, angiography and mammography. | Height adjustable table (TH-2) | | | |
| Fundamental
Scientific
Technology: | The proposed DigitalDiagnost C90 employs the same basic construction and
fundamental scientific technology as the currently marketed predicate DigtalDiagnost
C90 (K182973, January 11, 2019), with regards to the functionality of all its
components | | | | |
| | The proposed DigitalDiagnost C90 employs the same cleared features as predicate
DigitalDiagnost C90 as follows | | | | |
| | fixed RAD detector (Pixium 4343RCE, K170113, February 9, 2017), wireless detectors (SkyPlate Detector, cleared by Eleva Workspot for
DigitalDiagnost, K141736, July 25, 2014), image chain acquisition-station and workflow (Eleva Workspot with
SkyFlow, K153318, December 22, 2015). | | | | |
| Height
adjustment | 51.5 cm to 91.5
cm above floor,
motorized
adjustment | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Table
weight | 335 kg | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Max. patient
weight | • Static load center:
375 kg
• Dynamic load
center: 318 kg
• Dynamic load off
center: 210 kg | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Table top
Type | Floating table top
of sandwich
design with
Getalit overlay | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Table top
Dimension | 240 cm x 75 cm | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Table top
travel | • longitudinal: ±56
cm
• transverse: ±12.8
cm,
electromagnetic
brakes | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Single side suspended table (TH-S) | | | | | |
| Height
adjustment | 51 cm to 91 cm
motorized
adjustment | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Table
weight | 214 kg | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Max. patient
weight | • table top center:
225kg
• end of table top:
135kg | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Table top
Type | Floating table top
of sandwich
design with
Kevlar overlay,
flat top | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Table top
Dimension | 260 cm x 75 cm | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Thickness of
table top | 4.7 cm | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Table top
travel | • longitudinal: ±20
cm, hydraulic
brakes
• transverse: ±20
cm, hydraulic
brakes | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Patient
coverage
with fixed
RAD
detector | • longitudinal: 208
cm
• Transversal: 83
cm | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Celling Suspension CSM | | | | | |
| Type | Four-part
aluminum
telescopic column
with spring
counter balanced
holder for X-ray
tube assembly;
adaptable to
individual room
heights | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Ceiling
height at
source
image
distance 110
cm | 2.83 to 3.21 m | Same | Equivalent; No impact to the
safety and effectiveness of the
device. | | |
| Movement | 3.26 m to 3.41m | Same | Equivalent; No impact to the
safety and effectiveness of the
device. | | |
| Transverse
travel | 1.49 m to 3.21 m | Same | Equivalent; No impact to the
safety and effectiveness of the
device. | | |
| Vertical
travel | 1.65 m | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| X-ray tube
assembly
rotation | • around vertical
axis: 360° (±180°)
with lock position
every 45°
• around horizontal
axis: ±115°, lock | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| | positions 0° and | | | | |
| | ±90° | | | | |
| Length of
rails | 4.3 m | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Collimator | • Ralco P 225 ACS
DHHS
• Motorized
automatic
collimation
• Manual overrule
possible
• With light field
indicator
• With 2 Lasers and
Camera | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Vertical Stand | | | | | |
| | Vertical moveable stand (VM) | | | | |
| Hardware | Counterbalanced
rugged column
for motorized
vertical
movement of the
detector unit | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Vertical
travel | 35 cm to 185 cm | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Horizontal
travel | • Motorized: 3.475
m
• with extension
rails, motorized:
5.5 m | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Swiveling
range | 0° to 90° (right or
left orientated
execution) | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Lock-in
positions | manual or every
15° | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Fixed Vertical Stand (VS) | | | | | |
| Hardware | Counterbalanced
rugged column
for motorized and
manual vertical
movement of the
detector | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Vertical
travel | 30 cm to 180 cm | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Installation | Floor and wall
attachment or
floor only | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Fixed RAD
Detector | pixium 4343RCE | Same | Equivalent; No impact to
safety and effectiveness of the
device | | |
| Wireless
Static
Detector | • SkyPlate Small
(pixium 2430EZ)
• SkyPlate Large
(pixium 3543EZ) | • SkyPlate Large
(pixium 3543EZ)
• SkyPlate Small
(pixium 2430EZ)
• SkyPlate E
(pixium 3543DR) | Addition
of
SkyPlate
E
detector does not affect the
clinical workflow or clinical
image quality so there is no
impact to
the safety and
effectiveness of the device. | | |
| Generator | High-voltage
generator 65kW
or 80kW | Same | Equivalent; No impact
to
safety and effectiveness of the
device. | | |
| Tube | High power X-ray
Tube, Philips
SRO 33100 | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| SkyFlow | Yes | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Eleva
Workspot | Yes | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| SkyPlate
Detector
Sharing | Yes | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Automatic
Image
stitching | Yes | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Detectors | | | | | |
| Type | Digital wireless
flat detector | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Detector
Models | • SkyPlate Large
(pixium 3543EZ)
• SkyPlate Small
(pixium 2430EZ) | • SkyPlate Large
(pixium 3543EZ)
• SkyPlate Small
(pixium 2430EZ) | Addition
of
SkyPlate
E
detector does not affect the
clinical workflow or clinical
image quality so there is no
impact to the safety and
effectiveness of the device. | | |
| | | • SkyPlate E
(pixium 3543DR) | impact to the safety and
effectiveness of the device. | | |
| X-Ray
Absorber | CsI Scintillator | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Installation
type | Portable | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Readout
Mechanism | Thin Film
Transistor | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Detector
Size | • SkyPlate Small:
328mm x 268mm
x 16 mm
• SkyPlate Large:
384mm x 460mm
x 16 mm | • SkyPlate Small:
Same
• SkyPlate Large:
same
• SkyPlate E: 384.5
mm x 460.5 mm x
16.0 mm | Equivalent size does not affect
the clinical workflow or
clinical image quality so there
is no impact to the safety and
effectiveness of the device. | | |
| Maximum
X-ray Dose
for Linear
Response | $50 \mu Gy$ | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Maximum
Usable Dose | • SkyPlate Small:
$75 \mu Gy$
• SkyPlate Large:
$75 \mu Gy$ | • SkyPlate Small:
Same
• SkyPlate Large:
Same
• SkyPlate E: $80 \mu Gy$ | Equivalent or better; No
impact to safety and
effectiveness of the device. | | |
| Image
Processing | Eleva
Workstation | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Maximum
Lifetime
Dose | 100 Gy | Same | Equivalent; No impact to
safety and effectiveness of the
device. | | |
| Detector
Weight | • SkyPlate Small:
1.6 Kg including
battery
• SkyPlate Large:
2.8 kg including
battery | • SkyPlate Small:
Same
• SkyPlate Large
detector: same
• SkyPlate E: 3.1
kg including
battery | It has no impact on clinical
workflow. Therefore, no
impact on safety and
effectiveness of the device;
thus, demonstrating SE | | |
| Image Size
(X-ray field) | • SkyPlate Small:284X222mm
m
• SkyPlate Large:
344.8 mm x 421.2 mm | • SkyPlate Small:
Same
• SkyPlate Large:
Same
• SkyPlate E
detector: 345 mm
x 426 mm | This difference in the Image
Size (X-ray field) does not
impact clinical Image Quality.
Therefore, no impact on safety
and effectiveness of the
device; thus, demonstrating
SE | | |
| Pixel Size | • SkyPlate Small &
Large: 148 μm | • SkyPlate Small &
Large: Same
• SkyPlate E: 160
μm | The difference of 12 μm pixel
size does not impact the image
resolution to an extent that can
impact the clinical image
quality. Therefore, no impact
on safety and effectiveness of
the device; thus,
demonstrating SE | | |
| Image
matrix size
(Number of
pixels) | •SkyPlate Small:
1500 X 1920
Pixels
•SkyPlate Large:
2330 x 2846
pixels | • SkyPlate Small:
same
• SkyPlate Large:
same
• SkyPlate E: 2156
x 2662 pixels | Infinitesimal change in the
image size (X-ray field) and
reduction in number of pixels
due to 160 μm pixel size does
not impact clinical Image
Quality. Therefore, no impact
on safety and effectiveness of
the device; thus,
demonstrating SE | | |
| Nyquist
Frequency | • SkyPlate Small &
large: 3.38 lp/mm | • SkyPlate Small &
large: Same
• SkyPlate E: 3.125
lp/mm | This difference in the Nyquist
Frequency does not impact
clinical Image Quality.
Therefore, no impact on safety
and effectiveness of the
device; thus, demonstrating
SE | | |
| Modulation
Transfer
Function
(MTF),
typical
values | • SkyPlate Small &
Large
1 lp/mm 61%
2 lp/mm 30%
3 lp/mm 14%
3.38 lp/mm 10%
(Nyquist) | • SkyPlate Small &
large: Same
• SkyPlate E:
1 lp/mm 62%
2 lp/mm 34%
3 lp/mm 18%
3.125 lp/mm 16%
(Nyquist) | This difference in the
Modulation Transfer Function
does not impact clinical Image
Quality.
Therefore, no impact on safety
and effectiveness of the
device; thus, demonstrating
SE | | |
| Detective
Quantum
Efficiency
(DQE), | • SkyPlate Small &
large:
DQE at 2.0 μGy | • SkyPlate Small &
large: Same
• SkyPlate E: DQE
at 2.0 μGy | This difference in the
Detective Quantum Efficiency
does not impact clinical Image
Quality. | | |
| typical
values | Lp/mm | % | Lp/mm | % | Therefore, no impact on safety
and effectiveness of the
device; thus, demonstrating
SE |
| | 0 | 70 | 0 | 70 | |
| | 1 | 51 | 1 | 51 | |
| | 2 | 42 | 2 | 42 | |
| | 3 | 29 | 3 | 22 | |
| | 3.38
(Nyquist) | 19 | 3.125
(Nyquist) | 18 | |
| ADC
Digitisation | 16 Bit | | Same | | Equivalent; No impact to
safety and effectiveness of the
device. |
| Signal to
Electronic
Noise Ratio
(SENR) | • SkyPlate Small &
Large:
Min 38 dB –
typical: 43 dB (@
1 μGy) | | • SkyPlate Small &
large: Same
• SkyPlate E: Min
37 dB - typical:
42.8 dB (@ 1
μGy) | | Equivalent; No impact to
safety and effectiveness of the
device. |
| Data
Interface to
Workstation | • AP to workspot:
1 GBit/s
Ethernet
• Detector
Ethernet via
BUC: 100
Mbit/s Ethernet
• Detector to AP:
150 Mbit/s
WLAN (gross
transfer rate) | | Same | | Equivalent; No impact to
safety and effectiveness of the
device. |
| Grids | | | | | |
| Type | • Large Grids for
SkyPlate Large
(468 mm × 476
mm × 25 mm)
• Small Grid for
SkyPlate Small
(280 mm × 354
mm × 25 mm) | | • Large Grids for
SkyPlate Large:
Same
• Small Grid for
SkyPlate Small:
Same
• Large Grids for
SkyPlate E
(468 mm × 476
mm × 25 mm) | | Addition of new grids for
SkyPlate E introduction has
no impact on clinical
workflow.
Therefore, no impact on safety
and effectiveness of the
device; thus, demonstrating
SE |
| Indications
for Use | The
DigitalDiagnost
C90 is intended to
acquire, process,
store, display and
export digital | | Same | | Equivalent; No impact to
safety and effectiveness of the
device. |
5
Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is plain white.
Only modification to the proposed is the introduction of SkyPlate E Detector and their relevant grids (Reference device, K191813- August 2, 2019). The additional SkyPlate E detector that has been integrated in the proposed DigitalDiagnost C90, has equivalent design, technology and Image acquisition workflow compared to the previously cleared detector (SkyPlate Family detectors), used in the marketed predicate device DigtalDiagnost C90 (K182973, January 11, 2019), except difference in the pixel size. All technical detector 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.
The aforementioned modifications have also 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 comparison demonstrates that the minor differences in the technological characteristics do not affect the safety or effectiveness of the proposed DigitalDiagnost C90 when compared to the currently marketed and predicate DigitalDiagnost C90.
Summary of technological characteristics:
The proposed DigitalDiagnost C90 has same design, indications for use, fundamental scientific technology and similar technological characteristics as the marketed predicate device, DigitalDiagnost C90. Both devices are equivalent with respect to table features, Ceiling suspension CSM, Vertical stand feature. Both uses the same fixed RAD detector, Image chain acquisition station and workflow and Wireless detectors of SkyPlate family. The only modification in the proposed DigitalDiagnost C90 is the introduction of the SkyPlate E detector and its relevant grid. The modifications do not affect the clinical work flow or the clinical image quality demonstrating that the proposed DigitalDiagnost C90 is substantially equivalent to marketed predicate device, DigitalDiagnost C90 (K182973).
Table below provides comparison of the proposed DigitalDiagnost C90 with the predicate (marketed) DigitalDiagnost C90. It also includes the comparison of the SkyPlate E detector with the SkyPlate detector provided with the currently marketed and predicate DigitalDiagnost C90.
6
Image /page/6/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.
7
Image /page/7/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame.
8
Image /page/8/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out.
DigitalDiagnost C90 Premarket Notification – Special 510(k)
9
Image /page/9/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame.
10
Image /page/10/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.
11
Image /page/11/Picture/0 description: The image contains the word "PHILIPS" in a bold, sans-serif font. The word is written in a bright blue color. The background of the image is white, which makes the blue text stand out.
12
Image /page/12/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame.
13
| radiographic | ||
|---|---|---|
| images. The | ||
| DigitalDiagnost | ||
| C90 is suitable for | ||
| all routine | ||
| radiography | ||
| examinations, | ||
| including | ||
| specialist areas | ||
| like intensive | ||
| care, trauma or | ||
| pediatric work, | ||
| excluding | ||
| fluoroscopy, | ||
| angiography and | ||
| mammography | ||
Summary of Non-Clinical Performance Data:
This 510(k) premarket notification contains the technical documentation, which demonstrates that the proposed DigitalDiagnost C90 is substantially equivalent to the currently marketed predicate DigitalDiagnost C90 (K182973, January 11, 2019). The technical documentation includes non-clinical verification / validation tests. These tests have been performed on the proposed DigitalDiagnost C90 according to the following international and FDA-recognized consensus standards, as well as additional non-standard performance tests.
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 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 .
IEC 60601-1-6. General requirements for basic safety and essential ● performance - Collateral standard: Usability
ISO 14971, Medical devices. Application of risk management to medical ● devices
Additional non-standard performance tests have been performed to demonstrate the safety and effectiveness:
- System Verification Test ●
- . Image Quality Test
- . Human Factors and Usability Engineering Test
14
Image /page/14/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is plain white.
Non-Clinical performance testing confirmed the proposed DigitalDiagnost C90:
- Complies with the aforementioned international and FDA-recognized consensus standards.
- Meets the acceptance criteria of the non-standard performance tests and is adequate for its intended use.
The results of testing support that the proposed DigitalDiagnost C90 is substantially equivalent to the currently marketed and predicate device DigtalDiagnost C90 (K182973, January 11, 2019) in terms of safety and effectiveness.
The proposed DigitalDiagnost C90 did not require clinical study since substantial Summary of Clinical Data: 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; and
- . Safety and effectiveness.
Substantial The proposed DigitalDiagnost C90 is substantially equivalent to the currently Equivalence marketed predicate device DigtalDiagnost C90 (K182973, January 11, 2019) in terms Conclusion: of design features, fundamental scientific technology, indications for use, and safety and effectiveness.
Additionally, substantial equivalence was demonstrated with non-clinical performance (verification and validation) tests, which complied with the requirements specified in the international and FDA-recognized consensus standards, IEC 62304, IEC 62366 and ISO 14971. The results of these tests demonstrate that proposed DigitalDiagnost C90 met the acceptance criteria and is adequate for this intended use.