(23 days)
No
The summary describes a standard digital radiography system with image processing capabilities, but there is no mention of AI, ML, or related terms, nor any description of training or test sets typically associated with AI/ML development.
No
The device is described as generating radiographic images of human anatomy and is used for examinations, not for treating any condition or disease.
No.
The device is an imaging system used to generate radiographic images of human anatomy. It is not described as interpreting or analyzing these images for diagnostic purposes, nor does it provide diagnoses.
No
The device description explicitly lists multiple hardware components including a tube column with X-ray assembly, wall stand, patient table, high voltage generator, and acquisition and reviewing workstation.
Based on the provided information, the DuraDiagnost is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "generating radiographic images of human anatomy." This involves imaging the inside of the body, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details components like an X-ray assembly, wall stand, patient table, and workstation for image acquisition and viewing. These are all characteristic of medical imaging equipment, not devices used for laboratory testing of biological samples.
- Input Imaging Modality: The input is "Radiographic images," which are generated by X-rays passing through the body. IVD devices typically analyze biological samples.
IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment. The DuraDiagnost's function is to create images of the body itself, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. 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.
Product codes (comma separated list FDA assigned to the subject device)
KPR, MQB
Device Description
The DuraDiagnost is a flexible digital radiography (DR) system that is designed to provide fast and smooth radiography examinations of sitting, standing or lying patients.
The DuraDiagnost consist of the following components: Tube column with X-ray assembly, wall stand with detector carrier, patient table with detector carrier and floating table top, high voltage generator, and acquisition and reviewing workstation for post-processing, storage and viewing of images. Images may be transferred via a DICOM network for printing, storage and detailed review.
Mentions image processing
Yes
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 doctor or technician
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 verification and validation tests have been performed with regards to the intended use, the technical claims, requirement specifications, and the risk management results.
Non-clinical verification and validation test results demonstrate that DuraDiagnost:
- Complies with the aforementioned international . and FDA-recognized consensus standards and FDA guidance documents.
- meets the acceptance criteria and is adequate for ● its intended use.
Therefore, DuraDiagnost is substantially equivalent to the currently marketed and predicate DuraDiagnost (K141381, June 12, 2014) in terms of 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
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Philips Healthcare (Suzhou) Co., Ltd. % Ms. Mary Zhu Senior Regulatory Engineer No. 258, Zhong Yuan Road, Suzhou Industrial Park Suzhou, Jiangsu 215024 REPUBLIC OF CHINA
July 9, 2020
Re: K201640
Trade/Device Name: DuraDiagnost Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB Dated: June 1, 2020 Received: June 16, 2020
Dear Ms. Zhu:
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
Indications for Use
510(k) Number (if known) K201640
Device Name DuraDiagnost
Indications for Use (Describe)
The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) number: K201640
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:
Manufacturer: | June 01, 2020
Philips Healthcare (Suzhou) Co., Ltd.
No. 258, ZhongYuan Road, Suzhou Industrial Park, 215024
Suzhou, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA
Establishment Registration Number: 3009529630
2nd manufacturing site:
Philips Medical Systems Nederland B.V.
Veenpluis 6, 5684PC Best, The Netherlands
Establishment Registration Number: 3003768277 | |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Contact Person: | Mary Zhu
Senior Regulatory Engineer
Phone: +86-021-24128746(cell: +86-183-5113-2881)
Fax: +86-512-68018677
E-mail: Mary.ZHU@philips.com | |
| Device Name:
Classification: | DuraDiagnost
Classification Name: Stationary X-Ray System
Classification Regulation: 21CFR §892.1680
Classification Panel: Radiology
Device Class: Class II
Primary product code: KPR (System, X-Ray, Stationary)
Secondary code: MQB(21 CFR 892.1680) | |
| Predicate Device: | Trade Name: DuraDiagnost
Manufacturer: Philips Healthcare (Suzhou) Co., Ltd.
510(k) Clearance: K141381-June 12, 2014
Classification Regulation: 21 CFR, Part 892.1680
Classification Name: Stationary X-Ray System
Classification Panel: Radiology
Device Class: Class II
Product Code: KPR, MQB | |
| Reference Device 1: | Trade Name: MobileDiagnost WDR 2.2
Manufacturer: SEDECAL SA | |
| | 510(k) Clearance: | K191813- August 2, 2019 |
| | Classification Regulation: | 21CFR 892.1720 |
| | Classification Name: | Mobile x-ray system |
| | Classification Panel: | Radiology |
| | Device Class: | Class II |
| | Product Code | IZL, MQB |
| Reference Device 2: | Trade Name: | Philips Eleva Workspot with
SkyFlow |
| | Manufacturer: | Philips Medical Systems
DMC GmbH |
| | 510(k) Clearance: | K153318- December 22, 2015 |
| | Classification Regulation: | 21 CFR 892.1680 |
| | Classification Name: | Stationary X-Ray System |
| | Classification Panel: | Radiology |
| | Device Class: | Class II |
| | Product Code | MQB, LLZ |
| Reference Device 3: | Trade Name: | DigitalDiagnost C90 |
| | Manufacturer: | Philips Medical Systems
DMC GmbH |
| | 510(k) Clearance: | K182973- January 11, 2019 |
| | Classification Regulation: | 21CFR 892.1680 |
| | Classification Name: | Stationary X-Ray System |
| | Classification Panel: | Radiology |
| | Device Class: | Class II |
| | Product Code | MQB, KPR, LLZ |
| Device description: | The DuraDiagnost is a flexible digital radiography (DR) system that is designed to provide fast and smooth radiography examinations of sitting, standing or lying patients.
The DuraDiagnost consist of the following components: Tube column with X-ray assembly, wall stand with detector carrier, patient table with detector carrier and floating table top, high voltage generator, and acquisition and reviewing workstation for post-processing, storage and viewing of images. Images may be transferred via a DICOM network for printing, storage and detailed review. | |
| Indications for use: | The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the | |
4
Page 2 of 14
5
patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
The fundamental scientific technology utilized in the Fundamental scientific technology: DuraDiagnost and the currently marketed and predicate DuraDiagnost (K141381, June 12, 2014) is equivalent with regards to the functionality of the following components: Integrated tube column, patient table with a floating table top, high-voltage generator, dual-focus rotation anode X-Ray tube, manual beam limiting device, digital detector, wall stand and workstation for images post-processing, storage and viewing (See Table 1 comparing the DuraDiagnost to the currently marketed and predicate DuraDiagnost (K141381, June 12, 2014) provided below).
The outcome of this comparison demonstrates that the minor differences in the technological characteristics do not affect the safety or effectiveness of the DuraDiagnost when compared to the currently marketed and predicate DuraDiagnost (K141381, June 12, 2014).
The wireless portable detector of the DuraDiagnost is identical to the wireless portable detector (SkyPlate E) of the currently marketed and reference device 1, MobileDiagnost WDR 2.2 (K191813- August 2, 2019) manufactured by SEDECAL SA. Therefore, both the wireless portable detector (Skyplate E) of the DuraDiagnost and the currently marketed and reference device 1, MobileDiagnost WDR 2.2 employ identical fundamental scientific technology.
The DuraDiagnost and the currently marketed and Reference Device 3, DigitalDiagnost C90 (K182973- January 11, 2019) manufactured by Philips Medical Systems DMC GmbH are provided with identical; fixed RAD detector (Pixium 4343RCE), UNIQUE 2 Post Processing software and embedded Windows 10 operating system. Therefore, DuraDiagnost and the currently marketed and reference
6
device 3, DigitalDiagnost C90 employ identical fundamental scientific technology.
| Table 1 | |||
|---|---|---|---|
| Comparison of Technological Characteristics of Currently marketed and Predicate DuraDiagnost versus the DuraDiagnost | |||
| Feature | Predicate Device: | ||
| DuraDiagnost | |||
| (K141381) | Device: | ||
| DuraDiagnost | Comment | ||
| Basic information | |||
| Product Code | KPR & MQB | Identical | No difference; thus, |
| demonstrating SE. | |||
| Regulation No. | 21 CFR 892.1680 | Identical | No difference; thus, |
| demonstrating SE. | |||
| Device Class | II | Identical | No difference; thus, |
| demonstrating SE. | |||
| Electrical | |||
| Requirement | Input voltage: 3- phase, | ||
| 200/208/240/380/40 | |||
| 0/415/440/480/500V | |||
| ac; | |||
| Frequency:50/60Hz; | |||
| Current: | |||
| Short term: 112A (with | |||
| generator M-CABINET | |||
| CXA Pro 50kW), 134A | |||
| (with generator M- | |||
| CABINET CXA Pro | |||
| 65kW), 160A (with | |||
| generator M-CABINET | |||
| CXA Pro | |||
| 80kW); | |||
| Long term: 10A. | Input voltage: 3- phase, | ||
| 200/208/240/380/40 | |||
| 0/415/440/480/500V | |||
| ac; | |||
| Frequency:50/60Hz; | |||
| Current: | |||
| Short term: 112A (with | |||
| generator M-CABINET | |||
| CXA Pro 50kW), 134A | |||
| (with generator M- | |||
| CABINET CXA Pro | |||
| 65kW), | |||
| Long term: 10A. | Equivalent. The | ||
| DuraDiagnost and the | |||
| currently marketed and | |||
| predicate DuraDiagnost are | |||
| both provided with similar | |||
| electrical requirements. | |||
| Therefore, no impact on the | |||
| safety or effectiveness of the | |||
| device. Thus, demonstrating | |||
| SE. | |||
| Design characteristic | |||
| X-ray Tube | RO 1750 ROT 360 & | ||
| SRO 33100 ROT 360 | Identical | No difference; thus, | |
| demonstrating SE. | |||
| Max Tube | |||
| Voltage | 150kV | Identical | No difference; thus, |
| demonstrating SE. | |||
| Focal Spot Size | 0.6mm/1.2mm | Identical | No difference; thus, |
| demonstrating SE. | |||
| Tube Max power | 50KW/100KW | ||
| (250W equivalent anode | |||
| input power) | Identical | No difference; thus, | |
| demonstrating SE. | |||
| Anode Type | Rotation | Identical | No difference; thus, |
| demonstrating SE. | |||
| Generator | Philips Healthcare | ||
| (Suzhou), | |||
| M-CABINET CXA Pro | |||
| 50kW, | |||
| M-CABINET CXA Pro | |||
| 65kW, | |||
| M-CABINET CXA Pro | |||
| 80kW | Philips Healthcare | ||
| (Suzhou), | |||
| M-CABINET CXA Pro | |||
| 50kW, | |||
| M-CABINET CXA Pro | |||
| 65kW, | Equivalent. DuraDiagnost | ||
| and the currently marketed | |||
| and predicate DuraDiagnost | |||
| are both provided with | |||
| 50KW/65KW | |||
| generators. Thus, | |||
| demonstrating SE. | |||
| Max Power | 50KW/65KW/80KW | 50KW/65KW | |
| KV range | 40-150 | Identical | No difference; thus, |
| demonstrating SE. | |||
| Milli ampere sec | |||
| (mAs) product | 0.4 mAs-600 mAs (with | ||
| AEC control) | Identical | No difference; thus, | |
| demonstrating SE. | |||
| Collimator | |||
| Operation Mode | Manual collimation | Identical | No difference; thus, |
| demonstrating SE. | |||
| Shape of Beam | Rectangular | Identical | No difference: thus, |
| demonstrating SE. | |||
| Detector | |||
| Type | Digital Detector | ||
| • Fixed RAD Detector | |||
| • Wireless Static | |||
| Detector | Identical | No difference; thus, | |
| Demonstrating SE. | |||
| Fixed RAD | |||
| Detector | Pixium 4343RG | Pixium 4343RCE | |
| (Note: this detector is | |||
| identical to fixed RAD | |||
| detector of the currently | |||
| marketed and Reference | |||
| Device 3, DigitalDiagnost | |||
| C90 cleared under | |||
| K182973). | The difference between | ||
| 4343RCE and 4343RG is | |||
| scintillator material and other | |||
| minor differences of image | |||
| area and image matrix as | |||
| compared in this table. The | |||
| differences don't affect the | |||
| safety or effectiveness. | |||
| And the fixed RAD detector | |||
| Pixium 4343RCE of the | |||
| DuraDiagnost is identical to | |||
| the fixed RAD detector of the | |||
| currently marketed and | |||
| Reference Device 3, | |||
| DigitalDiagnost | |||
| C90(K182973- January 11, | |||
| 2019, Philips Medical | |||
| Systems DMC). | |||
| Thus, demonstrating SE | |||
| Wireless Static | |||
| Detector | • SkyPlate Large | ||
| (Trixell 3543EZ) | • SkyPlate Large (Trixell | ||
| 3543EZ) | The SkyPlate Large Detector | ||
| of the DuraDiagnost is | |||
| identical to the SkyPlate |
7
8
| | | | ● | SkyPlate E (Trixell
3543DR) (Note: this
detector is identical to
the Skyplate E
Detector of the
currently marketed and
reference device 1,
MobileDiagnost WDR
2.2 cleared under
K191813). | Large Detector of the
currently marketed and
Predicate DuraDiagnost
(K141381,
SkyPlate E is additionally
added dectector. There are
minor differences between
SkyPlate E and the Skyplate
Large detector of image area,
image matrix and pixel size as
compared in this table. The
minor differences don't affect
the safety or effectiveness.
And the Skyplate E Detector
of DuraDiagnost is identical
to the Skyplate E Detector of
the currently marketed and
reference device 1,
MobileDiagnost WDR 2.2
(K191813- August 2, 2019).
Thus, demonstrating SE |
|--------------------------------|--------------------------------------------------|------------------------------------------------|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| X-ray Scintillator
Material | ● | GdOS (Fixed: Pixium
4343RG) | ● | Cesium Iodide (Fixed:
Pixium 4343RCE.
Pixium 4343RCE is
identical to fixed RAD
detector of the
currently marketed and
Reference Device 3,
DigitalDiagnost C90
cleared under K182973
) | The fixed RAD detector of
the DuraDiagnost and
currently marketed and
Reference Device 3,
DigitalDiagnost
C90(K182973- January 11,
2019, Philips Medical
Systems DMC) are both
fabricated from identical
Cesium Iodide material , thus
demonstrating SE. |
| | ● | Cesium Iodide
(Wireless: SkyPlate
Large) | ● | Cesium Iodide
(Wireless: SkyPlate
Large and SkyPlate E) | The Wireless detector of the
DuraDiagnost and the
currently marketed and
predicate DuraDiagnost are
both fabricated from identical
Cesium Iodide material, thus
demonstrating SE. |
| Image Area | ● | 42.5cm x 42.5cm
(Fixed: Pixium
4343RG) | ● | 42.03cm x
42.54cm(Fixed:
Pixium 4343RCE) | The image area of the
DuraDiagnost, provided with
fixed RAD detector is |
| | 34.5cm x 42.1cm
(Wireless: SkyPlate
Large) | | 34.5cm x
42.1cm(Wireless:
SkyPlate Large) | identical to the image area of
the Fixed RAD Detector of
the currently marketed and
Reference Device 3,
DigitalDiagnost
C90(K182973- January 11,
2019, Philips Medical
Systems DMC), thus
demonstrating substantial
equivalence | |
| | | 34.5cm x
42.5cm(Wireless:
SkyPlate E) | | The image area of the
proposed DuraDiagnost,
provided with wireless
detector SkyPlate Large is
identical to the wireless
detector SkyPlate Large of the
currently marketed and
Predicate DuraDiagnost
(K141381). Thus,
demonstrating SE. | |
| | | | | The image area of the
proposed Wireless Detector
SkyPlate E is identical to the
Wireless Detector SkyPlate E
of the currently marketed and
reference device 1,
MobileDiagnost WDR 2.2
(K191813- August 2, 2019,
Sedecal SA,). thus
demonstrating SE | |
| Image Matrix | 2,874 x 2,869 (Fixed:
Pixium 4343RG) | | 2,874 x 2840 (Fixed:
Pixium 4343RCE) | The image matrix of the
proposed DuraDiagnost
Philips Medical Systems | |
| | 2330 x 2846
(Wireless-SkyPlate
Large) | | 2330 x 2846 (Wireless-
SkyPlate Large) | DMC, provided with fixed
RAD detector is identical to
the image matrix of the | |
9
10
| ● | 2156 x 2653 (Wireless-
SkyPlate E) | currently marketed and
Reference Device 3,
DigitalDiagnost
C90(K182973- January 11,
2019,). thus demonstrating
substantial equivalence. |
|---|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | The image matrix of the
DuraDiagnost
provided with the wireless
SkyPlate Large Detector is
identical to the wireless
SkyPlate Large of the
currently marketed predicate
Device DuraDiagnost,
(K141381). Thus
demonstrating SE. |
| | | The image matrix of the
DuraDiagnost provided with
wireless detector SkyPlate E
is similar to the currently
marketed and Reference
Device 1, MobileDiagnost
WDR 2.2 (K191813- August
2, 2019, Sedecal SA).
Infinitesimal change in the
image size (X-ray field) does
not impact clinical Image
Quality. Therefore, they are
equivalent and there is no
impact on the safety and
effectiveness of the device;
thus demonstrating SE. |
11
| Pixel Size | • 148 μm (Fixed: Pixium 4343RG)
• 148 μm(Wireless-SkyPlate Large) | • 148 μm (Fixed: Pixium 4343RCE)
• 148 μm(Wireless-SkyPlate Large)
• 160 μm (Wireless-SkyPlate E) | The pixel size of the proposed DuraDiagnost Philips Medical Systems DMC, provided with fixed RAD detector is identical to the pixel size of the currently marketed and Reference Device 3, DigitalDiagnost C90(K182973- January 11, 2019,). thus demonstrating substantial equivalence.
The pixel size of the DuraDiagnost provided with the wireless SkyPlate Large Detector is identical to the wireless SkyPlate Large of the currently marketed predicate Device DuraDiagnost, (K141381). Thus demonstrating SE.
The pixel size of the DuraDiagnost provided with wireless detector SkyPlate E is identical to the currently marketed and Reference Device 1, MobileDiagnost WDR 2.2 (K191813- August 2, 2019, Sedecal SA), thus demonstrating SE. |
|---------------------------------------|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analog / Digital (A/D) conversion | 16 bits | Identical | No difference; thus, demonstrating SE. |
| Table | | | |
| Table type | Fixed and Height adjustment | Height adjustment | The DuraDiagnost is provided with height adjustment table that is also provided with the currently marketed and predicate |
| | | | |
| Height adjustment | 51.5 cm to 75.0 cm above floor, motorized adjustment | 51.5 cm to 91.5 cm above floor, motorized adjustment | DuraDiagnost. Thus demonstrating SE.
The height adjustment of the proposed DuraDiagnost, provided with height adjustable table is identical to the currently marketed and Reference Device 3, DigitalDiagnost C90(K182973- January 11, 2019, Philips Medical Systems DMC). thus, demonstrating SE. |
| Tabletop longitudinal travel range | +/- 550mm | Identical | No difference; thus, demonstrating SE. |
| Tabletop Lateral travel | +/- 130mm | Identical | No difference; thus, demonstrating SE. |
| Loading (patient weight) | 210 Kg | Identical | No difference; thus, demonstrating SE. |
| Wall Stand | | | |
| Vertical movement range | 1500mm | Identical | No difference; thus, demonstrating SE. |
| Movement mode | Manual | Identical | No difference; thus, demonstrating SE.. |
| Tube Stand | | | |
| Type | Floor mounted | Identical | No difference; thus, demonstrating SE. |
| Tube rotation | +/- 120 degree | Identical | No difference; thus, demonstrating SE. |
| Longitudinal movement range | 1400mm | Identical | No difference; thus, demonstrating SE. |
| Source to Image Distance (SID) | | | |
| SID | Table: 40-115cm;
Wallstand: 110-245cm | Identical | No difference; thus, demonstrating SE. |
| External Connectivity | | | |
| DICOM | DICOM compatible | Identical | No difference; thus, demonstrating SE. |
| Software Platform | | | |
| Software | Eleva WorkSpot | Identical | No difference; thus, demonstrating SE. |
| SkyFlow Software | No | Yes | The DuraDiagnost includes the SkyFlow software that is also used in the currently marketed and Reference Device 3, Eleva Workspot with SkyFlow, (K153318- December 22, 2015, Philips Medical Systems DMC), thus, demonstrating SE. |
| Image Processing Algorithm | UNIQUE | UNIQUE 2 | UNIQUE 2 image processing algorithm provided with DuraDiagnost was |
| | | previously cleared with the
currently marketed and
Reference Device 3,
DigitalDiagnost C90
(K182973- January 11, 2019,
Philips Medical Systems
DMC).
Upgrading to UNIQUE2
image processing algorithm
does not alter the clinical
workflow, hence no impact on
the safety or effectiveness of
the device; thus,
demonstrating SE | |
| Operating System | Windows 7 embedded | Windows 10 embedded
Introduction of operating
system Windows 10
embedded does not impact
clinical image quality.
Therefore, there is no impact
on the safety and
effectiveness of the device;
thus, demonstrating SE. | |
DuraDiagnost Premarket Notification- Special 510(k)
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DuraDiagnost Premarket Notification- Special 510(k)
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Based on the information provided above, the DuraDiagnost is considered substantially equivalent to the currently marketed and predicate DuraDiagnost (K141381, June 12, 2014) in terms of fundamental scientific technology.
Summary of Non-Clinical This 510(k) premarket notification contains the technical Performance data: documentation, which demonstrates that the DuraDiagnost is substantially equivalent to the currently marketed and predicate DuraDiagnost (K141381, June 12, 2014). The technical documentation includes nonclinical verification / validation tests. These tests were performed on the DuraDiagnost according to the following international and FDA-recognized consensus standards:
- · International and FDA-recognized consensus standards:
- AAMI / ANSI ES60601-1: 2005/(R)2012 and . C1:2009/(R)2012 and, A2:2010/(R)2012 (consolidated text) Medical electrical equipment -Part 1: General requirements for basic safety and essential performance. (Edition 3.1). FDA/CDRH recognition number 19-4.
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- IEC 60601-1-2, Medical electrical equipment -● Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Disturbances - Requirements and tests (Edition 4.0 2014). FDA/CDRH recognition number 19-8.
- . IEC 60601-1-3, Medical Electrical Equipment Part 1-3: General Requirements for Basic Safety and Essential Performance-Collateral Standard: Radiation Protection in Diagnostic X-Ray Equipment. (Edition 2.1 2013). FDA/CDRH recognition number 12-269.
- IEC60601-2-28 Medical electrical equipment -● Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis, (Edition 2.0 2010-03). FDA/CDRH recognition number 12-204.
- IEC 60601-2-54, Medical Electrical Equipment-. Part 2-54: Particular Requirements for the Basic Safety and Essential Performance of X-Ray Equipment for Radiography and Radioscopy (Edition 1.1 2015). FDA/CDRH recognition number 12-296.
- IEC 60601-1-6, Medical Electrical Equipment ● Part 1-6: General Requirements for Basic Safety and Essential Performance- Collateral Standard: Usability (Edition 3.1 2013). FDA/CDRH recognition number 5-89.
- IEC 62304 Medical device software Software ● life cycle processes (Edition 1.1 2015) FDA/CDRH recognition number 13-79
- IEC 62366-1 Medical devices Part 1: ● Application of usability engineering to medical devices (Edition 1.0 2015). FDA/CDRH recognition number 5-114.
- ISO 14971 Medical devices Application of risk ● management to medical devices (Edition 2.0, corrected version, 2007). FDA/CDRH recognition number 5-40.
- · CFR 1020.30 Diagnostic x-ray systems and their major components.
- · CFR 1020.31 Radiographic equipment.
- · Device specific guidance document, entitled "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices - September 1, 2016"
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- · FDA's Guidance document entitled, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - May 11, 2005."
- · FDA's Guidance document entitled, "Guidance for Industry and FDA Staff - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" ,issued October 2, 2014
- · Pediatric Information for X-ray Imaging Device Premarket Notifications, issued November 28, 2017
Non-clinical verification and validation tests have been performed with regards to the intended use, the technical claims, requirement specifications, and the risk management results.
Non-clinical verification and validation test results demonstrate that DuraDiagnost:
- Complies with the aforementioned international . and FDA-recognized consensus standards and FDA guidance documents.
- meets the acceptance criteria and is adequate for ● its intended use.
Therefore, DuraDiagnost is substantially equivalent to the currently marketed and predicate DuraDiagnost (K141381, June 12, 2014) in terms of safety and effectiveness.
Summary of Clinical Data: The DuraDiagnost does not require clinical study since substantial equivalence to the primary currently marketed and predicate device was demonstrated with the following attributes:
- . Indication for use;
- Fundamental scientific technology; ●
- Non-clinical performance testing; and
- Safety and effectiveness. .
Furthermore, the SkyPlate E detector and Pixium 4343RCE detector utilizes the same design, technology and Image acquisition workflow compared to the previously Skyplate Large detector and Pixium 4343RG
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the marketed and detector used in predicate DuraDiagnost (K141381, June 12, 2014). 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.
Substantial Equivalence The DuraDiagnost is substantially equivalent to the Conclusion: currently marketed and predicate DuraDiagnost (K141381, June 12, 2014) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.
Additionally, substantial equivalence was demonstrated non-clinical performance (verification with and validation) tests, which complied with the requirements specified in the international and FDA-recognized consensus standards, ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, IEC 60601-1-6, IEC 60601-2-28, IEC 62304, and IEC 62366-1.
The results of these tests demonstrate that DuraDiagnost met the acceptance criteria and is adequate for its intended use.