(384 days)
No
The summary describes a standard digital x-ray system with motorized movements and automatic focusing, but there is no mention of AI or ML in the device description, intended use, or performance studies. The image processing mentioned is likely standard digital image processing, not AI/ML-based analysis.
No
The device is described as a diagnostic imaging system (x-ray system) used for radiographic exams, which means it helps in diagnosing conditions rather than treating them.
Yes
Explanation: The device is an x-ray system, which is used to create images for diagnostic purposes. Its intended use states it is suitable for "all radiographic exams," and it mentions "image processing," both indicative of a diagnostic function.
No
The device description clearly outlines numerous hardware components including an X Twin stand, x-ray image receptor, collimator, x-ray tube, generator, and motorized movement systems. While it includes imaging software, it is an integral part of a physical x-ray system.
Based on the provided information, the X Twin device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the X Twin is a digital multifunctional x-ray system for radiographic exams. This involves generating images of the internal structures of the body using X-rays.
- Device Description: The description details the components of an X-ray system, including the X-ray tube, image receptor, generator, and associated hardware for positioning and control.
- Input Imaging Modality: The input modality is X-ray.
- Anatomical Site: It's used for imaging various parts of the body.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
The X Twin operates by generating and capturing X-ray images of the patient's body directly, not by analyzing samples taken from the body. Therefore, it falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The X Twin is intended to be used as a digital multifunctional x-ray system, suitable for all radiographic exams, including specialist areas like trauma or pediatric work, excluding mammography.
X Twin shall only be operated by qualified, trained professionals. The patient can be in sitting, lying or standing position.
The device is a permanently installed device and is intended to be operated in medical rooms with appropriate radiation protection only. It is not intended to be used with flammable anesthetic agents or in potentially explosive atmospheres.
Product codes
KPR
Device Description
The X Twin is a digital multifunctional x-ray system, in which an X Twin stand holds the xray image receptor, the collimator and the x-ray tube including the x-ray tube housing assembly. The generator, x-ray tube, beam limiting device, image receptor, including the workstation for image processing plus imaging software and the optional mobile x-ray table are known components. The geometry of the X Twin contains two guide frames, two support arms, an x-ray tube column and an image receptor column. The movements of the columns and the arms as well as the SID adjustment are motorized. The x-ray tube support arm as well as the image receptor support arm is provided with an integrated control unit, located at the front of the support arms. These units allow an adjustment of angle, height and distance of the image receptor and x-ray in relation to the patient. Simultaneously an integrated electronic control system provides automatic focusing of the image receptor and x-ray tube. Additionally an integrated touch display for indication of current values and additional control options is implemented in the tube support arm. The device receives its power from the x-ray generator.
An essential part of the X-ray system X Twin is the digital Flat Panel Image Detector. In the X Twin System is mounted the Digital X-ray Detector DFP4343C7. The Digital X-ray Detector DFP4343C7 is a medical image processing unit. Especially, advanced digital imaging process allows considerably efficient diagnosis, all kind of information management, real-time sharing of image information on network. DFP4343C7 is a highresolution digital imaging detector, designed for general radiography. The X-ray Conversion Layer consists of Cesium lodide (CsI) with Amorphous Silicon (a-Si) Photodiode. The active area has a size of 430(H)x439(V)mm (16.9×17.3 inch), the Pixel Matrix has a size of 3008(H)x3072(V) with a Pixel Pitch of 143 µm.
The Cycle Time from Shot to Shot is 6sec.
The Digital X-ray Detector DFP4343C7 is released by the FDA in a 510 (k) process. The Release Number is K122589.
The software used in the X Twin consists of two systems:
X Twin Control Software: The X Twin Control Software controls only the motorized adjustment of angle, height and distance of the image receptor and x-ray in relation to the patient. These movements are only possible if corresponding switches are manually operated. When the switch is released, the movement is stopped immediately. Simultaneously an integrated electronic control system provides automatic focusing of the image receptor and x-ray tube. This function is also only possible during manually operated switches.
The angle and the SID is displayed on the control unit on the support arm of the X Twin. The control software controls also the emergency stop buttons ant the collision protection of the X Twin. The control software neither provides automatically movement actions nor does it take influence on the diagnosis.
Failures or latent design flaws are unlikely to cause any injury to the patient or operator. In accordance to the Guidance for Software used in Medical Devices Roesys has determined the Level of Concern of the X Twin Control software as Moderate.
Imaging Software DXRS: DXRS software is intended for acquisition, processing, viewing, printing, saving and transmittance of X-ray images to PACS server. DXRS software can retrieve patient data from other information systems (HIS/RIS).
DXRS software includes a main application (below referred to as SW application), its modules and utilities. SW application provides declared functionality. Modules and utilities provide additional functionality.
Brief description of the operation scenario: Operation scenario includes a sequence of actions described below. Manual input of patient data or its automatic retrieval using Worklist function. Acquisition of X-ray image by the detector manufacturer's service software, supplied with the detector. SW application displays recommended values of exposure parameters which operator can use to acquire an X-ray image of a specific body part. Recommended values are only displayed and do not define or influence exposure process in practice in any way.
Image processing is carried out manually to prepare images for diagnostics. Image processing includes zoom, navigation, flip and rotation, inversion, usage of collimators (program shutters) and adjustment of Window Width/Level. SW application also provides lateralization and a rollback function which removes results of actions applied to the image and brings image back to the initial state. As a result of post-processing operations, the image is ready to be displayed or to be used for diagnostic purposes.
Sending acquired X-ray images to a PACS server for storage
Printing images or creation of Patient Disks (if necessary)
In accordance to the Guidance for Software used in Medical Devices the Level of Concern for our device is Moderate. DXRS Software and the accompanying Digital X-Ray Detector DFP4343C7 are designed only for general radiographic systems. They are used neither in X-ray surgery nor mammography nor in life supporting systems. The DXRS software was part of the 510(k) Premarket Notification No. K122589.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not specified, suitable for "all radiographic exams"
Indicated Patient Age Range
Adult and pediatric subjects
Intended User / Care Setting
Qualified, trained professionals.
Medical rooms with appropriate radiation protection only.
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 Testing:
- IEC 60601-1
- IEC 60601-1-2
- IEC 60601-1-3 Test clauses: 7.6 Test for half-value layer, 8.5.2 Focal spot to image receptor distance, 12.4 Leakage radiation
- IEC 60601-2-54
- ISO 10993 Result of the biocompatibility Tests: There was no evidence found that the surfaces of the X Twin system may cause skin irritations or similar negative effects on the patient. The observed surface coatings are used on similar medical devices for 10 years, during this time was no case regarding skin irritation was known.
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices: The documentation and testing of the X Twin Control Software was classified and performed as Moderate. The documentation and testing of the Imaging Software DXRS was also performed in accordance to this guidance. This software is part of the Image Detector DFP4343C7 and is already released (K122589).
- Regarding the Image Detector DFP4343C7, a separate Non-Clinical performance testing was performed by NIPK Electron as 510(k) Applicant. The performance testing was performed according to Section VI of the Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices. All test results were satisfactory.
Clinical Performance Testing:
- Roesys GmbH did not perform any clinical testing for the X Twin.
- Regarding the Image Detector DFP4343C7, a Clinical Performance Testing was performed by NIPK Electron as 510(k) Applicant. The performance testing was performed according to Section VII of the Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices. All test results were satisfactory.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized emblem. The emblem depicts a stylized caduceus, a symbol often associated with healthcare, with a triple helix design representing the interconnectedness of health and human services. The text is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 3, 2014
Roesys GmbH % Mr. Jochen Dyszbalis Quality Manager Dr .- Max-Ilgner-Str. 2 Espelkamp, Nordrhein-Westfalen 32339 GERMANY
Re: K133496
Trade/Device Name: X Twin System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: October 22, 2014 Received: October 24, 2014
Dear Mr. Dyszbalis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
for
Janine M. Morris 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) K133496
Device Name X Twin System
Indications for Use (Describe)
The X Twin is intended to be used as a digital multifunctional x-ray system, suitable for all radiographic exams, including specialist areas like trauma or pediatric work, excluding mammography.
X Twin shall only be operated by qualified, trained professionals. The patient can be in sitting, lying or standing position.
The device is a permanently installed device and is intended to be operated in medical rooms with appropriate radiation protection only. It is not intended to be used with flammable anesthetic agents or in potentially explosive atmospheres.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
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:
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4
510(k) Summary
Name and Address of manufacturer:
Roesys GmbH Dr.-Max-Ilgner-Straße 2 32339 Espelkamp Germany
Owner/Operator Number: 10045270
Name, title and phone number of official correspondent: Jochen Dyszbalis Quality Manager +49 5772 91555 00
| Date of preparation: | November 11, 2013 |
|---|---|
| ---------------------- | ------------------- |
Device Identification:
| Device Trade Name: | X Twin |
|---|---|
| Common Name: | General purpose diagnostic X-ray unit |
Classification of the device:
| Device Classification Name: | System, X-ray, Stationary |
|---|---|
| Product Code: | KPR |
| Device Classification No.: | Part 892.1680 |
| Panel: | Radiology |
| Regulatory Status: | Class II |
Predicate device:
Device Trade Name: Applicant: 510(k) No.:
Essenta DR Philips Medical Systems DMC GmbH K070528
Device Description:
X Twin
The X Twin is a digital multifunctional x-ray system, in which an X Twin stand holds the xray image receptor, the collimator and the x-ray tube including the x-ray tube housing
5
assembly. The generator, x-ray tube, beam limiting device, image receptor, including the workstation for image processing plus imaging software and the optional mobile x-ray table are known components. The geometry of the X Twin contains two guide frames, two support arms, an x-ray tube column and an image receptor column. The movements of the columns and the arms as well as the SID adjustment are motorized. The x-ray tube support arm as well as the image receptor support arm is provided with an integrated control unit, located at the front of the support arms. These units allow an adjustment of angle, height and distance of the image receptor and x-ray in relation to the patient. Simultaneously an integrated electronic control system provides automatic focusing of the image receptor and x-ray tube. Additionally an integrated touch display for indication of current values and additional control options is implemented in the tube support arm. The device receives its power from the x-ray generator.
Imaqinq Device
An essential part of the X-ray system X Twin is the digital Flat Panel Image Detector. In the X Twin System is mounted the Digital X-ray Detector DFP4343C7. The Digital X-ray Detector DFP4343C7 is a medical image processing unit. Especially, advanced digital imaging process allows considerably efficient diagnosis, all kind of information management, real-time sharing of image information on network. DFP4343C7 is a highresolution digital imaging detector, designed for general radiography. The X-ray Conversion Layer consists of Cesium lodide (Csl) with Amorphous Silicon (a-Si) Photodiode. The active area has a size of 430(H)x439(V)mm (16.9×17.3 inch), the Pixel Matrix has a size of 3008(H)x3072(V) with a Pixel Pitch of 143 µm.
The Cycle Time from Shot to Shot is 6sec.
The Digital X-ray Detector DFP4343C7 is released by the FDA in a 510 (k) process. The Release Number is K122589.
Software
The software used in the X Twin consists of two systems:
X Twin Control Software ●
The X Twin Control Software controls only the motorized adjustment of angle, height and distance of the image receptor and x-ray in relation to the patient. These movements are only possible if corresponding switches are manually operated. When the switch is released, the movement is stopped immediately. Simultaneously an integrated electronic control system provides automatic focusing of the image receptor and x-ray tube. This function is also only possible during manually operated switches.
The angle and the SID is displayed on the control unit on the support arm of the X Twin. The control software controls also the emergency stop buttons ant the collision protection of the X Twin. The control software neither provides automatically movement actions nor does it take influence on the diagnosis.
Failures or latent design flaws are unlikely to cause any injury to the patient or operator. In accordance to the Guidance for Software used in Medical Devices Roesys has determined the Level of Concern of the X Twin Control software as Moderate.
6
Imaging Software DXRS .
DXRS software is intended for acquisition, processing, viewing, printing, saving and transmittance of X-ray images to PACS server. DXRS software can retrieve patient data from other information systems (HIS/RIS).
DXRS software includes a main application (below referred to as SW application), its modules and utilities. SW application provides declared functionality. Modules and utilities provide additional functionality.
Brief description of the operation scenario
Operation scenario includes a sequence of actions described below. Manual input of patient data or its automatic retrieval using Worklist function. Acquisition of X-ray image by the detector manufacturer's service software, supplied with the detector. SW application displays recommended values of exposure parameters which operator can use to acquire an X-ray image of a specific body part. Recommended values are only displayed and do not define or influence exposure process in practice in any way.
Image processing is carried out manually to prepare images for diagnostics. Image processing includes zoom, navigation, flip and rotation, inversion, usage of collimators (program shutters) and adjustment of Window Width/Level. SW application also provides lateralization and a rollback function which removes results of actions applied to the image and brings image back to the initial state. As a result of post-processing operations, the image is ready to be displayed or to be used for diagnostic purposes.
Sending acquired X-ray images to a PACS server for storage
Printing images or creation of Patient Disks (if necessary)
In accordance to the Guidance for Software used in Medical Devices the Level of Concern for our device is Moderate. DXRS Software and the accompanying Digital X-Ray Detector DFP4343C7 are designed only for general radiographic systems. They are used neither in X-ray surgery nor mammography nor in life supporting systems. The DXRS software was part of the 510(k) Premarket Notification No. K122589.
Intended Use:
The X Twin is intended to be used as a digital multifunctional x-ray system, suitable for all radiographic examinations including specialist areas like trauma or pediatric work, excluding mammography.
X Twin shall only be operated by qualified, trained professionals. The patient can be in sitting, lying or standing position.
The device is a permanently installed device and is intended to be operated in medical rooms with appropriate radiation protection only. It is not intended to be used with flammable anesthetic agents or in potentially explosive atmospheres.
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Table 1: Substantial Equivalence Chart
| Substantial Equivalent Device | Predicate Device | ||
|---|---|---|---|
| X Twin | Essenta DR (K070528) | ||
| Intended Use | The X Twin is intended to be used | ||
| as a digital multifunctional x-ray | |||
| system, suitable for all radiographic | |||
| exams, including specialist areas | |||
| like trauma or pediatric work, | |||
| excluding mammography. | |||
| X Twin shall only be operated by | |||
| qualified, trained professionals. The | |||
| patient can be in sitting, lying or | |||
| standing position. | |||
| The device is a permanently | |||
| installed device and is intended to | |||
| be operated in medical rooms with | |||
| appropriate radiation protection | |||
| only. It is not intended to be used | |||
| with flammable anesthetic agents | |||
| or in potentially explosive | |||
| atmospheres. | The ESSENTA DR is a digital | ||
| multifunctional X-ray system, | |||
| suitable for all routine | |||
| radiographic exams, including | |||
| specialist areas like trauma or | |||
| pediatric work, excluding | |||
| mammography. It is designed | |||
| for radiographic examination of | |||
| the standing or seated patient | |||
| or the recumbent patient in | |||
| combination with a mobile x- | |||
| ray table (trolley). The system | |||
| is intended for direct digital | |||
| imaging using the built in flat | |||
| panel detector and in addition | |||
| for free exposures on | |||
| radiographic cassettes. | Similar | ||
| Target | |||
| population | Adult and pediatric subjects | Adult and pediatric subjects | Equivalent |
| Operator | Qualified trained professionals | Qualified/trained doctor or | |
| technicians | Equivalent | ||
| Energy | |||
| Source | 400 V / 480 V ± 10%, 50/60 Hz | 400 V / 480 V ± 10%, 50/60 Hz | Equivalent |
| Power | |||
| consumption | 24 - 44 kVA | 50 - 80 kVA | Advanced, the |
| power | |||
| consumption is | |||
| reduced, but the | |||
| X-Ray | |||
| parameters are | |||
| similar | |||
| Maximum | |||
| output | Depends on chosen generator | ||
| model. | Depends on model of | ||
| generator chosen. | |||
| Models are available from 50 | |||
| kW to 80 kW. | Equivalent | ||
| User | |||
| Interface | Software Driven Touch Panel LCD |
- two individual control units
located at each support arm (one is
a wired remote control) | Software Driven Touch Panel
LCD, - remote control unit | Similar |
| Columns | Two columns (tube & receptor).
Guide frame mounted on floor | One main column.
Floor or wall mounted support | Different, but
does not
concern safety
or efficacy |
| Tube mount | Fixed to a tube column, arm can
rotate
Automatic focusing by an integrated
control system | Fixed with respect to receptor,
arm can rotate | Advanced |
| Receptor
mount | Fixed to a receptor column, arm
can rotate
Automatic focusing by an integrated
control system | Fixed on same column as tube
head | Difference:
Fixed to a
separate
column;
Does not
concern safety
or efficacy |
| Method of
control | Software Driven Touch Panel LCD, - two individual control units
located at each support arm
(one is a wired remote control) | Software Driven Touch Panel
LCD, - remote control unit
- Detector control unit | Similar |
| Electrical
safety | IEC 60601-1 | IEC 60601-1 | Equivalent |
| Source-to-
image
distance
(SID) | vertical: 40 -110 cm (16-44")
horizontal: 100-200 cm (40-79")
(also continuously adjustable and
dual speed motorized) | 110-200 cm (43-79")
continuously adjustable
(dual speed motorized
movement) | Advanced |
| Vertical
travel | 1,600 mm (63") | 1,330 mm (4' 4.4") | Equivalent |
| Longitudinal
travel | 100 cm (40")
(each column) | None | Advanced |
| Rotation
angle | ± 100°
(each arm) | -30° to +135° | Different, but
does not
concern safety
or efficacy |
| Total weight | 175 kg +410 kg = 585 kg
(1x 1290 lb)
(Guide frame with column + Vertical
pillar) | 300 kg (661.5 lb) | Different, but
does not
concern safety
or efficacy |
| Image
Detector | Electronic flat detector with High
Stability Scinitillator
Active detector area: 35 cm x 43
cm (14" x 17") with rotatable
detector carrier
lmage matrix size: 1920 pixel x
2367 pixel
Pixel size: 182 µm, with a pixel
depth of 14 bits | Flat Panel Detector with
Cesium lodide (Csl) for X-ray
scintillator
Active detector area: 43 cm x
43 cm (16.9" x 17.3") with
rotatable detector carrier
Image matrix size: 3008(H)
pixel x 3072(V) pixel
Pixel size: 143 µm, with a pixel
depth of 14 bits | Different, but
does not
concern safety
or efficacy |
8
9
Detailed description of the main differences between X Twin and the predicate Essenta DR:
| Power consumption: | The power consumption of the X Twin is lower than of the predicate
Essenta DR (24-44 kVA against 50-80 kVA).
This means that the twin X has better energy efficiency. The X-Ray
parameters are similar with the parameters of the Essenta DR, therefore
the difference does not concern safety or efficacy. |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Columns: | The difference of both systems is that the X Twin contains two moveable
columns and the Essenta DR has only one column.
The columns of the X Twin are motorized, positioned on floor mounted
guide frames. The column of the Essenta DR is fix floor or wall mounted.
The advantage of the X Twin is a higher flexibility for the positioning of
the system. Since the X-Ray imaging process is not affected from this
difference, it does not concern safety or efficacy. |
| Tube and Receptor
Mount: | The main difference in mounting the tube and the receptor is that these
components are fixed on an adjustable U-arm at the Essenta DR. The X
Twin uses separate arms, one for the tube and one for the receptor.
This allows the occasionally necessary recording with a beam path which
is not aligned at 90° to the Receptor. The advantage of the X Twin is a
higher flexibility for the positioning of the system. Since the X-Ray
imaging process is not affected from this difference, it does not concern
safety or efficacy. |
| Rotation Angle: | Both X-Ray systems have different rotation angles. The Essenta DR has
a rotation angle range of 165°, the X Twin has a rotation angle range of
200° (applicable for standard images: 180°). The advantage of this
difference is a higher flexibility for a wide range of examinations. Since
the X-Ray imaging process is not affected from this difference, it does
not concern safety or efficacy. |
| Total Weight: | The total weight of the X Twin is higher than the total weight of the
Essenta DR (difference: 285 kg / 628.5lb). The reason for this difference
is the second column with the second arm and the floor mounted guide
frames. Since these units are floor mounted, this difference does not
concern safety or efficacy. |
| Image Detector: | There are two differences between the used Image Detectors. The first
difference is the active detector area. The Predicate Essenta DR uses a
14" x 17" detector; the X Twin uses a 16.9″ x 17.3″ detector. This has the advantage
that even large organs such as thorax can be recorded on one image.
The second difference is the higher pixel resolution (Predicate 182 um -
X Twin 143 µm). This allows the creation of images with higher
resolution. An illustration of finer tissue structures is thus more feasible.) |
10
These main differences do concern safety or efficacy of the X Twin System neither individually nor in combination with each other.
Summary of Non-Clinical Performance Testing:
IEC 60601-1 IEC 60601-1-2 IEC 60601-1-3 Test clauses: 7.6 Test for half-value layer 8.5.2 Focal spot to image receptor distance 12.4 Leakage radiation IEC 60601-2-54 ISO 10993 Result of the biocompatibility Tests: There was no evidence found that the surfaces of the X Twin system may cause skin irritations or similar negative effects on the patient. The observed surface coatings are used on similar medical devices for 10 years, during this time was no case regarding skin irritation was known.
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices The documentation and testing of the X Twin Control Software was classified and performed as Moderate in accordance to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
The documentation and testing of the Imaging Software DXRS was also performed in accordance to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. This software is part of the Image Detector DFP4343C7, therefore the software is already released (see K122589).
Reqarding the Image Detector DFP4343C7 a separate Non-Clinical performance testing was performed by NIPK Electron as 510(k) Applicant.
The performance testing was performed according to Section VI of the Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices. All test results were satisfactory.
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Summary of Clinical Performance Testing:
Roesys GmbH did not perform any clinical testing for the X Twin.
Regarding the Image Detector DFP4343C7 a Clinical Performance Testing was performed by NIPK Electron as 510(k) Applicant.
The performance testing was performed according to Section VII of the Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices.
All test results were satisfactory.
12
Conclusion:
Roesys GmbH believes that the X Twin system is substantially equivalent to the currently legally marketed device. It does not introduce new indications for use, has the same technological characteristics and does not introduce new potential hazards or safety risks.