(25 days)
No
The description focuses on the hardware and process of scanning PSPs, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as a dental device used for scanning and processing digital images from X-ray exposures, which aids in diagnosis and image storage, not direct treatment.
Yes
The device scans and processes digital images exposed on Phosphor Storage Plates (PSPs) from dental X-rays, which are then displayed for clinicians to view. This process provides visual information that aids in the diagnosis of dental conditions.
No
The device description clearly outlines hardware components like a laser, MEMS mirror, optical sensor (PMT), LED-PCB, and plate inserts, which are integral to the device's function of scanning and processing images from phosphor plates. While software is mentioned (firmware, image processing), the device is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for "scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications." This involves imaging the internal structures of the body (teeth and surrounding tissues) using X-rays, which is an in vivo process.
- Device Description: The description details how the device reads images from plates that have been exposed to X-rays in the mouth of the patient. This confirms the in vivo nature of the data acquisition.
- Anatomical Site: The anatomical site is "Dental," which refers to a part of the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) outside of the body to provide information for diagnosis, monitoring, or treatment.
IVDs are specifically designed to perform tests on biological samples in vitro (outside the living organism). This device is used to process images obtained in vivo (within the living organism).
N/A
Intended Use / Indications for Use
The ScanX Swift 2.0 is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.
The ScanX Swift View 2.0 is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.
Product codes
MUH
Device Description
The ScanX Swift 2.0 and ScanX Swift View 2.0 are dental devices that scan photostimulable phosphor storage plates that have been exposed in place of dental X-Ray film and allows the resulting images to be displayed on a personal computer monitor and stored for later recovery. It will be used by licensed clinicians and authorized technicians for this purpose. The device is an intraoral Plate Scanner, which is designed to read out all cleared plates of the sizes 0, 1, 2, 3, and 4. The phosphor plates are made of rigid photostimulable material. Intraoral phosphor plate x-ray (also known as phosphor storage plate or PSP x-ray) eliminates the need for traditional film processing for dental radiography. Phosphor storage plates can convert existing film based imaging systems to a digital format that can be integrated into a computer or network system. The intraoral Plates are put into the mouth of the patient, exposed to X-rays and then are read out with the device. The read-out-process is carried out with a 639nm Laser. The laser beam is moved across the plate by an oscillating MEMS mirror. The laser beam stimulates the top coating of the plates, which consists of x-ray sensitive material. Depending on the exposed dose, the coating emits different levels of light. These light particles are then requisitioned by an optical sensor (Photo Multiplier Tube/ PMT) and transferred into an electrical output signal is digitalized and is the data for the digital X-ray image. The data is transmitted via an Ethernet link to a computer. Before the plate is discharged, the remaining data is erased by a LED-PCB. The user chooses which size of plate he has to use and prepares the device by inserting the appropriate plate insert into the device. He then exposes the plate and then puts the plate directly into the insert by pushing it out of the light protection envelope. The user closes the light protection cover and starts the read out process. After the read out process the picture is transmitted to the connected PC, the picture can be viewed and the IP is erased and ready to use for the next acquisition. The main difference between the two models is on the ScanX Swift View 2.0 the display is larger, has touch capability, and can show a preview of the scan image. The device firmware is based on the predicate firmware and is of a moderate level of concern.
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
licensed clinicians and authorized technicians
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)
Risk analysis and software validation was successfully performed. Cybersecurity issues were addressed by observance of the recommendations in the FDA Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Druq Administration Staff. MTF, DQE, and image resolution performance testing was performed in accordance with IEC 6220-1:2003. The results were measured values, not theoretical. Noise power spectrum measurements were documented. Clinical performance testing was not required to establish substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
MTF: Horizontal 59% Vertical 49% at 3LP/mm in 12.5µm pixel size mode
DQE: Horizontal 8.5%, Vertical 10.5% at 3LP/mm in 12.5µm pixel size mode with an exposure of 99µGy
Max. theoretical resolution: Approx. 40 Lp/mm
Image bit depth: 16 bits
Predicate Device(s)
Reference Device(s)
K192743, K170733, K203287, K213326
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
0
Image /page/0/Picture/0 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 6, 2023
Durr Dental SE % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114
Re: K230095
Trade/Device Name: ScanX Swift 2.0, ScanX Swift View 2.0 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: January 9, 2023 Received: January 12, 2023
Dear Mr. Kamm:
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
1
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 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 medical devices and radiation-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,
Lu Jiang
2023.02.06
16:03:19
-05'00'
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230095
Device Name ScanX Swift 2.0, ScanX Swift View 2.0
Indications for Use (Describe)
The ScanX Swift 2.0 is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.
The ScanX Swift View 2.0 is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental 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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510(k) Summary, DURR DENTAL SE K230095
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
Date Summary Prepared: January 25, 2023 1. Submitter's Identification:
DURR DENTAL SE Höpfigheimer Strasse 17 74321 Bietigheim-Bissingen Deutschland/Germany Tel: +49 (0) 71 42 70 5-0 Fax: +49 (0) 71 42 705-500 E-Mail info@duerr.de Internet: www.duerrdental.com
Submitter Contact: Mr. Oliver Lange Director of Quality Management DÜRR DENTAL SE Höpfigheimer Str. 17 74321 Bietigheim-Bissingen, Germany Phone: + 49 (0) 7142 70 5-190 Email: oliver.lange@duerrdental.com
U.S. Agent and Contact: Mr. Joseph Latkowski Director of Quality and Regulatory Air Techniques, Inc. 1295 Walt Whitman Road Melville, NY 11747, USA U.S. Phone: 516-214-5574 E-Mail: Joseph.Latkowski@airtechniques.com
-
- Device Name:
| Trade /Proprietary Name: | ScanX Swift 2.0, ScanX Swift View 2.0 |
|---|---|
| Regulation Number: | 21 CFR 872.1800 |
| Regulation Name: | Extraoral source x-ray system |
| Regulatory Class: | II |
| Product Code: | MUH |
- Legally Marketed Predicate Device Information:
| Trade/Device Name: | K202633, ScanX Edge |
|---|---|
| Regulation Number: | 21 CFR 872.1800 |
| Regulation Name: | Extraoral source x-ray system |
| Regulatory Class: | II |
| Product Code: | MUH |
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4. Device Description:
The ScanX Swift 2.0 and ScanX Swift View 2.0 are dental devices that scan photostimulable phosphor storage plates that have been exposed in place of dental X- Ray film and allows the resulting images to be displayed on a personal computer monitor and stored for later recovery. It will be used by licensed clinicians and authorized technicians for this purpose. The device is an intraoral Plate Scanner, which is designed to read out all cleared plates of the sizes 0, 1, 2, 3, and 4. The phosphor plates are made of rigid photostimulable material. Intraoral phosphor plate x-ray (also known as phosphor storage plate or PSP x-ray) eliminates the need for traditional film processing for dental radiography. Phosphor storage plates can convert existing film based imaging systems to a digital format that can be integrated into a computer or network system. The intraoral Plates are put into the mouth of the patient, exposed to X-rays and then are read out with the device. The read-out-process is carried out with a 639nm Laser. The laser beam is moved across the plate by an oscillating MEMS mirror. The laser beam stimulates the top coating of the plates, which consists of x-ray sensitive material. Depending on the exposed dose, the coating emits different levels of light. These light particles are then requisitioned by an optical sensor (Photo Multiplier Tube/ PMT) and transferred into an electrical output signal is digitalized and is the data for the digital X-ray image. The data is transmitted via an Ethernet link to a computer. Before the plate is discharged, the remaining data is erased by a LED-PCB. The user chooses which size of plate he has to use and prepares the device by inserting the appropriate plate insert into the device. He then exposes the plate and then puts the plate directly into the insert by pushing it out of the light protection envelope. The user closes the light protection cover and starts the read out process. After the read out process the picture is transmitted to the connected PC, the picture can be viewed and the IP is erased and ready to use for the next acquisition. The main difference between the two models is on the ScanX Swift View 2.0 the display is larger, has touch capability, and can show a preview of the scan image. The device firmware is based on the predicate firmware and is of a moderate level of concern.
- Indications for use: (Identical for two models, same as predicate) The ScanX Swift 2.0 is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications. The ScanX Swift View 2.0 is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.
-
- Summary of the technological characteristics of the device compared to the predicate device: The ScanX Swift 2.0 / ScanX Swift View 2.0 is a device that scans photostimulable phosphor storage plates that have been exposed in place of x-ray film and allows the resulting images to be displayed on a personal computer monitor. Safety concerns associated with the ScanX Swift View 2.0 were addressed by safety testing the device according to recognized consensus standards as listed in the section below: "List of Applied Standards". Design changes and risks associated with the introduction of the ScanX Swift View 2.0 were properly mitigated by DURR DENTAL SE's cGMP compliant Quality Management System, change control processes, risk assessments, and product validation. The ScanX Swift View 2.0 contains a Class 1 Laser Device as defined by 21 CFR 1040.10. The modified units employ RFID in the same manner as the predicate. Installation and operation manuals are provided with instructions for safe use and servicing of the ScanX Swift 2.0 / ScanX Swift View 2.0. The ScanX Swift View 2.0 is a non-patient contact Class II medical device.
-
- Equivalence to Predicate Device Summary:
DURR DENTAL SE's ScanX Swift 2.0 / ScanX Swift View 2.0 units are identical in function, and intended use to the DURR DENTAL SE ScanX Edge K202633. All three units capture, digitize, and process intraoral x-ray images that are stored in imaging plate recording media. The technological characteristics, including design, materials, composition, and energy source, are substantially the same, so there are no issues impacting safety and effectiveness. Both units have the convenience of RFID capability. The main difference is the addition of compatible plate sizes: Size 3: 27 x 54 mm and Size 4: 57 x 76 mm. Refer to the substantial equivalence comparison table below..
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| Device | Predicate device | Subject devices | Subject devices | Change Impact
Analysis |
|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade name | ScanX Edge | ScanX Swift 2.0 | ScanX Swift View 2.0 | --- |
| Model Name | ScanX Edge | XPS07.1A1 | XPS07.2A1 | --- |
| Clearance | K202633 | --- | --- | --- |
| Device Picture | Image: ScanX Edge | Image: ScanX Swift 2.0 | Image: ScanX Swift View 2.0 | Different. |
| Indications for
Use | The ScanX Edge is intended to be
used for scanning and processing
digital images exposed on Phosphor
Storage Plates (PSPs) in dental
applications. | The ScanX Swift 2.0 is intended to
be used for scanning and
processing digital images exposed
on Phosphor Storage Plates (PSPs)
in dental applications. | The ScanX Swift View 2.0 is intended
to be used for scanning and
processing digital images exposed on
Phosphor Storage Plates (PSPs) in
dental applications. | Identical. |
| Operating
principle | The PSPs are put into the mouth of the
patient, exposed to X-rays, and then
are read out with the device. The read-
out-process is carried out with a 639
nm Laser. The laser beam stimulates
the top coating of the plates, which
consists of x-ray sensitive material.
Depending on the exposed dose, the
coating emits different levels of light.
These light particles are then
requisitioned by an optical sensor and
transferred into an electrical output
signal. This signal is digitalized and is
the data for the digital X-ray image. | The PSPs are put into the mouth of the patient, exposed to X-rays, and
then are read out with the device. The read-out-process is carried out
with a 639 nm Laser. The laser beam stimulates the top coating of the
plates, which consists of x-ray sensitive material. Depending on the
exposed dose, the coating emits different levels of light. These light
particles are then requisitioned by an optical sensor and transferred into
an electrical output signal. This signal is digitalized and is the data for the
digital X-ray image. | | Identical. |
| | | Technical equivalence: | | |
| Device | Predicate device | Subject devices | Change Impact
Analysis | |
| Data transfer | The data is transmitted via an
Ethernet link. | The data is transmitted via an Ethernet link to a computer. With the
XPS07.2A1 the data can alternatively be transferred by a WLAN
interface or being stored on a removeable storage medium. | Similar. | |
| Erasing the
residual image
following
scanning for
plate reuse | After the scanning process, the
remaining data is erased by a LED
light. | After the scanning process, the remaining data is erased by a LED
light. | Identical. | |
| Display | The ScanX Edge does not have a
screen / display.
The device state is indicated via
status LEDs lights on the device. | 2.4"-Display
The display does not show
preview images.
5"-Touch Display: The touch
screen only shows a preview
which serves to provide an initial
impression of the final x-ray
image. For the purposes of
diagnosis, the x-ray image must be
viewed on a diagnostic PC
monitor.
Diagnostic monitor = PC monitor.
The scanner itself is not used for
diagnosis. | Similar. | |
| Imaging scanning | Laser / Photomultiplier Tube (PMT)
Components:
Photomultiplier 2"
Diode, Laser 639nm/10mW Fiber
coupled laser diode | Laser / Photomultiplier Tube (PMT)
Components: Photomultiplier 2"
Diode, Laser 639nm/10mW Fiber coupled laser diode | Identical. | |
| Plate guide | A specific plate guide for each PSP
size is available, thus the user
chooses which size of PSP he wants
to use and prepares the device by
inserting the appropriate plate guide
into the device. | A specific plate guide for each PSP size is available, thus the user chooses
which size of PSP he wants to use and prepares the device by inserting the
appropriate plate guide into the device. | Identical. | |
| Device | Predicate device | Subject devices | Change Impact
Analysis | |
| Transport / feed
mechanism | The plates are inserted into a size
specific interchangeable insert. If
the user wants to scan a different
plate size, the insert needs to be
exchanged. The insert is used to
transport the plate into the
scanning position. During the
scanning process the plate is not
move. Upon completion of the
scanning. | The plates are inserted into a size specific interchangeable plate
guide. If the user wants to scan a different plate size, the plate guide
needs to be exchanged.
The plate is transported beltway down the axis of the cylinder past
the slot. The motion of the laser and plates provides the two
orthogonal scan directions. This is a continuous feed device that
allows successive plates to be loaded as soon as the previous plates
have moved past the slot. | Similar.
The solutions for
the plate guides
have evolved for
ScanX Swift 2.0
and ScanX Swift
View 2.0. The
feed and
transport are
equivalent. | |
| WLAN (Wi-Fi) | No | Yes | Different. Added
interface
flexibility | |
| Ethernet | Yes | Yes | SAME | |
| RFID | Supports image plates with RFID
Tags. The information on the RFID
tag is used to identify the image
plate. | Supports image plates with RFID
Tags. The information on the
RFID tag is used to identify the
image plate. | Identical.
The RFID image
plates are
identical. | |
| Device | Predicate device | Subject devices | Change Impact
Analysis | |
| Operation /
Function | The image plate scanner is used
to read image data stored on an
image plate and to transfer the
data to the imaging software (e.g.
VisionX) on a computer.
The transport mechanism guides
the image plate through the
device. The image plate is read
using a laser inside the scanner
unit. The scanned data
is converted into a digital image
and transferred to the imaging
software.
After scanning, the image plate
runs through the erasure unit.
Image data still held on the image
plate is erased with the aid of
bright light.
The image plate is then ejected
for re-use. | The phosphor storage plate
scanner is used to scan image data
stored on a phosphor storage plate
and transfer the data to the
imaging software (e.g. VisionX) on
a computer.
The transport mechanism guides
the phosphor storage plate
through the device. The phosphor
storage plate is read using a laser
inside the scanner unit. The
scanned data is converted into a
digital image and transferred to
the imaging software.
After scanning, the phosphor
storage plate runs through the
erasure unit. Image data still held
on the phosphor storage plate is
erased with the aid of bright light.
The phosphor storage plate is then
ejected for re-use. | The phosphor storage plate scanner
is used to read image data stored on
the phosphor storage plate. The unit
can be used in two different ways: via
the imaging software (e. g. VisionX)
on a PC or directly via the touch
screen on the unit.
The transport mechanism guides the
phosphor storage plate through the
device. A laser in the scanner unit
scans the PSP. The scanned data is
converted into a digital image.
If a scanning job is started via the
imaging software, the image is
automatically transmitted to the
computer. If a scanning job is started
via the touch screen, the image is
saved to the memory card and needs
to be transferred to the computer
later on. After scanning, the
phosphor storage plate runs through
the erasure unit. Image data still held
on the phosphor storage plate is
erased with the aid of bright light.
The phosphor storage plate is then
ejected for re-use. | Identical.
Different:
ScanX Swift View
2.0:
The touch screen
allows the unit to
be operated in a
stand-alone
mode (without a
connection to a
computer). The
device is able to
generate the
image data itself
and to store it on
a data medium
(USB stick).
Instructions can
be entered on
the touch screen
with the tip of a
finger. |
| Phosphor
storage plates | Only AT Phosphor Storage Plates
with RFID tag:
Size 0: 22 x 35 mm
Size 1: 24 x 40 mm
Size 2: 31 x 41 mm | Only AT Phosphor Storage Plates with RFID tag:
Size 0: 22 x 35 mm
Size 1: 24 x 40 mm
Size 2: 31 x 41 mm
Size 3: 27 x 54 mm
Size 4: 57 x 76 mm | Similar. The
predicate device
uses the smaller
phosphor plates:
Size 0, 1 and 2. | |
| Device | Predicate device | Subject devices | | Change Impact
Analysis |
| Max. theoretical
resolution
(Line pairs/mm) | Approx. 40 Lp/mm | Approx. 40 Lp/mm | | SAME. |
| MTF | More than 40% at 3 LP/mm | Horizontal 59% Vertical 49% at 3LP/mm in 12.5µm pixel size mode | | Similar/better. |
| DQE | More than 3,4% at 3 LP/mm | Horizontal 8.5%, Vertical 10.5% at 3LP/mm in 12.5µm pixel size mode with
an exposure of 99µGy | | Similar/better. |
| Image bit depth | 16 bits | 16 bits | 16 bits | Identical. |
| Dimensions (mm)
(W x H x D) | 167 x 244 x 216 | 211 x 249 x 258 | 211 x 273 x 258 | Different. |
| Weight | Approx. 4 kg
(8,82 lb) | Approx. 5,1 kg
(11,24 lb) | Approx. 5,3 kg
(11,68 lb) | Different. |
| Energy Source
AC | 100 to 240VAC, 50/60 Hz | 100 to 240VAC, 50/60 Hz | 100 to 240VAC, 50/60 Hz | Identical. |
| Imaging
Software | • DBSWIN (K203287)
• VisionX (K213326) | • VisionX (K213326) | • VisionX (K213326) | Different.
The predicate can
be used with
DBSWIN or VisionX
imaging software,
whereas the
subject devices
exclusively used
with the VisionX
imaging software. |
| Patient
Contamination
Prevention | Single patient use barrier envelope
encloses the imaging plate while in
the patient's mouth. | Single patient use barrier envelope
encloses the imaging plate while in
the patient's mouth. | Single patient use barrier envelope
encloses the imaging plate while in
the patient's mouth. | Identical. |
| Additional
Features | None. | • Flip-side detection | • Stand-Alone-Mode
• Flip-side detection
• SmartScan Workflow:
ScanX Smart Reader | Different. The
ScanX Smart
Reader is a new
accessory which is
included in the
scope of delivery of
the subject device
ScanX Swift View
2.0. |
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7
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9
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Discussion of Similarities and Differences:
1) Interface between the subject devices and the imaging software (VisionX):
New: The image generation originates on the image plate scanner side of the software interface. Previously the image was assembled by the imaging software (e.g. VisionX). As a novelty, the composition of the image now takes place within the image plate scanner. The raw image data used to assemble the image is the same. The algorithm used for this process is the same as cleared in K192743 for the imaging software VisionX.
2) Smart Scan Workflow:
The ScanX Smart Reader is a new accessory which is included in the scope of delivery of the subject device ScanX Swift View 2.0. The ScanX Smart Reader is not a medical device. The unit is able to read RFID chips from different sources. Using the ScanX Smart Reader it is possible to assign IQ image plates to a patient. The images are then automatically assigned to this patient when they are scanned.
3) Stand-Alone Modus:
ScanX Swift View 2.0: The touch screen allows the unit to be operated in a stand-alone modus, without a connection to a computer. The device is able to generate the image data itself and to store it on a data medium (USB stick). Instructions can be entered on the touch screen with the tip of a finger.
4) Wifi
Applicable for ScanX Swift View 2.0 only. All models support Ethernet connection to the host computer.
5) Display/ Screen:
The subject devices have displays. The ScanX Swift View 2.0 does have a touch screen, which allows the unit to be operated in a stand-alone modus. The predicate device ScanX Edge does not have a screen. This difference does not influence the intended use for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.
6) Technology:
The feeding and scanning process are different.
- The predicate device ScanX Edge uses the MEMS technology: MEMS = Micro Electro Mechanical Systems.
- The subject devices ScanX Swift 2.0 and ScanX Swift View 2.0 use the Flying-Spot configuration (PCS technology): PCS = Photo Collecting Systems. This technology was already cleared for a predecessor device ScanX Intraoral View (IO View), in K170733.
7) Image Plate Sizes:
- The modified ScanX models allow the use of previously cleared larger plate sizes. These larger sizes were available on our previous model ScanX cleared in K170733.
The technological characteristics, including design, materials, composition, and energy source, are essentially the same, so there are no issues impacting safety and effectiveness.
11
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- Summary of non-clinical performance testing:
Risk analysis and software validation was successfully performed. Cybersecurity issues were addressed by observance of the recommendations in the FDA Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Druq Administration Staff The following FDA guidance documents were consulted during the development of this device:
- Summary of non-clinical performance testing:
FDA Guidance "Pediatric Information for X-ray Imaging Device Premarket Notifications" FDA Guidance "Radio Frequency Wireless Technology in Medical Devices."
FDA Guidance "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices,.
This device meets the applicable portions of the following international standards:
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014, (Professional healthcare facility environment / Emission class B) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
IEC-60825-1 Safety of laser products - Part 1: Equipment classification and requirements Ed.2. The laser aspects of this device comply with the US Performance Radiation Safety Standard in 21CFR1040.
MTF, DQE, and image resolution performance testing was performed in accordance with IEC 6220-1:2003. The results were measured values, not theoretical. Noise power spectrum measurements were documented. The following FDA Guidance Document was consulted during the development of this device: Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices, Guidance for Industry and Food and Drug Administration Staff,
The development of labeling was done in accordance with the FDA Guidance Pediatric Information for Xray Imaging Device Premarket Notifications, Guidance for Industry and Food and Drug Administration Staff. Because the modified unit employs RFID, we also consulted the FDA Guidance Radio Frequency Wireless Technology in Medical Devices Guidance for Industry and Food and Drug Administration Staff.
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- Summary of clinical performance testing: Not required to establish substantial equivalence.
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- Conclusion: In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, DÜRR Dental SE concludes that the ScanX Swift 2.0, ScanX Swift View 2.0 models are safe and effective and substantially equivalent to the predicate device as described herein.