ScanX Swift 2.0, ScanX Swift View 2.0

K230095 · Durr Dental SE · MUH · Feb 6, 2023 · Dental

Device Facts

• Record ID: K230095
• Device Name: ScanX Swift 2.0, ScanX Swift View 2.0
• Applicant: Durr Dental SE
• Product Code: MUH · Dental
• Decision Date: Feb 6, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended 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.

Device Story

ScanX Swift 2.0 and ScanX Swift View 2.0 are dental intraoral plate scanners. They process photostimulable phosphor storage plates (PSPs) previously exposed to X-rays in a patient's mouth. Operation involves inserting a plate into a size-specific guide; a 639nm laser scans the plate; an optical sensor (photomultiplier tube) captures emitted light; the device digitizes the signal into an X-ray image. The ScanX Swift View 2.0 features a touch screen for stand-alone operation, image preview, and storage on removable media (USB). Both models transmit data to a PC via Ethernet; the View model also supports WLAN. After scanning, an LED-PCB erases the plate for reuse. Used by clinicians/technicians in dental clinics. Output is a digital X-ray image for diagnostic review on a PC monitor. Benefits include transition from film to digital radiography, improved workflow efficiency, and integration with existing dental imaging software.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including MTF, DQE, and image resolution performance testing in accordance with IEC 6220-1:2003, and software validation.

Technological Characteristics

Materials: Rigid photostimulable phosphor plates. Sensing: 639nm laser, photomultiplier tube (PMT) optical sensor. Energy: 100-240VAC, 50/60 Hz. Connectivity: Ethernet, WLAN (Swift View 2.0), USB storage. Laser Class: Class 1 (21 CFR 1040.10). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 6220-1. Software: Moderate level of concern firmware.

Indications for Use

Indicated for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications for patients requiring dental radiography.

Regulatory Classification

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.

Predicate Devices

• ScanX Edge (K202633)

Reference Devices

• ScanX Intraoral View (K170733)
• DBSWIN (K203287)
• VisionX (K213326)
• VisionX (K192743)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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)

| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------|
| <input type="checkbox"/> 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: [phone] Fax: [phone] E-Mail [e-mail] 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: [e-mail]

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: [phone] E-Mail: [e-mail]

- 2. 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 |

3. 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.

5. 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.

- 6. 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.
- 7. 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<br>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<br>Use | The ScanX Edge is intended to be<br>used for scanning and processing<br>digital images exposed on Phosphor<br>Storage Plates (PSPs) in dental<br>applications. | The ScanX Swift 2.0 is intended to<br>be used for scanning and<br>processing digital images exposed<br>on Phosphor Storage Plates (PSPs)<br>in dental applications. | The ScanX Swift View 2.0 is intended<br>to be used for scanning and<br>processing digital images exposed on<br>Phosphor Storage Plates (PSPs) in<br>dental applications. | Identical. |
| Operating<br>principle | The PSPs are put into the mouth of the<br>patient, exposed to X-rays, and then<br>are read out with the device. The read-<br>out-process is carried out with a 639<br>nm Laser. The laser beam stimulates<br>the top coating of the plates, which<br>consists of x-ray sensitive material.<br>Depending on the exposed dose, the<br>coating emits different levels of light.<br>These light particles are then<br>requisitioned by an optical sensor and<br>transferred into an electrical output<br>signal. This signal is digitalized and is<br>the data for the digital X-ray image. | The PSPs are put into the mouth of the patient, exposed to X-rays, and<br>then are read out with the device. The read-out-process is carried out<br>with a 639 nm Laser. The laser beam stimulates the top coating of the<br>plates, which consists of x-ray sensitive material. Depending on the<br>exposed dose, the coating emits different levels of light. These light<br>particles are then requisitioned by an optical sensor and transferred into<br>an electrical output signal. This signal is digitalized and is the data for the<br>digital X-ray image. | | Identical. |
| | | Technical equivalence: | | |
| Device | Predicate device | Subject devices | Change Impact<br>Analysis | |
| Data transfer | The data is transmitted via an<br>Ethernet link. | The data is transmitted via an Ethernet link to a computer. With the<br>XPS07.2A1 the data can alternatively be transferred by a WLAN<br>interface or being stored on a removeable storage medium. | Similar. | |
| Erasing the<br>residual image<br>following<br>scanning for<br>plate reuse | After the scanning process, the<br>remaining data is erased by a LED<br>light. | After the scanning process, the remaining data is erased by a LED<br>light. | Identical. | |
| Display | The ScanX Edge does not have a<br>screen / display.<br>The device state is indicated via<br>status LEDs lights on the device. | 2.4"-Display<br>The display does not show<br>preview images.<br><br>5"-Touch Display: The touch<br>screen only shows a preview<br>which serves to provide an initial<br>impression of the final x-ray<br>image. For the purposes of<br>diagnosis, the x-ray image must be<br>viewed on a diagnostic PC<br>monitor.<br>Diagnostic monitor = PC monitor.<br>The scanner itself is not used for<br>diagnosis. | Similar. | |
| Imaging scanning | Laser / Photomultiplier Tube (PMT)<br>Components:<br>Photomultiplier 2"<br>Diode, Laser 639nm/10mW Fiber<br>coupled laser diode | Laser / Photomultiplier Tube (PMT)<br>Components: Photomultiplier 2"<br>Diode, Laser 639nm/10mW Fiber coupled laser diode | Identical. | |
| Plate guide | A specific plate guide for each PSP<br>size is available, thus the user<br>chooses which size of PSP he wants<br>to use and prepares the device by<br>inserting the appropriate plate guide<br>into the device. | A specific plate guide for each PSP size is available, thus the user chooses<br>which size of PSP he wants to use and prepares the device by inserting the<br>appropriate plate guide into the device. | Identical. | |
| Device | Predicate device | Subject devices | Change Impact<br>Analysis | |
| Transport / feed<br>mechanism | The plates are inserted into a size<br>specific interchangeable insert. If<br>the user wants to scan a different<br>plate size, the insert needs to be<br>exchanged. The insert is used to<br>transport the plate into the<br>scanning position. During the<br>scanning process the plate is not<br>move. Upon completion of the<br>scanning. | The plates are inserted into a size specific interchangeable plate<br>guide. If the user wants to scan a different plate size, the plate guide<br>needs to be exchanged.<br>The plate is transported beltway down the axis of the cylinder past<br>the slot. The motion of the laser and plates provides the two<br>orthogonal scan directions. This is a continuous feed device that<br>allows successive plates to be loaded as soon as the previous plates<br>have moved past the slot. | Similar.<br>The solutions for<br>the plate guides<br>have evolved for<br>ScanX Swift 2.0<br>and ScanX Swift<br>View 2.0. The<br>feed and<br>transport are<br>equivalent. | |
| WLAN (Wi-Fi) | No | Yes | Different. Added<br>interface<br>flexibility | |
| Ethernet | Yes | Yes | SAME | |
| RFID | Supports image plates with RFID<br>Tags. The information on the RFID<br>tag is used to identify the image<br>plate. | Supports image plates with RFID<br>Tags. The information on the<br>RFID tag is used to identify the<br>image plate. | Identical.<br>The RFID image<br>plates are<br>identical. | |
| Device | Predicate device | Subject devices | Change Impact<br>Analysis | |
| Operation /<br>Function | The image plate scanner is used<br>to read image data stored on an<br>image plate and to transfer the<br>data to the imaging software (e.g.<br>VisionX) on a computer.<br>The transport mechanism guides<br>the image plate through the<br>device. The image plate is read<br>using a laser inside the scanner<br>unit. The scanned data<br>is converted into a digital image<br>and transferred to the imaging<br>software.<br>After scanning, the image plate<br>runs through the erasure unit.<br>Image data still held on the image<br>plate is erased with the aid of<br>bright light.<br>The image plate is then ejected<br>for re-use. | The phosphor storage plate<br>scanner is used to scan image data<br>stored on a phosphor storage plate<br>and transfer the data to the<br>imaging software (e.g. VisionX) on<br>a computer.<br>The transport mechanism guides<br>the phosphor storage plate<br>through the device. The phosphor<br>storage plate is read using a laser<br>inside the scanner unit. The<br>scanned data is converted into a<br>digital image and transferred to<br>the imaging software.<br>After scanning, the phosphor<br>storage plate runs through the<br>erasure unit. Image data still held<br>on the phosphor storage plate is<br>erased with the aid of bright light.<br>The phosphor storage plate is then<br>ejected for re-use. | The phosphor storage plate scanner<br>is used to read image data stored on<br>the phosphor storage plate. The unit<br>can be used in two different ways: via<br>the imaging software (e. g. VisionX)<br>on a PC or directly via the touch<br>screen on the unit.<br>The transport mechanism guides the<br>phosphor storage plate through the<br>device. A laser in the scanner unit<br>scans the PSP. The scanned data is<br>converted into a digital image.<br>If a scanning job is started via the<br>imaging software, the image is<br>automatically transmitted to the<br>computer. If a scanning job is started<br>via the touch screen, the image is<br>saved to the memory card and needs<br>to be transferred to the computer<br>later on. After scanning, the<br>phosphor storage plate runs through<br>the erasure unit. Image data still held<br>on the phosphor storage plate is<br>erased with the aid of bright light.<br>The phosphor storage plate is then<br>ejected for re-use. | Identical.<br>Different:<br>ScanX Swift View<br>2.0:<br>The touch screen<br>allows the unit to<br>be operated in a<br>stand-alone<br>mode (without a<br>connection to a<br>computer). The<br>device is able to<br>generate the<br>image data itself<br>and to store it on<br>a data medium<br>(USB stick).<br>Instructions can<br>be entered on<br>the touch screen<br>with the tip of a<br>finger. |
| Phosphor<br>storage plates | Only AT Phosphor Storage Plates<br>with RFID tag:<br>Size 0: 22 x 35 mm<br>Size 1: 24 x 40 mm<br>Size 2: 31 x 41 mm | Only AT Phosphor Storage Plates with RFID tag:<br>Size 0: 22 x 35 mm<br>Size 1: 24 x 40 mm<br>Size 2: 31 x 41 mm<br>Size 3: 27 x 54 mm<br>Size 4: 57 x 76 mm | Similar. The<br>predicate device<br>uses the smaller<br>phosphor plates:<br>Size 0, 1 and 2. | |
| Device | Predicate device | Subject devices | | Change Impact<br>Analysis |
| Max. theoretical<br>resolution<br>(Line pairs/mm) | Approx. 40 Lp/mm…