ScanX Intraoral View

K170733 · Duerr Dental AG · MUH · May 1, 2017 · Dental

Device Facts

• Record ID: K170733
• Device Name: ScanX Intraoral View
• Applicant: Duerr Dental AG
• Product Code: MUH · Dental
• Decision Date: May 1, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The ScanX Intraoral View is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.

Device Story

ScanX Intraoral View is a dental radiography system; scans photostimulable phosphor storage plates (PSPs) exposed in place of X-ray film. Device uses a laser (approx. 650 nm) to scan plates in two orthogonal directions; light (approx. 380 nm) emitted from plates is collected by a photomultiplier tube; signal digitized to 16-bit depth. System includes inline erasing for plate reuse. Operated by licensed clinicians/technicians in dental clinics. Output displayed on 4.3" touch screen (preview) and external diagnostic monitors via computer software (DBSWIN/VistaEasy). Facilitates image storage, retrieval, and manipulation for diagnostic review. Benefits include digital conversion of intraoral X-rays for improved workflow and storage.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including electrical safety (EN 61010-1:2010), EMC (EN 61326-1:2013), and laser safety (IEC 60825-1). Imaging performance evaluated per FDA guidance for Solid State X-ray Imaging Devices, including MTF and DQE measurements referenced to IEC 62220-1:2003.

Technological Characteristics

Class II device; uses Class 1 laser (21 CFR 1040.10). Laser wavelength ~650 nm; emission detection ~380 nm. 16-bit image data depth. Mechanical beltway transport system. Connectivity via computer interface. Power: 100-240VAC, 50/60 Hz. Standards: EN 61010-1:2010 (Safety), EN 61326-1:2013 (EMC), IEC 62220-1:2003 (Imaging performance).

Indications for Use

Indicated for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications for use by licensed clinicians and authorized technicians.

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

• RIOScan (RPS500) (K160788)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 1, 2017

Duerr Dental AG % Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

Re: K170733

Trade/Device Name: ScanX Intraoral View Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: January 30, 2017 Received: March 10, 2017

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. 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.

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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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K170733

Device Name ScanX Intraoral View

Indications for Use (Describe)

The ScanX Intraoral View 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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# Exhibit 5. 510(k) SUMMARY

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# 510(k) Summary, DUERR DENTAL AG, K170733

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

#### 1. Date Summary Prepared:

April 12, 2017

#### 2. Submitter's Identification:

DUERR DENTAL AG Höpfigheimer Strasse 17 74321 Bietigheim-Bissingen Deutschland/Germany Tel: [phone] Fax: [phone] E-Mail [e-mail] Internet: www.duerrdental.com

### Contact:

Oliver Lange Email: [e-mail] Quality Manager Durr Dental AG Höpfigheimer Strasse 17 D-74321 Bietigheim-Bissingen Deutschland / Germany Phone: + 49 (0) 7142 / 705-0 Fax: + 49 (0) 7142 / 705-500 Email: [e-mail]

U.S. Contact: Suzanne Lucas Tel: [phone] Email: [e-mail]

#### 3. Device Name:

Trade /Proprietary Name: ScanX Intraoral View Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH

#### 4. Legally Marketed Predicate Device Information:

Trade/Device Name: RIOScan (RPS500) Manufactured by RAY Co., Ltd. Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH

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#### 5. Device Description:

The ScanX Intraoral View is a dental device that scans 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.

#### 6. Intended Use/Indications for use:

The ScanX Intraoral View is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.

#### 7. Safety and Effectiveness:

The ScanX Intraoral View 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 Intraoral View were addressed by safety testing the device with Intertek to IEC 61010-1 third edition (Electrical Safety), EN 61326-1:2013 (EMC) and IEC 60825-1 second edition (Laser safety). Design changes and risks associated with the introduction of the ScanX Intraoral View were properly mitigated by Duerr Dental's cGMP compliant Quality Management System, change control processes, risk assessments, and product validation.

The ScanX Intraoral View contains a Class 1 Laser Device as defined by 21 CFR 1040.10

Installation and operation manuals are provided with instructions for safe use and servicing of the ScanX Intraoral View. The ScanX Intraoral View is a non-patient contact Class II medical device.

#### 8. Substantial Equivalence to Predicate Device Summary

Duerr Dental's ScanX Intraoral View is identical in function, and intended use to the RIOScan RPS500 Dental Radiography System manufactured by RAY Co., Ltd whose dental units are in commercial distribution and are FDA cleared under 510K # K160788. ScanX Intraoral View and the RIOScan RPS500 capture, digitize, and process intraoral x-ray images that are stored in imaging plate recording media.

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| Comparison criteria | Predicate Device: RIOScan<br>RPS500 K160788, RAY Co. Ltd. | New Device ScanX Intraoral<br>View |
|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Photo | Image: RIOScan RPS500 K160788, RAY Co. Ltd. | Image: ScanX Intraoral View |
| Indications for Use | This system is a digital intraoral<br>dental radiographic imaging<br>system intended for use by<br>dentists and dental sub-specialists.<br>The system captures, digitizes,<br>displays and stores diagnostic<br>intraoral radiographic images. | The ScanX Intraoral View is<br>intended to be used for scanning<br>and processing digital images<br>exposed on Phosphor Storage<br>Plates (PSPs) in dental applications. |
| Mechanical design | The exposed and unwrapped<br>plates are scanned using a laser<br>with a certain wavelength. | The exposed and unwrapped<br>plates are scanned in two<br>orthogonal directions using a<br>laser with a wavelength of<br>approximately 650 nm. |
| Electrical design | Light with a certain wavelength<br>from the plate in proportion to<br>the number of captured x-ray<br>photons. This light is collected<br>and formed into an image that<br>may be viewed and stored on an<br>external display/computer. | Light with a wavelength of<br>approximately 380 nm is from the<br>plate in proportion to the<br>number of captured x-ray<br>photons. This light is collected<br>and formed into an image that<br>may be viewed on a video display<br>and stored for later recovery in a<br>computer memory. |
| Image scanning | Laser/Photomultiplier Tube | SAME |
| Erasing the residual<br>image following<br>scanning for plate<br>reuse. | Automatic plate erasing | The residual image is erased in<br>the scanner by an inline erasing<br>function. |
| Comparison criteria | Predicate Device: RIOScan<br>RPS500 K160788, RAY Co. Ltd. | New Device ScanX Intraoral<br>View |
| Viewing the image | The scanned images can be<br>displayed on an integrated LCD<br>panel, a 4.3" Touch Screen | 4.3" Touch Screen. 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<br>be viewed on a diagnostic<br>monitor. The scanned images are<br>displayed on an internal LCD or<br>an external monitor using a<br>computer and user software<br>including image storage,<br>retrieval and manipulation. |
| Transport/feed<br>mechanism | Gravity scan | The plates are transported by<br>"beltways" down the axis of the<br>cylinder past the slot. The motion<br>of the laser and plates provides<br>the two orthogonal scan<br>directions. This is a continuous<br>feed device that allows successive<br>plates to be loaded as soon as the<br>previous plates have moved past<br>the slot. |
| Phosphor Plates | Dental intraoral<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 | Same as predicate device. |
| Image Quality | Theoretical resolutions:<br>9, 16, or 21 lp/mm | Theoretical resolutions:<br>10, 20, 25 or 40 LP/mm |
| MTF | More than 35% at 3 lp/mm | More than 45% at 3 lp/mm |
| DQE | More than 10% at 3 lp/mm | More than 7.5% at 3 lp/mm |
| Image data<br>bit depth | 14 bits | 16 bits |
| Body size and<br>weight | 170 x 260 x 278 [mm];<br>3.6 [kg] | 380 x 410 x 450 [mm];<br>(W x L x H)<br>19.5 [kg] (42.99 lbs.) |
| Imaging Software | "RIOView" | DBSWIN/VistaEasy as cleared in<br>K161444 |
| User interface | It will be used by dentists and<br>authorized dental auxiliary<br>personnel. | Same as predicate device. |
| Energy Source AC | 100 to 240VAC, 50/60 Hz | Same as predicate device. |
| Comparison criteria | Predicate Device: RIOScan<br>RPS500 K160788, RAY Co. Ltd. | New Device ScanX Intraoral<br>View |
| Electrical safety<br>standards | IEC 60601-1 Electrical Safety<br>Medical Devices | EN 61010-1:2010 Safety<br>Requirements for Electrical<br>Equipment for Measurement,<br>Control, and Laboratory Use - Part 1:<br>General Requirements |
| EMC Testing | IEC 60601-1-2 EMC Medical Devices | EN 61326-1:2013 Electrical<br>equipment for measurement, control<br>and laboratory use. EMC<br>requirements. General requirements |
| Patient Contamination<br>prevention | Single patient use barrier envelope<br>encloses the imaging plate while in<br>the patient's mouth. | Same as predicate device |

#### 9. Table of comparison to Legally Marketed Device:

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The technological characteristics, including design, materials, composition, and energy source, are substantially the same, so there are no issues impacting safety and effectiveness.

#### 10. Summary of non-clinical performance testing:

Risk analysis and software validation was successfully performed. EMC Testing according to EN 61326-1:2013 was successfully performed. Electrical safety testing according to EN 61010-1:2010 was successfully performed. We chose safety standards that were more closely aligned with where the device is to be used: Equipment for Measurement, Control, and Laboratory Use. FDA guidance documents utilized in the development of the device:

a) Imaging performance evaluation according to the recommendations in the FDA guidance document: Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices Document issued on: September 1, 2016.

b) Software development: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

c) Cybersecurity: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.

MTF and DQE image performance testing was performed with reference to IEC 62220-1:2003. Noise power spectrum measurements were documented.

#### 11. Summary of clinical performance testing:

Not required to establish substantial equivalence.

#### 12. 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, Duerr Dental AG concludes that the ScanX Intraoral View is safe and effective and substantially equivalent to the predicate device as described herein.