(52 days)
Not Found
No
The summary describes a device that scans and processes digital images from PSPs. While it mentions image processing, there is no mention of AI, ML, or any related concepts like training or test sets for algorithmic performance. The performance studies focus on standard imaging metrics and safety/EMC testing, not AI/ML model validation.
No
The device is described as a dental device that scans and processes digital images from X-ray film. It is used for diagnostic purposes by displaying and storing images, rather than directly treating a medical condition.
No
The device is a scanner that digitizes images from phosphor storage plates; it does not perform any diagnostic analysis or interpretation itself.
No
The device description explicitly states it is a "dental device that scans photostimulable phosphor storage plates," indicating it includes hardware for scanning. The performance studies also mention EMC and electrical safety testing, which are relevant to hardware components.
Based on the provided information, the ScanX Intraoral View is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health.
- ScanX Intraoral View Function: The ScanX Intraoral View is used to scan and process digital images from phosphor storage plates that have been exposed to X-rays in the mouth (intraoral). It's a device for capturing and processing radiographic images, not for analyzing biological specimens.
- Intended Use: The intended use clearly states "scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications." This is related to imaging, not in vitro analysis.
- Device Description: The description reinforces that it scans plates exposed in place of dental X-ray film and displays the resulting images.
Therefore, the ScanX Intraoral View falls under the category of a medical imaging device, specifically for dental radiography, rather than an IVD.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
MUH
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.
Mentions image processing
The ScanX Intraoral View is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Intraoral (dental)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed clinicians and authorized technicians / dental applications
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. 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: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. Software development: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
MTF: More than 45% at 3 lp/mm
DQE: More than 7.5% at 3 lp/mm
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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/1 description: The image is the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, overlaid on three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
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.
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/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 (800) 638-2041 or (301) 796-7100 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
2
Indications for Use
510(k) Number (if known)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Exhibit 5. 510(k) SUMMARY
4
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: +49 (0) 71 42 70 5-0 Fax: +49 (0) 71 42 705-500 E-Mail info@duerr.de Internet: www.duerrdental.com
Contact:
Oliver Lange Email: lange.o@duerr.de 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: lange.o@duerr.de
U.S. Contact: Suzanne Lucas Tel: 516-214-5515 Email: slucas@airtechniques.com
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
5
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.
6
| Comparison criteria | Predicate Device: RIOScan
RPS500 K160788, RAY Co. Ltd. | New Device ScanX Intraoral
View |
|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Photo | Image: RIOScan RPS500 K160788, RAY Co. Ltd. | Image: ScanX Intraoral View |
| Indications for Use | This system is a digital intraoral
dental radiographic imaging
system intended for use by
dentists and dental sub-specialists.
The system captures, digitizes,
displays and stores diagnostic
intraoral radiographic images. | The ScanX Intraoral View is
intended to be used for scanning
and processing digital images
exposed on Phosphor Storage
Plates (PSPs) in dental applications. |
| Mechanical design | The exposed and unwrapped
plates are scanned using a laser
with a certain wavelength. | The exposed and unwrapped
plates are scanned in two
orthogonal directions using a
laser with a wavelength of
approximately 650 nm. |
| Electrical design | Light with a certain wavelength
from the plate in proportion to
the number of captured x-ray
photons. This light is collected
and formed into an image that
may be viewed and stored on an
external display/computer. | Light with a wavelength of
approximately 380 nm is from the
plate in proportion to the
number of captured x-ray
photons. This light is collected
and formed into an image that
may be viewed on a video display
and stored for later recovery in a
computer memory. |
| Image scanning | Laser/Photomultiplier Tube | SAME |
| Erasing the residual
image following
scanning for plate
reuse. | Automatic plate erasing | The residual image is erased in
the scanner by an inline erasing
function. |
| Comparison criteria | Predicate Device: RIOScan
RPS500 K160788, RAY Co. Ltd. | New Device ScanX Intraoral
View |
| Viewing the image | The scanned images can be
displayed on an integrated LCD
panel, a 4.3" Touch Screen | 4.3" Touch Screen. 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
monitor. The scanned images are
displayed on an internal LCD or
an external monitor using a
computer and user software
including image storage,
retrieval and manipulation. |
| Transport/feed
mechanism | Gravity scan | The plates are transported by
"beltways" 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. |
| Phosphor Plates | Dental intraoral
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 | Same as predicate device. |
| Image Quality | Theoretical resolutions:
9, 16, or 21 lp/mm | Theoretical resolutions:
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
bit depth | 14 bits | 16 bits |
| Body size and
weight | 170 x 260 x 278 [mm];
3.6 [kg] | 380 x 410 x 450 [mm];
(W x L x H)
19.5 [kg] (42.99 lbs.) |
| Imaging Software | "RIOView" | DBSWIN/VistaEasy as cleared in
K161444 |
| User interface | It will be used by dentists and
authorized dental auxiliary
personnel. | Same as predicate device. |
| Energy Source AC | 100 to 240VAC, 50/60 Hz | Same as predicate device. |
| Comparison criteria | Predicate Device: RIOScan
RPS500 K160788, RAY Co. Ltd. | New Device ScanX Intraoral
View |
| Electrical safety
standards | IEC 60601-1 Electrical Safety
Medical Devices | EN 61010-1:2010 Safety
Requirements for Electrical
Equipment for Measurement,
Control, and Laboratory Use - Part 1:
General Requirements |
| EMC Testing | IEC 60601-1-2 EMC Medical Devices | EN 61326-1:2013 Electrical
equipment for measurement, control
and laboratory use. EMC
requirements. General requirements |
| Patient Contamination
prevention | Single patient use barrier envelope
encloses the imaging plate while in
the patient's mouth. | Same as predicate device |
9. Table of comparison to Legally Marketed Device:
7
8
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.