(197 days)
The WDS X-POD and ZEN-X Digital X-Ray Sensors are intended to capture intraoral digital images when exposed to X-Rays. The process is automatic and transmits the digital image to a personal computer by wireless Bluetooth connection or by USB link. Additional legally marketed components such as conventional X-ray tubes and image capture software that are currently available commercially can be used with the WDS X-POD and ZEN-X Digital X-Ray Sensors.
The X-POD is comprised of the X-POD X-Ray sensitive digital sensor, with cable and connector, to be connected to a hand-held unit. X-POD X-ray Digital Sensor is a CMOS Sensor that receives the X-Ray image and converts it into an electronic format. The X-POD hand-held unit receives the X-ray images from the sensor and stores them on an secure digital card. It includes a color display with touch-screen capability. The display allows the user to check if the X-ray was correctly positioned on the image. It also includes an electronic board which allows the X-POD sensor to communicate with the PC through USB® and Bluetooth® links, and controls the display including the on-board circuits for charge control and monitoring the rechargeable battery. The X-POD handheld unit also includes an SD card to store the images. A Wall mount Battery Charger is used for recharge of the internal battery, or to operate the hand-held unit when the battery level is under a minimum value. The battery charger provides 9VDC, 1.5A. The rechargeable battery pack supplies the electricity to the electronic board and the sensor. The battery compartment is enclosed by a screwmounted panel and can only be replaced by qualified technicians (service). The battery charger is used for fast recharge of the internal battery, or to operate the hand-held unit when the battery level is under a minimum value. The battery charger provides 9VDC, 1.5A. The ZEN-X Sensor consists of the following components which are described in detail below: . ZEN-X Intraoral Sensor - ZEN-X interface . - CD-ROM with software, driver, and manuals . The ZEN-X intraoral sensor receives the X-ray image and converts it to an electronic format. The data from the X-ray image is transmitted from the sensor to the PC through the interface. The image data sent by the X-ray sensor is converted by the interface circuit into standard logic levels for the electronic circuit board to process the image data. The USB interface controls the flow of data and commands between the ZEN-X Interface and the computer. The ZEN-X Interface controls the timing and functions of the image data conversion and transmission.
Here's an analysis of the provided text regarding the acceptance criteria and study for the WDS X-POD and ZEN-X Digital X-Ray Sensors:
Based on the provided text, a formal study demonstrating performance against specific acceptance criteria is not explicitly described. The submission is a Special 510(k), which focuses on modifications to an existing predicate device (WDS Digital X-Ray Sensors, K061114) and argues for substantial equivalence based on design verification and design validation activities rather than a new clinical performance study with predefined acceptance criteria.
The key points from the document are:
- Modification: The primary modification is changing the sensor from a CCD to a CMOS sensor to improve functional performance (more images, ease of use).
- Safety and Effectiveness: "The appropriate design verification and design validation activities were conducted to address the potential risks identified in the Risk Analysis. These activities (discussed in Section 10.2) included electrical safety testing and electromagnetic compatibility testing to ensure that all design requirements were fulfilled. The results confirm that the modified X-POD and ZEN-X are safe and effective for capturing of digital X-ray images."
- Substantial Equivalence: The argument for substantial equivalence is based on the same intended use, principles of operation, and similar overall design, with the differences being "minor and raise no new issues of safety or effectiveness."
Therefore, I cannot populate most of the requested fields because the document does not contain information about a traditional performance study comparing specific acceptance criteria to device performance.
Here's a table summarizing what can be inferred or what is explicitly missing:
Acceptance Criteria and Device Performance for WDS X-POD and ZEN-X Digital X-Ray Sensors
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Image Resolution/Quality: (Specific metrics like line pairs/mm, contrast-to-noise ratio, spatial resolution, etc.) | Not explicitly stated. The document implies improved "functional performance" and effectiveness in "capturing of digital X-ray images" due to the CMOS sensor, but no quantitative performance metrics or acceptance thresholds are provided. |
| Signal-to-Noise Ratio (SNR): | Not explicitly stated. |
| Exposure Latitude: | Not explicitly stated. |
| Durability/Reliability: (e.g., MTBF, cycle testing) | Not explicitly stated beyond general "design verification and validation activities." |
| Electrical Safety: (Compliance with IEC 60601-1) | "electrical safety testing... to ensure that all design requirements were fulfilled." |
| Electromagnetic Compatibility (EMC): (Compliance with IEC 60601-1-2) | "electromagnetic compatibility testing to ensure that all design requirements were fulfilled." |
Study Details (Based on available information):
- Sample size used for the test set and the data provenance: Not explicitly stated. The submission refers to "design verification and design validation activities" and "potential risks identified in the Risk Analysis," but does not detail a specific test set of images or patients.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as a dedicated performance study with expert ground truth establishment for a test set is not described. The evaluation relies on technical testing rather than clinical interpretation.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a digital X-ray sensor, not an AI-powered diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is an image acquisition component.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the technical tests (electrical safety, EMC), the "ground truth" would be compliance with the respective standards. For image performance, if any objective measures were taken, they are not detailed. It is not based on clinical ground truth like pathology or expert consensus of diagnostic findings.
- The sample size for the training set: Not applicable. This device is a hardware component and does not involve AI/machine learning training sets.
- How the ground truth for the training set was established: Not applicable.
Summary of what the document implies about meeting requirements:
The device is not proven to meet acceptance criteria through a clinical performance study with defined metrics. Instead, its safety and effectiveness (and thus, its ability to function acceptably) are inferred through:
- Technical Testing: Electrical safety testing and electromagnetic compatibility testing were performed to confirm compliance with design requirements.
- Substantial Equivalence to Predicate: The core argument is that the new devices are "substantially equivalent" to a previously cleared device (WDS Digital X-Ray Sensors, K061114) because the changes (switching from CCD to CMOS) are considered minor and improve performance without raising new safety or effectiveness concerns. The assumption is that if the predicate device was safe and effective, and the changes are minor and enhance function, the new device will also be safe and effective.
{0}------------------------------------------------
Special 510(k) Summary for WDS X-POD and ZEN-X Digital X-Ray Sensors
1. SPONSOR
Cefla, s.c. - Cefla Dental Group via Selice Prov. le 23/a Imola, IT-BO Italy 40026
OCT 2 1 2010
Contact Person: Sergio Ghezzi
Telephone: +39 0542 653111
Facsimile: +39 0542 753344
K 100960
2. DEVICE NAME
| Proprietary Name: | WDS XPOD and ZEN-X |
|---|---|
| Common/Usual Name: | Intraoral X-ray sensor system |
| Classification Name: | Extraoral source x-ray system |
3. PREDICATE DEVICE
WDS Digital X-Ray Sensors, Cefla, s.c. - Cefla Dental Group, K061114
4. INTENDED USE
The WDS X-POD and ZEN-X Digital X-Ray Sensors are intended to capture intraoral digital images when exposed to X-Rays. The process is automatic and transmits the digital image to a personal computer by wireless Bluetooth connection or by USB link. Additional legally marketed components such as conventional X-ray tubes and image capture software that are currently available commercially can be used with the WDS X-POD and ZEN-X Digital X-Ray Sensors.
5. DEVICE DESCRIPTIONS
The X-POD is comprised of the X-POD X-Ray sensitive digital sensor, with cable and connector, to be connected to a hand-held unit. X-POD X-ray Digital Sensor is a CMOS Sensor that receives the X-Ray image and converts it into an electronic format.
The X-POD hand-held unit receives the X-ray images from the sensor and stores them on an secure digital card. It includes a color display with touch-screen capability. The
April 5, 2010
ﺔ ﺍﻟ
{1}------------------------------------------------
display allows the user to check if the X-ray was correctly positioned on the image. It also includes an electronic board which allows the X-POD sensor to communicate with the PC through USB® and Bluetooth® links, and controls the display including the on-board circuits for charge control and monitoring the rechargeable battery. The X-POD handheld unit also includes an SD card to store the images.
A Wall mount Battery Charger is used for recharge of the internal battery, or to operate the hand-held unit when the battery level is under a minimum value. The battery charger provides 9VDC, 1.5A. The rechargeable battery pack supplies the electricity to the electronic board and the sensor. The battery compartment is enclosed by a screwmounted panel and can only be replaced by qualified technicians (service).
The battery charger is used for fast recharge of the internal battery, or to operate the hand-held unit when the battery level is under a minimum value. The battery charger provides 9VDC, 1.5A. The battery charger is shown in Figure 3.
ZEN-X Digital X-Ray Sensor
The ZEN-X Sensor consists of the following components which are described in detail below:
- . ZEN-X Intraoral Sensor
- ZEN-X interface .
- CD-ROM with software, driver, and manuals .
The ZEN-X intraoral sensor receives the X-ray image and converts it to an electronic format. The data from the X-ray image is transmitted from the sensor to the PC through the interface. The image data sent by the X-ray sensor is converted by the interface circuit into standard logic levels for the electronic circuit board to process the image data. The USB interface controls the flow of data and commands between the ZEN-X Interface and the computer. The ZEN-X Interface controls the timing and functions of the image data conversion and transmission.
6. TECHNICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The overall design of the X-POD and ZEN-X Sensors are identical to the design of the parent WDS Sensor. The design modifications made to produce the X-POD and ZEN-X were implemented to improve the functional performance by allowing more images and ease of use of the digital X-ray sensor. The modifications are limited to changing the sensor from a CCD (charge coupled device) Sensor to a Complementary Metal Oxide Semiconductor (CMOS) sensor. The WDS X-POD and ZEN-X sensors when
CONFIDENTIAL APPENDIX E - Page 2 of 3
{2}------------------------------------------------
exposed to radiation capture the image in the form of a charge pattern on its surface. The resulting electronic output signals are digitized by a processor and sent to a computer screen for image presentation
The appropriate design verification and design validation activities were conducted to address the potential risks identified in the Risk Analysis. These activities (discussed in Section 10.2) included electrical safety testing and electromagnetic compatibility testing to ensure that all design requirements were fulfilled. The results confirm that the modified X-POD and ZEN-X are safe and effective for capturing of digital X-ray images.
Based on the comparison of intended use and technical features, and considering the results of the design control activities, Cefla, s.c. - Cefla Dental Group believes that the X-POD and ZEN-X is substantially equivalent to the parent device, the WDS Sensor (K061114). The proposed and predicate devices have the same general intended use and principles of operation. The overall design of the proposed and predicate devices is similar. The differences between these devices are limited to design modifications implemented to improve the convenience and functional performance of the proposed devices. These design modifications are minor and raise no new issues of safety or effectiveness.
Cefla, s.c. - Cefla Dental Group Special 510(k) WDS X-POD and ZEN-X
CONFIDENTIAL APPENDIX E - Page 3 of 3
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control.Room - WO66-G609 Silver Spring, MD 20993-0002
Cefla Dental Group % Cynthis J. M. Notle, Ph.D., RAC Senior Regulatory Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760
OCT 2 1 2010
Re: K100960
Trade/Device Name: WDS X-POD and ZEN-X Sensors Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: September 3, 2010 Received: September 8, 2010
Dear Dr. Notle:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
{4}------------------------------------------------
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
signature
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (if known): 100 960
100 960
Device Name: WDS X-POD and ZEN-X Sensors
Indications for Use:
The WDS X-POD and ZEN-X Sensors are intended to capture intraoral digital images when exposed to X-Rays. The process is automatic and continues transmitting the digital image to a personal computer by wireless Bluetooth connection or by USB link. Additional legally marketed components such as conventional X-ray tubes and image capture software that are currently available commercially can be used with the WDS X-POD and ZEN-X Digital X-Ray Sensors.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K160960
Cefla, s.c. - Cefla Dental Group Special 510(k) WDS X-POD and ZEN-X Digital X-Ray Sensors
April 5, 2010
Page vii
§ 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.