(28 days)
No
The summary describes a digital x-ray sensor and associated imaging software, focusing on image acquisition speed and quality metrics like DQE and MTF. There is no mention of AI, ML, or related concepts like training/test sets or advanced image processing beyond basic viewing and manipulation.
No.
The device is used for diagnostic imaging, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" states that the electronic impulses convert dental x-ray photons into electronic impulses that "may be stored, viewed and manipulated for diagnostic use by dentists." Additionally, the "Summary of Performance Studies" mentions "adequate quality for intra oral diagnosis."
No
The device description explicitly states that X Sensor is a "digital intraoral sensor" which is a hardware component that acquires images. It also mentions firmware for the sensor and connection to a computer, indicating a physical device is involved.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The X Sensor collects dental x-ray photons and converts them into electronic impulses to create images for diagnostic use by dentists. This process involves capturing energy from the body (x-rays) and creating an image, not analyzing a specimen taken from the body.
- Intended Use: The intended use clearly states it's for collecting dental x-ray photons and converting them into images for diagnostic use by dentists. This is a form of medical imaging, not in vitro testing.
Therefore, based on the provided information, the X Sensor is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
X Sensor is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.
Product codes
MUH
Device Description
X Sensor is a digital intraoral sensor which acquires digital intra-oral images. X Sensor acquires intra oral images with a sensor that is connected to a computer to produce an image almost instantaneously following exposure. The primary advantage of direct sensor systems is the speed with which images are acquired. X Sensor includes the firmware for the sensor and the previously cleared imaging software "ExDent-I".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray photons
Anatomical Site
Intraoral (Dental)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentists
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
Non-clinical test was performed according to FDA Guidance "Guidance for the Submissions of 510(k)'s for Solid State X- ray Imaging Devices".
DQE, MTF, and NPS test results demonstrated that X Sensor has better performance outcome than EzSensor XHD, the predicate sensor.
Electrical, mechanical, environmental safety and performance testing were performed according to to 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). EMC testing was conducted in accordance with standard IEC 60601-1-2:2014+AMD1:2020.
The clinical images obtained from the X Sensor and EzSensor XHD were reviewed and rated comparatively.
The image quality in terms of contrast and resolution are overall similar for the X sensor, the proposed new device and EzSensor XHD, the predicate device.
There are no observable radiographic findings and no quality issues with intra oral diagnostic images provided by both sensors.
The proposed device produces overall better definition and grayscale of bony and soft tissue images.
In conclusion, both the proposed new device and the predicate device produced radiographic images with adequate quality for intra oral diagnosis in terms of resolution and anatomic details.
Key Metrics
DQE (6 lp/mm) Full Resolution: Proposed 0.258, Predicate 0.204
MTF (3 lp/mm) Full Resolution: Proposed 0.889, Predicate 0.685
Predicate Device(s)
Reference Device(s)
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.
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October 11, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.
Qpix Solutions Inc % Dave Kim Medical Device Regulatory Affairs Mtech Group LLC 7505 Fannin St Suite 610 HOUSTON, TX 77054
Re: K242778
Trade/Device Name: X Sensor (Model: IOS-A151F, HDI-15DGF) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: Class II Product Code: MUH Dated: September 13, 2024 Received: September 13, 2024
Dear Dave Kim:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
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Sincerely,
Smita Kakar
for
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
Submission Number (if known)
Device Name
X Sensor
(Model: IOS-A15IF, HDI-15DGF)
Indications for Use (Describe)
X Sensor is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.
Type of Use (Select one or both, as applicable)
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."
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1. 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date 510K summary prepared: September 13, 2024
Submitter's Name, address, telephone number, a contact person:
| Submitter's Name : | Qpix Solutions Inc |
|---|---|
| Submitter's Address: | 1001 Aviation Parkway, Ste 200 |
| Morrisville, North Carolina, USA 27560 | |
| Submitter's Telephone: | +1-919-908-6917 |
| Contact person: | Mr. Seungman Yun / CEO / +1-919-908-6917 |
| Official Correspondent: | Dave Kim (davekim@mtechgroupllc.com) |
| Address: | 8310 Buffalo Speedway, Houston, TX 77025 |
| Telephone: | +713-467-2607 |
| Fax: | +713-583-8988 |
Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:
| Trade/proprietary name: | X Sensor (Model: IOS-A15IF, HDI-15DGF) |
|---|---|
| Common Name: | Digital Dental Intra Oral Sensor |
| Regulation number: | 21 CFR 872.1800 |
| Classification Name: | Extraoral source X-ray system |
| Regulatory Class: | Class 2 |
| Product Code: | MUH |
| Predicate Device : | |
| Manufacturer | : Qpix Solutions Inc |
| Device | : EzSensor XHD |
| 510(k) Number | : K232255 (Decision Date -09/27/2023) |
| The Regulation Number | : 21 CFR 872.1800 |
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| Classification Name | : Extraoral Source X-ray System |
|---|---|
| Regulatory Class | : Class 2 |
| Primary Product Code | : MUH |
2. Device Description
X Sensor is a digital intraoral sensor which acquires digital intra-oral images. X Sensor acquires intra oral images with a sensor that is connected to a computer to produce an image almost instantaneously following exposure. The primary advantage of direct sensor systems is the speed with which images are acquired. X Sensor includes the firmware for the sensor and the previously cleared imaging software "ExDent-I".
3. Indication for use
X Sensor is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.
4. Summary of Design Control Risk management
The risks and the hazardous impact of the device modification were analyzed with FMEA method. The specific risk control and protective measures to mitigate the risks from the modification were reviewed and implemented in the new product design phase. The overall assessment concluded that all risks and hazardous conditions identified arising from the design change were successfully mitigated and accepted.
5. Summary of the technological characteristics of the device compared to the predicate device
X Sensor described in this 510(k) has the same indications for use and similar technical characteristics as its predicate device.
These differences do not raise the questions of safety or effectiveness. Based on the laboratory testing results submitted in this 510k, we conclude that the subject device is substantially equivalent to the predicate device.
The potential risks for a new sensor size were analyzed by conducting complete verification for IEC 60601-1 and drop & vibration test which included electronic shock, leakage current, etc.
While applying the stainless-steel material to the frame, soft silicon material
6
surrounds the exterior of the USB connector to protect the sensors from a potential external impact. Additional risk analysis was conducted to mitigate the potential risks that may arise with respect to leakage current, sensor fracture or breakage, and cable disconnection. The risk mitigation measures were satisfactory to manage the new risks identified and the residual risks were within acceptable limits.
| Characteristic | Proposed | Predicate | |
|---|---|---|---|
| Manufacturer | Qpix Solutions Inc | Qpix Solutions Inc | |
| Device's name | X Sensor | ||
| (Model: IOS-A15IF, HDI-15DGF) | EzSensor XHD | ||
| Feature | Image: Proposed Feature | Image: Predicate Feature | |
| 510(k) number | - | K232255 | |
| X-ray converter | CsPbBr3 | ||
| Detection type | Direct conversion | ||
| Indications | |||
| for use | Digital Dental Intra Oral Sensor is | ||
| intended to collect dental x-ray photons | |||
| and convert them into electronic impulses | |||
| that may be stored, viewed, and | |||
| manipulated for diagnostic use by dentists. | Digital Dental Intra Oral Sensors are | ||
| intended to collect dental x-ray | |||
| photons and convert them into | |||
| electronic impulses that may be | |||
| stored, viewed and manipulated for | |||
| diagnostic use by dentists. | |||
| Sensor | |||
| Dimension(mm) | |||
| (±10%) | Size 1.5: 41.1 x 30.4 | Size 1.5: 41.1 x 30.4 | |
| Sensor | |||
| Thickness(mm) | 4.8 | 6.2 | |
| Active Area(mm) | Size 1.5: 23.98 x 33.00 | Size 1.5: 23.98 x 33.00 | |
| USB Module | Integrated USB 2.0 module | Integrated USB 2.0 module | |
| Max. Resolution | |||
| (lp/mm) | 33.8 | ||
| Pixel | |||
| Pitch | |||
| (μm) | Full | ||
| Resolution | 14.8 | ||
| DQE | |||
| (6 lp/mm) | Full | ||
| Resolution | 0.258 | 0.204 | |
| MTF | |||
| (3 lp/mm) | Full | ||
| Resolution | 0.889 | 0.685 | |
| Typical dose | |||
| range( $\mu$ Gy) | Incisor & Canine : 300 ~ 500 / Molar: 400 ~ 600 | ||
| Viewer Software | |||
| (option) | EzDent-i(K241114) | EzDent-i(K223820) |
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510(k) Submission - X Sensor (IOS-A15IF, HDI-15DGF)
| Viewer
Software
| (option) | 510(k) Number | Manufacturer | Comment |
|---|---|---|---|
| EzDent-i | K241114 | EWOO SOFT | Dental Imaging Viewer |
6.Summary of Performance Testing
The intended use, application of X Sensor is the same as that of the predicate device, EzSensor XHD.
X Sensor is a direct conversion sensor that utilizes a photoconductor (CsPbBr3) and single crystal Silicon as the sensing means whereas EzSensor XHD, the predicate device, utilizes a photoconductor(CsPbBr3) and single crystal Silicon as the sensing means. The performance test result indicates that the X Sensor intra oral sensor performed equally to the EzSensor XHD, the predicated device, as both sensors have the same pixel pitch, thereby providing the same maximum line-pair resolution. No additional safety risk is identified in the bench test: Non-clinical report.
Non-clinical test was performed according to FDA Guidance "Guidance for the Submissions of 510(k)'s for Solid State X- ray Imaging Devices".
DQE, MTF, and NPS test results demonstrated that X Sensor has better performance outcome than EzSensor XHD, the predicate sensor.
Electrical, mechanical, environmental safety and performance testing were performed according to to 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). EMC testing was conducted in accordance with standard IEC
8
60601-1-2:2014+AMD1:2020.
"Content of Premarket Submissions for Device Software Functions. Guidance for Industry and Food and Drug Administration Staff" was used in the development of the subject device and provide basic level of documentation for the firmware.
"Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Guidance for Industry and Food and Drug Administration Staff" was used in the development, documentation and testing for the cybersecurity of the subject device.
"Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff' guidance was used in the development of the subject device.
The clinical images obtained from the X Sensor and EzSensor XHD were reviewed and rated comparatively.
The image quality in terms of contrast and resolution are overall similar for the X sensor, the proposed new device and EzSensor XHD, the predicate device.
There are no observable radiographic findings and no quality issues with intra oral diagnostic images provided by both sensors.
The proposed device produces overall better definition and grayscale of bony and soft tissue images.
In conclusion, both the proposed new device and the predicate device produced radiographic images with adequate quality for intra oral diagnosis in terms of resolution and anatomic details.
7. Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. Qpix Solutions Inc concludes X SENSOR is safe and effective and substantially equivalent to predicate device as described herein.