(61 days)
Not Found
No
The summary describes a digital x-ray sensor and associated software for image acquisition and viewing, with no mention of AI or ML capabilities for image analysis, processing, or interpretation.
No
The device is described as an image acquisition system for diagnostic use, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the electronic impulses are "manipulated for diagnostic use by dentists."
No
The device description explicitly states that the EzSensor XHD is a "digital intraoral sensor" which "acquires intra oral images with a sensor that is connected to a computer". This indicates a hardware component (the sensor) is integral to the device's function, even though it also includes software (firmware).
Based on the provided information, the EzSensor XHD is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists." This describes a device used for imaging the internal structures of the body (specifically, the intraoral area) using external energy (x-rays).
- Device Description: The description confirms it's a "digital intraoral sensor which acquires digital intra-oral images." This further reinforces its role as an imaging device.
- IVD Definition: In vitro diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The EzSensor XHD does not perform tests on biological samples.
The EzSensor XHD is a medical imaging device, specifically a digital intraoral X-ray sensor.
N/A
Intended Use / Indications for Use
EzSensor XHD 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
EzSensor XHD is a digital intraoral sensor which acquires digital intra-oral images. EzSensor XHD 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. The ergonomic design based on human intraoral anatomy improves patient comfort. EzSensor XHD includes the software (firmware) with MODERATE level of concern.
Mentions image processing
EzSensor XHD 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.
EzSensor XHD is a digital intraoral sensor which acquires digital intra-oral images. EzSensor XHD acquires intra oral images with a sensor that is connected to a computer to produce an image almost instantaneously following exposure.
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
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 EzSensor XHD has better performance outcome than EzSensor Soft, the predicate sensor.
Electrical, mechanical, environmental safety and performance testing were performed according to IEC 60601-1:2005, AMD1:2012 (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.
The clinical images obtained from the EzSsensor XHD and EzSensor Soft were reviewed and rated comparatively.
EzSensor XHD produces overall better definition and grayscale of bony and soft tissue images in comparison with EzSensor Soft.
In conclusion, both the proposed device and the predicate device produced radiographic images with adequate quality for intra oral diagnosis in terms of resolution and anatomic details.
Key Metrics
Max. Resolution (lp/mm): 33.8
DQE (6 lp/mm): 0.204
MTF (3 lp/mm): 0.685
Predicate Device(s)
Reference Device(s)
Not Found
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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Image /page/0/Picture/0 description: The image shows 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.
September 27, 2023
Qpix Solutions Inc. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group LLC 7505 Fannin St., Suite 610 HOUSTON TX 77054
Re: K232255
Trade/Device Name: EzSensor XHD Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: July 31, 2023 Received: July 31, 2023
Dear Mr. 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 (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 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
1
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 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).
Sincerely.
Lu Jiang
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) K232255
Device Name EzSensor XHD
Indications for Use (Describe)
EzSensor XHD 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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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1. 510(k) Summary : K232255
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: July 27, 2023
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: | 7505 Fannin St. Suite 610, Houston, TX 77054 |
| Telephone: | +713-467-2607 |
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: | EzSensor XHD |
|---|---|
| Model Name: | IOS-A15IF, HDI-15DGF |
| Common Name: | Digital Dental Intra Oral Sensor |
| Regulatoin number: | 21 CFR 872.1800 |
| Classification Name : | Extraoral source X-ray system |
| Regulatory Class: | CL 2 |
| Product Code: | MUH |
Predicate Device :
| Manufacturer | : Rayence Co., Ltd. |
|---|---|
| Device | : EzSensor Soft, EzSensor Soft i, EzSensor Bio, |
| EzSensor Bio I, | |
| Model: 1.0, 1.5, 2.0 |
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| 510(k) Number | : K151707 (Decision Date –07/19/2015) |
|---|---|
| The Regulation Number | : 21 CFR 872.1800 |
| Classification Name | : Extraoral Source X-ray System |
| Regulatory Class | : CL 2 |
| Primary Product Code | : MUH |
2. Device Description
EzSensor XHD is a digital intraoral sensor which acquires digital intra-oral images. EzSensor XHD 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. The ergonomic design based on human intraoral anatomy improves patient comfort. EzSensor XHD includes the software (firmware) with MODERATE level of concern.
3. Indication for use
EzSensor XHD 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
EzSensor XHD 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...
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While applying the stainless-steel material to the inside of the frame, soft silicon material surrounds the exterior of the USB connector to protect the sensor from 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 | Rayence Co., Ltd |
| Device name | EzSensor XHD | |
| (Model: IOS-A15IF, HDI-15DGF) | EzSensor Soft, EzSensor Soft i, | |
| EzSensor Bio, EzSensor Bio i | ||
| Feature | Image: EzSensor XHD | Image: EzSensor Soft |
| 510(k) number | K232255 | K151707 |
| X-ray converter | CsPbBr3 | Gd2O2S:Tb |
| Detection type | Direct conversion | Indirect conversion |
| Indications | ||
| for use | EzSensor XHD 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 "1.0": 37.8 x 26.6 |
| Size "1.5": 40.8 x 30.6 | ||
| Size "2.0": 44.0 x 32.5 | ||
| Sensor Thickness(mm) | 6.2 | 5 |
| Available Active Area | ||
| size (mm) | Size 1.5: 23.98 x 33.00 | Size "1.0": 20.01 x 30.01 |
| Size "1.5": 23.98 x 33.00 | ||
| Size "2.0": 25.99 x 35.99 | ||
| USB Module | Integrated USB 2.0 module | Integrated USB 2.0 module |
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| Max. Resolution (lp/mm) | 33.8 | ||
|---|---|---|---|
| Pixel | |||
| Pitch(µm) | Full | ||
| Resolution | 14.8 | ||
| DQE | |||
| (6 lp/mm) | Full | ||
| Resolution | 0.204 | 0.144 | |
| MTF | |||
| (3 lp/mm) | Full | ||
| Resolution | 0.685 | 0.456 | |
| Typical dose range(µGy) | Incisor & Canine : 300 ~ 500 / Molar: 400 ~ 600 | ||
| Viewer Software (option) | EzDent-I (K223820) | Easydent or | |
| EzDent-I (K150747) |
6.Summary of Performance Testing
The indications for use, and application of EzSensor XHD is the same as that of the predicate device, EzSensor Soft.
EzSensor XHD is a direct conversion sensor that utilizes a photoconductor (CsPbBr3) and single crystal Silicon as the sensing means whereas EzSensor Soft, the predicate device, utilizes single crystal Silicon and fluorescent materials (Gd2O2S:Tb) as the sensing means.
The performance test results indicate that the EzSensor XHD intraoral sensor performed equally to the EzSensor Soft, 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 EzSensor XHD has better performance outcome than EzSensor Soft, the predicate sensor.
Electrical, mechanical, environmental safety and performance testing were performed according to IEC 60601-1:2005, AMD1:2012 (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.
The clinical images obtained from the EzSsensor XHD and EzSensor Soft were reviewed and rated comparatively.
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EzSensor XHD produces overall better definition and grayscale of bony and soft tissue images in comparison with EzSensor Soft.
In conclusion, both the proposed 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 EzSensor XHD is substantially equivalent to EzSensor Soft, the predicate device as described herein.