EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i

K151707 · Rayence Co., Ltd. · MUH · Jul 19, 2015 · Dental

Device Facts

• Record ID: K151707
• Device Name: EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i
• Applicant: Rayence Co., Ltd.
• Product Code: MUH · Dental
• Decision Date: Jul 19, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

EzSensor Soft, EzSensor Soft i, EzSensor Bio i 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 dagnostic use by dentists.

Device Story

Digital dental intraoral sensor system; acquires intraoral x-ray images using CMOS technology. Sensor captures x-ray photons, converts to electronic impulses; transmits via USB 2.0 interface to computer. Used in dental clinics by dentists/staff. Viewer software (Easydent or EzDent-i) manages patient info, image capture, display, and manipulation (windowing, measurement, editing). Provides rapid image acquisition compared to film; ergonomic design for patient comfort. Output used by dentists for diagnostic decision-making; enables lower radiation dose than film.

Clinical Evidence

Bench testing only. Performance evaluated via DQE, MTF, and linear response to x-ray exposure, demonstrating equivalence to the predicate. Electrical, mechanical, and environmental safety verified per IEC 60601-1; EMC testing per IEC 60601-1-2. No clinical data presented.

Technological Characteristics

CMOS-based digital intraoral sensor; amorphous silicon and fluorescent materials. USB 2.0 connectivity. Available in sizes 1.0, 1.5, 2.0. Thickness 5mm. Operates with Easydent or EzDent-i viewer software. Complies with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for dentists to collect, store, view, and manipulate dental x-ray images for diagnostic purposes in patients requiring intraoral dental radiography.

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

• EzSensor Soft [Alternative name : EzSensor Bio] (K143753)

Reference Devices

• EzDent-i 1.0 (K131594)
• EzDent-i 2.0 (K150747)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

July 19, 2015

Rayence Co. Ltd. % Mr. David Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025

Re: K151707

Trade/Device Name: EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i (Model: 1.0, 1.5, 2.0) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: June 23, 2015 Received: June 24, 2015

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. 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

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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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/Resourcesfor You/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,

Robert A Ochs

Robert Ochs, Ph.D. Acting 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) K151707

#### Device Name

EzSensor Soft, EzSensor Soft i, EzSensor Bio, EzSensor Bio i, Model: 1.0, 1.5, 2.0

Indications for Use (Describe)

EzSensor Soft, EzSensor Soft i, EzSensor Bio i 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 dagnostic use by dentists.

| 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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Image /page/3/Picture/0 description: The image shows the Rayence logo. The logo consists of the word "Rayence" in red, block letters. To the right of the word is a graphic of two overlapping circles in shades of orange and yellow. The logo is simple and modern.

ail. Hwaseong-si.

Date: June 23, 2015

To: Department of health & Human Services, Food and Drug Administration

# Special 510(k): Device Modification

## EzSensor Soft, EzSensor Soft i, EzSensor Bio, EzSensor Bio i Model: 1.0, 1.5, 2.0

### Reference : K143753, EzSensor Soft [Alternative name- EzSensor Bio] Decision Date : March 10, 2015

The Rayence Co., Ltd. hereby submits this Special 510(k) for EzSensor Soft, EzSensor Soft i, EzSensor Bio, EzSensor Bio i, (model: 1.0, 1.5, 2.0) to inform the following device modifications to the predicate device, EzSensor Soft or EzSensor Bio.

1) New device model names.

2) New Imaging Viewer Software Version Update

3) New sensor size 1.5

We believe these modifications are eligible for the Special 510(k) process since they have the same fundamental scientific technology and intended use as the predicate device. We consider our intent to market this device as confidential commercial information and requests that it be treated as such by FDA. We have taken precautions to protect the confidentiality of the intent to market these devices. We understand that the submission to the government of false information is prohibited by 18 U.S.C. 1001 and 21 U.S.C. 331(q).

Thank you in advance for your consideration of our application. If there are any questions, please feel free to contact me at [phone].

Sincerely yours,

Kee Dock Kim, RA Team manager Rayence Co., Ltd

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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: June 23, 2015

Submitter's Name, address, telephone number, a contact person:

| Submitter's Name : | Rayence Co., Ltd. |
|----------------------------------------------------|---------------------------------------------------------|
| Submitter's Address: | 14, Samsung 1-ro 1-gil, Hwaseong-si, Gyeonggi-do, Korea |
| Submitter's Telephone: | [phone] |
| Contact person: | Mr. Kee Dock Kim / RA Team Manager / [phone] |
| Official Correspondent:<br>(U.S. Designated agent) | Dave Kim ([e-mail]) |
| Address: | 8310 Buffalo Speedway, Houston, TX 77025 |
| Telephone: | [phone] |
| Fax: | [phone] |

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 Soft, EzSensor Soft i, EzSensor Bio,<br>EzSensor Bio I,<br>Model: 1.0, 1.5, 2.0 |
|-------------------------|------------------------------------------------------------------------------------------|
| Regulation Number : | 21 CFR 872.1800 |
| Regulation Name : | Extraoral source x-ray system |
| Regulatory Class: | II |
| Product Code: | MUH |
| Predicate Device : | |
| Manufacturer | : Rayence Co., Ltd. |
| Device | : EzSensor Soft [Alternative name : EzSensor Bio] |

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| 510(k) Number | : K143753 (Decision Date – March 10, 2015 |
|-------------------|-------------------------------------------|
| Regulation Number | : 21 CFR 872.1800 |
| Regulation Name | : Extraoral source x-ray system |
| Regulatory Class | : II |
| Product Code | : MUH |

#### 510(k) Submission - EzSensor Soft, EzSensor Soft i, EzSensor Bio, EzSensor Bio i

## 2. Device Description

EzSensor Soft, EzSensor Soft i, EzSensor Bio i are digital dental intraoral sensors which acquire digital intra oral images. Direct digital systems acquire images with a bendable sensor that is connected to a computer to produce an image almost instantaneously following exposure. The primary advantage of direct sensor systems is the image acquisition speed. For patient comfort, the ergonomic design is based on human intraoral anatomy.

- Excellent image quality based on advanced CMOS technology
- · Sensor's ergonomic shape is more comfortable for the human oral structure
- · Lower dose exposure (compared to film sensor)
- Enhanced durability
- · Easy-to-use USB interface

## 3. Indication for use

EzSensor Soft, EzSensor Soft i, EzSensor Bio i 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.

### 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 Soft, EzSensor Soft i, EzSensor Bio i Digital Dental Intra Oral Sensor described in this 510(k) has the same indications for use and similar technical characteristics as its predicate device, EzSensor Soft [Alternative name : EzSensor Bio] of Rayence Co., Ltd.

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### 5. 1 Separate model name

The following table lists the new devise model names and their respective hardware and software combination.

| | Model Name | Component |
|-----------|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Predicate | EzSensor Soft<br>(alternate name : EzSensor Bio)<br>Size: 1.0, 2.0 | Intra Oral Sensor + Easydent (Viewer Software)<br>Intra Oral Sensor + EzDent-i 1.0 (Viewer<br>Software, K131594) |
| Proposed | EzSensor Soft<br>(alternate name : EzSensor Bio)<br>Size: 1.0, 1.5, 2.0 | Intra Oral Sensor + Easydent (Viewer Software) |
| Proposed | EzSensor Soft i<br>(alternate name : EzSensor Bio i)<br>Size: 1.0, 1.5, 2.0 | Intra Oral Sensor + EzDent-i 2.0 (Viewer<br>Software, K150747) |

### 5. 2 Characteristic

| Characteristic | Proposed<br>Rayence Co., Ltd. | Predicate<br>Rayence Co., Ltd. |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Image: EzSensor Soft, EzSensor Soft i, EzSensor Bio and EzSensor Bio i | Image: EzSensor Soft [Alternative name : EzSensor Bio] digital dental image processing system |
| 510(k) number | - | K143753 |
| Indications<br>for use | EzSensor Soft, EzSensor Soft i,<br>EzSensor Bio and EzSensor Bio i<br>Digital Dental Intra Oral Sensors are<br>intended to collect dental x-ray<br>photons and convert them into<br>electronic impulses that may be<br>stored, viewed and manipulated for<br>diagnostic use by dentists. | EzSensor Soft [Alternative name :<br>EzSensor Bio] Digital Dental Intra<br>Oral Sensor is intended to collect<br>dental x-ray photons and<br>convert them into electronic impulses<br>that may be stored, viewed and<br>manipulated for diagnostic use by<br>dentists. |
| Sensor Dimension(mm)<br>(±10%) | Size "1.0": 37.8 x 26.6<br>Size "1.5": 40.8 x 30.6<br>Size "2.0": 44.0 x 32.5 | Size "1.0": 37.5 x 26.5<br>Size "2.0": 43.5 x 32.5 |
| Sensor Thickness(mm) | 5 | 5 |
| Active Area(mm) | Size "1.0": 20.01 x 30.01<br>Size "1.5": 23.98 x 33.00<br>Size "2.0": 25.99 x 35.99 | Size "1.0": 20 x 30<br>Size "2.0": 25.99 x 35.99 |
| USB Module | Integrated USB 2.0 module | Integrated USB 2.0 module |

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| Pixel<br>Pitch (μm) | Full Resolution | 14.8 | 14.8 |
|-----------------------------|-----------------|-------------------------------------------------|-------------------------------|
| | Binning mode | 29.6 | 29.6 |
| DQE<br>84.64 µGy<br>6 lp/mm | Full Resolution | 0.070 | 0.070 |
| | Binning mode | 0.070 | 0.070 |
| MTF<br>84.64 µGy<br>6 lp/mm | Full Resolution | 0.154 | 0.154 |
| | Binning mode | 0.133 | 0.133 |
| Typical dose range(µGy) | | Incisor & Canine : 300 ~ 500 / Molar: 400 ~ 600 | |
| Viewer Software* | | Easydent or EzDent-i(K150747) | Easydent or EzDent-i(K131594) |

510(k) Submission - EzSensor Soft, EzSensor Soft i, EzSensor Bio, EzSensor Bio i

This device is operated using viewer software. With the identical hardware configuration, the intraoral sensor model name is distinguished by the type and version of image viewing software available. The software functions include the patient information management, image capture, and viewer for captured images. Both EzDent-i 1.0 and 2.0 versions have the same indications for use and functionalities like operation software, computer platform, picture archiving and communication format, image format, image processing features, windowing, image edit, measurements and manipulation. The differences are that the EzDent-i 2.0 (K150747) has additional features such as "Hide the patient information", "Export to acquisition information", "Create New Report" and "Print Setting".

In addition, a new sensor size 1.5 is available to the existing sensor sizes 1.0 and 2.0 of the 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.

### 6. Summary of Performance Testing

The intended use, application and detector type of EzSensor Soft i, EzSensor Soft i, EzSensor Bio, EzSensor Bio i are identical to the predicate device. Both the subject and predicate device use the same amorphous silicon alley and materials for fluorescent as the sensing means. The performance test result indicates that the EzSensor Soft, EzSensor Soft i, EzSensor Bio, EzSensor Bio i detector performed equally the predicated device; EzSensor Soft [Alternative name : EzSensor Bio] and no additional safety risk is identified in the bench test: Non-clinical report.

Non-clinical according to FDA Guidance "Guidance for the Submissions of 510(k)'s for Solid State X-

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ray Imaging Devices" was performed.

The DQE, MTF and linear response to X-ray exposure test demonstrated that the subject sensor performed equivalently compared to the predicate device with the same dynamic range.

Electrical, mechanical, environmental safety and performance testing were performed according to standard IEC 60601-1: 2005 + CORR.1(2006) + CORR(2007) (Medical electrical equipment Part 1:General requirements for basic safety and essential performance). EMC testing was conducted in accordance with standard IEC 60601-1-2:2007.

## 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. Rayence Co., Ltd. concludes that EzSensor Soft, EzSensor Soft i, EzSensor Bio, EzSensor Bio i is safe and effective and substantially equivalent to predicate device as described herein.