RIS500

K143000 · Ray Co., Ltd. · MQB · Jan 23, 2015 · Radiology

Device Facts

• Record ID: K143000
• Device Name: RIS500
• Applicant: Ray Co., Ltd.
• Product Code: MQB · Radiology
• Decision Date: Jan 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

This system is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, views and manipulated for diagnostic use by dentists.

Device Story

RIOSensor (RIS500) is a digital intraoral X-ray imaging system; consists of a CMOS solid-state sensor and PC-based software. Device detects onset of X-ray exposure; automatically acquires and saves image data to a PC. Used in dental clinics by dentists to replace traditional film/screen systems. Output is a digital image displayed on a PC for diagnostic manipulation. Benefits include real-time digital image capture, storage, and improved diagnostic workflow compared to film.

Clinical Evidence

Clinical evaluation performed by two licensed practitioners who observed and verified the device's performance in a clinical setting. Bench testing conducted per FDA guidance for solid-state X-ray imaging devices, including MTF (>30% at 6 lp/mm) and DQE (>40% at 2.5 lp/mm) per IEC 61223-3-4. All test results were satisfactory.

Technological Characteristics

Solid-state CMOS X-ray sensor; USB 2.0 interface; pixel size 20x20 μm. Dimensions: Size 1 (39x25 mm), Size 2 (42x30 mm). Connectivity: PC-based via USB. Standards: IEC 60601-1 (electrical/mechanical safety), IEC 60601-1-2 (EMC), IEC 61223-3-4 (imaging performance).

Indications for Use

Indicated for dental patients requiring intraoral radiographic imaging for diagnostic purposes by dentists.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• EzSensor T (K121132)
• EzSensor (K090526)

Submission Summary (Full Text)

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

January 23, 2015

Ray Co., Ltd. % Mr. Andrew H. Paeng Consultant 4747 Hoen Avenue SANTA ROSA CA 95405

Re: K143000

Trade/Device Name: RIO Sensor (RIS 500) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: October 28, 2014 Received: October 30, 2014

Dear Mr. Paeng:

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.

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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) K143000

## Device Name

Trade Name: RIOSensor Proprietary Name: RIS500 Common Name: Intraoral Imaging Unit

Indications for Use (Describe)

This system is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, views and manipulated for diagnostic 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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# 5. 510(K) Summary

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## 510(k) Summary

The summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92.

Date:

| APPLICANT | RAY Co.,Ltd |
|----------------|--------------------------------------------------------------------------------------------------------------------------------|
| ADDRESS | #332-7, Samsung 1-ro, Hwaseong-si, Gyeonggi-do, 443-823, Korea |
| Manufacturer | RAY Co.,Ltd<br>332-7, Samsung 1-ro, Hwaseong-si, Gyeonggi-do, 443-823, Korea<br>TEL : [phone]<br>FAX : [phone] |
| Contact Person | Kyungha Seo<br>e-mail: [e-mail] |

#### Device Name

Trade Name: RIOSensor Proprietary Name: RIS500 Common Name: Intraoral Imaging Unit

#### Classification

Classification name: solid state x-ray imager (flat panel/digital imager) Regulatory Number: 21 CFR 892.1680 Class: II Product code: MQB Panel: Radiology

#### Description

RIOSensor(Model RIS500) is intended to acquire real-time, clinical digital intraoral X-ray images using a solid-state imaging sensor. This system consists of the CMOS sensor and software for image display. This system senses the onset of the X-ray exposure and automatically acquires and save the image data to a PC (software).

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#### Indication for use

This system is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, views and manipulated for diagnostic use by dentists.

"CAUTION: Federal (US) law restricts the sale of this device to, or on the order of, licensed professionals.

### Predicate device

- 1) Predicate device-1 Manufacturer: HUMANRAY Co., Ltd. Device: EzSensor T 510(k) Number: K121132
- 2) Predicate device-2 Manufacturer: E-WOO TECHNOLOGY Device: EzSensor 510(k) Number: K090526

#### Statement of Substantial Equivalence

| Parameter | Proposed Device | Predicated Device | Predicated Device |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufac<br>turer | RAY Co., Ltd | HUMANRAY Co., Ltd | E-WOO Technology Co., Ltd. |
| Device<br>Name | RIS500 | EzSensor P | EzSensor |
| 510(K)<br>Number | K143000<br>Traditional 510k | K121132<br>Special 510k | K090526<br>Traditional 510k |
| Feature | Image: Proposed Device Feature | Image: Predicated Device Feature | Image: Predicated Device Feature |
| Indications<br>for use | This system is intended to collect<br>dental x-ray photons and convert<br>them into electronic impulses that<br>may be stored, views and<br>manipulated for diagnostic use by<br>dentists. | EzSensor P, Intra-oral Imaging<br>System, isintended to collect<br>dental x-ray photons and convert<br>them into electronic impulses that<br>may be stored, viewed, and<br>manipulated for diagnostic use by<br>dentists. | Indicated for intended to collect<br>dental x-ray photons and convert<br>them into electronic impulses that<br>may be stored, viewed, and<br>manipulated for diagnostic use by<br>dentist. |
| Device<br>Description | RIOSensor(Model RIS500) is<br>intended to acquire real-time,<br>clinical digital intraoral X-ray<br>images using a solid-state imaging<br>sensor. This system consists of the<br>CMOS sensor and software for<br>image display. This system senses<br>the onset of the X-ray exposure<br>and automatically acquires and<br>save the image data to a PC<br>(software). | EzSensor P is a solid state x-ray<br>imager designed for dental<br>radiographic applications, The<br>EzSensot P digital intraoral sensor<br>provides digital image capture to<br>replace radiographic film/screen<br>system in general dental diagnostic<br>procedures. The captured digital<br>image is transferred to Personal<br>Computer via USB interface port. | The EzSensor is a solid state x-<br>ray imager designed for dental<br>radiographic applications, The<br>EzSensor provides digital image<br>capture for conventional<br>film/screen radiographic dental<br>examinations. The device is used<br>to replace radiographic film/screen<br>system in general dental diagnostic<br>procedures. The captured digital<br>image is transferred to Personal<br>Computer via USB interface port |
| Sensor<br>Dimension | Size 1: 39x25 mm<br>Size 2: 42x30 mm | Size "1.5": 38.7x29.2 mm<br>Size "2.0": 42.8x31.5 mm | Size "1.0": 35.7x25.2 mm<br>Size "1.5": 38.7x29.2 mm |
| Sensor<br>Thickness | 5.6 mm | 4.95 mm | 4.95mm |
| Active<br>Area(m<br>m) | Size 1: 39x25<br>Size 2: 42x30 | Size "1.5": 24.01x33.04<br>Size "2.0": 26.04x36.05 | Size "1.0": 20.02x30.03<br>Size "1.5": 24.08x31.85 |
| USB<br>Module | Integrated USB 2.0 module | Integrated USB 2.0 module | Integrated USB 2.0 module |
| Pixel<br>size | 20x20 μm | 20x20 μm | 35x35 μm |
| Pixel<br>Matrix | Size 1: 1000x1500 pixel<br>Size 2: 1300x1700 pixel | Size "1.5": 1200x1650 pixel<br>Size "2.0": 1300x1800 pixel | Size "1.0": 572x858 pixel<br>Size "1.5": 686x944 pixel |
| Pixel<br>Pitch | 20x20 μm | 20x20 μm | 35x35 μm |
| Theoretical<br>Resolution | 25 lp/mm | 25 lp/mm | 14.3 lp/mm |
| MTF | More than 30% at 6 lp/mm | More than 30% at 6 lp/mm | More than 30% at 6 lp/mm |
| DQE | More than 40% at 2.5 lp/mm | More than 40% at 2.5 lp/mm | More than 40% at 2.5 lp/mm |

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The intended use, constructions, construction materials, technical characteristics and safety characteristics between RIS500 and Its predicate device are same. Ray Co.,Ltd Page

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Accordingly we can claim the substantially equivalence of RIS500 to the predicate device.

#### Safety and Effectiveness Information:

Electrical, mechanical and environmental safety testing according to standard of IEC 60601-1(2005+ CORR.1(2006)+CORR.2(2007) was performed. EMC testing was conducted in accordance with the standard IEC 60601-1-2(2007).

The software of RIS500 has been validated according to FDA "Guidance for the Content d Premarket Submissions for Software Contained in Medical Devices" and applicable requirements contained in the guidance document.

Bench testing was conducted according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, section 18, Performance Testing - Bench"

Bench testing is used to assess whether or not the parameter measured for describing functionalities related to imaging properties of the dental X-ray device and patient dosage satisfies the designated tolerance.

Performance (Imaging performance) testing was conducted according to standard of IEC 61223-3-4.

All test results were satisfactory.

Non-clinical considerations were conducted in accordance with FDA Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices". All test results were satisfactory.

The tests include the MTF(Modulation Transfer Function) and DQE(Detective Quantum Efficiency) of detector. MTF of detector shows the resolution more than 30% at 6 lp/mm and The DQE of detector shows the resolution more than 40% at 2.5 lp/mm.

Base on the Non-Clinical Test report, Even though the pixel size and active area of predicate detectors are different, the diagnostic image quality of RIS500 detector is equal or better than that of predicate device and there is no significant difference in efficiency and safety.

Clinical considerations were conducted according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, section 20".

For clinical testing. two licensed practitioners/clinicians observed and verified that Intraoral Imaging Unit from RIOSensor(Model name: RIS500).

#### 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. RAY Co., LTD concludes that the RIS500 is safe and effective to perform its intended use as well as substantially equivalent to the predicate device.