(98 days)
Not Found
No
The summary describes a standard digital X-ray sensor and image display software. There is no mention of AI, ML, or advanced image processing techniques that would typically indicate the presence of such technology. The performance metrics and testing described are standard for digital imaging devices.
No
The device is described as collecting and converting dental x-ray photons for diagnostic use by dentists, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" states that the system is used "for diagnostic use by dentists," and the "Device Description" mentions acquiring "clinical digital intraoral X-ray images."
No
The device description explicitly states that the system consists of a "CMOS sensor and software for image display," indicating a hardware component (the sensor) is integral to the device's function.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: This device collects dental x-ray photons and converts them into electronic impulses for diagnostic use by dentists. It works by acquiring images directly from the patient's body using radiation, not by analyzing specimens taken from the body.
- Intended Use: The intended use clearly states it's for collecting dental x-ray photons and converting them for diagnostic use by dentists, which is an in-vivo imaging process.
- Device Description: The description confirms it's a solid-state imaging sensor for acquiring real-time, clinical digital intraoral X-ray images. This is a direct imaging modality, not an in-vitro test.
Therefore, this device falls under the category of a medical imaging device, specifically a dental x-ray sensor, rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device 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).
Mentions image processing
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).
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
MTF: More than 30% at 6 lp/mm
DQE: More than 40% at 2.5 lp/mm
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1680 Stationary x-ray system.
(a)
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.(b)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is rendered in a dark color, while the text is in a lighter color. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health & Human Services.
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.
1
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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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3
5. 510(K) Summary
4
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 |
| 332-7, Samsung 1-ro, Hwaseong-si, Gyeonggi-do, 443-823, Korea | |
| TEL : +82-31-605-1000 | |
| FAX : +82-2-6280-5534 | |
| Contact Person | Kyungha Seo |
| e-mail: Kyungha.seo@raymedical.co.kr |
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
-
- Predicate device-1 Manufacturer: HUMANRAY Co., Ltd. Device: EzSensor T 510(k) Number: K121132
-
- 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 | |||
| turer | RAY Co., Ltd | HUMANRAY Co., Ltd | E-WOO Technology Co., Ltd. |
| Device | |||
| Name | RIS500 | EzSensor P | EzSensor |
| 510(K) | |||
| Number | K143000 | ||
| Traditional 510k | K121132 | ||
| Special 510k | K090526 | ||
| Traditional 510k | |||
| Feature | Image: Proposed Device Feature | Image: Predicated Device Feature | Image: Predicated Device Feature |
| Indications | |||
| 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. | EzSensor P, Intra-oral Imaging | ||
| System, isintended to collect | |||
| dental x-ray photons and convert | |||
| them into electronic impulses that | |||
| may be stored, viewed, and | |||
| manipulated for diagnostic use by | |||
| dentists. | Indicated for intended to collect | ||
| dental x-ray photons and convert | |||
| them into electronic impulses that | |||
| may be stored, viewed, and | |||
| manipulated for diagnostic use by | |||
| dentist. | |||
| Device | |||
| 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). | EzSensor P is a solid state x-ray | ||
| imager designed for dental | |||
| radiographic applications, The | |||
| EzSensot P digital intraoral sensor | |||
| provides digital image capture to | |||
| replace radiographic film/screen | |||
| system in general dental diagnostic | |||
| procedures. The captured digital | |||
| image is transferred to Personal | |||
| Computer via USB interface port. | The EzSensor is a solid state x- | ||
| ray imager designed for dental | |||
| radiographic applications, The | |||
| EzSensor provides digital image | |||
| capture for conventional | |||
| film/screen radiographic dental | |||
| examinations. The device is used | |||
| to replace radiographic film/screen | |||
| system in general dental diagnostic | |||
| procedures. The captured digital | |||
| image is transferred to Personal | |||
| Computer via USB interface port | |||
| Sensor | |||
| Dimension | Size 1: 39x25 mm | ||
| Size 2: 42x30 mm | Size "1.5": 38.7x29.2 mm | ||
| Size "2.0": 42.8x31.5 mm | Size "1.0": 35.7x25.2 mm | ||
| Size "1.5": 38.7x29.2 mm | |||
| Sensor | |||
| Thickness | 5.6 mm | 4.95 mm | 4.95mm |
| Active | |||
| Area(m | |||
| m) | Size 1: 39x25 | ||
| Size 2: 42x30 | Size "1.5": 24.01x33.04 | ||
| Size "2.0": 26.04x36.05 | Size "1.0": 20.02x30.03 | ||
| Size "1.5": 24.08x31.85 | |||
| USB | |||
| Module | Integrated USB 2.0 module | Integrated USB 2.0 module | Integrated USB 2.0 module |
| Pixel | |||
| size | 20x20 μm | 20x20 μm | 35x35 μm |
| Pixel | |||
| Matrix | Size 1: 1000x1500 pixel | ||
| Size 2: 1300x1700 pixel | Size "1.5": 1200x1650 pixel | ||
| Size "2.0": 1300x1800 pixel | Size "1.0": 572x858 pixel | ||
| Size "1.5": 686x944 pixel | |||
| Pixel | |||
| Pitch | 20x20 μm | 20x20 μm | 35x35 μm |
| Theoretical | |||
| 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
7
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.