(123 days)
No
The summary describes a standard digital dental x-ray imaging system and does not mention any AI or ML capabilities. The image processing unit is likely for basic image manipulation, not AI-driven analysis.
No
The device is described as an intra-oral imaging system that collects dental x-ray photons and converts them into electronic impulses for diagnostic use by dentists. It does not perform any therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device produces images "for diagnostic use by dentists."
No
The device description explicitly mentions a "solid-state sensor," a "wire," and an "analog-to-digital USB box," which are all hardware components essential to the device's function of acquiring digital images.
Based on the provided information, the HDI 2000 / HDI 2000A is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic purposes.
- Device Function: The HDI 2000 / HDI 2000A is an intra-oral imaging system that collects dental x-ray photons and converts them into digital images. It works by directly capturing radiation that passes through the patient's body.
- Specimen Type: This device does not examine specimens derived from the human body (like blood, tissue, or urine). It directly interacts with the patient's anatomy using radiation.
- Intended Use: Its intended use is to provide images for diagnostic use by dentists, but this is achieved through imaging the patient's teeth and surrounding structures, not by analyzing biological samples.
Therefore, the HDI 2000 / HDI 2000A falls under the category of a medical imaging device, specifically a dental x-ray sensor, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HDI 2000 / HDI 2000A, an Intra-oral Imaging System, 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 (comma separated list FDA assigned to the subject device)
MQB, MUH
Device Description
The HDI 2000 / HDI 2000A Intra-oral imaging system is a device which acquires digital image. Direct digital systems acquire images with a solid-state 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 sensor is connected by a wire to an analog-to-digital USB box, which is connected to the computer. Images are produced within seconds of sensor exposure. The wire length from a direct sensor is about 3 meters and less. The USB box connects to the USB 2.0 port of the computer.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
intra-oral / 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, environmental safety and performance testing according to standard IEC 60601-1: 2005 + CORR.I(2006) + CORR(2007) (Medical electrical equipment Part 1:General requirements for basic safety and essential performance) was performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2:2007.
Non-clinical & Clinical considerations according to FDA Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices" was performed.
All test results were satisfactory.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
0
K140060
Page 1 of 4
510(k) Submission – HDI 2000 / HDI 2000A
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirement s of 21 CFR Part 807.92.
Date 510K summary prepared: January 3, 2014
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: | +82-31-8015-6459 |
| Contact person: | Mr. Kee Dock Kim / Manager / +82-31-8015-6459 |
| Official Correspondent: | Dave Kim (davekim@mtech-inc.net) |
| (U.S. Designated agent) | |
| 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: | HDI 2000, HDI 2000A |
|---|---|
| Common Name: | Medical Image Processing Unit |
| Classification Name : | 21CFR892.1680 / Stationary x-ray system |
| Product Code: | MQB |
Predicate Device :
| Manufacturer | : Rayence Co., Ltd. |
|---|---|
| Device | : EzSensor P |
| 510(k) Number | : K121132 (Decision Date - MAY. 10. 2012) |
2
1
Device Description :
The HDI 2000 / HDI 2000A Intra-oral imaging system is a device which acquires digital image. Direct digital systems acquire images with a solid-state 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 sensor is connected by a wire to an analog-to-digital USB box, which is connected to the computer. Images are produced within seconds of sensor exposure. The wire length from a direct sensor is about 3 meters and less. The USB box connects to the USB 2.0 port of the computer.
Indication for use :
HDI 2000 / HDI 2000A, an Intra-oral Imaging System, 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.
Summary of the technological characteristics of the device compared to the predicate device
The The indications for use, material, form factor, performance, and safety characteristics of HDI 2000 / HDI 2000A described in this 510(k) are the same as that of the predicate device, EzSensor P of Rayence Co., Ltd.
The primary difference is the size of new sensors and availability of optional image viewing software, Prora view, which is alreay cleared by FDA (K131594). As demonstrated by the technical comparison between the subject and predicate device, the difference in the physical dimension of the sensor does not present any new concerns in terms of safety and effectiveness.
2
1. HDI 2000 / HDI 2000A Summary
1.1 Hardware
The hardware of HDI 2000 and HDI 2000A are identical.
The shape of the top cover and case of EzSensor P ( K121132) are modified without affecting the sensor performance.
| Change | HDI 2000 / HDI 2000A | EzSensor P |
|---|---|---|
| Image: Sensor ASS'Y | Image: HDI 2000 / HDI 2000A exploded view | Image: EzSensor P exploded view |
| Sensor_ASS'Y | ||
| ③ : Upper Case | ||
| ⑤ : Top Cover |
1.2 Viewer Software
This device is operated using viewer software. With the identical hardware configuration, the model name is distinguished by the type of image viewing software available. The software functions include the patient information management, image capture, and viewer for captured images.
| Model | Sensor Type | Size (mm) | Viewer Software | Viewer Software
Manufacturer |
|-----------|-------------|--------------------|---------------------|---------------------------------|
| HDI 2000 | 1.5 | 38.7 x 29.2 x 4.95 | Easydent | Rayence Co., Ltd. |
| HDI 2000A | 1.5 | 38.7 x 29.2 x 4.95 | ProraView (K131594) | EWOO Soft |
| HDI 2000 | 2.0 | 42.8 x 31.5 x 4.95 | Easydent | Rayence Co., Ltd. |
| HDI 2000A | 2.0 | 42.8 x 31.5 x 4.95 | ProraView (K131594) | EWOO Soft |
Easydent is the same software used for the predicate device whereas ProraView image viewing software is a stand alone imaging viewer program with 510(k) clearance of its own. Both viewing programs have the similar functionality and performance. The main difference is the design of the user interface (UJ) and new consulting simulation tool for Prora View. Prora View requires a fee based license registration for the right to use whereas EasyDent is provided to users free of charge.
The design control risk analysis for ProraView describes hazards associated with respect to SRS and SDS. All risks are mitigated and any residual risks are determined acceptable.
3
K140060
Page 4 of 4
- 2.1) Difference for Easydent and ProraView
| Easydent | Prora View | |
|---|---|---|
| Function | Patient | Patient |
| View | View | |
| Acquisition | Acquisition | |
| Consultation | Consultation | |
| Report | Report | |
| License |
Summary for any testing in the submission
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1: 2005 + CORR.I(2006) + CORR(2007) (Medical electrical equipment Part 1:General requirements for basic safety and essential performance) was performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2:2007.
Non-clinical & Clinical considerations according to FDA Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices" was performed.
All test results were satisfactory.
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 HDI 2000 / HDI 2000A is safe and effective and substantially equivalent to predicate device as described herein.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and a symbol. The text element encircles the symbol and reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The symbol is a stylized representation of a human figure, with three overlapping figures in a dynamic, forward-leaning pose.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 13, 2014
Rayence Co. Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025
Re: K140060
Trade/Device Name: Digital Dental Intra Oral Sensor (HDI 2000, HDI 2000A) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB and MUH Dated: April 15, 2014 Received: April 18, 2014
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 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.
5
Page 2—Mr. Kim
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Smh.7)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K140060
Device Name
HDI 2000, HDI 2000A digital dental image processing system
Indications for Use (Describe)
HDI 2000 / HDI 2000A, an Intra-Oral 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 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
($m, 3)
FORM FDA 3881 (6/13)
PSL" Pakkatung Services { 101 \ 44 -47 \u
7
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