(123 days)
No
The description focuses on the hardware and basic image acquisition process, with no mention of AI or ML algorithms for image analysis, processing beyond basic conversion, or diagnostic assistance.
No.
The device is used for diagnostic imaging, not for treating a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the electronic impulses generated by the device "may be stored, viewed, and manipulated for diagnostic use by dentists." This indicates its role in providing data for diagnosis.
No
The device description explicitly states it includes a solid-state sensor, an analog-to-digital converter box, and connecting wires, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The HDI 1000 / HDI 1000A is an intra-oral imaging system that uses dental x-rays to create images of the inside of the mouth. It collects photons and converts them into electronic impulses for viewing and manipulation.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. It directly captures images using radiation.
Therefore, while it is a medical device used for diagnostic purposes, it falls under the category of medical imaging equipment rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HDI 1000 / HDI 1000A, an Intra-oral Imaging System, is used to collect dental x-rays photons and convert them into electronic impulses that may be stored, and manipulated for diagnostic use by dentists.
Product codes (comma separated list FDA assigned to the subject device)
MQB, MUH
Device Description
The HDI 1000 / HDI 1000A intra-oral imaging system is a device which acquires digital intra oral images. 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 converter 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. This wire plugs into an analogto-digital converter box. The converter box connects to the computer with a USB cable.
Mentions image processing
Medical Image Processing Unit
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.1(2006) + CORR(2007) (Medical electrical equipment Part I:General requirements for basic safety and essential performance) was performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2:2007.
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.
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K140056
Page 1 of 3
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: 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: | |
| (U.S. Designated agent) | Dave Kim (davekim@mtech-inc.net) |
| 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 1000, HDI 1000A |
|---|---|
| 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 |
| 510(k) Number | : K090526 (Decision Date - DEC. 2. 2009 |
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Device Description :
The HDI 1000 / HDI 1000A intra-oral imaging system is a device which acquires digital intra oral images. 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 converter 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. This wire plugs into an analogto-digital converter box. The converter box connects to the computer with a USB cable.
Indication for use :
HDI 1000 / HDI 1000A, an Intra-oral Imaging System, is used to collect dental x-rays photons and convert them into electronic impulses that may be stored, and manipulated for diagnostic use by dentists.
Summary of the technological characteristics of the device compared to the predicate device:
The indications for use, material, form factor, performance, and safety characteristics of HDI 1000 / HDI 1000A described in this 510(k) are the same as that of the predicate device, EzSensor 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.
See (012) for a summary of the technological characteristics of the HDI 1000 / HDI 1000A and EzSensor.
Summary for any testing in the submission
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1: 2005 + CORR.1(2006) + CORR(2007) (Medical electrical equipment Part I: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 "Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices" was performed.
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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 1000 / HDI 1000A is safe and effective and substantially equivalent to predicate device as described herein.
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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered horizontally in the image. The background of the image is white.
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: K140056
Trade/Device Name: Digital Dental Intra Oral Sensor (HDI 1000, HDI 1000A) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Il 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 10 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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/dcfault.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,
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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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) K140056
Device Name
HDI 1000, HDI 1000A digital intra-oral imaging system
Indications for Use (Describe)
HDI 1000 / HDI 1000A, an Intra-oral Imaging System, is used to collect dental x-rays 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)
2 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) | |
|---|---|
| ------------------------------------------------------------------------------ | -- |
FORM FDA 3881 (6/13)
PSC Publicitures Services (301) 445-674) EF
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