(123 days)
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.
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.
The provided text does not contain information about specific acceptance criteria or a study that proves the device meets those criteria with detailed performance metrics. The submission is a 510(k) summary for a digital dental intra-oral sensor (HDI 1000, HDI 1000A), which primarily focuses on demonstrating substantial equivalence to a predicate device.
The document states: "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." This indicates that the device is deemed acceptable because it performs similarly to an already approved device.
The "Summary for any testing in the submission" section mentions:
- Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1: 2005 + CORR.1(2006) + CORR(2007).
- EMC testing 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.
It concludes that "All test results were satisfactory" and the device is "safe and effective and substantially equivalent to predicate device." However, specific quantitative acceptance criteria or detailed results from these tests are not provided in this summary.
Therefore, most of the requested information regarding detailed acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not present in this 510(k) summary.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate device (EzSensor) in terms of: | - Device determined to be substantially equivalent to EzSensor (K090526).- Indications for use, material, form factor, performance, and safety characteristics are the same. |
| Electrical, mechanical, environmental safety and performance according to IEC 60601-1: 2005 + CORR.1(2006) + CORR(2007) | - All test results were satisfactory. |
| EMC compliance according to IEC 60601-1-2:2007 | - All test results were satisfactory. |
| Non-clinical & Clinical considerations according to FDA Guidance "Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices" | - All test results were satisfactory. |
2. Sample size used for the test set and the data provenance
- Missing: The document does not specify any sample sizes for test sets or data provenance (e.g., country of origin, retrospective/prospective). The testing mentioned seems to be primarily engineering and regulatory compliance, not clinical performance studies with patient data to establish diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Missing: This information is not provided as there is no mention of a clinical study involving experts establishing ground truth for diagnostic accuracy.
4. Adjudication method for the test set
- Missing: Not applicable, as no clinical test set requiring adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Missing: This is not an AI or CAD device. It's an imaging acquisition device. No MRMC study was conducted or is relevant based on the provided information.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Missing: Not applicable. This is an imaging sensor, not an algorithm.
7. The type of ground truth used
- Missing: As no clinical performance study for diagnostic accuracy is described, there's no mention of ground truth established through expert consensus, pathology, or outcomes data. The "ground truth" for this device's acceptance is its ability to meet safety and performance standards (e.g., IEC standards) and demonstrate substantial equivalence to a predicate device.
8. The sample size for the training set
- Missing: Not applicable. This is an imaging sensor, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Missing: Not applicable.
{0}------------------------------------------------
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 |
1
{1}------------------------------------------------
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.
{2}------------------------------------------------
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.
{3}------------------------------------------------
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.
{4}------------------------------------------------
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
{5}------------------------------------------------
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
{6}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
§ 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.