(34 days)
"HDS" 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.
The Intra-oral image system (HDS) is a device for digital intra oral X-rays imaging. It is fully USB compliant and can be plugged in any when computer is turned on.
Intra-oral image system (HDS) block diagram
PC
· Image interface box (Read-out Box)
· X-ray sensor
The provided document describes the VATECH "HDS" Intra-oral Imaging System, which is an intra-oral digital x-ray sensor. The submission is a 510(k) premarket notification, indicating that the device is seeking to demonstrate substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Suni Intraoral Imaging System, K021718) rather than setting specific numeric acceptance criteria for device performance. The "acceptance criteria" are implicitly the functional and performance characteristics of the predicate device, which the HDS system aims to match or exceed.
| Feature | Predicate: Suni Intraoral Imaging System (K021718) | "HDS" Intraoral Imaging System (Reported Performance) | Comparison to Predicate |
|---|---|---|---|
| Intended Use | Collect dental x-ray photons and convert them into electronic impulses for diagnostic use by dentists. | SAME | Equivalent |
| Computer interface | USB (version not specified) | USB, Specification 2.0 | Equivalent (with specific version) |
| Pixel Matrix | 271,000, 462,000, 1.26 M, or 1.8 M pixels (model dependent) | 650,000 pixels (688 × 944 pixel) | Within range/Comparable |
| Pixel Size | 22.5 or 45 um (model dependent) | 35 um | Within range/Comparable |
| Active Area | 26.8 x 21.6 mm, 32.7 x 20.6 mm, 36.8 x 26.6 mm, 36.8 x 26.6 mm | 24.08 mm x 33.04 mm | Within range/Comparable |
| External Dimensions | 32.5 x 26.4 mm, 37.8 x 24.7 mm, 43.0 x 31.8 mm, 43.0 x 31.8 mm (Thickness 3.2 mm) | 29 × 41 mm (Thickness 3.5 mm) | Within range/Comparable |
| Spatial Resolution | 12 lp/mm (Standard res model) | 14 lp/mm | Higher (Better) |
| Applicable PC | Not specified | Pentium 3, 1 GHz CPU; 128 MB RAM; 10GB HDD; 1024x768x24 bit VGA; Windows XP, Serial/USB port | Specified (Meets system requirements) |
2. Sample size used for the test set and the data provenance:
The provided document does not mention the sample size for any clinical test set, nor does it specify data provenance (country of origin, retrospective/prospective). The testing described appears to be internal engineering and software validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The document does not describe any studies involving human experts establishing ground truth for diagnostic accuracy.
4. Adjudication method for the test set:
Not applicable. No clinical test set involving human readers or 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:
No MRMC comparative effectiveness study is mentioned. This device is an imaging acquisition system, not an AI-powered diagnostic aid.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a hardware sensor for image acquisition. Performance is related to image quality and system functionality, not an "algorithm only" diagnostic performance.
7. The type of ground truth used:
For the technical performance aspects (e.g., spatial resolution, pixel matrix), the "ground truth" would be established using physical phantoms, test patterns, and metrology equipment rather than clinical ground truth (pathology, expert consensus, outcomes data). The document refers to "internal company procedures" and "written test protocols" for software testing and validation.
8. The sample size for the training set:
Not applicable. This device is a hardware sensor and does not utilize a training set in the context of machine learning.
9. How the ground truth for the training set was established:
Not applicable.
Summary of the Study and Evidence Presented:
The document describes a 510(k) submission for the VATECH "HDS" Intra-oral Imaging System. The primary "study" presented is a comparison of the technical specifications and intended use of the HDS system against a legally marketed predicate device, the Suni Intraoral Imaging System (K021718).
The evidence for meeting "acceptance criteria" (which are implicitly the performance characteristics of the predicate) is presented in the table comparing features of the HDS system to the predicate. The HDS system demonstrates comparable or superior technical specifications (e.g., higher spatial resolution), and identical intended use.
The document states: "Testing was performed according to internal company procedures. Software testing and validation were done according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release. Test results support the conclusion that actual device performance satisfies the design intent."
This indicates that internal technical assessments and software validation were conducted to confirm the device's functionality and performance met the design requirements, thereby supporting the claim of substantial equivalence to the predicate device. There is no mention of clinical trials, human expert studies, or AI-specific performance evaluations.
{0}------------------------------------------------
EXHIBIT 2 510(k) Summary VATECH
OCT 0 4 2004
Value Added Technology Co., Ltd. 75-11, Seokwoori, Dongtanmyun, Hwasungsi, Kyunggido, 445-811, Korea Tel: 82-31-377-9104 Fax: 82-31-377-1882 Chang Joon Ro, President & CEO July 29, 2004
-
- Identification of the Device: Proprietary-Trade Name: "HDS" Intra-oral Imaging System Classification Name: Extraoral source x-ray system, Product Code 90 MUH Common/Usual Name: Intra-oral digital x-ray sensor
-
- Equivalent legally marketed device: This product is similar in design and identical in function to the Suni Intraoral Imaging System (K021718, Suni Imaging Microsystems Inc.)
-
- Indications for Use (intended use): 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 dentists.
-
- Description of the device: The Intra-oral image system (HDS) is a device for digital intra oral X-rays imaging. It is fully USB compliant and can be plugged in any when computer is turned on.
- Intra-oral image system (HDS) block diagram
- PC
- · Image interface box (Read-out Box)
- · X-ray sensor
Image /page/0/Figure/12 description: The image shows a diagram of an X-ray sensor setup. The setup includes a computer with a display, an image interface box, a sensor cable, and a sensor. The computer is connected to the image interface box via a USB cable, and the image interface box is connected to the sensor via the sensor cable. The diagram labels each component of the setup.
{1}------------------------------------------------
-
- Safety and Effectiveness, comparison to predicate device:
| Feature | Predicate: Suni Intraoral ImagingSystem (K021718) | Intraoral Imaging System(HDS) |
|---|---|---|
| Intended Use | Intra-oral Imaging System isintended to collect dental x-rayphotons and convert them intoelectronic impulses that may bestored, viewed, and manipulatedfor diagnostic use by dentists. | SAME |
| Computer interface | USB (USB version not specified) | SAME, Specification 2.0 |
| Pixel Matrix | 271,000, 462,000, 1.26 M, or 1.8M pixels, depending on model | 650,000 pixels (688 × 944pixel) |
| Pixel Size | 22.5 or 45 um (depending onmodel) | 35 um |
| Active Area | 26.8 x 21.6 mm32.7 x 20.6 mm36.8 x 26.6 mm36.8 x 26.6 mm | 24.08 mm x 33.04 mm |
| External Dimensions | 32.5 x 26.4 mm37.8 x 24.7 mm43.0 x 31.8 mm43.0 x 31.8 mmThickness 3.2 mm | 29 × 41 mmThickness 3.5 mm |
| Spatial Resolution | 12 lp/mm (Standard res model) | 14 lp/mm |
| Applicable PC | Computer requirements notspecified. | -Software: Pentium 3,1 GHz-Memory size: 128 MB-Hard disk: 10GB-VGA; 1024x768x24 bit-Other: Window XP, SerialUSB port |
-
- Testing information and Conclusion
In all material respects, the "HDS" Intra-oral Imaging System is substantially equivalent to Suni Intraoral Imaging System (K021718, Suni Imaging Microsystems Inc.) Testing was performed according to internal company procedures. Software testing and validation were done according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release. Test results support the conclusion that actual device performance satisfies the design intent.
- Testing information and Conclusion
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized bird or human figure with three horizontal lines extending from its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 4 - 2004
VATECH Value Added Tech., Co., Ltd. % Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates 'PO Box. 7007 DEERFIELD IL 60015
Re: K042372 Trade/Device Name: "HDS" Intra-Oral Imaging System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 MUH
Dated: August 30, 2004 Received: September 13, 2004
Dear Mr. Kamm:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); 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.
{3}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premated predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): K042372
"HDS" Intra-oral Imaging System Device Name:
Indications For Use: "HDS" 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Syverson
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number .
Page 1 of 1
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.