The ESX is an extraoral source of X-rays, intended to be used for producing diagnostic dental radiographs for treatment of disease of the teeth, jaw and oral structures.

Device Description

ESX is an extraoral source dental X-ray system intended for intraoral imaging. It consists of X-ray generator, X-ray controller, beam limiting device, operation panel and mechanical arm. The X-ray controller allows for accurate exposure control, and an adjustable mechanical arm allows for easy positioning. The system can be used either with conventional film or a digital imaging system.

AI/ML Overview

The provided text describes a 510(k) submission for the ESX Dental Extraoral Source X-ray System. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study that proves the device meets specific acceptance criteria through performance metrics.

Therefore, many of the requested categories cannot be directly filled from the provided text as the type of study described (focused on electrical, mechanical, and safety standards) does not involve performance metrics like accuracy, sensitivity, or specificity for diagnostic tasks, nor does it typically involve human readers or ground truth established by experts in the same way an AI/CAD device would.

Here's what can be extracted and inferred from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (as described/implied)	Reported Device Performance
Electrical Safety	Compliance with IEC 60601-1	All test results satisfactory.
Mechanical Safety	Compliance with IEC 60601-1	All test results satisfactory.
Environmental Safety	Compliance with IEC 60601-1	All test results satisfactory.
Performance Safety	Compliance with IEC 60601-1	All test results satisfactory.
Specific Performance Standards	Compliance with IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32	All test results satisfactory.
EMC (Electromagnetic Compatibility)	Compliance with IEC 60601-1-2	All test results satisfactory.

Note: The document doesn't provide numerical performance metrics (e.g., accuracy, sensitivity, specificity) for a diagnostic task, as this is an X-ray system, not a diagnostic aid or AI/CAD device. The "performance" refers to the system's ability to operate safely and within technical specifications for an X-ray generator.

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable or not provided in the context of this 510(k) summary. The testing described (electrical, mechanical, safety, EMC) typically involves testing the physical device components and system functionality against established engineering standards, rather than evaluating diagnostic performance on a dataset of patient images. Therefore, "test set" and "data provenance" as applied to diagnostic image analysis are not relevant here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable or not provided. For this type of device (an X-ray system), the "ground truth" for the testing performed relates to established engineering standards (e.g., whether the device outputs the correct voltage, meets insulation requirements, operates safely). It does not involve human experts establishing ground truth for diagnostic image interpretation.

4. Adjudication Method for the Test Set

This information is not applicable or not provided. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human experts when establishing ground truth for diagnostic decisions. Since the testing here is against engineering and safety standards, such adjudication methods are not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done for this submission. This type of study is relevant for evaluating the impact of AI/CAD devices on human reader performance, which is not the purpose of this submission for an extraoral X-ray system.

6. If a Standalone (Algorithm Only Without Human-in-the-loop Performance) Was Done

This information is not applicable. The ESX is an X-ray system, not a diagnostic algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for the testing described in this submission is comprised of established engineering standards and regulatory requirements (e.g., IEC 60601 series standards). The testing verifies that the device's electrical, mechanical, and radiation output characteristics meet these predefined safety and performance specifications. It does not involve expert consensus, pathology, or outcomes data for diagnostic accuracy.

8. The Sample Size for the Training Set

This information is not applicable or not provided. The ESX is a physical X-ray system and does not involve AI or machine learning algorithms that require a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As the device does not employ AI or machine learning, there is no training set and therefore no ground truth establishment for a training set.

Summary

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K092103

510(k) Summary

OCT - 9 7009

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 872.1800.

Date: _May. 11, 2009

Company and Correspondent making the submission:

Name - Vatach Co., Ltd.

Address – 23-4, Seogu-Dong, Hwaseong-si, Gyeonggi-do, 445-170, Korea

Telephone — +82-31-679-2081

Fax – +82-31-337-1882 ・

Contact - Mr. Dong-Taek, Oh

Internet - http://www.vatech.co.kr

1. Device :

Trade/proprietary name	: ESX
Common Name	: Dental Extraoral Source X-ray System
Classification Name	: Unit, X-ray, Extraoral With Timer

Predicate Device :

Manufacturer	: Sirona Dental Systems GMBH
Device	: Heliodent Vario
510(k) Number	: K000672 (Decision Date - May. 02. 2000)

4 . Classifications Names & Citations :

21CFR 872.1800, EHD, Unit, X-ray, Extraoral With Timer, Class2

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Description :

5.1 General

ESX is an extraoral source dental X-ray system intended for intraoral imaging.

It consists of X-ray generator, X-ray controller, beam limiting device, operation panel and mechanical arm. The X-ray controller allows for accurate exposure control, and an adjustable mechanical arm allows for easy positioning. The system can be used either with conventional film or a digital imaging system.

5.2 Product features

1). Condition of Input

•Rated input voltage : AC 110 / AC 230V

·Guaranteed working voltage

-110V Mode : 100 ~120V / 230V Mode : 210 ~250V

•Possible working voltage

-110V Mode : 90 ~130V / 230V Mode : 190 ~ 250V

·Rated input frequency: 50Hz/60Hz

·Insulation withstanding: below than 1.5KV cap for more than one minute between first test and second test.

2) X-ray Tube

Tube Voltage : 50 65 kVp .
. Tube Current : 19 mA (Max)
Focal spot : 0.8 mm
Inherence Filtration : 0.8 mm Al
Total Filtration : 2.0 mm Al

High-voltage Generator

· Tube Voltage : 65 kVp(Fixed)
· Tube Current : 5 mA(Fixed)

X-Ray Controller : AutoSet Timer

· Exposure time: 0.05 ~ 1.5 s
Vatech Co., Ltd.

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510(k) Submission - ESX

· Beam Limiting (200mm)

Beam Limiting Device : Round Type

· Distance between focus and surface : 200 mm
· Output Radiation Field : Round Ø 65 mm
· Weight : 0.1 kg
1. Indication for use :

The ESX is an extraoral source of X-rays, intended to be used for producing diagnostic dental radiographs for treatment of disease of the teeth, jaw and oral structures.

1. Comparison with predicate device :
  Vatech Co., Ltd., believes that the ESX is substantially equivalent to the Heliodent Vario of Sirona Dental Systems Gmbh.

Safety, EMC and Performance Data :

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, and IEC 60601-2-32 was performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2. All test results were satisfactory.

9. Conclusion :

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Vatech Co., Ltd. concludes that ESX is safe and effective and substantially equivalent to predicate devices as described herein.

1. Vatech Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.

END

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and features an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the edge of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue . Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

VATECH Co., Ltd. % Mr. Vincent Lee Product Compliance Officer E-WOO Technologies USA, Inc. 256 North Sam Houston Pkwy E. #115 HOUSTON TX 77060

OCT - 9 2009

Re: K092103

Trade/Device Name: Dental Extraoral Source X-ray System (ESX) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: May 11, 2009 Received: July 14, 2009

Dear Mr. Lee:

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 (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

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number(if known):

KD92103

Device Name: ESX

Classification: Unit, X-ray, Extraoral With Timer

Indications for Use:

The ESX is an extraoral source of X-rays, intended to be used for producing diagnostic dental radiographs for treatment of disease of the teeth, jaw and oral structures.

Prescription Use_ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal, and Revological Devic 510(k) Number.

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Regulation Number and Section

§ 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.