(34 days)
The VEX-S100W 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.
VEX-S100W 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.
The VEX-S100W is an extraoral source dental X-ray system. The submission indicates that no clinical testing was performed or relied upon for this premarket notification. The device is claimed to be substantially equivalent to the predicate device, ESX (K092103), based on similar indications for use and technical characteristics.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define "acceptance criteria" as a set of quantified performance targets for diagnostic accuracy or clinical outcomes. Instead, it relies on demonstrating compliance with international standards and similarity to a predicate device. The performance testing described is focused on verifying compliance with specifications affecting image quality and patient dose, and detecting malfunctions.
The table below presents relevant performance specifications of the proposed device as compared to the predicate device. The "Acceptance Criteria" implicitly are that the device meets these specified technical characteristics and demonstrates satisfactory performance according to the cited engineering and safety standards.
| Characteristic | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (VEX-S100W) |
|---|---|---|
| Indications for Use | For producing diagnostic dental radiographs for treatment of disease of the teeth, jaw and oral structures. | The VEX-S100W 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. (Same as Predicate) |
| Performance Specification | Intraoral X-ray equipment | Intraoral X-ray equipment |
| Input Voltage | AC 100/230 V | AC 100-120 / 200-240 V |
| Tube Voltage | 65 kVp | 50-70 kVp (Variable as per table in doc) |
| Tube Current | 5 mA | 4-7 mA (Variable as per table in doc) |
| Exposure Time | 0.05 - 1.5 s | 0.04 – 2.0 s (Variable as per table in doc) |
| Total Filtration | > 2.0 mm Al | > 2.0 mm Al |
| Focal Spot Size | 0.8 mm | 0.4 mm |
| Focal Length (SSD) | 7.9 in | 1) Round: 200 mm (Default) 2) Round: 300 mm (Option) 3) Rectangular Cone: 200 mm (Option) 4) Rectangular Cone: 300 mm (Option) |
| Anode Material | Tungsten | Tungsten |
| Compatible with film and digital imaging | Yes | Yes |
| Weight (kg) | 23.8 kg (52.5 lbs) | 18.5 kg (40.8 lbs) |
| Compliance with Normative Standards | Satisfactory performance according to IEC61223-3-4, IEC60601-1, IEC60601-1-1, IEC60601-1-3, IEC60601-2-7, IEC60601-2-28, IEC60601-2-32, IEC 60601-1-2. | All performance tests and safety tests conducted were satisfactory. |
2. Sample Size Used for the Test Set and the Data Provenance
The submission explicitly states: "This premarket notification submission for a determination of substantial equivalence does not require nor rely on the clinical testing." Therefore, there is no clinical "test set" in the traditional sense of patient data in this submission. The "test set" refers to the device itself being tested for compliance with engineering and safety standards. No specific sample size of images or patients is mentioned as no clinical studies were performed. The testing was conducted on the VEX-S100W device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
There is no mention of experts establishing ground truth for a clinical test set, as no clinical testing was performed or relied upon. The ground truth for the engineering performance tests would be defined by the specified technical parameters and safety standards, the evaluation of which would be conducted by qualified engineers or technicians in a testing laboratory.
4. Adjudication method for the test set
Not applicable, as no clinical test set requiring adjudication of findings was used.
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 study or any clinical study involving human readers or AI assistance was performed. This device is an X-ray generator, not an image analysis or AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this device is a physical X-ray system, not an algorithm.
7. The type of ground truth used
For the engineering and safety performance tests, the "ground truth" would be the technical specifications and regulatory requirements outlined in standards like IEC61223-3-4, IEC60601-1, etc. Compliance with these established standards and specifications serves as the basis for satisfactory performance.
8. The sample size for the training set
Not applicable. As no clinical testing was performed and the device is an X-ray generator, there is no "training set" of data in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable, as there was no training set.
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510(k) Submission -- VEX-S100W
Special 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: November 8th, 2012
Submitter's Name, address, telephone number, a contact person:
| Submitter's Name : | Vatech Co., Ltd. |
|---|---|
| Submitter's Address: | 23-4, Seogu-Dong, Hwaseong-Si,Gyeonggi-Do, 445-170, Korea Republic |
| Submitter's Telephone: | Tel: +82-31-379-9585Fax: +82-31-379-9638 |
| Contact person: | Mr. Mr. Sung-Hee Park |
| Official Correspondent: | Dave Kim (davekim@mtech-inc.net) |
|---|---|
| (U.S. Designated agent) | |
| Address: | 12946 Kimberley Ln, Houston, TX 77079 |
| Telephone: | +713-467-2607 |
| Fax: | +713-464-8880 |
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: | VEX-S100W |
|---|---|
| Common Name: | Dental Extraoral Source X-ray System |
| Classification Name : | Unit, X-ray, Extraoral With Timer (21CFR 872.1800,Product code EHD, class2) |
Vatech Co., Ltd.
DEC 1 3 2012
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510(k) Submission – VEX-S100W
Product Code:
EHD
Predicate Device :
| Manufacturer | : Vatech Co.,Ltd. |
|---|---|
| Device | : ESX |
| 510(k) Number | : K092103 (Decision Date - 10/09/2009) |
Device Description :
VEX-S100W 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.
Indication for use :
The VEX-S100W 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.
Summary of the technological characteristics of the device compared to the predicate device:
VEX-S100W is described in this special 510(k) submission has the same indications for use and similar technical characteristics as ESX (K092103) of Vatech Co., Ltd.
| Characteristic | ProposedVatech Co., Ltd.VEX-S100W | PredicateVatech Co., Ltd.ESX |
|---|---|---|
| 510(k) number | - | K092103, dated on10/09/2009 |
| Indicationsfor use | The VEX-S100W is an extraoralsource of X-rays, intended to beused for producing diagnosticdental radiographs for treatment | The ESX is an extraoralsource of X-rays, intended tobe used for producingdiagnostic dental radiographs |
Vatech Co., Ltd.
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510(k) Submission — VEX-S100W
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| of disease of the teeth, jaw and oral structures. | for treatment of disease of the teeth, jaw and oral structures. | ||||||||||||||||||||||
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| Performance Specification | Intraoral X-ray equipment | Intraoral X-ray equipment | |||||||||||||||||||||
| Input Voltage | AC 100-120 / 200-240 V | AC 100/230 V | |||||||||||||||||||||
| Tube Voltage | 50-70 kVp (Refer to the table)Tube Voltage (kVp) Tube Current (mA) Exposure time (s) 50 4 | 65 kVp | |||||||||||||||||||||
| Tube Current | 4-7 mA (Refer to the table)Tube Voltage (kVp) Tube Current (mA) Exposure time (s) 50 4 | 5 mA | |||||||||||||||||||||
| Exposure Time | 0.04 – 2.0 s (Refer to the table)Tube Voltage (kVp) Tube Current (mA) Exposure time (s) 50 4 | 0.05 - 1.5 s |
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510(k) Submission - VEX-S100W
| Total Filtration | > 2.0 mm Al | > 2.0 mm Al |
|---|---|---|
| Focal Spot Size | 0.4 mm | 0.8 mm |
| Focal length(SSD) | 1) Round: 200 mm (Default)2) Round: 300 mm (Option)3) Rectangular Cone: 200 mm(Option)4) Rectangular Cone: 300 mm(Option) | 7.9 in |
| Anode material | Tungsten | Tungsten |
| Compatible withfilm and digitalimaging | Yes | Yes |
| Weight (kg) | 18.5 kg (40.8 lbs) | 23.8 kg (52.5 lbs) |
Note: The weight of the proposed device is less than the predicate device. The new X-ray tube head of the proposed device is more compact in design with the focal spot size of 0.4 mm compared to 0.8 mm of the predicate device. The mechanical arm of VEX-S100W is lighter than the predicate device and moves more smoothly compared to the predicate device with the improved arm joint function for better user experience and convenience.
The proposed device and predicate device are substantially equivalent, having the same intended use, form factor, material, performance and safety characteristics. The operating range of the X-ray tube, including tube voltage, tube current, exposure time, focal length and X-ray filtration of the proposed and predicate devices are similar. The product code for both proposed device and predicate device is categorized as EHD; equivalence between these models is evident. The differences are cosmetic and component use only. These differences do not raise any new questions of safety or effectiveness.
Summary of Performance Testing:
Vatech Co., Ltd.
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The performance test has been conducted for VEX-S100W to verify compliance of the installation with specifications affecting the image quality and patient dose and to detect malfunctions that are not in agreement with those specifications. All test instruments are calibrated calibration lap providing traceability to international standards (ISO/IEC 17025) The calibration is performed by comparison with measuring and test equipment, which is verified via factory measurement standards according to DIN EN ISO 9001/9003. Imaging. Imaging Performance Test is based on IEC61223-3-4 and partly referred to IEC60601-1, IEC60601-1-1, IEC60601-1-3, IEC60601-2-7, IEC60601-2-28, IEC60601-2-32 standard. All tests were satisfactory. Moreover, the performance and safety characteristics between VEX-S100W and ESX are very similar in terms of the indications for use, material and form factor. The primary difference is the focal spot size. The focal spot, the area on the target of the x-ray tube which the electron strikes and from which x-rays are emitted, is smaller for the new VEX-S100W compared to the predicate device. The smaller the area of the focal spot, the better is the diagnostic detail in the x-ray image.
This premarket notification submission for a determination of substantial equivalence does not require nor rely on the clinical testing.
Safety, EMC and Performance Data:
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1(A1+A2, 1995), IEC 60601-1-1 (2001), IEC 60601-1-3 (Ed. 1, 1994), IEC 60601-2-7 (1998), IEC 60601-2-28 (Ed. 1, 1993) and IEC 60601-2-32 (Ed. 1, 1994) were performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2.
Acceptance test according to IEC 61223-3-4 was performed. All test results were satisfactory.
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 VEX-S100W is safe and effective and substantially equivalent to predicate device as described herein.
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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services-USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter of the circle. Inside the circle is an emblem that features a stylized representation of a person with outstretched arms, symbolizing care and protection. The emblem is composed of three overlapping shapes, creating a sense of depth and movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 13, 2012
Vatech Co., Ltd. C/O Mr. Sung-Hee Park Manager 23-4. Seogu-Dong Hwaseong-si, Gyeonggi-Do, 445-170 Republic of Korea
Re: K123493
Trade/Device Name: VEX-S100W Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: November 9, 2012 Received: November 15, 2012
Dear Mr. Park:
We have reviewed your Section 510(k) premarket notification of intent to market the device wferenced 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 r 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 or any 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 CI ic rail 607); aboning (21 CFR 803); good manufacturing practice requirements as set de reo related acronology (21 CFR Part 820); and if applicable, the electronic foral in the quand of ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 MAMorris -S
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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Indications for Use
510(k) Number (if known): K123493
Device Name: VEX-S100W
Indications for Use:
The VEX-S100W 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_ Yes_
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Janine M. Morris -S 2012.12.13 ,13:00:41 -05'00'
(Division Sign Off)
Division of Radiological Health
Office of In Vitro Diagnostic and Radiological Health
510(k)
Page 1 of
§ 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.