(28 days)
No
The document describes a standard intra-oral X-ray system and does not mention any AI or ML components in the device description, intended use, or performance studies.
No.
The device is used for diagnosis (producing diagnostic dental radiographs), not for treatment.
Yes
The device is described as an "X-ray system for dental diagnosis" and is intended "for producing diagnostic dental radiographs."
No
The device description explicitly lists multiple hardware components including an X-ray generator, beam limiting device, control panel, mechanical arm, support device, chair, and backrest.
Based on the provided information, the Star-X 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.
- Star-X Function: The Star-X is an intra-oral X-ray system. It generates X-rays that pass through the patient's body to create images of the teeth, jaw, and oral structures. This is an in vivo (within the living body) diagnostic imaging process, not an in vitro test on a sample.
- Intended Use: The intended use clearly states it's for "producing diagnostic dental radiographs for treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors." This describes an imaging procedure, not a laboratory test.
Therefore, the Star-X falls under the category of medical imaging equipment, specifically dental X-ray equipment, and is not an IVD.
N/A
Intended Use / Indications for Use
Star-X is intra-oral X-ray system for dental diagnosis that can radiate X-ray images by irradiating X-rays generated by high voltage to an anode in an X-ray tube and reacting with the receptor (film, sensor).
Star-X is a dental X-ray equipment (extra-oral source system) intended for use by qualified dentist or dental technician for both adult and pediatric patient for producing diagnostic dental radiographs for treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors.
Product codes
EHD
Device Description
The Star-X is an X-ray generator for dental intra-oral X-ray imaging and intended to be used for producing diagnostic dental radiographs for treatment of disease of teeth, jaw and oral structures. The Star-X is consisted of X-ray generator, beam limiting device (cone), control panel, mechanical arm, support device, chair and backrest. The control panel allows for accurate exposure control and adjustable arm provide for convenient patient positioning.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
teeth, jaw, and other oral structures
Indicated Patient Age Range
adult and pediatric patient
Intended User / Care Setting
qualified dentist or dental technician
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)
Non-Clinical Test Summary:
- Electrical Safety, Electromagnetic Compatibility and Performance: The Star-X complies with the electrical safety and electromagnetic compatibility requirements established by the standards ES60601-1, IEC 60601-1-2, IEC 60601-1-3, and 60601-2-65.
- Software Validations: The Star-X uses original software with a MODERATE level of concern. Software was designed, developed, verified, and validated according to a software development process and FDA guidance. Cybersecurity information was also provided.
- Biocompatibility: Not necessary as proper device disinfection is sufficient.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
HDX WILL Corp. % Mr. Myoung-Joon Lee General Manager #105,106,201,202,203,204,38, Osongsaengmyeong-4-ro Osong-eup, Heungdeok-gu Cheongju-si, Chungcheongbuk-do 28161 REPUBLIC OF KOREA
March 15, 2019
Re: K190357
Trade/Device Name: Star-X, Intraoral X-ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: EHD Dated: February 14, 2019 Received: February 15, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Thalia Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190357
Device Name Star-X; Intraoral X-ray System
Indications for Use (Describe)
Star-X is intra-oral X-ray system for dental diagnosis that can radiate X-ray images by irradiating X-rays generated by high voltage to an anode in an X-ray tube and reacting with the receptor (film, sensor).
Star-X is a dental X-ray equipment (extra-oral source system) intended for use by qualified dentist or dental technician for both adult and pediatric patient for producing diagnostic dental radiographs for treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image is a logo for HDX Will. The logo consists of a green and blue square with a white "W" inside, followed by the text "HDX Will" in blue. The text is in a bold, sans-serif font.
510(k) Summary
[As required by 21 CFR 807.92]
K190357
1. Date Prepared [21 CFR 807.92(a)(1)]
March 11th, 2019
2. Submitter's Information [21 CFR 807.92(a)(1)]
| - Name of Manufacturer: | HDX WILL CORP. |
|---|---|
| - Address: | #105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong |
| 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, | |
| Chungcheongbuk-do, 28161, Korea | |
| - Contact Person: | Myoung-Joon Lee / General Manager |
| - Telephone No.: | +82-43-710-7318 |
| - Fax No.: | +82-43-710-7312 |
| - Email Address: | mjlee@iwllmed.com |
| - Registration No.: | 3013511605 |
3. Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)]
| Device Name | Star-X; Intraoral X-ray System |
|---|---|
| Regulation Number | 21 CFR 872.1800 |
| Common/Usual Name | Extraoral source X-ray system |
| Regulatory Class | Class II |
| Product Code | EHD |
| Classification Name | Unit, X-Ray, Extraoral With Timer |
| Panel | Radiology |
4
Image /page/4/Picture/0 description: The image shows the logo for HDxWill. The logo consists of a green and blue square with the letter "W" in white inside the square. To the right of the square is the text "HDxWill" in blue. The logo is simple and modern, and the colors are bright and eye-catching.
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicate devices within this submission are shown as follow;
Predicate device #1
| - 510(k) Number: | K970975 |
|---|---|
| - Applicant: | PLANMECA OY |
| - Device Name: | PROSTYLE INTRA (PLANMECA INTRA) |
| - Regulation Number: | 21 CFR 872.1800 |
| - Regulation Name: | Extraoral source x-ray system |
| - Regulatory Class: | Class II |
| - Product Code: | EHD |
| - Classification Name: | Unit, X-Ray, Extraoral With Timer |
Predicate device #2
| - 510(k) Number: | K042260 |
|---|---|
| - Applicant: | TAKARA BELMONT USA, INC. |
| - Device Name: | PHOT-X II, MODEL 303 |
| - Regulation Number: | 21 CFR 872.1800 |
| - Regulation Name: | Extraoral source x-ray system |
| - Regulatory Class: | Class II |
| - Product Code: | EHD |
| - Classification Name: | Unit, X-Ray, Extraoral With Timer |
There are no significant differences between the Star-X and the predicate device that would adversely affect the use of the product. It is substantially equivalent to these devices in technical characteristics, output characteristics and operation mode.
5. Description of the Device [21 CFR 807.92(a)(4)]
The Star-X is an X-ray generator for dental intra-oral X-ray imaging and intended to be used for producing diagnostic dental radiographs for treatment of disease of teeth, jaw and oral structures. The Star-X is consisted of X-ray generator, beam limiting device (cone), control panel, mechanical arm, support device, chair and backrest. The control panel allows for accurate exposure control and adjustable arm provide for convenient patient positioning.
5
Image /page/5/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a green and blue square with the letter "W" in white inside the square. To the right of the square is the text "HDX Will" in blue, with the letters slightly slanted to the right. The logo is simple and modern, and the colors are bright and eye-catching.
6. Indications for Use [21 CFR 807.92(a)(5)]
Star-X is intra-oral X-ray system for dental diagnosis that can radiate X-ray images by irradiating X-rays generated by high voltage to an anode in an X-ray tube and reacting with the receptor (film, sensor).
Star-X is a dental X-ray equipment (extra-oral source system) intended for use by qualified dentist or dental technician for both adult and pediatric patient for producing diagnostic dental radiographs for treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors.
6
Image /page/6/Picture/0 description: The image shows the logo for HDXWill. The logo consists of a square with a green upper-left triangle and a blue lower section with a white "W" in the left side of the logo. To the right of the square is the text "HDXWill" in a stylized blue font.
7. Determination of Substantial Equivalence
Summary of technological characteristics of the device compared to the predicate device. [21 CFR 807.92(a)(6)]
| Applicant | HDX WILL CORP. | PLANMECA OY | TAKARA BELMONT USA,
INC. | SE Note |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Device Name | Star-X | PROSTYLE INTRA
(PLANMECA INTRA) | PHOT-X II, MODEL 303 | - |
| | Subject Device | Predicate Device #1 | Predicate Device #2 | - |
| 510(k)
Number | K190357 | K970975 | K042260 | - |
| Common/Usu
al Name | Extraoral source x-ray
system | Extraoral source x-ray
system | Extraoral source x-ray
system | - |
| Regulation
Number | 872.1800 | 872.1800 | 872.1800 | - |
| Product Code | EHD | EHD | EHD | - |
| Class | Class II | Class II | Class II | - |
| Model | Star-X | PROSTYLE INTRA | Model 303 | - |
| Indications
for Use | Star-X is intra-oral X-ray
system for dental diagnosis
that can radiate X-ray
images by irradiating X-rays
generated by high voltage to
an anode in an X-ray tube
and reacting with the
receptor (film, sensor).
Star-X is a dental X-ray
equipment (extra-oral source
system) intended for use by
qualified dentist or dental
technician for both adult and
pediatric patient for
producing diagnostic dental
radiographs for treatment of
diseases of the teeth, jaw,
and other oral structures
using intra-oral image
receptors. | The Planmeca Prostyle Intra
X-ray Unit is an extraoral
source X-ray system, which
is intended for dental
radiographic examination
and diagnosis of diseases of
the teeth, jaw, and oral
structures. The Prostyle Intra
is intended to be used with
intraoral film, either hold in
place by the patient with
finger or placed to a film
holder which is pressed
between the teeth.
The use of the device is
allowed only under
supervision of a dentist. | PHOX-X II MODEL 303 is a
extraoral source dental
radiographc x-ray unit. This
unit works as a diagnostic
purpose x-ray source for
human teeth with the
resultant image recorded on
intraoral dental x-ray film or
image receptor. The design,
function and positioning of
the x-ray unit is similar to
most all other x-ray
machines manufactured for
this specific purpose over the
past thirty years. | Same |
| Mechanical | | | | |
| Mechanical
configuration | Floor-mounted type | Wall-mounted type | Wall-mounted type | Similar |
| Minimum
Source to
skin distance | > 200 mm | 200 mm (Regular cone)
300 mm (Long cone) | 203 mm (Regular cone)
305 mm (Long cone) | Similar |
| Electrical & X-ray tube assembly | | | | |
| Rated mains
voltage | 100-120/200-240 VAC | 110-115 VAC | 120 VAC | Similar |
| Tube Voltage | 65 kV | 50, 53, 55, 57, 60, 63, 66, 70
kV | 60 or 70 kV | Similar |
| Tube Current | 3 or 6 mA | 8 mA | 4 or 7 mA | Similar |
| | | | | |
| Exposure
Time | 0.01-3.2 s (in 0.01 step) | 0.01-3.2 sec (23 steps) | 0.01-3.2 s (23 steps) | Same |
| Inherent
filtration | 0.8 mm Al | 1.0 mm Al Equivalent at 70
kV | 1.7 mm Al Equivalent | Similar |
| Total
Filtration | > 1.8 mm Al | 2.0 mm Al Equivalent at 70
kV | 2.0 mm Al Equivalent at 70
kV | Similar |
| Focal Spot
Size | 0.8 mm | 0.7 mm x 0.7 mm | 0.7 mm x 0.7 mm | Similar |
| Anode
Material | Tungsten | Tungsten | Tungsten | Same |
| Compatible
with Digital
Imaging | Applicable | Applicable | Applicable | Same |
| Duty Cycle | 1:60 | 1:15 | 1:50 | Similar |
a) Technological Characteristics
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Image /page/7/Picture/0 description: The image shows the logo for HDXWill. The logo consists of a green square with a white "W" inside, followed by the text "HDXWill" in blue. The "W" in the square is stylized with a curved shape, and the "HDXWill" text is in a bold, sans-serif font.
b) Substantial Equivalence Discussion
There are no significant differences between the Star-X and the predicate device that would adversely affect the use of the product. It is substantially equivalent to these devices in technical characteristics, output characteristics and operation mode.
8
HDXWill
8. Non-Clinical Test Summary
The Star-X complies with voluntary standards for electrical safety, electromagnetic compatibility. The following data were provided in support of the substantial equivalence determination:
1) Electrical Safety, Electromagnetic Compatibility and Performance:
The Star-X complies with the electrical safety and electromagnetic compatibility requirements established by the standards.
- Electrical Basic Safety and Essential Performance requirements in accordance with ES60601-1
- Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2
- Radiation Protection In diagnostic X-Ray Equipment requirements of IEC 60601-1-3
- Dental Intra-Oral X-Ray Equipment requirements of 60601-2-65
The manufacturing facility is in conformance with the relevant EPRC standards as specified in 21 CFR 1020.30, and 1020.31. The records are available for review.
2) Software Validations
The Star-X use original software. The Star-X contains MODERATE level of concern software. Software was designed and developed according to a software development process and was verified and validated.
Software information is provided in accordance with FDA guidance: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005."
Cybersecurity information is provided in accordance with FDA guidance: "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued on October 2, 2014"
3) Biocompatibility
A biocompatibility study is not necessary and proper device disinfection is sufficient to address any health concerns.
9. Conclusion [21 CFR 807.92(b)(3)]
The Star-X has same indications for use and technical characteristic to the predicate device. The differences in technological characteristics do not raise different questions of safety and effectiveness. In addition, performance testing conducted demonstrate that the subject device is as safe as effective as the predicate. Therefore, the subject device is substantially equivalent to the predicate devices.