Star-X, Intraoral X-ray System

{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) | | |---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------| | <div> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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." {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<br>4-ro, Osong-eup, Heungdeok-gu, Cheongju-si,<br>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,<br>INC. | SE Note | |---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Device Name | Star-X | PROSTYLE INTRA<br>(PLANMECA INTRA) | PHOT-X II, MODEL 303 | - | | | Subject Device | Predicate Device #1 | Predicate Device #2 | - | | 510(k)<br>Number | K190357 | K970975 | K042260 | - | | Common/Usu<br>al Name | Extraoral source x-ray<br>system | Extraoral source x-ray<br>system | Extraoral source x-ray<br>system | - | | Regulation<br>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<br>for Use | Star-X is intra-oral X-ray<br>system for dental diagnosis<br>that can radiate X-ray<br>images by irradiating X-rays<br>generated by high voltage to<br>an anode in an X-ray tube<br>and reacting with the<br>receptor (film, sensor).<br>Star-X is a dental X-ray<br>equipment (extra-oral source<br>system) intended for use by<br>qualified dentist or dental<br>technician for both adult and<br>pediatric patient for<br>producing diagnostic dental<br>radiographs for treatment of<br>diseases of the teeth, jaw,<br>and other oral structures<br>using intra-oral image<br>receptors. | The Planmeca Prostyle Intra<br>X-ray Unit is an extraoral<br>source X-ray system, which<br>is intended for dental<br>radiographic examination<br>and diagnosis of diseases of<br>the teeth, jaw, and oral<br>structures. The Prostyle Intra<br>is intended to be used with<br>intraoral film, either hold in<br>place by the patient with<br>finger or placed to a film<br>holder which is pressed<br>between the teeth.<br>The use of the device is<br>allowed only under<br>supervision of a dentist. | PHOX-X II MODEL 303 is a<br>extraoral source dental<br>radiographc x-ray unit. This<br>unit works as a diagnostic<br>purpose x-ray source for<br>human teeth with the<br>resultant image recorded on<br>intraoral dental x-ray film or<br>image receptor. The design,<br>function and positioning of<br>the x-ray unit is similar to<br>most all other x-ray<br>machines manufactured for<br>this specific purpose over the<br>past thirty years. | Same | | Mechanical | | | | | | Mechanical<br>configuration | Floor-mounted type | Wall-mounted type | Wall-mounted type | Similar | | Minimum<br>Source to<br>skin distance | > 200 mm | 200 mm (Regular cone)<br>300 mm (Long cone) | 203 mm (Regular cone)<br>305 mm (Long cone) | Similar | | Electrical & X-ray tube assembly | | | | | | Rated mains<br>voltage | 100-120/200-240 VAC | 110-115 VAC | 120 VAC | Similar | | Tube Voltage | 65 kV | 50, 53, 55, 57, 60, 63, 66, 70<br>kV | 60 or 70 kV | Similar | | Tube Current | 3 or 6 mA | 8 mA | 4 or 7 mA | Similar | | | | | | | | Exposure<br>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<br>filtration | 0.8 mm Al | 1.0 mm Al Equivalent at 70<br>kV | 1.7 mm Al Equivalent | Similar | | Total<br>Filtration | > 1.8 mm Al | 2.0 mm Al Equivalent at 70<br>kV | 2.0 mm Al Equivalent at 70<br>kV | Similar | | Focal Spot<br>Size | 0.8 mm | 0.7 mm x 0.7 mm | 0.7 mm x 0.7 mm | Similar | | Anode<br>Material | Tungsten | Tungsten | Tungsten | Same | | Compatible<br>with Digital<br>Imaging | Applicable | Applicable | Applicable | Same | | Duty Cycle | 1:60 | 1:15 | 1:50 | Similar | #### a) Technological Characteristics {7}------------------------------------------------ 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.