(92 days)
This X-ray Unit is intended to be used in portable applications, by a qualified/trained dentist or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of dental structures.
The Xcam is a portable X-ray for taking diagnostic radiographic exposures of body parts and operates on 11.1V DC supplied by a battery. Xcam is composed of x-ray generator including x-ray tubes, equipment controller, power controller, user interface and x-ray collimator. Xcam can be used with an imaging sensor. The image receptor, necessary component for a fully functional x-ray system, is not part of the submitted device.
The provided text is a 510(k) summary for the Xcam dental X-ray system, which focuses on demonstrating substantial equivalence to a predicate device (REXTAR X) based on technical characteristics and compliance with electrical safety, EMC, and radiation protection standards.
It does NOT contain information about acceptance criteria or a study that proves the device meets those criteria, particularly not in the context of AI/ML performance metrics like sensitivity, specificity, or AUC, or human reader studies with AI assistance.
The document discusses:
- Device Description and Indications for Use: The Xcam is a portable X-ray unit for diagnostic radiography of dental structures in adults and pediatric subjects, used by qualified dentists or technicians.
- Substantial Equivalence: It compares the Xcam's technical specifications (dimensions, weight, tube voltage, tube current, exposure time, filtration, focal spot size, etc.) to the predicate device, concluding no significant differences that would adversely affect use.
- Non-Clinical Testing: It mentions compliance with electrical safety (ES60601-1), electromagnetic compatibility (IEC 60601-1-2), radiation protection (IEC 60601-1-3, 60601-2-65), and EPRC standards. It also notes software validation for "MODERATE level of concern software" and cybersecurity considerations.
Therefore, based solely on the provided text, I cannot describe acceptance criteria or a study proving the device meets them in the manner requested (e.g., performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, ground truth establishment). The document confirms the device meets regulatory standards for a traditional X-ray system, not an AI/ML-driven diagnostic aid.
To answer your request, if this were an AI/ML device, the missing information would typically be found in a separate section detailing the clinical performance study.
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December 27, 2019
Image /page/0/Picture/1 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 is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
HDX WILL Corp. % Myoung-Joon Lee General Manager #105,106,201,202,203,204,38, Osongsaengmyeong 4-ro Osong-eup, Heungdeok-gu Cheongju-si. Chungcheonbuk-do 28161 REPUBLIC OF KOREA
Re: K192700
Trade/Device Name: Xcam Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: EHD Dated: November 8, 2019 Received: November 13, 2019
Dear Myoung-Joon 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
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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192700
Device Name Xcam
Indications for Use (Describe)
This X-ray Unit is intended to be used in portable applications, by a qualified/trained dentist or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of dental structures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the 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 - K192700
1. Date Prepared [21 CFR 807.92(a)(1)]
November 8th, 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, Osongsaengmyeong4-ro, Osong-eup, Heungdeok-gu, Cheongju-si,Chungcheongbuk-do, 28161, Republic of Korea |
| - Contact Person: | Myoung-Joon Lee / General Manager |
| - Telephone No.: | +82-43-710-7318 |
| - Fax No.: | +82-43-710-7312 |
| - Email Address: | mjlee@iwillmed.com |
| - Registration No.: | 3013511605 |
3. Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)]
| Device Name | Xcam |
|---|---|
| Regulation Number | 21 CFR 872.1800 |
| Common/Usual Name | Portable Dental X-ray System |
| Regulatory Class | Class II |
| Product Code | EHD |
| Classification Name | Unit, X-Ray, Extraoral With Timer |
| Panel | Radiology |
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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" inside, followed by 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
| - 510(k) Number: | K132041 |
|---|---|
| - Applicant: | POSDION CO., LTD. |
| - Device Name: | REXTAR X |
| - 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 Time |
There are no significant differences between the Xcam 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 Xcam is a portable X-ray for taking diagnostic radiographic exposures of body parts and operates on 11.1V DC supplied by a battery.
Xcam is composed of x-ray generator including x-ray tubes, equipment controller, power controller, user interface and x-ray collimator. Xcam can be used with an imaging sensor.
The imaqe receptor, necessary component for a fully functional x-ray system, is not part of the submitted device.
6. Indications for Use [21 CFR 807.92(a)(5)]
This X-ray Unit is intended to be used in portable applications, by a qualified/trained dentist or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of dental structures.
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Image /page/5/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 a dark blue, bold font. The logo is simple and modern, and the colors are eye-catching.
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. | POSDION CO., LTD. | SE Note |
|---|---|---|---|
| Device Name | Xcam | Rextar X | |
| Subject Device | Predicate Device | - | |
| 510(k) Number | K192700 | K132041 | - |
| Common/UsualName | Portable Dental X-ray System | Portable X-ray System | - |
| RegulationNumber | 872.1800 | 872.1800 | - |
| Product Code | EHD | EHD | - |
| Class | Class II | Class II | - |
| Model | Xcam | Rextar X | - |
| Indications forUse | This X-ray Unit is intended to be usedin portable applications, by aqualified/trained dentist or technician onboth adult and pediatric subjects fortaking diagnostic radiographicexposures of dental structures. | REXTAR X is a portable X-ray systemto be used by trained dentists anddental technicians as a mobile,extraoral x-ray source for producingdiagnostic x-ray images using intraoralimage receptors. It is intended for bothadult and pediatric subjects. | Similar |
| Dimension(Length x Heightx Width) | 167.51 mm x 127.55 mm x 97.05 mm | 146 mm x 155 mm x 139 mm | Similar |
| Weight | 1.8 kg | 2 kg | Similar |
| Energy Source | 11.1 VDC | 11.1 VDC | Same |
| Battery Type | Rechargeable | Rechargeable | Same |
| Display | LCD Panel Display | LCD Panel Display | Same |
| Tube Voltage | 70 kV | 70 kV | Same |
| Tube Current | 2 mA | 2 mA | Same |
| Exposure Time | 0.05-1.3 s (39 steps) | 0.01-1.30 sec (43 steps) | Similar |
| InherentFiltration | At least 1.0 mm Al | At least 1.0 mm Al | Same |
| Total Filtration | At least 1.5 mm Al | At least 1.5 mm Al | Same |
| Focal Spot Size | 0.4 mm | 0.4 mm | Same |
| Anode Material | Tungsten | Tungsten | Same |
| Target Angle | 12.5° | 12° | Similar |
| Compatible withDigital Imaging | Applicable | Applicable | Same |
a) Technological Characteristics
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Image /page/6/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.
b) Substantial Equivalence Discussion
There are no significant differences between the Xcam 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.
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8. Non-Clinical Test Summary
The Xcam 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 Xcam 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 Xcam use original software. The Xcam 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 cleaning is sufficient to address any health concerns.
9. Conclusion [21 CFR 807.92(b)(3)]
The Xcam 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 device.
§ 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.