MINE

K180671 · Rht Co., Ltd. · EHD · Jun 5, 2019 · Dental

Device Facts

• Record ID: K180671
• Device Name: MINE
• Applicant: Rht Co., Ltd.
• Product Code: EHD · Dental
• Decision Date: Jun 5, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The MINE is intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.

Device Story

Portable dental X-ray system; hand-held enclosure containing X-ray generator, controller, and beam-limiting device. Operates on 11.1V DC rechargeable Li-Polymer battery. High-frequency inverter converts DC to AC to drive X-ray tube. Produces X-ray beam to penetrate tooth/jaw area; images captured on external intra-oral receptors or film. Used in dental clinics by dentists or dental technicians. User interface allows selection of tooth region, patient type (adult/child), and receptor type (film/sensor). Provides diagnostic images for dental assessment; small radiation dose minimizes exposure.

Clinical Evidence

Bench testing only. Compliance with IEC/EN 60601-1, 60601-1-3, 60601-2-28, 60601-2-65, and EN/IEC 60601-1-2 (EMC) standards. Phantom images provided to demonstrate performance within an intraoral imaging chain. Compliance with 21 CFR 1020 federal performance standards confirmed.

Technological Characteristics

Portable hand-held X-ray system. Energy source: 11.1V DC Li-Polymer battery. High-frequency inverter. Focal spot: 0.4mm. Constant potential (DC) waveform. 2mA fixed current, 60kV fixed voltage. Exposure time: 0.01-1.3s. Source-to-skin distance: 20cm. Cone diameter: 6cm. Heat capacity: 4300J (6 KHU).

Indications for Use

Indicated for use by trained dentists and dental technicians as an extra-oral x-ray source for producing diagnostic images of teeth and jaws in adult and pediatric patients using intra-oral receptors or film.

Regulatory Classification

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.

Predicate Devices

• EXARO (K122124)

Submission Summary (Full Text)

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RHT Co., Ltd. % Ms. April Lee Consultant Withus Group, Inc. 106 Superior IRVINE CA 92620

Re: K180671

Trade/Device Name: MINE Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: EHD Dated: May 16, 2019 Received: May 17, 2019

Dear Ms. 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 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

June 5, 2019

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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 ([e-mail]) or phone [phone] 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) K180671

Device Name MINE

Indications for Use (Describe)

The MINE is intended to be used by trained dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.

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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### 510(k) Summary

#### Submitter

RHT Co., Ltd. Joon-Ho, Oh 207, cheomdangwagiro, 208 bungil 50, Bukgu, Gwangju, 61012, South Korea Email: [e-mail] Phone: [phone] Fax: [phone]

#### Official Correspondent

Withus Group Inc April Lee 106 Superior, Irvine, CA 92620 USA Email: [e-mail] Phone: [phone] Fax: [phone]

### Device Information

- K number: K180671 ●
- Trade Name: MINE
- Common Name: Portable X-ray System ●
- Classification Name: Extra-oral source x-ray system
- Product Code: EHD ●
- Panel: Dental ●
- Regulation Number: 872.1800 ●
- Device Class: Class II ●
- Date prepared: 06/04/2019

#### Predicate Device

- K number: K122124 ●
- Trade Name: EXARO
- Common Name: Portable X-ray System ●
- Classification Name: Extra-oral source x-ray system ●
- Product Code: EHD
- Panel: Dental ●
- Regulation Number: 872.1800 ●
- Device Class: Class II ●

#### Device Description

MINE, a portable dental X-ray system, operates on 11.1V DC supplied by a rechargeable LiPolymer battery pack, The X-ray tube head, controls and power source are assembled into a single hand-held enclosure. The package includes a battery charger.

The portable X-ray system. MINE, being composed of X-ray generator, controller, and beam limiting device is designed to diagnose tooth and jaw through generated and controlled X-ray. The operating principle of MINE starts from the generation of X-ray by high voltage electricity, which in turn penetrates tooth and jaw area after flowing through X-ray tube and produces X-ray images on X-ray receptors (i.e. chemical film or digital sensor)

This device contains a high frequency inverter that converts direct to alternating current, X-ray tube head, electrical protective devices, and other elements. The MINE produces sharp and clear images and prevents patients and dentists from radiation exposure with utilizing small dose of radiation.

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| Characteristic | MINE | |
|-------------------|----------------------|------------|
| Anode current | 2mA | |
| Expose time | 0.01~1.3sec | |
| Battery | Battery part No. | BT17070001 |
| | Battery Current | 1500mA |
| | Battery Max. Current | 25A |
| Battery case size | (max) 52x62x22 | |

## Indications for use

The MINE is intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.

### Summary of Technological Characteristics

| | NEW | Predicate Device |
|--------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Manufacturer | RHT Co., Ltd. | OSSTEM IMPLANT Co,. Ltd. |
| Model | MINE | EXARO |
| 510(k)<br>Number | K180671 | K122124 |
| Energy<br>Source | Rechargeable 11.1V, DC Lithium<br>Polymer Battery pack | Rechargeable 25.2V, DC Lithium<br>Polymer Battery pack |
| Expose Time | 0.01sec ~ 1.30sec | 0.01~2.0 seconds, 0.01 increments |
| Time Accuracy | ±(10%+1ms) | ±(10%+1ms) |
| Heat Capacity | 4300J (6 KHU) | 8.5 KHU |
| Power Output | 100W | 100W |
| mA | 2mA Fixed | 2mA Fixed |
| kVp | 60kV Fixed | 60kV Fixed |
| Focal Spot | 0.4mm | 0.8mm |
| Wave Form | Constant Potential (DC) | Constant Potential (DC) |
| Safety, EMC and<br>Performance | IEC/EN 60601-1, IEC/ EN 60601-1-3<br>and IEC/EN 60601-2-28 | IEC 60601-1, IEC 60601-1-2, IEC<br>60601-2-7, IEC 60601-2-28 |
| Source to skin<br>Distance | 20cm | 20cm |
| Cone Diameter | 6cm | 6cm |
| User Interface | Exposure time: up, down.<br>Selection buttons of parts of teeth,<br>adult and child, film and sensor with | Exposure time: up, down.<br>Selection buttons of parts of teeth,<br>adult and child, film and sensor |

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| | display. 12channel save. | with display. |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Exposure switch | Control panel key | Control panel and remote controller |
| Tube head<br>Mounting | Yes | Yes |
| Principle of<br>Operation | X-ray generated by high voltage<br>electricity into X-ray tube, which<br>penetrates hand, tooth and jaw, and<br>makes X-ray images on receptor<br>(Chemical Film or Digital Sensor) | X-ray generated by high voltage<br>electricity into X-ray tube, which<br>penetrates hand, tooth and jaw, and<br>makes X-ray images on receptor<br>(Chemical Film or Digital Sensor) |
| Intended Use | intended to be used by trained dentists and dental technicians as extra-oral x-<br>ray source for producing diagnostic x-ray images using intra-oral image<br>receptors or film. Its use is intended for both adult and pediatric subjects. | |

The subject and predicate devices are similar in indications, design, technology, functions, source to skin distance and principle of operation.

The difference between the two devices is as follows.

- Heat Capacity: The heat capacity of the subject device is 4300J and predicate device's is 6000J. ● The subject device has Less Heat Capacity than the predicate device, but the efficiency is similar.
- Focal Spot: The focal spot of the subject device is 0.4mm and predicate device's is 0.8mm. ● Reducing focal spot size results in a sharper image quality than predicate device.
- . Energy Source: The Energy source of the subject device is 11.1V and predicate device's is 25.2V. Since this product is designed with low voltage, it can be used with low voltage battery.

Any differences do not raise different questions of safety and effectiveness than the predicate. Therefore, there is no difference between the subject and predicate with respect to the indications or technology.

# Non-clinical Testing

The compliance of MINE will satisfy the applicable requirements of the Underwriters Laboratories Standard for Safety-IEC/EN 60601-1. IEC/ EN 60601-1-3. IEC/EN 60601-2-28 and IEC 60601-2-65. All required documents and reports will be submitted to the appropriate oversight agency to establish compliance with the applicable requirements.

EMS test was performed for MINE in accordance with Standard EN/IEC 60601-1-2. All test results were complied with the requirements.

Phantom images were provided to demonstrate the overall performance of the device as part of a complete intraoral x-ray imaging chain.

The subject device, MINE was found to be compliant with all applicable federal performance standards under 21 CFR 1020.

# Conclusion

In reference to the Federal Food, Drug, and Cosmetic Act, 21 CFR Part 807 and the comparison information provided substantial equivalent chart above, the RHT Co.,Ltd. believes that the MINE is substantially equivalent to its predicate device.