RXS 1000

K202369 · Rolence Enterprise, Inc. · MUH · Sep 15, 2021 · Dental

Device Facts

• Record ID: K202369
• Device Name: RXS 1000
• Applicant: Rolence Enterprise, Inc.
• Product Code: MUH · Dental
• Decision Date: Sep 15, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The RXS 1000 is an Intraoral Digital X-ray Sensor and is intended to be used by dentists and dental technicians diagnostic diseases of the teeth, jaw and oral structures. Its use is intended for adult subjects.

Device Story

RXS 1000 is an intraoral digital X-ray sensor system; acquires real-time clinical digital intraoral X-ray images. System comprises CMOS sensor and PC-based software. Sensor detects onset of X-ray exposure; automatically acquires and saves image data to PC. Used in dental clinics by dentists and dental technicians. Output displayed on PC for diagnostic assessment of teeth, jaw, and oral structures. Benefits include rapid digital image acquisition and storage, facilitating clinical decision-making for dental disease diagnosis.

Clinical Evidence

Bench testing only. Device performance evaluated against IEC 60601-1 (safety) and IEC 60601-1-2 (EMC) standards. Risk management conducted per ISO 14971. Software documentation and performance metrics (DQE, MTF) verified against predicate device specifications.

Technological Characteristics

CMOS sensor with CsI scintillator; 42 x 26.2 x 6.7 mm dimensions; 20 x 20 μm pixel size; 1500 x 1000 pixel resolution. Connectivity via USB 3.0 (backward compatible with USB 2.0). Input voltage DC 5V. DQE >20% at 3.5 ln/mm; MTF >40% at 5 lp/mm. Software-based image acquisition and display.

Indications for Use

Indicated for adult patients requiring radiographic examination of teeth, jaw, and oral structures for diagnostic purposes by dentists and dental technicians.

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

• Apex Dental Sensors Size #1 (K163282)

Submission Summary (Full Text)

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September 15, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Rolence Enterprise Inc. % Ben Chang QA Associate Manager 18-3 Lane 231 Pu Chung Rd., Chungli Taovuan, 32083 TAIWAN

Re: K202369

Trade/Device Name: RXS 1000 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: July 14, 2021 Received: August 6, 2021

### Dear Ben Chang:

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 mediation-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) K202369

Device Name RXS 1000

Indications for Use (Describe)

The RXS 1000 is an Intraoral Digital X-ray Sensor and is intended to be used by dentists and dental technicians diagnostic diseases of the teeth, jaw and oral structures. Its use is intended for adult 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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## Submitter's Information:

Firm Name: Rolence Enterprise Inc. Address: 18-3 Lane 231 Pu Chung Rd., Chungli, Taoyuan, Taiwan Phone: [phone] FAX: [phone]

### Contact Person:

Contact: Ben Chang Position: QA Associate Manager E-mail: [e-mail] Phone: [phone] FAX: [phone]

#### Date of Summary Preparation: 2020/7/28

#### Device Information:

510(k) Number: K202369 Trade Name (Model Name): RXS 1000 Common Name: Intraoral Digital X-ray Sensor Classification Name: System, X-Ray, Extraoral Source, Digital Classification: Class II per 21 CFR 872.1800 Product Code: MUH Classification Panel: Dental

### Predicate Device Information:

510(k) Number: K163282 Trade Name: Apex Dental Sensors Size #1 Common Name: Intraoral Digital X-ray Sensor Classification Name: System, X-Ray, Extraoral Source, Digital Classification: Class II per 21 CFR 872.1800 Product Code: MUH Classification Panel: Dental

#### Device Description:

The RXS1000 is intended to acquire real-time, clinical digital intraoral X-ray images using a solidstate imaging sensor. This system consists of the CMOS sensor and software for image display. This system senses the onset of the X-ray exposure and automatically acquires and save the image data to a PC(software).

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## Indication for Use:

The RXS 1000 is intended to be used by dentists and dental technicians diagnostic diseases of the teeth, jaw and oral structures. Its use is intended for adult subjects.

# Technological Characteristics:

| Parameter | Subject Device | Predicate Device | Equivalent or<br>Difference |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Model Name | RXS 1000 | Apex Dental Sensors Size<br>#1 | N/A |
| K Number | K202369 | K163282 | N/A |
| Manufacturer | Rolence Enterprise Inc. | Masterlink LLC | N/A |
| Classification Name | System, X-Ray, Extraoral<br>Source, Digital | System, X-Ray, Extraoral<br>Source, Digital | Equivalent |
| Classification | Class II<br>21 CFR 872.1800 | Class II<br>21 CFR 872.1800 | Equivalent |
| Product Code | MUH | MUH | Equivalent |
| Classification Panel | Dental | Dental | Equivalent |
| Indications for use | The RXS 1000 is intended<br>to be used by dentists and<br>dental technicians<br>diagnostic diseases of the<br>teeth, jaw and oral<br>structures. Its use is<br>intended for adult subjects. | The Apex Dental Sensors<br>is intended to be used for a<br>radiographic examination<br>by a dental professional to<br>assist in the diagnosing of<br>diseases of the teeth, jaw<br>and oral structures. | Equivalent |
| Sensor type | CMOS | CMOS | Equivalent |
| Scintillator Material | CsI | CsI | Equivalent |
| Sensor dimension | 42 x 26.2 x 6.7 mm | 39 x 25 x 5.3 mm | RXS 1000 is<br>larger than<br>predicate<br>device, but<br>patient isn't feel<br>uncomfortable<br>when use. |
| Image area | 30 x 20 mm | 30 x 20 mm | Equivalent |
| Pixel size | 20 x 20 μm | 20 x 20 μm | Equivalent |
| Resolution | 1500 x 1000 pixels | 1500 x 1000 pixels | Equivalent |
| DQE | More than 20% at 3.5<br>ln/mm | More than 20% at 3.5<br>ln/mm | Equivalent |
| MTF | More than 40% at 5 lp/mm | More than 40% at 5 lp/mm | Equivalent |
| Cable length | 3 m | 2 m | For our<br>research, user<br>prefer 3m length<br>cable. |
| USB interface | USB 3.0 | USB 2.0 | USB 3.0 is not<br>only higher<br>transfer data<br>speed, but also<br>can backwards<br>compatibility<br>USB 2.0<br>interface. |
| Sensor Input Voltage | DC 5V | DC 5V | Equivalent |

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## Summary of Testing:

RXS 1000 applied IEC standards for IEC 60601-1 and IEC 60601-1-2. Risk management was according to ISO 14971. Performance testing, software documentation conducted were according to FDA guidance.

## Conclusion:

Except the dimension and USB cable length, RXS 1000's specification is equivalent to predicate device.