(392 days)
Not Found
No
The summary describes a standard digital X-ray sensor and software for image display and acquisition, with no mention of AI, ML, or advanced image processing beyond basic acquisition and saving.
No.
The device is used for diagnostic purposes (acquiring X-ray images to diagnose diseases), not for treating or preventing diseases.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended to be used by dentists and dental technicians diagnostic diseases of the teeth, jaw and oral structures."
No
The device description explicitly states the system consists of a "CMOS sensor and software for image display," indicating a hardware component (the CMOS sensor) is part of the device.
Based on the provided information, the RXS 1000 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.
- RXS 1000 Function: The RXS 1000 is an imaging device that captures digital X-ray images of the teeth, jaw, and oral structures. It works by sensing X-rays passing through the body and converting them into a digital image. This is an in vivo process (occurring within the living body), not an in vitro process (occurring outside the living body).
- Intended Use: The intended use clearly states it's for diagnostic diseases of the teeth, jaw, and oral structures using intraoral digital X-ray. This is a form of medical imaging, not a laboratory test on a biological sample.
Therefore, the RXS 1000 falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MUH
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
teeth, jaw and oral structures
Indicated Patient Age Range
adult subjects
Intended User / Care Setting
dentists and dental technicians
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)
Performance testing, software documentation conducted were according to FDA guidance.
Except the dimension and USB cable length, RXS 1000's specification is equivalent to predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
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
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/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 (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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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
Submitter's Information:
Firm Name: Rolence Enterprise Inc. Address: 18-3 Lane 231 Pu Chung Rd., Chungli, Taoyuan, Taiwan Phone: +886-3-4631999 FAX: +886-3-4631997
Contact Person:
Contact: Ben Chang Position: QA Associate Manager E-mail: ben@rolence.com.tw Phone: +886-3-4631999 FAX: +886-3-4631997
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).
4
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
Difference |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Model Name | RXS 1000 | Apex Dental Sensors Size
#1 | N/A |
| K Number | K202369 | K163282 | N/A |
| Manufacturer | Rolence Enterprise Inc. | Masterlink LLC | N/A |
| Classification Name | System, X-Ray, Extraoral
Source, Digital | System, X-Ray, Extraoral
Source, Digital | Equivalent |
| Classification | Class II
21 CFR 872.1800 | Class II
21 CFR 872.1800 | Equivalent |
| Product Code | MUH | MUH | Equivalent |
| Classification Panel | Dental | Dental | Equivalent |
| Indications 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. | The Apex Dental Sensors
is intended to be used for a
radiographic examination
by a dental professional to
assist in the diagnosing of
diseases of the teeth, jaw
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
larger than
predicate
device, but
patient isn't feel
uncomfortable
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
ln/mm | More than 20% at 3.5
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
research, user
prefer 3m length
cable. |
| USB interface | USB 3.0 | USB 2.0 | USB 3.0 is not
only higher
transfer data
speed, but also
can backwards
compatibility
USB 2.0
interface. |
| Sensor Input Voltage | DC 5V | DC 5V | Equivalent |
5
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.